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Vaccine Innovation Forum (VIF) World 2024 to be held in China aims to bring together experts, researchers, policymakers, and industry leaders from around the world to collaborate and advance the field of vaccine development and immunization.
As the world faces emerging infectious threats and ongoing health challenges, it is crucial to foster international cooperation and knowledge exchange in the realm of vaccine development. This conference will serve as a platform to share cutting-edge research findings, discuss innovative vaccine technologies, address global immunization gaps, and promote equitable vaccine distribution.
Scientific Advisory Board:
Photos
Panel Discussion:
Talks:
Exhibition
Q&A:
1-ON-1 Meeting
Welcome Reception
Statistics
Key Sessions & Topics
Novel Vaccine Innovation:
Infectious diseases
RNA Technology
Bacterial vaccines
Veterinary Vaccines
Cancer Vaccines & Immunotherapies
Bioprocessing & Manufacturing
Clinical Trial/Vaccine Safety
Market Access/Regulatory/International Partnership
Adjuvant, Formulation, and Delivery Technologies
Young Scientist Poster Session:
The future of vaccine innovation rests in the hands of the next generation of scientists, whose fresh perspectives and innovative ideas are driving breakthroughs that will shape global health. This dynamic and interactive poster session, dedicated to young scientists, provides a platform for emerging researchers to showcase their cutting-
edge work and engage in meaningful discussions within the esteemed community of the Vaccine Innovation Forum.
Pls click here for poster application
One-on-One Meeting System:
Whether you are an early-career scientist seeking mentorship, a researcher pursuing collaborative projects, or a representative of an organization exploring partnerships, this system provides the tools to shape your event experience. By matching your expertise, interests, and goals with the right counterparts, we aim to cultivate an environment where collaboration flourishes and transformative ideas take root.
Embrace this opportunity to leverage the power of personal connections in the pursuit of innovative solutions. Join us at the Vaccine Innovation Forum World and unlock the potential of one-on-one interactions that will shape the future of vaccine research, development, and deployment.
Download Event Agenda:
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Dr. Siber is an infectious disease trained physician with more than 40 years of experience in developing vaccines and antibody products. From 1996 to 2007, Dr. Siber served as Executive Vice President and Chief Scientific Officer of Wyeth Vaccines (now Pfizer) where he led the development and approval of multiple innovative childhood vaccines, including Prevenar 7 and 13, the first pneumococcal conjugate vaccines, Rotashield, the first rotavirus diarrhea vaccine, Meningitec, the first meningococcal meningitis conjugate vaccine and FluMist, the first nasal influenza vaccine. Prior to Wyeth, Dr. Siber was Harvard Medical School Associate Professor of Medicine at Dana Farber Cancer Institute and Director of the Massachusetts Public Health Biologic Laboratories where he developed multiple vaccines and immune globulins, including Respigam, the first antibody licensed for respiratory syncytial virus. Dr. Siber most recently was a Co-founder and Board Member of Affinivax which developed a 24 valent pneumococcal vaccine and was acquired by GSK in 2022. Dr. Siber currently serves on the Scientific Advisory Boards of AdVaccine, CanSino, Clover, Everest Medicines, ILiAD, Valneva, Vaxart and Vaxxinity and has been a consultant to the NIH, EU, WHO and the Gates Foundation. Dr.Siber was member of the Board of Trustees of the International Vaccine Institute. Dr Siber has received multiple awards including the 2016 Albert Sabin Gold Medal in vaccinology. Dr. Siber holds an MD degree from McGill University in Canada, received post‑doctoral training in Internal Medicine at Rush‑Presbyterian Hospital in Chicago and Beth Israel Hospital in Boston and training in Infectious Diseases and Vaccinology at Boston Children’s Hospital and Beth Israel Hospital, Harvard Medical School.
Dr. Lu is a physician scientist and a translational vaccine researcher. Currently he is an Emeritus Professor at the University of Massachusetts Medical School (UMMS), USA. Before his retirement in late 2022, he was the Director, Laboratory of Nucleic Acid Vaccines at UMMS since 1996.
Dr. Lu was one of scientists who started the nucleic acid vaccines in early 1990s and continued to advocate the further advancement of this field in the last 3 decades. He promoted the heterologous prime-boost vaccination concept and developed the world first polyvalent DNA/protein HIV vaccine which showed the robust and broadly cross-reactive immune responses in human clinical studies including the recently completed HVTN124 which sets a new milestone for HIV vaccine development.
Dr. Lu is the Editor-in-Chief, Emerging Microbes and Infections (EMI), a global leading journal in emerging infections published by Nature and Taylor & Francis, respectively, in addition to editorial board memberships for Journal of Virology, Vaccine, NPJ Vaccine, and Human Vaccines & Immune Therapeutics.
Dr. Lu has been a board member for International Society for Vaccines (ISV) since 2008 and served as ISV president for the term of 2011-2013 and Chair of Board in 2022. He has co-organized or served as Chairs for a wide range of vaccine congresses over the last two decades. He is a Fellow of ISV and a Fellow of ACP (America College of Physicians).
Dr. David Weiner directs a translational research laboratory at The Wistar Institute in the area of Molecular Immunology. His group is one of the pioneering research teams in establishing the field of DNA vaccines and immunotherapies. Important reports from his lab include the first DNA vaccine studied for HIV as well as for cancer immunotherapy, the early development of DNA encoded genetic adjuvants including the particularly relevant IL-12, advances in gene optimization, and advances in electroporation (EP) technologies resulting in improved gene delivery among others. His group worked with collaborators to become the first to move DNA technology into human study. His laboratory’s work helped revitalize the field through advancement of new synthetic DNA design and modification of EP delivery approaches resulting in potent immune induction as well as the first successful Phase IIb DNA efficacy study (for HPV immunotherapy) in humans. Dr. Weiner is the recipient of numerous honors including election as a fellow to both the American Association for the Advancement of Science in 2011 and the International Society for Vaccines in 2012. He is the recipient of the NIH Director’s Transformative Research Award and received the Vaccine Industry Excellence Award for Best Academic Research Team in 2015 at the World Vaccine Congress. Weiner was honored with the prestigious Hilleman Lectureship in 2015 at the Children’s Hospital of Philadelphia Grand Rounds session and received a Stone Family Award from Abramson Cancer Center for his groundbreaking work on DNA vaccines for cancer immunotherapy. In 2019, Dr. Weiner was honored with the Scientific Achievement Award from Life Sciences PA (LSPA). Dr. Weiner returned to Wistar in 2016 from his position at The University of Pennsylvania School of Medicine as professor of Pathology and Laboratory Medicine. From 1990 to 1993, Weiner held a joint position as assistant professor of Pathology and Laboratory Medicine at The Wistar Institute and the University of Pennsylvania School of Medicine. Dr. Weiner is a co-founder of Inovio Pharmaceuticals and is a member of the Board of Directors. Dr. Weiner graduated with a B.S. in biology from SUNY at Stony Brook, N.Y., a M.S. in biology from the University of Cincinnati and a Ph.D. in developmental biology from the University of Cincinnati College of Medicine.
Dr. Chen has been a Professor at the State Key Lab of Respiratory Disease, Guangzhou Medical University since 2013. Dr. Chen received a medical degree from Shanghai Medical College in 1984. He obtained a Ph.D. in Biochemistry and Molecular Biology from Indiana University School of Medicine. Dr. Chen completed his postdoctoral training at Dana-Farber Cancer Institute, Harvard Medical School. From 1997-2001, Dr. Chen served as a Senior Research Fellow at Merck Research Laboratories, where he was the first inventor of Merck's Ad5-based AIDS vaccine that entered clinical trials worldwide. Dr. Chen served as Vice President of R&D for GlaxoSmithKline in 2009-2011 and as Vice President at Sanofi Pasteur in 2012. Dr. Chen has over 200 publications in infectious diseases, vaccine research, and cancer research. His current research is focused on vaccine and antibody research on adenovirus, influenza virus, and emerging viruses. Since 2020, Dr. Chen has been working on developing user-friendly intranasal vaccines and mucosal immunity.
Dr. Yan graduated and earned his B.S. and Ph.D at Wuhan University. He continued to work as a teaching staff member in College of Life Sciences, Wuhan University until 1998. From 1998 to 2002, he worked with Prof. Michael E. Lamm as a Research Associate in Department of Pathology, School of Medicine, Case Western Reserve University, Cleveland, Ohio and conducted scientific research on mucosal immune functions of IgA in relation to virus infections. He returned to Wuhan University in autumn 2002 and joined in the newly established Modern Virology Research Center, College of Life Sciences, Wuhan University as an associate professor. In 2006, he moved to the Wuhan Institute of Virology, Chinese Academy of Sciences, where he was appointed as a professor and group leader to set up an independent research lab named Mucosal Immunity Research Group. His lab is a group member of the State Key Laboratory of Virology in China. He has continued his research on the mucosal IgA functions against virus infections and focused more on the intra-epithelial activities of IgA against viral non-surface and non-structure components, which helps to reveal novel anti-viral mechanisms of IgA antibodies. His lab demonstrated that measles virus (MV) non-surface protein such as matrix protein (M), non-structural protein such as phosphoprotein (P) specific IgA can interact with viral newly synthesized proteins during IgA transport through the viral infected epithelial cells, and inhibit viral replication intracellularly. He also extended his study in developing optimized recombinant flagellin as mucosal adjuvant for designing novel subunit mucosal vaccines. He obtains 3 patents issued by the United States Patent and Trademark Office and 4 patents issued by the State Intellectual Property Office of the PRC related to novel flagellin adjuvants as well as anti-caries vaccine and anti-RSV vaccine. His research is mostly funded by National Natural Science Foundation of China, the Ministry of Science and Technology of China.
Prof. Ken J. Ishii, M.D., Ph.D., currently Director for Int. Vaccine Design Center, The Institute of Medical Science, the University of Tokyo, has 27 years of experience in Vaccine R&D since 1998 including 7 years as a IND reviewer at US Food and Drug Administration (FDA), 15 years as a basic immunologist at Osaka University, 9 years as a vaccine adjuvant expert at National Institute (NIBIOHN), 2 years as managing director at AMED (medical funding agency), as well as Advisor for PMDA (regulatory agency), GHIT (global fund) and CEPI. He has contributed to basic research on infectious diseases and immunology, resulted in numerous books and over 250 periodical publications and 35,000 citations with H-index 84 as well as over 50 patents related to vaccine and adjuvant, and to regulation of many vaccines and guidelines for vaccine preclinical and clinical trials in Japan and US.
Dr. Frank Chia-Jung Chang obtains his Ph.D. from Life Science and Institute of Genome Science department of Taiwan Yang-Ming Medical University in 2012. He received his postdoctoral training at Molecular Biology Institute of Academia Sinica (Taiwan) and worked as visiting scholar in Frances H. Arnold’s laboratory (Nobel Prize in Chemistry winner in 2018), Chemical Engineering Department of Caltech (U.S.). He joined Reber Genetics as the supervisor of R&D Division in 2014. From 2017, Frank also works for business development and strategic layout of vaccine products (technology included).
Dr. Chang has considerable expertise in virology, microbiology, reverse vaccinology and protein engineering for industrial production. His group has successfully developed novel subunit vaccines of swine PRRSV, pan-PCV, Mycoplasma, CSFV and PEDV in Reber Genetics, furthermore, also support the study of safe vector vaccine against ASF with external partners.
Dr. Tao Zhu, Ph.D. the University of Pittsburgh
Co-founder and Chief Scientific Officer of CanSino Biologics Inc.
Dr. Zhu is a member of the 14th National Committee of the Chinese People's Political Consultative Conference (CPPCC) and the “Healthy China Construction” professional committee of the Chinese Peasants and Workers Democratic Party.
Dr. Zhu focuses on the research and development of biological products. He established multiple core technology platforms, including viral vector, polysaccharide protein conjugate vaccine, VLP recombinant vaccine and mRNA vaccine technology at CanSino. Multiple projects led by him have been selected as national “Major Science and Technology Projects for New Drug Creation” and “Major Science and Technology Projects for Infectious Diseases”.
Dr. Zhu has led the team to develop a series of vaccine products, of which 6 vaccine products have been registered and marketed, another 7 vaccine products are in different stages of clinical studies. He co-developed the adenovirus vector-based Ebola virus vaccine (2018), the Recombinant COVID-19 Vaccine (Convidecia, 2021), the Recombinant COVID-19 Vaccine for Inhalation(Convidecia Air, 2022), and the Recombinant COVID-19 XBB Vaccine for Inhalation(2023), with the team of Academician Chen Wei of the Institute of Bioengineering, Academy of Military Medical Sciences, all of which have been marketed. Especially, Convidecia Air is the first developed inhalation vaccine product in the global. Menhycia, which was approved in 2021, is currently the only quadrivalent meningococcal conjugate vaccine on the market in China. Dr. Zhu also holds over 50 patents and 70 publications, including 15 papers from The Lancet publishers.
Michel De Wilde holds a PhD in Biochemistry and has a long and successful career in Vaccine Research and Development. He currently consults for the vaccine community and is member of several Scientific Advisory Boards
From 2001 till June 2013, Michel De Wilde was Senior Vice President, Research & Development, at sanofi pasteur where he drove the development and licensure of a number of products.
From 1978 till 2000, De Wilde was at SmithKline Beecham Biologicals (now GSK Vaccines) where he held positions of increasing responsibility. He played a key role in the development of several new vaccines, most notably the recombinant Hepatitis B vaccine, as well as GSK’s Malaria vaccine.
July 2022 - current : AstriVax
CEO and Co-founder
July 2021 – July 2022: KU Leuven
Entrepreneur in Residence
June 2018 – August 2022: Oxurion
Head Regulatory Affairs
Business Development
Chief Operating Officer
March 2009 – May 2018: GSK Vaccines
Regulatory Affairs
Vaccine Development Leader
Sept 2008 – Feb 2009 – Gevers Patents
Trainee patent attorney
About
Diverse experience in the life science industry exhibiting a unique capability to merge operational execution and strategic development - implementation. Global industry experience in large pharmaceutical industry as well as into smaller biotech environment. Strong experience in development of commercial, late or early stage vaccines, monoclonal antibodies, peptides and small molecules. Regulatory affairs, drug and vaccine development expertise blended with business and corporate development. Proven track record to build up and lead diverse teams. Innovative mindset, with demonstrated ability to think beyond commonly accepted boundaries, understanding well different personalities and able to perform complex and challenging tasks and capable to distil the essence from the noise.
