沈海戈

详妍咨询 合伙创始人

沈海戈博士是详妍咨询的联合创始人，目前致力于为于为多家制药及生物科技公司提供专业咨询服务。海戈拥有杜克大学统计学博士学位及北京理工大学电子工程学博士学位。曾就职于新加坡国立大学生物信息中心，从事药物发现中的数据处理与分析方法研究。2008年加入美国诺华制药，从事肿瘤药物研发的注册临床研究；后在上海诺华制药领导眼科产品中国临床开发注册项目；2013年加入中国诺华生物医学研究中心临床肿瘤转化部门，领导多个肿瘤药物全球临床早期开发项目的统计学工作。在创建详妍咨询之前，在Panacea CRO作为统计副总裁任职一年。

胡劲捷

美国FDA同仁会主席 美国Axteria BioMed咨询公司总裁

Dr. Jinjie Hu is the president of Axteria BioMed Consulting Inc. and International Network Committee chair of the FDA Alumni Association. She was a senior consultant working at Biologics Consulting Group for more than 5 years. She has almost 12 years of experience with the Food and Drug Administration, Center for Biologic Research and Review. She was a senior expert regulatory/scientific reviewer for multiple analytes In Vitro Diagnostic Devices (IVD) products. She leaded and chaired many review committees for 510 (k), IDE, PMA, IND and BLA. Dr. Hu’s responsibility included reviewing CMC, analytical and clinical study data, and labeling. She also has extensive experience working within the Center offices and other Centers of the FDA in reviewing companion diagnostic products, combination products, and applications for Clinical Laboratory Improvement Amendments (CLIA) waivers. As a trained manufacturer facility reviewer and CGMP inspector, she performed many pre-approval inspections of IVD manufacturing facilities. She also served CBER education planning committee and an instructor for CBER’s Medical Device Training course for 4 years (2009-2012). She has been serving as scientific advisor, dossier reviewer and manufacturer facility inspector for the In Vitro Diagnostic Pre-Qualification Program at WHO since 2009. As the chair for the International Network Committee of the FDA Alumni Association, she provides leadership to collaborate with developing and emerging regulatory agencies for regulatory capacity building and training. Jinjie received her B.S. in Cell Biology from Beijing Normal University and her Ph.D. in Comparative Pathology from University of California, Davis, followed by postdoctoral fellowship at National Institute of Allergy and Infectious Diseases at the NIH.

Sumathi Nambiar

Director of the Division of Anti-Infective Products, Office of Antimicrobial Products

Dr. Sumathi Nambiar is Director of the Division of Anti-Infective Products, Office of Antimicrobial Products, since July 2013. Dr. Nambiar joined the Division of Anti-Infective Products in 2002. In her current role, Dr. Nambiar provides regulatory oversight for anti-infective products, including antibacterial, antifungal, and antiparasitic drugs. Dr. Nambiar is board-certified in pediatrics and pediatric infectious diseases. She completed her pediatric residency at the Inova Fairfax Hospital for Children, VA and her fellowship in pediatric infectious diseases at Children’s National Medical Center, Washington DC. She received her MPH from The George Washington University School of Public Health.

张菁

副教授

张菁，副教授，临床药理室副主任，硕士导师。主要从事抗生素临床药理研究，包括抗菌药物临床药代动力学研究，抗菌药物人体生物利用度和生物等效性研究，抗菌药物药代动力学／药效学模型研究，抗菌药物群体药代动力学模型研究等。作为主要完成者和承担者，曾获得上海市科技进步二等奖3项，卫生部科技进步奖三等奖1项和上海医科大学科技进步奖1项。作为第一作者发表论文17篇，合作发表论文40余篇，国外核心杂志上发表第一作者论文1篇，合作发表3篇。

袁征宇博士

总裁兼首席执行官

袁征宇博士拥有25年以上的药物研发经验，尤其是新型抗菌药的研发。他创立了盟科，坚持不懈地开发新型抗菌药和抗真菌药物。 他曾是Vicuron生物有限公司(2005年年底被Pfizer以19亿美元收购)的创始科学家，任研发高级副总裁。负责Vicuron的药物研发工作， 在3年内开发了7个临床候选化合物，并且在几个其他的临床前研究项目中取得重大突破。袁征宇博士在药物设计、生物化学和药理学方面都有很好的成功记录。 在加入Vicuron以前，袁征宇博士曾经在Syntex、Affymax和GlaxoWellcome任职 。他在Cornell大学获得生物化学博士学位，在复旦大学获得化学学士学位。袁征宇博士被授权多项专利并在权威学术性期刊发表了近40篇文章。

郑凝

赛诺菲临床文件撰写及管理部高级医学写作

仲为栋

南京希麦迪医药科技有限公司 | Booth#N02,N03

何洁如

Medidata中国区解决方案顾问

季川

Medidata中国区解决方案顾问

Michael TUCKER

Medidata资深临床解决方案专家

张志伟

Medidata，中国区解决方案顾问

Eunho SHIN

Medidata亚太区解决方案顾问负责人

潘麓蓉 博士

全球健康药物研发中心（清华大学，盖茨基金合办）

欧阳龙湘

杨森中国研发中心医学写作与翻译中心经理

刘炜

爱特曼首席技术官

刘昌芳

北京爱特曼智能技术有限公司 企业服务总监

张海

海正药业生物药临床运营中心总监

张海作为浙江海正药业股份有限公司生物药临床团队的负责人，负责整个海正集团生物药临床试验的计划与执行，供应商的管理，试验用药品供应链管理，数据管理和统计分析， PV部分。 2005年毕业于沈阳药科大学，加入浙江海正药业股份有限公司之前，曾先后就职于多家全球和国内的领先制药企业，从事团队管理和项目管理工作，并在国外总部工作。先后管理及参与临床试验项目近30项，涉及多个不同的治疗领域。 目前担任DIA CMP Forum成员，上海药学会临床研究专委会项目管理学组副组长。

刘昌东

丽珠单抗生物技术有限公司，临床开发副总经理

周颖

商务发展总监

彭逸天

药研社联合创始人

张云

赛诺菲巴斯德医学事务负责人

赵耐青

复旦大学 生物统计学教授教授 博士生导师

中国预防医学学会生物统计专业委员会副主任委员等2个全国性学术组织生物统计学的副主任委员 国家食品和药品监督局药品评审中心的外审专家 中国医学数学会副理事长 国际临床流行病工作网成员 复旦大学学报（医学版）副主编 研究方向：复杂临床试验设计中的统计问题，复杂的临床诊断试验设计 多结局生存分析 时间依赖性协变量的生存分析统计方法 临床试验中补救用药的有效性评估。 负责完成2个国自然基金项目，负责和完成2个科技部临床重大专项的子课题，1个973子课题，2个863子课题工作等，负责85个临床试验的研究设计及其数据管理和统计分析。 在国内外杂志上发表200余篇论文，主编2本国家规划教材和2本其他教材，副主编5本教材，参编8本相关教材和专著。

季东

恒瑞医药资深医学总监

梁素娟

阿里健康及天猫医药药品行业运营专家

顾娟红

君实生物 临床研究与运营副总裁

Andrew SLACK

康龙化成放射科学业务拓展副总裁

Chris HICKEY

康龙化成临床业务拓展副总裁

肖丽君

希麦迪注册高级总监

阳华

康龙化成首席科学家

蔡绪柳

北京经纬传奇医药科技有限公司创始人

梁茂植

华西医院国家药物临床试验机构·GCP中心主任,I期临床试验研究室和临床药理研究室主任

胡颖廉

国家行政学院副教授

卓永清

RDPAC原执行总裁、清华大学法学院卫生法研究中心研究员

吴玉霞

江苏恒瑞医药股份有限公司副总经理

王晨光

原清华大学法学院院长

唐民皓

原上海食品药品监督管理局副局长

金迪蒂

北京经纬传奇医药科技有限公司副总经理、质控培训总监

谭勇

《E药经理人》杂志总编辑

Mark J. GOLDBERGER 医学博士，公共卫生硕士

美国FDA同仁会 前美国FDA药品审评与研究中心药品审评四部部长 前美国雅培制药法规政策副总裁

Mark J. Goldberger, MD, MPH Dr. Goldberger received his MD degree from the Columbia University College of Physicians and Surgeons in New York and his MPH from George Washington University in Washington, DC. He completed his postgraduate training at the Presbyterian Hospital in New York and the Centers for Disease Control (CDC) in Atlanta. He is board certified in internal medicine and infectious disease and is a fellow of the Infectious Diseases Society of America. Dr. Goldberger was on the faculty of Columbia University for nine years. Dr. Goldberger joined the Food and Drug Administration in 1989. At FDA he served as primary reviewer, medical team leader, Director of the Division of Special Pathogen and Immunologic Drug Products and Director of the Office of Antimicrobial Products within the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA). In addition to these positions he coordinated drug shortage activities within the CDER from 1990 -­ 2006. Dr. Goldberger also was the FDA lead in an assessment of the readiness of the Pharmaceutical Industry for Y2K. In 2000 he spent 8 months as acting Associate Center Director for Quality Assurance in CDER during which time he developed the concept of the Regulatory Briefing. In 2003-­2004 he was Acting Deputy Center Director of CDER. In 2006 he became Medical Director for Emerging and Pandemic Threat Preparedness within the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration. In October 2007 he joined Abbott as Divisional Vice President – Regulatory Policy and Intelligence. In this role he was involved in multiple areas of both product and policy development. He continued in this position when AbbVie separated from Abbott until May 2013 when he became VP Regulatory Affairs and Senior Advisor. In this position he provided regulatory and scientific input both into multiple development programs and in the preparation of marketing applications. In September 2014 he retired from AbbVie and opened his own consulting practice as Mark Goldberger MD MPH LLC. While at Abbott and AbbVie he participated in PhRMA and efpia working groups on antibiotic resistance and twice presented on this subject to the European Medicines Agency as well as to the FDA. As a member of the FDA Alumni Association he has participated in several training sessions for staff from CDE/CFDA as well as for CDE/TFDA. He has presented multiple times at DIA China as well as at APEC 2012 and 2016 in Taiwan.

Florence HOUN 医学博士，公共卫生硕士

美国FDA同仁会 美国塞尔基因公司法规科学副总裁 前美国FDA药品审评与研究中心药品审评三部部长

Florence Houn, MD, MPH, FACP Dr. Florence Houn is VP for Global Regulatory Science at Celgene Corporation. She is also a consultant to industry and health authorities regarding drug development programs and regulatory capacity building. She was Vice President, Global Regulatory Policy, Intelligence and Strategy from 2008-2015 at Celgene. Prior to this, she served 15 years in the US Food and Drug Administration (US FDA) as Division Director, Deputy Office Director and Office Director. In recognition of her contributions to public health, Dr. Houn received the US Department of Health and Human Services’ (DHHS) Career Achievement Award in January 2009. In 2014, she received the FDA Distinguished Alumni Award from Commissioner Margaret Hamburg for contributions to global regulatory capacity building. Prior to joining government, she served four years in the National Health Service Corps in a manpower health shortage area in Baltimore. Dr. Houn was the founding co-chair of the FDA Alumni Association’s (FDAAA) International Network (FDAAAIN) and is a member of the FDAAA Board of Directors since 2012. She is a member of the Centers for Medicare and Medicaid Services (CMS) Medicare Evidence Development and Coverage Advisory Committee (MEDCAC), January 2017 to 2019. She served on the PDUFA V negotiating team representing the Biotechnology Industry Organization (BIO) with FDA in 2010-2011. She serves on the Asia Pacific Economic Cooperation (APEC) Harmonization Center’s Advisory Board (2013 to now) and is on the Board of Directors for the International Partnership for Microbicides (IPMglobal.org) (2016-now). Dr. Houn received her Bachelor of Arts degree from Harvard University and her medical degree from the Albert Einstein College of Medicine. She completed her Cancer Prevention and Control Fellowship at the National Cancer Institute and obtained her MPH from the Johns Hopkins School of Hygiene and Public Health. She attended the Johns Hopkins Breast and Ovarian Surveillance Service as an Instructor in Oncology.

吕玉真

罗氏药品临床研发亚太区注册事物负责人

玉真 罗氏（中国）投资有限公司 药品临床研发亚太中心副总负责人/ 亚太区注册部负责人 Head of Regulatory, Asia Pacific, Roche (China) Ltd. Bio Janet Lu，as a licensed pharmacist, is currently as currently as Head of Regulatory Affairs, Asia Pacific, Roche. Janet now is also served as Biological Working Stream Leader, Rx Regulatory Group of RDPAC. In past 17 years, she worked with Upjohn, Pharmacia & Upjohn, Pharmacia, Pfizer and MSD in Regulatory Affairs in China. Before joining industry, Janet was a teacher assistant in Pharmacy Department, Shanghai Medical University (current FU DAN University). Janet obtained her master degree and bachelor degree from Peking University and Shanghai Medical University, majored in Pharmacy and International Pharmaceutical Engineering Management respectively. 吕玉真，执业药剂师，北京大学国际药物工程管理硕士和上海医科大学药学专业学士。现担任罗氏亚太地区注册部负责人和RDPAC药品注册生物制品小组召集人。 在过去的17年里，曾就职于普强、法玛西亚普强、法玛西亚，辉瑞及默沙东公司注册部。加入制药公司之前，在上海医科大学（现为复旦大学医学院）药学院药学教研室担任助教。

冯毅

方恩医药发展有限公司大中华区总裁 前国家药品审评中心主任助理兼业务管理部部长

张海

海正药业股份有限公司生物药临床运营总监

张海作为浙江海正药业股份有限公司生物药临床团队的负责人，负责整个海正集团生物药临床试验的计划与执行，供应商的管理，试验用药品供应链管理，数据管理和统计分析， PV部分。 2005年毕业于沈阳药科大学，加入浙江海正药业股份有限公司之前，曾先后就职于多家全球和国内的领先制药企业，从事团队管理和项目管理工作，并在国外总部工作。先后管理及参与临床试验项目近30项，涉及多个不同的治疗领域。 目前担任DIA CMP Forum成员，上海药学会临床研究专委会项目管理学组副组长。

张惠军

科文斯临床研究总监

Education Bachelor in medicine in the Jilin university medical college MBA course in Beijing university international business administration center Previous employment from latest Eight years working as cardiologist. Eighteen years in clinical research industry. Working as operation head 7 years from Jan 2011 in Novartis, ICON and current in Covance Main Responsibilities  Responsible for the oversight of China Clinical Trial Operations key responsibilities  Responsible for the supervision of assigned direct reports within China Clinical Trial Operations  Effectively communicate and develop management strategies, policies and procedures in conjunction with leadership teams  Develop and maintain effective relationships with management team to manage assigned staff in a matrix environment  Develop and maintain good working relationships with internal and external clients to ensure opportunities for acquiring additional new business

张文静

赛诺菲全球/亚太项目总监

Wenjing ZHANG, Sanofi Director , Diabetes & Cardiovascular, Global & Asia Project Leader 17- years experience in drug development in MNCs-AstraZeneca, Pfizer & Sanofi Physician background Contributed to bring a number of novel drugs to Chinese patients: 英立达®, 索坦®, 畅沛®, 得妥®, 信必可®，耐信®, 可定®,易瑞沙® , 来得时®（儿科… more to come… Personal vision/passion: being an inspiring leader to contribute to drug development and bring promising drugs to patients earlier

朱立红 工商管理硕士

DIA中国区董事总经理

Ms. Zhu serves as the Senior Vice President/Managing Director for DIA Greater China. She joined DIA from the Bill & Melinda Gates Foundation, where she was the Senior Program Officer for R&D Programs. Prior to her work at the Foundation, she was the founder and CEO of START Shanghai, which was one of the earliest Phase I oncology service companies in China. Ms. Zhu brings twenty years of experience in clinical research, business operations, and project management in the pharmaceutical industry, having held positions at Merck Sharp & Dohme (MSD) and GSK.  Her work was key to establishing GSK’s R&D Center in Shanghai, where she led the clinical and business operations.  Ms. Zhu received her B.S. degree in Pharmaceutical Science from Peking University Health Science Center (Beijing Medical University) and an MBA from Rutgers University, USA.

杨建新 医学博士

基石药业临床开发高级副总裁、首席医学官

杨建新 Chief Medical Officer Senior Vice President，Clinical Development National “Thousand Talents” Expert MD, PhD in Molecular Genetics Dr. Jason Yang joined CStone Pharmaceuticals in 2016, as its Chief Medical Officer (CMO). He has over 25 years of global experience in biomedical research and clinical development of oncology drugs. Prior to joining CStone, Dr. Jason Yang served as the Senior Vice President and Head of Clinical Development at BeiGene since 2014. He and his team generated key safety and proof of concept efficacy data that supported BeiGene’s two successful financing rounds in 2014 and 2015, the IPO and a follow-on offering in the US NASDAQ market in 2016. Prior to joining BeiGene, Dr. Yang served as Oncology Medical Director at Covance, Senior Principal Scientist in oncology translational biomarkers at Pfizer, and Research Scientist in cancer genomics at Tularik/Amgen. Throughout his career, Dr. Yang has made significant contributions to the successful development of several anticancer drugs. He is also the author of over 30 publications and the inventor of 9 patents. In 2015, he is honored as a “Distinguished Expert” by the China’s national “1000 Talents Program” and the Beijing “Haiju Program.” Dr. Yang was trained as a physician at Hubei Medical College and Nanjing Medical University. He then received his PhD training with Nobel Laureates Drs. Mike Brown and Joseph Goldstein at the University of Texas Southwestern Medical Center at Dallas. He completed his postdoctoral training with Dr. Stuart Schreiber at Harvard University.

焦庆安

强生（中国）投资有限公司全球临床研究运营部高级总监

张明强 博士

安进公司全球研发副总裁

张明强 博士 全球研发副总裁 美国安进公司 张明强博士现任美国安进公司全球研发副总裁、全球转化医学领导团队成员、亚洲研发中心负责人、安进生物医药研发（上海）有限公司总经理、法人代表。张博士同时兼任中国外商投资企业协会药品研制和开发行业委员会(RDPAC)研发委员会主席、中国药学会药物化学专业委员会副主任委员、中欧生物医药委员会副主席、以及若干政府和产业机构生物医药产业顾问。张博士从事新药研发20多年，在中枢神经、肿瘤、炎症和病毒等疾病领域的新药研发中，多有建树。他领导开发和作为第一发明人的全球首创肌松药拮抗剂布瑞亭（默沙东，舒更葡糖钠注射液）已在全球60多个国家成功上市, 年销售约5亿美元。 张博士已发表/发明100多篇论文/专利。他是英国皇家化学会院士，全英华人生命科学院院士并担任欧洲药物化学联合会学术顾问委员会委员，【MedChemComm】、【Current Drug Discovery】、【Chinese J Med Chem】、【BAO J Pharm Sci】等学术杂志编委。他是2007年英国皇家化学会“莫肯-坎贝尔”纪念大奖得主，也是2008年苏格兰“尼科舍斯”生命科学创新奖获得者。2016年Bridion荣获有“生物医药界诺贝尔奖”的美国盖伦奖(Prix Galien USA) “最佳创新药物”提名。在加入安进公司之前，张博士曾任美国默沙东公司全球研发副总裁、亚太区研发总裁，并担任“默沙东研发（中国）有限公司”创始总经理、法人代表。张博士还创建过研发型企业，其中致力于抗病毒新药研发的ViroChem公司于2009年以3亿8千万美元为美国Vertex公司所兼并。

吴舟艳

默沙东研发（中国）有限公司人力资源部副总监，HR商务合伙人

Amy Wu serves as HR Leader to support MSD China R&D since 2012 when the R&D center was newly set up. She sits in MSD R&D leadership team and China HR Leadership team . Amy is playing a very important role to design and execute the MSD China R&D Talent Strategy Roadmap in the past years and with proven successful track record to support business development and success. She was recognized as a great business partner to develop organization capability and a professional HR consultant to help business going through various challenging experience. Amy is with 13 years of HR consulting and practice with Fortune Top 500 company. Before MSD China R&D , Amy was HRBP of Adobe Systems supporting Adobe Greater China(China mainland, HK, TW). Amy Wu received her M.S degree in Beihang University, majored in English Linguistics.

Elisabeth SVENSSON

DIA全球市场和商务拓展高级副总裁

Elisabeth Svensson Senior Vice President, Global Marketing & Business Development As Senior Vice President, Global Marketing and Business Development for DIA, Ms. Svensson leads DIA’s worldwide strategic marketing and business development teams. Prior to joining DIA, Ms. Svensson led the strategic accounts team at Cardinal Health Specialty Solutions, delivering services and products that spanned product life-cycle, from regulatory and scientific consulting to commercialization, including analytics. She also conceptualized, crafted, and executed the new brand identity for Cardinal Health Specialty Solutions, for three strategic customer groups: providers, payers, and pharmaceutical clients. In her role at Cardinal Health, Ms. Svensson oversaw strategic marketing initiatives including new product/service development and enhancements, value-based pricing strategies, market segmentation, digital solutions, social media, voice of the customer research, new consultative services, and technology solutions. Before joining Cardinal Health, Ms. Svensson held marketing, sales, and product management leadership roles at Pharmacia (now part of Pfizer), BMS, Acusphere, and AMAG Pharma. Ms. Svensson began her career with AstraZeneca, in Sweden, in sales and product management, and quickly expanded responsibility to include marketing across Europe, USA, and Latin America. Ms. Svensson holds a BS in Business Administration and Economics from the University of Stockholm in Sweden.

Clement CHEW

Barrington James亚太办公室副总监

Clement Chew (周晋锋） Associate Director Life Sciences Recruitment Clement serves as Associate Director for the APAC Regional Office at Barrington James, a global leading life sciences recruitment firm. He has been recruiting within the life sciences industry since 2009 and has a successful history supporting organizations recruit the best talent in the market as well as helping candidates take their career to the next level. The team at Barrington James focuses on mid to senior level recruitment for the APAC region in functional areas such as medical affairs, clinical development, regulatory affairs, clinical research, quality, market access, R&D, HEOR and commercial (sales and marketing).

黄璐

晨兴创投董事总经理

黄璐 博士： 晨兴集团董事总经理 黄女士于2003年加入晨兴集团，目前带领晨兴中国的医疗投资团队。具有十三年生物医药/医疗健康领域的风险投资经验，先后在大中国地区和北美参与了三十余家生物医药/医疗健康公司的投资并任多家公司董事。晨兴医疗健康团队在中国的投资涉及领域涵盖新药研发，生物技术，医疗设备，临床诊断，医疗服务，医疗信息化等各个领域。 在加入晨兴前，黄女士在美国纽约Continuum Health Partners公共关系及市场部先后从事市场研究，市场营销及公共关系等工作，该机构为纽约著名的医疗管理机构，为纽约大都会地区的综合性医院提供管理服务。 黄女士毕业于上海交通大学医学院（原上海第二医科大学），在大学附属医院完成妇产科住院医生训练，随后在纽约圣约翰大学获得工商管理学硕士学位。

林亮

礼来亚洲基金合伙人

林亮先生担任礼来亚洲基金投资总监，负责投资项目的考察筛选，尽职调查，和被投资公司的管理。他在医药行业具有10年以上的运营管理与投资经验。此前他先后在葛兰素史克负责企业收购兼并以及产品的引进和对外授权，在默克-雪兰诺负责核心产品的市场营销，在三九医药创建了战略规划部并领导公司战略规划与业务拓展方面的工作。 林亮先生拥有中国药科大学药物化学硕士学位和中欧国际工商学院MBA学位及执业药师资格。

王印祥 博士

北京加科思新药研发有限公司董事长

生物学博士，毕业于美国耶鲁大学。贝达创始人，曾任贝达药业总裁兼首席科学家、中组部“千人计划”获得者、科技部重大专项评审专家。中国药学会抗肿瘤药物专业委员会副主任委员，中国医学科学院新药安全评估中心和中国协和医科大学新药安全评审研究中心特聘教授。

张丹 博士

方恩（天津）医药发展有限公司董事长兼首席执行官

张丹, 方恩医药董事长,任百华协会（Bayhelix）董事。曾任美国华人生物医药科技协会会长（Chinese Biopharmaceutical Association-USA）及美中药协（Sino-American Pharmaceutical Association）执行董事。曾任科技部新药研发海外专家委员。目前是中组部“千人计划”生物医药国家特聘专家,并任“千人计划”专家联谊会秘书长及欧美同学会理事。中国医药创新促进会药物研发专业委员会主任委员。同时任国家”十二五”重大新药创制计划责任专家,参加医药项目申请的评审工作,并参与国家食品药品监督管理总局药审中心的技术指南制订,新药临床评审及药审人员培训工作。

陈连勇 博士

通和毓承创始人及管理合伙人

陈连勇博士是通和资本的创始人及管理合伙人，先后作为风险投资家、跨国公司高管、创业者和科学家拥有在中美两地生命科学领域超过20年的行业经验。陈博士是国家“千人计划”的评审专家，也是苏州纳米生物园的特邀顾问。在创立通和资本之前，陈博士历任富达亚洲成长基金合伙人和百奥维达中国基金的管理合伙人。自2005年起陈博士主导了多项在中国生命科学和医药领域的投资，包括中信医药、凯赛生物、海利生物、华领医药、信达生物、天演药业和迈迪顶峰。在投身风险投资行业前，陈博士作为管理咨询顾问就职于麦肯锡欧洲布鲁塞尔办事处和安永美国加州办事处，并担任旧金山湾区生命科学战略咨询公司的创始人和董事合伙人。陈博士的职业生涯起步于美国新泽西州的先灵葆雅医药公司，他曾是降胆固醇药物Zytia/Vytorin发明团队的核心成员 ，该药物年销售数十亿美元。陈先生拥有美国麻省理工学院博士后，比利时新鲁汶大学博士学位(最高荣誉奖)及北京大学学士学位。陈博士持有6项美国发明专利，并参与编纂了著名的安永生物科技年鉴的第14和15期。

张志民 博士,工商管理硕士

礼来亚洲基金风险合伙人

张志民博士 乐土投资集团跨境投资董事、总经理 百华协会董事会前主席 曾任强生创新商务合作全球副总裁，在默沙东（美国默克）大中华区任早期投资董事、总经理。负责默沙东在大中华区技术转让、并购及对外研发合作、联盟和合作伙伴的管理以及风险投资

蒋海洪

上海健康医学院医疗器械学院副教授

中国著名医疗器械法规专家、上海健康医学院医疗器械监管专业主任，上海汉盛律师事务所执业律师。中国首部医疗器械蓝皮书副主编、首个医疗器械监管专业创始人与负责人。主持完成多项医疗器械法规相关重点课题，公开发表相关专业文章30余篇，出版专著1部：《最新〈医疗器械监督管理条例〉研究与解读》、主编书籍3部：《中国医疗器械行业发展报告（2017）》、《医疗器械法规汇编与案例精析》、《医疗器械监管法规》。兼任国家食品药品监督管理总局高级研修学院特聘专家、中国医疗器械行业协会特聘法规专家、上海医疗器械行业协会管理者代表协调委员会顾问等职务。

William SUTTON

美国食品药品管理局驻华办公室副主任 国际项目和政策分析官员（医疗器械）

William M. Sutton FDA Assistant Country Director, China William (Bill) Sutton is an Assistant Country Director in the Office of International Programs (OIP) at the United States Food and Drug Administration (FDA) China Office where he serves as the International Program and Policy Analyst (IPPA) for medical devices. Before being named Assistant Country Director of the FDA China Office, Mr. Sutton was the Deputy Director of the Division of Industry and Consumer Education (DICE) at FDA’s Center for Devices and Radiological Health (CDRH) where he led the Division in the strategic development of regulatory education on medical device topics spanning premarket and postmarket policy. Mr. Sutton began his career at FDA in 1983, and has held positions in CDRH, the Office of Device Evaluation (ODE), and the Office of Communication and Education (OCE). During his tenure at the FDA he served as an administrative reviewer at ODE and as a Supervisory Consumer Safety Officer at the mandated industry and international assistance program in OCE. In both roles he worked on domestic and international compliance issues, and served as Chairman of FDA’s Third Party Recognition Board (TPRB), which administered both the Accredited Persons (AP) for 510(k) review and AP for Inspection programs. For over 21 years he has educated the worldwide medical device community about Federal medical device regulations and policies. Mr. Sutton received a Bachelor of Science in Management Studies from the University of Maryland University College. 萨盾 美国食品药品管理局 驻华办公室助理主任 萨盾是在美国食品药品管理局（USFDA）国际项目办公室下属的FDA驻华办公室助理主任，他负责医疗器械的国际项目和政策分析。在被任命为FDA驻华办公室助理主任之前，萨盾先生是医疗器械和放射健康中心（CDRH）的行业与消费者教育处（DICE）副处长。他主要负责该处在医疗器械上市前和上市后相关法规教育工作的战略发展。 萨盾先生1983年起开始在FDA工作，曾在医疗器械评审办公室（ODE）和交流教育办公室（OCE）工作。在FDA工作期间，曾在ODE担任行政评审员，在OCE的企业和国际协助项目中担任消费者安全官主管。在这两项工作中，他负责国内和国际合规事务，并担任FDA第三方认可委员会（TPRB）主席，管理510(k)评审的认可人员（AP）和现场检查的AP。在过去的21年中，他参与了多国大量医疗器械相关联邦法规政策的培训。萨盾先生获得马里兰大学大学学院分校的科学管理学士学位。

王宇红

施乐辉有限公司法规临床事务及质量保证副总裁

现任施乐辉医用产品国际贸易（上海）有限公司法规临床事务和质量保证副总裁。毕业于北大医学部药学院，工商管理硕士。2012年加入施乐辉公司，负责法规临床事务和质量保证。之前曾任美敦力（上海）管理有限公司，默沙东（中国）有限公司法规注册部负责人。进入医药企业之前，曾在原卫生部药品不良反应监察中心工作6年，参与建立中国药品不良事件报告体系。目前是中国药品监督管理研究会医疗器械监管研究专业委员会委员，欧盟商会医疗器械工作组主席。 王宇红在跨国公司工作的20年间， 致力于医药产品的上市前评价、临床研究、上市后监测和评价，以及公司质量保证体系的建立等工作。作为中国、美国及国际协调组织的药品和医疗器械监管法规法规方面的专家，曾参与医疗器械监督管理相关法规规章的起草讨论，ICH指南(药品注册的国际技术要求)的引进出版, 多次组织或积极参与国内国际会议研讨药品医疗器械注册相关法规、标准和质量控制、医疗器械的生物安全性及国际临床试验要求等。曾作为AHWP秘书处及专注于临床的第5工作小组成员，积极参与区域法规协调工作。

Gauden GALEA

世界卫生组织中国代表处驻华代表

PJ CHEN

联生药中国总裁

Michael MONTELLO

IQVIA全球研发技术负责人，副总裁

Mike Montello Vice President, Global Head of R&D Solutions Information Technology Mike Montello is vice president, divisional CIO, and global head of R&D Solutions Information Technology for IQVIA, and is responsible for strategy and innovation initiatives that help R&D Solutions stakeholders accelerate clinical development, leverage evidence for protocol design and planning, improve operational execution, quality, patient safety, and investigator performance. Mike is accountable for the execution of the R&D Solutions technology platform which includes investigator portals, core clinical transactional systems, R&D data factory, risk based monitoring, next generation advanced analytics, clinical IoT, artificial intelligence, and mobile capabilities which enables one of the world’s largest clinical research organizations. Prior to joining IQVIA in 2015, Mike led R&D Information Technology at Shire Pharmaceuticals, a global rare diseases biotech. As a member of Shire’s Information Technology leadership team, Mike led IT integration for multiple biotech acquisitions and led HCP and patient centric transformation technology initiatives and strategic technology roadmap for R&D platform technology. Prior to Shire, Mike worked at Accenture for 12 years as a management consultant and outsourcing leader in Health and Life Sciences practices. In addition to his industry role at IQVIA, he delivered innovative data and technology driven solutions for 6 of the top global Pharmaceutical and Healthcare companies including Pfizer, Merck, BMS, Biogen, Daiichi-Sankyo, and United Health Group. Mike holds a BA in Mechanical Engineering from the Pennsylvania State University.

Ross ROTHMEIER

Ross ROTHMEIER

Ross Rothmeier Vice President, Technology Solutions and Innovation Labs at Medidata Solutions • University of Michigan 美国 大纽约地区 Executive management specialist in computer systems and technology used in clinical research since 1993. With leadership in the sponsor, CRO, and technology sides of the pharmaceutical industry, I have expertise in strategy, implementation, process optimization, and product assessment. I frequently attend and speak at conferences in the United States, Europe and Asia, and am always delighted to hear and talk with others about the exciting things happening in clinical research. 公司名称 Medidata Solutions, Vice President, Technology Solutions and Innovation Labs 入职日期2013 年 8 月 - 至今 任职时长•4 年 9 个月 所在地区New York City Lead a global team of world class technology experts in the delivery of software-as-a-service solutions for clinical trials. Increase the efficiency and quality of trials through innovative, web-based solutions that can be used by non-technical people. 公司名称Covance, Executive Director, Global Technical Solutions 入职日期2008 年 8 月 - 2013 年 7 月 任职时长•5 年 Manage the global portfolio of projects using and integrating with clinical data systems across Covance. Responsible for process optimization, innovation, organizational adoption, business development support, and partner relationships. 公司名称Novartis ,Director EDC Application Development 入职日期2002 年 - 2008 年 任职时长•6 年 Directed a global team in the US, India, and Switzerland in the development, testing, validation, and technical support of applications used for Electronic Data Capture for all clinical trials conducted at Novartis. Defined the development and testing process, led the release of enhancements to the software, and redefined the software environment for the company to ensure regulatory compliance and expand system capacity. Directed the overall global program team implementing the the next generation electronic Clinical Data Management system which is a multi-million dollar, multi-year, cross-functional program replacing five current systems, streamlining processes, and leveraging technology for clinical trial conduct and management. Estimated savings from the program target over $25M annually.

李星

北京深度智耀科技有限公司首席执行官创始人

张和平 博士

耶鲁大学公共卫生学院统计科学合作中心主任，生物统计系教授

Joseph SCHEEREN 药学博士

德国拜耳全球研发高级顾问, 高级副总裁

Joseph Scheeren, PharmD Chair-Elect DIA Senior Advisor R&D Bayer AG Dr. Scheeren started his pharmaceutical industry career in 1982 with Servier in Paris, responsible for Regulatory Affairs Northern and Eastern Europe, and Clinical Development in Munich from 1986 – 1987. In 1991, he was appointed Head of Worldwide Regulatory Affairs at Serono, Geneva. In 1992, he took over responsibility of the Global Regulatory Affairs department of Roussel UCLAF. In 1996, he moved to New Jersey to head the Global Marketed Product Regulatory Affairs Department of Hoechst Marion Roussel. He joined Bayer Pharmaceuticals as Senior Vice President, Head of Global Regulatory Affairs, in 2004 responsible for development in the US and in 2009 became Site Head US in Montville, NJ. In addition, he took over the position Head of Global Development Asia in Beijing in 2012. In 2015, he was appointed Head of Global Regulatory Affairs Pharma and Consumer Care of Bayer Healthcare, Basel. Dr. Scheeren holds many memberships and designations, serving on Advisory Boards at the Center for Innovation in Regulatory Science, SAFE-PHARMA, the Regulatory Affairs track at Yale University, the Center of Regulatory Excellence Singapore, the Research & Development-based Pharmaceutical Association in China, and the China Core Research and Development Committee. He has served as Chairman of the DIA Regional Advisory Council for Europe, Middle East & Africa; he is also a foreign member of the Academie Nationale de Pharmacie, France, and a lecturer at Yale University. Dr. Scheeren studied pharmacy at the University of Leiden.

郭彤 博士

IQVIA大中华区销售副总裁

Tong GUO, PhD Head of Global Biostatistics Africa & Asia Group at QuintilesIMS Dr. Tong Guo is the Head of Global Biostatistics Africa & Asia Group at QuintilesIMS. In this position, Dr. Guo oversees the off-shore Biostatistics functions in Africa and Asia. Prior to QuintilesIMS, Dr. Guo was the Head of Global Data Sciences & Analytics Beijing R&D Center at Bayer HealthCare, leading a team of biostatisticians, clinical programmers and clinical data managers to support the global, regional and local clinical development programs. Dr. Guo had worked as the Vice-President and Head of Clinical Informatics & FSP at WuXiPRA, and had successfully established & grown the FSP Business Unit at WuXiPRA. Before joining WuXiPRA, Dr. Guo was the Head of Biostatistics and Life Sciences BPS at Cognizant Technology Solutions (Shanghai) and led the establishment and enhancement of Biometrics capacities in China. Dr. Guo began his clinical research career in 1998 as a Biostatistician at McMaster University in Ontario, Canada. He was a Biostatistician in the United States in both CRO (MDS Pharma Services) and pharmaceutical companies (Bristol-Myers Squibb and Johnson & Johnson) with increasing responsibilities. Tong received his M.Sc and Ph.D. degrees in Biostatistics from McGill University, Montreal Canada. 郭彤博士现任昆泰艾美仕公司亚太及非洲生物统计执行总监，负责昆泰公司生物统计全球欧美以外的离岸团队及交付业务。郭彤博士曾获加拿大麦吉尔大学生物统计学硕士及博士学位。具有近二十年的国际大制药公司新药研发经验。曾任拜耳医药保健有限公司北京国际研发中心，数据科学与分析亚太总监；上海康德保瑞医学临床研究有限公司副总裁，临床信息及FSP业务部门负责人；高知特信息技术(上海)有限公司生物统计及生命科学BPS部门主管；美国百时美施贵宝主任生物统计师及美国强生研发总部生物统计师；并在加拿大麦科马思特大学心血管项目中心及兰州生物制品研究所从事过研究工作。主持过多个全球多中心临床试验的统计设计及分析。特别是对生物统计及大数据分析在生命科学及新药研发上的应用方面颇具建树。

郭翔 博士

百济神州生物统计和编程部执行总监

中国统计负责人/执行总监，百济神州 郭翔博士毕业于美国北卡州立大学（NCSU）统计系，目前是百济神州中国统计负责人，执行总监。加入百济之前，郭翔博士于2013-2017年担任默沙东实验室生物统计亚太负责人，高级总监，领导默沙东中国位于北京和上海的生物统计团队。郭翔博士在糖尿病，抗感染，肿瘤等治疗领域有丰富的临床试验经验。在赛诺菲工作期间，郭翔博士负责了来得时产品儿童人群适应症的全球申报并获得批准，支持了Rimonabant在欧盟的申请以及Lixisenatide在FDA的申报并获得批准。在默沙东期间，郭翔博士负责了默沙东中国Gardasil 疫苗以及布瑞亭的申请工作并获得上市批准，支持了Keytruda和Zeptier在FDA以及PMDA的申请并获得上市批准。 XIANG (TONY) GUO Biographical Sketch Dr. Guo currently is an Executive Director, head of Biometric China for BeiGene, a Nasdaq listed Chinese biotech company. Before joining BeiGene, Dr. Guo served as Senior Director, head of AP Statistics group of Merck Research Laboratories. Before his service in MSD China, Dr. Guo also worked in Sanofi China as the manager of statistics group and the lead statistician for Sanofi’s best seller Lantus in Sanofi US. Dr. Guo received his Ph.D. degree in Statistics from North Carolina State University. His research interests focus on statistical inference in Multi-regional Clinical Trial, benefit risk assessment, missing data analysis and adaptive design. Besides his industrial position, Dr. Guo also holds adjunct teaching positions in Beijing Normal University. Dr. Guo is the chair of DIA China statistical community, a member of DIA Advisory Committee of China, a member of China Clinical Trial Statistics Working Group (CCTS) and the secretary general of Beijing Biometrics Association.

刘宗宇

动脉网蛋壳研究院院长

刘宗宇，动脉网蛋壳研究院执行院长，2003年～2016年工作于《微型计算机》杂志社，历任记者、评测室主任、副主编、主编。2016年加入动脉网以来，撰写的《互联网医疗生存报告：5年来获得投资的533家公司今何在？ 》、《民营独立血透中心行业报告》、《2017医疗大数据和人工智能产业报告》、《医疗区块链白皮书》等多份研究成果在医疗创投领域产生了非常大的影响力。

钟昕

图玛深维创始人兼首席执行官

钟昕先生，清华大学生物医学工程学士，密执根大学生物工程学, 电子工程学硕士，曾在美国高通公司多媒体部任资深高级工程师兼项目经理，具有十数年研究开发国际一流智能电子产品的技术经验和团队管理经验，技术领域包括：深度学习，大数据处理和数据挖掘，计算机视觉学，计算机三维图形，语音识别，数码相机成像等。 　　他在 2009 年到 2010 年期间在卡内基-¬‐梅隆大学商学院就读工商管理专业，毕业后先后在纽约摩根斯丹利银行固定收益部、高盛银行证券交易部，美林银行财富管理部就职，具有先进的金融投资和管理经验。2013 年重新加入高通公司之后，他带领团队进行深层神经元网络，自动场景识别，物体辨识，物体跟踪和手写识别的研发工作。他同时担任计算机视觉学应用的经理，主要市场集中在智能手机，智能家居，安全监控，生物识别，及智能汽车自动驾驶，成功地帮助小米、OPPO、中兴、三星等公司把物体跟踪技术集成到旗舰智能手机上。他拥有 20 多项国际美国和国际技术专利，并在 2013-¬‐2015 年间多次代表高通公司参加消费者电子产品会展（CES），世界移动通讯会展（MWC），美国广播协会会展（NAB）等国际贸易展会的展示。 　　2015 年 4 月，钟昕先生与同在高通公司任职的高大山博士共同创建 12 SIGMA TECHNOLOGIES 公司，自主研发了临床断层影像的肺癌结节自动辨识和诊断系统，其中应用到机器学习和计算机视觉学的多种前沿技术，在肺癌早期筛查中显示出高准确率和高可靠度并举的良好效果。 　　钟昕先生担任公司 CEO，负责公司在中国，美国及海外的商业开发与合作，国内外市场开拓。最终目标是把全球领先的深度学习技术引入到各类医学计算机自动诊断（CADe 和 CADx）和数据分析中，结合到国际上通用的 RIS，PACS 以及远程医疗平台，实现智能医疗。 　　教育背景 　　2009-¬‐2010 卡内基-¬‐梅隆大学，泰铂商学院，工商管理硕士 　　1995-¬‐1997 密执根大学，电子工程与计算机科学系硕士 　　1995-¬‐1997 密执根大学，生物医学工程系硕士 　　1990-¬‐1995 清华大学，生物医学工程专业学士

管峥

北京深度智耀科技有限公司首席科学官

Guan Zheng received BSc. and MSc. degree from Peking University (Pharmaceutical Science). Then he started working at Centre for Human Drug Research (CHDR, Leiden, the Netherlands) and served as a PK/PD modeler and a project leader. He mainly focused on PK/PD modeling & simulation and early phase clinical trials. Zheng had PhD. training of clinical pharmacology in Leiden University Medical Center (LUMC) since 2012. Zheng joined Johnson & Johnson China R&D clinical pharmacology team from 2013 to 2018 working in multiple disease areas. From early 2018, Zheng joined Deep Intelligent Pharma as a founding partner. Zheng has authored and coauthored 15+ publications in pharmaceutical science.

