Advisors

Ralf Clemens

Ralf Clemens, MD PhD, is a long-time leader in vaccine industry and academia. He is currently serving as Advisor to the Bill & Melinda Gates Foundation and is Member/ Chair of various scientific and management boards including IVI, GHIT, CEPI as well as Curevac AG, Germany, and Valneva SE, France. Prior to this he was Head Global Vaccines Development at GSK, Novartis and Takeda Vaccines. At GSK Vaccines he was additionally in charge of developing country business strategies and technology transfers to developing country manufacturers. During his almost 30 years in vaccine industry he developed and brought to licensure over 25 different vaccines. Ralf graduated in medicine from the University of Mainz, Germany, and he holds an executive degree in Management from the Wharton Business School. Ralf has more than 180 publications and given more than 250 scientific presentations mainly on vaccines, immunization and pharmaceutical development.

William Ripley Ballou

Dr Ballou currently serves as a Senior Scientific Advisor to IAVI where he works on monoclonal antibody programs targeting HIV. He was previously Vice President and Head at GSK Global Vaccines, based in Maryland, US where he led programs developing vaccines for RSV, Dengue, and CMV. Prior to that he was Vice President and Head, Clinical Research and Translational Science, Vaccine Discovery and Development at GSK Vaccines in Rixensart, Belgium. He has also served as Deputy Director for Vaccines, Infectious Diseases Development, Global Health at the Bill and Melinda Gates Foundation and as a Vice President, Clinical Development at MedImmune where he worked on early and late-stage vaccine and monoclonal antibody programs. Dr Ballou received his MD from Emory University School of Medicine, trained in Medicine and Infectious Disease at the Walter Reed Army Medical Centre and began his research career in vaccine development at the Walter Reed Army Institute of Research where he led a team that, with GSK, co-developed a malaria vaccine that was recently recommended by the WHO for widespread use in subSaharan Africa.

Heinz-Josef (Joe) Schmitt

Joe Schmitt is an infectious disease paediatrician and Professor of infectious diseases and vaccine development. He has served a member and chair of the German vaccination advisory board (STIKO), advisor to the Paul Ehrlich Institute (PEI) and different WHO committees, including SAGE and the GACVS-groups. He also served as Global Head, Medical Affairs with Novartis Vaccines and his last industry position was Vice President for Medical-, Developmental-, Scientific- and Clinical-Affairs (MDSCA) and Global Lead Viral Vaccines at Pfizer (to 2021).

Xavier Sáez Llorens

Xavier Sáez Llorens is Professor of Pediatrics, Chief of the Infectious Disease Department, and Director of Clinical Research at the Hospital del Niño Dr. José Renán Esquivel. He is a distinguished Investigator of the National Research System (Senacyt) and of the Center for Vaccine Investigation (Cevaxin), as well as a member of the National Ethics Committee on Clinical Research in Panama City. Prof Sáez Llorens has been involved with, and led, multiple large international vaccine trials.

Clement Lewin

Clement Lewin, PhD MBA, is a Principal at CSL Vaccine Consulting with expertise in medical affairs, policy and strategy. Clem has 25 years of experience from vaccine development at Merck, Chiron, Acambis, Novartis and Sanofi Pasteur. He served as VP Strategic Planning & Business Intelligence and then VP Government Affairs & Immunization Policy for the US at Chiron. He served as Head of Government Affairs, Strategic Planning and Marketing at Acambis, helping to secure large government contracts for a small-pox vaccine. He headed Medical Affairs & Immunization Policy for North America, at Novartis Vaccines, where he was responsible for Medical Affairs activities and the CDC and National Vaccine Program Office helping launch several vaccines and manage the response to the 2009 pandemic. He served as AVP of R&D Strategy and headed the BARDA Office and NV Stakeholder Engagement for Sanofi Pasteur, securing and managing over $2 billion in BARDA funding for pandemic influenza and COVID-19 vaccines development. Clem obtained his BSc and PhD from the University of London, and an MBA with distinction from Cornell University. He served as the Biotechnology Innovation Organization liaison to the Advisory Committee on Immunization Practices from 2004 to 2014, and served on the National Vaccine Advisory Committee from 2009-2012. He has published over 50 papers in peer reviewed journals.