Dr. Xu Rong has over 20 years of experience in innovative vaccine research and development and in leading vaccine R&D teams within multinational corporations. She particularly excels in preclinical vaccine research and evaluation, the development and validation of immunological methodologies, and the CMC development of vaccine products.
Before joining Delonix, Dr. Xu held the position of Senior Vice President of Preclinical Vaccine R&D at Clover Biopharmaceuticals. Prior to that, she served as the Vice President of R&D at the Sabin Vaccine Institute in the United States, where she led the CMC development, clinical immunology assay development and validation, and non-clinical safety and efficacy studies of vaccines. Additionally, she has held several key vaccine R&D and team management roles at Profectus Biosciences, Pfizer (Wyeth), and the Seattle Biomedical Research Institute.
In 2016, Dr. Xu was honored with the Distinguished Female Scientist Award by the Westchester Association in New York, recognizing her outstanding contributions to vaccine research and development. Dr. Xu holds a Bachelor degree in Medicine from Peking University and a Ph.D. in Immunology from the Weizmann Institute of Science in Israel.
Biography :
n Senior Scientist, Brain Research Centre, University of British Columbia (UBC), Canada (09.1994-07.2019)
n Associate Professor of Neurosurgery, UBC (tenured) (09.1994-07.2019)
n Chief Scientific Officer, Co-founder of Virogin Biotech Ltd (05.2015- present)
n Chief Scientific Officer, CNBG-Virogin Biotech Ltd (2019- present)
Dr. Jia obtained his PhD in neurobiology from University of British Columbia (1991), MSc. Psychology (1987) from Dalhousie University in Canada, and BSc. Biology from Fudan University (1982) in China. In 2015, Dr.Jia co-founded Virogin Biotech, an oncolytic virotherapy company in Canada. He is currently the chief scientific officer of Virogin and CNBG-Virogin to develop oncolytic viruses and novel vaccines.
Jingxin Li, PhD, Professor, is working at Jiangsu Provincial Center for Disease Control and Prevention. Her research is focused on vaccine clinical evaluation and immunization strategy. She has participated in a lot of epidemiology investigations and a series of clinical trials of novel vaccines, including Enterovirus type 71 vaccine, recombinant human Ad5 vectored Ebola vaccine, and Covid-19 vaccines. She has got National Natural Science Outstanding Youth Founds and Jiangsu Provincial Natural Science Funds for Distinguished youths, and hosted or participated in seven National Natural Science Founds or National Science and Technology Major Projects. She has published over 25 articles in medical journals on vaccine clinical studies, including Nature Med, Lancet Respir Med, Lancet Glob Health, etc.
Xia JIN，MD, PhD is currently an executive director and Chief Executive Officer of Immuno Cure BioTech Ltd., Hong Kong. He has hold a number of academic positions previously, including Professor of Fudan University Shanghai Public Health Clinical Center, and its Director of Vaccine & Immunology Center; Distinguished Professor of the Chinese Academy of Science(CAS), and Deputy Director of Vaccine Research Center of the Institute Pasteur of Shanghai, and Deputy Director of CAS Molecular Virology & Immunology Key Lab. Before returning China, he has been a tenure-track Associate Professor of University of Rochester. His research focuses on the immune pathogenesis of human infectious diseases such as HIV and Dengue, and pre-clinical and clinical development of vaccines against these and other human pathogens. He has published in 140 papers in peer-reviewed journals such as Science，J. Exp. Med.，J. Clin. Inv.，Nat. Commn., J Virol., Vaccine etc..
Dr. Alameh is an Assistant Professor at Department of Pathology and Laboratory Medicine in the University of Pennsylvania and the Children Hospital of Philadelphia (CHOP), and the co-director of the Engineered mRNA and Targeted Nanomedicine Core at the Penn RNA Institute for RNA Innovation.
Dr. Alameh obtained his Ph.D. in Biomedical Engineering in 2017 from Polytechnique Montreal under the supervision of Dr. Michael D. Buschmann and joined the laboratory of the now Nobel laureate Dr. Drew Weissman. Dr. Alameh explored the development of a novel lipid nanoparticle (LNPs) based adjuvant platform and developed potent mRNA-based vaccines against various pathogens including Clostridium difficile.
His research program lies at the interface of nanotechnology, material science, engineering, and medicine to develop prophylactic and therapeutic nucleic acid-based delivery platforms and optimize their manufacturing. His team studies, and model Structure-Activity Relationships of material for improved delivery systems, and nucleic acid-based vaccines.
Igor Smolenov is the Chief Development Officer of Arcturus Therapeutics. Dr. Smolenov is an infectious disease physician dedicated to the clinical development of novel vaccines, with a proven record of accomplishment in both small biotechnology and large pharmaceutical companies. He contributed to the successful development and licensure of several innovative vaccines.
Before joining Arcturus, Dr. Smolenov was the Executive Vice President at Clover Pharmaceuticals, where he built a robust team able to rapidly generate pivotal clinical data leading to adjuvanted COVID-19 vaccine authorization. Prior to that, Dr Smolenov served as Therapeutic Area Head, leading the development of several seasonal influenza vaccines in Seqirus (CSL), and Head of Clinical Development in Moderna Therapeutics, leading the initiation of the first clinical trials of mRNA vaccines in humans. At Novartis Vaccines, Dr. Smolenov contributed to the development and global licensure of meningococcal vaccines (Menveo, Bexsero, and MenABCWY) and the overall commercial success of the meningococcal vaccines franchise.
Igor Smolenov graduated from Volgograd State Medical University, Russia, and holds MD, Ph.D., and Doctor of Science (Habilitation) degrees from this university. Before starting his career in the industry, he passed multiple academic steps from junior researcher to professor and head of the Allergy/immunology department of the university. He is the author of more than 50 publications in peer-reviewed journals in clinical pharmacology and vaccine development.
Dr. Raman Rao joined as the Chief Executive Officer at Hilleman Laboratories in February 2020. Dr. Rao has more than two decades of experience in research and development, manufacturing and commercialisation of vaccines for infectious diseases in global pharma and biotech companies. Prior to joining Hilleman Laboratories, Dr. Rao served as the Vice President of Global Product Operations with Takeda, Singapore, where he enhanced the global product portfolio while successfully leading an international team across Japan, Singapore and the United States. The teams worked in the areas of dengue, norovirus, zika, polio and other vaccines.
Dr. Rao started his career in 2002 with Shantha Biotechnics Limited, part of Sanofi Aventis Group in India, in Clinical Research and Scientific Affairs. He holds a MD in Medical Microbiology from the Postgraduate Institute of Medical Education and Research.
He plans to carry forward Dr. Maurice Hilleman’s legacy for providing effective solutions for global health, especially those impacting low- and middle-income countries.
Dr. Raman Rao joined as the Chief Executive Officer at Hilleman Laboratories in February 2020. Dr. Rao has more than two decades of experience in research and development, manufacturing and commercialisation of vaccines for infectious diseases in global pharma and biotech companies. Prior to joining Hilleman Laboratories, Dr. Rao served as the Vice President of Global Product Operations with Takeda, Singapore, where he enhanced the global product portfolio while successfully leading an international team across Japan, Singapore and the United States. The teams worked in the areas of dengue, norovirus, zika, polio and other vaccines.
Dr. Rao started his career in 2002 with Shantha Biotechnics Limited, part of Sanofi Aventis Group in India, in Clinical Research and Scientific Affairs. He holds a MD in Medical Microbiology from the Postgraduate Institute of Medical Education and Research.
He plans to carry forward Dr. Maurice Hilleman’s legacy for providing effective solutions for global health, especially those impacting low- and middle-income countries.
Professor Liang is dedicated to the development of large molecular drugs in the field of recombinant protein. He has been engaged in the research of drug action mechanism-related structural biology and physicochemical analysis for many years, leading the development of multiple innovative monoclonal antibody drugs and subunit vaccines. Through the transformation of achievements and cooperation with enterprises, he has promoted the approval of clinical trials or market launch by the US FDA and China NMPA.
Heinrich Haas， Department of Biopharmaceutics and Pharmaceutical Technology Johannes Gutenberg-Universität, Mainz Mainz, Germany. Ph.D. in the group of Prof. Dr. Helmuth Möhwald at Johannes-Gutenberg Universität Mainz. Researched lipid membranes and organized bio-molecular systems. In pharmaceutical industry (Munich Biotech, Medigene, BioNTech) developed different types of nanoparticle products to clinical stage. Focus on advanced approaches for nanoparticle development and control.
Dr. Hoon Sang Lee is a medical doctor and a global health expert, and currently the Chief Strategy Officer (CSO) of the RIGHT Foundation (Research Investment for Global Health Technology Foundation) and an adjunct professor at Yonsei University School of Public Health in Korea. Dr. Lee is also a member of Health Sector Advisory Committee of KOICA and a founding member of the Board for Korea Society of Global Health. Previously, he has worked as a health adviser for KOICA (Korea International Cooperation Agency) for bilateral health projects in various countries of Africa and Asia. Prior to KOICA, Dr. Lee worked as a medical officer at Korea CDC, managing national hepatitis B and measles immunization programme, and was involved in North Korea health programme for immunization support. Dr. Lee studied Economics and Public Policy at University of Chicago, received MD and PhD from Yonsei University School of Medicine and received MPH from Johns Hopkins School of Public Health.
Dr. Xinling Wang received her Ph.D. degree in 2021 and was then engaged in postdoctoral research at Fudan University. In October 2023, she as a Young Investigator (eq. to an Associate Professor) joined the Shanghai Institute of Major Infectious Diseases and Biosafety, Fudan University and master's supervisor. Her research focuses on the entry mechanism and prevention/treatment strategies of emerging viruses. In the past five years, she as the first or co-first author has published 18 papers in Cell Research (IF=44.1), Signal Transduction and Targeted Therapy (IF=39.1, x3), Cell Discovery (IF=33.5), Trends in immunology (IF=16.8) and other SCI journals. She as a co-inventor has participated in 4 patent applications, one of which was successfully licensed by a company. As a PI, she has obtained the Youth Fund of the National Natural Science Foundation of China, and as a project-leader in 2023 Shanghai Science and Technology Innovation Action Plan, and as a key researcher in two National Science and Technology Major Projects
Professor Xu focuses on the pathogenesis of respiratory RNA viruses (influenza, coronavirus) and the development of antiviral drugs and vaccines. More than 40 SCI papers have been published in internationally influential academic journals such as Science Translational Medicine, Cell Research, PNAS, Nature Communications, Protein & Cell, and PLoS Pathogens, cited more than 3300 times (including 5 ESI high-cited papers). The research results have been selected as a highlight or cover story by Science, Cell Research, Protein & Cell, Journal of Virology, and the China Science Foundation.
The group made a series of progress in the mechanism of respiratory virus co-infection and broad-spectrum vaccine or drug candidates, promoted one antiviral drug into multinational clinical trials, and transformed a universal vaccine to deal with antigen drift. The above research results provide candidate strategies for epidemic prevention and control.
Mr. Jian Dong has 35 years’ experience in biopharma manufacturing, quality management and facility construction.
Joining WuXi Biologics in 2014, he is CEO of WuXi Vaccines and SVP of WuXi Biologics, previously SVP and Head of Global Manufacturing and Head of Global Engineering of WuXi Biologics responsible for the management and R&D of biological drug clinical and commercial manufacturing and construction of production facilities.
Mr. Dong has led team passing China’s first FDA PLI and EMA GMP inspection and obtaining approval of WuXi Biologics DS and DP manufacturing facilities as well as the design, construction, validation and delivery of various R&D centers and manufacturing sites of WuXi Biologics worldwide.
Before WuXi Biologics, he was Deputy Chief Engineer in Shenzhen Kangtai Biological Products, Senior Process Engineer in Eli Lilly & Co., U.S., VP of Manufacturing and VP of Quality in Shanghai Celgen Biopharma, Deputy General Manager in UBPL and Shanghai United Cell Biotechnology, Unilab’s subsidiary. During his tenure in China before joining WuXi Biologics, he made significant contribution to the approval of one NDA, four BLA and four GMP licenses, including the technical transfer of MSD’s recombinant hepatitis B vaccine to China.
Haifei Zhang, PhD, DABT, Associate Professor
Senior Director, Inhalation& International Toxicology, JOINN Laboratories (Suzhou) Inc.
Committee member of Chinese Safety Pharmcology Society
Committee member of Chinese inhalational toxicology Society
PhD in Pharmacology and MS in Toxicology.
Got Diplomate of American Board of Toxicology in 2016. Set up a comprehensive platform for inhalation toxicology & safety pharmacology, in vitro and in vivo cardiovascular and respiratory pharmacology studies. Conducted toxicity, safety pharmacology and pharmacodynamic studies for over 200 IND to NMPA or FDA. Participated in key new drug research projects of the 12th national five-year plan and 13th national five-year plan and got 3 patents.
Dr. Xu Gelin, senior expert of Wuhan Institute of Biological Products (WIBP), experienced on vaccine development for nearly 40 years.
Dr. Tan is responsible for drug discovery, preclinical development, translation research and external collaboration in China. Dr. Tan got his Ph.D. in Molecular Medicine from UT Health Science Center San Antonio and received his Postdoctoral training with Dr. Michael Karin at UC San Diego. Dr. Tan worked in Pfizer and Novartis for 9 years, specialized in drug discovery and translational research, bridging preclinical research to early clinical trials. Dr. Tan worked at Biosion Biotech and Coherent Biopharma before he joined Clover. Dr. Tan was selected as Jiangsu Innovation and Entrepreneur Talent and Suzhou Innovation and Entrepreneur Leading Talent.