李星

北京深度智耀科技有限公司首席执行官创始人

李树婷

临床研究促进公益基金（北京世纪慈善基金会）秘书长

李树婷 中国医学科学院肿瘤医院 中国GCP联盟副秘书长，中国CRC 之家理事长CACA稽查协作组指导委员，ISPE中国核心组成员等 专业领域和成就：临床研究和GCP，伦理审查 获得奖励、称号 从事GCP和伦理审查工作20余年，是我国最早实施GCP的人员之一。审核各种临床研究方案1000项以上，参与新药方案设计百余项。作为主要参与者承担了国家“九•五”至“十三•五”国家重大专项项目；2014年获得中华医学会科技进步成果一等奖，中国药学会科技一等奖，华夏医学科技一等奖，教育部科技成果一等奖等。

梁嘉琳

财新健康点医疗研究总监

金晓玮 博士

华领医药技术（上海）有限公司生物部总监

金晓玮博士，现担任华领医药生物研发总监。拥有超过16年的生物制药业的工作经历。曾任美迪西制药生物研发部副总裁，负责建立和管理生物研发平台。所深入涉及到的研究领域包括中枢神经疾病、炎症、癌症、代谢与心血管疾病等。回国之前，她曾担任美国波士顿CombinatoRx公司神经退行性疾病领域的负责人，负责多个中枢神经系统相关的药物研发项目，包括小儿脊髓性肌萎缩（SMA）和亨廷顿舞蹈病（HD）。金晓玮博士曾就职于Biogen的药理部，负责建立和分管分子药理学功能来支持Biogen的多个小分子药物的研发项目，包括充血性心力衰竭和帕金森氏病。 金晓玮博士在美国弗吉尼亚大学获得生物化学和药理学博士学位，并在哈佛大学医学院从事了博士后研究。她本科毕业于中国科技大学，以最高荣誉获得学士学位。金博士曾在Cell，Neuron，Nature Biotech，JCI，Molecular Pharmacology，MCB等杂志发表20多篇科研论文及综述，多次在国际会议上受邀做讲演，并拥有多项美国及国际专利。

吴云

上海罗氏制药有限公司医学部患者支持与患者教育高级经理

吴云，患者支持与患者教育高级经理，罗氏医学部 医学硕士，18年医药行业从业经历，先后任职于市场部和医学部，在患者参与方面开展了大量的工作。 2009年加入罗氏，负责患者支持与患者教育，涉及十多个疾病领域，和多个基金会、协会、患者组织保持良好合作关系，包括中国健康促进基金会、中国抗癌协会癌症康复会、淋巴瘤之家、中国血友之家等，合作或支持开展患者教育、患者支持及患者关爱项目。 罗氏全球医学部“患者参与”领导团队成员之一，积极推进中国患者组织与国际患者组织的连结和交流，提供必要的平台与培训，帮助提升中国患者组织能力建设和长期发展。   Yun Wu, Senior Manager, Patient Support and Patient Education, China Medical Affairs, Roche Master of Medicine. 18 years of working experience in pharmaceutical industry, served in Marketing and Medical Department successively and carried out a lot of work in patient engagement. Joined Roche in 2009 and responsible for Patient Support and Patient Education covering more than 10 disease areas. Working with foundations, associations and patient organizations including China Health Promotion Foundation, Chinese Cancer Rehabilitation Society CACA, Lymphoma Home of China and Hemophilia Home of China on projects regarding patient education, patient support and patient care. One of Medical Patient Engagement Leadership Team members of PDMA, Roche Global, proactively promote the connection and exchange between Chinese and international patient organizations, support on the capability improvement and long-term development of Chinese patient organizations by providing necessary platforms and training.

管珊珊

夏尔中国患者服务部负责人

管珊珊，毕业于河北医科大学临床医学专业，现任夏尔中国患者服务部负责人。曾在默克雪兰诺、罗氏、诺华从事患者援助项目管理及患者教育工作；并曾就职于中华慈善总会负责格列卫患者援助项目管理近7年。专注于患者服务、患者援助领域超过14年。

洪飞

多发性硬化之家、淋巴瘤之家创始人

洪飞 多发性硬化之家 淋巴瘤之家 创始人 2010年在不幸患上霍奇金淋巴瘤并完成治疗后，于2011年3月29日在病友和家属的支持下创立了国内唯一的淋巴瘤患者在线交流平台--淋巴瘤之家。 目前，淋巴瘤之家注册患者及家属人数已经突破5万人，是国际淋巴瘤联盟Lymphoma Coalition的第68个成员。 2014年在认识了几位多发性硬化患者后，创立服务罕见病：多发性硬化患者的多发性硬化之家网。 在未来，我们会为更多罕见病与肿瘤患者建立交流平台，帮助他们寻找到希望，了解疾病知识。

黄如方

中国罕见病组织发展中心主任

黄如方 (Kevin Huang) 罕见病发展中心（CORD）主任, 瓷娃娃罕见病关爱中心联合创始人。 黄如方于2006年毕业于浙江大学，广告学专业。作为一名罕见病患者，2003年他开始对罕见病领域感兴趣，随后积极从事于罕见病社群工作。 2008年，当他发起成立瓷娃娃罕见病关爱中心时，“罕见病”的概念在中国仍然鲜为人知，社会上看不到罕见病组织的存在。之后，他成功将国际罕见病日带进中国，经过这几年的倡导、宣传工作，“罕见病”这个曾经极少人知道的群体，已被成千上万的中国人所了解和认识。2013年，他成立了中国唯一一家专注于整个罕见病领域的非营利性机构——罕见病发展中心（CORD）。如今，在该中心下发起成立的中国罕见病网络组织发展迅速，已有超过50家罕见病组织机构。罕见病中心（CORD）也已成为在国内罕见病领域中一家集罕见病信息发布、宣传倡导、组织赋能培育、政策倡导于一体的综合性、规模化公益性组织，在为推动中国罕见病事业的发展中起着越来越重要的作用。 人物经历： 2003年04月，组织策划杭州市民艾滋病调查，并写有《杭州市民有关艾滋病知识以及态度的调查》调查报告 2003年11月，举办了“了解艾滋病，理解艾滋病人”城市学院艾滋病宣传周活动 2004年10月，带领三名学生前往河南开封，商丘，上蔡以及郑州四地采访调查艾滋孤儿 2004年11月，组织举办《他们的故事》——河南艾滋孤儿探访活动 2004年12月，联合杭州四所高校举办“平等，倾听，战胜艾滋” 杭州高校艾滋病宣传周，项目得到福特基金会和国际教育协会资助 2005年4月——2006年2月，红丝带协会同性恋优秀影片展映（15部） 2005年5月，联合《今日早报》举办“校园飘动着红丝带，六一节关注河南艾滋孤儿” 2005年6月，成立全国高校第一家以艾滋病为主题的“红丝带”展览厅 2005年7月，举办“放飞理想，拥抱未来”河南艾滋孤儿杭州夏令营 2005年11月，设计策划“预防艾滋病，你我共参与”系列明信片全国高校宣传日记，在全国六大高校同步开展 2006年1月，受邀参加在北京召开的“公民健康状况与受教育权工作委员会”会议，并被推选为委员 所获奖项： 连续三年获得社会工作，教育实践，优秀学生干部等四个学院奖学金 连续三年获得浙江省自强奖学金 2005年评为杭州市优秀社团骨干 中国罕见病现状及罕见病发展中心（CORD）工作介绍

丁洁 教授

原北京大学第一医院副院长, 儿科副主任、儿科学教授、研究员、博士生导师

丁洁，北京大学第一医院副院长，儿科副主任、儿科学教授、研究员、博士生导师。1982年毕业于北京医学院医疗系，1989年完成中美联合培养博士生项目并获北京医科大学医学博士学位，1994年在美国完成博士后及多年学习工作后回国。一直从事小儿肾脏疾病的研究和临床工作，尤其关注遗传性肾脏疾病的基础与临床研究和肾病综合征蛋白尿发生机制的研究。 现为全国政协委员。在国内外学术团体曾先后担任国际儿科学会常委（2007-现在），国际儿科肾脏病学会理事（2001-2007），亚洲小儿肾脏病学会理事（2001-现在），中华医学会儿科学分会肾脏学组组长（2007-现在）；现任国务院学位委员会成员、北京大学医学部学术委员会委员、北京大学第一医院学术委员会主任委员；任北京大学学报（医学版）、儿科临床杂志、中国实用儿科杂志、PEDIATRICS中文版副主编；任中华儿科杂志、中华肾脏病杂志、肾脏病与透析肾移植杂志等10余家国内学术期刊编委，任国际学术期刊儿科肾脏病杂志（Pediatric Nephrology）、美国肾脏病杂志（American Journal of Kidney Diseases）以及国际肾脏病杂志（Kidney International）审稿专家

赵琨

国家卫生健康委员会卫生发展研究中心，卫生技术评估研究室主任

赵琨，研究员，国家卫计委卫生发展研究中心卫生政策与技术评估室主任。毕业于加拿大英属哥伦比亚大学，在卫生经济评价和项目评价领域具有丰富的理论基础和实践经验。担任中国卫生政策与技术评价专业委员会副主任委员、 ISPOR卫生技术评估委员会委员及亚洲联盟主席、国际疾病优先控制领域咨询委员会委员、亚洲卫生技术评估联盟董事会成员。主持开展国家卫计委分级诊疗制度重点课题、国家卫计委实现分级诊疗的高效卫生服务体系研究、中国一体化诊疗临床路径与支付方式改革实践与推广研究、卫生事业发展“十二五”规划评价、中国康复医疗服务体系建立与完善试点项目评价、中国临床路径第三方独立评估、中国农村临床诊治技术优化和医院补偿机制改革项目评价、中国卫生发展优先领域确定、西部地区妇幼卫生提供体系优先领域确定、世界卫生组织中国乙肝丙肝治疗经济学评价、脑卒中治疗模式的成本效果评价、疫苗接种预防慢阻肺急性干预措施的经济评价、联合国儿童基金会面粉营养强化项目经济学评价等。作为第一作者和通讯作者在核心杂志上发表文章40余篇，作为国家卫生计生委“十二五”规划教材《卫生项目管理》和《卫生技术评估》的编委。

Agnes SAINT-RAYMOND 医学博士

EMA国际事务及Portfolio Board负责人

Agnès Saint-Raymond Head of International Affairs; Head of Portfolio Board, European Medicines Agency, European Union Head of International Affairs (ad interim), Head of Portfolio Board MD and qualified Paediatrician. Chef de Clinique in Paed. in Necker-Enfants-Malades Hospital (Paris, 1985-1990). Joined French Agency for medicines (now ANSM) in 1995 as Head of a Pharmaco-Toxico-Clinical Assessment Unit. Joined EMA in 2000. Head of Special Areas for Human Medicines (Paediatric Medicines, Orphan Medicines, Scientific Advice, SME Office, and Scientific Support & Projects) until 2013. Head of Portfolio Board since Aug 2013. Head of International Affairs (a.i.) since Nov 2016.

Rosamund ROUND

精鼎PRSG副总监兼患者中心及创新部负责人

Rosamund Round Bio Rosamund is PAREXEL’s Patient Centricity Lead and spends her time devoted to simplifying the patient journey in clinical trials. Focused on the reduction of geographical, financial and practical barriers to study participation, Rosamund is excited by the industry shift towards a truly patient centric approach. Her first job in an oncology clinic at Massachusetts General Hospital (USA), sparked her passion for putting patients at the centre of clinical research planning and implementation. Subsequent roles in patient recruitment in both the pharma and CRO industries have enabled her to innovate and explore better ways to communicate with patients. This includes addressing literacy and health literacy, exploring technological advancements, and constantly scanning the environment to help generate new ideas to make clinical trial participation more accessible and convenient. Always looking for the next best thing in patient recruitment, Rosamund is delighted to share her learnings around patient centricity and innovation in patient engagement at DIA China.

Kenneth GETZ

临床研究参与者信息和研究中（CISCRP）主席 Tufts药物发展研究中心资助研究项目部主任

Kenneth A. Getz, MBA Director of Sponsored Programs, Associate Professor Center for the Study of Drug Development, Tufts University Kenneth A. Getz is the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise. He is also the Director of Sponsored Research and an associate professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine where he conducts research programs on drug development management strategies and tactics, outsourcing, global investigative site and patient recruitment practices and policies. Ken has twice been nominated for a Distinguished Faculty award at Tufts University. A well-known speaker at conferences, symposia, universities, investor meetings and corporations, Ken has published extensively in peer-review journals, books and in the trade press. He holds a number of board appointments in the private and public sectors. He is currently a board member of WCG and the Metrics Champion Consortium, LLC; on the editorial boards of Pharmaceutical Medicine and Therapeutic Innovation and Regulatory Science; and writes a bi-monthly column nominated for a Neal Award in Applied Clinical Trials. Ken holds an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, Phi Beta Kappa, from Brandeis University. Ken is the founder of CenterWatch, a leading publisher in the clinical trials industry.

蔡伊志 博士

罕见病发展中心高级顾问 前DIA中国区董事总经理

赵大尧 博士

辉瑞中国副总裁，中国药物开发部负责人

赵大尧，医学博士，辉瑞中国研发中心总经理兼中国药物研发团队负责人，副总裁 从2016年至今，大尧作为辉瑞中国药物研发团队负责人，一直专注于优化提升临床研发流程，并在国内建立一流的团队。大尧在北京大学医学院获得神经科与儿科专业医学博士学位，同时也是哈佛医学院神经生物学与分子生物学博士。大尧在美国获得了丰富的药物发现和研发方面的经验，并分别在多家规模不一的医药公司工作过，包括日本协和医药公司、健赞公司、诺华公司、辉瑞公司以及强生公司。 辉瑞公司 2011年到2015年1月期间，赵大尧任职强生制药中国药物研发部副总裁。在职期间，他为公司的研发与科学事务打造了一个清晰的愿景，以支持杨森的新战略，并将杨森中国与亚洲研发中心（上海）的几个团队进行合并，打造一个全新的中国研发团队。在过去六年中，赵大尧博士领导完成了300多项临床试验，在国内外注册了一个又一个的新产品。大尧在中国的政策提案中也发挥了重要作用。同时，他还与政府机构、中国外商制药协会和其他的行业协会有着紧密的合作关系，并担任了2015年中国药物信息协会主席。 Dayao Zhao, M.D., Ph.D. Dayao Zhao, M.D., Ph.D. is Vice President, Head of Development China Vice President, Head of Development China Pfizer Inc. From January 2016 to present, Dayao has been the Head of Development China at Pfizer Inc. His role focuses on optimizing the clinical development process and establishes a first-class team in China. Dayao holds an M.D. in Neurology and Pediatrics from Beijing University Medical School and a Ph.D. in Neurobiology and Molecular Biology from Harvard Medical School. Dayao brings extensive experience in drug discovery and development in the US. He has worked in small (Kyowa Pharmaceutical), mid-sized (Genzyme), and large Pharmaceutical companies (Novartis, Pfizer, and JNJ). From 2011 to January 2015, Dayao served as VP, Head of China R&D at JNJ Pharmaceuticals. He shaped a clear vision of the research and development and scientific affairs to support the new Janssen strategy, bringing together several groups from both Janssen China and the Asia R&D center (Shanghai) into one end-to-end R&D organization in China. Over last 6 years, he has led over 300 clinical trials and registered many new products in China and around the world. Dayao plays an important role in policy initiatives in China. He works closely with the government agencies, RDPAC and other industry associations. He was the Chairman of 2015 DIA China.

Jan PETRACEK 医学博士

英国PrimeVigilance公司首席执行官

Jan Petracek, MD, MSc • CEO • European Pharminvent Services, Czech Republic Dr. Jan Petracek qualified as a physician from Charles University in Prague and holds a Master of Science with Distinction in Quality and Safety in Healthcare from Imperial College London. Jan has over 15 years of experience in all areas of pharmacovigilance, being former Head of Risk Management Section at European Medicines Agency, Head of Pharmacovigilance in the Czech Republic, Head of Strategy and Development of the Czech National Authority, and member of CHMP Pharmacovigilance Working Party. He has established guidelines and registries for PASS at national level back in 2003, and since then he was involved in development of standards and regulations surrounding non-interventional studies in safety areas

Gerald DAL PAN 医学博士

美国FDA药物评价和研究中心（CDER)流行病学办公室主任

Gerald J. Dal Pan, MD Chair, Council of Regulators Liaison Committee US Food and Drug Administration Liaison to the DIA Board Director, Office of Surveillance and Epidemiology, CDER, FDA Dr. Dal Pan currently serves as the Director of the Office of Surveillance and Epidemiology in the Food and Drug Administration’s Center for Drug Evaluation and Research, where he has been responsible since 2005 for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. In this capacity, he is involved in both the premarket and postmarket regulation of drugs and therapeutic biologics, and in the implementation of the drug safety provisions of the Food and Drug Administration Amendments Act and other initiatives. He is a member of the World Health Organization Advisory Committee on the Safety of Medicinal Products, and has served on working groups of the Council of International Organization of Medical Sciences and the International Conference on Harmonisation. Dr. Dal Pan completed residency training in Internal Medicine at the Hospital of the University of Pennsylvania and in Neurology at the Johns Hopkins Hospital. He is board certified in both Internal Medicine and Neurology. He joined the Food and Drug Administration in 2000 as a medical reviewer in the Center’s Office of New Drugs. Before working at the Food and Drug Administration, he was a faculty member in the Department of Neurology at Johns Hopkins and also worked in the pharmaceutical industry. Dr. Dal Pan received his MD at Columbia University College of Physicians and Surgeons, and his Master of Health Science in Clinical Epidemiology at the Johns Hopkins University School of Hygiene and Public Health

苏敏实

西安杨森制药有限公司医学安全副总监

Minshi Su, Associate Director Medical Safety, Xian Janssen Pharmaceutical Company Ltd. Minshi has been engaged in pharmacovigilance for more than ten years and has extensive experience in establishing pharmacovigilance systems and drug risk management. In 1993, Minshi entered the Department of Clinical Medicine, Capital Medical University and graduated in 1998. After graduating from university, he worked at the Department of Neurosurgery at Xuanwu Hospital of Capital Medical University from 1998 to 2004. In 2004, he joined Bayer Health Care Company Ltd and was responsible for drug safety work. He has served as an officer, supervisor, manager, and head from 2004 to 2010. Since 2011, he took the role of Global Safety Leader of Primary Care therapeutic area in global organization. He joined Xian Janssen Pharmaceutical Co., Ltd. in February 2017 and is responsible for drug risk management

Boaz MENDZELEVSKI 医学博士

英国Cardiac Safety咨询公司顾问

Dr. Mendzelevski received his degree in Medicine and Board Certification in Internal Medicine from the Ben-Gurion University Medical School and Hospital in Beer-Sheva, Israel. He then trained in cardiology and received a board certification in Cardiology from the Shaare-Zedek Medical Centre and Hebrew University in Jerusalem, Israel. Dr. Mendzelevski completed further postgraduate training in Interventional Cardiology and Clinical Electrophysiology at the Royal Brompton National Heart and Lung Hospital in London. During his work at the Royal Brompton Hospital Dr. Mendzelevski founded the first European CRO ECG laboratory in London, England, which was later acquired and moved to Mumbai, India. He also served as the Vice President of Cardiology in the industry and was one of the first pioneers of Safety Cardiology in the pharmaceutical industry. He has been involved in all stages of drug development clinical trials since 1995 and most recently held the position of Director of Cardiology for Covance Inc. Dr Mendzelevski is currently a principal at Cardiac Safety Consultants and Director of Cardiology at Medifacts International, a leading Cardiac Safety Core Lab.

赵子贤 博士

阿斯利康美国药物安全监测部门主管医学执行总监

Dr. Sean Zhao is a senior pharmaceutical executive with over 20 years of diverse working experience. He possesses proven abilities in pharmacovigilance, pharmacoepidemiology, post marketing evidence generation, risk evaluation, management and mitigation, post marketing safety studies, safety process development and refinement, and outcomes research. He has successfully built and led a global safety department, safety surveillance teams, and pharmacoepidemiology teams, as well as effectively managed safety business alliances and outsourcing vendors in various mid- and large-size biotech and pharmaceutical companies. Dr. Zhao possesses deep knowledge of the safety regulations and guidance, and experience of appropriate regulatory interactions with FDA, EMA, CFDA, Health Canada, and Japan Regulatory Authorities. He has participated in pharmaceutical industry wide and regulatory agencies’ safety initiatives, activities, working groups, and expert panels. Currently, he serves as Head of US Patient Safety Department in AstraZeneca.

Stefan BRAAM 博士

荷兰Ncardia公司首席执行官

Biography Stefan Braam, PhD Stefan Braam is the co-founder and CEO of Ncardia. Stefan brings Ncardia over a decade of experience in stem cell technology, product development and general management. Before the appointment as CEO of Ncardia, Stefan was the CEO of Pluriomics. As co-founder and key inventor of Pluriomics/Ncardia technologies he has been instrumental in the establishment and growth of the company. Earlier in his career, Stefan obtained a MSc and PhD (both cum laude) in stem cell biology under supervision of Prof. Dr Mummery and obtained international experience in labs in the UK and Australia. Stefan won the NGI venture challenge (2009), the Niaba biobusiness Masterclass (2010), published in multiple leading scientific journals, is an inventor on multiple patent families, secured multiple grants and commercial research collaborations and was with increasing responsibilities instrumental in Pluriomics/Ncardia pre-seed, seed, Series A and B financing rounds.

磨筱垚

北京人和广通资讯有限公司药物安全顾问、合伙人

磨筱垚女士为北京人和广通资讯有限公司药物安全顾问。她有19年的国际大药企(强生，辉瑞，默克，阿斯利康）的医学部和R&D药物研发经验, 从事过药物临床研究监察, 医学信息处理与应用；近15年专注于药物安全和风险管理， 对于制药公司药物安全职能建立和运营有丰富经验，风在药械风险管理方面能提供有效解决方案。 在加入制药行业前，她是一名临床内科医生。 她也是国内药物安全行业的带头人，自2005年至今2014年被推选为RDPAC药物警戒工作组组长; 于2009-2012年是中国ICH学习小组M组专家; 2008-2012曾为北大国际创新药物研发和管理课程讲师。她不断结合我国药监特点和实际情况, 介绍和发展国际药物安全的技术知识和理念, 长期致力于推动中国药物安全事业的发展。

李海燕

心血管教授，北京大学第三医院药物临床试验机构主任

李海燕，心血管内科主任医师，硕士生导师。 现任北京大学第三医院药物临床试验机构主任，北京大学第三医院心血管受体研究北京市重点实验室副主任，北京大学临床研究所副所长，中国药理学会药物临床试验专业委员会副主任委员。 研究方向:新药临床研究（包括Ⅰ期至Ⅳ期），涉及溶栓药、抗高血压药、调脂药、抗心力衰竭药、治疗冠心病药物等 教育经历 1983年9月-1989年7月北京医科大学医疗系获医学学士学位 2003年8月-2005年4月美国加州大学洛杉矶分校（UCLA）血管内超声中心实验室及心导管室做访问学者。 工作经历 1989年8月-1994年9月北京医科大学第三医院内科住院医师及住院总医师 1994年9月-1999年6月北京医科大学第三医院心内科主治医师 1999年7月-2007年8月北京大学第三医院心内科副主任医师 2007年8月-至今北京大学第三医院心内科主任医师 2005年7月-2006年10月北京大学第三医院药物临床试验机构副主任 2006年10月-至今北京大学第三医院药物临床试验机构主任 2012年3月-至今北京大学第三医院心血管受体研究北京市重点实验室副主任

颜崇超 博士

恒瑞临床数据科学中心负责人

Sameer THAPAR 博士

甲骨文全球药物警戒总监

Sameer Thapar, PharmD – Brief Bio Dr. Sameer Thapar holds a doctorate of pharmacy (PharmD) and is Oracle Health Science Consulting’s Global Pharmacovigilance Director, based in the US. Dr. Thapar has over 20 years of experience in operations within the pharmaceutical, biotech, and CRO industries, with cross-functional experience in medical affairs, clinical operations, quality assurance, and subject matter expertise in pharmacovigilance operations and compliance. From 2012-2017, he was on faculty at Rutgers University School of Health Professions as an Assistant Professor of Pharmacovigilance in the Masters of Clinical Trial Sciences program. He has built global departments and defended in successful FDA, MHRA, and EMA health authority inspections. He is an active advisor in US based life science industry conferences and participates as an invited speaker and panelist in global industry conferences.

马欢

辉瑞全球产品开发卓越运营中心信息管理部中国区负责人

马欢 辉瑞（中国）研究开发有限公司 信息管理部门负责人 马欢是辉瑞（中国）研发中心信息管理团队负责人。 已在辉瑞工作17年 (其中美国辉瑞9年)，在软件 开发和支持方面有丰富的经验，精通药物开发的各 个领域及相应的计算机系统功能和架构。2010年回国后 将初创的功能单一的团队发展成覆盖整个药物开发领域的信息管理团队，包括政策法规系统管理(Regulatory Solutions), 临床研究系统管理(Clinical Trial Solutions), 药物安全系统管理(Safety Solutions), 文档系统管理(Content Management & Authoring) 和技术支持服务中心（ Centralized Service）等，通过技术、人才与业务的合作，实现系统开发、环境部署、业务咨询、风险控制等不同领域的支持，共同致力于为用户提供全面完善的信息整体解决方案。 马欢于西安电子科技大学获得计算机软件硕士学位 James Ma Pfizer China R&D Center IMCS Shanghai Site Lead James Ma, the head of Information Management Shanghai Site at Pfizer China R&D Center, has 17 years of working experience in Pfizer (including 9 years in Pfizer US), with a profound experiences in software development and supporting, and rich expertise in each domain of drug development as well as related computer system and architecture. Coming back to China since year of 2010, as the team founder, James Ma has led a group providing single function steadily growing into today’s Information Management China Team which covers every domain of drug development including Regulatory Solutions, Clinical Trial Solutions, Safety Solutions, Content Management & Authoring, and Centralized Service etc. The mission of IM China Team is to support business lines by providing comprehensive information solutions through an integrated collaboration of technologies, resource as well as business processes. James Ma holds a Master’s Degree majoring in Computer Software from Xidian University

Rajesh AGGARWAL 博士

辉瑞全球安全及药政事务部高级总监兼安全监测及风险管理治疗领域负责人

Rajesh Aggarwal PhD, Senior director, Disease Area Cluster Lead, Safety Surveillance and Risk Management, Worldwide Safety and Regulatory, Pfizer Dr. Raj Aggarwal has diverse leadership experience as a pharmaceuticals professional with significant accomplishments in all aspects of pharmacovigilance, drug safety and, and late-stage clinical development across a broad range of pharma therapeutic areas and consumer product areas. Dr. Aggarwal joined Pfizer Safety in 1998. He has extensive experience in post-marketing safety and risk management, with a special interest developing technical tools for pharmacovigilance and signal detection activities at Pfizer. He is currently working as Disease Area Cluster Lead within the Safety Surveillance and Risk Management group at Pfizer where he is responsible for marketed products within the Cardiovascular, Men’s and Women Health, Gastrointestinal, Genitourinary, and Metabolic/Endocrine therapeutic disease areas. Dr. Aggarwal earned a PhD in Pharmacology from Columbia University in NY and completed Post-doctoral research training in Cardiology at the University of Maryland Medical Center in Baltimore MD, specializing in models of cardiac arrhythmias and heart failure. Rajesh Aggarwal 博士, 高级总监，治疗领域负责人，安全监测及风险管理，全球安全及药政事务部，辉瑞 Rajesh Aggarwal博士在药物警戒、药物安全和后期临床开发等方面有着丰富的工作和领导经验、并取得显著的成就。他的工作涉及不同药物治疗领域和消费品领。Rajesh Aggarwal博士于1998年加入辉瑞公司药物安全部门，在上市后安全和风险管理方面有多年丰富的经验，特别在药物警戒和信号检测活动的技术及工具上有深入研究。Rajesh Aggarwal博士目前担任辉瑞公司的安全监测和风险管理部门治疗领域负责人及高级总监一职，负责心血管、生殖健康、消化系统、泌尿生殖系统和代谢/内分泌治疗领域的上市后产品。 Rajesh Aggarwal博士在哥伦比亚大学获得药理学博士学位，并在马里兰大学医学中心完成心脏病学博士后研究，主要研究心律失常和心力衰竭的模型。

申华琼 医学博士

天镜生物副总裁兼研发负责人

Joan obtained PhD in life science and is a licensed physician with board certification in US. She had postdoctoral trainings in endocrinology, psychopharmacology and clinical pharmacology. She worked in Eli Lilly & Co, Wyeth and Pfizer while in US, where she was responsible for global clinical development programs cross phase 1-4 and gained rich experiences of working with FDA, EMEA, CFDA, PMDA, KFDA and etc. She holds academic positions as the guest professor of Beijing University Clinical Research Institute and adjunctive professor of Indiana University School of Medicine. An expatriate of Pfizer, she became Pfizer China clinical head in 2011. She later joined Hengrui pharmaceutical as the CMO. She was granted the honor of “Talent of Innovation” by the “National Thousand Talent Program”. In Hengrui, she built the clinical team for innovative drug development and led the successful conduction of clinical trials in China, USA and Australia. Joan joined Janssen Pharmaceutical Companies of Johnson & Johnson as the China development head in 2015 and responsible for all the development programs, where she led multiple successful NDA approvals by CFDA. During this time, she is elected as the co-chair of RDPAC R&D core team. Most recently Joan joined I-Mab biopharma as the head of R&D and is leading the efforts of China to China and China to global. 申华琼 （Joan Shen），科学博士，临床医学博士， 天境生物科技（上海）有限公司 申华琼博士先后在东南大学临床医学专业及四川大学华西医学院获医学学士及硕士学位，并曾担任外科医生。后赴美深造获得印第安纳大学生命科学博士学位。经过住院医生资格论证及培训成为美国有处方权的执照医生并通过了美国精神心理学和神经病学委员会专科认证。作为印第安纳大学临床兼职教授在附属医院做临床医生的同时在礼来公司从事临床药物研发。她还获得国际糖尿病基金会专项研究基金进行内分泌与代谢学博士后研究，在糖尿病及肥胖学的研究方面取得显著成就。此后还从事了精神病药物学和临床药理学的博士后研究。2009及2010年，她连续两年被授予”美国最佳精神心理医生”的荣誉称号，还发表了20多篇学术论文。她新近被北京大学聘为客座教授。 申华琼博士曾在美国礼来，惠氏，辉瑞担任全球临床研发高管10 多年，回国后又加入恒瑞医药并帮助建立了创新药临床团队，成功开拓了在澳洲及美国的临床试验。她被选为2014“国家千人计划创新人才”并当选中国药物临床评价研究专业委员会第二届委员.她2015年加入强生，成为中国开发中心副总裁及总负责, 负责中国地区的注册试验及亚洲的创新项目。在她的带领下强生中国将多个新药成功上市。在此期间当选RDPAC研发核心工作组的预备主席。申华琼博士新近以研发总裁和董事的资格加入天境生物科技（上海）有限公司。

高杲

辉瑞全球安全及药政事务部安全监测及风险管理总监

Gao Gao is a safety risk lead and director with Safety Surveillance & Risk Management, Worldwide Safety and Regulatory in Pfizer. She is responsible for developing safety strategy, overseeing pharmacovigilance activities and risk management in a multidisciplinary team to support Pfizer PEH products on global market. Gao received her medical degree from Fudan University. She joined Pfizer in 2009 as External Research Manager, mainly responsible for managing the scientific collaboration and business development activities between Pfizer and a broad network of academic institutes, biotech and CROs in Asia. Prior to Pfizer, she worked in McKinsey & Company as a business consultant focusing on healthcare industry. 高杲现任辉瑞(中国)研究开发有限公司安全监测与风险管理部总监，产品全球安全风险负责人。从事药物安全监测、信号检测与评价、风险管理等工作, 与跨部门团队共同支持辉瑞全球市场的产品线。 高杲毕业于复旦大学医学院，获临床医学专业硕士学位。她于2009年加入辉瑞担任合作研究经理一职,主要负责辉瑞与亚洲学术机构，生物制药企业及CRO的研发项目合作。加入辉瑞前，她在麦肯锡公司担任医药行业咨询顾问。

钱镭 医学博士

苏州信达生物医药临床战略部高级总监

工作经历 2018.5- 至今 高级总监，临床策略部，信达生物制药（苏州）有限公司 主要负责代谢疾病领域化合物（PCSK9与OXY）的研发策略与计划的制定 2017.4-2018.5 高级总监，临床研究部，上海海和药物研发有限公司 糖尿病足溃疡化合物 ON-101国内研发策略制定；领导进行Pre-Ph3 CDE沟通会； PAM抑制剂 FIH临床研究方案制定； 2016.8-2017.4 副总监，科学沟通，礼来中国 领导有10名团队成员的科学沟通团队； 负责礼来中国全部化合物注册材料准备； 负责注册临床研究方案/研究报告撰写，以及临床研究数据披露 2014.9-2016.8 副总监， 临床研究医师，医学部，礼来中国 领导并参与糖尿病化合物在中国 GRA，PEG-Lispro，Nasal Glucagon的研发策略制定； 担任PEG-Lispro 两个多国多中心注册临床研究Study physician； 2011.6-2014.9 高级医学经理，临床研究医师，医学部，礼来中国 领导设计多国多中心四期CLASSIFY研究，并担任Study physician； 担任礼来-勃林格医学团队礼来方面负责人，支持欧唐宁上市前准备； 负责优泌乐，优泌林的医学策略与年度医学计划制定； 2008.7-2011.6 内分泌科医师，上海交通大学附属上海第一人民医院 作为骨干，负责本专业临床科研及教学任务。 第一责任人申请并承担国家自然科学基金青年基金，上海市卫计委青年人才研究基金。 专业技能 内分泌科主治医师，临床研究，医学事物 SCI杂志邀请审稿人: Diabetic Medicine、Journal of Diabetes and its complication、Journal of Diabetes Research 教育经历 09/2005-06/2008, 内分泌学博士，上海交通大学医学院 09/2002-06/2005, 内分泌学硕士，郑州大学医学院 09/1997-06/2002, 临床医学，河南医科大学（现郑州大学医学院） 获奖 2010年 上海市第一人民医院优秀医务工作者 2011年 上海医学科技奖二等奖 2014年 中华医学科技奖三等奖 2014年 礼来中国糖尿病领域学术影响力奖 2015年 礼来中国研发中心创新奖

金建军 医学博士

礼来中国医学部高级医学总监

James Jin, MD & PhD, graduated from Fudan University Shanghai Medial School. He has more than 14 years working experience in Clinical Development & Medical Affairs Dept., MNC. He currently is the Sr. Medical Director of Medical Science, Eli Lilly Pharmaceutical Company. Before joining Lilly, he worked as Head of Medial Affairs in Boehringer-ingelheim Pharmaceutical Co., Ltd and Sr. Medical Manager in Wyeth Pharmaceutical Co., Ltd. 金建军，临床医学博士，毕业于复旦大学上海医学院。有超过14年在跨国医药公司从事临床研发和医学事务的工作经验。目前在礼来公司医学部，担任医学科学高级医学总监。在加入礼来公司前，曾担任勃林格殷格翰公司的医学事务总监，以及美国惠氏公司的高级医学事务经理。

陈小祥

和铂医药执行副总裁，临床开发和注册科学负责人

Xiaoxiang Chen, MD陈小祥 医师 执行副总裁, 临床开发和注册科学负责人 陈小祥医师在全球及区域临床研究领域已有超过20年的领导及管理经验。加入和铂医药前，陈小祥医师在德国勃林格殷格翰 (Boehringer Ingelheim) 总部任新兴市场医学负责人。 陈小祥医师在职业生涯中，成功领导团队完成20多个新药在中国的临床开发及新药注册工作，涵盖了肿瘤、自身免疫、感染、心血管、呼吸、代谢、神经精神等诸多治疗领域，包括了恩利（Etanercept）, 替加环素（Tigecyline）, 文拉法辛（Venlafaxine）， 阿法替尼（Afatinib）, 尼达尼布（Nintedanib）,达比加群（Dabigatran）, 利格列汀（Linagliptin）, 恩格列净 (Empagliflozin) 等市场重磅产品。 任职德国勃林格殷格翰新兴市场的医学负责人期间，陈医师全面管理并协调包括东南亚，中国、台湾、香港，印度，中东及非洲地区等超过80个国家和地区的医学、临床工作。并在此之前担任该公司大中华区副总裁，负责所有医学临床事务。在此之前在惠氏制药 (Wyeth) 中国公司历任注册管理、医学事务、临床研究等管理职务，直至惠氏制药亚太研发中心临床研究总监，以及慢性疼痛及抗感染新药全球研发的医学项目主管。陈医师毕业于南京医科大学。 Executive Vice President, Head of Clinical Development and Regulatory Science Dr. Chen brings to Harbour BioMed more than 20 years of leadership experience in regional and global clinical development, most recently as Boehringer Ingelheim's Vice President, Regional Medical Management for Emerging Markets. During his career, Dr. Chen has led the successful clinical development and registration into the China market of more than 20 global innovative products across multiple therapeutic areas, including etanercept, tigecycline, venlafaxine, afatinib, nintedanib, dabigatran, linagliptin and empagliflozin. In his role as Medical Lead for Emerging Markets at Boehringer Ingelheim, Dr. Chen had overall medical responsibilities, including clinical development, in more than 80 countries and regions, including China, Taiwan, Hong Kong, South Eastern Asia, India, the Middle East and Africa. Previously, he served as Boehringer Ingelheim's Vice President, Head of Medicine Development of Greater China. Prior to Boehringer Ingelheim, Dr. Chen served as Director, Clinical Research & Development Organization of Wyeth Asia Pacific, until Global Medical Monitor for chronic pain and infections. Dr. Chen received his Medical Degree from Nanjing Medical University.

谢抒

雅培制药中国医学总监

谢抒是雅培中国成熟药品部医学总监，带领医学事务、临床研究、药物警戒和医学信息团队。她曾任职于医疗器械企业和制药企业，包括美敦力、西安杨森、阿斯利康，具有多年的医学事务和临床研究经验。她现任RDPAC医学事务小组成员。 Lyra Xie is the Medical Director at Abbott Established Pharmaceuticals Division in China. In her current role, she leads a team of Medical Affairs, Clinical Research, Pharmacovigilance and Medical Information. She has worked for a variety of medical device and pharmaceutical companies including Medtronic, Xi’an Janssen, AstraZeneca and Abbott, where she has got a lot of experience of Medical Affairs and Clinical Research. She is a member of RDPAC Medical Affairs Group.

范俊豪

珐博进医学总监

Kurt Fan has been working in Pharma Industry for more than 12 years. With his 12 years of career journey in Medical Affairs. He has worked in the field as MSL and MSL manager, and centrally as Medical Advisor, Associate Medical Director and eventually Medical Director. He kept focusing on Medical affairs and accumulated rich experience in handling various products with different lifecycles. He was most recently Medical director at Fibrogen China. Before joining Fibrogen, he has been working in multiple pharma companies such as UCB China Xian Janssen, Roche, Pfizer and Wyeth in the therapeutic areas of nephrology, immunology and transplantation. He graduated from Shanghai Second Medical University with the Masters degree in Clinical Medicine, and practiced as a nephrologist at Shanghai Xinhua Hospital before entering industry.

王瑞石

勃林格殷格翰呼吸部副总监

Grace WANG, associate director of Respiratory TA, Boehringer-ingelheim. Grace had been working in hospitals as a clinical nephrologist for 8 years, and worked in a health-care company for more than 3 years. Before joined Boehringer-ingelheim, Grace gained working experience in both Sanofi-aventis and Roche as a medical manager and group medical manager for more than 6 years. As TAH of Respiratory in Boehringer, Grace is leading a medical team consists of medical advisors and MSLs, providing medical support on 5 brands.

徐聪

礼来亚洲基金投资副总裁/瑛派药业医学副总裁

李智

勃林格殷格翰医学事务部总监

李智 / Eugen LI 勃林格殷格翰 医学事务I 部 总监Medical Affairs China Group I Director, Clinical Development and Medical Affairs Boehringer Ingelheim Dr Zhi LI is Director, Medical Affairs group I with Boehringer Ingelheim China since 2015. He was Medical Advisor, and Sr, Manager of Medical Affairs including MSL function with MSD and Roche in China. He was trained as clinical physician and practiced clinical medicine for more than 10-year with leading teaching hospital in China.

王昕

武田大中华区医学部医学合规和医学质控高级经理

宋莉莉

乔治健康研究所心脑血管项目部主管 高级研究员

Lily Song – 宋莉莉 Leader, Cardiac & Stroke Senior Research Fellow 心脑血管项目部主管 高级研究员 China 中国 Lily Song joined The George Institute, China in July, 2016. As the leader of Cardiac & Stroke Program, She is fully in charge of INTERACT3 project. Prior to TGI, she worked for the 85th hospital of Shanghai and was Associate chief physician in 2010. Lily graduated from Second Military Medical University with a Doctor degree in Neurology in 2004.

刘熠

缔脉生物医药临床科学和医学事务部副总裁

刘熠 / Yi LIU, MD, MPH 武田中国医学事务负责人 Head of Medical Affairs, Takeda China Yi is currently the Head of Medical Affairs, Takeda China and leads the TA, medical information/medical operation, medical excellence and PV teams. Prior to Takeda, Yi had more than 10 years industry experience in both medical affairs and clinical development, including medical affairs TA Head of Cardiovascular and thrombosis in Sanofi and director of clinical development in GSK R&D. Before joining industry, Yi had 4 years clinical practice experience as a cardiologist in a tertiary hospital and 2 years clinical research experience in a university hospital in Australia. She received MD from Zhejiang University and MPH from University of Queensland, Australia.

夏志敏

丁香园医学内容总监

夏志敏,骨科医生，丁香园内容总监。负责丁香园面向医生的内容运营和新媒体运营，建设运营丁香头条等 37 个微信公众号和医学时间 App，多次参与医疗卫生领域重大新闻采访和策划，带领团队完成国际、国内各重要学术会议的报道。

汪湛

辉瑞全球对外沟通部高级医学信息运作经理

汪湛经理在辉瑞全球对外沟通部，也就是国内所说的医学信息部门有十年的工作经验。在进入辉瑞之前，他曾经是三甲医院医生兼丁香园论坛资深版主；进入辉瑞之后，他和多数同行一样，接过热线电话、回复过邮件咨询、写过定题综述、奔波于数据库之间；他又和很多同行不同，管理过业绩连续多年增长的辉瑞医学信息网站，开发过面向医生的辉瑞医谷APP，参与过全球数字化平台的本地化，组织过十几个国家和地区参与的国际业务交流，目前正在运营面向患者的微信号辉瑞小药箱等多个项目。下面，我们就有请辉瑞高级医学信息运作经理汪湛为我们带来精彩的分享：探讨患者为中心的医学信息“智慧”服务。

陈森鹏

阿斯利康医学信息经理

李健

阿斯利康医学事务总监

李健（医学总监，阿斯利康中国） 李健于2012年加入阿斯利康中国医学部，目前担任医学信息和医学合规团队负责人。阿斯利康中国医学合规团队承担着预防公司在医学合规领域发生违规行为的职责。为此，医学合规团队针对公司发起或支持的所有项目、从合规策略角度予以前期指导，针对所有由公司制作的、与公司产品和/或治疗领域有关的材料进行审核和批准，通过政策制定和政策培训、优化阿斯利康中国医学合规管控体系，同时积极参与阿斯利康全球医学标准的制定和修订。 在加入阿斯利康中国之前，李健曾在艾伯维、雅培和勃林格殷格翰中国医学部担任医学顾问、医学事务经理和医学经理。李健还拥有两年的医药广告和PR行业经验，曾就职于Havas集团。在此之前，李健在上海新华医院担任呼吸内科医师，拥有九年临床工作经验。 李健毕业于上海第二医科大学（临床医学本科）和上海交通大学（内科学硕士）。

王莉 医学博士

礼来公司药物研发及医学事务高级副总裁

礼来中国高级副总裁，药物研发及医学事务中心负责人

杨建红

沈阳药科大学亦弘商学院研究中心研究员

杨建红 主任药师 原国家药品审评中心化药药学二部副部长（主持工作），亦弘商学院研究员

雷继峰

上海安必生制药技术有限公司首席执行官，亦弘商学院研究员

Biography of Jifeng Lei 雷继峰 ，上海安必生制药技术有限公司，任CEO,化学工程硕士和工商管理硕士学位。ISPE（国际制药工程协会）中国区2015-2016年度主席。 雷继峰曾任职多家跨国制药公司。1988年至1999年历任西安杨森制药公司设备工程师，工程技术部经理，生产部经理和运营总监；2000年至2003年任法国赛诺菲(杭州)制药公司的工厂总经理，2003年至2007年任葛兰素史克(天津)制药公司的工厂总监，其28多年的制药经历涵盖了制药工程和生产、药品工艺开发和优化、制药工厂管理和研发公司的创建和经营. 雷继峰担任国家药品食品监督管理总局（CFDA）药品认证中心的GMP讲师和专家，二十余次为国家药监局GMP认证检查员的提供培训，参与了我国2010版GMP的修订工作。担任2010版GMP三个技术指南编写小组的组长。 2007以来，其创办的上海安必生制药技术公司为国内多家大型制药企业在美国市场研发和申报了二十余个制剂产品（ANDA）雷继峰先生还是北京大学国际制药工程硕士项目（IPEM）的授课老师和ISPE (国际制药工程协会）口服固体制剂和工艺验证课程的培训师。 Mr.Jifeng Lei , Founder and CEO of Shanghai Anbison Lab. Co. Ltd. , M.S in Chemical Engineering and EMBA, Chairman of ISPE China in year of 2015-2016. Before Anbsion Lab. was founded in year of 2007, Mr.Lei was the site director of GSK（Tianjin）from year 2003 to 2006, plant director of Sanofi (Hangzhou ) from year 2000 to 2003 ,operations director of Xian-Janssen pharmaceutical Co.Ltd since 1996. Mr.Lei joined Xian-Janssen in year of 1988 and experienced a increased responsibility. His 30 years of experience in pharmaceutical industry covered pharmaceutical engineering, product & process development , technology transfer,, GMP compliance & plant management. Mr. Lei has been the qualified instructor to Chinese GMP inspectors since year of 1993 and he was involved in drafting of new Chinese GMP. Mr. Lei is also the organizer and leader of 3 GMP guidance published in year of 2011 to cope with the implementation of new Chinese GMP. Anbison lab., under the leadership of Mr.Lei, has developed and filed over 20 ANDA for several top Chinese pharmaceutical companies in USA..Mr.lei is also the qualified instructor by ISPE on OSD (Oral Solid Dosage) as well as the PV (Process Validation) course and the lecturer in IPEM (International Pharmaceutical Engineering Master ) in Peking University

李冰 博士

美洲华人药学会副会长

李冰博士现任美国美洲华人药学会（ACPA）副会长，FDA资深药物评审专家，药物评审中心仿制药司生物等效处一处处长。李冰毕业于北京医科大学（现为北京大学医学部）并留校任教，2001年获美国威斯康星大学临床药理学博士，后进入美国百时美•施贵宝药业集团担任研究员。加入FDA后,李冰负责仿制药评审管理决策，领导多个科研小组,主持或参与完成了多部药政法规的编写,编撰了数项 FDA 药品研发指南性文件。

Deborah M. AUTOR 法学博士

迈兰全球质量和注册策略负责人 国际仿制药和生物类似药协会(IGBA)科学委员会副主席 FDAAA董事会成员 前FDA副局长，前FDA CDER合规办公室主任

Deb Autor is Head of Strategic Global Quality and Regulatory Policy at Mylan, one of the largest generics and specialty pharmaceutical companies in the world. In this role, Deb represents Mylan’s diverse and complex operations to government officials globally and advises Mylan’s most senior leaders on how to navigate and influence the regulatory landscape. She also leads Mylan’s work on international trade policy, preventing antimicrobial resistance, and implementing global serialization. Previously, as Mylan’s Global Head of Quality, Deb managed thousands of personnel around the world, driving quality improvements across scores of manufacturing sites. Prior to joining Mylan, Deb served for 12 years at FDA, most recently as Deputy Commissioner for Global Regulatory Operations and Policy, where she supervised more than 4,000 employees in FDA’s Office of Regulatory Affairs and Office of International Programs in their efforts to confront the challenges of globalization and import safety. She also served for five years as Director of the Office of Compliance of FDA’s Center for Drug Evaluation and Research, where she led policymaking and enforcement for key programs for drugs, including current good manufacturing practices; human subject protection and bioresearch monitoring; marketed unapproved drugs; pharmaceutical import and export; Internet and health fraud; over-the-counter monograph compliance; adverse event reporting; registration and listing; risk evaluation and mitigation strategies; and drug recalls. Before joining FDA, Deb served for six years as a Trial Attorney at the Office of Consumer Litigation of the U.S. Department of Justice. Ms. Autor’s many commendations include the Meritorious Executive Presidential Rank Award and the Food and Drug Law Institute's Distinguished Service and Leadership Award. She also was a finalist for the prestigious Service to America Medal.

