James E. Valentine, J.D., M.H.S.

James E. Valentine, J.D., M.H.S., brings nearly two decades of experience in drug development, FDA regulatory strategy, and related policy, spanning roles in government, private practice, and patient advocacy. He is a Director at Hyman, Phelps & McNamara, P.C., a leading food and drug regulatory law firm, where he advises biotechnology and pharmaceutical companies on regulatory strategy for the development and approval of new drugs and biologics. His practice focuses particularly on serious and rare diseases and complex development programs, including accelerated approval, innovative clinical trial designs, novel endpoints, and other approaches to addressing the challenges of developing therapies for small patient populations. He has helped companies successfully navigate FDA development and approval of numerous drugs and biologics across a range of therapeutic areas and modalities. He also advises biotechnology and pharmaceutical companies and investors on regulatory strategy, due diligence, and development risks in connection with financings, licensing transactions, mergers and acquisitions, and other strategic transactions.

Prior to joining Hyman, Phelps & McNamara in 2014, Mr. Valentine served at the U.S. Food and Drug Administration, where he worked on a range of drug development and regulatory policy initiatives and helped develop and launch FDA’s Patient-Focused Drug Development initiative, advancing the incorporation of patient perspectives into regulatory decision-making.

Mr. Valentine also serves as Vice Chair of the Board of the RARE Foundation, a national rare disease advocacy organization. He holds a J.D. from the University of Maryland Francis King Carey School of Law and an M.H.S. from the Johns Hopkins Bloomberg School of Public Health.