Beijing special expert, Beijing COVID-19 prevention and technology talent, Beijing Normal University adjunct professor, Tsinghua University doctor, Oregon State University postdoctoral. Dr. Sun Le studied under Professor G. Sato, a member of the American Academy of Sciences, scientific Advisor to President Nixon, inventor of monoclonal antibody drugs, and Professor Zhao Nanming, former Dean of the School of Life Sciences and Medicine of Tsinghua University. Formerly Director of production and scientific research at Upstate/Merck USA; Founded A&G Pharmaceuticals in the United States in 2000 and served as President. Having undertaken a number of major national and Beijing science and technology projects, Jingtiancheng, as a key enterprise in Beijing's infectious disease emergency prevention and control platform, has played an important role in the fight against rabies, hand-foot-mouth EV71, avian influenza H1N1/H7N9, new Pornia virus, Norovirus, Ebola virus and novel coronavirus. Established a huge library of infectious disease pathogens antibodies, including pneumonia 18, HPV9, meningitis 4, DPT, rabies, Bunya Virus, EV71, CA16, HBV, HCV, HEV, HIV, IPV, rubella virus, RSV, RAV,JEV mouse mab thousands of species. In this outbreak, Dr. Sun Le was supported by the Major COVID-19 Emergency Project of the Beijing Municipal Science and Technology Commission and the Gates Foundation COVID-19 Emergency Project respectively.
Doctor of Clinical Laboratory Diagnostics - Chongqing Medical University
Master of Drug Delivery - Aston University, UK
Bachelor of Clinical Medicine - Chongqing Medical University
Practicing Physician
Member of the Standardization Committee of the China Association for Vaccines
Member of the Professional Committee of the Chinna Safety Pharmacology
Vice Chairman of the Chongqing Laboratory Animal Technology Association
Dr.LIU Yan has extensive experience in the R&D of new drugs, especially in the field of pharmacokinetics and pharmacodynamics in clinical research of new drugs.
Prof. Yuelong Shu
Director, Institute of Pathogen Biology, Chinese Academy of Medical Sciences & Peking Union Medical College. He is a member of the Chinese Academy of Medical Sciences and a Fellow of the American Academy of Microbiology. He was selected as the first batch of ‘National Science and Technology Innovation Leader’and‘2014 Top Ten Scientific and Technological Innovators’, and is the winner of National Science Fund for Distinguished Young Scholars and the China Youth Science and Technology Award. He has been honored with the National Science and Technology Progress Grand Prize, First Prize, Second Prize, the National Medical and Health System Advanced Individual, the National Innovation Award, the Public Health and Preventive Medicine Development Contribution Award, etc. He is currently the Chairman of the Branch of Medical Virology of the Chinese Medical Association and the Chairman of the Asia-Pacific Alliance for the Control of Influenza (APACI). He was the founding dean of the School of Public Health of Sun Yat-sen University (Shenzhen), the editor-in-chief of the Chinese Journal of Virology, the deputy director of the Institute of Viral Diseases of the Chinese Center for Disease Control and Prevention (CDC), the director of the National Influenza Center, and the director of the WHO Collaborating Center for Reference and Research on Influenza.
Shu has long focused on influenza prevention and control research, and has made outstanding achievements in the discovery of new viruses, the development of detection reagents, and the pathogenesis of infection. Through the systematic establishment of new influenza detection and surveillance technology, it was found for the first time in the world that a variety of new avian influenza viruses such as H7N9, H5N6 and H10N8 can lead to human infection and death; The first successful development of pandemic H1N1 2019 and H7N9 avian influenza detection reagent; The origin, evolution and infection mechanism of H7N9 and other avian influenza viruses were clarified, which provided key scientific and technological support for the successful prevention and control of the epidemic in China. He has published nearly 200 papers in Science, Nature, NEJM, Lancet and other academic journals as a corresponding author. The research results were selected as one of the ‘China’s 100 most influential international academic papers in 2013’and ‘2013 Top Ten Scientific Advances in China’.
John Mo is the general manager of Shanghai SDM and has 17 years of experience in vaccine clinical trials.
l He used to be the director of Guangxi Disease Control and Vaccine Research Institute, a member of the Expert Committee for Drug Registration and Evaluation of the State Administration of Medicine, a member of the Vaccine Research and Development Expert Group of the Joint Prevention and Control Mechanism Scientific Research Team of the State Council, a member of the National Immunization Program Technical Working Group, and a member of the Chinese Preventive Medicine Association Vaccine Member of the Standing Committee of Clinical Professional Committee, former national and provincial GCP inspector.
l Participated in the compilation and discussion of relevant regulations and technical guidelines for vaccine clinical trials in many countries. As a PI, he co-chaired more than 70 vaccine clinical trials, including the world's first human diploid cell EV71 inactivated vaccine, the first domestic mRNA new crown vaccine, HPV vaccine, rotavirus vaccines, microcard vaccine, rabies vaccines, IPV, bOPV, influenza, pneumonia vaccines, and meningococcal vaccines.
l Participated in the compilation and discussion of regulations and technical guidance principles for vaccine clinical trials in multiple countries, and has been involved in special projects of major new drug creation science and technology for many times. Published nearly 30 SCI papers in international journals. He is an editorial board member for the translation of the seventh edition of vaccinology, and an editorial board member for the design and implementation of clinical trials.
Meng LI has been leading the International business team of CNBG since 2013, oversees CNBG’s international cooperation and registration activities. She also serves on the board of CNBG-Virogen, and the board of Emerging Biopharmaceuticals Manufacturers Network (EBPMN). During her 19 year experiences in biological industry, she established extensive networks with academia, NGOs, enterprises internationally, and successfully completed a number of landmark projects. Including the bOPV capacity expansion and prequalification program with BMGF (received over 23Million USD financial supports from BMGF, prequalified by WHO in 2019), establishment of CNBG’s first JV with foreign enterprise, the first overseas acquisition by CNBG, roll-out of the Covid-19 vaccine PhIII trials in 6 countries and its registration in over 100 countries. Meng Li has successfully signed a number of in-license, research cooperation, commercialization and industrialization projects with NIH, Oxford, France Institut Pasteur, PATH, IVI, biotech companies and developing country manufacturers. She worked as temporary advisor to WHO inspectorate during WHO’s first inspection to China NMPA in 2010, and was elected as the executive committee member of DCVMN from 2014-2016.
Dr. Anna Schlüter is a pharmacist by training and joined LTS in 2016 as formulation scientist for the development of transdermal therapeutic systems (TTS) and oral thin films (OTF). Since 2020 she is a lab head in the microarrays patch (MAP) team and responsible for the formulation and process development for collaboration and internal MAP projects. She is experienced in leading multifunctional teams for formulation development and scale-up projects for transdermal delivery systems.
Dr. Hu Yong, founder of Rhegen Bio, professor of Hubei Industry, Shenzhen Overseas High-level Talent, Shenzhen Nanshan District "Pilot Talent", excellent Communist Party member, former PI and PhD supervisor of Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences, is now the chairman and general manager of Shenzhen Rhegen Biotechnology.
Dr. Hu has more than 10 years of R&D experience in the mRNA field, focusing on the research and industrial transformation of mRNA-related underlying technologies, and the development of novel mRNA vaccines and drugs for emergent infectious diseases, cancer immunotherapy, and protein-deficiency disorders, etc. In the past five years, he has filed applications for mRNA vaccines and drugs. In the past five years, he has applied for more than 200 patents of mRNA-related technologies, and has been authorized 48 domestic invention patents and many PCT patents. He has presided over a number of national, provincial and municipal key projects, such as the National Biopharmaceutical Technology Innovation Center's nucleic acid drug "unveiling the list of commanding officers" technology research project (lyophilized COVID-19 mRNA vaccine research and development), the Shenzhen High-tech Zone Development Special Plan Innovation Platform Construction Project (mRNA innovative vaccine and drug pilot base), Shenzhen Key Project of Technology Tackling (Research and Development of COVID-19 mRNA Vaccine), Shenzhen Basic Discipline Layout (Research on New Generation of Highly Efficient mRNA Drug Molecular Technology). The research results have been published in Cell Discovery, Nature Protocol, Nature Communication, Circulation Research, Biomaterial and other well-known journals, Biomaterial and other well-known journals.
Dr. Hu led the team to establish the R4 platform, which is an independent and controllable technology platform for the whole chain of mRNA drug development, led the establishment and release of two mRNA industry group standards, developed the world's first lyophilized COVID-19 mRNA vaccine, which has been approved for clinical trials in many countries and regions, and the first mRNA therapeutic drug using non-LNP delivery technology has been approved for Phase I clinical trials by the Human Research Ethics Committee of Australia. In addition, the first mRNA therapeutic drug using non-LNP delivery technology has received ethical approval from the Australian Human Research Ethics Committee for Phase I clinical trials.
Xingchen Peng
M.D. Ph.D
Professor and Chief Physician, State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University.
Dr. Peng is recognized as a Young Changjiang Scholar by the Ministry of Education, a leading talent in the Sichuan Province Ten Thousand Talent Program. Dr. Peng has completed a postdoctoral fellowship in radiation oncology at Massachusetts General Hospital, Harvard Medical School. He is also a candidate for the academic and technical leadership reserve of the Sichuan Provincial Health Department.
Dr. Peng's work focuses on the integrated treatment of malignant tumors, including radiation therapy, chemotherapy, targeted therapy, and immunotherapy. He has special expertise in the treatment of nasopharyngeal carcinoma, head and neck tumors, melanoma, and soft tissue sarcoma. He is currently leading several multicenter clinical trials in head and neck tumors and has extensive clinical experience in the diagnosis and treatment of recurrent metastatic head and neck squamous cell carcinoma. In 2017, he was recognized as the most promising young oncologist by the Chinese Society of Clinical Oncology (CSCO).
Dr. Peng is also responsible for major projects funded by the National Natural Science Foundation of China and the Sichuan Provincial Department of Science and Technology. He has published more than 45 high-impact papers as first or corresponding author, and his research has been cited in guidelines in Brazil, the United States.
Dr. Hu Yong, founder of Rhegen Bio, professor of Hubei Industry, Shenzhen Overseas High-level Talent, Shenzhen Nanshan District "Pilot Talent", excellent Communist Party member, former PI and PhD supervisor of Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences, is now the chairman and general manager of Shenzhen Rhegen Biotechnology.
Dr. Hu has more than 10 years of R&D experience in the mRNA field, focusing on the research and industrial transformation of mRNA-related underlying technologies, and the development of novel mRNA vaccines and drugs for emergent infectious diseases, cancer immunotherapy, and protein-deficiency disorders, etc. In the past five years, he has filed applications for mRNA vaccines and drugs. In the past five years, he has applied for more than 200 patents of mRNA-related technologies, and has been authorized 48 domestic invention patents and many PCT patents. He has presided over a number of national, provincial and municipal key projects, such as the National Biopharmaceutical Technology Innovation Center's nucleic acid drug "unveiling the list of commanding officers" technology research project (lyophilized COVID-19 mRNA vaccine research and development), the Shenzhen High-tech Zone Development Special Plan Innovation Platform Construction Project (mRNA innovative vaccine and drug pilot base), Shenzhen Key Project of Technology Tackling (Research and Development of COVID-19 mRNA Vaccine), Shenzhen Basic Discipline Layout (Research on New Generation of Highly Efficient mRNA Drug Molecular Technology). The research results have been published in Cell Discovery, Nature Protocol, Nature Communication, Circulation Research, Biomaterial and other well-known journals, Biomaterial and other well-known journals.
Dr. Hu led the team to establish the R4 platform, which is an independent and controllable technology platform for the whole chain of mRNA drug development, led the establishment and release of two mRNA industry group standards, developed the world's first lyophilized COVID-19 mRNA vaccine, which has been approved for clinical trials in many countries and regions, and the first mRNA therapeutic drug using non-LNP delivery technology has been approved for Phase I clinical trials by the Human Research Ethics Committee of Australia. In addition, the first mRNA therapeutic drug using non-LNP delivery technology has received ethical approval from the Australian Human Research Ethics Committee for Phase I clinical trials.
Naked DNA plasmids, when i.m. or i.d. administered without assistance, are relatively poor in transfection efficiency and consequently show low
level of immunogenicity. A possible solution to this problem is microneedle array patch (MAP) delivery which utilizes microscopic projection
arrays on a plaster to deliver a vaccine on the skin. We will report our recent progress in developing MAP-based DNA vaccines that can effectively
induce protective immunity against SARS-COV-2 variants. MAP technology may open a new avenue for novel vaccine development
Ø Explore the latest advancements in vaccine technologies, such as mRNA vaccines and viral vector platforms.
Ø Discuss the potential impact of these innovations on global vaccine development and deployment.
Ø Address challenges related to safety, efficacy, and public perception of these cutting-edge vaccine modalities.
Advances in technology: reverse vaccinology 2.0, structural vaccinology, mRNA and more
Remaining gaps: mucosal immunity, understanding the immunome, pandemic preparedness
Based on the bovine rotavirus UK Compton strain, we developed a human-bovine reassortant hexavalent rotavirus vaccine (HRV) containing G1, G2, G3, G4, G8 and G9 serotypes to cover most serotypes of rotavirus in the world. The phase I and phase II clinical studies showed that HRV was well-tolerated in all adults, toddlers and infants, and was highly immunogenic in infants. The phase III clinical study showed vaccine efficacy(VE) against rotavirus gastroenteritis (RVGE), severe RVGE, and hospitalization caused by rotavirus serotypes contained in HRV were 69.21% (95%CI: 53.31–79.69), 91.36% (95%CI: 78.45–96.53), and 89.21% (95%CI: 64.51–96.72). VE against RVGE, severe RVGE, and hospitalization caused by any type of rotavirus were 62.88% (95%CI: 49.11–72.92), 85.51%.