雅乃琦 博士

eVenus Pharmaceutical Laboratories总裁

Dr. Naiqi Ya become the President of eVenus Pharmaceutical Laboratories Inc., a subsidiary of Jiangsu Hengrui Medicine Co., Ltd., in April 2018. He started his FDA career in 1996 as a Chemistry Reviewer, and then being promoted to Team Leader, Deputy Division Director and Acting Director Division. Since OPF’s formation in 2015, Naiqi has served as the Director for the Division of Process Assessment II and III and Acting Senior Science Advisor. In this capacity, Naiqi applied his extensive knowledge and experience to A/NDA assessment by implementing scientific policies related to sensitive, controversial, and critical issues; initiating and developing a triage program to improve the office review process; developing a platform to enhance knowledge sharing; and advancing OPF risk assessment and OPQ Knowledge-aided Assessment and Structured Application (KASA) initiative. In addition, Naiqi has presented on CMC review topics at a variety of workshops and conferences, participated in various working groups for developing Guidance for Industry, and served as an office representative in the electronic submission and electronic review project. Prior to joining the FDA, Naiqi worked in the R&D department at Biocraft Laboratories, Inc. He received his B.S. degree in radiochemistry from Peking University and Ph.D. degree in bioanalytical and biophysical chemistry from New York University.

柯雷恩 博士

美国食品药品管理局驻华办公室副主任

Lane Christensen, Ph.D. Assistant Country Director, FDA China Office Dr. Lane Christensen is an Assistant Country Director of the China Office in the Office of International Programs (OIP) at the US Food and Drug Administration (FDA) where he serves as the International Program and Policy Analyst (IPPA) for Drugs. Before joining the FDA China Office, he was a Branch Chief in the Office of Process and Facilities (OPF), in the Office of Pharmaceutical Quality (OPQ), CDER, FDA which is tasked with the review of manufacturing process and established facility inspections for abbreviated and new drug applications (A/NDAs). Previously he was with the Office of Generic Drugs (OGD) as a Team Leader in a review division and as a Chemist with the Immediate Office having various responsibilities related to Chemistry Manufacturing Control activities such as ANDA review, Control Correspondences, Citizen Petitions, and policy development. Lane was extensively involved in various initiatives related to OPQ reorganization and new user fee implementation under GDUFA including the lead for hiring efforts and involvement with risk-based review efforts. He received his Ph.D. in Pharmaceutics and Pharmaceutical Chemistry from the University of Utah followed by a post-doctoral fellowship within the pharmaceutical industry. Lane began his FDA career with the CDRH Office of Compliance. 柯雷恩 博士 助理主任，美国食品药品管理局中国办公室 柯雷恩博士任职美国FDA国际项目办公室（OIP）下设的中国办公室助理主任，担任药品国际项目和政策分析官员。在此之前，他曾担任药品审评研究中心（CDER）药品质量办公室（OPQ）工艺和设施办公室（OPF）分部主任，主要负责A/NDA中生产工艺及设施检查的审评。 此前，他在仿制药办公室（OGD）担任审评处的组长，并曾作为化学家在直属办公室任职，负责CMC相关的多项工作，包括ANDA评审，沟通管理，公民请愿书及政策开发。柯雷恩博士曾广泛的参与到OPQ重组以及GDUFA框架下新的使用者付费的执行等多项工作中，包括主导招聘工作，参与基于风险的审评。他在犹他大学获得了制药和药物化学的博士学位，此后在制药行业从事博士后研究。柯雷恩博士从医疗器械和放射健康中心（CDRH）的合规办公室开始其FDA生涯。

张象麟

沈阳药科大学亦弘商学院院长

张象麟，高级职称，现任沈阳药科大学亦弘商学院院长。 主要研究方向：药品监管、药品注册管理法规及技术审评管理、药品标准管理等。 1982年毕业于山东大学，后取得中欧管理学院EMBA学位。长期从事药品研究监督和技术审评管理工作，多年来对国际（包括美国FDA、欧盟EMEA、澳大利亚TGA、日本PDMA）药品注册管理法律法规及其监管实践，进行了长期的跟踪和深入的研究，发表了数十篇研究文章。深度参与了我国《药品注册管理办法》等相关法规和规范性文件的起草和制定工作，作为国家863课题“新药研究信息系统技术平台课题之创新药物技术评价支持系统研究课题”总负责人完成了25项药品研究技术指导原则的起草和修订，并构建了我国药品研究技术指导原则的形成机制。在从事药品技术审评管理的实践中，确立了技术评价学科建设的目标，创立了符合药品技术评价规律并适应我国经济社会发展阶段的技术评价机制。组织创办了《药品技术评价论坛》，组织连续出版了《药品技术评价文集》。对药品监督管理的理论研究和丰富的实践经验构成了其专业特色。目前，还担任着《中国新药杂志》、《中国药事》和《中国执业药师》的副主编及多种刊物的编委。

范勇 医学博士

A2Z Reg Solution资深顾问

Dr. Yong Fan received her MD at Jilin Medical College in China and received further training in cancer immunotherapy at The Academy of Military Medical Sciences in Beijing and completed post-doctoral training hematopoietic stem cell transplantation and graft engineering research and translation at New York Blood Center. She served as Director of Cell Processing Laboratory at The Brooklyn Hospital Center in New York, Supervisor/Coordinator of Stem Cell Processing Laboratory at Columbia Presbyterian Medical Center and Supervisor of Cellular Activities of Gene Transfer Core Facility at Memorial Sloan-Kettering Cancer Center. She served as a staff scientist at the Cell Processing Section of Department of Transfusion Medicine at NIH where she worked with researchers and clinicians in developing and translating cancer cellular and gene therapy technologies. She served as a senior product quality reviewer for a diverse range of products, including cell therapies, medical devices used in the processing and storage of cellular products, and combination products at the Office of Tissues and Advanced Therapies of Center for Biologic Review and Research of the US Food and Drug Administration from 2007 to 2017. She has experience in developing and regulatory oversight of all phases of product development including investigational and marketing. She became an independent CMC consultant early this year to assist manufactures with investigational and commercial application preparations.

Ana HIDALGO-SIMON 医学博士

EMA人类用药品研究和开发支持处专业科学负责人

Ana Hidalgo-Simon Head of Specialised Scientific Disciplines Department Human Medicines Research & Development Support Division, EMA Nationality: Spanish Career to date: • Head of Specialised Scientific Disciplines, European Medicines Agency (2013-present) • Head of Risk Management, European Medicines Agency (2012-2013) • Head of Risk Management (ad interim), European Medicines Agency (2011-2012) • Head of Signal Detection and Data Analysis, European Medicines Agency (2009-2011) • Scientific Administrator, European Medicines Agency (2003-2009) • Medical Editor, EuroTransmed, United Kingdom (1998-2003) • Scientific Project Manager, Medical Action Communications, United Kingdom (1997- 1998) • International Clinical Trials Coordinator, SymbioClin, United Kingdom (1996-1997) • Post-doctoral Researcher, Clinical Research Centre, United Kingdom (1995-1996) Education: • Diploma in heath economics, University of York , United Kingdom (2003) • Doctor of Philosophy in clinical research, Royal Free Hospital School of Medicine , London, United Kingdom (1995) • Doctor of medicine and surgery, University of the Basque Country , Bilbao, Spain (1990)

张海洲 医学博士

博际生物医药科技（杭州）有限公司首席执行官

Haizhou （Joe）Zhang, Ph.D., MD., DABT CEO, BJ Bioscience Inc. Dr. Zhang is the CEO of BJ Bioscience Inc., which is a biotech company with a focus on discovering and developing innovative biologics for unmet medical needs. Prior to joining BJ Bioscience, Dr. Zhang served quite a number of organizations including CFDA, Covance, Boehringer Ingelheim, and Roche with increased roles and responsibilities from scientist to vice president during his more than 20 years of professional career in pharmaceutical R&D. Dr. Zhang is a pharmaceutical industry veteran trained in the United States and China. He received his Ph.D. in Toxicology from Indiana University and is a certified toxicologist by American Board of Toxicology. He also has medical degrees from Beijing Medical University.

朱建伟 博士

上海交通大学药学院院长

朱建伟，男，博士，讲席教授，博士生导师，中组部 “千人计划”特聘专家，上海交通大学 “细胞工程及抗体药物教育部工程研究中心(筹)”负责人，首席科学家，全面主持抗体工程中心的运行和发展，从事生物技术药物的产业化研发工作。1987年毕业于中国上海医药工业研究院，并获得博士学位。曾主持国家首批“863”重组蛋白药物的产业化平台项目，并先后在美国麻省理工学院(MIT)、哈佛大学(Harvard University)和美国国家卫生国立研究院(NIH)的生物药物实验室工作，回国前任美国国立卫生研究院生物药物开发计划的技术运行总监。朱博士在美国Frederick国家癌症研究实验室工作的十六年中，共主管、主持领导了研发和生产团队对38个各类生物候选药物，2个天然候选药物的生产工艺可行性研究，工艺开发和优化，及工程放大产业化。其中15个候选药物处于生产工艺可行性研究或临床前药效研究，23个进入GMP生产以提供给早期临床I/II期的研究，1个进入临床III期。发表SCI学术论文20多篇，专利3项。近年来，朱博士在哺乳动物细胞重组蛋白表达、重组蛋白以及免疫毒素的生产工艺等方面发表了专著、综述和研究论文，具有丰富的生物药物研究、开发、产业化经验。

周新华 博士

嘉和生物首席执行官

周新华博士,嘉和生物药业有限公司首席执行官,沃森生物副总裁。中央组织部千人计划专家，还担任中国药学会药物生物技术理事会特邀副理事长、中国蛋白质药物质量联盟发起人和第一届主席、ISPE（国际制药工程协会）中国区生物药产品与工艺发起人和第一届主席、AMGEN中国校友会会长发起人和第一届主席，和北京大学国际药物工程管理硕士项目客座教授。曾任全球最大生物制药公司Amgen工艺开发科学总监。周博士在工艺研究、工艺优化、病毒清除与验证、蛋白质药物特性确定、实验室建立以及项目管理等方面具有丰富的经验。至今共发表国际专利20多篇，研发文章50多篇，工艺开发英文书籍8章，全球讲演120次。 Dr. Zhou, Xinhua (Dr. Joe Zhou) is the CEO of Genor Biopharma, a VP and the R&D head of Walvax Bio Group. He has been selected as a national expert of the TOP 1000 TALENTS program in China since 2010. Dr. Zhou also is a visiting professor teaching Master Degree Program in International Pharmaceutical Engineering Management (IPEM) at Peking University, China. He is an invited vice-chair of Biopharmaceuticals Committee under China Pharmaceuticals Society, the Founder and first Chair of China Protein Drug Quality Alliance (CPDQA), the Founder and first Chair of Biological Drug Product and Process Committee of China ISPE, and the Founder and first Chair of Amgen Aluminums Association (AAA) in China. Previously, Dr. Zhou was Scientific Director at Amgen for bioprocess development and trouble shooting for bioprocess and bio-manufacturing. He has over 20-years industrial experience of process development, multiple project management capacity in cGMP and non-GMP reproducible purification/production of protein/antibody therapeutics from FIH to CPD with depth knowledge of CHO clone selection, cell culture optimization, viral clearance, real time analytical assays, formulation and product specification for drug substances and drug products.

朱向阳 博士

华奥泰生物医药有限公司总经理

华奥泰生物制药公司，华博生物医药技术有限公司（华海制药）总经理朱向阳博士是拥有16年生物制药研发和工艺开发方面的专家。在单抗筛选和鉴定，双靶点抗体的工程改造，细胞株的建立，工艺开发, 技术转移, 中试厂房的设计和建设等领域拥有丰富经验。目前，朱向阳负责华海制药的全球生物制药研发。 加入华海制药之前，曾长期在勃林格殷格翰（BI）的不同领域和地点工作，领导和参与了30多个单抗或双靶点抗体项目的研究，其中包括目前临床二期和三期的项目。朱向阳是单抗rasankizumab的发明人和项目负责人 朱向阳在BI期间，还参与了多个生物产品的工艺开发，中试厂房的设计和建设。朱向阳获得伊利诺伊大学免疫学博士学位。朱向阳是“国家千人”特聘专家 Dr. Zhu is an expert in antibody drug discovery and process development with more than 16 years of industrial experience. He has extensive experience in antibody drug discovery (including lead generation/optimization, engineering), cell line and process development, and manufacture facility construction. In March 2014, Dr. Zhu joined Hua hai Pharm and ledits global biological research as CEO for Huaota Biopharmaceuticals (a member of Huahai Pharm).Prior to joining Huahai, he worked with Boehringer Ingelheim for more than 8 years indifferentfunction areas at multiple locations:(Ridgefield, USA; Biberach, Germany; and Shanghai, China). He led and engaged inover 30 global BI biological research projects including market products and current clinic Phase I, II and III projects. Dr. Zhu is one of the inventors and project leader for Risankizumab; healso led and participated inup/downstream process development of multiple biological products as well as in the design and construction of the pilot plant at Shanghai. From 2000 to 2005, Dr. Zhu worked at Metamorphic INC as a Senior Scientist in developing the rapeutic antibodies and fusion proteins. Dr. Zhu obtained his PhD in microbiology and immunology from the University of Illinois at Chicago and has authored more than 20 publications in peer-reviewed journals. Dr. Zhu is a receiver of the“National Thousand Talent” and has also received awards from Zhejiang province as the leader of an innovative biotherapeutical discovery team in 2014.

Shein-Chung CHOW 博士

美国FDA药物评价与研究中心（CDER)转化科学办公室生物类似药审评副主任

Shein-Chung Chow, Ph.D. is currently an Associate Director at Office of Biostatistics, CDER/FDA. Prior to joining FDA, Dr. Chow was a Professor at the Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC. He was also a special government employee (SGE) appointed by the FDA as an Advisory Committee member and consultant to the FDA. Prior to that, Dr. Chow also held various positions in the pharmaceutical industry such as Vice President, Biostatistics, Data Management, and Medical Writing at Millennium Pharmaceuticals, Inc., Cambridge, MA; Executive Director, Statistics and Clinical Programming at Covance, Inc., Director and Department Head at Bristol-Myers Squibb Company, Plainsboro, NJ. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Editor-in-Chief of the Biostatistics Book Series at Chapman and Hall/CRC Press of Taylor & Francis Group. He was elected Fellow of the American Statistical Association in 1995 and an elected member of the ISI (International Statistical Institute) in 1999. Dr. Chow is the author or co-author of over 280 methodology papers and 28 books including Design and Analysis of Bioavailability and Bioequivalence Studies, Sample Size Calculations in Clinical Research, Adaptive Design Methods in Clinical Trials, Translational Medicine, Design and Analysis of Bridging Studies, Biosimilars: Design and Analysis of Follow-on Biologics., and Quantitative Methods for Traditional Chinese Medicine Development. Dr. Chow received a B.S. in mathematics from National Taiwan University, Taiwan, and a Ph.D. in statistics from the University of Wisconsin, Madison, Wisconsin.

申梅玉 博士

美国FDA药物评价与研究中心（CDER)转化科学办公室，生物统计办公室，生物统计IV处数学统计专家

Dr. Meiyu Shen is an expert mathematical statistician, a senior statistics reviewer, and a team leader of the CMC statistics team at the Center of Drug Evaluation and Research, Food and Drug Administration (FDA). She obtained her Ph.D. in statistics from Statistics Program of Department of Mathematics at University of Maryland, College Park, in 2015. She obtained her Ph.D. in Chemical Engineering from Department of Chemical Engineering at Iowa State University in 1999. She received one FDA scientific achievement award for excellence in review science and four FDA Outstanding Service Awards for significant efforts and contributions in statistics related to reviews and research in evaluating the Chemistry and Manufacturing Control and biosimilar submissions. She has published 38 papers in the statistical, medical, and engineering journals and 2 book chapters on statistics.

Victoria CHANG 博士

美国艾伯维数据和统计科学部经理

Qualification • Ph.D. in statistics with 4 years of experience in pharmaceutical industry and national research institute • Lead statistician in Rheumatology and oncology trials from phase I to phase III • Managing Editor of Journal of Biopharmaceutical Statistics for 12 years • Research interest in biosimilarity assessment, bioequivalence test, superiority test and sample size requirement • Master of Business Administration with leadership experience in electronic industry • Statistical software skills: SAS and R Education 2011-2014 Temple University, Fox School of Business, USA Ph.D. in Statistics 2009-2011 Temple University, Fox School of Business, USA Master in Statistics, Qualified Exam: Rank 2 2001-2003 University of Southampton, School of Management, UK MBA 1997-2001 National Taiwan University, Taiwan B.S. in Landscape, Horticulture Department Employment Manager, Statistics 2017- Present AbbVie Stemcentrx, Data and Statistical Science, USA • Lead statistician for phase I ovarian programs Senior Statistician 2014- 2017 Boehringer Ingelheim, Biostatistics and Data Science, USA • Lead statistician for global Psoriatic Arthritis program • Lead statistician for global Ankylosing Spondylitis program • Trial statistician for clinical trials including Psoriasis and oncology • Experience on all phase I, phase II and phase III trials Statistician Intern 2013 June-Sep. 2012 Aug.-Dec. Food and Drug Administration (FDA), USA Center for Drug Evaluation and Research (CDER) • Statistical research on biosimilar/bioequivalence clinical trials • Delivered presentations to discuss open questions in biosimilar trials Instructor 2010-2011 Temple University, Department of Statistics, USA • Taught undergraduate courses: pre-calculus, calculus and statistics Project Manager/ Regional Manager 2005-2008 Taiwan Carol Electronics Co., Ltd, Taiwan • Taiwan Carol is a leading global OEM manufacturer of microphones, megaphones and conference systems for over 40 years • Managed the sales account of the largest two clients generating 35% of total revenue • Conducted projects and led a workforce of engineers within the R&D department • Oversaw the Asia, Middle East and North America markets in the marketing department Oncology Project Coordinator 2005 National Health Research Institute, Taiwan • Acted as liaison between the Taiwan government and the National Clinical Trial Network Coordination Center • Managed data collection, statistical analysis and preparation of reports Publication • Chow S.C., Pong A, Chang Y.W. (2006) On Traditional Chinese Medicine Clinical Trials. Drug Information Journal, 40(4): 395-406 • Chow S.C., Pong A, Chang Y.W. (2010) Traditional Chinese Medicine-General Consideration, Encyclopedia of Biopharmaceutical Statistics (3rd Edition), Chapter 221 • Chang Y.W., Tsong Y., Dong X., Zhao Z. (2014) Sample Size Determination for a Three-Arm Equivalence Trial of Normally Distributed Responses, Journal of Biopharmaceutical Statistics, 24(6): 1190-1202 • Chang Y.W., Tsong Y., Zhao Z. (2017) Sample Size Determination for a Three-arm Equivalence Trial of Poisson and Negative Binomial Responses, Journal of Biopharmaceutical Statistics, 27(2): 239-256 • Chang Y.W., Tsong Y., Dong X., Zhao Z. (2017) Sample Size Determination for a Three-arm Ratio of Mean Differences Equivalence Test, Encyclopedia of Biopharmaceutical Statistics (4rd Edition), Accepted • Chang Y.W., Tsong Y., Xia Q. Multiregional Biosimilar Trials, in progress • Journal Special Issue: Chang Y.W., Endrenyi L. (Ed.) (2017) Special Issue of Biosimilarity Assessment of Journal of Biopharmaceutical Statistics, to be appeared. Presentation/ Award Oral Presentation: Invited Apr., 2013 UMBC Probability and Statistics Day, USA Invited June, 2013 ICSA/ISBS Joint Statistics Conference, USA Invited Aug., 2015 Joint Statistical Meeting (JSM), USA Invited Oct., 2015 Duke-Industry Statistics Symposium, USA Invited June., 2017 Multiple Comparison Procedures Conference, USA Contributed July, 2013 Joint Statistical Meeting (JSM), Canada Contributed Aug., 2013 FDA ORISE Presentation, USA Contributed Aug., 2014 Joint Statistical Meeting (JSM), USA Contributed June., 2017 ICSA/ISBS Joint Statistics Conference, USA

赵蓉 博士

弘晖资本投资合伙人

Dr. Rong Zhao is currently a Venture Partner at Highlight Capital. Before this she was the Vice President at CStone Pharmaceuticals, overseeing the strategy in DMPK and clinical pharmacology. She had worked at Novartis for 6 years as the Head of Clinical PK/PD, DMPK responsible for preclinical DMPK and clinical pharmacology strategy, including first-in-human, clinical proof-of-concept, and profiling clinical pharmacology studies, to support global and China drug development. Her team was responsible for multiple submissions and approvals in China, e.g., Entresto, Ultibro, Lucentis, Omalizumab, Exelon patch, etc. Before Rong joint Novartis, she served as the Head of DMPK and project leader at Roche R&D Center China for about 4 years. And she was responsible for in-house and outsourcing DMPK activities, and provided ADME and modeling & simulation support for multiple projects in various disease areas from inception to entry into human. Rong received her B.S. and M.S. in Pharmaceutics from China Pharmaceutical University, Nanjing, China, and Ph.D. in Pharmaceutical Sciences from School of Pharmacy, the University of North Carolina at Chapel Hill, US. 赵蓉博士现为弘晖资本投资合伙人。在此之前曾在基石药业作为药代动力学及临床药理副总裁。此前在作为诺华（中国）生物医学研究有限公司药代动力学部门负责人期间，参与全球项目的临床前及临床研发与开发，包括首次人体临床试验，临床概念验证，及为支持注册的临床药理学试验，并领导团队支持诺华中国不同疾病领域的新药递交及获批（包括但不限于诺心妥，杰润，诺适得，茁乐，艾斯能贴剂）。在加入诺华之前，她作为DMPK部门负责人及项目负责人就职于罗氏研发（中国）有限公司，负责公司内部不同疾病领域的项目支持及内部和外包实验管理。 赵蓉获得中国药科大学药剂学本科及硕士学位，并于美国北卡罗莱纳大学药学院获得药物科学博士学位。

Yanguang (Carter) CAO 博士

北卡罗来纳大学教堂山分校助理教授

Short Bio – Yanguang Cao, Ph.D. Yanguang (Carter) Cao Ph.D. Assistant Professor at University of North Carolina at Chapel Hill, Adjunct Assistant Professor at SUNY Buffalo, faculty member of UNC Lineberger Comprehensive Cancer Center, US NIH outstanding investigator award recipient. His research is largely focused on pharmacokinetics and pharmacodynamics, and physiologically-based pharmacokinetics models, for large therapeutic molecules and particle-centered complex drugs. His group is particularly interested in developing system pharmacology platforms (models) integrating PK/PD to facilitate drug development and optimize therapeutics for cancers and autoimmune diseases. He has years’ experience working on target therapy, including monoclonal antibody, cell-based therapy, and nanoparticle based therapeutics. His research is greatly supported by US NIH and US FDA. So far, he has received over than 3 million federal grants as principle investigator to study the PK/PD properties of therapeutic antibodies.

王亚宁 博士

药政专家

Yaning Wang, Ph.D. Dr. Yaning Wang is currently the Director (acting) and Deputy Director in the Division of Pharmacometrics in the Office of Clinical Pharmacology at FDA. Before joining FDA, Dr. Wang received his Ph.D. in Pharmaceutics and master’s degree in Statistics from the University of Florida from 1999 to 2003. He also obtained a master’s degree in Biochemistry (1999) from National Doping Control Center and a bachelor’s degree in Pharmacy (1996) from Peking University in China. At his current position, Dr. Wang oversees reviews, research projects, and policy development within the Division of Pharmacometrics for all disease areas. During his thirteen years of service at FDA, Dr. Wang received numerous awards, including Award of Merit (the most prestigious honor awarded at FDA) and FDA Outstanding Service Award. Dr. Wang is an Adjunct Professor in the Department of Pharmaceutics at the University of Florida and an invited lecturer in the College of Engineering and College of Pharmacy at the University of Michigan. Dr. Wang is a regulatory expert lecturer for American Course on Drug Development and Regulatory Sciences (ACDRS) organized by University of California at San Francisco (UCSF), European Course in Pharmaceutical Medicine (ECPM) organized by University of Basel, and Chinese Course on Drug Development and Regulatory Sciences (CCDRS) organized by Peking University Clinical Research Institute in collaboration with University of Basel and UCSF. Dr. Wang is the chair of the FDA working group to draft a new guidance for the industry to optimize dose selection during the clinical development stage. Dr. Wang served as a committee member for multiple Ph.D. candidates from various universities. He mentored more than thirty former research fellows (visiting scholars, post-doctoral scholars, and Ph.D. candidates) at FDA. Dr. Wang is an invited manuscript reviewer for eighteen scientific journals in the medical, pharmaceutical and statistical areas. He has published 53 papers and given 130 presentations at various national and international meetings. He is a member of the Advisory Committee for Chinese Pharmacometrics Society and a member of the Editorial Advisory Board for the Journal of Pharmacokinetics and Pharmacodynamics.

胡蓓 医学博士

教授，北京协和医院l期临床研究室主任

教授，北京协和医院临床药理中心 胡蓓教授1982年毕业于北京医科大学获医学学士学位，1989年毕业于中国协和医科大学获医学博士学位。1991年至1994年在美国国立卫生研究院（NIH）福格地奖学金的资助下，在美国华盛顿大学药物化学系从事博士后研究3年。 目前担任北京协和医院临床药理中心临床药理学教授，I期临床研究室主任，从事临床药理学的教学和研究20年，至今已经发表文章70余篇。主要研究方向包括：新药的早期临床研究及定量药理学研究。

廖梦妮

北京信立达医药科技有限公司高级数据管理经理

付海军 博士

上海韧致医药科技有限公司首席执行官

HADRIAN FU 付海军 EDUCATION BACKGROUND: 1996-9→2001-6: Ph.D Department of Epidemiology and Biostatistics, Shanghai Medical Univ, China 1991-9→1996-6: B.S, M.D Zhejiang Medical Univ, China WORK EXPERIENCES: Company Position 2015-7 – Present Shanghai Zenith Medical Tech, Co, Ltd CEO 2004-7 - 2015-7 Shanghai CARES Bio-tech, Co, Ltd General Manager 2001-4 - 2004-7 Clinical Research Center, AAI China, AAIPharma Executive Director MEMBERSHIP • Secretary of Clinical Data Management working group of China • Vice secretary general of bio-statistics working group of China medical education association • Member of CFDA data management & bio-statistics guideline committee • Member of china steering committee of SCDM • Member of Medical Data Analysis Committee, China Association for Medical Devices Industry (CAMDI) • Member of Clinical Research Branch, China Information Association For Traditional Chinese Medicine and Pharmacy • Member of Clinical Research Committee, Shanghai Pharmaceutical Association EXPERIENCE: • More than 450 clinical studies from Phase I to IV covering most therapeutic areas.

王宏伟

百济神州数据管理总监

Hongwei Wang Director, Head of Data Management, BeiGene 12+ years of experience in clinical development in global Pharma and CROs, including biostatistics, SAS programming and data management. He joined BeiGene as head of data management in 2017, prior to BeiGene, he is head of China data management at Covance China, responsible to oversight Data Management Operations and Database Design team, with more than 60 team members. He also worked for Merck Serono and PRA (formerly RPS) as data management manager.

邓亚中 工商管理硕士

北京信立达医药科技有限公司首席执行官

Head of Clinical Data Analysis and Reporting Organization (CDARO), Covance, China Yazhong DENG is Head of Clinical Data Analysis and Reporting Organization (CDARO) in Covance China. Yazhong joined Covance in 2008 and set up the CDARO team in China. Within 2 years, he has successfully to expand the team to 100 employees now. Prior to Covance, Yazhong worked in an Asian CRO (Gleneagles CRC) for 7 years. He has been in different positions: Biostatistician, Data Manager, Biometrics manager, Regional head of Biometrics and General Manager for China office. Yazhong got his master degree of Biostatistics in Chinese Academy of Preventive Medicine, and degree of clinical epidemiology from Erasmus University Rotterdam. Yazhong also hold a MBA from Peking University. He is always actively involved in developing industry association in China, i.e.: Beijing Biometric Forum (BBF), C3C, and Data Management China Network (DMCN).

夏凡 博士

百济神州统计部高级主任统计师

Dr. Fan Xia currently works in BeiGene and supports the company PD-1 molecule Tislelizumab global and China development in lung and bladder, including both early phase and registrational studies . Before joining BeiGene, Dr. Xia worked in Roche and supported multiple molecules, including Atezolizumab, global MRCTs, China/Asia Pacific regional studies, and clinical development plans. Dr. Xia received her Ph.D. from statistics from the University of Hong Kong and Bachelor degree in statistics from Renmin University of China.

卜玲玲

罗氏制药生物统计与数据编程高级统计师

Lilian Bu joined Roche in 2008 and now is senior statistical scientist. Over the years Lilian has been statistician representative to provide China drug development support to a number of key oncology projects in China. She has also been study statistician involving in many global studies. Lilian obtained master degree of epidemiology and health statistics from Medical School of Fudan University and bachelor degree of preventive medicine from Shanghai Medical University.

朱超 博士

礼来中国生物统计与统计计算部负责人

朱超博士现任礼来中国统计与统计计算部负责人。在加入礼来中国之前，朱博士曾担任美国百时美施贵宝公司肿瘤免疫组肺癌项目统计师。朱博士在医药研发领域拥有超过十年的经验，先后在包括统计学以及临床试验领域在内的多种专业学术期刊及会议上发表论文、摘要和会议报告二十余篇。朱博士的研究领域涉及区间删失数据的生存分析、肿瘤临床试验设计和分析以及肿瘤免疫治中的统计学问题等。朱博士毕业于美国密苏里大学并获统计学博士学位。

黄博 博士

辉瑞全球产品研发总监

Dr Bo Huang is a Director of Biostatistics at Pfizer. He has more than 10 years of experience across all stages of global clinical development of medical products and is currently working in the field of immuno-oncology. Over the years, Bo has made significant contributions to Pfizer Oncology product development. Beyond projects, Bo has more than 30 publications in peer-reviewed statistical and medical journals, authored 2 book chapters and contributed to over 40 external oral presentations and short courses. In addition, he holds a patent in the US on cancer research. Bo received several poster and paper awards from the American Statistical Association and the International Biometric Society and is an elected Board Director of the International Chinese Statistical Association. Bo received his PhD in Statistics from the University of Wisconsin-Madison.

汪涛 博士

恒瑞医药创新药临床开发部生物统计与编程部负责人，高级总监

rief Introduction of Tao Wang Tao Wang, graduated from School of Public Health, Fudan University in 1994 and got his PhD in Biostat and Epidemiology at the University of Tokyo, Japan in 2003. He joined in Pfizer in 2006 and Hengrui in 2015. Now he is the Head of Dept. of Biostat and Programming.

殷悦 博士

基石药业生物统计高级总监

Dr. Yin is the Senior Director of Biometrics in CStone Pharmaceutical. She is responsible for building the biometrics group to support CStone’s portfolio. In addition to her functional responsibilities, Dr. Yin is also leading molecule program team, which sets the development plan of the molecule and oversees its implementation. Before joining CStone in May 2017, she was an associate director of oncology biostatistics in Roche Shanghai office. Dr. Yin led a group of statisticians, providing statistical and strategic support to Roche’s global and China HER2 and immunotherapy portfolio. Prior to her seven-year tenure with Roche Shanghai, Dr. Yin had worked in Genentech South San Francisco for three years, supporting hematology development programs. Dr. Yin obtained her PhD degree in Biostatistics from Johns Hopkins University, and her bachelor's degree in mathematics from Peking University. 殷博士是基石药业生物统计部高级总监。 她负责建立生物剂量部门，支持基石药业的产品线开发。除部门职责外，殷博士同时带领一个产品开发团队，负责制定产品发展规划并管理其实施。 于2017年5月加入基石药业之前，她曾在罗氏亚太研发中心（上海）任职7年，担任肿瘤生物统计副总监。 殷博士带领统计生物团队，为罗氏全球和中国的HER2和免疫治疗产品线提供统计和战略支持。在回到罗氏上海任职之前，殷博士曾在美国基因泰克（南旧金山）工作三年，支持血液学研究项目。殷博士于约翰霍普金斯大学获得生物统计学博士学位，于北京大学获得数学学士学位。

陈朝华

信达生物制药（苏州）有限公司首席医学官

陈朝华（Jessie Chen） ，现任信达生物制药（苏州）有限公司首席医学官，负责产品线全流程临床研究及上市后医学及药物预警支持，职能部门包括临床、注册、转化医学等。曾任辉瑞（中国）研究开发有限公司高级总监负责临床试验管理及辉瑞产品线项目管理部门，支持辉瑞中国新产品项目的规划，执行，跟踪及报告工作，从而使辉瑞研发的新药用于帮助中国的病患。此前Jessie于2008年起担任临床数据服务部门负责人，临床数据服务部门为辉瑞全球研发项目提供全流程数据管理和技术处理服务。包括支持几乎全部FIH至POC的早期研发项目（phase1/2），全部中国及以中国为主的亚洲多中心临床试验，全部日本临床试验及部分日本上市后非介入性研究项目，以及部分辉瑞全球后期研发项目（phase3/4）。在加入临床数据服务部门之前，陈朝华曾负责标准操作流程、培训及流程执行部门。在担任该职位的两年（2007-2008）里，她不仅为辉瑞全球发展运作中心提供各种职能支持，而且为亚太地区除日本以外的12个国家的医学或临床运作部门提供支持。在2007年和2008年间，陈朝华带领着一支专业的培训团队为大约300名CRA完成辉瑞内部CRA认证。在加入辉瑞中国研发中心之前，她在辉瑞中国医学部门供职8年并获得丰富的临床运作经验。陈朝华毕业于首都医科大学，临床医学专业。毕业后，她积累了三年的临床医生经验。 Zhaohua (Jessie) Chen, Chief Medical Officer, Innovent Biologics (Su Zhou) Co. Ltd., responsible to manage end to end process of clinical research for portfolio development and provide post marketing medical and pharmacovigilance support, functions cover clinical and operations, regulatory affairs, and translational medicine, etc.. Jessie used to be Sr. Director, the Head of Clinical Trial Management and Portfolio Project Management in Pfizer China R&D Center (CRDC). She leads both departments that are responsible to plan, execute, monitor, and report Pfizer China portfolio deliverables and execute clinical trials to bring Pfizer new product to China patients. Prior to it she was heading Clinical Data Services (CDS) Department since 2008. The department provides end to end data management and technical operation services to Pfizer global early development portfolio through FIH to POC (close to 100%), China and China Regional portfolio (100%) , Japan Clinical Trials (100%) and Post Marketing Surveillance studies, as well as some Pfizer global late development portfolio through phase 3 to phase 4 studies. Before that, Jessie had worked on SOPs, training, and process implementation for 2 years supporting multiple functions of Pfizer Development Operations in China R&D Center as well as the medical/clinical operations organizations in 12 countries of Asia/Pacific region (exclude Japan). During that period, Jessie had led a group of training expertise completed Pfizer internal CRA Certification program to about 300 CRAs in the region during 2007 and 2008. Prior to join CRDC, she had worked in Pfizer China Medical department for about 8 years where she obtained extensive experiences on clinical operations. Jessie was graduated from the Capital University of Medical Sciences major in clinical medicines. She started her professional experience as a physician for about 3 years.

宇井英明 博士

日本PMDA非临床及合规部检查部长

Dr. Hideaki Ui is currently Division Director, Office of Non-clinical and Clinical Compliance in Pharmaceuticals and Medical Devices Agency (PMDA), Japan. After joining to PMDA in 2008, he has worked as GCP inspector in the Office and as an International Coordinator in Office of International Programs since 2013. He was also a member of Expert Working Group of ICH-E6(R2). He graduated from Keio University, Faculty of Sciences and Technology, followed by obtaining Ph.D.in Biomedical engineering from the University in 1997. After that he joined to Kitasato Institute as a basic researcher in the field of Microbial Chemistry, and was appointed as a faculty member of Kitasato University before joining to PMDA.

孙华龙 医学博士

美达临床数据技术有限公司总经理

孙华龙 医学博士 美达临床数据技术有限公司总经理 孙华龙，日本东京大学医学研究医学博士，DIA中国顾问委员会理事成员，中国临床数据管理学组（CDMC）成员，中国医疗器械行业协会数据分析专业委员会委员，近20年临床开发经验，曾就职于默克雪来诺，PAREXEL等跨国药企和CRO, 先后担当生物统计，数据管理，项目主管，数据管理等部门负责人，在肿瘤，泌尿生殖，心血管，免疫等治疗领域的临床试验都有丰富的经验，先后在DIA组织领导多场数据管理，文档管理等培训活动，深受参会者喜爱。

谢洋

IQVIA大中华区真实世界洞察负责人,管理咨询资深总监

Dr. Xie leads the Real-World Evidence and Health Economics and Outcomes Research work at IQVIA (f.k.a. QuntilesIMS) for Greater China. He has more than 15 years of experience teaching and conducting research in real-world evidence, health economics and health policy research. Before IQVIA, Dr. Xie had been in different roles in research consulting, MNC Pharma and academia. He had served as General Manager for Pharmerit Chima, Regional Head of Real-World Evidence for MSD Asia Pacific and Emerging Markets, and Assistant Professor for Health Services Research at University of Iowa. Dr. Xie has published more than 20 manuscripts and book chapters in health services research, health economics and health policy. He had also been invited as guest speaker at Harvard University, University of Michigan, Peking University and China Pharmaceutical University. Dr. Xie holds PhD in Economics and MPH from State University of New York at Stony Brook.

宇山佳明 博士

日本药品与医疗器械管理局（PMDA)医学信息学和流行病学部部长

戴鲁燕 博士

和铂生物医药临床开发执行总监

戴鲁燕 博士 勃林格殷格翰泛亚太生物统计负责人 Dr. Luyan Dai is currently heading the Asia statistics group overseeing both teams in China and Japan and contributing to the global development at BI. She was relocated to Asia in 2012 to build up the statistics team in Shanghai for Boehringer Ingelheim. Prior to this, she worked at Boehringer Ingelheim in USA. Dr. Luyan Dai received her PhD in statistics at the University of Missouri-Columbia, USA.

索小鹏

科睿克医学研究有限公司业务发展总监

张兰 药学博士

教授，首都医科大学宣武医院药学部主任，国家药物临床试验机构副主任

张兰简历 药理学博士，医院药事管理硕士，美国哈佛医学院药物政策研究博士后。教授、研究员，博士生导师。首都医科大学宣武医院药学部主任，国家药物临床试验机构副主任。新世纪百千万人才工程北京市级人选，北京市卫生系统“215”高层次卫生技术人才---学科带头人（药学）。兼任中国药理学会常务理事、北京药理学会副理事长、中国老年保健医学研究会合理用药分会副主任委员，中国药学会老年药学专业委员会常务委员等职。 长期从事神经药理、抗衰老药理、临床药理及老年药学研究，作为课题负责人承担纵向课题21项，其中4项国家级课题，6项省部级课题。作为PI，承担药物I期临床试验20余项。获北京市科学技术一等奖1项，国家科学技术进步二等奖1项。获授权新药国际发明专利3项、中国发明专利13项。已在国内外期刊上发表论著近200篇，第一作者及通讯作者论文60余篇。

王皓

施贵宝中国临床研究运营部高级总监

王皓目前担任施贵宝中国大陆和香港地区临床研究运营部高级总监。负责多项I-III期全球多中心及中国的注册临床研究，治疗领域涉及免疫肿瘤，肿瘤，抗病毒，心血管及免疫等。 在加入施贵宝前，王皓在辉瑞中国研发中心担任临床试验流程和质量部门负责人，主要职责包括临床试验流程设计，专业培训，以及质量和风险管理。在这期间，王皓曾经担任辉瑞武汉研发中心的临时负责人，负责管理武汉研发中心的所有部门以及辉瑞总部和中国相关部门之间的协调合作。 王皓在制药行业有超过19年的成功经验，包括在临床研究运营，培训和质量管理等多个领域。在施贵宝和辉瑞之前，她在礼来中国负责肿瘤领域的临床研究运营。 王皓是医学硕士，研究方向为炎性肠病。

刘海涛

杨森（中国）研究开发中心生物研发质量合规部，质量计划与策略副总监

刘海涛 (Heidi Liu) 现就职于强生（中国）投资有限公司杨森（中国）研究开发中心生物研发质量合规部，担任质量计划与策略副总监。 自上海医科大学临床医学专业毕业后，于复旦大学附属中山医院从事临床工作。2003年赴澳洲学习，获悉尼大学国际公共卫生硕士学位后，开始介入药物临床研究工作，为世界卫生组织热带疾病研究与培训特别项目署（WHO/TDR）的临床项目担任临床监察与稽查工作。2006年作为访问学者赴美国西部伦理委员会（WIRB）学习。自2006年担任FERCAP （亚太地区伦理委员会论坛）医学官员，在亚太地区进行药物临床试验质量管理规范（GCP）与伦理审查培训及伦理委员会评估工作。2009年至2010年就职于复旦大学附属华山医院，负责药物临床试验质量管理以及GCP和研究伦理培训工作。2011年就职于北京大学临床研究所，负责完善北京大学生物医学伦理委员会的建设，以及北京大学生物医学研究项目的伦理咨询工作和伦理相关的培训项目。2012年开始从事药企临床研究稽查工作。 Currently Heidi Liu is acting as Associate Director of BioResearch Quality & Compliance at JnJ Janssen Research and Development Center. Graduated from Shanghai Medical University, Heidi had her clinical practice in Shanghai Zhongshan Hospital as a General Physician. She completed her Master Degree of International Public Health in Sydney University in 2004. For the past 13 years, she has been working in the field of clinical trials. This has included experience in pharmaceutical company as clinical monitor and project manager, monitoring and auditing WHO TDR’s projects, medical officer of Forum of Ethical Review Committees in Asian & Western Pacific Region (FERCAP), Training and Compliance Officer in the Clinical Research Institute of Shanghai Huashan Hospital, Fudan University, the Office Director for Peking University Institutional Review Board, mainly responsible for IRB administration, developing and implementing IRB policies and procedures, providing and organizing training activities. She joined industry in 2012 taking the role as quality assurance professional for GCP audit since then.

