Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Biologics Track
Presenter
Peter J. Weina, PhD, MD
Associate Director for Medical Countermeasures and Scientific Affairs
Office of Vaccines Research and Review (OVRR)
Center for Biologics Evaluation and Research (CBER)
US Food and Drug Administration (FDA)
Peter J. Weina, PhD, MD, FACP, FIDSA is the Associate Director for Medical Countermeasures and Scientific Affairs in the Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA). Prior to this position, Dr. Weina retired as a Colonel after 46 years with the U.S. Army where he was last assigned as the Director of the Office of Research Protections for the Defense Health Agency. Dr. Weina is a clinically active Infectious Diseases Staff at A.T. Augusta Military Medical Center and a Full Professor at the Uniformed Services University of the Health Sciences. Dr. Weina is board certified in Internal Medicine and Infectious Diseases and holds a Certificate of Knowledge in clinical tropical medicine and travelers’ health. He was Chief of Pharmacology and Director of Viral Diseases with the Army. A Fellow of the American College of Physicians, a Fellow of the Infectious Diseases Society of America, Dr. Weina has more than 75 scholarly articles in peer-reviewed journals, 2 books and 5 book chapters. Dr. Weina worked on the availability and licensure of intravenous artesunate since 1988 and continued serving until its licensure in 2020. He is a world-recognized expert in leishmaniasis and former Director of the only College of American Pathologists-accredited leishmania diagnostics laboratory.
Dr. Weina is the former Director of the WRAIR Tropical Medicine Course that educates medical personnel from around the world in tropical medicine competency. Dr. Weina’s distinguished recognitions include the Federal CDC Silo Buster’s Collaborative Award of Excellence in 2008, the Colonel George W. Hunter III Certificate in 2011, the Major Jonathan Letterman Medical Excellence Award in 2014, the USUHS Alumni Association Lifetime Achievement Award in 2015, the BEYA Modern Day Technology Leader Award in 2020, and the Federal Laboratory Consortium Excellence in Technology Transfer in 2021. Dr. Weina’s military awards include the Expert Field Medical Badge, the Order of Military Medical Merit, the Bronze Star for Service in Iraq during the first year of Operation Iraqi Freedom, the Soldier’s Medal for Heroism, the Legion of Merit Medal, and the Defense Superior Service Medal.
Abstract
This presentation explores the challenges posed by artificial intelligence (AI) in vaccine development, a field characterized by rapid evolution. The regulatory science addressing AI is similarly developing, with the FDA’s formalized approaches being relatively new, including guiding principles, an executive order, and publications released within the last year. Key principles guiding AI development and use emphasize safety, security, equity, and civil rights, highlighting concerns about inherent biases in training data and the necessity of human checks for AI outputs. The FDA aims to foster collaboration across its centers, support innovation rather than suppress it due to uncertainty, and promote harmonized standards internationally. AI is already being utilized within the agency, with growing submissions, particularly in oncology and infectious diseases, for tasks like prediction, classification, and supporting manufacturing quality. While AI is seen as a powerful tool to speed the development of biologics, challenges remain, including understanding the “black box” nature of some AI processes. The FDA strongly encourages early engagement from sponsors as partners, recognizing that the agency is also still learning how best to regulate this quickly advancing technology.