· mRNA technology advances focusing on access and sustainability
· overview and progress of the mRNA technology development and transfer programme
· product pipeline for mRNA vaccines addressing neglected diseases
· interpandemic sustainability of mRNA vaccine production expansions
Microneedle Array Patches (MAPs) contain micron-sized projections that mechanically disrupt the outermost skin barrier (stratum corneum), in a minimally invasive manner, for delivery of APIs (vaccine or drug) to the underlying skin. As part of the Center of Excellence for Microneedle Array Patch (MAP) technology, PATH has partnered with Cardiff University to Chair a group that aims to provide independent scientific opinions and recommendations that help define the regulatory pathway for this emerging dosage form, and thus expedite clinical translation of the technology. This MAP Regulatory Working Group (MAP-RWG) includes representatives from both the commercial and academic sectors, vaccine development experts and representatives from national regulatory authorities, international pharmacopoeia and the WHO pre-qualification of medicines programme.
MAP-RWG activities focus on key contemporary regulatory issues for MAPs that have been identified in consultation with stakeholders. Four parallel work streams have emerged and these aim to: (i) define the MAP dosage form; (ii) identify and categorise the MAP critical quality attributes (CQAs); (iii) develop standardised validated test methods to evaluate these CQAs and the quality of finished MAP products and/or the development of pre-clinical prototypes; and (iv) inform the microbiological requirements for MAP products (https://doi.org/10.1016/j.jconrel.2023.07.001). This talk will provide a general overview of progress against these workstreams and highlight the future directions for the MAP-RWG. More details about this endeavour can be found on the website: www.microneedleregulatory.org.
Quantoom Biosciences, a Belgian biotech company, and a subsidiary of the Univercells Group, has developed an innovative system named NtensifyTM for mRNA manufacturing. NtensifyTM leverages an optimized mRNA production process executed by a fully automated equipment, resulting in industry-leading yields and recovery rates. The system enables a significant reduction of the CoGs for the development and commercial manufacturing of mRNA-based therapeutics. In this presentation, I will introduce the NtensifyTM machine, and explain how it can be empowered to develop novel mRNA vaccines for global health. I will present data on the development of an mRNA rabies vaccine using this technology.
The groundbreaking success of mRNA vaccines is undeniably significant, yet their inherent challenges, such as thermo-instability and susceptibility to biological degradation, pose formidable obstacles. Herein, we present a ROMA (rapid onsite microfluidic assembly) platform to fundamentally address these problems.
Distinguished by its organic solvent-free working process, the ROMA platform revolutionizes traditional mRNA manufacturing by obviating the need for dialysis, purification, sterile filtration, and large-scale filling processes. It enables the rapid assembly of pre-made mRNA and blank lipid nanoparticles (LNPs) into injectable mRNA vaccines within mere minutes at the point of care. Noteworthy is the fact that the entire ROMA system, along with its raw materials, remains viable at ambient temperatures, requiring minimal user intervention.
The versatility of the ROMA platform extends across different LNP formulations and various nucleic acids, encompassing mRNA, circular RNA, saRNA, and plasmid DNA, spanning lengths from 1,000 nt to 13,000 nt. Crucially, the ROMA vaccine achieves in-vivo mRNA expression levels comparable to conventional methods. Positioned as a paradigm shift, ROMA emerges as an adaptable solution applicable across diverse scenarios, from fundamental research to bedside vaccination. Its advantages not only pave the way for efficient and accessible vaccine production but also underscore its potential to reshape the landscape of mRNA-based therapies.
The RNA platform technology has emerged as one of the most promising and strategic technologies for rapid global vaccination, infectious disease control, biotherapeutics development, and preparedness for future healthcare challenges. Since this is a platform technology, the manufacturing infrastructure, the product and process analytical technologies, the product-process interactions, and learnings can be re-used or transferred from existing products to new products. To reach the full potential of this disease agnostic RNA platform, we are developing a set of synergistic technologies consisting of physical production processes (enzymatic RNA synthesis, downstream purification, and lipid nanoparticle formulation), analytical technologies, computer models and software. These technologies are co-developed under a patient-centric Quality by Digital Design (QbDD) framework. In this QbDD framework, first-principle or data-driven relationships are established between the critical process parameters (CPPs) of the production process and the critical quality attributes (CQAs) of the RNA vaccine and therapeutic product. The obtained models can be used for defining the design space and for advanced automation using model-predictive control. By combining the QbDD framework with the RNA platform, vaccines and therapeutics can be developed and mass-produced faster against a wide range of diseases. However, the regulatory approval of the digital tools used for process and product quality control is required in order to accelerate the development and manufacturing of RNA products. A form of production process template “pre-qualification” or “pre-approval” could expedite development and regulatory approval by re-using and computationally processing disease agnostic-prior knowledge, based on the platform nature of both the RNA vaccine manufacturing process and of the QbDD framework.
Mosquito-borne viruses, such as Dengue, Chikungunya, and Zika viruses, pose significant global health threats. Dengue, the most prevalent mosquito-transmitted viral disease, affects 50 to 100 million individuals annually, leading to over 25,000 deaths. Over the past decade, Chikungunya and Zika viruses have undergone substantial geographic expansion, causing multiple outbreaks worldwide. With climate change, increased global travel, and other factors expanding the range of disease-carrying mosquitoes, the risk of further outbreaks by these and other viruses remains high. Consequently, there is an urgent need to develop effective strategies for combating these pathogens, focusing on preventive and therapeutic interventions, including vaccines and passive immunotherapies. Addressing these risks is crucial to safeguard global health.
Recent advancements in the field of systems biology have led to significant progress in the development of nucleic acid-based vaccines and monoclonal antibodies (mAbs) for the prevention and treatment of viral infections. This talk highlights the successful generation of these vaccines and mAbs, emphasizing their effectiveness in conferring protection against viral diseases. Specifically, the rapid protection offered by mAbs prophylaxis is discussed, along with compelling evidence demonstrating that the co-administration of nucleic acid-based mAbs and vaccines can provide both immediate and long-lasting immunity against infections. These findings have profound implications, particularly for populations with varying immune statuses, and hold great promise for resource-limited settings where traditional antibody therapies are economically unfeasible. This study underscores the potential of a systems biology approach in addressing global viral challenges and improving healthcare outcomes.
This presentation highlights the utility of synthetic nucleic acid technology in the rapid development of immune therapeutics against infectious diseases.
Therapeutic cancer vaccines are promising next-generation treatments for cancers with tumor-associated or tumor-specific antigens. However, the cancer vaccine development encounters some major obstacles, such as the complication of intratumoral immune suppressive mechanism and the failure of generating sufficient self-antigen-specific cellular immune responses, et al. Virogin has developed a mRNA-and-oncolytic virus (OV)-based immune therapy that effectively induces tumor regression.
In our mRNA therapeutic vaccine, an antigen presenting cells (APC)-targeting cancer antigen (HPV E6/7) was expressed and delivered through a mRNA-LNP platform. The vaccine elicited a robust peripheral CD8+ T-cell immune response and effectively prevented antigen-related cancer development in mouse. The antigen-specific T cells and other immune cells proficiently infiltrated into solid tumors leading to tumor regression. However, as the tumor progresses, intratumoral immune suppression intensifies, which is one of the major obstacles of cancer vaccines. This suppression restricted the infiltration of vaccine-induced immune cells and inactivated cytotoxic T cells in the tumor microenvironment (TME), limiting the therapeutic outcome, even when peripheral CD8+T cell immunity remained high. To address this challenge, we harnessed an OV therapy in combination with the mRNA vaccine as a prime-boost strategy. The OV intratumoral infection alters the TME through increasing cytotoxic T cells infiltration and polarizing neutrophils to antitumoral linages. As a results, the OV intratumoral boost following the intramuscular mRNA vaccination showed superior therapeutic efficiency in treating advanced solid tumors.
Overall, Virogin's mRNA&OV prime-boost therapy offers a compelling solution for both preventing and treating cancers that are induced by HPV infection. The strategy proves highly effective in overcoming the intratumoral immune suppression. These dual approaches, each harnessing unique strengths, collectively underpin our comprehensive strategy in the battle against cancer with identified tumor antigens.
Coronavirus disease pandemic has fostered major advances in vaccination technologies; however, there are urgent needs of mucosal immune responses and single-dose, non-invasive administration. We develop a SARS-CoV-2 vaccine for single-dose, dry-powder aerosol inhalation that induces potent systemic and mucosal immune responses. Our vaccine encapsulates proteinaceous cholera toxin B subunit-assembled nanoparticles displaying the SARS-CoV-2 RBD antigen (R-CNP) within microcapsules of optimal aerodynamic size, and such unique nano-micro coupled structure supports efficient alveoli delivery, sustained R-CNP release, and antigen presenting cell uptake, which are favourable for invocation of immune responses. Moreover, our vaccine successfully induces robust serological IgG and secretory IgA production, collectively conferring effective protection from SARS-CoV-2 challenge (including pseudovirus and the authentic virus) in mice, hamsters, and non-human primates. Finally, we also demonstrate a “mosaic iteration” of our vaccine that co-displays ancestral and Omicron’s antigens, thus extending the breadth of antibody response against co-circulating strains and transmission of Omicron variant. These findings support our inhalable vaccine as a promising candidate to prevent SARS-CoV-2 infection, disease, and transmission.
Respiratory diseases including low air track infections became leading causes of death globally. With EUA of SCB-2019, Clover successfully grew into a full-fledged biopharma. Clover is aiming at building a pipeline including vaccines against influenza, SARS-COV2, RSV and other pathogens causing respiratory diseases utilizing established Trimer-Tag platform. RSV is the major virus which causes infections in the low air track. It has been a long journey to develop RSV vaccines before Abrysvo and Arexvy were successfully commercialized in US and Europe in 2023. Both vaccines contain PreF trimer antigens. Clover is also developing a bivalent RSV protein subunit vaccine with a different strategy to stabilize RSV PreF. The vaccine candidate is currently in phase I clinical development.
1) Current status of titer evaluation methods for human vaccines
2) Development and application of polysaccharide turbidimetric monoclonal antibody
3) Research and development of IPV, HPV and rabies stable specific neutralizing active MAB and construction of in vitro titer ELISA methodology
SARS-CoV-2 Omicron subvariant XBB with an unprecedented high rate of mutations, high resistance to neutralizing antibodies (nAbs), and high transmissibility have swept the world during the past year, resulting in low effectiveness of the first-generation COVID-19 vaccines to prevent viral infection and transmission, thus calling for the development of pan-HCoV vaccines to combat SARS-CoV-2 variants and the emerging and reemerging HCoV in the future. We have used the following non-changeable against changeable strategies to develop pan-sarbecovirus and pan-HCoV vaccines containing the relatively conserved neutralizing epitopes in the receptor-binding domain (RBD) in S1 subunit, heptad repeat 1 (HR1), C-terminal helix (CH) and stem helix (SH) domains in S2 subunit of spike (S) protein of the original SARS-CoV-2 strain plus a novel adjuvant CF501. We found that CF501/RBD-Fc-based pan-sarbecovirus vaccine could elicit highly potent and long-lasting cross-nAb and T cell responses against SARS-CoV-2 and its variants, including Omicron and its subvariants (e.g., XBB), as well as SARS-CoV and bat SARS-related coronaviruses (SARSr-CoVs), while the CF501/HR1LS-based pan-β-CoV vaccine was able to induce potent cross-nAb and T cell responses against SARS-CoV-2, SARS-CoV, bat SARSr-CoVs, MERS-CoV, HCoV-OC43, HCoV-229E, and HCoV-NL63 in the immunized animals. These results suggest that both pan-sarbecovirus vaccine and pan-HCoV vaccine can be further developed to combat the current COVID-19 pandemic and future outbreaks of HCoV infectious diseases.
Bullet Point:
➢ It is essential to develop broad-spectrum vaccines to combat the RNA viruses with high rate of mutations (e.g., SARS-CoV-2);
➢ It is better to use “non-changeable against changeable” strategy (i.e, using the relatively conserved regions containing neutralizing epitopes in surface proteins of the original virus strain) to design and develop broad-spectrum (e.g., pan-HCoV) vaccines;
➢ The recombinant vaccine containing heptad repeat 1 (HR1), C-terminal helix (CH) and stem helix (SH) domains in S2 subunit of spike (S) protein of the original SARS-CoV-2 strain (HR1LS) plus a novel adjuvant CF501 could elicit potent cross-nAb and T cell responses against α- and β-HCoVs, having potential to be further developed as a pan-HCoV vaccine to combat the current COVID-19 pandemic and future outbreaks of HCoV infectious diseases.
The potential of mRNA as a new class of medicines has been well demonstrated by the successfully development of mRNA vaccines for COVID-19 pedantic. Among many applications of mRNA for unmet medical needs, vaccine products currently dominate mRNA development pipelines. Using Respiratory Syncytial Virus mRNA vaccine development as a case study, the presentation illustrates how structure-based vaccine design could ensure precise vaccine targeting capabilities. The study provides insight into the importance of optimized protein molecules leading to enhanced stability, improved delivery, and ultimately, more potent immune responses.
1. Atomic level structural information allows engineering of viral fusion proteins as potent vaccine immunogens
2. Protein immunogens optimized for genetic delivery enables superior mRNA vaccine efficacy
3. The strategy may be applied to type I viral fusion proteins and other protein immunogens facilitating the development of mRNA therapeutics
More than ten kinds of tumors are associated with the infection of Epstein-Barr virus (EBV). For EBV-driven tumors, vaccines using EBNA1, LMP1, and LMP2 as antigens were found to induce anti-tumor immunity. Here,we developed novel mRNA nano-vaccines (EBV-mRNA/LNPs) against EBV-positive tumors. The EBV-mRNA/LNPs contained the innovative immune-enhancer (IE) introduced into the mRNA sequence encoding antigens and the ionizable lipid with new structure. Thus, the better safety and enhanced anti-tumor immunogenicity were observed in the investigator-initiated clinial trials (IIT) against nasopharyngeal carcinoma and NK/T lymphoma.
· Further development of RNA-based pharmaceuticals requires advanced technologies for assembly and control.
· Here, strategies for control of nanoparticles comprising RNA and other active ingredients are presented.