王在琪 博士

罗氏早期医学部门负责人

王在琪 医学博士 罗氏研发（中国）有限公司 罗氏创新中心上海 负责人 王博士 1983 年毕业于河南医科大学，1992 年在美国获得生物化学 博士学位，同时具有美国内科医生和临床药理资格证书。王博士有近二十年临床研究 经验，从首次人体到IV 期临床试验，在多个治疗领域、多个国家、多个著名的制药 企业积累了丰富的国际临床研究经验；王博士先后在美国礼来、先灵葆雅、默沙东工 作，并于2009 年在新加坡建立MSD 临床转化医学中心，2011-2017 年为默沙东 中国临床研究负责人，带领团队完成了多个新药的注册和批准。

张玥

博纳西亚临智（上海）数据科技有限责任公司总裁

张玥 /Carrie ZHANG 博纳西亚临智（上海）数据科技有限责任公司 总裁 CEO， eClinWise Co.，Ltd. Panacea Technology Co., Ltd. SCDM Global Board Member 曾多年就职默沙东全球数据管理中心并任亚太区负责人。在加拿大蒙特利尔大学医学生物信息中心、MDS Pharma Services 中心实验室、中国疾病预防控制中心、默沙东研发等国际、国内和跨国公司从事了近23年的临床研究数据管理和运营工作, 对国际国内临床试验数据管理法规及专业知识有着深入的理解和丰富的经验。现为临床数据管理协会SCDM全球委员会委员、中国临床试验数据管理学组CDMC成员。曾多次在DIA、SCDM全球年会、中国制药工业协会、北京药理学会等国际国内的重要业界年会、年度培训上受邀为会场主席或演讲嘉宾。 Carrie has more than 23 years’ experience working on clinical data management and project operation. She has been the Head of Merck Global Data Management&Standards Data Management Center in Asia Pacific and working in Merck global data management function for more than 5 years. Carrie has rich working experience globally in University of Montreal Bioinformatics Center, MDS Pharma Services Central Lab, MSD R&D (China) Co., Ltd, and Chinese Center for Disease Control and Prevention, cumulated in depth understanding and knowledge across international, domestic, transnational corporations of global pharmaceutical industry. She is the Society for Clinical Data Management (SCDM) Global Board Member, member of China Data Management of China (CDMC), and has been invited by DIA China and China pharmaceutical industry key committees as panel chair or invited speaker in annual meetings and industry wide workshops.

沈彤

强生中国研发中心临床数据管理总监

清华大学学士，纽约大学硕士 现任杨森中国研发临床数据管理总监 具有20余年跨国药企数据管理经验，SCDM认证临床数据经理CCDM™ 中国临床试验数据管理学组核心成员，中国临床试验数据管理学组数据管理计划和数据管理报告学组组长 中国临床试验数据管理计划和数据管理报告专家共识主要撰稿人 临床数据管理协会中国指导委员会成员

王柯 博士

礼来中国资深研究顾问

Dr. Ke Wang currently works as a Senior Health Outcomes Consultant (Associated Director) in Lilly China and has more than 10 years of experience in HEOR and biostatistics at affiliate and global functions of Lilly and Abbvie. He obtained his PhD degree in biostatistics from Boston University, master degree in neuroscience from UBC, and bachelor degree in Biology from Tsinghua.

陈峰 博士

南京医科大学公共卫生学院院长中国卫生统计学会统计理论与方法专业委员会主任委员 中国临床试验生物统计学组（CCTS）组长

陈峰 教授 南京医科大学研究生院院长 中国卫生统计学会统计理论与方法专业委员会主任委员 中国临床试验生物统计学组（CCTS）组长 Feng CHEN, Professor Dean, Graduate School, Nanjing Medical University Chair of China Association of Biostatistics (CABS) Chair of China Clinical Trial Statistics (CCTS) Working Group

许燕勋 博士

约翰霍普金斯大学助理教授

Dr. Yanxun Xu is an assistant professor in the department of Applied Mathematics and Statistics in Whiting School of Engineering at Johns Hopkins University. She is also an adjunct assistant professor in the department of Biostatistics in Bloomberg School of Public Health, Institute of Data Science, Division of Biostatistics and Bioinformatics in School of Medicine at Johns Hopkins University. Dr. Xu’s research focuses on Bayesian early-phase clinical trial designs, machine learning methods for electronic health/medical record data, and cancer genomics. Her research has appeared in many high-impact journals, such as Nature Biotechnology, Cancer Cell, JASA, JMLR, etc.

孙鑫 博士

四川大学华西医院中国循证医学中心主任、ISPOR华西分会主席， 中国版《真实世界研究规范》筹划及牵头人、博士生导师

孙鑫，教授，博士生导师。入选国家中组部“青年千人计划”。现任四川大学华西医院中国循证医学中心主任、IDEAL中国中心主任（外科临床研究机构）、ISPOR华西分会主席, 以及《中国循证医学杂志》和《Journal of Evidence-based Medicine》执行主编。发起建立了中国真实世界数据与研究联盟（ChinaREAL）。先后获得来自国家自然科学基金、国家科技部重大专项/重大研发计划等课题20余项。发表SCI论文77篇，其中在权威医学杂志（含NEJM、JAMA、BMJ）发表13篇。获BMJ杰出研究成就奖。

狄佳宁 博士

强生公司统计和决策科学部中国区负责人，总监

朱笛

江苏恒瑞医药股份有限公司临床数据科学中心高级经理

朱笛 恒瑞临床数据科学中心 - 高级经理 从事数据管理相关工作8年。现任职于恒瑞医药，主要负责数据管理相关项目和团队的管理、以及部门流程、质量和培训相关的工作。2012年加入罗氏药品临床研发亚太中心，任高级项目数据经理，主要负责肿瘤药上市前国际多中心临床研究的数据管理相关工作。2010年加入Paraxel，担任临床数据管理员，主要负责来自日本申办方的临床研究数据管理相关工作。

张薇

葛兰素史克（上海）医药研发有限公司临床数据管理部门负责人

Wei Zhang is currently the Head of Data Management at GSK China R&D center Shanghai. Prior to joinging GSK, Wei worked at Pfizer US and China R&D Center taking project data manager and the DM TA lead roles after working as a data management project coordinator at Indiana University (IU) School of Medicnine. Wei started her career as a data manager providing end to end data strategy from CRF design to delivering statistical analysis datasets for IU medical school clinical studies, where she also helped IU cancer center build the first EDC system. Wei has rich experience in EDC design and setup, SAS programming, and project management. She has also led vaious projects in building digital platform, quality, innovation and continous improvement into data management processes. Wei earned her bachlor’s degree in clinical medicine from Beijing Medical University, and a MS in Computer Science from Purdue University in US.

孙华龙 医学博士

美达临床数据技术有限公司总经理

郭彤 博士

IQVIA大中华区销售副总裁

Tong GUO, PhD Head of Global Biostatistics Africa & Asia Group at QuintilesIMS Dr. Tong Guo is the Head of Global Biostatistics Africa & Asia Group at QuintilesIMS. In this position, Dr. Guo oversees the off-shore Biostatistics functions in Africa and Asia. Prior to QuintilesIMS, Dr. Guo was the Head of Global Data Sciences & Analytics Beijing R&D Center at Bayer HealthCare, leading a team of biostatisticians, clinical programmers and clinical data managers to support the global, regional and local clinical development programs. Dr. Guo had worked as the Vice-President and Head of Clinical Informatics & FSP at WuXiPRA, and had successfully established & grown the FSP Business Unit at WuXiPRA. Before joining WuXiPRA, Dr. Guo was the Head of Biostatistics and Life Sciences BPS at Cognizant Technology Solutions (Shanghai) and led the establishment and enhancement of Biometrics capacities in China. Dr. Guo began his clinical research career in 1998 as a Biostatistician at McMaster University in Ontario, Canada. He was a Biostatistician in the United States in both CRO (MDS Pharma Services) and pharmaceutical companies (Bristol-Myers Squibb and Johnson & Johnson) with increasing responsibilities. Tong received his M.Sc and Ph.D. degrees in Biostatistics from McGill University, Montreal Canada. 郭彤博士现任昆泰艾美仕公司亚太及非洲生物统计执行总监，负责昆泰公司生物统计全球欧美以外的离岸团队及交付业务。郭彤博士曾获加拿大麦吉尔大学生物统计学硕士及博士学位。具有近二十年的国际大制药公司新药研发经验。曾任拜耳医药保健有限公司北京国际研发中心，数据科学与分析亚太总监；上海康德保瑞医学临床研究有限公司副总裁，临床信息及FSP业务部门负责人；高知特信息技术(上海)有限公司生物统计及生命科学BPS部门主管；美国百时美施贵宝主任生物统计师及美国强生研发总部生物统计师；并在加拿大麦科马思特大学心血管项目中心及兰州生物制品研究所从事过研究工作。主持过多个全球多中心临床试验的统计设计及分析。特别是对生物统计及大数据分析在生命科学及新药研发上的应用方面颇具建树。

刘群

诺华制药临床研究开发部肿瘤临床研究经理负责人

刘群 北京诺华制药有限公司临床开发部肿瘤临床研究负责人 从2008年起至今就职于北京诺华制药有限公司临床开发部担任肿瘤临床研究负责人。从临床监查员、临床项目经理、临床研究经理到现在作为所有肿瘤临床研究的负责人，从事临床研究工作近16年，积累了丰富的经验。特别是最近十年在诺华一直专注于肿瘤领域的临床研究管理工作。多次顺利通过中国、美国、欧盟和日本官方的核查。对整个临床研究的管理有自己一套独特的思路。刘群女士本科毕业于上海第二军医大学药学系，并获得第二军医大学医学统计专业硕士学位，现于清华大学经管学院攻读MBA。

曹晓春

泰格医药科技股份公司执行副总裁兼董事会秘书

曹晓春 联合创始人、董事、执行副总裁、 董事会秘书、思默总经理 • 协助泰格医药总裁一起负责管理泰格医药集团整体事务，分管集团人力资源、行政、政府事务等职能部门。全面负责杭州思默医药科技有限公司日常工作 • 浙江中医药大学中医专业毕业,浙江大学药学院药学硕士，执业药师,高级工程师 • 近25年药品研发、注册和临床研究工作经验，15年企业管理经验。 Xiaochun Cao Co-founder, Board Director, Executive Vice President,, Board Secretary,, General Manager of SIMO • Assist the chairman to manage the whole business of Tigermed. Be responsible for the functional departments of Human Resources, Administration, Government Affairs, and etc. Be totally responsible for the daily work of Hangzhou Simo Co., Ltd. • Assist the chairman to manage the whole business of Tigermed. Be responsible for the functional departments of Human Resources, Administration, Government Affairs, and etc. Be totally responsible for the daily work of Hangzhou Simo Co., Ltd. • Nearly 25-year working experience of drug research and development, register, and clinical research, with 15 years of experience in business management.

韩滢滢

索元生物临床运营副总裁

韩滢滢 Isabel Han Executive Director, Clinical Operations, Denovo Biopharma 公司名称Denovo Biopharma 入职日期2016 年 9 月 - 至今 任职时长•1 年 8 个月 Covance Director, Head of Operations, Clinical Development Service, China 入职日期 2013 年 1 月 - 2016 年 7 月 Actelion Clinical Development Director 入职日期 2011 年 11 月 - 2013 年 1 月 教育经历 • Beijing Medical University, now as Peking University Health Science Cente

刘致显

精鼎董事会副主席

Albert Liou serves as Vice Chairman of the Board for Asia-Pacific and is responsible for the overall business and operations for the region Before joining PAREXEL, Albert founded APEX International Clinical Research, which PAREXEL acquired in 2007. Under his leadership, APEX grew rapidly over nine years to become one of the largest CROs in the Asia-Pacific region with a presence in China, Taiwan, Hong Kong, South Korea, Malaysia, Thailand, Singapore, The Philippines, Australia, Indonesia and India. Work Experience Mr. Liou has over 30 years of clinical research experience, of which 11 years were spent in the United States and 19 years in Asia. After working at Harvard Medical School as a Senior Statistician, he had managerial role in biopharmaceutical companies such as Liposome Technology Inc. which later became part of Johnson & Johnson. He then worked at Amgen where he was a member of the senior management team, responsible for clinical data management. He then returned to Asia and founded APEX International which became a leading CRO in the Asia/Pacific region. In addition to his professional responsibilities, Albert was an Advisor Committee member in the Development Center for Biotechnology of the Republic of China. He also has served as an Assistant Professor at Fu-Jen Catholic University from 2006~2010 and 2015.

吴䶮 博士

和黄医药副总裁

Dr. Yan Wu is vice president, head of Clinical Operation and head of Immunology Development in Hutchison MediPharma. He leads the clinical team to manage 30 studies in oncology and immunology worldwide. Over the past 20+ years, Yan has worked at several multinational companies with increasing responsibilities, including Project Manager with Astra, Clinical Manager with Quintiles, Head of Clinical Development with Boehringer Ingelheim, Biogen and Daiichi Sankyo. Yan has extensive experience in medical affairs and clinical development of pharmaceutical products including building up and leading Asia clinical research hubs and managing collaborations with academic institutions, hospitals and CROs.

任科

上海药明康德新药开发有限公司副总裁兼SMO事业部津石医药负责人

任科，药明康德津石医药科技有限公司副总裁 担任DIA中国SMO协作组主任委员，中国药物临床试验机构联盟青年委员会副主任委员。在《医药经济报》、《China Sourcing》、《E药经理人》等专业杂志发表十多篇文章 在临床研究领域工作15年，在药明康德、CCBR、PPD/依格斯、阿斯利康、三九医药积累了包括跨国药企、国内药企、跨国CRO、本土CRO和SMO各个业态的工作经验 从事过包括CRA, 临床研究经理，商务总监，数据管理总监，总经理的全面工作 参与过上百项肿瘤、心血管、呼吸、消化、内分泌、免疫、神内、眼科、感染等多方面创新药的临床开发

Lynn EVANS

杨森公司生物研究质量与合规，质量规划与策略负责人

Denise REYES

TransCelerate生物制药临床基地委员会项目总监

Denise Reyes Program Director, Sites Subcommittee, TransCelerate BioPharma Inc Denise started her career in 2001 at the University of Pennsylvania supporting Academic Research Trials in Neuroscience, focusing on Addictions Medicines. In this role, Denise served as Primary Study Coordinator, but also co-designed CRFs with Principal Investigators and developed a home-grown Web Based Data Capture system. Denise transitioned into the Pharmaceutical Industry, working for AstraZeneca for the next 11 years. In her role at AZ, Denise held various leadership roles in Clinical Operations, with a primary focus on Innovating & Improving the Process & Technology needed to execute Trials. Denise has experience in the development and delivery of large, global, transformational projects in both areas of clinical business processes and technologies. This experience led to the acceptance of her current role at TransCelerate, where Denise is accountable for the delivery of such transformational initiatives, like the Shared Investigator Platform. Denise spent her last year at AZ in Shanghai as Business Strategy & Planning Director, responsible for the placement of Global Trials across the Asia Region. In this role, Denise learned the intricacies of the global clinical trial landscape in China. Denise is currently the Program Director for the Site Subcommittee where she has responsibility for integrating the investigator site perspective and overseeing all TransCelerate’s site-facing initiatives with a common goal of reducing burdens on sites, while enhancing the site & sponsor relationship.

戴欣

武田公司亚洲临床运营负责人

戴欣 医师 / Paul DAI , MD 北京诺华制药有限公司，国际临床开发部大中华、亚太、中东及非洲区域高级总监Senior Director, Regional Head of ICRO AMAC & Greater China Region, Beijing Novartis Pharma Co., Ltd. 戴欣医师目前就任北京诺华制药有限公司临床研发高级总监，主要负责东北亚地区(大中国区、台湾及韩国)的临床运营。他在医药行业有近16年的工作经验，先后在一些大的制药公司如诺华、礼来制药公司和葛兰素史克公司任职。他毕业于北京大学医学院，之后成为北京心血管和肺疾病研究中心和北京安贞医院的心脏科医生。他深入参与中国多种治疗领域的临床开发及医学事务，包括心血管、神经系统、乙型肝炎、糖尿病、呼吸疾病、肿瘤及抗感染疾病等。戴欣医师经常在各种学术会议上做演讲。 Dr. Paul Dai is currently working for Novartis as Director, Clinical Development, responsible for clinical operation activities in Northeast Asia region (Greater China, Taiwan and Korea). He has been working in the pharmaceutical industry for almost 16 years in couple of big pharma companies like Novartis, Eli Lilly and GSK. He graduated from medical school of Peking University and then became cardiologist in Beijing Cardiovascular and Lung Disease Research Center and Beijing Anzhen Hospital. He got deeply involved in clinical development and medical affairs in variety of the therapeutic areas including CVS, neuroscience, Hepatitis B, diabetes, respiratory, oncology and anti-infectious diseases in China. Dr. Dai participated in many scientific conferences as speaker/panelist.

陈华

强生中国质量策略总监

陈华 / Hannah CHEN 强生公司质量策略亚太总监 Director, AP, Quality Strategy, Johnson & Johnson Hannah于2012年9月份加入强生亚太与中国研发机构的生物学研究质量与合规部门（BRQC) 担任质量总监. 2016年9月起，她担任生物学研究质量与合规部门中国区负责人，负责亚太区和中国区研发部门质量管理系统中战略性地整合质量保证与合规性的内容。在加入强生公司之前，Hannah曾在葛兰素史克公司工作15年，其中有10年时间从事审核工作。她曾在亚太地区的很多国家从事药物临床试验管理规范方面的审核工作，也在美国、欧洲、拉丁美洲和非洲的很多国家工作过。自2009年起，她就与FDA中国办公室和CFDA密切合作，在药物临床试验管理规范等方面提供了大量的咨询并起草指南性文件。 Hannah is leading a team of auditors in AP region covering: non-regulated, GLP, GCLP, GCP and PV audits; she also provides strategic input to audit program to ensure risks in AP region are communicated and reflected in the audit program. She joined Johnson & Johnson in September 2012 from GlaxoSmithKline (GSK). She has worked for GSK for more than 15 years, including 10 years in the area of auditing. Hannah conducted a variety of GCP audits in many AP countries, as well as in US, Europe, Latin America and African countries. She also has experience in PV system audits and clinical lab audits. She has been involved in many internal and external training programs, assisted US FDA inspection training workshop in China from April 2010 to Oct. 2012. Hannah has been working closely with China FDA since 2009, provides consultation and involves in the development of guidance documents in GCP area. Hannah has also spent approximately 5 years in Clinical Research. Prior to joining GSK, Hannah worked for almost 8 months as a sales representative in Mead Johnson. Hannah obtained her Medical Degree from Capital University of Medical Sciences in China and worked as a Pediatrician for years before joined industry in 1996

曹烨 博士

中山大学附属肿瘤医院临床试验中心机构办公室主任，助理研究员

曹烨，女，肿瘤学博士，现任中山大学附属肿瘤医院“临床研究部/药物临床试验机构”办公室主任，SAE和培训专员 2000年本科毕业于中山医科大学, 后一直在中山大学附属肿瘤医院“国家药物临床试验机构／临床研究部”工作至今。2011年取得肿瘤学博士学位。2012年2月－2014年1月期间赴美国哈佛大学医学院DF/HCC癌症研究中心进修学习临床研究管理。 工作期间参与过多项新药临床试验，先后参与1类I期新药研究，国际多中心II-III期临床试验20余项和国内注册临床试验多项。参与国家“863”、“十一五”科技攻关项目“抗肿瘤药物临床试验平台建设”；受邀在中华医学会和中国药学会主办的“中国制药医学大会”和第二届DIA中国年会上进行论文交流和大会发言，2011年4月受邀在美国ACRP年会上交流“中国研究护士培养与管理模式”。发表过多篇临床研究管理论文。 社会任职：广东省药学会药物临床试验专业委员会秘书长，青年委员会主任委员。

丁劼

默沙东生物统计与研究决策科学部亚太区负责人，高级总监

Dr. Jie Ding has been working as an industrial statistician in the US since 2002 in global pharmaceuticals including GlaxosmithKline (GSK), and currently at Merck Sharp & Dohme (MSD). Jie has extensive experiences in clinical trials, across multiple therapeutic areas including oncology, infectious diseases, diabetes, and neurosciences. Most recently Jie was the project lead statistician on Keytruda (PD-1) MSI-H indication US FDA submission and approval at Merck Sharp & Dohme. Jie transferred to Merck Sharp & Dohme China in November 2017, and currently is Sr. Director, the site head of Biostatistics and Research Decision Sciences – Asia pacific (BARDS-AP) at Merck.

游广智 工商管理硕士

香港大学临床试验中心执行总监及名誉助理教授

周立萍

默沙东亚太区质量保证总监

周立萍 / Liping ZHOU 默沙东研发（中国）有限公司亚太区质量保证总监 Director, Quality Assurance, Asia Pacific, MSD R&D (China) Co., Ltd Liping有15年的跨国制药企业工作经验. 加入默沙东（研发）有限公司前，Liping就职于拜耳医药保健有限公司全球研发质量保证部门，曾先后从事GCP/GPvP (Good Pharmacovigillance Practice) 稽查 和 药监部门检查的管理工作，足迹遍及亚太及欧、美地区。从事质量保证工作以来，Liping积极参与中国QA论坛（CQAF）的建设及质量保证活动, 致力于与业内同仁及专业人士合作，共同推动中国药物临床试验的质量。Liping 与1999年毕业于北京医科大学（现北京大学医学部）。

焦庆安

强生（中国）投资有限公司全球临床研究运营部高级总监

焦庆安 医师 / Qinan JIAO, MD, MSc 西安杨森制药有限公司全球临床研究运营部高级总监 Sr. Director, Global Clinical Research Operation, Xian Janssen Pharmaceutical Co.,Ltd. 焦庆安医师目前是杨森（中国）研发中心全球临床研究运营部高级总监，负责中国临床研究运营部的管理。 他在药物开发和临床研究领域拥有20多年的丰富的项目管理和人员管理经验。 在加入杨森公司之前，焦庆安医师在罗氏、赛诺菲、MDS Pharma Services及辉瑞公司的中国或亚太研发中心就任不同的管理或高级管理职位，管理了中国或亚太区的不同规模的临床研究团队和多项国际多中心临床试验。 他于1986年获得临床医学本科学位，1989年获得医学免疫学硕士学位。 焦庆安医师曾是DIA中国区临时顾问委员会成员，并经常被邀请在国内外药物研发的大会或研讨会上做关于药物临床研究方面的专题演讲或参与嘉宾讨论。 Dr. QingAn JIAO is currently Senior Director, Head of Global Clinical Operations (GCO) China, at Janssen (China) Research & Development Center, a Division of Johnson & Johnson (China) Investment Ltd. He has over 20 years of experience in drug development and clinical research, and is very experienced in managing clinical trials and clinical operations team in China and in Asia Pacific. Prior to joining Janssen, he was taking different management or senior management roles in China or Asia Pacific R&D Center at Roche, Sanofi, MDS Pharma Services and Pfizer, managing medium or large sized clinical operations team, with extensive experience in the management of multinational clinical trials in China and in Asia Pacific. He received his Medical degree in 1986 and Master degree in Medical Immunology in 1989. He has spoken at various international and national conferences and seminars on topics of clinical research and R&D activities, and was one of the members of the DIA Provisional Advisory Council of China (pACC).

薛松林 博士

美国安斯泰来公司全球药物警戒执行副总裁、主管

1982年获山西医学院医学学士，1985年获湖南医学院医学硕士。1986－1988 在广州医学院预防医学及肺癌教研室任讲师和副主任。1988年赴美留学于1992年获美国明尼苏达大学流行病学博士。 1992年以来就职于数家大型国际医药公司，包括 Roche（罗氏），Pfizer（辉瑞）， Novartis (诺华)，Takeda（武田）从事药物临床安全评价及药物流行病学方面工作。先后曾但任资深临床流行病学家， 临床安全医学总监，资深医学总监，助理副总裁，副总裁，资深副总裁。现任 Astellas（安斯泰来）公司执行副总裁，主管全球药物警戒，临床安全评价，药物流行病学，药物安全风险管理， 以及安斯泰来在五十多个国家的药物警戒部门。 近些年来，薛松林还担任国际药物流行病学学会董事会成员和全球发展委员会主席，世界卫生组织药物临床安全知囊团成员， 美国FDA与药物研发协会共同组织的药物肝脏安全执委会成员，美国药物研发协会流行病学专家委员会成员，中国预防医学教育理事会成员, 以及中国药物流行病学会专业委员会理事。薛松林任中国中南大学湘雅医学院客座教授。 Songlin Xue, M.D., Ph.D., is Executive Vice President and Head of the global Pharmacovigilance for Astellas. In this position he leads a global pharmacovigilance organization which includes pharmacovigilance operation and processes, medical safety, risk management, and epidemiology functions for clinical development compounds and for post-approval products worldwide. Before he joined Astellas, Dr. Xue served in a number of positions such as Clinical Epidemiologist, Associate Medical Director, Medical Director, Senior Medical Director, Assistant Vice President, Vice President, and Senior Vice President at several international pharmaceutical companies including Hoffman-La Roche, Pfizer, Wyeth, Novartis, and Takeda. Dr. Xue received his medical training in China and epidemiology training in the United States. He developed his core career in the areas of clinical drug safety and pharmacoepidemiology. He also developed interest and expertise in risk management and benefit-risk assessment. Dr. Xue has been an active member of several organizations and committees including International Society for Pharmacoepidemiology (as a Board Director 2007-2010), US PhRMA/FDA Liver Toxicity Steering Committee (2010-2007), PhRMA Pharmacovigilance and Epidemiology Committee (2001-2008), Think-Tank member for the World Health Organization Collaborating Center for International Drug Monitoring (2003-2010), WHO CIOMS VIII Working Group (2007).

Dalvir GILL

TransCelerate首席执行官

Dalvir Gill Chief Executive Officer, TransCelerate BioPharma Inc. Dalvir Gill, PhD, is the Chief Executive Officer of TransCelerate and serves on its Board of Directors. Dr. Gill has more than 25 years of drug development experience. Prior to his appointment as CEO of TransCelerate in December 2012, Dr. Gill was the President of Phase II-IV Drug Development at PharmaNet-i3, an international contract research organization. In this role, he was responsible for a global business spanning nearly 40 countries and had P&L responsibility for all operational departments and business development. Dr. Gill earned his BSc in Applied Biology from the University of Hertfordshire and his PhD in Pathobiology from the Royal Free Hospital School of Medicine, University of London. He also holds a diploma in the health economics of pharmaceuticals from the executive program of the Stockholm School of Economics. Dr. Gill has presented his research and spoken at numerous conferences, and has authored more than 30 scientific publications. He also is an elected fellow of the Royal Society of Medicine.

Janice CHANG

TransCelerate运营高级副总裁

Janice Chang Senior Vice President, Global Operations, TransCelerate BioPharma, Inc. Janice Chang is the Senior Vice President, Global Operations at TransCelerate Biopharma Inc. In her position, Janice works closely with the CEO and the Board of Directors to shape the long-term strategic vision and objectives for the organization. Janice also works closely with the CEO to define TransCelerate’s overall external engagement strategy and identify synergistic opportunities with other industry groups and regulatory bodies. Since 2013, she has played an instrumental role in launching and delivery the five initial initiatives, as well as shaping the newly launched initiatives in 2014. Janice has the overall accountability of overseeing TransCelerate’s corporate operations and the ongoing delivery of the Board-approved initiatives. Janice has 15 years of industry experience working across large pharma, biotechnology, and medical devices environments. She has extensive experience in delivering transformational programs to help pharmaceutical companies define business strategies, implement global, complex technology solutions, as well as process and organizational redesign and implementations. Janice also has a deep background in regulatory compliance, having worked closely with various Quality organizations across the industry. Prior to joining TransCelerate, Janice was part of Accenture Management Consulting’s Global Life Sciences R&D leadership team.

徐敏 博士

派格生物医药（苏州）有限公司首席执行官

徐敏，派格生物医药(苏州)有限公司CEO，在徐敏看来，中国的创新药必然是从me-too到me-better，最后实现first-in-class的历程。“新药研发需要十几年的时间，每个环节是非常细分化的，所要求的知识面和经验不一样。因此，一个人不可能把一个药的全部流程都了解得很清楚，包括对技术的把握度、对法规的认知。”也许，正是这份诚实和谦逊支撑他走过许多创业的曲折。

高璐 博士

罗氏上海创新中心病毒研发部, 免疫、炎症及抗感染疾病领域高级总监，病毒研发部负责人

Dr. Lu Gao is a Senior Director and Head of Virology in Roche Research and Early Development. Since joining Roche Innovation Center Shanghai in 2008, Lu has established research team, strategy, and portfolio in respiratory viral disease area and Hepatitis B disease area, and led a number of innovative projects from discovery, through IND filing, into clinical trials globally. She has broad drug discovery experience in infectious diseases, immunology, and oncology programs using small molecule, large molecule, and RNA therapeutic approaches. She obtained her B.S. in Biochemistry and Molecular Biology from Peking University and Ph.D. in Molecular Microbiology & Immunology from University of Southern California. Her postdoctoral training at Ludwig Institute for Cancer Research focused on post-translational modifications in DNA-damage signaling pathways. She was a research scientist in translational medicine of oncolytic viral therapy at University of California, San Diego.

吴劲梓 博士

歌礼生物科技（杭州）有限公司创始人

吴劲梓 博士Jinzi J. Wu, PhD 国家“千人计划”特聘专家，中科院药物所客座研究员。在创立歌礼之 前，曾担任葛兰素史克公司（GLAXOSMITHKLINE，世界第三大制药 公司，全球500强企业）副总裁（美国），负责艾滋病新药的全球研发 。他还曾先后担任加拿大Ambrilia生物制药公司副总裁；美国安进公司 （AMGEN/IMMUNEX）部门主任；诺华美国（NOVARTIS）资深研 究员，部门主管；安万特公司（AVENTIS）（美国）资深生化科学家， 项目主管。拥有20多年新药研发经验，直接负责和领导其团队成功开发 了多个世界领先的抗肿瘤和传染病的临床新药。获美国亚利桑那大学癌 症生物学博士学位。吴劲梓博士是著名的百华协会会员。 • Prior to founding Ascletis, Dr. Wu was Vice President, global HIV Drug Discovery, GlaxoSmithKline based on Research Triangle Park, NC, with responsibilities ranging from target identification to clinical development. • Before joining GlaxoSmithKline, he was Vice President, Ambrilia Biopharma in Montreal. He was directly responsible for the discovery and development of multiple clinical-stage drugs at Ambrilia. • During his 20+ years drug discovery and development career, he also held senior management positions with increasing responsibilities at Immunex/Amgen, Novartis and Aventis. • He received his PhD in Cancer Biology from University of Arizona, Tucson, Arizona, USA. • A member of China National “Thousand Talent Program” .

张昕伟

葛兰素史克传染疾病和公共卫生研究院临床开发副总监

Xinwei Zhang graduated from Medical School of Qinghai university majored in clinical medicine and then joined Center for Disease Control and Prevention in 1998. After working on several infectious disease control projects and Expanded Program on Immunization in Qinghai CDC for more than 8 years, he went to the University of Tokyo as a visiting researcher. Mr. Zhang received his Master of Medical Science Degree from Department of Global Health Policy, University of Tokyo in 2010 and then returned to China in same year. From 2010-2016, he worked in Sinovac Biotech company, MSD Pharmaceutical Co. and Xian Janssen Pharmaceutical Co. respectively for medical affairs and clinical development mainly focusing on vaccine and infectious disease compound development. Mr. Zhang joined GSK China R&D in late 2016 and currently is a Physician Project Leader in Institute for Infectious Diseases and Public Health.

杨大俊 博士

亚盛医药董事长兼首席执行官

杨大俊 共同创始人、董事长、首席执行官 “中组部”千人计划特聘专家，医学博士、遗传学博士 二十余年癌症新药研发经验 美国Ascenta和亚盛医药共同创始人，曾组建四个新药研发公司及其管理, 融资, 策略, 合作谈判及商业开发 曾任晨兴创投集团生物技术及医药董事总经理 美国乔治城大学和密西根大学内科学副教授，曾获得美国NIH、癌症基金会、NCI RAID等专项研究经费近1000万美元 论文及摘要100多篇, 十多项国际专利及专利申报 美国华人生物医药科技协会（CBA）创始会员、前会长，百华协会（BayHelix)会员 获国家药监局药审中心特殊贡献奖

Gregory FANNING 博士

强生中国研发中国探索中心负责人

Gregory Fanning Bio Gregory Fanning is the joint Head of Shanghai Discovery Centre, Janssen with an 18-year career in Pharmaceutical research that includes Gene therapy, small molecule and translational science research. He is driven by the belief that nobody should die of an infection and has led multidisciplinary teams on infectious disease projects from early discovery through to Phase I/II development. Greg’s responsibilities include building the discovery capabilities in China for Janssen as well as the end to end strategy for Hepatitis B research and development in China for the global infectious disease therapeutic area. He has a PhD from Oxford University in Genetics and a BSc in biological sciences.

徐颐

观合中心实验室首席执行官

Rajan GEORGE 博士

Chimigen公司总裁兼首席科学官

Rajan George, M.Sc, Ph.D Currently, President and Chief Scientific Officer of Chimigen Inc. and Akshaya Bio Inc., biotechnology companies developing vaccines and immunotherapy. Previously, Executive Vice President and Chief Technology Officer of Paladin Biosciences, a division of Paladin Labs Inc., Edmonton, Alberta, Canada. Adjunct professor in the Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada. Over 25 years of experience in the field of infectious diseases, especially hepatitis. Is co-inventor of Chimigen® Technology (13 patents) which received the Alberta Science and Technology award for innovation in 2004. Recipient of a Grand Challenges Explorations grant from the Bill & Melinda Gates Foundation in 2009. Was Senior Vice President, Research and Development and a founding member of ViRexx Medical Corp., Edmonton, Alberta, Canada. Previously, a Research Scientist at the Glaxo Heritage Research Institute, University of Alberta, Edmonton, Canada. Received Ph.D degree in Biochemistry from the Indian Institute of Science (Bangalore, India). Had Postdoctoral training at the University of Wisconsin in Madison, WI, USA and at the University of Alberta. Published over 50 articles in reputed international journals.

牛俊奇 医学博士

吉林大学第一医院转化医学研究院副院长 感染病中心主任, 肝病科主任, 临床药理试验病房教授

牛俊奇，主任医师，教授，副院长，感染症科主任，博士，博士生导师，硕士生导师。 1992年-1994年在英国伦敦大学圣玛丽医院从事丙型肝炎病毒的研究，1997年-1999年赴美国康州大学医学院从事核酶抗肝炎的研究。现担任吉林省肝病学会主任委员，吉林省传染病学会主任委员，第九、十届国家自然科学基金评审组委员(终审专家)，卫生部继续教育委员会委员，吉林省医学会理事，中华传染病学会委员，《临床肝胆病杂志》副主编，《中华肝脏病杂志》，《中华传染病杂志》，《中国免疫学杂志》等十家杂志的编委。2003年获长春市总工会颁发的“五一劳动者奖章”，并被评为长春十大新闻人物。2004被国家人事部，卫生部评为全国卫生系统先进工作者。2005年获得吉林省第八批有突出贡献的中青年专业技术人才及吉林省第一批拔尖创新人才。同年，被吉林省委、省政府命名为吉林省高级专家。2006年被吉林大学评为白求恩名医。 目前主要研究领域：病毒性肝炎的基因诊断及治疗的研究，宿主免疫和遗传因素对抗乙型肝炎病毒的影响,新型核苷类似物抗乙肝病毒的实验研究,中药治疗肝纤维化及脂肪肝的研究。一直坚持工作在临床第一线，致力于传染病的临床诊断与治疗。承担卫生部部属医院临床学科重点项目(200万)、“十一五”国家高技术研究发展计划（863计划）、5项国家自然科学基金课题、卫生部博士点专项基金等多个项目。已发表学术论文130多篇；其中第一作者34篇、通讯作者45篇，包括在Hepatology、J Clin Pathol、J Medical Virology等国际性学术期刊上发表SCI收录论文7篇；发表译著一部，参加编写论著5部；另外，在包括美国肝病年会（AASLD），欧洲肝病年会（EASL），亚太肝病年会 (APASL)等国际会议上报告9次。

王福生 院士

中国科学院院士 中国人民解放军第302医院主任医师，教授

王福生传染病学、肝病学专家 1984年毕业于蚌埠医学院，1992年获军事医学科学院博士学位。2015年当选为中国科学院院士。现为解放军第三〇二医院教授。 主要从事重大传染病（病毒性肝炎、艾滋病等)和疑难危重肝病的临床诊治工作，并结合临床难题开展研究。首次揭示了乙型肝炎临床免疫学特征及肝脏损伤机制；提出了优化慢性乙肝抗病毒治疗与免疫应答恢复的“爬坡假说”；阐明了艾滋病免疫重建失败的关键机制；开拓了疑难肝病和艾滋病细胞治疗与研究的新方向，提高了临床疗效。获国家科技进步二等奖3项，中华医学科技奖等省部级一等奖3项；获“全军杰出专业技术人才奖”与“军队科技领军人才奖”，国家科技部“十一五国家科技计划执行突出贡献奖”，以及世界消化病大会（2013年）上颁发的奥田（Okuda）学者奖。

任红

重庆医科大学附属第二医院院长

任红 重庆医科大学附属第二医院院长 国家首批“百千万人才工程”第一、二层次人选、国家卫生部有突出贡献的中青年专家、国家级重点学科带头人、享受国务院政府特殊津贴、市首届学术技术带头人、市优秀专业技术人才。 早在1988午就获得重医大硕士上学位的任红，从1986年开始就从事传染病病毒性肝炎研究。1993年赴伦敦大学作访问学者，在英国的两年里，他率先在国际肝病领域里发现了S基因可发生多点的免疫逃避性突变，提出从分子病毒及免疫学水平深入研究乙型肝炎基因变异与发病机制的关系，获得高水平的科研成果，使他在国际肝病研究领域名声大振。 肝病本身就是道难题，在我国，病毒性肝炎一直困扰着我们。乙肝病毒携带者1．2亿，丙肝4千万……为此，任红师承我国知名肝病专家张定凤，参加了国家“七五”、“八五”、“九五”有关肝病领域重点攻关课题，他先后负责6项国家自科学基金和1项自然科学基金重点项目，成绩斐然。1995年，他与课题组同志一道证明肝瘤坏死因子在肝细胞坏死中起着一种重要的介导作用，发现肝瘤坏死因子的水平升高及表达异常与肝炎患者肝坏死程度有关。该项目获得国家科技进步三等奖，运用于临床实践中，有效地降低了重型肝炎的死亡率。 近年来，任红培养出7名硕士、12名博士及1名博士后，还创新性地开展了病毒性肝炎及肝癌的DCS瘤苗的治疗研究及整体酵母重组活菌瘤苗的研究工作。这项研究有望成为肝炎及肝癌生物治疗的一种新方法。 2001年在任红的带领下，重医大附二院传染病科成为国家重点学科。重庆市肝病治疗研究中心，该中心以病毒性肝炎防治为重点，针对病毒、细菌、寄生虫、酒精、药物、毒物所致的一大类肝病及不同阶段的疾病谱，采用基础临床药物、外科手术、人工肝、肝脏移植等联合研究，制定成熟而稳定的诊断治疗措施。

John FLAHERTY

吉利德肝病领域临床开发高级总监

John F. Flaherty, Pharm.D. Dr. Flaherty holds a Doctor of Pharmacy degree from the University of Southern California, School of Pharmacy, in Los Angeles, and completed his postdoctoral residency and fellowship training at the University of California at San Francisco (UCSF). He was a member of the clinical pharmacy faculty at the UCSF School of Pharmacy for 13 years, and currently serves as Professor of Clinical Pharmacy on a volunteer basis. Dr. Flaherty transitioned to a career in the pharmaceutical industry in 1998 where he has held various positions within Clinical Research and Medical Affairs at Gilead Sciences for over 19 years working in both HIV and HBV clinical drug development. He is currently a Senior Director of Clinical Research in Liver Diseases Therapeutics at Gilead where he leads the clinical program for tenofovir alafenamide (Vemlidy), which was recently FDA-approved for the treatment of chronic hepatitis B. Dr. Flaherty is an author on 65 peer-reviewed journal articles and has delivered numerous presentations at national and international scientific and professional conferences while working in academia and within the pharmaceutical industry.

Edward COX医学博士

美国FDA药物评价和研究中心抗菌产品办公室主任

Dr. Edward Cox is Director of the Office of Antimicrobial Products, where he has served since 2007. As Director for the Office of Antimicrobial Products, Dr. Cox oversees the review, approval and safety of antimicrobial (antibacterial, antiviral, antifungal, and antiparasitic) drugs, ophthalmic drugs, and immunosuppressive agents for patients who have received solid organ transplants. Dr. Cox has worked extensively on the science and design of clinical trials for evaluating antimicrobial drugs. Dr. Cox received his M.D. from the University of North Carolina School of Medicine. He completed an internship and residency in Internal Medicine at the Hospital of the University of Pennsylvania and an Infectious Disease fellowship at the National Institute of Allergy and Infectious Diseases of the National Institutes of Health. He also holds a Masters of Public Health Degree from the Johns Hopkins School of Hygiene and Public Health. He joined FDA in 1998.

陈成伟 教授

《肝脏》杂志主编 中华医学会肝脏病学分会前副主席，上海肝脏病学分会前主委

陈成伟，1967年毕业于上海第二军医大学，主任医师、教授，文职1级将军。现任上海南京军医临床肝病中心主任，中华医学会肝病学会副主任委员，上海医学会肝病学会名誉主任委员，《中华肝脏病杂志》副总编辑，《肝脏》杂志主编兼编辑部主任，医学参考报《肝脏学频道》执行主编，中华肝脏病学网站主任。曾获全军科技进步奖多项、二等奖1项，上海市科技进步一等奖1项、国家科技进步二等奖1项，荣立二等功一次。1991年被评为上海市"十佳"中青年医师，获国家特殊津贴。 擅长肝脏病的诊断与治疗，在慢性肝炎，重症肝炎，肝硬化和肝癌等方面发 陈成伟 [1] 表过众多有创见性的论文和专著。于1985年首创用人胎肝细胞治疗重症肝炎，作为国家科委"七五"攻关主要治疗手段，使病死率大大下降，被认为是国内最早广意的同种异基因肝细胞移植治疗肝功能衰竭，并为以后研制问世以及克隆和基因工程生产肝细胞生长素奠定了基础。在慢性肝炎的抗病毒治疗方面积累了丰富的经验。在失代偿肝硬化治疗方面，于上世纪九十年代建立了快速腹水浓缩和腹腔-颈内静脉分流术，明显提高了这些患者的生活质量。对无手术指征的中晚期肝癌，形成了独特的免疫化疗治疗个体化体系，大大延长了这些患者的生存期，使不少患者获得Ⅱ期手术的机会。2002年成功编著了我国第一部《药物与中毒性肝病》专著，2012年将以再版。最近，与他的同事们一起完成了脐带间充质干细胞治疗终末期肝病的剂量爬坡安全性临床试验。

刘秀峰 医学博士

中国人民解放军第八一医院全军肿瘤中心内科主任、肝癌专家 中国临床肿瘤学会（CSCO）副秘书长和理事

Yury POPOV 医学博士

哈佛医学院Beth Israel Deaconess医学中心肝病研究主任，副教授

Yury V. Popov, MD, PhD Dr. Popov received an M.D. (1997) from Grodno State Medical School, Belarus and PhD in Biochemistry (2004) from Institute of Biochemistry of National Academy of Sciences of Belarus. He was the first scientist from Eastern Europe to win the prestigious Sheila Sherlock EASL fellowship award to pursue postdoctoral training in translational liver fibrosis research at the University of Erlangen-Nuremberg in Germany. In 2005, Dr. Popov relocated to USA and joined faculty at Beth Israel Deaconess Medical Center and Harvard Medical School. He is the recipient of a number of industry, foundations and institutional grants. Dr. Popov is currently directing a Liver Fibrosis Research Lab and Core and holding an appointment of Assistant Professor of Medicine at Beth Israel Deaconess Medical Center and Harvard Medical School. He is also an Associate Editor of American journal of Physiology-Gastrointestinal and Liver Physiology, and ad hoc reviewer for over 30 scientific journals including Journal of Clinical Investigation, Science Translational Medicine, Gastroenterology and Hepatology. Dr. Popov’s laboratory's major research focus is on liver fibrosis/cirrhosis and its life-threatening sequelae. Specifically, his team investigates the basic mechanisms of progression and regression of liver scarring, with the goal of the development of non-invasive diagnostic tools to measure these processes in the clinic, and novel therapies to prevent and reverse cirrhosis and its life-threatening complications such as primary liver cancers. Popov laboratory is also actively working on the development, validation and optimization of small animal models of cirrhosis and liver cancer for novel drug target discovery and efficacy testing. Some of his lab’s current basic research projects include the investigation of a novel macrophage-mediated pathway of fibrosis reversal, a role of intestinal microbiota in chronic liver disease, and elucidating the molecular mechanisms of fibrotic matrix stabilization and collagen cross-linking which make liver scarring irreversible. Most recently, he became interested in understanding how pathological micro-environment, such as fibrotic extracellular matrix in cirrhosis, promotes development of liver cancers in chronic liver diseases. RECENT PUBLICATIONS (selected) • Ikenaga N, Peng ZW, Vaid KA, Liu SB, Yoshida S, Sverdlov DY, Mikels-Vigdal A, Smith V, Schuppan D, Popov YV. Selective targeting of lysyl oxidase-like 2 (LOXL2) suppresses hepatic fibrosis progression and accelerates its reversal. Gut. 2017 Sep; 66(9):1697-1708 • Liu SB, Ikenaga N, Peng ZW, Sverdlov DY, Greenstein A, Smith V, Schuppan D, Popov Y. Lysyl oxidase activity contributes to collagen stabilization during liver fibrosis progression and limits spontaneous fibrosis reversal in mice. FASEB J. 2016 Apr; 30(4):1599-609. PMID: 26700732. • Peng ZW, Ikenaga N, Liu SB, Sverdlov DY, Vaid KA, Dixit R, Weinreb PH, Violette S, Sheppard D, Schuppan D, Popov Y. Integrin avß6 critically regulates hepatic progenitor cell function and promotes ductular reaction, fibrosis, and tumorigenesis. Hepatology. 2016 Jan; 63(1):217-32. PMID: 26448099. • Ikenaga N, Liu SB, Sverdlov DY, Yoshida S, Nasser I, Ke Q, Kang PM, Popov Y. A new Mdr2(-/-) mouse model of sclerosing cholangitis with rapid fibrosis progression, early-onset portal hypertension, and liver cancer. Am J Pathol. 2015 Feb; 185(2):325-34. PMID: 25478810 • Yoshida S, Ikenaga N, Liu SB, Peng ZW, Chung J, Sverdlov DY, Miyamoto M, Kim YO, Ogawa S, Arch RH, Schuppan D, Popov Y. Extrahepatic platelet-derived growth factor-ß, delivered by platelets, promotes activation of hepatic stellate cells and biliary fibrosis in mice. Gastroenterology. 2014 Dec; 147(6):1378-92. PMID: 25173753. • Kuramitsu K, Sverdlov DY, Liu SB, Csizmadia E, Burkly L, Schuppan D, Hanto DW, Otterbein LE, Popov Y. Failure of fibrotic liver regeneration in mice is linked to a severe fibrogenic response driven by hepatic progenitor cell activation. Am J Pathol. 2013 Jul; 183(1):182-94. PMID: 23680654; PMCID: PMC3702745.

