The United States Pharmacopeial Convention (USP) announced that Robert Femia, Ph.D., has assumed the role of Senior Vice President, Chemical Medicines and General Chapters. Femia reports to USP’s Chief Science Officer and Executive Vice President, Jaap Venema, and has responsibility for industry standards collaboration as well as chemical medicine monograph and general chapter standards in USP’s compendia, United States Pharmacopeia—National Formulary (USP–NF).
“USP standards are vital in helping to ensure the quality and safety of chemical medicines that play such a dominant role in healthcare,” said Femia. “I’m proud to be a part of an organization that is so critical to the overall safety net that protects public health.”
Most recently, Dr. Femia was Vice President, Research and Development and Regulatory Affairs (North America), at Sun Pharma/Ranbaxy/Ohm Laboratories (Princeton, NJ), where he provided strategic leadership on product development, regulatory and legal matters, and the development and filings of new products and key site transfers. Prior to joining Sun Pharma, Femia was Vice President, Pharmaceutical Research and Development, at GAT/Nortec (Ramsey, NJ), where he led a new pharmaceutical product division that included drug research and development, regulatory issues and compliance. Earlier in his career, Femia held numerous leadership and technical positions at Par Pharmaceutical, Novartis/Sandoz, Sanofi-Aventis/Hoechst Celanese and Applied Biosystems. He was an Adjunct Professor in the Department of Chemistry at William Paterson University. Dr. Femia received his B.S. in Chemistry from Fairfield University and an M.S. and Ph.D. in Chemistry from Seton Hall University.
One of USP’s current strategic goals is to bring USP–NF’s monographs up-to-date by 2020, an effort in which Femia’s leadership will play a central role. USP’s quality standards for chemically-based small molecule drugs—many of which are generic products in the U.S.—are enforceable under federal law.
“We’re excited to have someone with Bob’s rich experience in pharmaceutical research, quality and industry at USP,” said Dr. Venema. “As the global pharmaceutical landscape continues to grow and transform, USP’s standards will also evolve. Having Bob lead our efforts in chemical medicines and general chapters will be an important part of that transformation.”