Jean Smal

Jean Smal is a Senior Consultant with global experience in the R&D and Manufacturing Vaccine Industry. He is currently supporting the vaccine projects of various companies and serves as a member of the WHO Advisory Panel for the Polio Eradication Program. He is chairman or independent board member of several biotech companies. He has previously served as Vice-President, Head of New Product Development at GSK Vaccines, covering development and scale-up of manufacturing processes, analytical methods, manufacturing for Phase I-III clinical trials, development strategy and organizational development. In this role, he directly contributed to the development and the launch of 12 new vaccines from 1998 to 2016, totaling over €4bn in sales in 2020. Prior to joining GSK, Jean served in roles from Project Leader to General Manager of Eurogentec, CDMO Division, a Company offering development and GMP services for biopharmaceutical products. Jean Smal holds a degree in Bio Engineering, a PhD in Biochemistry and Prost-graduate degree in Business Management. He has published over 50 peer reviewed scientific papers/communications in the biochemical field.

Michael Pfleiderer

Dr. Pfleiderer is a principal consultant at BioPharma-Excellence. He was the Head of the Human Viral Vaccines Section at the Paul-Ehrlich-Institut (PEI), German Federal Institute for Vaccines and Biomedicines. His team had a leading function as Rapporteur, Co-Rapporteur or Peer Reviewer for a significant proportion of the Marketing Authorization Applications (MAAs) for vaccines submitted to the European Medicines Agency (EMA) in London. He has served as Chair of the CHMP Vaccine Working Party (VWP) at the European Medicines Agency (EMA) in London; Member of the Biologics Working Party (BWP) of the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) in London; Chair of the BWP Influenza ad hoc Working Group which he is chairing; Member of the CHMP Coordination Group (CG); Chair and Vice chair of EMA’s Pandemic Task Force (ETF); as well as part of WHO vaccine pre-qualification teams.

Peter Patriarca

Peter A. Patriarca, MD, is the Principal of Immuno-Vax, LLC, and a senior affiliate consultant with the Biologics Consulting Group, Inc. (Alexandria, Virginia). He has provided technical and regulatory consulting services for all phases of vaccine and drug development for the past 14 years, including approximately 400 IND submissions and 12 successful Biologics License Applications (BLAs) or NDAs. Prior to consulting, Dr. Patriarca was Corporate Head and Vice President, Worldwide Regulatory Affairs and Pharmacovigilance at MedImmune, Inc. (2001-2005) and also served as Medical Officer in the U.S. Public Health Service at the Centers for Disease Control and Prevention (1980-1992) and the US Food and Drug Administration (1993-2001). At FDA, Dr. Patriarca served, among other positions, as Director of the Division of Viral Products in the Office of Vaccines Research and Review (OVRR), CBER. In that capacity, he was responsible for laboratory-based research and review activities of more than 100 scientific staff in eight laboratories and was intimately involved with regulatory decisions and policy affecting vaccine development and licensure. While at CDC, Dr. Patriarca was assigned to the National Immunization Program, where, among other positions, he served as the Chief Medical Epidemiologist in the Influenza Division and the first head of CDC’s program in support of the Global Poliomyelitis Eradication Initiative. He has authored more than 100 peer-review publications and has served on multiple scientific advisory bodies for CDC, WHO, the Bill and Melinda Gates Foundation, the American Academy of Pediatrics, the National Academy of Sciences, and numerous pharmaceutical companies.

Inca Kusters

Inca C. Kusters, Ph.D. has long experience of more than 20 years at Sanofi Pasteur. Actually, she is heading the External Research and Development Department for the European region. This Department comprises a group of scientists that evaluates the scientific value of external vaccine projects and technologies. In the past, she has led different vaccine projects as the pandemic H1N1 vaccine development in 2009 and the SARS-CoV1 vaccine development in 2003. She is a guest lecturer at different French universities (Lyon I, Paris IX, Paris XIII).