Nikolai NAOUMOV 医学博士

瑞士诺华公司免疫学与皮肤科国际肝病科学与创新全球药物开发执行总监

Nikolai Naoumov works at Novartis Global Drug Development as Executive Director for Hepatology Science and Innovation, based in Basel, Switzerland. His focus is on developing new therapies for patients with liver diseases especially NASH, autoimmune diseases, liver fibrosis and complications of cirrhosis. In addition to his work at Novartis Global, Nikolai is also Honorary Scientific Advisor to the Foundation for Liver Research in the UK and Board member of the Liver Foundation in Switzerland. Before joining Novartis in 2007, Nikolai was a tenured Professor of Hepatology at University College London and Consultant Hepatologist at University College London Hospitals. Nikolai has been involved in the development and evaluation of many of the new treatments for patients with liver diseases, initially at the Institute of Liver Studies, King’s College Hospital in London and subsequently at the Institute of Hepatology, University College London. Nikolai has more than 200 publications in the fields of liver immunology, treatment of viral hepatitis and liver transplantation. He is Fellow of both the Royal College of Physicians (London) and the Royal College of Pathologists in the UK, and member of the Association of Physicians of Great Britain and Northern Ireland. He joined EASL in 1987, served as member of the EASL Scientific Committee (1991-1994), and was elected as a Fellow of the American Association for the Study of Liver Diseases (AASLD).

刘佳

泰格医药国际业务部负责人，副总裁

侯金林 教授

主任医师, 博士生导师，教授 原亚太肝病学会主席，中国南方医院肝病中心主任

侯金林，教授，主任医师， 第一军医大学南方医院传染病科教授，主任医师，第一军医大学南方医院传染病科和肝病中心主任 当选中华医学会感染病分会副主任委员和广东省感染病学会主任委员，并年获“新世纪百千万人才工程”国家级人选和珠江特聘教授等荣誉，以及受聘中华传染病杂志、Hepatology(肝病杂志)中文版副主编。 带领科室获得国家杰出青年基金、国家十一五重点传染病专项、国家自然科学基金重点项目、国家973子课题项目等重量级项目5项，其它省部级以上项目8项，涉及经费达近5000多万元。近五年在学科发表国内外论文40余篇包括Hepatology、Science等。获得广东省一等奖2项、中华医学科技奖二等奖1项。 积极开展国际国内交流，与英国牛津大学、上海人类基因组中心、第二军医大学免疫所等合作攻关，为新发传染病的基础研究作出重要贡献。与英国医学研究会（MRC）所属牛津大学合作研究SARS取得重要进展，受到MRC和学校领导的关注。

朱立红 工商管理硕士

DIA中国区董事总经理

Ms. Zhu serves as the Senior Vice President/Managing Director for DIA Greater China. She joined DIA from the Bill & Melinda Gates Foundation, where she was the Senior Program Officer for R&D Programs. Prior to her work at the Foundation, she was the founder and CEO of START Shanghai, which was one of the earliest Phase I oncology service companies in China. Ms. Zhu brings twenty years of experience in clinical research, business operations, and project management in the pharmaceutical industry, having held positions at Merck Sharp & Dohme (MSD) and GSK.  Her work was key to establishing GSK’s R&D Center in Shanghai, where she led the clinical and business operations.  Ms. Zhu received her B.S. degree in Pharmaceutical Science from Peking University Health Science Center (Beijing Medical University) and an MBA from Rutgers University, USA.

贾士东 医学博士

慧渡（上海）医疗科技有限公司首席执行官

Dr. Shidong Jia is the Founder and CEO of Predicine Holdings Ltd, an international precision medicine organization that is committed to developing innovative diagnostics, therapeutics and big data in cancer and other serious diseases. The company operates in California, USA and Shanghai, China. Driven by a passion to improve personalized medicine, Dr. Jia has dedicated the past 21 years to basic, translational, and clinical cancer research. His previous work identified p110beta as novel drug target for PTEN-deficient tumors (Jia S, et al. Nature, 2008), a finding that laid the foundation for clinical development and testing of p110beta inhibitors in cancers. Most recently, he and his colleagues at Predicine have developed world’s first comprehensive circulating tumor RNA (ctRNA) and circulating tumor DNA (ctDNA) combined liquid biopsy test in support of personalized cancer care and precision clinical trials. A former Scientist, Principal Investigator and Prostate Cancer Disease Area Biomarker Lead at Genentech, Dr. Jia spearheaded the biomarker strategies and drug & diagnostics co-developments efforts in support of clinical oncology pipeline at various stages. Prior to joining Genentech, Dr. Jia was Laboratory Head for Oncology Drug Discovery at the Novartis Institutes for BioMedical Research in Cambridge, MA. Dr. Jia serves as the Editor-in-Chief of "Journal of Circulating Biomarkers”, Guest Associate Editor of "Frontiers in Oncology", and Members of National Cancer Institute Review Committees and the Italian Ministry of Health - Scientific Research and Health Innovation Review Committee. Dr. Jia is a BayHelix member and receipt of several awards, including the "Young Investigator Award" at the Fourth Asian Congress for Microcirculation in Indonesia and the "P.A.R.T. Investigatorship Award" at the Dana-Farber Cancer Institute, Harvard Medical School in Boston.

高栋 博士

中国科学院生物化学与细胞生物学研究所细胞生物学国家重点实验室研究员

Dong Gao, Ph.D. Professor Dong received his B.S. in Biotechnology from Northeast Forest University, Ha’erbin, China. He earned his Ph.D. in Cell Biology from Peking University, where he worked with Dr. Zhonghe Zhai and Dr. Danying Chen. Dong identified a E3 ubiquitin ligase called REUL as a crucial antiviral activator. This work provided the key mechanism for regulating RIG-I mediated antiviral innate immunity. In 2012, Dong joined the laboratory of Dr. Yu Chen as a postdoctoral fellow at Memorial Sloan Kettering Cancer Center, New York. There, he developed the patients derived organoid culture system for prostate cancer. Dong have generated the biggest prostate organoids biobank. The organoid lines recapitulate the phenotypic diversity of castration resistant prostate cancer, including AR-dependent adenocarcinoma, AR-negative adenocarcinoma, neuroendocrine carcinoma, and squamous differentiation. Importantly, these lines are amenable to drug testing in vitro and in vivo. The cancer organoids system is very promising for large scale drug screening and fundamental cancer biology research. In 2016, Dong joined the faculty at Shanghai Institute of Biochemistry and Cell Biology, Chinese Academy of Sciences as a professor in the State Key Laboratory of Cell Biology. The main goal of Dong’s research group is establishing cancer organoids system, understanding the mechanisms of therapy resistance, identifying novel biomarkers, and developing therapeutic approaches to prevent or overcome resistance.

Patrice HUGO 博士

Q2 Solutions首席科学官

Dr. Hugo is Chief Scientific Officer at Q2 Solutions, a Quintiles Quest joint venture. He currently leads global scientific strategy and is responsible for the medical affairs and scientific activities for the central laboratories, the genomic and the BioAnalytical/ADME activities worldwide. Dr. Hugo has more than 25 years of senior scientific leadership experience with extensive management expertise in laboratory operations, biomarker discovery and validation applied to diagnostics, therapeutic targets and clinical trials. He obtained his Ph.D. at McGill University and completed 5 years of post-doctoral fellowship at the Walter Elisa Hall Institute in Australia, and Howard Hughes Medical Institute in Denver, Colorado. Dr. Hugo was Associated Vice President Chief Scientist, Scientific Affairs, at Laboratory Corporation of America (LabCorp)/Covance, and has held several other senior leadership positions at Clearstone Central Laboratories, Caprion and PROCREA BioSciences. A noted industry expert, Dr. Hugo has more than 75 scientific publications in internationally renowned journals. He also played an active role in a number of industry organizations, including being a member of the Board of Directors for the non-for-profit Personalized Medicine Partnership for Cancer in Quebec, and the Steering Committee for the Biomarker Factory. Here are the topics I will be addressing during my presentation Title: Laboratory to support Immuno-Oncology Clinical Trial Studies. Topics:  End-to-End Biomarker solutions  Protocol requirements: Regional versus centralized testing in a global environment?  Companion Diagnostics support

Jun LUO 博士

Johns Hopkins医院泌尿外科、肿瘤科副教授

Jun Luo, Ph.D. Associate Professor, Urology, Oncology Hinman Endowed Chair 411 Marburg, Johns Hopkins Hospital 600 N Wolfe Street Baltimore, MD 21287 Tel: 443-2875625 Email: jluo1@jhmi.edu Biographical Summary Dr. Jun Luo is an Associate Professor of Urology at the James Buchanan Brady Urological Institute and the Department of Urology at the Johns Hopkins University. He specializes in prostate cancer. His main translational research efforts included discovery, validation, and clinical implementation of molecular markers useful in precision medicine for prostate cancer. He conducted one of the first expression microarray studies on prostate cancer, leading to the discovery of a highly sensitive and specific prostate cancer tissue marker named AMACR, which has been widely adopted as an ancillary Surgical Pathology tool in diagnosis of prostate cancer. He discovered alternately spliced versions of the androgen receptor (AR), including AR-V7, that are implicated in castration-resistant prostate cancer. Dr. Luo developed and validated a non-invasive method to measure AR-V7 in circulating tumor cells isolated from blood of prostate cancer patients, establishing clinical relevance of AR-V7 testing in men with metastatic castration-resistant prostate cancer (mCRPC) undergoing treatment with abiraterone, enzalutamide, and taxane chemotherapies. Dr. Luo’s research laboratory continues to focus on genetic/genomic studies of liquid and tissue biopsies for diagnostic and prognostic utilities, as well as biomarker-driven clinical trials aimed at developing new agents for castration-resistant prostate cancer.

Agnes SAINT-RAYMOND 医学博士

EMA国际事务及Portfolio Board负责人

Agnès Saint-Raymond Head of International Affairs; Head of Portfolio Board, European Medicines Agency, European Union Head of International Affairs (ad interim), Head of Portfolio Board MD and qualified Paediatrician. Chef de Clinique in Paed. in Necker-Enfants-Malades Hospital (Paris, 1985-1990). Joined French Agency for medicines (now ANSM) in 1995 as Head of a Pharmaco-Toxico-Clinical Assessment Unit. Joined EMA in 2000. Head of Special Areas for Human Medicines (Paediatric Medicines, Orphan Medicines, Scientific Advice, SME Office, and Scientific Support & Projects) until 2013. Head of Portfolio Board since Aug 2013. Head of International Affairs (a.i.) since Nov 2016.

刘雅容 博士

上海恒润达生生物科技有限公司研发部研发总监

Dr. Yarong Liu, director of Research and Development of HRAIN Biotechnology Co., Ltd. Prior to joining HRAIN Biotech, Dr. Liu involved in the research of three generations of CAR-T in Amgen in U.S. Dr. Liu finished her Ph.D. and post-doctoral research at the University of Southern California, with 8 years experience of engineering AAV, lentivirus and other viral vectors for targeted gene therapy research and industrialization of lentivirus. Dr. Liu has published 27 papers in Gene Therapy, Small, Molecular Therapy, Pharmaceutical Research, Molecular Pharmaceutics, Biomaterials, J.A.C.S, ACS Nano, Virology and other international journals, owned 1 US patent. Served as guest editor of ‘Organic Materials in Nanomedicine’ and Grand Award Judge for Biochemistry of “2014 Intel International Science and Engineering Fair” (Intel ISEF 2014), edited and published the fifth volume of the “The World Scientific Encyclopedia of Nanomedicine and Bioengineering I” of “Frontiers in Nanobiomedical research series" (Frontiers in Nanobiomedical Research, ISSN:2251-3965). Dr. Liu also got invited to give presentations in more than 20 international/domestic academic conferences. Dr. Liu has been awarded with Shanghai 1000plan Expert (2017), Chinese Government Award for Outstanding Self-financed Student Abroad (2013), the Student Achievement Award of University of Southern California, and the Best Dissertation Award at Chemical Engineering Department of University of Southern California.

汪敏 博士

博生吉医药科技有限公司CAR-T事业部经理

汪敏，2017年毕业于中国科学技术大学，细胞生物学专业博士，现任博生吉安科细胞技术有限公司CAR-T事业部经理，负责CAR-T产业化工艺的开发与质检方法的建立。

何霆 博士

北京艺妙神州医疗科技有限公司首席执行官

毕业于清华大学癌症生物学实验室，在国际期刊发表多篇论文，申请多项专利，曾获北京市雏鹰人才、清华大学校长杯金奖等.

梁旻 博士

东源生物医药科技（上海）有限公司总经理

梁旻 博士、教授级高级工程师 东源生物医药科技（上海）有限公司 总经理 学历 复旦大学肿瘤学专业博士学位毕业 中国疾病预防控制中心病毒病预防控制所免疫学硕士学位毕业 武汉大学生物化学专业学士学位毕业 经历 从事生物医药领域研究开发工作23年，致力于肿瘤基因及免疫治疗领域的研究，及相关单克隆抗体药物及基因治疗新药的开发和产业化。1999-2009年担任上海三维生物技术有限公司首席科学官，负责研发和新产品产业化工作，成功研发出世界上第一个溶瘤病毒产品-安科瑞。2009年起创建东源生物，兼东曜药业执行副总，负责多项溶瘤病毒、治疗性单克隆抗体项目的研发和产业化工作。 承担了多项中国国家和上海市政府有关部门资助的科研开发课题工作，获上海市科学技术二等奖。担任国家及上海市项目审评专家，美国基因及细胞治疗学会（ASGCT）海外委员会委员。 专利及论文 拥有11项发明（PCT）专利，7项得到授权，发表中英文研究论文15篇。

秦民民 博士

和铂生物医药高级副总裁，CMC负责人

Minmin Qin, PhD Senior Vice President, Head of CMC 秦民民 博士 高级副总裁，CMC负责人 秦博士拥有 20 多年的生物药工艺开发和商业化生产，临床申报和药品注册的成功经验，以及丰富的高级管理经验。加入和铂医药之前，秦博士任药明生物的技术与工艺研发副总裁；在此之前，秦博士曾先后任国家分子医学转化科学中心（西安）抗体药物技术中心首席科学官，第四军医大学和西安交通大学特聘教授，浙江特瑞思和上海津曼特首席技术官。秦博士为浙江省“千人计划”特聘专家。在回国之前，秦博士于 2005到 2012 年任 FivePrime 制药生产工艺研发高级总监；作为 BioMarin 制药的创始科学家，秦博士从 1997到 2004 年先后担任分子生物学总监，蛋白纯化生产工艺总监，和生产工艺科学高级总监。 秦博士同时是一位杰出的科学家，有多篇文章发表在 Nature, Science, Science Translational Medicine, PNAS 等顶级科学杂志上，是 10 项专利的发明人。秦博士于 1991 年获得美国威斯康辛大学遗传学与分子生物学博士学位，并在加州伯克利大学从事数年博士后研究。 Dr. Qin has over 20 years of experience in successful development and commercialization of biopharmaceuticals. He specializes in various expression technologies for antibodies and complex glycoproteins, as well as in process development and cGMP manufacturing. In addition to his extensive regulatory filing and senior management experience, Dr. Qin is also a distinguished scholar and has had numerous publications in Nature, Science, Science Translational Medicine, PNAS etc. He is also a co-author of 10 patents. Dr. Qin was a founding member of BioMarin where he served at his last position as Senior Director of Process Sciences from 1997 to 2004. From 2005 to 2012, he was Senior Director of Process Development at Five Prime Therapeutics. From 2012 to 2017, Dr. Qin served as CTO/SVP of Shanghai JMT-Bio and Zhejiang Teruisi, and Director/CSO of Technology Center for Antibody Therapeutics in National Translational Medicine Center for Molecular Medicine (Xi'an) and Distinguished Professor at Fourth Military Medical University and Xi'an Jiaotong University. Prior to joining us, Dr. Qin was Vice President of Technology and Process Development at WuXi Biologics. Dr. Qin graduated from University of Wisconsin-Madison with Ph.D. in Genetics/Molecular Biology in 1991 and carried out his postdoctoral research at University of California at Berkeley.

戎一平 博士

和铂生物医药发现生物学部负责人

戎一平 博士发现生物学部负责人Yiping Rong, PhD Head of Discovery Biology 在加入和铂医药之前，戎一平博士在赛诺菲亚太研发中心担任癌症研究副总监，他领导了多个靶向肝癌的药物研发项目并取得了靶点验证的里程碑。在强生中国研发中心，他负责临床前转化医学小组，主要研究肝癌中细胞生长因子信号通路和表观遗传调控，作为生物项目负责人，成功完成临床前体内体外药理和病人筛选肿瘤标志物的研究，同团队一起申报了新药临床。在此之前，戎博士在罗氏中国研发工作，是肿瘤部大分子研究项目负责人，并参与外部引进项目的评估和协调。 作为项目负责人，他领导过多个小分子或抗体研发项目，包括凋亡，表观遗传学，肿瘤免疫学和信号通路上的激酶，代谢酶和蛋白蛋白相互作用等靶点。 戎一平博士于华东理工大学取得分子生物学硕士学位，美国凯斯西储大学获得药理学博士学位。 Before joining Harbour BioMed, Dr. Rong was Associate Director of Cancer Research at Sanofi Asia Pacific R&D Center. Prior to that, he was at Johnson & Johnson China Discovery Center, where he was the Group Leader for preclinical translational oncology research, studying cell growth factor signaling pathway and epigenetic regulation in liver cancer. As biology leader, he successfully generated the preclinical data package and patient stratification biomarker strategy to support novel oncology drug IND filing. Before that, Dr. Rong worked at Roche R&D as a group leader for biologics project in Discovery Oncology Department and was also involved in external project evaluation and coordination. Dr. Rong obtained his Pharmacology PhD from Case Western Reserve University.

俞磊 博士

上海优卡迪生物医药科技有限公司首席科学家

俞磊俞磊，博士。华东师范大学"紫江特聘教授"，博士生导师，生物医学工程与技术研究所所长，工程技术研究中心副主任，美国犹他大学药剂学和药物化学系客座教授，复旦大学智能化递药教育部重点实验室、智能化全军重点实验室客座教授。1979-1988毕业于上海第一医学院（现复旦大学医学院）医学专业；后留学加拿大1991-1996获得阿尔伯塔大学微生物与免疫学博士学位。此后在美国基因治疗领域的开拓者之一西奥多?弗里德曼教授所在的圣地亚哥的加州大学医学院儿科系的分子遗传学中心进行博士后研究，主攻基因载体研发和基因治疗。2000-2012任美国Nitto Denko Technical技术公司主任及副总裁，负责公司创业、科研及产业化并与华东师范大学进行了长期的科研合作。现致力于高分子生物材料和生物材料在生物医学应用技术研发领域的研究；可控抗癌化疗药物输送载体的研究；小干扰RNA药物输送载体的研究；诱导多能干细胞(iPS)和可控诱导生物材料为基础的细胞组织工程的研究。上海优卡迪生物医药科技有限公司首席科学家 ,2004年至2012年8月俞磊博士在美国加州圣地亚哥创建了“创新生命科学公司” (Kinovate Life Science, KLS) 并任公司副总裁，进行肿瘤细胞免疫技术的转化和产品开发，包括基因工程化细胞免疫治疗肿瘤和溶瘤病毒肿瘤治疗。但是俞磊博士毅然决然的放弃公司，选择2012年年底回国，在华师大组建了生物医学工程和技术研究所并建立了药物制剂专业，同时与多家全国著名的血液科开展多中心临床实验合作。在难治复发急性B淋巴细胞白血病的治疗中取得了86%以上的完全缓解率，达到了国际先进水平，同时在临床安全性方面具有明显优势。

何勇 医学博士

重庆大坪医院呼吸内科主任、主任医师、教授

何勇，主任医师，教授，科主任，医学博士，留美博士后，研究生导师。 第三军医大学首批“1510优秀青年人才出国计划苗圃工程”人选，第三军医大学大坪医院野战外科研究所首批“1135人才工程”人选，第三军医大学“教学明星”。美国癌症研究协会（AACR）会员，国外《Lung Cancer》等多家SCI杂志的特邀审稿人。曾赴美国排名第一的肿瘤医院MD Anderson癌症中心胸外科做访问学者和博士后研究，研究方向为肺癌的早期诊断、预后标志物的研究和肺癌的微创手术治疗。 目前主要研究方向是肺癌靶向治疗耐药及对策的研究，对肺癌EGFR-TKI、ALK-TKI等靶向治疗药物的应用有深入的认识，为患者制定最优化的肺癌个体化诊疗方案，使患者最大限度获益是我的追求。获得包括国家自然科学基金课题多项，经费60余万。发表学术论文30余篇，其中SCI论文4篇。获得军队科技进步一等奖1项。参编专著7部。从事胸心外科临床工作近20年，有扎实的专业基础理论知识和丰富的临床经验。

陆舜 医学博士

教授，上海胸科医院肺癌中心主任

陆舜 肿瘤科科主任，主任医师，副教授，博士生导师，医学博士。擅长胸部肿瘤的鉴别诊断和治疗，尤其是肺癌的多学科综合治疗。 详细介绍 肿瘤科主任，主任医师，副教授，博士生导师，医学博士。上海市医学领军人才。 掌握了国内外肺癌化疗最新进展，对肺癌的早期诊断，肺癌靶向治疗及综合治疗均有较高造诣。参加和承担国家和上海市科研基金项目近10项。参与或承担20余项国际国内多中心临床研究，其中国际多中心临床研究10项。第一作者发表论文及论著60余篇，其中SCI收录13篇。参编近10部著作。 任美国临床肿瘤学会（ASCO）国际事务部委员（中国大陆唯一）、ASCO多学科诊治小组（MCMC）成员、欧洲肿瘤协会（ESMO）会员、国际肺癌研究会（IASLC）组织委员会委员、国家食品药品监督管理局新药评审专家、中华医学会肿瘤学会委员等20余项学术职务。担任10余本国内外学术期刊编委。多次担任全国、国际学术会议大会主席或专场主席。 作为访问学者曾赴美国德州大学MD. Anderson癌症医学中心工作，作为访问教授曾赴美国德州大学MD. Anderson癌症医学参加肺癌的基础、转化性科研和综合讨论。

刘晓曦 博士

和铂生物医药副总裁；早期研发与科学运营负责人

杨晨

盛德国际律师事务所资深顾问律师

杨晨律师是盛德中国生命科学业务的资深顾问律师。杨律师主要为生命科学产业提供行业监管、公司法和商法领域的法律服务。 杨律师在过去的20年中代表跨国公司参与中国不同行业领域的投资项目及收购活动，自2007年以来专注于为跨国生命科学公司提供公司法、交易及法规事务方面的法律服务。杨律师还协助中国政府部门处理美国诉讼事务。 杨律师常年代理跨国药品、医疗器械、食品和化妆品公司处理市场准入、产品本土化、市场推广、产品召回、临床实验及美国海外反腐败法及反贿赂等方面的事务，并就行业特有的监管、合规及稽查方面的问题提供法律咨询。杨律师的业务范围还包括合资企业、公司并购及许可法律事务。 杨律师曾处理并具代表性的案例包括： • 代表中国商务部，以“法庭之友”的形式参与美国针对中国被告（维生素C产品的生产及出口企业）提起的首起反垄断诉讼。最终美国联邦第二巡回法院驳回起诉并修改了一审法院的判决； • 代表GlaxoSmithKline PLC参与其收购中国制药公司南京美瑞制药有限公司，这是近年来首宗由一家顶尖的国际制药公司收购中国本土处方药制药公司的交易。此项目被《中国商法杂志》（China Business Law Journal）评为2011年“年度最佳并购交易”； • 代表几家主要的跨国制药和医疗器械公司，参与其在中国的收购活动，特别关注与收购有关的监管和合规问题； • 为跨国公司在中国寻求产品批准、临床研究、市场营销、推广与分销、市场准入、定价和报销提供法律咨询，涉及的广泛产品包括人用处方药、OTC药物、疫苗和生物制品、医疗器械、食品和膳食补充剂、动物保健产品等； • 代表跨国制药和医疗器械公司，探索在中国的企业合资和战略合作，包括授权、共同推广和联合营销交易； • 为跨国制药和医疗器械公司应对由中国不同监管机构发起的执法行动提供法律咨询。 杨律师获得《亚洲律师》（The Asian Lawyer）评选的生命科学“All-Star”律师，并且在《PLC律师年鉴》（PLC’s Which Lawyer）评选的 “中国/香港地区公司法/商法杰出律师”以及 “全球杰出生命科学律师”中均名列前茅。她曾被《国际金融法评论》（IFLR 1000）评为“中国杰出并购律师”以及被《钱伯斯(亚洲)》（Chambers Asia Pacific）评为“中国/香港地区生命科学领域杰出律师”。《国际金融法评论》（IFLR 1000）称赞其“时刻以客户需求为中心，工作质量精确无瑕。她亦被《法律名人录》（Who’s Who Legal）评为领先的生命科学律师。杨律师获得2016年《钱伯斯中国》生命科学（国际律师事务所）类别“第一等级”排名并获得2016年《钱伯斯亚太》生命科学类别“杰出律师”荣誉。 在成为执业律师之前，杨律师曾在中国主要立法机关之一的国务院法制办任立法官员，并曾在北京市基层检察院反贪局任职。 杨律师于1991年从北京大学获得法学学士学位，同时被授予“年度最佳毕业生”殊荣，之后于1997年从美国乔治亚大学获得法学硕士学位，并取得美国纽约州执业资格。杨律师经常在全国和国际性行业大会及研讨会上发表演讲。 杨律师的母语为中文，并通晓英语。

罗家立 博士

勃林格殷格瀚生物药业（中国）有限公司总经理

董敏 博士

亿腾医药临床开发及药政事务高级副总裁

Dr. Min Dong is currently the Senior VP of Clinical Development & Regulatory Affairs at EOC Pharma, an oncology-focused specility Pharma in China, responsible for establishing development strategy of EOC pipeline, as well as leading the execution of a concerted effort to materialize various development plans. Prior to joining EOC, Dr. Dong worked for 12 years at Novartis, where she took various roles with increasing responsibilities from preclinical safety to oncology early clinical development, primarily driving first-in-human to PoC stage clinical programs. Dr. Dong also worked briefly as Chief Scientist for Daan Gene, one of the leading clinical diagnostic companies in China. Dr. Dong holds a Ph.D. degree in Molecular and Systems Toxicology and Pharmacology from MIT, a MS degree in Molecular Biophysics from Tsinghua University, and a BS degree in Medicinal Chemistry from Beijing Medical University.

闫小军

百济神州全球药政事务负责人，高级副总裁

闫小军，百济神州高级副总裁 •22年药政事务工作经验 •前拜耳医药保健有限公司国际研发中心中国药政事物部负责人，注册总监，全球注册战略发展特药负责人 •前葛兰素史克中国药政事物部负责人，注册总监 •前阿斯利康中国高级药政事物经理 •Staffordshire University工商管理硕士 •北京中医药大学医学学士 •执业药师 Wendy Yan SVP, Global Head of Regulatory Affairs •More than 22 years of regulatory affairs experience at a number of multinational pharmaceutical companies •Former Director, Head of Regulatory Affairs China, Global Regulatory Strategist at Bayer Healthcare Global R&D Center •Director, Head of Regulatory Affairs at GlaxoSmithKline Pharmaceuticals China •Senior Regulatory Affairs Manager at AstraZeneca •M.B.A. at Staffordshire University •Bachelor of Medicine at Beijing Traditional Chinese Medicine University •Licensed pharmacist

赵大尧 博士

辉瑞中国副总裁，中国药物开发部负责人

赵大尧，医学博士，辉瑞中国研发中心总经理兼中国药物研发团队负责人，副总裁 从2016年至今，大尧作为辉瑞中国药物研发团队负责人，一直专注于优化提升临床研发流程，并在国内建立一流的团队。大尧在北京大学医学院获得神经科与儿科专业医学博士学位，同时也是哈佛医学院神经生物学与分子生物学博士。大尧在美国获得了丰富的药物发现和研发方面的经验，并分别在多家规模不一的医药公司工作过，包括日本协和医药公司、健赞公司、诺华公司、辉瑞公司以及强生公司。 辉瑞公司 2011年到2015年1月期间，赵大尧任职强生制药中国药物研发部副总裁。在职期间，他为公司的研发与科学事务打造了一个清晰的愿景，以支持杨森的新战略，并将杨森中国与亚洲研发中心（上海）的几个团队进行合并，打造一个全新的中国研发团队。在过去六年中，赵大尧博士领导完成了300多项临床试验，在国内外注册了一个又一个的新产品。大尧在中国的政策提案中也发挥了重要作用。同时，他还与政府机构、中国外商制药协会和其他的行业协会有着紧密的合作关系，并担任了2015年中国药物信息协会主席。 Dayao Zhao, M.D., Ph.D. Dayao Zhao, M.D., Ph.D. is Vice President, Head of Development China Vice President, Head of Development China Pfizer Inc. From January 2016 to present, Dayao has been the Head of Development China at Pfizer Inc. His role focuses on optimizing the clinical development process and establishes a first-class team in China. Dayao holds an M.D. in Neurology and Pediatrics from Beijing University Medical School and a Ph.D. in Neurobiology and Molecular Biology from Harvard Medical School. Dayao brings extensive experience in drug discovery and development in the US. He has worked in small (Kyowa Pharmaceutical), mid-sized (Genzyme), and large Pharmaceutical companies (Novartis, Pfizer, and JNJ). From 2011 to January 2015, Dayao served as VP, Head of China R&D at JNJ Pharmaceuticals. He shaped a clear vision of the research and development and scientific affairs to support the new Janssen strategy, bringing together several groups from both Janssen China and the Asia R&D center (Shanghai) into one end-to-end R&D organization in China. Over last 6 years, he has led over 300 clinical trials and registered many new products in China and around the world. Dayao plays an important role in policy initiatives in China. He works closely with the government agencies, RDPAC and other industry associations. He was the Chairman of 2015 DIA China.

徐宁 医学博士

再鼎制药执行副总裁,临床研发及法规事务负责人

徐宁 医学博士，工商管理学硕士 / Ning XU, MD, MBA 再鼎制药执行副总裁 临床研发及法规事务负责人 Executive Vice President, Head of Clinical Development and Regulatory Affairs, ZaiLaboratory 现任再鼎医药临床研发和法规事务执行副总裁。徐宁博士毕业于中国协和医科大学医学系，曾在北京协和医院呼吸科任主治医师多年，先后主管呼吸重症监护室和呼吸综合病房，积累了大量临床经验。之后，在美国伊利诺斯州立大学医学院药理系从事分子生物学研究，建立了原发性和继发性急性肺损伤小鼠模型，研究中性粒细胞抑制因子对急性肺损伤的控制。工作期间，在高水平专业杂志上发表了多篇文章。同时还在该校攻读并获得工商管理学硕士。徐宁博士先后在美国和中国就职于跨国医药研发企业，专注于临床试验的实施、公司或部门管理工作、以及研发专业团队的建设。不仅积累了深厚的药物临床研发经验并显著推动了所在企业或部门的迅猛发展。同时，徐宁博士还活跃于行业界的学术和经验交流，参与了国家药监局的多项指南起草工作。2011年至2015年期间任全球医药信息协会中国区顾问委员会主席，主持了大量学术会议和交流活动，积极推动中国临床研究与世界的接轨。 Dr. Ning Xu is currently the Executive Vice President, Head of Clinical Development and Regulatory Affairs at ZaiLaboratory. Prior to the current position, Ning was Vice President, Head of Clinical Development Services, Covance China, where he developed full functions for the organization and grew the business by 10 times in 5 years. Dr. Xu has many years of experience of clinical research both in pharmaceutical and CRO industries. He had worked for pharmaceutical companies such as J&J and GSK as well as CROs such as Excel PharmaStudies and Parexel US. Dr. Xu had been the Chairman of the Advisory Council of DIA China and DIA global board of director from 2011 to 2015. Dr. Xu got his M.D. from Peking Union Medical Colleague in 1991. As a pulmonary physician he worked in Beijing Union Hospital for 6 years, and then he completed his postdoctoral fellowship in the Medical School, University of Illinois at Chicago, investigating on neutrophil inhibitory factor in preventing acute lung injury. He got his MBA from the University of Illinois at Chicago in 2000.

苏 岭 博士

沈阳药科大学教授，礼来亚洲基金风险合伙人

苏岭博士在药品法规及注册审评管理、新药研发策略和管理、临床研究、药物安全和药物警戒、药物流行病学等领域拥有丰富经验。曾任职于原卫生部药政管理局和美国FDA，担任药物信息协会 (DIA) 全球理事会主席等职。先后在默沙东、罗氏、惠氏、诺华等多家跨国制药企业从事临床研究和药物研发的高级管理工作

黑永疆 医学博士

齐鲁制药临床开发首席医学官

Dr. Hei is the Corporate VP and Chief Medical Officer (CMO) at Qilu Pharmaceuticals responsible for the overall strategy and operations of clinical development programs in all therapeutic areas. He also leads the corporate development strategy and business development and alliance functions. Dr. Hei joined Qilu from the San Diego-based biotechnology company Ambrx Inc., where he served as the CMO responsible for the clinical strategy and operations, focusing on antibody-drug conjugates (ADCs) and CD3-based biospecifics. Prior to Ambrx, Dr. Hei had worked at Amgen for more than 9 years as the Executive Medical Director in oncology global development and medical affairs in the capacity of global development leaders for several oncology pipeline molecules and marketed products including small molecules such as motesanib as well as biologics such as conatumumab and Vectibix. Additionally, during his tenure at Amgen, Dr. Hei spent 3 years in China as the medical head to build the clinical medical teams and establish product development and clinical operations capabilities for Amgen China. Before Amgen, Dr. Hei worked for Roche Laboratories, Inc., and Novartis oncology as the US Medical Director for Roche, and Senior Global Brand Medical Director/Executive Director for Novartis Oncology where he led the development and execution of medical plans and expanded the investigator-initiated clinical research. In addition, Dr. Hei supported regulatory filings and submissions at the FDA, PMDA (Japan) EMA, and the Chinese FDA (cFDA). Dr. Hei received his medical degree from Shihezi Medical College in China, and graduate degrees from the West China University of Medical Sciences (M.Sc) and the University of British Columbia in Canada (Ph.D.).

李志宏 博士

美国方恩医药发展有限公司国际法规事务副总裁

概述 • 美国FDA及制药公司12年新药临床研发及审评工作经验，广泛参与了新药从FIH到批准后各期临床研发和审评工作。丰富的新药及仿制药eCTD文件撰写及审评经验。专项技能包括临床研发计划，管理法规策略方面的支持以满足美国FDA 对新药研发的要求。对美国FDA政策法规，指导文件的解读及在新药研发中的履行。 • 2015 – 2017：高级主审官，美国FDA仿制药办公室生物等效部。主管ANDA综合审评，包括PK/PD 生物等效试验及相关的生物分析方法，质控及生物等效溶出方法，配方的审评。 • 2009 – 2015：高级主审官，美国FDA临床药理办公室。审评工作涵盖INDs，505(b)(1) 及505(b)(2) NDAs，BLAs，351(k) biosimilars。 • 2006 – 2009：辉瑞制药公司经理，临床药理主管。提供新药研发从IND到NDA各阶段临床策略及试验的设计，报批工作。 • 工作涉及疾病领域包括心理及神经科药物，代谢及内分泌药物，麻醉，止疼及成瘾性药物，风湿和肿瘤药物。 • 在美国FDA成功领导了一个ICH新 Guideline 工作组。所建议Guideline已经通过CDER审评并进入ICH 协调阶段。 • 美国FDA CEDR 级奖项获奖者。 • 多篇新药临床研发相关的文章 _____________________________________________________________________________ 教育背景 药学博士 美国明尼苏达大学双城分校药学院 药物分析硕士 北京医科大学药学院 药学学士 北京医科大学药学院 _____________________________________________________________________________

Ana HIDALGO-SIMON 医学博士

EMA人类用药品研究和开发支持处专业科学负责人

Ana Hidalgo-Simon Head of Specialised Scientific Disciplines Department Human Medicines Research & Development Support Division, EMA Nationality: Spanish Career to date: • Head of Specialised Scientific Disciplines, European Medicines Agency (2013-present) • Head of Risk Management, European Medicines Agency (2012-2013) • Head of Risk Management (ad interim), European Medicines Agency (2011-2012) • Head of Signal Detection and Data Analysis, European Medicines Agency (2009-2011) • Scientific Administrator, European Medicines Agency (2003-2009) • Medical Editor, EuroTransmed, United Kingdom (1998-2003) • Scientific Project Manager, Medical Action Communications, United Kingdom (1997- 1998) • International Clinical Trials Coordinator, SymbioClin, United Kingdom (1996-1997) • Post-doctoral Researcher, Clinical Research Centre, United Kingdom (1995-1996) Education: • Diploma in heath economics, University of York , United Kingdom (2003) • Doctor of Philosophy in clinical research, Royal Free Hospital School of Medicine , London, United Kingdom (1995) • Doctor of medicine and surgery, University of the Basque Country , Bilbao, Spain (1990)

邓婷

赛诺菲药政事务中国负责人

龚焱

勃林格殷格翰公司中国市场药政事务高级总监

Dr. Yan Gong is the head of regulatory affairs ROPU T.C.M. in Boehringer Ingelheim. She received her B.S. from Fu Dan University, Master and Ph.D. from Copenhagen University before eventually becoming physician in Novo Nordisk Corporate, Denmark in 2006. After her five year career there, Dr. Gong joined BI Corporate in 2011. Years of experience in clinical development and medical affairs and an author of 20ish scientific publications.

董艳平

罗氏亚太药品研发中心注册事物高级经理

董艳平 女士 罗氏亚太药品研发中心注册事务部 高级注册经理 毕业与中国药科大学。2006年加入罗氏中国药品注册事务部，一直从事抗肿瘤领域产品的注册相关工作，包括上市前临床开发及上市后产品维护。2012年9月至2013年6月曾在美国基因泰克公司进行轮训，支持相关产品在美国和全球的注册工作.

大坪泰斗

日本PMDA新药办公室II主任审评员

Mr. Yasuto Otsubo is a reviewer of Office of New Drug II at Pharmaceuticals & Medical Devices Agency (PMDA). In this position, Mr. Otsubo is responsible for reviewing cardiovascular drugs, antiparkinsonian drugs, and anti-Alzheimer's drugs as the team leader. Mr. Otsubo has over 10 years' experience in the regulatory agencies. Mr. Otsubo is also a member of MRCT Working Group and Companion Diagnostics Project Team of PMDA.

Joseph SCHEEREN, 药学博士

德国拜耳全球研发高级顾问,高级副总裁 DIA后任主席

Dr. Scheeren started his pharmaceutical industry career in 1982 with Servier in Paris, responsible for Regulatory Affairs Northern and Eastern Europe, and Clinical Development in Munich from 1986 – 1987. In 1991, he was appointed Head of Worldwide Regulatory Affairs at Serono, Geneva. In 1992, he took over responsibility of the Global Regulatory Affairs department of Roussel UCLAF. In 1996, he moved to New Jersey to head the Global Marketed Product Regulatory Affairs Department of Hoechst Marion Roussel. He joined Bayer Pharmaceuticals as Senior Vice President, Head of Global Regulatory Affairs, in 2004 responsible for development in the US and in 2009 became Site Head US in Montville, NJ. In addition, he took over the position Head of Global Development Asia in Beijing in 2012. In 2015, he was appointed Head of Global Regulatory Affairs Pharma and Consumer Care of Bayer Healthcare, Basel. Dr. Scheeren holds many memberships and designations, serving on Advisory Boards at the Center for Innovation in Regulatory Science, SAFE-PHARMA, the Regulatory Affairs track at Yale University, the Center of Regulatory Excellence Singapore, the Research & Development-based Pharmaceutical Association in China, and the China Core Research and Development Committee. He has served as Chairman of the DIA Regional Advisory Council for Europe, Middle East & Africa; he is also a foreign member of the Academie Nationale de Pharmacie, France, and a lecturer at Yale University. Dr. Scheeren studied pharmacy at the University of Leiden.

吕玉真

罗氏药品临床研发亚太区注册事务负责人

吕玉真，执业药剂师，北京大学国际药物工程管理硕士和上海医科大学药学专业学士。现担任罗氏亚太地区注册部负责人和RDPAC药品注册生物制品小组召集人。 在过去的17年里，曾就职于普强、法玛西亚普强、法玛西亚，辉瑞及默沙东公司注册部。加入制药公司之前，在上海医科大学（现为复旦大学医学院）药学院药学教研室担任助教。

沈琳 教授

北京大学肿瘤医院副院长

黄钦博士

药品审评中心

张玥

博纳西亚子公司临智数据 总裁

Takefumi GEMBA 博士

临床和法规战略执行主任

Mark ROBERTS 博士

诊断开发高级总监

Claudia FILOZOF 博士

执行医学总监, CVMER (心血管, 新陈代谢, 内分泌）

Beatriz ROCHA 博士

副总裁，战略产品开发咨询总监

William HANLON 博士

开发总监

林峰

捷信医药总经理

李雪宁 教授

复旦大学中山医院临床机构办主任，临床药理研究室主任

宋毅

捷信医药业务解决方案副总裁

吉萍 医学博士

北京大学临床研究所（深圳）副所长

Current Position: Vice Director Peking University Clinical Research Institute (Shenzhen) Clinical Research Institute, Shenzhen PKU (Peking University)-HKUST(Hong Kong University of Science and Technology) Medical Center Working Experiences: Dr. Ji began her clinical research career as medical writer in 2007. She has rich experience in protocol development and project quality management for new drug development and investigator–initiated studies. Dr. Ji also took the role as director of Quality Assurance Office in Peking University Human Research Protection Program(HRPP). Her primary responsibilities were to oversee investigator–initiated projects implementation and assure high quality operation in Peking University Clinical Research Institute. Since July 2016, she moved to Shen Zhen for building research platforms for supporting high quality clinical research in Shen Zhen.