· A method for quantitative determination of size-dependent quality attributes of the nanoparticles is proposed
Using innovative technology platforms, Hilleman Laboratories provides end-to-end product development solutionsirom concept to cGMP and Phase ll clinical development for affordable, high-value vaccines and biologics. lts latesticapability in GiP manufacturing of vaccines and biologics is able to pivot to manufacture vaccines for emergencyuse during pandemics. This is enabled through its modular, nimble and clever design which allows the facility toremain platfiorm-agnostic and product-independent. Leveraging various manufacturing platfomms for productinnovation, Hilleman Labs is committed to strengthening innovation in vaccine research and development for globahealth impact.
The outbreak of monkeypox virus infection urgently needs effective vaccines. However, the vaccines approved so far are all based on live viruses, which raises safety concerns. mRNA vaccines have demonstrated their high efficacy and safety against SARS-CoV-2 infection. Here, we developed three mRNA vaccines encoding monkeypox proteins M1R and A35R, including A35R-M1R fusions with a signal peptide leading the A35R extracellular domain (VGPox 1 and VGPox 2) and a mixture of encapsulated full-length mRNAs for A35R and M1R (VGPox 3). All three vaccines induced anti-A35R total Immunoglobulin G (IgG) as early as day 7 following a single vaccination. However, only VGPox 1 and 2 produced anti-M1R IgG at early dates following vaccination, while VGPox 3 did not show significant anti-M1R antibodies until day 35. Similar results were also found for neutralizing antibodies and the T cell immune response. However, all mRNA vaccine groups post 2 dose vaccination completely protected mice from a lethal dose virus challenge and effectively cleared virus in lungs. Furthermore, VGPox 1 and 2 demonstrated superior anti-viral immunity compared to a sublethal VACV-WR virus at an earlier time point post vaccination. Collectively, our results indicate that the novel mRNA vaccines encoding the fusion protein of A35R and M1R—to allow extracellular presentation of both antigens—enhanced immunogenicity. A single dose of VGPox 1 and VGPox 2 can provide sterilizing protection against the lethal viral challenge even within 7 days post vaccination. They can therefore be an alternat
To combat COVID-19, all old vaccine platforms have been utilized, and some new vaccine platforms have been developed. Here, we report the development of a novel DC-targeting DNA vaccine platform and its application to constructing human vaccines. Our preliminary clinical trial data indicate that these vaccines are safe and immunogenic, and thus such DNA vaccines warrants further exploration and testing for a broader spectrum of diseases .
Abstract/Bullet Point
Human antibody response to SARS-CoV-2 has become increasingly complex as new variants continue to emerge and spread across the world, resulting in multiple waves of breakthrough infections with distinct antibody potency and breadth. During the outbreak of Omicron subvariant BF.7 across the major cities in China in late 2022 after extended lockdown, we have identified two individuals with exceptional plasma neutralization to a diverse panel of sarbecoviruses including major SARS-CoV-2 variants, SARS-CoV-1, and ACE-2-using bat and pangolin coronaviruses. From the two individuals, we have isolated a total of 963 monoclonal antibodies (mAbs) and some of which demonstrated exceptionally broad and potent neutralizing activity to SARS-CoV-1, all SARS-CoV-2 variants tested including the most recent Omicron subvariant HK3, HV.1, JD.1.1 and JN.1, as well as ACE-2-using bat and pangolin coronaviruses, resembling that of corresponding plasma samples. Crystal and cryo-EM structural analysis revealed some unique features of antibody epitope and recognition. While the exact underlying mechanism for inducing such broad neutralizing antibodies remains unknown, it is at least partially attributed to the repeated exposure of SARS-CoV-2 antigens through both intramuscular and intranasal routes. Discovery and in-depth analysis of these broad and potent mAbs serves as the first and important step to inform the development of next-generation antibody therapeutics and vaccine against diverse human and animal coronaviruses.
In vaccine development, broadly or cross-type neutralizing antibodies (bnAbs or cnAbs) are frequently targeted to enhance protection. Utilizing immunodominant antibodies could help fine-tune vaccine immunogenicity and augment the precision of immunization strategies. However, the methodologies to capitalize on the attributes of bnAbs in vaccine design have not been clearly elucidated. In this study, we discovered a cross-type neutralizing monoclonal antibody, 13H5, against human papillomavirus 6 (HPV6) and HPV11. This nAb exhibited a marked preference for HPV6, demonstrating superior binding activity to virus-like particles (VLPs) and significantly higher prevalence in anti-HPV6 human serum as compared to HPV11 antiserum (90% vs. 31%). Through co-crystal structural analysis of the HPV6 L1 pentamer:13H5 complex, we delineated the epitope as spanning four segments of amino acids (Phe42-Ala47, Gly172-Asp173, Glu255-Val275, and Val337-Tyr351) on the L1 surface loops. Further interaction analysis and site-directed mutagenesis revealed that the Ser341 residue in the HPV6 HI loop plays a critical role in the interaction between 13H5 and L1. Substituting Ser341 with alanine, which is the residue type present in HPV11 L1, almost completely abolished binding activity to 13H5. By swapping amino acids in the HPV11 HI loop with corresponding residues in HPV6 L1 (Ser341, Thr338, and Thr339), we engineered chimeric HPV11-6HI VLPs. Remarkably, the chimeric HPV11-6HI VLPs shifted the high immunodominance of 13H5 from HPV6 to the engineered VLPs and yielded comparable neutralization titers for both HPV6 and HPV11 in mice and non-human primates. This approach paves the way for the design of broadly protective vaccines from antibodies within the main immunization reservoir.
Using innovative technology platforms, Hilleman Laboratories provides end-to-end product development solutionsirom concept to cGMP and Phase ll clinical development for affordable, high-value vaccines and biologics. lts latesticapability in GiP manufacturing of vaccines and biologics is able to pivot to manufacture vaccines for emergencyuse during pandemics. This is enabled through its modular, nimble and clever design which allows the facility toremain platfiorm-agnostic and product-independent. Leveraging various manufacturing platfomms for productinnovation, Hilleman Labs is committed to strengthening innovation in vaccine research and development for globahealth impact.
mRNA vaccination for SARS-CoV-2 results in polyclonal antibody responses that differ in antigen-specific breadth compared to viral infection, but it is still unclear to what extent vaccine- and infection-induced B cell responses differ at a B cell clonal level. We used a highly multiplexed panel of DNA-tagged antigens including full SARS-CoV-2 Spike, S1, S2, receptor binding domain (RBD), and nucleoprotein (N), as well as RBDs from up to 21 viral variants to simultaneously label and sort over 5,000 antigen-binding B cells from peripheral blood of 17 mRNA vaccinees, 28 infected patients and the spleen and lymph nodes from the mediastinum and mesentery of 22 deceased organ donors. Integrated analysis of single-cell tranome, BCR heavy and light chain sequences identified an activated B cell phenotype found almost exclusively in infected patients, and a highly enriched antigen-binding memory B cell subset with evidence of recent germinal centre exposure. mRNA vaccination stimulates a subset of BCR clonotypes preferentially, resulting in greater antigen binding breadth. Secondary lymphoid tissues show corresponding B cell phenotypes and similar antigenic variant breadth of binding in donors who had been vaccinated versus infected prior to death. Antigen-specific and convergent B cell and plasma cell clonal frequencies in the bone marrow were greater in infected compared to vaccinated individuals, particularly for RBD binders. These results systematically define human blood and lymphoid tissue responses that differ following exposure to highly similar spike antigens delivered by mRNA vaccination compared to infection. Multiplexed DNA-tagged panel analysis of specific B cells will provide a massive increase in throughput for human immunology studies in a variety of disease and therapeutic contexts.
During the Covid-19 pandemic, a mRNA research, development and production capabilities were established to develop mRNA Covid-19 vaccine and resulted in the first authorized monovalent XBB.1.5 mRNA vaccine in China. This presentation will highlight the journey of developing a safe and efficacious vaccine to prevent COVID-19 caused by newly emerged SAS-COVID-2 virus variants.
1. Safety and immunogenicity of an orally inhaled adv5 vectored COVID -19 vaccine
2. Immunogenicity of the orally inhaled adv5 vectored COVID -19 vaccine using as a booster in primed population
3. Efficacy of the orally inhaled adv5 vectored COVID -19 vaccine using as a booster
4. Environmental impact assessment for the use of the orally inhaled adv5 vectored COVID -19 vaccine in clinics
SARS-CoV-2 belongs to the coronavirus family and is a pathogen that can spread across races and easily cause respiratory diseases. The symptoms of the disease caused by the virus are mainly fever, cough and dyspnea, and imaging changes accompanied by patchy diffuse infiltration of the lungs. The symptoms of the disease caused by the virus are mainly fever, cough and dyspnea, and imaging changes accompanied by patchy diffuse infiltration of the lungs. Genome sequencing analysis indicated that the virus is different from any known virus. WHO named the virus severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and the disease caused by the virus was named COVID - 19. WHO listed the epidemic as a public health emergency of international concern. Prof. Dr. M. Raza Shah lead Phase 1 trial of Sinopham vaccine in Pakistan and also remained country PI of phase-3 clinical trial of mRNA based vaccine. He will be talking about both trial in the conference and will be sharing his experiencing and some results.
The RIGHT Foundation is a research funding agency dedicated to supporting global health research and development (R&D), established with of goal of providing a platform to catalyse collaborations between Korean and international researchers and partners to develop essential health technologies as global public goods. The presenstation will discuss about how RIGHT Foundation provides overview of how RIGHT Foundation support the R&D on vaccine to improve global health equity in the area of vaccine
The presentation will address the mode of action of polymeric vaccine adjuvants, focusing on how the physicochemical properties of the particle/polymer regulate innate and adaptive immune responses. There will be a focus on recent work showing roles for canonical and noncanonical inflammasomes and nucleic acid sensors in adjuvanticity.
The development of safe and effective vaccines is a key requirement to conquering pandemic and other infectious disease threats as well as potentially offering treatments for chronic diseases such as cancer and Alzheimer’s disease. After a surge of innovation approximately 50 years ago with introduction of the first recombinant protein and polysaccharide conjugates vaccines and adjuvants based on squalene oil emulsions and saponins, the field became relatively quiet in respect of innovations. All that changed with the COVID-19 pandemic which arguably has seen the greatest number of new vaccine technology innovations introduced all in just a few years, including approval of mRNA, DNA and adenoviral vector delivery approaches, new combination adjuvants, and use of structural modelling approaches using artificial intelligence and nanotechnology-based analytical techniques to design more stable vaccine antigens. The COVID-19 pandemic has emphasized the importance of ongoing innovation in the vaccine field. This current wave of innovation is spilling over into other vaccine programs, including new and improved vaccines against HIV, tuberculosis and malaria, plus treatments for allergy, cancer and Alzheimer’s disease. This talk will highlight these transformative innovations, particularly relating to Vaxine’s Advax-CpG adjuvant and how this is transforming the future for protein-based vaccines.
We generated a replication-incompetent recombinant adenovirus type 5, Ad5-S-Omicron and evaluated in an IIT to test intranasal vaccination in people who had inactivated vaccines. The vaccine is safe and well-tolerated without any SAEs. All participants who completed 2 doses remained no infection between Dec.2022 to April 2023. Nasal mucosal lining fluids collected after intranasal booster contained secretary IgA (sIgA) that can bind to at least 10 spike proteins of Omicron subvariants and pre-Omicron strains. Instillation of nasal lavage fluids into mouse nostril conferred protection against Omicron challenge. We found that nasal sIgA is over 100-fold more potent than serum IgG in neutralizing Omicron subvariant XBB. Intranasal booster using Ad5-S-Omicron can establish an effective immunity wall against infection of Omicron subvariants. We also developed a rapid and convenient assay to detect nasal sIgA for predicting the risk of infection.
Respiratory mucosa is the first barrier to prevent the invasion of various respiratory viruses. On the other hand, respiratory mucosa becomes a main portal for the invasion and infection of respiratory viruses. Fortifying the frontier of respiratory tract with enhanced mucosal immune defense is critical for prevention against respiratory virus invasion, infection and transmission. Intranasal (i.n.) immunization can induce local mucosal IgA antibody and T cell responses besides comprehensive systemic immune response. Flagellin, as a TLR5 agonist, is an established mucosal adjuvant for enhancing mucosal IgA responses by i.n. immunization. Nasal epithelial cells (NECs) are the first sentinel cells to be exposed to antigen and play an important role in the mucosal adjuvant activity of flagellin. We found that the flagellin-activated NECs functionally modulate airway DCs and convey the regulation for enhancement of IgA production. Based on the TLR5 activity of flagellin, we constructed a series of recombinant flagellin for development of mucosal adjuvants. A subunit mucosal vaccine targeting the phosphoprotein (P) of RSV was developed by integrating the target immunogen into flagellin frame for inducing mucosal immune responses against virus infection by i.n. immunization. We also designed a multi-valent chimeric triple-RBD immunogen 3R-NC, which can elicits broad-spectrum immune responses and potent mucosal immune responses, especially the mucosal IgA antibody responses in the upper-respiratory tract by i.n. immunization. The immune responses confer protection against viral infection in the upper and lower respiratory tracts, indicting potential for prevention against infection and transmission of SARS-CoV-2.
