王勇

药明康德生物统计副总裁

Dr. Yong Wang is senior director, Head of Biostatistics for the Asia-Pacific region at PAREXEL. He is a life sciences executive and a PhD statistician with significant experience in leading clinical trial activities. Dr. Wang has worked on designing, implementing, analyzing, and reporting all phases of clinical trials for more than 20 years across areas of biopharmaceuticals and medical devices. He has extensive experience in regulatory submissions, interactions with regulatory authorities, product in-licensing, and commercial development.

纪菲

礼来统计顾问

纪菲博士毕业于纽约州立大学石溪分校（Stony Brook University）应用数学和统计系，现任礼来中国统计副总监, 负责礼来中国的自身免疫疾病领域的临床研究。加入礼来中国前，纪博士先后任职于纽约洛克菲勒大学基因统计学实验室，华盛顿DC的Statistical Collaborative, 马里兰州的MedImmune，有十年丰富的临床研发经验，是多个药品的全球研发负责统计师，涉猎肿瘤，自身免疫，疫苗，抗感染等多个疾病领域。纪菲博士的研究兴趣主要集中在缺失数据的统计方法，贝叶斯方法在中国亚组中的使用，国际多中心研究设计与分析等研究领域。

陈刚

诺思格医药科技股份有限公司高级副总裁

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。

何崑

诺思格医药公司首席统计学家 前FDA药审中心血液和肿瘤学药物审批中心生物统计部副主任

何崑博士曾就职于美国FDA任肿瘤药物审评中心生物统计部副主任。何崑博士1982年从中国科学技术大学获得数学学士学位，1984年从北京大学获得统计硕士学位，在清华大学任教两年后，1986年留学美国康奈尔大学并于1991年获得统计博士学位。在明尼苏达大学和堪薩斯大学任教八年后，于1999年加入美国FDA并于2019年加入了诺思格。在FDA二十年的工作中，何崑博士参于制定了许多监管政策，参于审评或设计了许多重大的临床试验包括GBM AGILE, Lung MAP, 和ISPY2, 负责审批了许多重要的药物包括Keytruda和Opdivo的最初审批。何崑博士在FDA肿瘤学中心的审评中，发挥了重要的作用并同时积累了丰富的药物审批和研发的经验。

朱超

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。

Martin ROESSNER

精鼎公司生物统计副总裁

Martin Roessner, who possesses a MS in Mathematics and Biostatistics from the University of Aachen, Germany, has over 40 years of experience in the pharmaceutical industry. He has extensive experience in drug development in a large Pharma company first in Europe and later in the US, covering Phase I – Phase IV in adults and pediatric patients with successful health authority agency interactions resulting in various approvals worldwide including FDA, EMA and Japan. He has particularly experience in clinical development plans, protocol development, study design, conduct, analysis and reporting of clinical trials and regulatory submissions in drug development for Infectious Diseases, Cardiovascular (Hypertension, Cardiac Failure, Stroke, Peripheral Vascular Disease), CNS (Alzheimer’s disease and Vascular Dementia, Parkinson’s disease, Depression, Schizophrenia, MS and Sleep Disturbance), Pain, Osteoarthritis, Rheumatoid Arthritis, Psoriasis, Diabetes, Oncology (solid tumors and hematological malignancies) , Vaccines and Devices. This includes indications which are common diseases but also includes rare diseases which present different challenges for the clinical development. He held senior Biostatistics positions at a major pharmaceutical company first in Europe (Hoechst) and later in the US (Aventis/Sanofi) and directed the development, submission and approval efforts for many projects including due diligence services to license other products. He has also supported reimbursement applications. Before joining PAREXEL he has been leading Biostatistics teams, was responsible for Therapeutic Area developments and worked as Expert in submissions at the previous company, reviewed all regulatory submissions and provided guidance on the content of submission documents to ensure an easy and rapid regulatory review. He has joined PAREXEL in 2010 and has led since then the Biostatistics organization worldwide and continues to provide consulting services to Pharmaceutical and biotechnology companies. Recently he supported the FDA approval of a seasonal flu vaccine through the preparation and participation in other US FDA Advisory Committee meetings for our clients. Since February 2017 he is a full-time consultant for Biostatistics at PAREXEL and since September 2017 a member of the company’s Executive Committee.