李庆红

辉瑞医学质量保证部负责人

现担任辉瑞全球医学质量保证部中国负责人，主要负责辉瑞公司在中国进行的临床研究的质量及合规性，建立健全质量管理体系，营造和推进辉瑞中国研发中心的质量文化。医学质量保证中国团队对在中国及亚太地区的临床研究者/机构，公司内部临床运行团队等做合规稽查工作，支持和保证药政当局的临床试验的检查。同时积极参与中国和亚太地区的与质量保证相关的活动。， 庆红从事临床研究和稽查20余年. 从1997年1月作为阿斯利康加拿大的临床研究监查员开始，在加拿大负责中枢神经系统，消化和呼吸方面的临床研究5年多。之后转入阿斯利康全球的临床研究质量保证部，负责北美地区和亚洲地区的稽查工作。2008年4月加入辉瑞（中国）研究开发有限公司。 近年来，庆红还在DIA, PhRAM 等国际性学术会议上多次作为嘉宾发言。曾历任China Quality Assurance Forum的主席，现在是TransCelerate QMS APAC subcomittee核心团队成员。 庆红毕业于上海复旦大学，医学院临床医学系，在美国工作期间于2002年完成了Temple大学药学院的RA/QA硕士学习。2008年回国后，于2012年完成了复旦大学管理学院的工商管理(MBA).

蒋海洪

上海健康医学院医疗器械学院副教授

中国著名医疗器械法规专家、上海健康医学院医疗器械监管专业主任，上海汉盛律师事务所执业律师。中国首部医疗器械蓝皮书副主编、首个医疗器械监管专业创始人与负责人。主持完成多项医疗器械法规相关重点课题，公开发表相关专业文章30余篇，出版专著1部：《最新〈医疗器械监督管理条例〉研究与解读》、主编书籍3部：《中国医疗器械行业发展报告（2017）》、《医疗器械法规汇编与案例精析》、《医疗器械监管法规》。兼任国家食品药品监督管理总局高级研修学院特聘专家、中国医疗器械行业协会特聘法规专家、上海医疗器械行业协会管理者代表协调委员会顾问等职务.

William SUTTON

美国食品药品管理局驻华办公室副，主任国际项目和政策分析官员（医疗器械）

萨盾是在美国食品药品管理局（USFDA）国际项目办公室下属的FDA驻华办公室助理主任，他负责医疗器械的国际项目和政策分析。在被任命为FDA驻华办公室助理主任之前，萨盾先生是医疗器械和放射健康中心（CDRH）的行业与消费者教育处（DICE）副处长。他主要负责该处在医疗器械上市前和上市后相关法规教育工作的战略发展。 萨盾先生1983年起开始在FDA工作，曾在医疗器械评审办公室（ODE）和交流教育办公室（OCE）工作。在FDA工作期间，曾在ODE担任行政评审员，在OCE的企业和国际协助项目中担任消费者安全官主管。在这两项工作中，他负责国内和国际合规事务，并担任FDA第三方认可委员会（TPRB）主席，管理510(k)评审的认可人员（AP）和现场检查的AP。在过去的21年中，他参与了多国大量医疗器械相关联邦法规政策的培训。萨盾先生获得马里兰大学大学学院分校的科学管理学士学位。

王宇红

施乐辉有限公司法规临床事务及质量保证副总裁

王宇红 施乐辉有限公司法规临床事务&质量保证副总裁 现任施乐辉医用产品国际贸易（上海）有限公司法规临床事务和质量保证副总裁。毕业于北大医学部药学院，工商管理硕士。2012年加入施乐辉公司，负责法规临床事务和质量保证。之前曾任美敦力（上海）管理有限公司，默沙东（中国）有限公司法规注册部负责人。进入医药企业之前，曾在原卫生部药品不良反应监察中心工作6年，参与建立中国药品不良事件报告体系。目前是中国药品监督管理研究会医疗器械监管研究专业委员会委员，欧盟商会医疗器械工作组主席。 王宇红在跨国公司工作的20年间， 致力于医药产品的上市前评价、临床研究、上市后监测和评价，以及公司质量保证体系的建立等工作。作为中国、美国及国际协调组织的药品和医疗器械监管法规法规方面的专家，曾参与医疗器械监督管理相关法规规章的起草讨论，ICH指南(药品注册的国际技术要求)的引进出版, 多次组织或积极参与国内国际会议研讨药品医疗器械注册相关法规、标准和质量控制、医疗器械的生物安全性及国际临床试验要求等。曾作为AHWP秘书处及专注于临床的第5工作小组成员，积极参与区域法规协调工作。

Michael MONTELLO

IQVIA全球研发技术负责人，副总裁

刘锦雷

德勤产品开发副总裁

Jinlei is a VP at Deloitte Consulting US where he leads product development of the ConvergeHEALTH Miner, a cloud based big data analytics platform that helps to accelerate evidence generation and unlock the full potential of health data in a life science organization. Jinlei has worked on data analytics solutions in the life sciences and healthcare industry for the past 14 years. He gained his bio-informatics training from a major biomedical and genomic research center where he was a leading contributor to the Genome Sequencing Platform. While at Deloitte Jinlei has worked with global biopharma companies and academic medical centers. His experience includes translational research, Real World Data(RWD) studies, and machine learning based data analytics. Jinlei is also a contributor to i2b2/tranSMART and Observational Health Data Sciences and Informatics (OHDSI) open source communities. Jinlei earned BE in Electronics Engineering from Tsinghua University and MS in Computer Science from Northeastern University.

吴刚

双桥首席执行官

A graduate of Peking University and Colorado State University, DoubleBridge Technologies President and CEO Dr. George Wu began his long technology career in the 1980s, as a senior software engineer with international financial companies such as Citibank and AIG. In 1997, he joined Oracle Corporation as a practice director for the firm’s New York office while contributing to Oracle’s China business. In the same year, George Wu launched DoubleBridge Technologies, leveraging his experience with the Chinese market to transform the small startup into a significant player in the global IT industry. In 2007, Dr. Wu guided his company through a merger with ChinaSoft International, one of the world’s most successful IT firms, and was subsequently named chief technical officer of ChinaSoft. Today, DoubleBridge functions as a key part of ChinaSoft’s global success, leading the firm’s North American efforts to expand into the pharmaceutical, financial, and healthcare sectors. In addition to his work in the private sector, Dr. Wu has been involved with several government-sponsored public transportation projects, including the Metro EZ Pass systems in New York and Philadelphia.

谷成明 博士

辉瑞制药副总裁，医学部负责人

谷成明 医学博士 辉瑞制药有限公司大中华区副总裁，医学部负责人。从2000年起至今，一直负责知名外资制药企业药物研发及医学事务工作，具有丰富的国内和国际工作经验。 谷成明博士毕业于中国医学科学院，中国协和医科大学，北京协和医院消化内科，获消化内科医学博士，曾在北京协和医院，威斯康星医学院，蒙特利尔大学等工作，共有16年临床和科研工作经历。曾就读美国新泽西州立大学获EMBA学位。 社会兼职：河北省特约政协委员；中山大学、河北科技大学客座教授；新泽西州立大学董事会顾问；河北省卫生经济与药物研究中心主任；中国卫生经济学会基层卫生经济专业委员会副主任委员，卫生费用与政策专业委员会常委；中华预防医学会慢性病预防与控制分会副主任委员；中国外商投资企业协会药品研制和开发行业委员会(RDPAC)医学事务组主席；中华内科杂志特约编委。

马欢

辉瑞全球产品开发卓越运营中心信息管理部中国区负责人

马欢是辉瑞（中国）研发中心信息管理团队负责人。 已在辉瑞工作17年 (其中美国辉瑞9年)，在软件 开发和支持方面有丰富的经验，精通药物开发的各 个领域及相应的计算机系统功能和架构。2010年回国后 将初创的功能单一的团队发展成覆盖整个药物开发领域的信息管理团队，包括政策法规系统管理(Regulatory Solutions), 临床研究系统管理(Clinical Trial Solutions), 药物安全系统管理(Safety Solutions), 文档系统管理(Content Management & Authoring) 和技术支持服务中心（ Centralized Service）等，通过技术、人才与业务的合作，实现系统开发、环境部署、业务咨询、风险控制等不同领域的支持，共同致力于为用户提供全面完善的信息整体解决方案。 马欢于西安电子科技大学获得计算机软件硕士学位.

朱宏图 博士

MD Anderson癌症中心生物统计系教授

朱宏图教授为德克萨斯大学MD Anderson癌症中心生物统计系教授，美国统计学会图像统计方向八个创始人之一。朱宏图教授多年来一直致力于医学图像统计分析、结构方程模型、统计诊断、变量选择、删失数据分析、函数型数据分析、流形数据统计分析等几个方面的研究，在统计学和生物统计学等多个领域作出了杰出贡献。朱宏图教授现担任国际统计界顶级学术期刊Annals of Statistics和Journal of the American Statistical Association副主编，同时还担任Statistica Sinica和Statistics and its Inference副主编。先后被选为美国统计学会（American Statistical Association）终身会员，国际数理统计学会（Institute of Mathematical Statistics，IMS）终身会士。

李洪哲 博士

宾夕法尼亚大学生物统计教授

Dr. Hongzhe Li is a Professor of Biostatistics and Statistics at the Perelman School of Medicine at the University of Pennsylvania (Penn). He is the Chair of the Graduate Program in Biostatistics and Director of Center of Statistics in Big Data at Penn. Dr. Li has been elected as a Fellow of the American Statistical Association (ASA), a Fellow of the Institute of Mathematical Statistics (IMS) and a Fellow of AAAS. Dr. Li severed on the Board of Scientific Counselors of the National Cancer Institute of NIH and regularly serves on various NIH study sections. He is currently an Associate Editor of Biometrics, Statistica Sinica and also co-Editor-in-Chief of Statistics in Biosciences. He serves as Chair of the Section on Statistics in Genomics and Genetics of the ASA. Dr. Li’s research has been focused on developing powerful statistical and computational methods for analysis of large-scale genetic, genomics and metagenomics data and high dimensional statistics with applications in genomics. He has published papers in Science, Nature, Nature Genetics, Science Translational Medicine, JASA, JRSS, Biometrika, etc.

蔡天西 博士

哈佛大学公共卫生学院生物统计教授

Education: ScD Biostatistics Harvard University (1996-1999) Boston, MA BSc Mathematics University of Science and Technology of China (1991-1995) P.R. China Academic Appointment - Professor of Biostatistics, Harvard University (2012- ) - Associate Professor of Biostatistics, Harvard University (2006-2011) - Assistant Professor of Biostatistics, Harvard University (2002-2006) - Assistant Professor of Biostatistics, University of Washington (2000-2002) Editorial Appointment - Associate Editor, JASA Theory and Methods (2011--) - Associate Editor, JASA Application and Case Studies (2010--) - Associate Editor, Biometrics (2008--2012) - Associate Editor, Lifetime Data Analysis (2010--) - Associate Editor, Statistics in Biosciences (2009--) - Guest Editor, Statistics and Its Interface Special Issue for IMS-China Conference on Statistics and Probability (2009) Honors - Fellow, American Statistical Association - Joy Foundation Fellow, Radcliffe Institute for Advanced Studies (2007-2008) - Distinguished Visiting Junior Scholar, Peter Wall Institute of Advanced Study (2001) - Student Travel Award, ENAR International Biometrics Society (1999) - Authur T. Lyman and Henry S. Grew Scholarship, Harvard University (1998-1999) - Robert Reed Award for Academic Excellence in Biostatistics, Harvard University (1997) - Pfizer Scholarship (1997-1998) Honors - Fellow, American Statistical Association - Joy Foundation Fellow, Radcliffe Institute for Advanced Studies (2007-2008) - Distinguished Visiting Junior Scholar, Peter Wall Institute of Advanced Study (2001) - Student Travel Award, ENAR International Biometrics Society (1999) - Authur T. Lyman and Henry S. Grew Scholarship, Harvard University (1998-1999) - Robert Reed Award for Academic Excellence in Biostatistics, Harvard University (1997) - Pfizer Scholarship (1997-1998) Honors - Fellow, American Statistical Association - Joy Foundation Fellow, Radcliffe Institute for Advanced Studies (2007-2008) - Distinguished Visiting Junior Scholar, Peter Wall Institute of Advanced Study (2001) - Student Travel Award, ENAR International Biometrics Society (1999) - Authur T. Lyman and Henry S. Grew Scholarship, Harvard University (1998-1999) - Robert Reed Award for Academic Excellence in Biostatistics, Harvard University (1997) - Pfizer Scholarship (1997-1998) Honors - Fellow, American Statistical Association - Joy Foundation Fellow, Radcliffe Institute for Advanced Studies (2007-2008) - Distinguished Visiting Junior Scholar, Peter Wall Institute of Advanced Study (2001) - Student Travel Award, ENAR International Biometrics Society (1999) - Authur T. Lyman and Henry S. Grew Scholarship, Harvard University (1998-1999) - Robert Reed Award for Academic Excellence in Biostatistics, Harvard University (1997) - Pfizer Scholarship (1997-1998)

范剑青 博士

普林斯顿大学弗雷德里克·摩尔(Frederick L. Moore) 金融系教授 统计研究委员会主任

Education:PhD Statistics University of California, Berkeley (1986-1989) Berkeley, CA MSc Statistics Chinese Academy of Sciences (1982-1985) P.R. China Academic Appointment : - Assistant, associate, and full professor at the University of North Carolina at Chapel Hill (1989-2003) - Professor at the University of California at Los Angeles (1997-2000) - Professor of Statistics and Chairman at the Chinese University of Hong Kong (2000-2003) - Professor at the Princeton University (2003- ) Editorial Appointment: - Editor of Probability Theory and Related Fields (2003-2005), Econometrical Journal (2007-2012) - Co-editor of Journal of Econometrics and associate editor of Journal of the American Statistical Association (1996--) - Co-editor (-in-chief) of the Annals of Statistics (2004-2006) - On the editorial boards of several other journals, including Statistica Sinica (1996-2002), Annals of Statistics (1998-2003), Journal of Financial Econometrics (2009-2012), and Econometrica (2010-2013). Award - Academician (elected), Academia Sinica, (2012) - Guggenheim Fellow, (2009) - Morningside Gold Medal for Applied Mathematics, (2007) - The 2000 COPSS Presidents' Award, (2000)

张和平 博士

耶鲁大学公共卫生学院统计科学合作中心主任，生物统计系教授

Academic Appointment - Associate Professor (with tenure) of Public Health (Biostatistics), Yale University (2001-) - Associate Professor (with tenure) of Biostatistics, Child Study and Statistics Yale University (2001-2003) - Professor (with tenure) of Biostatistics and Child Study (2003-) Publications - Generalized Score Test of Homogeneity for Mixed Effects Models. Annals of Statistics, 2006. - Detection of Genes for Ordinal Traits in Nuclear Families and a Unified Approach for Association Studies. Genetics, 2006. - Linkage Analysis of Ordinal Traits for Pedigree Data. Proceedings of the National Academy of Sciences, 2004. Honors - Royan International Research Award, Royan Institute (2011) - Medallion Lecturer, Institute of Mathematical Statistics (2011) - Fellow, Institute of Mathematical Statistics (2006) - Independent Scientist Award, NIH/National Institute on Drug Abuse (NIDA) (2004) - Fellow, American Statistical Association (2000) - Elected Member, International Statistical Institute (1995)

郭彤 博士

IQVIA大中华区销售副总裁

邓剑雄

广东省药品不良反应监测中心主任

孟渊

西安杨森/强生大中华区药品安全负责人

孟渊目前担任西安杨森制药有限公司跨业务领域药品安全负责人职务。在此职位 上，他负责中国大陆、香港及台湾地区的药品和消费品的安全策略和药物警戒的营 运工作。以确保维持对法律规章和公司规定的最高级别的合规；确保对所有早期或 后期临床研究的医学安全；与所负责地区、亚太区及总部相关部门人员共同领导产 品安全管理工作；起草执行当地风险管理计划，主动地解决安全关切！ 孟渊加入强生前就职于辉瑞公司全球注册及安全部，安全监测及风险管理部门。在 此职位上孟渊主要负责肿瘤治疗领域相关产品的主动安全监测和风险管理，包括信 号检测，信号评价，风险评估，风险最小化。孟渊是其负责肿瘤治疗领域产品的安 全管理组的主持人，和该产品的全球安全代表人。同时作为所负责产品的安全联络 人，须确保有关药物安全信息统一有效的沟通，清晰的表达公司对有关安全问题的 立场。 在此之前曾任职于多家跨国制药企业，包括美国礼来制药（2000-2003）， 惠氏制 药（2003-2007），施贵宝制药（2007-2011）。孟渊毕业于上海医科大学（现复旦 大学上海医学院）。孟渊在加入制药界之前在上海瑞金医院从事神经科临床医疗实 践及教学工作（1997-2000）。 孟渊的主要职业经验来自于临床药物安全，药物风险管理以及药物的风险受益评价 等领域。是最早将 MedDRA 介绍到我国的药物安全同仁之一，并参与了最初版本 的翻译校对工作。同时他也是 DIA 中国临床安全及药物警戒沙龙的活跃成员。

周凌芸

赛诺菲中国及亚太区安全负责人

任曙光

拜耳医药保健有限公司国际药品安全行政总监

任曙光 (Dawn Ren): 目前职位：拜耳制药，国际药品安全行政总监 (Global Safety Leader) 1995年毕业于哈尔滨医科大学。在妇产科临床工作8年。2005年进入制药行业，先后在默沙东、罗氏及拜耳从事临床试验数据管理和药物警戒工作。至今在药物警戒领域工作11年，其中7年在药品安全风险管理领域（risk management），负责在研药物和上市后药物的获益风险评估 (benefit risk assessment)，发现新药的安全性特性（safety profile）, 对已上市药物进行信号探测 (signal detection)，制定风险管理计划 (risk management plan) 和风险最小化措施 (risk minimization measures)等。

Nina STUCCIO

默克实验室医学安全审评和临床试验安全报告副总裁

Nina Stuccio, D.O. has over 15 years of experience in the biopharmaceutical industry and is currently the Global Head of Medical Safety Review and Clinical Trial Safety Reporting at MSD. An internist and nephrologist, with experience as a clinical trial investigator and emergency medicine, she joined the biopharmaceutical industry in 2002 as a Medical Safety Review physician at Janssen/Johnson & Johnson. During her 11 years at Amgen, she provided medical safety support for marketed and late development products as Executive Medical Director, Therapeutic Area Head and Global Safety Officer, General Medicine and Bone prior to leading the successful implementation of a new global safety database. She was then Head of Quality Management for Global Regulatory Affairs and Safety at Amgen prior to joining MSD in 2014 as Global Head of Medical Safety Review and Clinical Trial Safety Reporting. Nina was the Clinical Safety & Risk Management Oncology Therapeutic Area Lead for two years prior to returning to her current role.

张轶菁

拜耳中国药物警戒中国区负责人

林钦

默沙东研发（中国）有限公司药物安全部中国区负责人、总监

Qin Lin has 15 years of experience in the biopharmaceutical industry and is currently the China PV lead at MSD. As internist and cardiologist, she worked in the hospital for three years. With clinical experience she joined in the clinical operation team in CMIC in 2003. During her 5 years at CMIC, she took CRA, CPM and CQM roles to successfully complete several clinical trials. And in 2008, she joined MSD China PV team and is responsible for local PV actives in China. Qin is MSD China PV lead for four years.

薛富波 博士

杨森中国研发中心医学写作及语言服务部负责人

Fubo (Bruce) Xue, Head of Medical Writing and Language Services, Janssen China R&D, J&J. He joined Janssen China in 2008 and was leading the biostatistics group in study design, protocol development, clinical data analysis and reporting, and quality control of outsourced projects for R&D and MA studies. He is now in charge of Medical Writing and Language Services covering scientific writing in clinical trials and document development/preparation for submissions. Before joining Janssen China, he worked as the head of biometrics department in Excel PharmaStudies Inc. (now PPD China branch) for 1 year and as a teacher of health statistics in the Fourth Military Medical University for 10 years.

王楠 博士

拜耳医药普药医学写作中国及芬兰地区负责人

PROFESSIONAL EXPERIENCE: Bayer Health Care: Scientific medical writer, Sr. scientific medical writer, Head, Medical Writing, General Medicine, FL/CN, Main responsibility: author clinical study protocol, clinical study report, clinical submission documents and responses to Authorities in the USA, EU and China. 04. 2010 – 03. 2012 Medical writer Main responsibility: author clinical study report and publications based on clinical studies Novo Nordisk (China) 04. 2009 – 01. 2010 Research scientist Pfizer R&D (UK) EDUCATION 09. 2004- 01. 2008 University of Nottingham Ph.D Major: pharmacy 09. 2003- 08. 2004 University of Nottingham Master of Research Major: pharmacy 09. 1996- 07. 2000 Beijing University of Chemical Technology Bachelor of Science Major: pharmacy

Sophia HUANG

拜耳医药全球递交管理及计划部副总监

Sophia Huang Associate Director, Regulatory Submission Management & Planning Beijing Bayer Healthcare Company Limited Sophia Huang currently works in Development Beijing, and has been the site head of Regulatory Submission Management & Planning Beijing since 2015. Her team contributes in Global Dossier Publishing for new drug application in EU and US; and is also responsible for eCTD publishing in emerging eCTD countries (i.e. Gulf countries, South Africa etc.) for Bayer’s Pharma portfolios. Since 2015, CFDA/CDE showed interest on eCTD implementation. Sophia, as representative of Bayer in both CDE and RDPAC eCTD core working groups, contributes to promote eCTD knowledge to Chinese Pharmaceutical industry; share global experience with HA. In addition, since 2016, Sophia’s team took over the electronic submission support for OTC portfolios globally except the United States. Sophia joined Bayer in 2009, and has been in different positions: site head of Regulatory Compliance Management Beijing, and then Senior GRA Manager (worked in Bayer’s headquarter in Germany). She graduated from Edinburgh Napier University in UK in 2007 with a master’s degree in biomedical sciences.

Bryan GRIFFIN 博士

精鼎医学写作服务高级医学撰稿人

Bryan Griffin is a Senior Medical Writer in the Medical Writing department of PAREXEL International. Bryan holds a Bachelor of Science degree and PhD in Pharmacology from University College Dublin, Ireland. He has co-authored 11 peer-reviewed publications in the fields of immunology and microbiology. Bryan has 8 years’ experience in medical writing and medical affairs roles in the pharmaceutical industry in Europe and Asia. Since February 2014, he has been based in PAREXEL’s Singapore office. Bryan has strong experience in developing clinical protocols, ICFs, study reports, DSURs, CTDs and responses to health authority questions. His work has covered a wide range of investigational product types (including vaccines, biosimilars and generics), study types (Phase Ib-IV clinical studies and observational studies) and therapeutic areas.

Joan AFFLECK

默克医学写作负责人

Affleck is an Executive Director and Head of Medical Writing at Merck. Her group supports late stage development programs in all therapeutic areas. It is a dynamic and highly successful pipeline. She has over 20 years of international experience in the pharmaceutical industry in operational leadership, strategy, and innovation, and has a track record of developing high-functioning teams, and delivering expanded business services and cost reductions. In the past 2 years she built a medical writing team at Merck, starting with a department of one and growing it to 200. In addition, she continues her innovative work in the management of clinical information through structured content authoring to help Merck gain efficiencies and competitive advantage. Joan is passionate about creating a work environment in which ideation is essential to the culture, unique perspectives are valued, and the team is always looking for new opportunities to further the Merck mission. She has served as an advisor to the TransCelerate Common Protocol Template Initiative and is a member of the Healthcare Businesswomen’s Association Circle of Advisors. Joan is a Villanova University graduate and received her MBA from Columbia University, where she is a regular guest lecturer. When not in the office you can find Joan on a running trail or enjoying outdoor activities with her family.

Julia COOPER 博士

精鼎医学写作服务全球负责人兼副总裁

Julia Cooper oversees the Medical Writing department and all its deliverables, from clinical protocols and study reports, through to CTD/NDA, post-marketing and clinical trials disclosure documents. During her tenure as global head, the Medical Writing team has grown to over 180 professionals across the Americas, Asia, Europe and South Africa, and has established a highly successful track record for quality and timeliness of medical writing deliverables. In 2013, Julia Cooper relocated from the UK to PAREXEL’s Shanghai office, in order to focus more on the Asia writing team. Since January 2017, she is based in PAREXEL’s Dublin office. Julia Cooper has over 25 years’ experience in the pharmaceutical industry, including more than 23 years as a medical writer. She holds a Bachelor degree in Natural Sciences, and a PhD in Biotechnology, both from the University of Cambridge, UK, and is a Fellow of the Royal Society of Chemistry. Julia Cooper is a member of the European Medical Writers Association (EMWA), and has previously served on the committee for 11 years as Education Officer, President and Secretary. She has also served as a Core Committee member of the DIA Medical Writing China Regional Community, is a member of the American Medical Writers Association (AMWA), and has regularly presented at DIA and other industry conferences. In 2015, Julia Cooper was presented with the EMWA Nick Thompson Fellowship, for services to the medical writing profession.

Roger NOSAL 博士

美国辉瑞公司全球CMC副总裁

Roger Nosal is Vice President & Head of Global Chemistry, Manufacturing & Controls at Pfizer. Roger has contributed to the evolution of Quality by Design & has advocated for global regulatory harmonization through several PhRMA, ICH, ISPE, PQRI, AAPS, IFPAC, ACS & DIA technical committees. He is currently the PhRMA Topic Leader for ICH M9, Chair of ISPE Pharmaceutical Engineering and co-chair of ISPE Regulatory Track and DIA Quality Program Committees. Roger’s 35 years of experience at G. D. Searle, Monsanto, Pharmacia & Pfizer, includes 22 years in regulatory CMC. Prior to his regulatory role, Roger was a Medicinal Chemist, author of 24 patents for several medicinal candidates (PAF, leukotriene, 5-HT3 & 5-HT4 antagonists & agonists, COX-2 & serotonin inhibitors) & a Process Chemist, focused on synthetic development & analytical control of derivatives of aspartame & manufacturing optimization of prostaglandin syntheses.

陈琦琬 博士

美国辉瑞公司执行总监 美国FDA校友同仁会会员

Chi-wan Chen is Executive Director in Global CMC, Pfizer, responsible for regulatory CMC policies and strategies with a focus on Asia Pacific. She chairs the Asia Pacific Focus Group under the International Society of Pharmaceutical Engineering (ISPE), and serves as an ad hoc CMC advisor to the China R&D-based Pharmaceutical Association Committee (RDPAC) and to the Association of South East Asia Nations (ASEAN) Pharmaceutical Research Industry Association (APRIA). Dr. Chen has made numerous presentations on regulatory and CMC topics in Asia Pacific. Prior to joining Pfizer in 2008, Dr. Chen had served in the U.S. FDA for more than 21 years and held several management positions in the Center for Drug Evaluation and Research (CDER), including Deputy Director in the Office of New Drug Quality Assessment (ONDQA). She represented CDER on the ICH Q1AR, Q3AR/Q3BR, and Q8R Expert Working Groups (EWGs) between 1998 and 2008. Dr. Chen is currently an active member of the Food and Drug Administration (FDA) Alumni Association International Network (FDAAAIN). She has a Ph.D. degree in organic chemistry from the University of Wisconsin, U.S.A.

Eric DONG

FDA CDER药品质量办公室，监测办公室消费者安全官

Eric Dong has been with FDA for over 7 years in various roles including drug chemist, GDUFA investigator, and most recently Consumer Safety Officer in Office of Surveillance within the Office of Pharmaceutical Quality in CDER. His responsibilities as Consumer Safety Office includes compliance review of foreign facility inspections, issuance of inspection dossier, and scientific review and quality evaluation of the manufacturing process and facilities filed in drug application. As a GDUFA drug investigator, he had performed numerous surveillance and pre-approval inspections both domestically and internationally. Prior to joining the FDA, he worked as a validation chemist in the pharmaceutical industry related to analytical method development, and cleaning validation. Eric received his B.S. in Chemistry from Binghamton University, State University of New York.

Susan LASKA

FDA监管事务办公室运行助理局长医药产品高级顾问

苏森•拉斯卡 苏森•拉斯卡女士于1989年入职FDA，任职于FDA费城地区办公室。作为FDA费城地区办公室检查员，拉斯卡女士主要开展药品检查，包括美国境内外的药品GMP和GCP检查。2006年，拉斯卡女士获得进入FDA三级药品检查团资质并曾是二级药品检查稽核员。拉斯卡女士曾是全国药品专家、检查员主管，现任FDA监管事务办公室运行助理局长医药产品高级顾问。拉斯卡女士自开始即深度参与了FDA-欧盟药品检查互认倡议以及国际药品监管公约/药品监管合作计划。

Ellen MORRISON

FDA法规事务办公室，药品和烟草业务助理处长

艾琳•默瑞森 默瑞森女士是美国食品药品管理局(FDA)助理局长，负责监管事务办公室(ORA)医药产品和烟草运行部，在医药产品和烟草领域领导四个项目主管进行ORA各分支地区和总部的协调和管理工作。默瑞森女士是领导实地生物制品项目、药品质量、医疗器械和放射健康以及生物研究检测项目的项目领导层的首届领导人。这包括医药产品相关的检查、应急准备和响应活动。 默瑞森女士在哈佛大学肯尼迪政府学院完成了危机管理领导和全国应急领导力项目并于2013年获得圣安德鲁斯大学恐怖主义研究硕士学位。 默瑞森女士最初在FDA任检查员，后在几个FDA地区办公室任职专门开展生物制品检查，再后来即入职ORA总部。2002年，FDA任命默瑞森女士担任危机管理办公室应急运行部主任，负责领导和协调FDA与其他联邦、州、地方和国际监管部门之间的应急准备和响应工作。2003年，默瑞森女士成为新成立的危机管理办公室的首届主任，通过应急演练、危机管理、FDA的安全政策和项目方面的工作推进了FDA局长的多个重点项目。2012年，默瑞森女士回到监管事务办公室任代理运行助理局长，一年后正式被任命为助理局长。默瑞森女士获得了很多FDA奖项，其公共服务也多次被嘉奖。默瑞森女士把自己看成是公共服务人员以及培养下一代公众健康卫士的导师。

柯雷恩 博士

美国食品药品管理局驻华办公室副主任

柯雷恩 博士 助理主任，美国食品药品管理局中国办公室 柯雷恩博士任职美国FDA国际项目办公室（OIP）下设的中国办公室助理主任，担任药品国际项目和政策分析官员。在此之前，他曾担任药品审评研究中心（CDER）药品质量办公室（OPQ）工艺和设施办公室（OPF）分部主任，主要负责A/NDA中生产工艺及设施检查的审评。 此前，他在仿制药办公室（OGD）担任审评处的组长，并曾作为化学家在直属办公室任职，负责CMC相关的多项工作，包括ANDA评审，沟通管理，公民请愿书及政策开发。柯雷恩博士曾广泛的参与到OPQ重组以及GDUFA框架下新的使用者付费的执行等多项工作中，包括主导招聘工作，参与基于风险的审评。他在犹他大学获得了制药和药物化学的博士学位，此后在制药行业从事博士后研究。柯雷恩博士从医疗器械和放射健康中心（CDRH）的合规办公室开始其FDA生涯。

Eric MASSON

美国Biogen公司临床药理及药物测量学负责人，副总裁

Eric Joined Biogen in September 2017. He is the Vice President of Clinical Pharmacology and Pharmacometrics. Prior to joining Biogen, Eric was the global clinical pharmacology disciplined lead and co-leading oncology at AstraZeneca. Eric started his career in academia as an assistant professor of pharmacy at Universite Laval. He later built drug development experience, and built diverse teams at the following companies: Anapharm Inc, Novartis Oncology and Bristol-Myers Squibb. Eric has extensive small/large molecule experience, and is an expert in oncology and immune-oncology. Eric obtained his B.Pharm degree from Universite Laval, his Pharm.D. from SUNY Buffalo, and completed two-year post-doctoral fellowship at St. Jude Children’s Research Hospital in Memphis, TN. Outside work, Eric enjoys skiing, ice hockey and tennis. Eric also enjoys hiking with his wife Dominique and their dog Madie. Eric has 3 children in College: Florence, Louis-Charles, and Edouard.

陶晓路 博士

先声药业DMPK及临床药理执行总监

Dr. Xiaolu Tao is currently Executive Director of Simcere Pharmaceutical Group, heading DMPK and Clinical Pharmacology. Prior to this, she was the Sr. Fellow and global Clin Pharm lead for several biosimilar programs, including bevacizumab, aflibercept and epoetin alfa, from 2015-2016. Before joining Sandoz, she worked at BMS from 2009 as Sr. Research Investigator to Associate Director in therapeutic area of oncology/immunology, where she served as a Clinical Pharmacology representative for multiple projects involving both small molecules and biologics, and, later on, with increasing responsibility as Outsourcing Study Director focusing virology. Before that, Dr. Tao worked as a Senior Manager in Clinical Pharmacology of Akros Pharma Inc. She is the one of co-inventors of one patent and has multiple publications. Dr. Tao now is also the member of a council of Translational Medicine Center of JITRI (Jiangsu Industrial Technology Research Institute) Dr. Tao received her Ph.D. from Temple University School of Pharmacy, and received both BS and MS degree from China Pharmaceutical University.

王亚宁 博士

药政专家

Dr. Yaning Wang is currently the Director (acting) and Deputy Director in the Division of Pharmacometrics in the Office of Clinical Pharmacology at FDA. Before joining FDA, Dr. Wang received his Ph.D. in Pharmaceutics and master’s degree in Statistics from the University of Florida from 1999 to 2003. He also obtained a master’s degree in Biochemistry (1999) from National Doping Control Center and a bachelor’s degree in Pharmacy (1996) from Peking University in China. At his current position, Dr. Wang oversees reviews, research projects, and policy development within the Division of Pharmacometrics for all disease areas. During his thirteen years of service at FDA, Dr. Wang received numerous awards, including Award of Merit (the most prestigious honor awarded at FDA) and FDA Outstanding Service Award. Dr. Wang is an Adjunct Professor in the Department of Pharmaceutics at the University of Florida and an invited lecturer in the College of Engineering and College of Pharmacy at the University of Michigan. Dr. Wang is a regulatory expert lecturer for American Course on Drug Development and Regulatory Sciences (ACDRS) organized by University of California at San Francisco (UCSF), European Course in Pharmaceutical Medicine (ECPM) organized by University of Basel, and Chinese Course on Drug Development and Regulatory Sciences (CCDRS) organized by Peking University Clinical Research Institute in collaboration with University of Basel and UCSF. Dr. Wang is the chair of the FDA working group to draft a new guidance for the industry to optimize dose selection during the clinical development stage. Dr. Wang served as a committee member for multiple Ph.D. candidates from various universities. He mentored more than thirty former research fellows (visiting scholars, post-doctoral scholars, and Ph.D. candidates) at FDA. Dr. Wang is an invited manuscript reviewer for eighteen scientific journals in the medical, pharmaceutical and statistical areas. He has published 53 papers and given 130 presentations at various national and international meetings. He is a member of the Advisory Committee for Chinese Pharmacometrics Society and a member of the Editorial Advisory Board for the Journal of Pharmacokinetics and Pharmacodynamics.

Ana HIDALGO-SIMON 医学博士

EMA人类用药品研究和开发支持处专业科学负责人

Nationality: Spanish Career to date: • Head of Specialised Scientific Disciplines, European Medicines Agency (2013-present) • Head of Risk Management, European Medicines Agency (2012-2013) • Head of Risk Management (ad interim), European Medicines Agency (2011-2012) • Head of Signal Detection and Data Analysis, European Medicines Agency (2009-2011) • Scientific Administrator, European Medicines Agency (2003-2009) • Medical Editor, EuroTransmed, United Kingdom (1998-2003) • Scientific Project Manager, Medical Action Communications, United Kingdom (1997- 1998) • International Clinical Trials Coordinator, SymbioClin, United Kingdom (1996-1997) • Post-doctoral Researcher, Clinical Research Centre, United Kingdom (1995-1996) Education: • Diploma in heath economics, University of York , United Kingdom (2003) • Doctor of Philosophy in clinical research, Royal Free Hospital School of Medicine , London, United Kingdom (1995) • Doctor of medicine and surgery, University of the Basque Country , Bilbao, Spain (1990)

Inger MOLLERUP

瑞士诺和诺德公司CMR药政顾问

More than 25 years’ experience in Drug Development and more than 12 years Regulatory Affairs experience with global regulatory responsibility for a number of drug development projects. Experienced in developing and leading regulatory strategy and implementation toward the NDA approval and life-cycle management. Has in that capacity overseen a number of license application and approval projects with multiple agency interactions in several regions of the world including USA (incl. Advisory Committee preparations), EU, Japan, China, Canada, India, Latin America and Southeast Asia. Has also held the project leadership responsibility for conducting a CVOT interim analysis to support regulatory decisions. Internationally recognized expert in biologics including biosimilars and represents Novo Nordisk in scientific and regulatory questions on biosimilar products. Has in that capacity been active in science-based policy engagement with regulators, legislators and industry trade organizations (including EMA/WHO/IABS/HC/FDA/US Congress with presentations at EMA and WHO workshops as well as testifying to the US Government Oversight and Reform Committee) and presented in numerous scientific conferences as well as agency led meetings and workshops. Broad leadership experience covering line management as well as global project management encompassing both quality, nonclinical and clinical areas.

杨建红

沈阳药科大学亦弘商学院研究中心研究员

杨建红 主任药师 原国家药品审评中心化药药学二部副部长（主持工作），亦弘商学院研究员

王海彬 博士

浙江海正药业股份有限公司高级副总裁，亦弘商学院研究员

蔺亚萌

罗氏(中国)投资有限公司 高级经理

蔺亚萌2004年加入罗氏，主要负责生物制品临床试验申请、上市申请相关的注册活动。2009-2010年间曾被公司派往瑞士总部工作17个月，任区域注册经理，负责支持中国和香港的药品注册，期间她还加入了几个临床开发团队，积累了全球药品开发和欧洲和发展中国家的注册经验。她在2011年加入罗氏CMC政策团队，负责制定中国技术政策的影响策略，并带领全球跨部门的团队开展与中国药品监管部门和行业协会之间的沟通与合作，此外她还支持全球技术注册负责人来制定中国的注册策略。 加入罗氏之前，她曾在北京双鹤药业工作近3年，负责药品出口贸易以及在药品在东南亚、东欧和非洲的注册。 她于2001年毕业于沈阳药科大学并于2016年获得北京大学国际药物工程管理硕士学位。 她积极参于工业协会、学术组织以及非营利组织的各种学术交流互动活动。她是中国外商投资企业协会药品研制和开发行业委员会（RDPAC）药学专业组核心成员，曾任RDPAC 药学专业组主席，带领工业界就药学领域的问题与监管部门进行积极的沟通并开展多次学术交流活动。过去5年中她积极参与组织药物信息协会（DIA）中国年会的多个生物和药学分会，自从2015年开始她被推选为DIA中国顾问委员会的一员。2017、2018年她在美国华盛顿召开的WCBP（良好鉴定的生物制品大会）上组织并主持了“中国生物制品监管”分会。

David KIGER

BioClinica首席商务官

David brings a wealth of experience as a senior commercial leader with deep pharmaceutical industry and domain knowledge of medical imaging and technology. As Bioclinica's Chief Commercial Officer, Medical Imaging & Technology, David provides leadership to our alignment and go-to-market teams while strengthening our value propositions, accelerating the unification and growth of the business. Previously David was VP Product Strategy and Marketing Business Partner at PAREXEL where he defined go-to-market approaches and launches in the areas of patient, clinical, and regulatory technologies. David lives in the San Francisco Bay Area and brings a diversified career of 25 years of experience in business development, product and digital marketing, product management, alliances, and management consulting at companies such as Commerce One, Siebel Systems, and Accenture. Dave earned a Bachelor's in Business Administration-Computer Information Systems and graduated Summa Cum Laude from the University of Wisconsin-Whitewater.

James STREETER

甲骨文生命科学产品策略全球副总裁

As the global head of life sciences product strategy for Oracle, James Streeter collaborates closely with Oracle customers, regulatory agencies, analysts, and industry thought leaders to develop and help execute the overall business and product strategy for Oracle Health Sciences. He previously held leadership roles at PPD in both operations, as the Global Head of Global Clinical Technical Operations and EDC and recently in IT, as Global Head of Systems Development, Business Operations Teams, and eClinical Strategy and Innovation. James has 25 years of data acquisition and analysis experience utilizing computerized systems and has focused on eClinical systems and processes for trials for the last 15 years. James’ experience includes implementing end to end eClinical Solutions and processes across all therapeutic areas and all phases of studies. James’ early experience in eClinical was gained at Pfizer Inc., where he was Senior Director of Global Clinical Data Services, heading the global data acquisition department for the company’s global research and development organization. Prior to joining Pfizer, he was a Senior Hardware, Software and Systems Engineer for the U.S. Navy Underwater Sound Laboratory with a focus in data acquisition and analysis.

颜崇超 博士

恒瑞临床数据科学中心负责人

颜崇超，DIA（中国）顾问委员会委员,中国临床数据管理学组（CDMC）成员，现任上海恒瑞临床数据科学中心副总经理。曾是辉瑞（中国）研发中心数据服务部的技术运营负责人，并在上海医药临床研究中心数据管理部任高级总监。先后在美国勃林格殷格翰从事临床研究数据管理工作，以及在意大利高级卫生研究院，美国亚利桑那大学医学院和纽约大学医学院从事医学研究。在国内外期刊上发表过40余篇学术论文。《医药临床研究中的数据管理》书作者，北京，科学出版社，2011。

庄永龙 博士

北京百奥知信息科技有限公司董事长

庄永龙 博士 北京百奥知信息科技有限公司创始人。 清华大学自动化系本科(1994-1999)，生物信息学博士（1999-2004）。 国家“十一五”信息专题“疾病分子分型标准化与软件开发”负责人，国家 “十二五”重点项目主导者与参与者，国家“863”生物医药信息专题评审专家，中国生物工程协会计算生物学与生物信息学专业委员会主任委员，中国医药教育协会医药统计专业委员。 领导开发具有自主知识产权的生命科学一体化信息云与服务领域的全面应用，关键技术上处于领先优势地位，覆盖生物医药的全生命周期管理：包括电子数据采集系统、临床试验项目管理系统、随机化与试验药物管理系统、安全警戒管理信息系统、临床数据全流程管理系统、临床试验全文档管理系统等。

代囡

美达临床数据技术有限公司数据管理部副总监

代囡 美达临床数据技术公司临床数据管理部经理 Dorothy DAI Manger, Clinical Data Management, Meta Clinical Technology 10年以上行业经验，曾就职于精鼎医药（PAREXEL International）、上海津村等跨国药企和CRO，具有丰富的欧美、日本和中国国内的I-IV期的临床试验经验以及EDC、CDMS系统使用经验。

Michael TUCKER

Medidata公司资深临床解决方案专家

three essential qualities: • passionate about people • passionate about learning • passionate about finding solutions to complex problems It is these three passions that help him to know no strangers and to be able to work in many industries with incredibly brilliant people to help them tell their stories about their inventions and creations in ways that other people can understand their value. That’s the bottom line in developing a business. You may have the greatest technology in the industry, but if you can’t demonstrate value, no one will want to use it.

刘川 博士

北京科林利康医学研究有限公司首席科学官

刘川博士，曾任CFDA药审中心临床试验数据标准化工作指导组核心成员，DIA全球培训理事会理事，DIA中国临床试验数据管理学术沙龙负责人，中国临床试验数据管理学组副组长，CFDA高级研修学院客座教授，美国临床数据管理协会（SCDM）中国区指导委员会委员，现就职于北京科林利康医学研究有限公司，任首席科学官。曾就职于诺华，辉瑞，赛诺菲，先灵葆雅，强生，Medidata等跨国药物公司的全球临床研究部门，从事全球临床试验管理和运营等工作20余年。近六年来在国内外讲授临床相关课程80余场次，组织和参加过DIA举办的年度会议，各类数据管理，临床运营和安全性监督等GCP相关主题培训10余场，主编《药物临床试验方法学》，参与国际GCP补充指南《Computerized Systems in Clinical Research: Current Data Quality and Data Integrity Concepts》的编写工作；国际GCP指南丛书《Good Clinical Practice: A Question and Answer Reference Guide》特约撰稿人，合编《New Drug Approval Process》等书籍，并在国内外专业期刊发表论文20余篇

Andrea MYERS 医学博士

诺华中国转化临床肿瘤全球负责人

Dr. Andrea Myers is the Global Head of Translational Clinical Oncology China, and currently based in Shanghai. In this capacity she leads multi-disciplinary teams responsible that are responsible for the early clinical development of new cancer therapies. She has experience developing novel targeted therapies and immunotherapies as single agent and combinations. Prior to her arrival at Novartis, Dr. Myers was an Instructor of Medicine at the Dana Farber Cancer Institute and Harvard School of Medicine, where she cared for cancer patients. Her clinical and research efforts were focused on the development of new therapies for women’s cancers. Dr. Myers completed her MD and PhD degrees at Stanford University School of Medicine. She is board certified in Internal Medicine and Medical Oncology. She completed her Internal Medicine training at the Massachusetts General Hospital, and her Medical Oncology training in at the Dana Farber Cancer Institute and Massachusetts General Hospital.