Mucosal drug delivery has gained significant attention due to its advantages over traditional injection, e.g., convenience and avoidance of blood-borne diseases. During mucosal administration, a key factor that must be considered is the mucus barrier. Various surface modification strategies, including PEG and zwitterionic polymer, have been explored for mucus-penetrating carriers. However, the microenvironment of mucus varies under different physiological or pathological conditions, and the influence of surface properties of nanoparticles on their mucus penetration in various microenvironments remains unclear. In our study, we have prepared a comprehensive library of amine-, carboxyl-, and PEG-modified nanoparticles with controlled surface ligand densities. We demonstrated that surface properties are critical factors in determining their mucus penetration, which is affected by the mucus pH microenvironments, the type of surface modification, and the ligand density of NPs. PEG- and amine-modified particles exhibited pH-independent immobilization under iso-density conditions, while carboxyl-modified particles exhibited enhanced movement only in weakly alkaline mucus. Biophysical analysis indicated that the penetration behavior was mediated by the NP-mucin interaction, including electrostatic interaction and hydrogen bond. Based on these mechanistic insights, we have engineered mucosal vaccine delivery nanoparticles. In a respiratory syncytial virus (RSV) vaccine model, these particles have been shown to enhance both humoral and cellular immune responses, leading to the production of antigen-specific IgA in mucosal compartments and IgG in the serum. Our study reveals the underlying mechanisms of mucus penetration and provides valuable insights for the rational design of prophylactic and therapeutic mucosal vaccines.
mRNA vaccines are a new class of vaccines that have been used in the COVID-19 pandemic. In the post-COVID-19 era, mRNA will show great potential in various preventive and therapeutic vaccines. The efficient delivery technology of mRNA is the core technology and lipid nanoparticle obtained great success in COVID-19. However, the present technology is far from ideal. It suffers from low protein expression and non-specific expression in the liver, leading to the safety risk of vaccination. In this talk, I will present a powerful strategy to modulate ionizable lipids for LNP application by multi-component reaction. A large IL toolbox was established simply and efficiently, allowing us to identify the top-performing ILs in delivering mRNA. We established a novel delivery platform for mRNA application with high expression and organ selectivity as well as high safety.
Despite progress in HIV diagnosis rates, linkage to care and treatment, and the increasing availability of chemoprophylaxis, an estimated 1·5 million new HIV infections occurred in 2021 worldwide. Therefore, the development of a safe and effective HIV vaccine remains an important objective toward ending the HIV epidemic. I will provide an update on the global effort of HIV vaccine development and more specifically the results of HVTN 124, a phase 1, placebo-controlled safety and immunogenicity trial evaluating a vaccine consisting of polyvalent, multi-subtype, DNA plasmids with matching adjuvanted gp120 proteins (polyvalent DNA-protein HIV vaccine, PDPHV). In addition to the excellent safety profile, PDPHV demonstrated excellent immunogenicity outcomes including a combination of both magnitude and breadth. These immune responses compared very favorably to those observed in contemporaneous early-phase vaccine candidate studies and were of magnitudes that exceeded those associated with vaccine protection in efficacy trials. Further evaluation of this combination in larger trials with more robust statistical methods is warranted.
Introduction
Human noroviruses are the primary viral pathogens causing acute gastroenteriis worldwidc, lcading to a considerable economic burdenWhile the development of a norovirus vaccine has been regarded as significant, any vaccine has not been licensed yet. An effecive norovirusvaccine development has been dificul due to the wide genetic and antigenic diversity of noroviruses and the co-circulalion of multiple variants ofvarious genotypes. In the context of this diversity, effective vaccine must elicit broad protective immunity
Results
We confirmed high-eficient soluble expression of the recombinant VP1 proteins in E. col and the improvements in purity andhomogeneity of the norovirus VP1-based VPs assembled in viro. The trivalent norovirus VP vaccine candidates showed excellent immuneresponses with 2-dose administralions in the animal studies and the vaccine candidate-induced antibodies showed the ability to block the bindingof norovirus VLPs and HBGA. Furthermore, GLP-based toxicology and pharmacology data sets confrmed that VLP vaccine candidates did notinduce any unexpected toxicity or pharmacological outcomes associated with CNS, respiratory or cardiology aspects
Conclusion
The results demonstrate that E. col-derived norovirus VLPs enable mass and rapid production of norovirus vaccines. Moreover, in vitroassembly of purified VP1 proteins faclitated production of high quality VLP vaccine candidates with high homogeneity and low impurities, whichmight result in increased efficacy and reduced side effects. The results in preclinical studies suggest that the E. col-derived trivalent VlP has apotential as a norovirus vaccine candidate with high efficacy and safety. Thus, this study supports that the E.col-derived & self-assemblednorovirus VLPs are worthy to proceed into clinical study for further development as a vaccine candidate.
Without an effective vaccine, AIDS remains an infectious disease that has a huge impact on global public health. An important feature of HIV is the high level of genetic diversity which results in up to 30% difference in the amino acid sequences of the envelope glycoprotein among HIV-1 subtypes. Importantly, the viral evolution within infected individuals is faster than the development of potent neutralizing antibodies in the same infected individuals. These observations pose a huge challenge to the development of effective AIDS vaccines. Since the viruses among different HIV-1-infected individuals are highly divergent, a vaccine that cannot elicit broadly reactive immune responses will not be able to control infections by diverse HIV-1 variants. Therefore, developing an AIDS vaccine that can induce broadly neutralizing antibodies (bnAbs) is a key objective that needs to be achieved urgently. Our previous results showed the requirement of several years for bnAbs to mature, the key role of genetic variation of HIV-1 in bnAb production, and the importance to efficiently trigger proper unmutated common ancestors of bnAbs. Our recent studies indicate that the neutralizing strength and breadth of vaccine-induced antibody responses can be improved by the modification of envelope glycoprotein trimers to increase their stability, the sequential immunization mimicking natural infection, and the nanoparticle vaccine technology. Therefore, an in-depth understanding of the evolutionary pathways of HIV-1 and further optimization of immunization regimens can accelerate the development of effective AIDS vaccines.
SARS-CoV-2 continues to accumulate mutations to evade immunity, leading to breakthrough infections after vaccination. How researchers can anticipate the evolutionary trajectory of the virus in advance in the design of next-generation vaccines requires investigation. Here, we performed a comprehensive study of 11,650,487 SARS-CoV-2 sequences, which revealed that the SARS-CoV-2 spike (S) protein evolved not randomly but into directional paths of either high infectivity plus low immune resistance or low infectivity plus high immune resistance. The viral infectivity and immune resistance of variants are generally incompatible, except for limited variants such as Beta and Kappa. The Omicron variant has the highest immune resistance but showed high infectivity in only one of the tested cell lines. To provide cross-clade immunity against variants that undergo diverse evolutionary pathways, we designed a new pan-vaccine antigen (Span). Span was designed by analysing the homology of 2675 SARS-CoV-2 S protein sequences from the NCBI database before the Delta variant emerged. The refined Span protein harbors high-frequency residues at given positions that reflect cross-clade generality in sequence evolution. Compared with a prototype wild-type (Swt) vaccine, which, when administered to mice, induced serum with decreased neutralization activity against emerging variants, Span vaccination of mice elicited broad immunity to a wide range of variants, including those that emerged after our design. Moreover, vaccinating mice with a heterologous Span booster conferred complete protection against lethal infection with the Omicron variant. Our results highlight the importance and feasibility of a universal vaccine to fight against SARS-CoV-2 antigenic drift.
To support efforts to develop vaccines to combat emerging viral zoonoses, we are developing a Nipah virus (NiV) vaccine for use in pigs, which would reduce the risk that NiV poses to the Asian pig industry, livestock keepers and public health. Pig-to-human transmission was responsible for the first and most severe NiV outbreak. This outbreak caused severe and lasting economic costs to the Malaysian pig industry. Despite the threat NiV poses to some of the most pig dense regions of the world, no vaccines are currently available. We have therefore evaluated the immunogenicity of recombinant NiV glycoprotein (G or F) based vaccine candidates delivered as protein subunits or by viral or mRNA vectors in pigs. Three vaccine candidates have been evaluated for efficacy and shown to confer a high degree of protection following a prime-boost regimen. In addition to providing a platform for the development of a NiV vaccine for pigs, we hope these studies will also benefit ongoing human vaccine development efforts. Two scenarios are envisaged for how a NiV vaccine for pigs could be deployed: (1) as part of a government vaccine bank and used in an outbreak situation; consequently, a vaccine that provides a rapid onset of immunity after a single immunisation would be preferable, and (2) incorporated into routine vaccination programmes to reduce the risk of NiV outbreaks occurring; a dual purpose/bivalent vaccine would make this a more financially viable approach. We are evaluating an approach to address the requirements for both scenarios i.e., a single dose NiV vaccine that could also be used as a bivalent vaccine. We hypothesised that a single immunisation with live attenuated pseudorabies virus (PrV) expressing both NiV G and F will induce protective responses. Live attenuated PrV strains are highly efficacious vaccines that can be recombined to encode heterologous antigens from other pathogens, thus making live attenuated PrV an ideal candidate for a multivalent vaccine vector. Since PrV vaccination is widely practiced across the NiV-endemic region, there is the potential that a PrV vaccine expressing NiV glycoproteins could be routinely used to establish NiV immunity in Asian pigs. We engineered the attenuated PrV Bartha strain to express NiV G and F. Immunisation of pigs with this recombinant PrV induced neutralising antibody titres following the booster immunisation comparable to previously tested vaccine candidates. PrV-specific responses were comparable to those elicited by wild type PrV Bartha immunisation. Further studies are now required to determine the efficacy against both NiV and PrV.
In this lecture，taking foot-and-mouth disease as an example, speaker will propose the thinking of quality control of virus-like particle vaccine by introducing the necessity and significance of the research and development of foot-and-mouth disease virus-like particles. With the advantages of nanobodies, the specific nanobodies for virus-like particles were screened, and the site recognition characteristics were used to establish an immunological method for the quantification of virus-like particles, which achieved the objective, accurate and rapid goal of the quality control of FMD new vaccines. At the same time, the neutralization characteristics of specific nanobodies were used to further track the neutralization mechanism and specific neutralization sites, providing a theoretical and preliminary basis for the use of nanobodies as a new prevention and control product.
Three chimeric subunit vaccines was developed using reverse vaccinology (RV) technique by Reber. The recombinant proteins chosen for the three vaccines contains multi-epitopes from the porcine reproductive and respiratory syndrome virus (PRRSV), Mycoplasma hyorhinis and Mycoplasma hyopneumoniae. PRRSV-negative piglets vaccinated with PRRSQ subunit vaccines demonstrated significantly lower (P < 0.05) mean rectal temperatures, respiratory scores, lung lesions and PRRSV nucleic acid level within interstitial pneumonia, as well as reduced type 1, type 2 PRRSV and HP-PRRSV viremia compared to unvaccinated pigs after challenge. Vaccination with PRRSQ also induced PRRSV-specific INF-g cellular immunity and complement neutralizing antibody in pigs. Vaccination with chimeric subunit vaccines of Mycoplasma hyorhinis and Mycoplasma hyopneumoniae also significantly reduce porcine arthritis polyserositis, and pneumonia. The data presented supports the claims that the commercialized novel sub-unit vaccines are effective tools in the control of heterologous PRRS viruses and mycoplasma. This chimeric fusion platform has also proven to be effective in controlling and eliminating respiratory pathogens of immunosupressive diseases in advanced mammals such as porcine and human.
The qBac® baculovirus/insect cell protein expression system has been engineered with gene knockouts that impact protein yield, incorporates siRNA to inhibit host cell apoptosis, and features fine-tuned expression levels of tranion factors. This has resulted in a suite of robust and distinctive protein expression solutions centered around the baculovirus expression vector, significantly enhancing the expression of exogenous proteins to 1-5 g/L.
In the vaccine industry (particularly subunit vaccines), we leverage the systemic advantages of the qBac® Bacmid to support a comprehensive five-in-one technology platform, which includes gene-engineered subunit vaccines, peptide/epitope vaccines, gene-deleted vaccines, nucleic acid vaccines, and live vector vaccines. This platform underpins our strategic deployment in animal vaccine product lines, including livestock, poultry, aquaculture, and pet vaccines.
Dr. Raman Rao joined as the Chief Executive Officer at Hilleman Laboratories in February 2020. Dr. Rao has more than two decades of experience in research and development, manufacturing and commercialisation of vaccines for infectious diseases in global pharma and biotech companies. Prior to joining Hilleman Laboratories, Dr. Rao served as the Vice President of Global Product Operations with Takeda, Singapore, where he enhanced the global product portfolio while successfully leading an international team across Japan, Singapore and the United States. The teams worked in the areas of dengue, norovirus, zika, polio and other vaccines.
Dr. Rao started his career in 2002 with Shantha Biotechnics Limited, part of Sanofi Aventis Group in India, in Clinical Research and Scientific Affairs. He holds a MD in Medical Microbiology from the Postgraduate Institute of Medical Education and Research.
He plans to carry forward Dr. Maurice Hilleman’s legacy for providing effective solutions for global health, especially those impacting low- and middle-income countries.
Mr. Jian Dong has 35 years’ experience in biopharma manufacturing, quality management and facility construction.
Joining WuXi Biologics in 2014, he is CEO of WuXi Vaccines and SVP of WuXi Biologics, previously SVP and Head of Global Manufacturing and Head of Global Engineering of WuXi Biologics responsible for the management and R&D of biological drug clinical and commercial manufacturing and construction of production facilities.
Mr. Dong has led team passing China’s first FDA PLI and EMA GMP inspection and obtaining approval of WuXi Biologics DS and DP manufacturing facilities as well as the design, construction, validation and delivery of various R&D centers and manufacturing sites of WuXi Biologics worldwide.
Before WuXi Biologics, he was Deputy Chief Engineer in Shenzhen Kangtai Biological Products, Senior Process Engineer in Eli Lilly & Co., U.S., VP of Manufacturing and VP of Quality in Shanghai Celgen Biopharma, Deputy General Manager in UBPL and Shanghai United Cell Biotechnology, Unilab’s subsidiary. During his tenure in China before joining WuXi Biologics, he made significant contribution to the approval of one NDA, four BLA and four GMP licenses, including the technical transfer of MSD’s recombinant hepatitis B vaccine to China.
