Frank F. Weichold, MD, PhD

Frank F. Weichold, MD, PhD

Frank F. Weichold, MD, PhD

Director, Critical Path and Regulatory Science Initiatives, US Food and Drug Administration

Dr. Weichold is director for the Office of Critical Path and Regulatory Science Initiatives in the office of the Chief Scientist and the Office of the Commissioner for the Food and Drug Administration. He also chairs the FDA Senior Science Council and he represents FDA at the Maryland Life Science Advisory Board. The expertise he brings to the regulatory agency builds on his ability to advance, coordinate, and integrate scientific resources for FDA by addressing mission critical scientific regulatory challenges in a global environment. The FDA Centers of Excellence in Regulatory Science and Innovation (CERSI) network is being built under Dr. Weichold’s leadership in collaboration with academic institutions to leverage scientific expertise, resources and capacity toward FDA’s mission. He is leading strategic partnership arrangement and value generation at the agency, including intellectual property development and technology transfer.

Dr. Weichold’s experience includes execution of strategic and operational initiatives across the sciences’ value chain. Dr. Weichold has led the development of international collaborations and public private partnerships for discovery and early medical product development, implemented global operating and development models, and executed large-scale business model transformations. He has accumulated more than a decade of industrial research and medical product development experience while leading teams in Clinical Pharmacology, DMPK, as a Director at MedImmune LLC, and AstraZeneca. Prior, he directed research and clinical development of vaccines at the Aeras Foundation (founded by The Bill and Melinda Gates Foundation).

As a tenured Professor in the University of Maryland system, he developed and managed independent research programs and trained graduate students. He also held faculty positions at the University of Maryland Biotechnology Institute to study signal transduction pathways that affect immune responses, as well as at the Humboldt University, Berlin (Germany) to teach and study microbial immune modulation. During the five years of postdoctoral education, Dr. Weichold worked at the National Institutes of Health in Bethesda, Maryland, first at the National Cancer Institute where he researched immune pathologies in HIV infection, then at the Hematology Branch of the National Heart Lung and Blood Institute where bone marrow pathologies, transplantation immunology and gene therapy were the focus of his clinical research studies. His medical practice and clinical experience include Infectious Diseases and Immunology/Rheumatology.