薛晓强 博士

IQVIA数据科学、药物安全和药政（RSSD)科学顾问

薛晓强，PhD from UNC Chapel Hill. Scientific Advisor，IQVIA。薛晓强2007年加入IQVIA，主要职责是为客户提供临床试验方案设计，战略咨询。主要兴趣在Bayesian Adaptive design，Optimal trial design，Trial optimization，Risk based monitoring。

Yuan JI

芝加哥大学公共卫生科学系生物统计教授

Dr. Yuan Ji graduated from Fudan University with a bachelor in Mathematics, University of Wisconsin – Madison with a PhD in Statistics. He spent 9 years at The University of Texas M. D. Anderson Cancer Center as Assistant and Associate Professor in Biostatistics and Bioinformatics. Currently, Dr. Yuan Ji is Assistant Vice President, Director of Computational Genomics & Medicine at NorthShore University HealthSystem. Dr. Ji is also Professor of Biostatistics at The University of Chicago. He is an NIH-funded PI focusing on innovative computational and statistical methods for translational cancer research. Dr. Ji is author of over 110 publications in peer-reviewed journals, conference papers, book chapters, and abstracts. His recent work on precision medicine was elected as one of the top 10 ideas of the Precision Trials Challenge hosted by The Harvard Business School in 2015. He is also a co-founder of Laiya Consulting, Inc., focusing on innovative and adaptive designs for clinical trials in new drug development, including the development of new immune-oncology agents such as CAR-T therapeutics.

李杰

缔脉统计部高级总监

Jie has 15 years industry experience and he has proven ability for study design and statistics in clinical trial. Jie has 2 years working experience in CRO and 12 years working experience in multinational pharmaceutical company including Pfizer, Astrazeneca and GSK. Currently, Jie is senior director of statistics at dMed Biopharmaceutical. Jie has abundant regulatory panel defense experience and has good connections with statistics key opinion leaders. Jie is familiar with FDA/CFDA statistics related guidelines. Jie got his master degree in Pharmacology (Fudan University) and his PhD program is in Biostatistics (Fudan University).

朱连升 博士

诺华制药全球药物开发临床开发与分析学生物统计组负责人

Liansheng ZHU, PhD Biostatistics Site Head, China, Global Drug Development, Clinical Development & Analytics, Novartis

沈海戈 博士

详妍咨询 合伙创始人

沈海戈博士是详妍咨询的联合创始人，目前致力于为于为多家制药及生物科技公司提供专业咨询服务。海戈拥有杜克大学统计学博士学位及北京理工大学电子工程学博士学位。曾就职于新加坡国立大学生物信息中心，从事药物发现中的数据处理与分析方法研究。2008年加入美国诺华制药，从事肿瘤药物研发的注册临床研究；后在上海诺华制药领导眼科产品中国临床开发注册项目；2013年加入中国诺华生物医学研究中心临床肿瘤转化部门，领导多个肿瘤药物全球临床早期开发项目的统计学工作。在创建详妍咨询之前，在Panacea CRO作为统计副总裁任职一年。

Amy XIA 博士

安进公司生物统计部执行总监

Amy Xia is Executive Director, Biostatistics at Amgen. Amy has worked on designing, implementing, and analyzing Phase I-IV clinical trials as well as observational studies in the past 20 years. Currently, she is Head of Design and Innovation in the Center for Design and Analysis at Amgen, providing leadership and holistic vision for strategic drug development and driving innovative program/study designs across Amgen’s portfolios for evidence generation and decision-making. Amy’s research interests include Bayesian and adaptive design, safety biostatistics, meta-analysis and innovative approaches for pediatrics/rare diseases drug development. She currently is the Vice-Chair/Chair-Elect for the DIA Bayesian Scientific Working Group. Amy is an ASA Fellow. Amy received her Ph.D. in Biostatistics from the University of Minnesota, and her medical degree from Peking University, China.

金风斌 博士

PTC公司高级主任统计师

金风斌博士1997年毕业于美国爰达荷大学。于2015年作高级主任统计师就职于PTC公司， 参与了该公司杜氏肌营养不良症病的新药研发和申请工作。在美国制药业已经工作二十多年, 有丰富的新药I期至IV期的临床试验数据分析的经验和成功的新药申请的经历。

Chito HERNANDEZ 博士

BioMarin公司副总裁兼生物统计负责人

Chito Hernandez is a life science executive and a PhD statistician with significant experience in leading Biometrics organizations. He is currently serving as Vice President and Head of Biometrics at BioMarin, a company that develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. Chito is Founder and Senior Partner at FocusQ LLC, a statistical consulting firm based in the San Francisco Bay Area. He previously served as Vice President of Biometrics and Information Management for Elan Pharmaceuticals, a neuroscience-focused company based in Ireland; and as Vice President of Biometrics at Janssen AI, a subsidiary company of Johnson & Johnson. Chito has been involved in several regulatory filings including NDAs, a PMA, BLAs, and MAAs. He has worked mainly in Research and Development but has experience in Medical Affairs at Rhone-Poulenc Rorer and Business Development at Scirex Corporation. He received his PhD from Arizona State University.

马端 医学博士

复旦大学教授，博士生导师 复旦大学代谢分子医学教育部重点实验室副主任，复旦大学出生缺陷研究中心副主任

马端，教授，博士生导师。上海市领军人才，上海市优秀学术带头人，上海市曙光学者。复旦大学出生缺陷研究中心副主任，复旦大学代谢分子医学教育部重点实验室副主任。中华医学会医学遗传学分会副主任委员，中国医师协会医学遗传分会临床遗传学专委会副主任委员，上海市医学会医学遗传学专委会主任委员，上海市医学会罕见病专委会副主任委员，上海市健康科技协会基因健康专委会主任委员。主持国家重点研发计划、973、863、重大新药研制、科技支撑项目40余项；发表论文240余篇，其中SCI论文130余篇，被引用2500余次；主编《生物学前沿技术在医学研究中的应用》和《临床遗传学》；获中国和美国发明专利7项。 研究方向：遗传相关疾病的病因、发病机制与早期防治。

王勇 博士

精鼎生物统计高级总监

1. Dr. Yong Wang has more than 20 years of experience with clinical development in both pharmaceutical and medical device industries. 2. He has extensive experience in regulatory submissions and interactions with regulatory agencies 3. He had worked for a cardiovascular medical device company (St. Jude Medical, 圣犹达医疗公司) for 9 years, then followed by working for pharmaceutical companies (mostly with former Forest Labs --- now Allergan) for more than 10 years as a clinical statistician in the United States. 4. Starting from late 2015, he works for his current company PAREXEL (精鼎医药)，a global CRO company as the head of biostatistics of Asia-Pacific Region. He is currently based in Shanghai 5. Dr. Yong Wang holds a Ph.D. in mathematics and had his postdoc fellowship in biostatistics and epidemiology.

张明强 博士

RDPAC研发工作委员会主席 安进公司全球研发副总裁

张明强博士现任美国安进公司全球研发副总裁、全球转化医学领导团队成员、亚洲研发中心负责人、安进生物医药研发（上海）有限公司总经理、法人代表。张博士同时兼任中国外商投资企业协会药品研制和开发行业委员会(RDPAC)研发委员会主席、中国药学会药物化学专业委员会副主任委员、中欧生物医药委员会副主席、以及若干政府和产业机构生物医药产业顾问。张博士从事新药研发20多年，在中枢神经、肿瘤、炎症和病毒等疾病领域的新药研发中，多有建树。他领导开发和作为第一发明人的全球首创肌松药拮抗剂布瑞亭（默沙东，舒更葡糖钠注射液）已在全球60多个国家成功上市, 年销售约5亿美元。 张博士已发表/发明100多篇论文/专利。他是英国皇家化学会院士，全英华人生命科学院院士并担任欧洲药物化学联合会学术顾问委员会委员，【MedChemComm】、【Current Drug Discovery】、【Chinese J Med Chem】、【BAO J Pharm Sci】等学术杂志编委。他是2007年英国皇家化学会“莫肯-坎贝尔”纪念大奖得主，也是2008年苏格兰“尼科舍斯”生命科学创新奖获得者。2016年Bridion荣获有“生物医药界诺贝尔奖”的美国盖伦奖(Prix Galien USA) “最佳创新药物”提名。在加入安进公司之前，张博士曾任美国默沙东公司全球研发副总裁、亚太区研发总裁，并担任“默沙东研发（中国）有限公司”创始总经理、法人代表。张博士还创建过研发型企业，其中致力于抗病毒新药研发的ViroChem公司于2009年以3亿8千万美元为美国Vertex公司所兼并。

王锦

麦肯锡咨询公司全球董事合伙人

Jin Wang is a Partner in McKinsey’s Shanghai office. She joined the Firm in 2003 and co-leads the Greater China healthcare practice. She advises global and Chinese pharmaceutical companies on a broad range of topics, including growth strategies, commercial excellence, organization, market access, BD and partnership. Over the past 4 years, Jin has been leading McKinsey’s collaboration with RDPAC and other industry associations, local companies, academia experts and government stakeholders on “Fostering a Sustainable Ecosystem for Drug Innovation”. Jin holds an MBA from MIT Sloan School of Management, and holds a B.A. in Economics from the University of International Business and Economics in China.

王拥军 教授

首都医科大学附属北京天坛医院副院长、神经病学中心主任，国家神经系统疾病临床医学研究中心副主任，国家卫计委神经内科质量控制中心主任，中国卒中学会常务副会长

王拥军教授，男，主任医师、教授、博导，北京学者。 现任首都医科大学附属北京天坛医院副院长、神经病学中心主任，国家神经系统疾病临床医学研究中心副主任，国家卫计委神经内科质量控制中心主任，中国卒中学会常务副会长。 王拥军教授长期从事脑血管病病因与发病机制、关键防治技术与体系建立的相关研究。作为国家“十二五”、“十三五”脑血管病等重大慢病重点研发计划的首席科学家，在脑血管病病因和发病机制分型、脑血管病防控优化体系的建立等方面取得了多项系统性、创新性的研究成果，获得新药发明专利，改写了国际脑血管病防治指南与国内外教科书，并广泛应用于临床。在New England Journal of Medicine，JAMA，Circulation等杂志发表SCI期刊论文300余篇，被他引1000余次。其中，针对高危非致残性脑血管病的短程、早期、优化的抗血小板治疗新技术，被New England Journal of Medicine杂志评为“2013年度国际医学领域重大进展”，被Lancet Neurology评为“国际神经病学领域年度八大进展之一”。入选“万人计划”科技领军人才、“北京学者”、“京市高层次创新创业人才支持计划杰出人才”，获得国家科技进步二等奖、教育部科技进步一等奖、北京市科学进步一等奖、中华预防医学会科学技术一等奖、全国优秀科技工作者等多个奖项。带领团队获得科技部首批创新团队荣誉称号。

游广智 工商管理硕士

香港大学临床试验中心执行总监及名誉助理教授

游广智 Henry Yau 理学士（生物化学），工商管理硕士（金融财务） 香港大学临床试验中心执行总监及名誉助理教授 游总监现为香港大学临床试验中心 (HKU-CTC) 的执行总监及名誉助理教授，拥有理学士（生物化学）及工商管理硕士（金融财务）学位。他早于90年代初已开始服务医药界，并于2000年加入HKU-CTC。游总监亦于多个本地及国际组织担任多项公职，包括：  国际临床试验中心联盟 (International Clinical Trial Center Network, ICN) 指导委 员会员；  研究伦理评估学习 与资源计划 (Training and Resources in Research Ethics Evaluation Program, TRREE) 亚洲区顾问；  香港大学深圳医院 临床 研究管理委员 会；  上海交通大学-香港大学转化医学联盟专家委员会委员；  台湾中国医药大学附设院临床试验心咨 询委员会；  香港医院管理局新界西联网临床及研究伦理委员会独立委员；  香港儿童医院 研究伦理委员会名誉顾问；  香港大学/医院管理局港岛西联网伦理委员会之管治委员会委员；  香港临床研究机构协调 组织委员；及  香港科研制药联会临床试验工作组顾问。 游总监具备多元化的临床试验管理专业，包括临床试验机构管理组织 (SMO) 、合同研究组织 (CRO) 及一期临床试验室之管理，尤其专长于临床试验机构运営、研究伦理及法规事务、合同与财务管理、研究项目管理、质量管理、风险管理及策略性业务开拓等。他创建之崭新SMO管理模式，取名为临床试验业务及项目促进平台 (Business & Project Acceleration Team, BPAT) ，是行内已知的有效临床试验机构管理模式。经过多年的努力，他已透过1,000多项申办方发起的临床研究项目而跟全球近300家申办方及CRO建立起良好伙伴关系，并参与管理约200项研究者发起的临床研究项目。 游总监一直致力于整合及推广临床试验之管理与运営的实战经验。多年來他曾获邀为世界各地超过100个研讨会/论坛/培训班作为讲者或论坛专家。由他及其团队开发之培训课程–PRACTISE (Professional Research Accreditation for Clinical Trials Investigative Site Executives)–是专为照顾研究者及研究机构人员的实际需要而设计的。该课程并已获亚洲、中东及北非地区多个医疗机构及监管单位之认可，且符合 TransCelerate BioPharma (一个由多家主要的国际医药企业成立的合作平台）对研究者及研究机构人员ICH GCP培训之要求。游总监也积极撰写临床试验相关的书籍和制度文件，如《临床试验机构之管理与合规守则》 (Clinical Research Management and Compliance at Study Sites, 2010/2015)、《临床试验专用术语手册》 (Clinical Trial Terminology Handbook, 2009)、香港伦理委员会标准操作规程模板 (2014)、及一期临床试验伦理监督与科学评估指导原则 (Guideline on Ethics Oversight and Scientific Evaluation of Phase 1 Clinical Trials, 2014) 等。

赵俊

南京医科大学第一附属医院党委书记、教授、博士生导师

赵俊，男，汉族，医学社会学博士、研究员、教授、博士生导师。现任江苏省人民医院（南京医科大学第一附属医院）党委书记，南京医科大学党委常委。

乔杰 院士

中国工程院院士, 北京大学第三医院院长、妇产科主任、生殖医学中心主任

中国工程院院士。医学博士、教授、主任医师、博士生导师，国家杰出青年基金获得者、长江学者特聘教授、新世纪百千万人才、何梁何利基金获得者，科技部“生殖与发育重大专项”首席科学家。现任北医三院妇产科主任、生殖医学中心主任，中国医师协会生殖医学分会主任委员，北京医学会生殖医学分会主任委员。一直从事生殖健康相关的临床与基础研究工作，曾作为访问学者在香港大学学习，并于斯坦福大学做博士后研究。从配子、受精、胚胎和着床四方面进行不孕症机制综合研究，并对多囊卵巢综合征（PCOS）的发病机制及诊治新方法进行了系统研究。

吴远彬 司长

科技部社会发展科技司司长

职务：中华人民共和国科技部办公厅主任 2015年6月，吴远彬任中共科技部直属机关委员会常务委员会委员。

蒋立新 教授

中国医学科学院阜外医院副院长，主任医师，博士生导师, 国家心血管病中心主任助理

蒋立新，女，临床医学博士，主任医师，博士生导师，国家“万人计划”科技创新领军人才，国家卫生计生突出贡献中青年专家，FACC，FAHA，FESC。中国医学科学院阜外医院 副院长，国家卫生计生委心血管药物临床研究重点实验室 主任，国家心血管疾病临床医学研究中心 常务副主任；国家心血管病中心 主任助理，国家基本公共卫生服务项目基层高血压管理办公室 主任，中国牛津国际医学研究中心 联合主任，国家心血管病中心-伦敦政治经济学院卫生经济与政策研究中心 联合主任，心血管生物样本资源中心 主任；The Lancet 中文版杂志 主编，国际 Circulation: Cardiovascular Quality and Qutcomes 杂志 编委，国际 Atherosclerosis 杂志 编委，国际 Hypertension 杂志 编委。

胡蓓 医学博士

教授，北京协和医院l期临床研究室主任

教授，北京协和医院临床药理中心 胡蓓教授1982年毕业于北京医科大学获医学学士学位，1989年毕业于中国协和医科大学获医学博士学位。1991年至1994年在美国国立卫生研究院（NIH）福格地奖学金的资助下，在美国华盛顿大学药物化学系从事博士后研究3年。 目前担任北京协和医院临床药理中心临床药理学教授，I期临床研究室主任，从事临床药理学的教学和研究20年，至今已经发表文章70余篇。主要研究方向包括：新药的早期临床研究及定量药理学研究。

任科

上海药明康德新药开发有限公司副总裁兼SMO事业部津石医药负责人

戴欣

武田公司亚洲临床运营负责人

戴欣 医师 / Paul DAI , MD 现任武田公司亚洲临床运营负责人 戴欣医师之前就任于北京诺华制药有限公司临床研发高级总监，主要负责东北亚地区(大中国区、台湾及韩国)的临床运营。他在医药行业有近16年的工作经验，先后在一些大的制药公司如诺华、礼来制药公司和葛兰素史克公司任职。他毕业于北京大学医学院，之后成为北京心血管和肺疾病研究中心和北京安贞医院的心脏科医生。他深入参与中国多种治疗领域的临床开发及医学事务，包括心血管、神经系统、乙型肝炎、糖尿病、呼吸疾病、肿瘤及抗感染疾病等。戴欣医师经常在各种学术会议上做演讲。

胡劲捷 博士

美国FDA同仁会主席 美国Axteria BioMed咨询公司总裁

张菁 博士

复旦大学附属华山医院抗生素研究所副所长，临床药理学教授

Sumathi NAMBIAR 医学博士

美国FDA药物评价和研究中心抗菌产品办公室抗感染产品处处长

袁征宇 博士

盟科医药首席执行官

Edward COX 医学博士

美国FDA药物评价和研究中心抗菌产品办公室主任

胡劲捷 博士

美国FDA同仁会主席 美国Axteria BioMed咨询公司总裁

朱煦

Everest Medicines公司感染疾病首席医学官

崔瑾

中国食品药品国际交流中心

Mark GOLDBERGER 医学博士

美国FDA同仁会 前美国FDA药品审评与研究中心药品审评四部部长 前美国雅培制药法规政策副总裁

Nancy MYERS 法学博士

Catalyst健康咨询公司总裁

Senthil SOCKALINGAM

IQVIA新加坡真实世界洞察亚洲负责人，副总裁

Dr. Senthil Sockalingam has more than a decade of experience in healthcare, including working in high impact positions with key oncology compounds in Asia Pacific and China. He has been involved in clinical development strategies with particular focus on Asia as well as managing medical marketing activities in the region. In addition to the clear understanding of drug development strategies in Asia, Dr. Senthil has led advisory boards and coordinated investigator-led studies for these compounds, and in doing so has built an extensive personal network of experts and key opinion leaders. Prior to joining IQVIA, Dr. Senthil has held strategic positions with companies such as Genzyme, Bayer Healthcare and Novartis, and managed key oncology and hematology brands in Asia, including Glivec, Afinitor, Exjade, Nexavar and Kogenate. He also led the Asian clinical development strategy, and supported registration, commercialization and competitive intelligence activities to ensure the success of these compounds. Dr. Senthil received his medical Training from University of Malaya, Malaysia and is a Member of the Australasian College of Pathologists.

宁毅 博士

北京大学Meinian健康研究所执行主任，教授

宁毅，葛兰素史克传染疾病和公共卫生研究院流行病学总监和临床流行病学家，葛兰素史克（GSK），以研发为基础的药品和保健品公司，年产药品40亿盒，产品遍及全球市场。 葛兰素史克由葛兰素威康和史克必成合并而成，于2000年12月成立。两家公司的历史均可追溯至19世纪中叶，各自在一个多世纪的不断创新和数次合并中，在医药领域都确立了世界级的领先地位。

Gerald DAL PAN 医学博士

美国FDA药物评价和研究中心(CDER)流行病学办公室主任

Dr. Dal Pan currently serves as the Director of the Office of Surveillance and Epidemiology in the Food and Drug Administration’s Center for Drug Evaluation and Research, where he has been responsible since 2005 for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. In this capacity, he is involved in both the premarket and postmarket regulation of drugs and therapeutic biologics, and in the implementation of the drug safety provisions of the Food and Drug Administration Amendments Act and other initiatives. He is a member of the World Health Organization Advisory Committee on the Safety of Medicinal Products, and has served on working groups of the Council of International Organization of Medical Sciences and the International Conference on Harmonisation. Dr. Dal Pan completed residency training in Internal Medicine at the Hospital of the University of Pennsylvania and in Neurology at the Johns Hopkins Hospital. He is board certified in both Internal Medicine and Neurology. He joined the Food and Drug Administration in 2000 as a medical reviewer in the Center’s Office of New Drugs. Before working at the Food and Drug Administration, he was a faculty member in the Department of Neurology at Johns Hopkins and also worked in the pharmaceutical industry. Dr. Dal Pan received his MD at Columbia University College of Physicians and Surgeons, and his Master of Health Science in Clinical Epidemiology at the Johns Hopkins University School of Hygiene and Public Health.

陈建炜 博士

台大医院医学研究部主任

Dr. Chan is a physician epidemiologist with 30 years of global research experience in academia and private sector, with a primary focus on post-marketing evaluation of pharmaceutical agents and vaccines. He received medical training at NTU in Taipei (MD-equivalent, 1987) and advanced training in epidemiology at Harvard School of Public Health (Doctor of Science, 1992). He served on the faculty at NTU (1993-1998) and Harvard School of Public Health (1998 - 2005) and joined the private industry in 2005, subsequently became the Chief Scientist of the Epidemiology Unit at Optum. Dr. Chan returned to NTU in 2013 and is currently a professor at NTU College of Medicine, Director of the NTU Health Data Research Center, and Director of Medical Research Department at NTU Hospital. In addition to scientific research, he has provided consulting input to Taiwan Food and Drug Administration and related health authority for more than 20 years. Dr. Chan has authored or co-authored more than 100 peer-reviewed articles and co-edited one of the two widely used English textbook on pharmacoepidemiology

Bruce REED 博士

美国国立卫生研究院科学审查中心开发和老龄化部，神经科学处处长

Bruce Reed has joined the Center for Scientific Review as director of its Division of Neuroscience, Development and Aging. He comes from the University of California, Davis, where he has been a professor of neurology and associate director of its NIH-funded Alzheimer’s Disease Center as well as a neuropsychologist at Veterans Affairs Northern California in Martinez. “The search committee and I were compelled by Dr. Reed’s impressive expertise and experience,” said CSR director Dr. Richard Nakamura. “He is a well-published neuroscientist in a variety of fields including Alzheimer’s and he has significant management experience.” Nakamura noted that Reed also brings valued extramural perspectives, including those of a long-time reviewer. He also has served as chair of CSR study sections on adult psychopathology and disorders of aging and clinical neuroscience and neurodegeneration. Reed earned his Ph.D. from the State University of New York at Stony Brook School of Medicine and he did his postdoctoral training at Braintree Hospital in Massachusetts, in conjunction with Tufts New England Medical College and Boston University Medical College. His research has expanded our understanding of risk factors—especially vascular factors— that accelerate cognitive decline in old age, as well as factors such as cognitive reserve that protect against decline. He is an expert in neuropsychological and brain imaging methods and he has extensive experience in the use of demographically diverse aging cohorts to better understand the heterogeneity of cognitive aging.

Edward COX 医学博士

美国FDA药物评价和研究中心抗菌产品办公室主任

Dr. Edward Cox is Director of the Office of Antimicrobial Products, where he has served since 2007. As Director for the Office of Antimicrobial Products, Dr. Cox oversees the review, approval and safety of antimicrobial (antibacterial, antiviral, antifungal, and antiparasitic) drugs, ophthalmic drugs, and immunosuppressive agents for patients who have received solid organ transplants. Dr. Cox has worked extensively on the science and design of clinical trials for evaluating antimicrobial drugs. Dr. Cox received his M.D. from the University of North Carolina School of Medicine. He completed an internship and residency in Internal Medicine at the Hospital of the University of Pennsylvania and an Infectious Disease fellowship at the National Institute of Allergy and Infectious Diseases of the National Institutes of Health. He also holds a Masters of Public Health Degree from the Johns Hopkins School of Hygiene and Public Health. He joined FDA in 1998.

吴文达 医学博士

比尔及梅琳达·盖茨基金会北京代表处健康创新与合作副主任

Dr. Alexander Ng leads a team that works to build health partnerships with key stakeholders in China, including the Chinese government, private sector and NGOs. The goal is to identify, develop and deliver high-quality, low-cost health products (drugs, vaccines, biologics, diagnostics) for use in developing countries to tackle endemic diseases and other urgent health needs. Alex’s team also works with local partners to design and deliver programs that address domestic health challenges such as tuberculosis, HIV/AIDS and poverty. Alex joined the foundation in 2015 after 9 years at McKinsey & Co., where he was an Associate Partner and co-led McKinsey’s Healthcare Practice and Corporate Finance Practice in Greater China, where he served public, private and social sector clients on strategy, health system reform, operations transformation and investments. Alex completed his undergraduate and medical studies at the University of Auckland, New Zealand, and a postgraduate diploma in Health Informatics at the University of Otago, New Zealand. From 2004 to 2005 he served as Chief Resident at Auckland’s Middlemore Hospital – a tertiary referral hospital for South Pacific, before completing an MPH in Health Policy and Management at the Harvard School of Public Health. Since 2010, Alex has been an Honorary Professor with the Faculty of Medicine, University of Hong Kong and has been a Council Member of Hong Kong Council of Smoking and Health since 2012.

苏岭 博士

沈阳药科大学教授，礼来亚洲基金风险合伙人

苏岭博士在药品法规及注册审评管理、新药研发策略和管理、临床研究、药物安全和药物警戒、药物流行病学等领域拥有丰富经验。曾任职于原卫生部药政管理局和美国FDA，担任药物信息协会 (DIA) 全球理事会主席等职。先后在默沙东、罗氏、惠氏、诺华等多家跨国制药企业从事临床研究和药物研发的高级管理工作.

李一诺 博士

比尔及梅琳达 盖茨基金会北京代表处首席代表

李一诺女士负责领导盖茨基金会中国团队，与中国的公共、私营以及非营利部 门共同合作，致力于参与解决中国及全球健康、发展与政策领域的重要问题。 在2015 年加入基金会之前，李一诺女士是麦肯锡公司美国加州帕罗奥图办公 室的合伙人。一诺于2005 年加入麦肯锡加州洛杉矶办公室，并于2008 年至2013 年调任麦肯锡北京办公室。在此期间，一诺担任医疗产业领域的联席领导人，并负 责社会与全球公共卫生领域的工作。她的专长领域包括包括健康体系和医疗改革、 全球健康、医药和诊断产品、数字化医疗以及卫生融资等。一诺服务过的客户包括 大型跨国及本土医药和生命科学企业、机构投资者、行业协会、政府部门、非营利 组织和学术机构等。 李一诺女士于2011 年升任麦肯锡合伙人。2014 年，她调任至麦肯锡帕罗奥图 办公室工作。就职期间，她主要致力于健康以及社会领域事务。一诺还活跃于医疗 行业发展、战略管理、人才招聘与培养，以及女性领导力等领域的各类讨论中。 李一诺女士毕业于清华大学生物系，并在美国加州大学洛杉矶分校取得了分子 生物学博士学位。

王辰 院士

主任医师，教授， 中国工程院院士 中国医学科学院北京协和医学院院校长

Chinese Academy of Medical Sciences and Peking Union Medical College Academician of the Chinese Academy of Engineering Director, National respiratory clinical research center Leader, National Key Disciplines for Respiratory Medicine Prof. Wang has long been engaged in clinical practice, teachings and research on respiratory problems such as pulmonary embolism, pulmonary hypertension, respiratory failure, pulmonary heart disease, chronic obstructive pulmonary diseases (COPD, Chronic Bronchitis Emphysema), new respiratory infectious diseases and tobacco epidemiology. He has achieved many important innovations including thrombolysis therapy and sequential mechanical ventilation, which have been adopted to the international treatment guidelines. He is in charge of multiple national research projects and international programs. Prof. Wang has published more than 100 articles in international authoritative medical journals, such as the New England Journal of Medicine, The Lancet and Annals of Internal Medicine (Ann Intern Med). He has been honored as the Second Prize (three times), the First Prize (once) and the Special-class Prize (once) of the National Science and Technology Progress Award, and has received the Scientific and Technological Progress Award of the Ho Leung Ho Lee Foundation and the Outstanding Contribution Award for Tobacco Control of WHO, etc. Prof. Wang has made impressive progress in disciplinary construction and hospital management when he served as senior administrator of medical institutions including the Beijing Chao-Yang Hospital, Beijing Hospital and the China-Japan Friendship Hospital. He once worked as the Deputy Director-General of the Department of Health Sciences, Technology and Education of China‘s National Health and Family Planning Commission (NHFPC), presiding over the department by promoting medical education and research at the national level. 王辰 院士 主任医师，教授，中国工程院院士 中国医学科学院北京协和医学院院校长 王辰，呼吸病学与危重症医学专家。主任医师，教授，中国工程院院士。中国医学科学院北京协和医学院院校长。国家呼吸临床研究中心主任。中国医院协会副会长，中国医师协会副会长兼呼吸医师分会会长，中华医学会呼吸病学分会荣誉主任委员，国家毕业后医学教育专家委员会副主任委员。世界卫生组织慢性非传染性疾病专家委员会委员，世界卫生组织戒烟与呼吸疾病预防合作中心主任，英国帝国理工学院医学部荣授院士。Chinese Medical Journal总编辑，Clinical Respiratory Journal主编。 长期从事肺栓塞与肺动脉高压、呼吸衰竭与呼吸支持技术、新发呼吸道传染病、慢性阻塞性肺疾病、烟草病学等领域的医疗、教学与研究工作。长于呼吸疑难病与危重症诊治。做出序贯机械通气、肺栓塞减量溶栓疗法、确证中药对流感疗效等多项创新并进入国际指南，指导改善临床实践。承担国家及国际重要研究项目10余项。在New Engl J Med、Lancet等国际权威期刊发表论文100余篇。主编专著《肺栓塞》《呼吸支持技术》与国家规划教材《内科学》《危重症医学》等10余部。获国家科技进步奖二等奖3项、一等奖1项、特等奖1项。获何梁何利基金科学与技术进步奖，世界卫生组织控烟杰出贡献奖。 具有中日医院、北京医院和北京朝阳医院3家大型综合医院和北京呼吸疾病研究所的领导和管理工作经验，在学科建设和医院管理发展上取得显著业绩。曾主持原卫生部和国家卫生计生委科技教育司工作，推行建立国家住院医师规范化培训制度和专科医师规范化培训制度，倡导推动国家临床医学研究体系建设和能力提升。

Barbara Lopez KUNZ

DIA全球首席执行官

薛斌

原中国食品药品国际交流中心主任 2018中国国际药物信息大会暨第十届DIA中国年会联席主席

唐雪

辉瑞中国药物安全团队亚太区负责人

袁林

原国家食品药品监督管理总局国际合作司司长

秦晓岺

原国家食品药品监督管理总局国际合作司司长

周思源

国家药品监督管理局ICH工作办公室主任

周思源，原国家食品药品监督管理总局药品审评中心副主任。 1982-1990 同济医科大学公共卫生学院，医学硕士。 1990-2006国家药品审评中心临床组审评员、化药及生物制品室临床组组长、审评管理与协调部副部长、审评管理与协调部部长。 2006-2011国家食品药品监督管理局办公室综合处副处长、行政受理服务中心副主任。 2011-2015国家食品药品监督管理局人事司干部处处长。

Inger MOLLERUP

瑞士诺和诺德公司CMR药政顾问

More than 25 years’ experience in Drug Development and more than 12 years Regulatory Affairs experience with global regulatory responsibility for a number of drug development projects. Experienced in developing and leading regulatory strategy and implementation toward the NDA approval and life-cycle management. Has in that capacity overseen a number of license application and approval projects with multiple agency interactions in several regions of the world including USA (incl. Advisory Committee preparations), EU, Japan, China, Canada, India, Latin America and Southeast Asia. Has also held the project leadership responsibility for conducting a CVOT interim analysis to support regulatory decisions. Internationally recognized expert in biologics including biosimilars and represents Novo Nordisk in scientific and regulatory questions on biosimilar products. Has in that capacity been active in science-based policy engagement with regulators, legislators and industry trade organizations (including EMA/WHO/IABS/HC/FDA/US Congress with presentations at EMA and WHO workshops as well as testifying to the US Government Oversight and Reform Committee) and presented in numerous scientific conferences as well as agency led meetings and workshops. Broad leadership experience covering line management as well as global project management encompassing both quality, nonclinical and clinical areas.

陈刚 博士

诺思格（北京）医药科技股份有限公司首席科学官，高级副总裁 北京大学临床研究所客座教授

陈博士于1992-2016年分别在制药工业，监管机构和学术界/临床研究机构任职。在FDA肿瘤药物评审中心生物统计部门任负责人近8年。2003-2013年在强生公司任肿瘤药物研发统计部负责人。2013-2016任强生公司中国研发定量科学部负责人。2013-2016任强生公司中国研发定量科学部负责人。过去6年里同监管部门，工业界及学术界生物统计学部的同事一起在MRCT、一致性研究、桥接试验方面做了大量的研究工作并发表很多重要论文。陈刚博士以其药物研发审评人和申办方双重角色的经历，在药物研发过程中积累了丰富的理论和实践经验。

宇山佳明 博士

日本药品与医疗器械管理局医学信息学和流行病学部部长

Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals and Medical Devices Agency Dr. Uyama is currently Director, Office of Medical Informatics and Epidemiology, Pharmaceuticals & Medical Devices Agency, Japan. He received his PhD degree and became a research fellow for the promotion of science within Japanese society. He was a post-doctoral fellow at the University of Calgary (Canada) from 1994 – 1995 and researcher in the Tokyo Metropolitan Institute of Medical Science from 1995 – 1998). Dr. Uyama joined the Ministry of Health and Welfare (now the Ministry of Health, Labour and Welfare) as a technical officer in 1998. In 2001, he started new drug review in the Pharmaceuticals and Medical Devices Evaluation Center of National Institute of Health Science, and has continued his career in drug review for the Pharmaceuticals and Medical Devices Agency since April 2004. His extensive experience in the review and safety assessment of new drugs includes serving as the Review Director (2007 – 2010); International Conference on Harmonisation Technical Coordinator (2004 – 2009); ICH E15 and E16 topic leader (2011 – 2012); Division Director for Regulatory Science Research (2011 – 2012); Division Director of Review Planning and Pharmaceutical Affairs Consultation (2012 –2013); Director, Division of Epidemiology (2014); and as Rapporteur of the International Conference on Harmonisation E17 Expert Working Group (2014). Dr. Uyama received his PhD degree from the Nagoya City University in 1994.

孙家庚

辉瑞（中国）研究开发有限公司全球药品法规运营注册出版与药品许可支持部药品注册文件出版团队主管 (成熟市场- 北美及欧盟)

Bruce joined Pfizer from 2012 as role of Publishing Manager supporting publishing activities of Regulatory Submissions and Clinical Study Reports (CSR) across Pfizer global markets. In 2018, Bruce was appointed as Publishing Team Lead focusing on eCTD submissions of Pfizer Established Markets (US/Canada/EU). Bruce has profound knowledge of eCTD standards, system expertise and regulatory operational experiences across markets and led multiple critical eCTD transition projects within Pfizer in APAC region (Thailand eCTD: 2015; China eCTD: 2017-now). He was also invited as guest speaker at various industry association conferences or forums. -7th Pharma Regulatory Affairs conference (2014) -CMWC forum(China Medical Writing Community) (2015-2017) -eCTD Masterclass in Regulatory Summit China (2016) -RDPAC Annual Meeting  (R&D based Pharmaceutical Association Committee) (2017) Bruce holds a bachelor’s degree in Bioinformatics from Shanghai Jiao Tong University.

吉申齐

辉瑞（中国）研究开发有限公司全球药品法规运营注册出版与药品许可支持部亚太区药品注册文件出版负责人

Handsome Ji started in the Pharmaceutical industry in 2006 as a Clinical Study Report Coordinator/Publisher at Pfizer. After 3 years’ working experience in Clinical Operations, Handsome moved to Regulatory Operations team as a Regulatory Submission Specialist. In 2012, Handsome was appointed as APAC Publishing Lead directing a team which is responsible for publishing CMC Dossiers, Clinical Study Reports and Regulatory Submissions, this team works on the CMC Reports, Clinical Study Reports from Phase I to IV and regulatory submissions across all regions during all stage of a product lifecycle. Handsome has considerable project and operations experience, has developed and implemented strategies resulting in operational excellence and process efficiencies. He is highly driven and experienced, with 12 years operational, project and change management experience within multi-cultured global environments. Handsome was invited as guest speaker in DIA China 7th Annual Meeting, served as host and Speaker for CMWC (China Medical Writing Community) forum in 2015 and 2016 and Workshop leader for eCTD Masterclass in 2016 China Regulatory Summit. Recently, Handsome has been invited as China DIA Young Member of Advisory Council (YMAC) in March 2018. Handsome holds bachelor degree in Computer Science from Fudan University.

Titus MODSCHING

德国精鼎监管解决方案和客户支持部业务分析师

SUMMARY OF EXPERIENCE:  Detailed regulatory tracking and publishing know-how with focus on software implementation and upgrade projects  SOP & Process Development, business-requirements analysis  Detailed knowledge of entire RIM (LIQUENT Insight Suite) platform products  Implementation / Upgrade: System Setup -, Business Process - Workshops  Customized training design & Train-the-Trainer / Core-Team workshops  Planning and Schedule of employee training curricula PROFESSIONAL EXPERIENCE: Business Analyst, Client Enablement, Regulatory Solutions, PAREXEL International GmbH, Berlin, Germany May 2013 - Present  Since September 2017: LIQUENT InSight Workflow Integrations implementation project at TIER 2  July – August 2017: LIQUENT InSight Suite Upgrade - TIER 2 – System Setup Workshop & support  November 2016 – February 2017: LIQUENT InSight Publisher Upgrade - TIER 2 – System Setup Workshops & implementation support  May 2016 – July 2018: LIQUENT InSight Suite Implementation - TIER 1 – Requirements & System Setup Workshop, Core-Team Training, template-work, special team workshops, implementation support  June-September 2016: TIER 1 SPT Upgrade; System Setup & Business Process Workshop  March – May 2016: IDMP Gap-Analysis Workshop at a TIER 2 company  February 2016 – July 2017: LIQUENT InSight Publisher Implementation at TIR 1 – Requirements Analysis, Business Process & System Setup Workshop, Core-Team Training & implementation support  February/March 2016: LIQUENT InSight Registrations Upgrade - TIER 2 – System Setup Workshop  June 2015 – December 2016: LIQUENT InSight Publisher Implementation - TIER 1 – Requirements workshop, System Setup Workshop, Core-Team Training, Train-the-Trainer, template-work  July – December 2015: LIQUENT InSight for Registrations Implementation project - TIER 3 – Regulatory Tracking Analysis, Core-Team Training and System Setup Workshop  April – December 2015: TIER 2 IDMP project – process development, set-up implementation process  November 2014 – January 2015: eCTD import project - TIER 2  September 2014: Regulatory/Training Workshop InSight Publisher/Registrations - TIER 3  July 2014: System Setup Workshop for InSight Publisher implementation - TIER 3  March – September 2014, TIER 1 - gCTD import project  January - March 2014, TIER 2 - GRATIS regulatory tracking implementation: Core Team Training, Data Gathering (Administration) support, Train-the-Trainer  January 2013 – January 2014, TIER 2 – Core Team Training for entire InSight platform, Train-the-Trainer, training material customization Senior Instructional Designer/Trainer, Liquent Ltd., Education Services, Munich, Germany April 2010 – April 2013  Lead of EU wide trainings for InSight Suite / training center Munich  January – May 2013, EU implementation lead TIER 2 regulatory tracking, Power Users & Trainers  January – August 2012, Application consultant for system setup workshops – TIER 3 (InSight for Registrations)  September – December 2011, Development of client specific SOPs - TIER 1  August – September 2011, Project lead rollout/upgrade RIM trainings, business process design TIER1 Instructional Designer/Trainer, Liquent Ltd., Education Services, Munich, Germany April 2008 – March 2010  Lead of EU wide trainings for InSight Suite / training center Munich  Coordination and execution of product & software trainings for Liquent InSight  Project lead rollout training InSight for Registrations at TIER 2  Development of client specific SOPs for TIER 2 and conduction of customized training Deputy Team Manager Systems & Data, Sales & Marketing Academy, O2 Germany, Munich November 2002 – January 2008  Lead of planning for all trainings at O2 Germany  Coordination and execution of product, software and soft-skills trainings at O2 Germany  Performed trainings and consulting for service providers  January 2006 – January 2008, Project lead training & OQ, Sales & Marketing Academy –CRM-implementation Senior employee, technical back office, data cleansing, VIAG Interkom February 1999 – October 2002: EDUCATION:  Continuous internal training according to PAREXEL training schedule (e.g. GMP, Regulatory, Clinical)  DIA & EMA, London: eXtended EudraVigilance Medicinal Product Dictionary Training Course (XEVMPD), March 2012  DIA, Prague – European Regulatory Affairs: In-depth review of current registration procedures, October 2010  Trainer-certification PE Support (e.g. learning, coaching, communication, neuro-linguistic programming, transactional analysis, education-methods), August 2006 – February 2007  Basic principles of project-management I, II (O2 Germany) Structogram® training system, Coaching (O2 Germany), June – October 2006  Certified as Instructional Trainer O2 Germany (Grundig Akademie), April 2003  Master of Business Administration (BA), Ravensburg - Germany, December 1998  education of vocational instructors (AdA) - Chamber of Commerce and Industry‘s instructor certification (IHK), Ravensburg – Germany, October 1997  School leaving examination (A-levels), Neumarkt – Germany, July 1993

陆舜

教授，上海胸科医院肺癌中心主任

肿瘤科主任，主任医师，副教授，博士生导师，医学博士。上海市医学领军人才。 掌握了国内外肺癌化疗最新进展，对肺癌的早期诊断，肺癌靶向治疗及综合治疗均有较高造诣。参加和承担国家和上海市科研基金项目近10项。参与或承担20余项国际国内多中心临床研究，其中国际多中心临床研究10项。第一作者发表论文及论著60余篇，其中SCI收录13篇。参编近10部著作。 任美国临床肿瘤学会（ASCO）国际事务部委员（中国大陆唯一）、ASCO多学科诊治小组（MCMC）成员、欧洲肿瘤协会（ESMO）会员、国际肺癌研究会（IASLC）组织委员会委员、国家食品药品监督管理局新药评审专家、中华医学会肿瘤学会委员等20余项学术职务。担任10余本国内外学术期刊编委。多次担任全国、国际学术会议大会主席或专场主席。 作为访问学者曾赴美国德州大学MD. Anderson癌症医学中心工作，作为访问教授曾赴美国德州大学MD. Anderson癌症医学参加肺癌的基础、转化性科研和综合讨论。

宁志强

深圳微芯生物科技有限责任公司临床及研发副总裁

1978年入承德医学院医疗系学习，毕业后任空军北戴河医院内科医生。1988获中国军事医学科学院实验血液学硕士学位，1996年获英国伦敦大学免疫学博士学位。1996~2001年在美国辛辛那提大学(University of Cincinnati)医学院任博士后研究员、研究助理教授。2001年作为深圳微芯生物科技有限责任公司创始人之一，参与公司的发起和创建。任公司副总裁，负责企业的新药研发工作，带领团队完成一个抗肿瘤原创新药从发现到上市的全程研发和注册工作，以及一个糖尿病原创新药从发现到进入III期临床试验研究。对在中国开展原创性新药研发具有深刻的体验，对自主原创新药的国际联合开发具有成功的实践经历。作为课题负责人和主要参加者，承担多项国家和地方重大科技项目。任全国生物芯片标准化技术委员会委员，国家各级科技项目评审专家，浙江大学兼职博士生导师。作为合作单位和个人，获得2013年国家科学技术进步一等奖。在国际期刊上发表论文50余篇，获得国际、国内发明专利20余项。

刘川 博士

北京科林利康医学研究有限公司首席科学官

刘川博士，曾任CFDA药审中心临床试验数据标准化工作指导组核心成员，DIA全球培训理事会理事，DIA中国临床试验数据管理学术沙龙负责人，中国临床试验数据管理学组副组长，CFDA高级研修学院客座教授，美国临床数据管理协会（SCDM）中国区指导委员会委员，现就职于北京科林利康医学研究有限公司，任首席科学官。曾就职于诺华，辉瑞，赛诺菲，先灵葆雅，强生，Medidata等跨国药物公司的全球临床研究部门，从事全球临床试验管理和运营等工作20余年。近六年来在国内外讲授临床相关课程80余场次，组织和参加过DIA举办的年度会议，各类数据管理，临床运营和安全性监督等GCP相关主题培训10余场，主编《药物临床试验方法学》，参与国际GCP补充指南《Computerized Systems in Clinical Research: Current Data Quality and Data Integrity Concepts》的编写工作；国际GCP指南丛书《Good Clinical Practice: A Question and Answer Reference Guide》特约撰稿人，合编《New Drug Approval Process》等书籍，并在国内外专业期刊发表论文20余篇

孙华龙 医学博士

美达临床数据技术公司总经理

孙华龙，日本东京大学医学研究医学博士，DIA中国顾问委员会理事成员，中国临床数据管理学组（CDMC）成员，中国医疗器械行业协会数据分析专业委员会委员，近20年临床开发经验，曾就职于默克雪来诺，PAREXEL等跨国药企和CRO, 先后担当生物统计，数据管理，项目主管，数据管理等部门负责人，在肿瘤，泌尿生殖，心血管，免疫等治疗领域的临床试验都有丰富的经验，先后在DIA组织领导多场数据管理，文档管理等培训活动，深受参会者喜爱。

刘晓曦

和铂生物医药副总裁；早期研发与科学运营负责人

刘晓曦博士是和铂医药早期开发和科学运营负责人。加入和铂医药之前，刘晓曦博士在诺华肿瘤药物开发事业部担任临床药理开发总监，负责中国区肿瘤药物临床药理开发，早期临床开发管理以及生命周期管理。加入诺华之前，刘博士在赛诺菲，葛兰素史克，以及 Guilford Pharmaceuticals 等知名药企，担任临床前和临床药理和早期开发项目负责人，以及法规注册，对于Lusedra®, Anoro®, Ellipta®, Insuman, Mozobil, Signifor ®, LEE011, LDK378, and LCI699等药物的早期开发，临床药理研究，以及法规注册做出杰出贡献. 刘晓曦博士具有超过20年的药理研究，开发，管理的经验。曾经在知名药厂和生物技术公司领导过药物发现研究，生物分析，药物代谢和药代动力学，临床药理学，项目管理。刘博士是中国药理学会临床药理学专业委员会委员；DIA中国顾问团成员(ACC)和美国药学科学家协会成员(AAPS)。 刘博士于1990年获南京大学生物学学士学位，1999年在普渡大学药学与药物科学学院获得药物化学和分子药理学博士学位。

刘江 博士

药政专家

Dr. Jiang Liu is currently a Team Leader in the division of pharmacometrics, Office of Clinical Pharmacology, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). He was also a scientific lead of the interdisciplinary review team for QT from 2014 to 2016 in the FDA. Before he joined the FDA in 2009, Dr. Liu received his Ph.D. in Pharmaceutical Science and M.S. in Statistics from the University of Florida. He had also earned a M.S. in Bioinformatics and a M.S. in Microbiology and Immunology. His work in the FDA focuses on drug cardiac safety assessment, model-informed drug development, and drug benefit-risk assessment based on quantitative clinical pharmacology. He has developed strong expertise in strong expertise in drug development and clinical trial designs in the above areas. He has deeply involved in the development of FDA Guidance for Industry in multiple areas. He has published various peer-reviewed papers and book chapters, edited/reviewed submissions for academic journals, trained several postgraduate fellows, and served as a grant evaluation expert for multiple organizations.