Meng LI has been leading the International business team of CNBG since 2013, oversees CNBG’s international cooperation and registration activities. She also serves on the board of CNBG-Virogen, and the board of Emerging Biopharmaceuticals Manufacturers Network (EBPMN). During her 19 year experiences in biological industry, she established extensive networks with academia, NGOs, enterprises internationally, and successfully completed a number of landmark projects. Including the bOPV capacity expansion and prequalification program with BMGF (received over 23Million USD financial supports from BMGF, prequalified by WHO in 2019), establishment of CNBG’s first JV with foreign enterprise, the first overseas acquisition by CNBG, roll-out of the Covid-19 vaccine PhIII trials in 6 countries and its registration in over 100 countries. Meng Li has successfully signed a number of in-license, research cooperation, commercialization and industrialization projects with NIH, Oxford, France Institut Pasteur, PATH, IVI, biotech companies and developing country manufacturers. She worked as temporary advisor to WHO inspectorate during WHO’s first inspection to China NMPA in 2010, and was elected as the executive committee member of DCVMN from 2014-2016.
Michel De Wilde holds a PhD in Biochemistry and has a long and successful career in Vaccine Research and Development. He currently consults for the vaccine community and is member of several Scientific Advisory Boards
From 2001 till June 2013, Michel De Wilde was Senior Vice President, Research & Development, at sanofi pasteur where he drove the development and licensure of a number of products.
From 1978 till 2000, De Wilde was at SmithKline Beecham Biologicals (now GSK Vaccines) where he held positions of increasing responsibility. He played a key role in the development of several new vaccines, most notably the recombinant Hepatitis B vaccine, as well as GSK’s Malaria vaccine.
Dr. Xu Gelin, senior expert of Wuhan Institute of Biological Products (WIBP), experienced on vaccine development for nearly 40 years.
Dr. Anna Schlüter is a pharmacist by training and joined LTS in 2016 as formulation scientist for the development of transdermal therapeutic systems (TTS) and oral thin films (OTF). Since 2020 she is a lab head in the microarrays patch (MAP) team and responsible for the formulation and process development for collaboration and internal MAP projects. She is experienced in leading multifunctional teams for formulation development and scale-up projects for transdermal delivery systems.
Dr. David Weiner directs a translational research laboratory at The Wistar Institute in the area of Molecular Immunology. His group is one of the pioneering research teams in establishing the field of DNA vaccines and immunotherapies. Important reports from his lab include the first DNA vaccine studied for HIV as well as for cancer immunotherapy, the early development of DNA encoded genetic adjuvants including the particularly relevant IL-12, advances in gene optimization, and advances in electroporation (EP) technologies resulting in improved gene delivery among others. His group worked with collaborators to become the first to move DNA technology into human study. His laboratory’s work helped revitalize the field through advancement of new synthetic DNA design and modification of EP delivery approaches resulting in potent immune induction as well as the first successful Phase IIb DNA efficacy study (for HPV immunotherapy) in humans. Dr. Weiner is the recipient of numerous honors including election as a fellow to both the American Association for the Advancement of Science in 2011 and the International Society for Vaccines in 2012. He is the recipient of the NIH Director’s Transformative Research Award and received the Vaccine Industry Excellence Award for Best Academic Research Team in 2015 at the World Vaccine Congress. Weiner was honored with the prestigious Hilleman Lectureship in 2015 at the Children’s Hospital of Philadelphia Grand Rounds session and received a Stone Family Award from Abramson Cancer Center for his groundbreaking work on DNA vaccines for cancer immunotherapy. In 2019, Dr. Weiner was honored with the Scientific Achievement Award from Life Sciences PA (LSPA). Dr. Weiner returned to Wistar in 2016 from his position at The University of Pennsylvania School of Medicine as professor of Pathology and Laboratory Medicine. From 1990 to 1993, Weiner held a joint position as assistant professor of Pathology and Laboratory Medicine at The Wistar Institute and the University of Pennsylvania School of Medicine. Dr. Weiner is a co-founder of Inovio Pharmaceuticals and is a member of the Board of Directors. Dr. Weiner graduated with a B.S. in biology from SUNY at Stony Brook, N.Y., a M.S. in biology from the University of Cincinnati and a Ph.D. in developmental biology from the University of Cincinnati College of Medicine.
Igor Smolenov is the Chief Development Officer of Arcturus Therapeutics. Dr. Smolenov is an infectious disease physician dedicated to the clinical development of novel vaccines, with a proven record of accomplishment in both small biotechnology and large pharmaceutical companies. He contributed to the successful development and licensure of several innovative vaccines.
Before joining Arcturus, Dr. Smolenov was the Executive Vice President at Clover Pharmaceuticals, where he built a robust team able to rapidly generate pivotal clinical data leading to adjuvanted COVID-19 vaccine authorization. Prior to that, Dr Smolenov served as Therapeutic Area Head, leading the development of several seasonal influenza vaccines in Seqirus (CSL), and Head of Clinical Development in Moderna Therapeutics, leading the initiation of the first clinical trials of mRNA vaccines in humans. At Novartis Vaccines, Dr. Smolenov contributed to the development and global licensure of meningococcal vaccines (Menveo, Bexsero, and MenABCWY) and the overall commercial success of the meningococcal vaccines franchise.
Igor Smolenov graduated from Volgograd State Medical University, Russia, and holds MD, Ph.D., and Doctor of Science (Habilitation) degrees from this university. Before starting his career in the industry, he passed multiple academic steps from junior researcher to professor and head of the Allergy/immunology department of the university. He is the author of more than 50 publications in peer-reviewed journals in clinical pharmacology and vaccine development.
Haifei Zhang, PhD, DABT, Associate Professor
Senior Director, Inhalation& International Toxicology, JOINN Laboratories (Suzhou) Inc.
Committee member of Chinese Safety Pharmcology Society
Committee member of Chinese inhalational toxicology Society
PhD in Pharmacology and MS in Toxicology.
Got Diplomate of American Board of Toxicology in 2016. Set up a comprehensive platform for inhalation toxicology & safety pharmacology, in vitro and in vivo cardiovascular and respiratory pharmacology studies. Conducted toxicity, safety pharmacology and pharmacodynamic studies for over 200 IND to NMPA or FDA. Participated in key new drug research projects of the 12th national five-year plan and 13th national five-year plan and got 3 patents.
Dr. Tan is responsible for drug discovery, preclinical development, translation research and external collaboration in China. Dr. Tan got his Ph.D. in Molecular Medicine from UT Health Science Center San Antonio and received his Postdoctoral training with Dr. Michael Karin at UC San Diego. Dr. Tan worked in Pfizer and Novartis for 9 years, specialized in drug discovery and translational research, bridging preclinical research to early clinical trials. Dr. Tan worked at Biosion Biotech and Coherent Biopharma before he joined Clover. Dr. Tan was selected as Jiangsu Innovation and Entrepreneur Talent and Suzhou Innovation and Entrepreneur Leading Talent.
Beijing special expert, Beijing COVID-19 prevention and technology talent, Beijing Normal University adjunct professor, Tsinghua University doctor, Oregon State University postdoctoral. Dr. Sun Le studied under Professor G. Sato, a member of the American Academy of Sciences, scientific Advisor to President Nixon, inventor of monoclonal antibody drugs, and Professor Zhao Nanming, former Dean of the School of Life Sciences and Medicine of Tsinghua University. Formerly Director of production and scientific research at Upstate/Merck USA; Founded A&G Pharmaceuticals in the United States in 2000 and served as President. Having undertaken a number of major national and Beijing science and technology projects, Jingtiancheng, as a key enterprise in Beijing's infectious disease emergency prevention and control platform, has played an important role in the fight against rabies, hand-foot-mouth EV71, avian influenza H1N1/H7N9, new Pornia virus, Norovirus, Ebola virus and novel coronavirus. Established a huge library of infectious disease pathogens antibodies, including pneumonia 18, HPV9, meningitis 4, DPT, rabies, Bunya Virus, EV71, CA16, HBV, HCV, HEV, HIV, IPV, rubella virus, RSV, RAV,JEV mouse mab thousands of species. In this outbreak, Dr. Sun Le was supported by the Major COVID-19 Emergency Project of the Beijing Municipal Science and Technology Commission and the Gates Foundation COVID-19 Emergency Project respectively.
Dr. Xinling Wang received her Ph.D. degree in 2021 and was then engaged in postdoctoral research at Fudan University. In October 2023, she as a Young Investigator (eq. to an Associate Professor) joined the Shanghai Institute of Major Infectious Diseases and Biosafety, Fudan University and master's supervisor. Her research focuses on the entry mechanism and prevention/treatment strategies of emerging viruses. In the past five years, she as the first or co-first author has published 18 papers in Cell Research (IF=44.1), Signal Transduction and Targeted Therapy (IF=39.1, x3), Cell Discovery (IF=33.5), Trends in immunology (IF=16.8) and other SCI journals. She as a co-inventor has participated in 4 patent applications, one of which was successfully licensed by a company. As a PI, she has obtained the Youth Fund of the National Natural Science Foundation of China, and as a project-leader in 2023 Shanghai Science and Technology Innovation Action Plan, and as a key researcher in two National Science and Technology Major Projects
Dr. Tao Zhu, Ph.D. the University of Pittsburgh
Co-founder and Chief Scientific Officer of CanSino Biologics Inc.
Dr. Zhu is a member of the 14th National Committee of the Chinese People's Political Consultative Conference (CPPCC) and the “Healthy China Construction” professional committee of the Chinese Peasants and Workers Democratic Party.
Dr. Zhu focuses on the research and development of biological products. He established multiple core technology platforms, including viral vector, polysaccharide protein conjugate vaccine, VLP recombinant vaccine and mRNA vaccine technology at CanSino. Multiple projects led by him have been selected as national “Major Science and Technology Projects for New Drug Creation” and “Major Science and Technology Projects for Infectious Diseases”.
Dr. Zhu has led the team to develop a series of vaccine products, of which 6 vaccine products have been registered and marketed, another 7 vaccine products are in different stages of clinical studies. He co-developed the adenovirus vector-based Ebola virus vaccine (2018), the Recombinant COVID-19 Vaccine (Convidecia, 2021), the Recombinant COVID-19 Vaccine for Inhalation(Convidecia Air, 2022), and the Recombinant COVID-19 XBB Vaccine for Inhalation(2023), with the team of Academician Chen Wei of the Institute of Bioengineering, Academy of Military Medical Sciences, all of which have been marketed. Especially, Convidecia Air is the first developed inhalation vaccine product in the global. Menhycia, which was approved in 2021, is currently the only quadrivalent meningococcal conjugate vaccine on the market in China. Dr. Zhu also holds over 50 patents and 70 publications, including 15 papers from The Lancet publishers.
Heinrich Haas， Department of Biopharmaceutics and Pharmaceutical Technology Johannes Gutenberg-Universität, Mainz Mainz, Germany. Ph.D. in the group of Prof. Dr. Helmuth Möhwald at Johannes-Gutenberg Universität Mainz. Researched lipid membranes and organized bio-molecular systems. In pharmaceutical industry (Munich Biotech, Medigene, BioNTech) developed different types of nanoparticle products to clinical stage. Focus on advanced approaches for nanoparticle development and control.
July 2022 - current : AstriVax
CEO and Co-founder
July 2021 – July 2022: KU Leuven
Entrepreneur in Residence
June 2018 – August 2022: Oxurion
Head Regulatory Affairs
Business Development
Chief Operating Officer
March 2009 – May 2018: GSK Vaccines
Regulatory Affairs
Vaccine Development Leader
Sept 2008 – Feb 2009 – Gevers Patents
Trainee patent attorney
About
Diverse experience in the life science industry exhibiting a unique capability to merge operational execution and strategic development - implementation. Global industry experience in large pharmaceutical industry as well as into smaller biotech environment. Strong experience in development of commercial, late or early stage vaccines, monoclonal antibodies, peptides and small molecules. Regulatory affairs, drug and vaccine development expertise blended with business and corporate development. Proven track record to build up and lead diverse teams. Innovative mindset, with demonstrated ability to think beyond commonly accepted boundaries, understanding well different personalities and able to perform complex and challenging tasks and capable to distil the essence from the noise.
Biography :
n Senior Scientist, Brain Research Centre, University of British Columbia (UBC), Canada (09.1994-07.2019)
n Associate Professor of Neurosurgery, UBC (tenured) (09.1994-07.2019)
n Chief Scientific Officer, Co-founder of Virogin Biotech Ltd (05.2015- present)
n Chief Scientific Officer, CNBG-Virogin Biotech Ltd (2019- present)
Dr. Jia obtained his PhD in neurobiology from University of British Columbia (1991), MSc. Psychology (1987) from Dalhousie University in Canada, and BSc. Biology from Fudan University (1982) in China. In 2015, Dr.Jia co-founded Virogin Biotech, an oncolytic virotherapy company in Canada. He is currently the chief scientific officer of Virogin and CNBG-Virogin to develop oncolytic viruses and novel vaccines.
Xia JIN，MD, PhD is currently an executive director and Chief Executive Officer of Immuno Cure BioTech Ltd., Hong Kong. He has hold a number of academic positions previously, including Professor of Fudan University Shanghai Public Health Clinical Center, and its Director of Vaccine & Immunology Center; Distinguished Professor of the Chinese Academy of Science(CAS), and Deputy Director of Vaccine Research Center of the Institute Pasteur of Shanghai, and Deputy Director of CAS Molecular Virology & Immunology Key Lab. Before returning China, he has been a tenure-track Associate Professor of University of Rochester. His research focuses on the immune pathogenesis of human infectious diseases such as HIV and Dengue, and pre-clinical and clinical development of vaccines against these and other human pathogens. He has published in 140 papers in peer-reviewed journals such as Science，J. Exp. Med.，J. Clin. Inv.，Nat. Commn., J Virol., Vaccine etc..
Dr. Raman Rao joined as the Chief Executive Officer at Hilleman Laboratories in February 2020. Dr. Rao has more than two decades of experience in research and development, manufacturing and commercialisation of vaccines for infectious diseases in global pharma and biotech companies. Prior to joining Hilleman Laboratories, Dr. Rao served as the Vice President of Global Product Operations with Takeda, Singapore, where he enhanced the global product portfolio while successfully leading an international team across Japan, Singapore and the United States. The teams worked in the areas of dengue, norovirus, zika, polio and other vaccines.
Dr. Rao started his career in 2002 with Shantha Biotechnics Limited, part of Sanofi Aventis Group in India, in Clinical Research and Scientific Affairs. He holds a MD in Medical Microbiology from the Postgraduate Institute of Medical Education and Research.