王亚宁 博士

药政专家

王亚宁于1996年毕业于原北京医科大学药学院药学系，1999 年在国家兴奋剂检测中心获得仪器分析硕士学位后，于同年被美国佛罗里达大学药学院录取攻读药学博士。2003 年王亚宁获得药学博士和统计学硕士双学位，毕业于佛罗里达大学并加入美国FDA。现任美国食品药品监督局（FDA）药物审评研究中心（CDER）临床药理审评部定量药理学审评室副主任。

Jorg TAUBEL 医学博士

英国伦敦St George’s大学Richmond Pharmacology公司首席执行官

Dr Jorg Taubel is a medical practitioner and CEO of Richmond Pharmacology which he co-founded in 2001. He has worked in clinical pharmacology for 24 years and during that time he has conducted more than 400 early phase studies in patients and healthy volunteers; usually in the capacity of Principal Investigator since 1995. His experience ranges from first time in man (FTIM) to proof of concept (POC) studies. He has extensive experience in cardiology, neurology, gastroenterology, ethnic bridging studies. His work currently focusses on providing expert advice in cardiac safety assessments and ethnic comparison studies. Dr Taubel is an honorary fellow at St George's University and author of over 50 publications in scientific journals. He is currently researching the role of hyperglycaemia in relation to sudden cardiac death in Type I diabetic patients. He presented his research at numerous international meetings and workshops in Europe, US and Japan. Dr Taubel is a Fellow of the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom and the Institute of Directors (IOD). He is a Regent in the Arbeitsgemeinschaft für Angewandte Humanpharmakologie (AGAH). He is a member of the (British) Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI) and the Royal Society of Medicine. His international memberships include the Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT), the American College of Clinical Pharmacology (ACCP). He is currently representing CCRA in the MHRA stakeholder discussions reviewing the MHRA Phase 1 Accreditation Scheme for clinical trials units in the UK. Since 1999 he has been involved in the design, programming and implementation of a pan-European research volunteer registry, designed to prevent study participants from oversubscribing to clinical studies.

杨晨

盛德国际律师事务所资深顾问律师

杨晨律师是盛德中国生命科学业务的资深顾问律师。杨律师主要为生命科学产业提供行业监管、公司法和商法领域的法律服务。 杨律师在过去的20年中代表跨国公司参与中国不同行业领域的投资项目及收购活动，自2007年以来专注于为跨国生命科学公司提供公司法、交易及法规事务方面的法律服务。杨律师还协助中国政府部门处理美国诉讼事务。 杨律师常年代理跨国药品、医疗器械、食品和化妆品公司处理市场准入、产品本土化、市场推广、产品召回、临床实验及美国海外反腐败法及反贿赂等方面的事务，并就行业特有的监管、合规及稽查方面的问题提供法律咨询。杨律师的业务范围还包括合资企业、公司并购及许可法律事务。

李改玲 博士

杨森中国药物研发和科学事务中心临床药理部高级总监

Gailing Li, Ph.D. Senior Director, Head of Clinical Pharmacology at Janssen Pharmaceutical R& D and Medical Affairs, China. She is an extensively experienced Clinical Pharmacologist with a wide drug development experience from early drug discovery to late phase clinical trials and new drug registration in Johnson & Johnson (Since 2011), Pfizer Ltd (2006-2011, UK), GlaxoSmithKline (2003-2006, UK), LACDR (1997-2002, NL) and WBL Peking Univ. Biotech (1993-1996, China) in multiple therapeutic areas. During her early years working in Peking University (1991-1999), she as one of key innovators for the discovery and approval of New TCM “Xue Zhi Kang” in China. In 1997-2002, She was responsible for a research program on the controlled delivery of anti-Parkinson drugs from ex-vivo investigation to clinical safety and efficacy evaluation, which successfully resulted in two international patents (granted by USA, EU and South Africa). She received her B.S.& M.S. education in Chemistry & Physical Chemistry from Peking University in 1984-1991, and Ph.D. in Clinical Pharmacology & Biopharmaceutics from Leiden University (2002, NL).

罗家立

勃林格殷格瀚生物药业（中国）有限公司总经理

David STRAUSS 医学博士

美国FDA药物评价与研究中心临床药理学办公室，转化科学办公室，监管科学处处长

在药物和医疗器械的实验、转化和临床研究方面具有丰富经验的医生-科学家。 领先FDA研究项目的良好记录，包括体外分析、诱导多能干细胞分析、临床前研究和临床研究、生物标志物、个性化医学、个体-患者元分析以及比较有效性和结果研究等一系列课题和方法。 目前担任应用管制科学司司长，力求将新的科学纳入林业发展局的审查进程，缩小科学创新和医疗产品审查之间的差距，并通过建立药物应对知识并将其转化为以科学为基础、以患者为中心的管理决定来改善公共卫生。 监督和协调FDA的研究活动，支持全面体外心律失常检测（CiPA）。

严干新 医学博士

美国托马斯杰弗逊大学医学系教授 Lankenau研究所及西安交通大学教授

严干新，国际著名心脏电生理专家、美国lankenau心脏中心主任。 现任美国Thomas Jefferson大学Jefferson医学院Lankenau医学中心医学教授和高级研究员。心电生理研究成果被写入美国医科大学教材，成为心脏科医生必须掌握的知识，并被美国心脏学界称为“心脏电生理领域的巨人”。在国际上首次命名了Brugada综合征及J波综合征。发表论文120余篇，Google引用率＞15,000。国际著名心电生理杂志Journal of Cardiovascular Electrophysiology、Cardiology和Heart Rhythm的编委。近年，作为主编或副主编参与了3本英文版心脏病学书的编写。 同时担任多个国际知名医学杂志审稿和多个跨国制药集团技术顾问及美国心脏学会专业委员。他的心电生理研究成果被写入美国医科大学教材，成为心脏科医生必须掌握的知识，他被美国心脏学界称为心脏电生理领域的巨人。

Boaz MENDZELEVSKI 医学博士

英国Cardiac Safety咨询公司顾问

Dr. Mendzelevski received his degree in Medicine and Board Certification in Internal Medicine from the Ben-Gurion University Medical School and Hospital in Beer-Sheva, Israel. He then trained in cardiology and received a board certification in Cardiology from the Shaare-Zedek Medical Centre and Hebrew University in Jerusalem, Israel. Dr. Mendzelevski completed further postgraduate training in Interventional Cardiology and Clinical Electrophysiology at the Royal Brompton National Heart and Lung Hospital in London. During his work at the Royal Brompton Hospital Dr. Mendzelevski founded the first European CRO ECG laboratory in London, England, which was later acquired and moved to Mumbai, India. He also served as the Vice President of Cardiology in the industry and was one of the first pioneers of Safety Cardiology in the pharmaceutical industry. He has been involved in all stages of drug development clinical trials since 1995 and most recently held the position of Director of Cardiology for Covance Inc. Dr Mendzelevski is currently a principal at Cardiac Safety Consultants and Director of Cardiology at Medifacts International, a leading Cardiac Safety Core Lab.

李海燕

心血管教授，北京大学第三医院药物临床试验机构主任

李海燕，心血管内科主任医师，硕士生导师。 现任北京大学第三医院药物临床试验机构主任，北京大学第三医院心血管受体研究北京市重点实验室副主任，北京大学临床研究所副所长，中国药理学会药物临床试验专业委员会副主任委员。 研究方向:新药临床研究（包括Ⅰ期至Ⅳ期），涉及溶栓药、抗高血压药、调脂药、抗心力衰竭药、治疗冠心病药物等 教育经历 1983年9月-1989年7月北京医科大学医疗系获医学学士学位 2003年8月-2005年4月美国加州大学洛杉矶分校（UCLA）血管内超声中心实验室及心导管室做访问学者。 工作经历 1989年8月-1994年9月北京医科大学第三医院内科住院医师及住院总医师 1994年9月-1999年6月北京医科大学第三医院心内科主治医师 1999年7月-2007年8月北京大学第三医院心内科副主任医师 2007年8月-至今北京大学第三医院心内科主任医师 2005年7月-2006年10月北京大学第三医院药物临床试验机构副主任 2006年10月-至今北京大学第三医院药物临床试验机构主任 2012年3月-至今北京大学第三医院心血管受体研究北京市重点实验室副主任

董敏

亿腾医药临床开发及药政事务高级副总裁

Dr. Min Dong is currently the Senior VP of Clinical Development & Regulatory Affairs at EOC Pharma, an oncology-focused specility Pharma in China, responsible for establishing development strategy of EOC pipeline, as well as leading the execution of a concerted effort to materialize various development plans. Prior to joining EOC, Dr. Dong worked for 12 years at Novartis, where she took various roles with increasing responsibilities from preclinical safety to oncology early clinical development, primarily driving first-in-human to PoC stage clinical programs. Dr. Dong also worked briefly as Chief Scientist for Daan Gene, one of the leading clinical diagnostic companies in China. Dr. Dong holds a Ph.D. degree in Molecular and Systems Toxicology and Pharmacology from MIT, a MS degree in Molecular Biophysics from Tsinghua University, and a BS degree in Medicinal Chemistry from Beijing Medical University.

李志宏

美国方恩医药发展有限公司国际法规事务副总裁

• 美国FDA及制药公司12年新药临床研发及审评工作经验，广泛参与了新药从FIH到批准后各期临床研发和审评工作。丰富的新药及仿制药eCTD文件撰写及审评经验。专项技能包括临床研发计划，管理法规策略方面的支持以满足美国FDA 对新药研发的要求。对美国FDA政策法规，指导文件的解读及在新药研发中的履行。 • 2015 – 2017：高级主审官，美国FDA仿制药办公室生物等效部。主管ANDA综合审评，包括PK/PD 生物等效试验及相关的生物分析方法，质控及生物等效溶出方法，配方的审评。 • 2009 – 2015：高级主审官，美国FDA临床药理办公室。审评工作涵盖INDs，505(b)(1) 及505(b)(2) NDAs，BLAs，351(k) biosimilars。 • 2006 – 2009：辉瑞制药公司经理，临床药理主管。提供新药研发从IND到NDA各阶段临床策略及试验的设计，报批工作。 • 工作涉及疾病领域包括心理及神经科药物，代谢及内分泌药物，麻醉，止疼及成瘾性药物，风湿和肿瘤药物。 • 在美国FDA成功领导了一个ICH新 Guideline 工作组。所建议Guideline已经通过CDER审评并进入ICH 协调阶段。 • 美国FDA CEDR 级奖项获奖者。 • 多篇新药临床研发相关的文章

闫小军

百济神州全球药政事务负责人，高级副总裁

•22年药政事务工作经验 •前拜耳医药保健有限公司国际研发中心中国药政事物部负责人，注册总监，全球注册战略发展特药负责人 •前葛兰素史克中国药政事物部负责人，注册总监 •前阿斯利康中国高级药政事物经理 •Staffordshire University工商管理硕士 •北京中医药大学医学学士 •执业药师

郭翔 博士

中国统计负责人/执行总监，百济神州

郭翔博士毕业于美国北卡州立大学（NCSU）统计系，目前是百济神州中国统计负责人，执行总监。加入百济之前，郭翔博士于2013-2017年担任默沙东实验室生物统计亚太负责人，高级总监，领导默沙东中国位于北京和上海的生物统计团队。在加入默沙东中国之前，郭翔博士曾于赛诺菲美国研发中心和中国研发中心担任高级统计经理以及来得时（LANTUS）项目统计负责人。 郭博士的研究兴趣主要集中在缺失数据的统计方法，适应性临床研究设计和国际多中心研究设计与分析等研究领域。郭博士目前是药物信息协会（DIA）中国统计分会主席，DIA 中国顾问委员会成员，中国临床研究统计专家组（CCTS）成员和北京生物统计和数据管理研究会（BBA）秘书长。

戴鲁燕 博士

勃林格殷格翰泛亚太生物统计负责人

Dr. Luyan Dai is currently heading the Asia statistics group overseeing both teams in China and Japan and contributing to the global development at BI. She was relocated to Asia in 2012 to build up the statistics team in Shanghai for Boehringer Ingelheim. Prior to this, she worked at Boehringer Ingelheim in USA. Dr. Luyan Dai received her PhD in statistics at the University of Missouri-Columbia, USA.

赵大尧

辉瑞中国副总裁，中国药物开发部负责人

从2016年至今，大尧作为辉瑞中国药物研发团队负责人，一直专注于优化提升临床研发流程，并在国内建立一流的团队。大尧在北京大学医学院获得神经科与儿科专业医学博士学位，同时也是哈佛医学院神经生物学与分子生物学博士。大尧在美国获得了丰富的药物发现和研发方面的经验，并分别在多家规模不一的医药公司工作过，包括日本协和医药公司、健赞公司、诺华公司、辉瑞公司以及强生公司。 辉瑞公司 2011年到2015年1月期间，赵大尧任职强生制药中国药物研发部副总裁。在职期间，他为公司的研发与科学事务打造了一个清晰的愿景，以支持杨森的新战略，并将杨森中国与亚洲研发中心（上海）的几个团队进行合并，打造一个全新的中国研发团队。在过去六年中，赵大尧博士领导完成了300多项临床试验，在国内外注册了一个又一个的新产品。大尧在中国的政策提案中也发挥了重要作用。同时，他还与政府机构、中国外商制药协会和其他的行业协会有着紧密的合作关系，并担任了2015年中国药物信息协会主席。

夏结来 博士

教授,空军军医大学（第四军医大学）卫生统计学教研室主任

夏结来，博士，空军军医大学（第四军医大学）卫生统计学教研室主任、教授、博士生导师，国家食品药品监督管理总局审评咨询专家(生物统计)、中国信息协会统计理论与方法专业委员会副主任委员、中华预防医学会生物统计学分会侯任主任委员，中国卫生统计杂志编委、CCTS副组长、CDMC组长。 先后获7项国家自然科学基金项目资助，参与3项十一五科技创新项目研究，与CDE联合申报获得十三五重大科技专项一项。获国家科技进步二等奖一项、军队科技进步一、二等奖各一项、陕西省科技进步二等奖一项。 提出了回归系数有偏估计方法––根方估计和广义根方估计。先后在香港中文大学威尔士亲王医院临床与流行病学研究中心、美国鲁易斯安娜州立大学医学中心遗传与统计系访问研究。主要研究方向是临床试验设计与统计分析方法。参与了数十项的涉及化药、中药、生物制品、医疗器械等临床试验相关指导原则制定。

徐宁

再鼎制药执行副总裁,临床研发及法规事务负责人

现任再鼎医药临床研发和法规事务执行副总裁。徐宁博士毕业于中国协和医科大学医学系，曾在北京协和医院呼吸科任主治医师多年，先后主管呼吸重症监护室和呼吸综合病房，积累了大量临床经验。之后，在美国伊利诺斯州立大学医学院药理系从事分子生物学研究，建立了原发性和继发性急性肺损伤小鼠模型，研究中性粒细胞抑制因子对急性肺损伤的控制。工作期间，在高水平专业杂志上发表了多篇文章。同时还在该校攻读并获得工商管理学硕士。徐宁博士先后在美国和中国就职于跨国医药研发企业，专注于临床试验的实施、公司或部门管理工作、以及研发专业团队的建设。不仅积累了深厚的药物临床研发经验并显著推动了所在企业或部门的迅猛发展。同时，徐宁博士还活跃于行业界的学术和经验交流，参与了国家药监局的多项指南起草工作。2011年至2015年期间任全球医药信息协会中国区顾问委员会主席，主持了大量学术会议和交流活动，积极推动中国临床研究与世界的接轨。

Vlad DRAGALIN 博士

杨森制药定量科学科学会士，副总裁 ICH E9(R1)工作组成员

苏岭

沈阳药科大学教授，礼来亚洲基金风险合伙人

苏岭博士在药品法规及注册审评管理、新药研发策略和管理、临床研究、药物安全和药物警戒、药物流行病学等领域拥有丰富经验。曾任职于原卫生部药政管理局和美国FDA，担任药物信息协会 (DIA) 全球理事会主席等职。先后在默沙东、罗氏、惠氏、诺华等多家跨国制药企业从事临床研究和药物研发的高级管理工作

黑永疆

齐鲁制药临床开发首席医学官

Hi博士是齐鲁制药公司的副总裁和首席医疗官（CMO），负责在所有治疗领域的临床发展项目的总体战略和操作。他还领导公司的发展战略和业务发展和联盟的功能。Hi博士加入了来自圣地亚哥的生物技术公司AMBRX公司的齐鲁，在那里他担任CMO负责临床策略和操作，专注于抗体药物结合物（ADC）和基于CD3的生物标记物。在Ambrx之前，Hi博士曾在AMGEN工作超过9年，作为肿瘤学全球发展和医疗事务的执行医学主任，其能力是全球肿瘤学导管分子和市场化产品（包括MOTESA等小分子）的全球发展领导者的能力。NIB以及生物制剂如CONATUMUMAB和VIDEBIX。此外，在他任职期间在安进公司，喜花在中国博士3年医疗头建立临床医疗队伍和建立安进中国的产品开发和临床操作能力。在安根之前，Hi博士为罗氏实验室公司工作，诺华肿瘤学为罗氏美国医疗主任，诺华肿瘤科高级全球品牌医学主任/执行主任，他领导医疗计划的开发和执行，并扩大了研究者的发起人。D临床研究。此外，HII博士还支持FDA、PMDA（日本）EMA和中国FDA（CFDA）的监管文件和提交文件。黑正宏博士在中国石河子医学院获得医学学位，并毕业于中国西部医科大学（硕士）和加拿大英属哥伦比亚大学（博士）。

Ana HIDALGO-SIMON

EMA人类用药品研究和开发支持处专业科学负责人

• Head of Specialised Scientific Disciplines, European Medicines Agency (2013-present) • Head of Risk Management, European Medicines Agency (2012-2013) • Head of Risk Management (ad interim), European Medicines Agency (2011-2012) • Head of Signal Detection and Data Analysis, European Medicines Agency (2009-2011) • Scientific Administrator, European Medicines Agency (2003-2009) • Medical Editor, EuroTransmed, United Kingdom (1998-2003) • Scientific Project Manager, Medical Action Communications, United Kingdom (1997- 1998) • International Clinical Trials Coordinator, SymbioClin, United Kingdom (1996-1997) • Post-doctoral Researcher, Clinical Research Centre, United Kingdom (1995-1996)

邓婷

赛诺菲药政事务中国负责人

陈韶风 博士

艾伯维公司数据和统计科学，渠道统计和编程副总裁

Dr. Ivan S.F. Chan has 20+ years of experience in pharmaceutical industry. He is Vice President, Pipeline Statistics and Programing, Data & Statistical Sciences, at AbbVie Inc. In this capacity, he leads the statistics and programing groups supporting discovery, biomarker development, clinical development and global medical affairs for all therapeutic areas. Prior to joining AbbVie, Ivan was Executive Director of Biostatistics at Merck Research Laboratories. Ivan earned his B.S. and M.S. in Statistics from The Chinese University of Hong Kong and a Ph.D. in Biostatistics from University of Minnesota, United States. Professionally, Ivan serves as Executive Director of the International Society for Biopharmaceutical Statistics (ISBS) and as an External Advisor to the University of Hong Kong. Also, he is an Associate Editor (AE) for Statistics in Biosciences, Statistics in Biopharmaceutical Research, and Journal of Biopharmaceutical Statistics. He was the 2012 President of the International Chinese Statistical Association. He has 80+ publications in statistical and clinical journals. Ivan is a Fellow of the American Statistical Association (ASA) and a Fellow of the Society for Clinical Trials (SCT).

陈峰 博士

南京医科大学公共卫生学院院长 中国卫生统计学会统计理论与方法专业委员会主任委员 中国临床试验生物统计学组（CCTS）组长

陈峰 教授 南京医科大学研究生院院长 中国卫生统计学会统计理论与方法专业委员会主任委员 中国临床试验生物统计学组（CCTS）组长

董艳平

罗氏亚太药品研发中心注册事物高级经理

毕业与中国药科大学。2006年加入罗氏中国药品注册事务部，一直从事抗肿瘤领域产品的注册相关工作，包括上市前临床开发及上市后产品维护。2012年9月至2013年6月曾在美国基因泰克公司进行轮训，支持相关产品在美国和全球的注册工作.

Vlad DRAGALIN 博士

杨森量化科学咨询全球负责人，副总裁 ICH E9(R1)工作组成员

Vlad Dragalin is a Vice President, Scientific Fellow in Quantitative Sciences at Janssen Pharmaceutical Companies of Johnson & Johnson. Vlad is the Head of QS Consulting and is chairing the QSTEPS (QS Technical Excellence and Program Strategy) Advisory Committee. He joined Janssen in 2014 as the Head the Adaptive Clinical Trial Center of Excellence. Vlad is a well-known adaptive design expert with 30 years of experience in developing the statistical methodology of adaptive designs and with 20 years of experience in pharmaceutical industry, including positions of increasing responsibilities at GlaxoSmithKline, Wyeth, Pfizer, Quintiles, and Aptiv Solutions. He has made significant contributions to the development of the methodology of adaptive designs and to their application in clinical trials and has more than 75 publications in peer reviewed journals and books. Vlad is a PhRMA representative on ICH E9(R1) Expert Working Group. He is Fellow of the American Statistical Association, a Member of the Drug Information Association, the Society for Clinical Trials, the International Society for CNS Clinical Trials and Methodology, and an Associate Editor of the Journal of Biopharmaceutical Statistics and Statistics in Biopharmaceutical Research.

殷悦

罗氏药品临床研发亚太区注册事务负责人

殷博士是基石药业生物统计部高级总监。 她负责建立生物剂量部门，支持基石药业的产品线开发。除部门职责外，殷博士同时带领一个产品开发团队，负责制定产品发展规划并管理其实施。 于2017年5月加入基石药业之前，她曾在罗氏亚太研发中心（上海）任职7年，担任肿瘤生物统计副总监。 殷博士带领统计生物团队，为罗氏全球和中国的HER2和免疫治疗产品线提供统计和战略支持。在回到罗氏上海任职之前，殷博士曾在美国基因泰克（南旧金山）工作三年，支持血液学研究项目。殷博士于约翰霍普金斯大学获得生物统计学博士学位，于北京大学获得数学学士学位。

刘恋 博士

诺华生物统计总监

Dr. Lian Liu is Director, Biostatistics, heading the Early Development Biostatistics team in China in Novartis. Before joining Novartis, Lian worked as a biostatistician for over 10 years with increasing responsibilities in global pharmaceutical companies including Merck in Pennsylvania, USA and Roche in Shanghai, China. His most recent position is Associate Director, Statistics in GSK R&D China leading a team to support both China registration studies and global preclinical/early clinical studies. His working experience covers several therapeutic areas including neuroscience, oncology, respiratory, cardiovascular, and dermatology. He received a Ph.D. in Statistics from Texas A&M University, USA and a B.S. in Probability and Statistics from Peking University, China.

大坪泰斗

日本PMDA新药办公室II主任审评员

Mr. Yasuto Otsubo is a reviewer of Office of New Drug II at Pharmaceuticals & Medical Devices Agency (PMDA). In this position, Mr. Otsubo is responsible for reviewing cardiovascular drugs, antiparkinsonian drugs, and anti-Alzheimer's drugs as the team leader. Mr. Otsubo has over 10 years' experience in the regulatory agencies. Mr. Otsubo is also a member of MRCT Working Group and Companion Diagnostics Project Team of PMDA.

Joseph SCHEEREN

德国拜耳全球研发高级顾问,高级副总裁,DIA后任主席

Dr. Scheeren started his pharmaceutical industry career in 1982 with Servier in Paris, responsible for Regulatory Affairs Northern and Eastern Europe, and Clinical Development in Munich from 1986 – 1987. In 1991, he was appointed Head of Worldwide Regulatory Affairs at Serono, Geneva. In 1992, he took over responsibility of the Global Regulatory Affairs department of Roussel UCLAF. In 1996, he moved to New Jersey to head the Global Marketed Product Regulatory Affairs Department of Hoechst Marion Roussel. He joined Bayer Pharmaceuticals as Senior Vice President, Head of Global Regulatory Affairs, in 2004 responsible for development in the US and in 2009 became Site Head US in Montville, NJ. In addition, he took over the position Head of Global Development Asia in Beijing in 2012. In 2015, he was appointed Head of Global Regulatory Affairs Pharma and Consumer Care of Bayer Healthcare, Basel. Dr. Scheeren holds many memberships and designations, serving on Advisory Boards at the Center for Innovation in Regulatory Science, SAFE-PHARMA, the Regulatory Affairs track at Yale University, the Center of Regulatory Excellence Singapore, the Research & Development-based Pharmaceutical Association in China, and the China Core Research and Development Committee. He has served as Chairman of the DIA Regional Advisory Council for Europe, Middle East & Africa; he is also a foreign member of the Academie Nationale de Pharmacie, France, and a lecturer at Yale University. Dr. Scheeren studied pharmacy at the University of Leiden.

于言

百时美施贵宝临床试验运营部临床监查副总监

Yan has more than 12 years experience in the Pharmaceutical Industry working in BMS, Astrazeneca and Boehringer Ingelheim,. During her career, she has held positions including Clinical Research Associate, Project Manager and Clinical Research Manager. Yan holds Master degree in public health (MPH) in Deakin University (Australia) and Bachelor degree in clinical medicine from Shanghai 2nd Medical University (now Shanghai Jiaotong University medical school).

吕玉真

罗氏药品临床研发亚太区注册事务负责人

吕玉真，执业药剂师，北京大学国际药物工程管理硕士和上海医科大学药学专业学士。现担任罗氏亚太地区注册部负责人和RDPAC药品注册生物制品小组召集人。 在过去的17年里，曾就职于普强、法玛西亚普强、法玛西亚，辉瑞及默沙东公司注册部。加入制药公司之前，在上海医科大学（现为复旦大学医学院）药学院药学教研室担任助教。

岳向阳

百时美施贵宝全球临床试验运营部临床监查经理

Bristol-Myers Squibb Location: Beijing, China Sarah Yue has more than 7 years’ experience in clinical research. First 2 years she worked in CRO, and has worked in BMS for 5 years. Before conducting SMM, she has worked as clinical site monitor for 6 years. Sarah Yue now is responsible for people management for all site monitors in Beijing from Sep of 2016. Sarah has master degree in Pharmacology Analysis from Shandong University, and bachelor degree from Sichuan University.

Marion WOLFS

杨森研发风险管理及中央监测总监

Lynn EVANS

杨森公司生物研究质量与合规，质量规划与策略负责人

Lynn has been with Johnson & Johnson for over 17 years. Lynn is currently the Head of Quality Planning & Strategy in Bioresearch Quality & Compliance (BRQC) Janssen where she leads a global team to identify and mitigate quality risk in the Janssen R&D portfolio. Lynn is responsible for setting the vision and strategy for QP&S, ensuring a streamlined and integrated BRQC Janssen approach to interacting with key business partners. Lynn also manages Licensing & Acquisition, divestitures, inspection support, quality agreements, and vendor oversight. Lynn is working to transform the QP&S organization and provide strategic quality consultation to key stakeholders by developing proactive quality support, real-time issue management, utilizing analytics-based data and leveraging cross-segment and cross-functional expertise. Prior to joining BRQC Janssen, Lynn was the Compliance Officer for the External Manufacturing Audit program in Johnson & Johnson Regulatory Compliance (JJRC). Lynn has over 22 years of experience in Quality & Compliance supporting Pharmaceutical Research & Development, Medical Device and Consumer products. She has extensive experience managing highly complex, heavily scrutinized quality projects and has successfully led the corporate compliance oversight of the McNeil Consent decree. Lynn also has a history of establishing and implementing risk management framework and strategy, such as her leadership of a risk categorization of suppliers across the Johnson & Johnson Enterprise. She has held a variety of quality leader positions and strengthened key stakeholder interaction and improved the quality culture, such as her prior role supporting new product development teams for J&J R&D. Prior to joining J&J, Lynn held quality leadership positions at Merck, Omnicare and Integra Life Sciences. Lynn holds a Bachelor of Science degree in Chemistry from the University Of Maryland and a Master of Science degree is Quality Assurance/Regulatory Affairs from Temple University. Lynn lives in Doylestown, Pennsylvania with her husband and 2 children where she enjoys kickboxing and cycling in her spare time.

Ellyne SETIAWAN

勃林格殷格翰医学质量负责人

1998 年 12 月 - 2002 年 10 月，任职时长3 年 11 个月，所在地区新加坡 ，公司名称Merck Sharp & Dohme (I.A) Pte Singapore，Clinical Research and Drug Regulatory Associate 2002 年 10 月 - 2010 年 5 月，任职时长7 年 8 个月，所在地区新加坡，公司名称Lundbeck，Regional Manager, Project Management 2010 年 5 月 - 2014 年 7 月，任职时长4 年 3 个月，所在地区Singapore，公司名称Boehringher Ingelheim ，Clinical Operations, CRO Management & Medical Business 2014 年 8 月 - 至今，任职时长3 年 10 个月，所在地区中国 上海，公司名称Boehringer Ingelheim，Head of Quality Management, ROPU TCM

黄洁仪

中国香港默沙东亚太地区临床质量管理区域总监

Helen started her career in Pharmaceutical Industry with Merck Sharp & Dohme (MSD) Hong Kong in 1998 as a Medical Affairs Associate. After three years, she moved to the split Regulatory Affairs function of the local Medical Department and also assumed the local Pharmacovigilance Contact role. In 2003, she was promoted to Regulatory Affairs Manager. In 2005, Helen was appointed to lead the expanding Clinical Research function in Hong Kong as a Clinical Research Manager. In 2009, Helen moved to take an Asia-Pacific (AP) regional role in MSD as the Regional Sigma Manager. She led and supported various process improvement projects in AP, as well as some projects at the global level. A few years later, she moved into the Headquarters function “Clinical Quality & Performance Management” for global quality and process improvement initiatives and activities, while continuously based in Hong Kong. In 2016, she was back to the region to take up the Regional Director, Clinical Quality Management (CQM) Asia-Pacific until now. She has been leading and developing the CQM team in AP in MSD serving the country clinical operations. Helen graduated with First Class Honors and a Bachelor’s degree in pharmacy from the University of Sydney, Australia and a Master’s degree in Health Administration from the University of New South Wales, Australia. She is a certified Lean Six-Sigma (LSS) Black Belt and LSS Green Belt trainer. She has also been a Section Editor of Hong Kong Pharmaceutical Journal (HK Pharm J) since 2000.

Deborah DRISCOLL

默克研究实验室质量保证副总裁

Deborah Driscoll has twenty plus years of broad-based experience working in academia and the pharmaceutical industry. She began her career as a research technician at the Boston VA Medical Center and Boston University. She moved to Hoffmann-La Roche holding positions in pharmacology, neuroscience, oncology and HIV research. Deborah worked at Pfizer for several years working in the areas of clinical research, global pharmacovigilance, drug safety surveillance and quality systems development. Deborah joined Merck as the head of Quality Assurance for Merck Research Laboratories in July 2015. Outside the work place, in 2014 Deborah assumed the leadership role for TransCelerate BioPharma Inc. Clinical Quality Management System Team working with 18+ member companies to develop and advance a clinical quality framework. Deborah has a devoted interest in supporting proactive quality and compliance initiatives globally. Deborah holds a B.S. in Animal Science and an M.S. in Biology.

Agnes SAINT-RAYMOND 医学博士

EMA国际事务及Portfolio Board负责人

Joined French Agency for medicines (now ANSM) in 1995 as Head of a Pharmaco-Toxico-Clinical Assessment Unit. Joined EMA in 2000. Head of Special Areas for Human Medicines (Paediatric Medicines, Orphan Medicines, Scientific Advice, SME Office, and Scientific Support & Projects) until 2013. Head of Portfolio Board since Aug 2013. Head of International Affairs (a.i.) since Nov 2016.

陈华

强生公司质量策略亚太总监

强生公司质量策略亚太总监 Director, AP, Quality Strategy, Johnson & Johnson Hannah于2012年9月份加入强生亚太与中国研发机构的生物学研究质量与合规部门（BRQC) 担任质量总监. 2016年9月起，她担任生物学研究质量与合规部门中国区负责人，负责亚太区和中国区研发部门质量管理系统中战略性地整合质量保证与合规性的内容。在加入强生公司之前，Hannah曾在葛兰素史克公司工作15年，其中有10年时间从事审核工作。她曾在亚太地区的很多国家从事药物临床试验管理规范方面的审核工作，也在美国、欧洲、拉丁美洲和非洲的很多国家工作过。自2009年起，她就与FDA中国办公室和CFDA密切合作，在药物临床试验管理规范等方面提供了大量的咨询并起草指南性文件。

Jan PETRACEK 医学博士

英国PrimeVigilance公司首席执行官

Jan Petracek, MD, MSc • CEO • European Pharminvent Services, Czech Republic Dr. Jan Petracek qualified as a physician from Charles University in Prague and holds a Master of Science with Distinction in Quality and Safety in Healthcare from Imperial College London. Jan has over 15 years of experience in all areas of pharmacovigilance, being former Head of Risk Management Section at European Medicines Agency, Head of Pharmacovigilance in the Czech Republic, Head of Strategy and Development of the Czech National Authority, and member of CHMP Pharmacovigilance Working Party. He has established guidelines and registries for PASS at national level back in 2003, and since then he was involved in development of standards and regulations surrounding non-interventional studies in safety areas。

Sonja BRAJOVIC 医学博士

美国FDA监管科学医学官

Sonja Brajovic is a Medical officer in the Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). She is responsible for coordination of projects related to the Medical Dictionary for Regulatory Activities (MedDRA), including monitoring MedDRA coding quality of reports in the FDA Adverse Event Reporting System (FAERS). Sonja serves as the Regulatory Chair on the ICH* MedDRA Points to Consider workgroup and she is the FDA representative on the CIOMS** Implementation workgroup on Standardised MedDRA Queries (SMQs). Sonja obtained her medical degree in former Yugoslavia. --ICH: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use --CIOMS: Council for International Organisations for Medical Sciences

祝蓉 医学博士

缔脉生物医药科技有限公司 药物安全与药物警戒部门负责人

祝蓉博士是缔脉生物医药科技有限公司药物安全与药物警戒部门负责人，负责为生物医药企业提供药物警戒法规咨询、体系搭建和战略规划，领导团队提供全面的不良事件报告处理、安全性数据评估和风险管理、上市后药物安全性监测等一体化药物警戒解决方案。 祝蓉于复旦大学上海医学院（原上海医科大学）获得临床医学博士学位。 加入缔脉前，祝蓉就职于辉瑞公司全球药物安全部，安全评估与报告部门，担任药物安全医学总监。在此职位上她主要负责肿瘤治疗领域相关产品的安全性数据评估，包括个例安全报告的医学审核、定期汇总性安全报告的审阅、做为所负责产品的风险管理委员会成员进行安全信号评价和风险评估。 在进入医药行业之前，祝蓉先后在上海市第一人民医院和上海市中山医院从事临床和科研工作。

Jan PETRACEK 医学博士

英国PrimeVigilance公司首席执行官

Jan Petracek, MD, MSc • CEO • European Pharminvent Services, Czech Republic Dr. Jan Petracek qualified as a physician from Charles University in Prague and holds a Master of Science with Distinction in Quality and Safety in Healthcare from Imperial College London. Jan has over 15 years of experience in all areas of pharmacovigilance, being former Head of Risk Management Section at European Medicines Agency, Head of Pharmacovigilance in the Czech Republic, Head of Strategy and Development of the Czech National Authority, and member of CHMP Pharmacovigilance Working Party. He has established guidelines and registries for PASS at national level back in 2003, and since then he was involved in development of standards and regulations surrounding non-interventional studies in safety areas.

颜崇超 博士

恒瑞临床数据科学中心负责人

颜崇超，DIA（中国）顾问委员会委员,中国临床数据管理学组（CDMC）成员，现任上海恒瑞临床数据科学中心副总经理。曾是辉瑞（中国）研发中心数据服务部的技术运营负责人，并在上海医药临床研究中心数据管理部任高级总监。先后在美国勃林格殷格翰从事临床研究数据管理工作，以及在意大利高级卫生研究院，美国亚利桑那大学医学院和纽约大学医学院从事医学研究。在国内外期刊上发表过40余篇学术论文。《医药临床研究中的数据管理》书作者，北京，科学出版社，2011。

Pär Tellner

欧洲制药工业协会联盟（EFPIA）驻ICH代表，总监

Pär Tellner is Director, Team Leader and ICH Coordinator at EFPIA since 2012. He is also in charge of the EFPIA support to the international regulatory affairs. Pär has previously been working as Compliance officer (marketing ethics) and Director of Veterinary Medicine, LIF Sweden and as Head of regulatory affairs for several pharmaceutical companies, e.g Octapharma, Biovitrum, Pharmacia Plasma Products and Novartis. Pär has also been working as Senior Pharmaceutical Officer for the Swedish Medical Products Agency. Pär graduated as a pharmacist at Uppsala University in 1986.

Michelle LIMOLI 博士

FDA驻ICH协调员 （培训委员会） FDA CBER 国际健康政策高级顾问

Dr. Limoli is Senior International Health Science Advisor in US FDA’s Center for Biologics (CBER). She is responsible for coordinating and collaborating on activities and strategic programs with various international organizations and governments, as well as within the CBER. During her career at FDA, she has coordinated activities in various harmonization and multilateral initiatives such as ICH, VICH, ICCR, GHTF, IMDRF, APEC RHSC, OECD, and WHO. Dr. Limoli joined CBER after having worked in the Center for Drug’s international programs and the Office of the Commissioner where she served as the Director of FDA’s Europe Office. Dr. Limoli is a clinical pharmacist with both hospital and community pharmacy experience. She earned a B.S. Pharm and Pharm.D. from the University of Georgia.

富永俊義 博士

ICH Assembly主席 欧盟药品委员会资深专家

Dr. Tominaga is Associate Executive Director (for International Programs) in PMDA, Japan. He supervises the overall strategy and conduct of international operations by PMDA. He joined Japan’s MHLW after he acquired his Ph. D. degree in 1987 from Faculty of Pharmaceutical Sciences, the University of Tokyo. As a career official, he has experienced positions dealing with narcotics control, R&D enhancement, NDA review, and drug pricing. His international experience includes two-year graduate study at Harvard School of Public Health (1990-1992), three-year stay in Vienna as a diplomat (1999-2002), and one-year stay at FDA, US as an adviser to Director of OIP (2008-2009). Dr. Tominaga was formerly Director of the Office of International Programs (OIP) of PMDA (2009-2012), he returned to PMDA in August 2014 after he worked at the Osaka City University Medical School as Professor and Director of the Food and Drug Evaluation Center(2012-2014).

Lenita Lindström-Gommers 博士

ICH Assembly主席 欧盟药品委员会资深专家

Chair of the ICH Assembly, Lenita Lindström-Gommers works since several years in the pharmaceuticals Unit in the European Commission (Unit B5 "Medicines: Policy, authorisations,monitoring") where she is in charge of international relations. She is dealing mainly with ICH where she has actively contributed, as the representative of EC, Europe, to the work on reforming ICH. In addition to international work, she has worked on various legislative files in the field of pharmaceuticals and held responsibilities for coordinating relations with the European Medicines Agency. Before joining the pharmaceuticals unit, she worked in the Directorate General for Competition (anti-trust) of the Commission. Lenita Lindström-Gommers is a lawyer by education and holds a Master of Laws degree from the University of Helsinki, Finland.

殷悦

博士

Dr. Yin is the Senior Director of Biometrics in CStone Pharmaceutical. She is responsible for building the biometrics group to support CStone’s portfolio. In addition to her functional responsibilities, Dr. Yin is also leading molecule program team, which sets the development plan of the molecule and oversees its implementation. Before joining CStone in May 2017, she was an associate director of oncology biostatistics in Roche Shanghai office. Dr. Yin led a group of statisticians, providing statistical and strategic support to Roche’s global and China HER2 and immunotherapy portfolio. Prior to her seven-year tenure with Roche Shanghai, Dr. Yin had worked in Genentech South San Francisco for three years, supporting hematology development programs. Dr. Yin obtained her PhD degree in Biostatistics from Johns Hopkins University, and her bachelor's degree in mathematics from Peking University. 殷博士是基石药业生物统计部高级总监。 她负责建立生物剂量部门，支持基石药业的产品线开发。除部门职责外，殷博士同时带领一个产品开发团队，负责制定产品发展规划并管理其实施。 于2017年5月加入基石药业之前，她曾在罗氏亚太研发中心（上海）任职7年，担任肿瘤生物统计副总监。 殷博士带领统计生物团队，为罗氏全球和中国的HER2和免疫治疗产品线提供统计和战略支持。在回到罗氏上海任职之前，殷博士曾在美国基因泰克（南旧金山）工作三年，支持血液学研究项目。殷博士于约翰霍普金斯大学获得生物统计学博士学位，于北京大学获得数学学士学位。

张菁 博士

复旦大学上海医学院附属华山医院抗生素研究所副主任，临床药理学教授

Edward COX 医学博士

美国FDA药物评价和研究中心抗菌产品办公室主任

Mark GOLDBERGER 医学博士

美国FDA同仁会 前美国FDA药品审评与研究中心药品审评四部部长 前美国雅培制药法规政策副总裁

Agnes Saint-Raymond 医学博士

EMA国际事务及Portfolio Board负责人