He plans to carry forward Dr. Maurice Hilleman’s legacy for providing effective solutions for global health, especially those impacting low- and middle-income countries.
Dr. Xu Rong has over 20 years of experience in innovative vaccine research and development and in leading vaccine R&D teams within multinational corporations. She particularly excels in preclinical vaccine research and evaluation, the development and validation of immunological methodologies, and the CMC development of vaccine products.
Before joining Delonix, Dr. Xu held the position of Senior Vice President of Preclinical Vaccine R&D at Clover Biopharmaceuticals. Prior to that, she served as the Vice President of R&D at the Sabin Vaccine Institute in the United States, where she led the CMC development, clinical immunology assay development and validation, and non-clinical safety and efficacy studies of vaccines. Additionally, she has held several key vaccine R&D and team management roles at Profectus Biosciences, Pfizer (Wyeth), and the Seattle Biomedical Research Institute.
In 2016, Dr. Xu was honored with the Distinguished Female Scientist Award by the Westchester Association in New York, recognizing her outstanding contributions to vaccine research and development. Dr. Xu holds a Bachelor degree in Medicine from Peking University and a Ph.D. in Immunology from the Weizmann Institute of Science in Israel.
Prof. Yuelong Shu
Director, Institute of Pathogen Biology, Chinese Academy of Medical Sciences & Peking Union Medical College. He is a member of the Chinese Academy of Medical Sciences and a Fellow of the American Academy of Microbiology. He was selected as the first batch of ‘National Science and Technology Innovation Leader’and‘2014 Top Ten Scientific and Technological Innovators’, and is the winner of National Science Fund for Distinguished Young Scholars and the China Youth Science and Technology Award. He has been honored with the National Science and Technology Progress Grand Prize, First Prize, Second Prize, the National Medical and Health System Advanced Individual, the National Innovation Award, the Public Health and Preventive Medicine Development Contribution Award, etc. He is currently the Chairman of the Branch of Medical Virology of the Chinese Medical Association and the Chairman of the Asia-Pacific Alliance for the Control of Influenza (APACI). He was the founding dean of the School of Public Health of Sun Yat-sen University (Shenzhen), the editor-in-chief of the Chinese Journal of Virology, the deputy director of the Institute of Viral Diseases of the Chinese Center for Disease Control and Prevention (CDC), the director of the National Influenza Center, and the director of the WHO Collaborating Center for Reference and Research on Influenza.
Shu has long focused on influenza prevention and control research, and has made outstanding achievements in the discovery of new viruses, the development of detection reagents, and the pathogenesis of infection. Through the systematic establishment of new influenza detection and surveillance technology, it was found for the first time in the world that a variety of new avian influenza viruses such as H7N9, H5N6 and H10N8 can lead to human infection and death; The first successful development of pandemic H1N1 2019 and H7N9 avian influenza detection reagent; The origin, evolution and infection mechanism of H7N9 and other avian influenza viruses were clarified, which provided key scientific and technological support for the successful prevention and control of the epidemic in China. He has published nearly 200 papers in Science, Nature, NEJM, Lancet and other academic journals as a corresponding author. The research results were selected as one of the ‘China’s 100 most influential international academic papers in 2013’and ‘2013 Top Ten Scientific Advances in China’.
Dr. Siber is an infectious disease trained physician with more than 40 years of experience in developing vaccines and antibody products. From 1996 to 2007, Dr. Siber served as Executive Vice President and Chief Scientific Officer of Wyeth Vaccines (now Pfizer) where he led the development and approval of multiple innovative childhood vaccines, including Prevenar 7 and 13, the first pneumococcal conjugate vaccines, Rotashield, the first rotavirus diarrhea vaccine, Meningitec, the first meningococcal meningitis conjugate vaccine and FluMist, the first nasal influenza vaccine. Prior to Wyeth, Dr. Siber was Harvard Medical School Associate Professor of Medicine at Dana Farber Cancer Institute and Director of the Massachusetts Public Health Biologic Laboratories where he developed multiple vaccines and immune globulins, including Respigam, the first antibody licensed for respiratory syncytial virus. Dr. Siber most recently was a Co-founder and Board Member of Affinivax which developed a 24 valent pneumococcal vaccine and was acquired by GSK in 2022. Dr. Siber currently serves on the Scientific Advisory Boards of AdVaccine, CanSino, Clover, Everest Medicines, ILiAD, Valneva, Vaxart and Vaxxinity and has been a consultant to the NIH, EU, WHO and the Gates Foundation. Dr.Siber was member of the Board of Trustees of the International Vaccine Institute. Dr Siber has received multiple awards including the 2016 Albert Sabin Gold Medal in vaccinology. Dr. Siber holds an MD degree from McGill University in Canada, received post‑doctoral training in Internal Medicine at Rush‑Presbyterian Hospital in Chicago and Beth Israel Hospital in Boston and training in Infectious Diseases and Vaccinology at Boston Children’s Hospital and Beth Israel Hospital, Harvard Medical School.
Professor Liang is dedicated to the development of large molecular drugs in the field of recombinant protein. He has been engaged in the research of drug action mechanism-related structural biology and physicochemical analysis for many years, leading the development of multiple innovative monoclonal antibody drugs and subunit vaccines. Through the transformation of achievements and cooperation with enterprises, he has promoted the approval of clinical trials or market launch by the US FDA and China NMPA.
John Mo is the general manager of Shanghai SDM and has 17 years of experience in vaccine clinical trials.
l He used to be the director of Guangxi Disease Control and Vaccine Research Institute, a member of the Expert Committee for Drug Registration and Evaluation of the State Administration of Medicine, a member of the Vaccine Research and Development Expert Group of the Joint Prevention and Control Mechanism Scientific Research Team of the State Council, a member of the National Immunization Program Technical Working Group, and a member of the Chinese Preventive Medicine Association Vaccine Member of the Standing Committee of Clinical Professional Committee, former national and provincial GCP inspector.
l Participated in the compilation and discussion of relevant regulations and technical guidelines for vaccine clinical trials in many countries. As a PI, he co-chaired more than 70 vaccine clinical trials, including the world's first human diploid cell EV71 inactivated vaccine, the first domestic mRNA new crown vaccine, HPV vaccine, rotavirus vaccines, microcard vaccine, rabies vaccines, IPV, bOPV, influenza, pneumonia vaccines, and meningococcal vaccines.
l Participated in the compilation and discussion of regulations and technical guidance principles for vaccine clinical trials in multiple countries, and has been involved in special projects of major new drug creation science and technology for many times. Published nearly 30 SCI papers in international journals. He is an editorial board member for the translation of the seventh edition of vaccinology, and an editorial board member for the design and implementation of clinical trials.
Doctor of Clinical Laboratory Diagnostics - Chongqing Medical University
Master of Drug Delivery - Aston University, UK
Bachelor of Clinical Medicine - Chongqing Medical University
Practicing Physician
Member of the Standardization Committee of the China Association for Vaccines
Member of the Professional Committee of the Chinna Safety Pharmacology
Vice Chairman of the Chongqing Laboratory Animal Technology Association
Dr.LIU Yan has extensive experience in the R&D of new drugs, especially in the field of pharmacokinetics and pharmacodynamics in clinical research of new drugs.
Jingxin Li, PhD, Professor, is working at Jiangsu Provincial Center for Disease Control and Prevention. Her research is focused on vaccine clinical evaluation and immunization strategy. She has participated in a lot of epidemiology investigations and a series of clinical trials of novel vaccines, including Enterovirus type 71 vaccine, recombinant human Ad5 vectored Ebola vaccine, and Covid-19 vaccines. She has got National Natural Science Outstanding Youth Founds and Jiangsu Provincial Natural Science Funds for Distinguished youths, and hosted or participated in seven National Natural Science Founds or National Science and Technology Major Projects. She has published over 25 articles in medical journals on vaccine clinical studies, including Nature Med, Lancet Respir Med, Lancet Glob Health, etc.
Dr. Hoon Sang Lee is a medical doctor and a global health expert, and currently the Chief Strategy Officer (CSO) of the RIGHT Foundation (Research Investment for Global Health Technology Foundation) and an adjunct professor at Yonsei University School of Public Health in Korea. Dr. Lee is also a member of Health Sector Advisory Committee of KOICA and a founding member of the Board for Korea Society of Global Health. Previously, he has worked as a health adviser for KOICA (Korea International Cooperation Agency) for bilateral health projects in various countries of Africa and Asia. Prior to KOICA, Dr. Lee worked as a medical officer at Korea CDC, managing national hepatitis B and measles immunization programme, and was involved in North Korea health programme for immunization support. Dr. Lee studied Economics and Public Policy at University of Chicago, received MD and PhD from Yonsei University School of Medicine and received MPH from Johns Hopkins School of Public Health.
Dr. Chen has been a Professor at the State Key Lab of Respiratory Disease, Guangzhou Medical University since 2013. Dr. Chen received a medical degree from Shanghai Medical College in 1984. He obtained a Ph.D. in Biochemistry and Molecular Biology from Indiana University School of Medicine. Dr. Chen completed his postdoctoral training at Dana-Farber Cancer Institute, Harvard Medical School. From 1997-2001, Dr. Chen served as a Senior Research Fellow at Merck Research Laboratories, where he was the first inventor of Merck's Ad5-based AIDS vaccine that entered clinical trials worldwide. Dr. Chen served as Vice President of R&D for GlaxoSmithKline in 2009-2011 and as Vice President at Sanofi Pasteur in 2012. Dr. Chen has over 200 publications in infectious diseases, vaccine research, and cancer research. His current research is focused on vaccine and antibody research on adenovirus, influenza virus, and emerging viruses. Since 2020, Dr. Chen has been working on developing user-friendly intranasal vaccines and mucosal immunity.
Dr. Yan graduated and earned his B.S. and Ph.D at Wuhan University. He continued to work as a teaching staff member in College of Life Sciences, Wuhan University until 1998. From 1998 to 2002, he worked with Prof. Michael E. Lamm as a Research Associate in Department of Pathology, School of Medicine, Case Western Reserve University, Cleveland, Ohio and conducted scientific research on mucosal immune functions of IgA in relation to virus infections. He returned to Wuhan University in autumn 2002 and joined in the newly established Modern Virology Research Center, College of Life Sciences, Wuhan University as an associate professor. In 2006, he moved to the Wuhan Institute of Virology, Chinese Academy of Sciences, where he was appointed as a professor and group leader to set up an independent research lab named Mucosal Immunity Research Group. His lab is a group member of the State Key Laboratory of Virology in China. He has continued his research on the mucosal IgA functions against virus infections and focused more on the intra-epithelial activities of IgA against viral non-surface and non-structure components, which helps to reveal novel anti-viral mechanisms of IgA antibodies. His lab demonstrated that measles virus (MV) non-surface protein such as matrix protein (M), non-structural protein such as phosphoprotein (P) specific IgA can interact with viral newly synthesized proteins during IgA transport through the viral infected epithelial cells, and inhibit viral replication intracellularly. He also extended his study in developing optimized recombinant flagellin as mucosal adjuvant for designing novel subunit mucosal vaccines. He obtains 3 patents issued by the United States Patent and Trademark Office and 4 patents issued by the State Intellectual Property Office of the PRC related to novel flagellin adjuvants as well as anti-caries vaccine and anti-RSV vaccine. His research is mostly funded by National Natural Science Foundation of China, the Ministry of Science and Technology of China.
Professor Xu focuses on the pathogenesis of respiratory RNA viruses (influenza, coronavirus) and the development of antiviral drugs and vaccines. More than 40 SCI papers have been published in internationally influential academic journals such as Science Translational Medicine, Cell Research, PNAS, Nature Communications, Protein & Cell, and PLoS Pathogens, cited more than 3300 times (including 5 ESI high-cited papers). The research results have been selected as a highlight or cover story by Science, Cell Research, Protein & Cell, Journal of Virology, and the China Science Foundation.
The group made a series of progress in the mechanism of respiratory virus co-infection and broad-spectrum vaccine or drug candidates, promoted one antiviral drug into multinational clinical trials, and transformed a universal vaccine to deal with antigen drift. The above research results provide candidate strategies for epidemic prevention and control.
Dr. Raman Rao joined as the Chief Executive Officer at Hilleman Laboratories in February 2020. Dr. Rao has more than two decades of experience in research and development, manufacturing and commercialisation of vaccines for infectious diseases in global pharma and biotech companies. Prior to joining Hilleman Laboratories, Dr. Rao served as the Vice President of Global Product Operations with Takeda, Singapore, where he enhanced the global product portfolio while successfully leading an international team across Japan, Singapore and the United States. The teams worked in the areas of dengue, norovirus, zika, polio and other vaccines.
Dr. Rao started his career in 2002 with Shantha Biotechnics Limited, part of Sanofi Aventis Group in India, in Clinical Research and Scientific Affairs. He holds a MD in Medical Microbiology from the Postgraduate Institute of Medical Education and Research.
He plans to carry forward Dr. Maurice Hilleman’s legacy for providing effective solutions for global health, especially those impacting low- and middle-income countries.
Dr. Frank Chia-Jung Chang obtains his Ph.D. from Life Science and Institute of Genome Science department of Taiwan Yang-Ming Medical University in 2012. He received his postdoctoral training at Molecular Biology Institute of Academia Sinica (Taiwan) and worked as visiting scholar in Frances H. Arnold’s laboratory (Nobel Prize in Chemistry winner in 2018), Chemical Engineering Department of Caltech (U.S.). He joined Reber Genetics as the supervisor of R&D Division in 2014. From 2017, Frank also works for business development and strategic layout of vaccine products (technology included).
Dr. Chang has considerable expertise in virology, microbiology, reverse vaccinology and protein engineering for industrial production. His group has successfully developed novel subunit vaccines of swine PRRSV, pan-PCV, Mycoplasma, CSFV and PEDV in Reber Genetics, furthermore, also support the study of safe vector vaccine against ASF with external partners.
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