PPD, Inc. has named Frank Gallo as executive director of risk management, strengthening its expertise in risk evaluation and mitigation strategies (REMS). Mr. Gallo will lead the development, management and implementation of REMS programs that align with client program goals and product commercialization.
Mr. Gallo brings more than 13 years of pharmaceutical, commercial and risk management experience to PPD’s risk management teams in epidemiology, late stage surveillance studies, pregnancy registries, pharmacovigilance and medical communications. He previously served as vice president of Rienzi & Rienzi, a healthcare communications company, where he developed and designed REMS communications strategies and programs for U.S. Food and Drug Administration (FDA) approval. Mr. Gallo’s expertise includes risk management and commercial positions with Talecris Biotherapeutics and Mylan Inc.
“The safety of marketed drugs remains an important concern for our clients and regulatory authorities,” said Lori Eberhardt, vice president of global late stage research for PPD. “Frank brings strong expertise across a range of risk management programs and therapies, which will benefit our clients in developing REMS strategies for drugs or biologics that offer significant benefits but may also involve health or safety risks.”
Mr. Gallo earned his bachelor of science from West Virginia University and is a member of the Drug Information Association (DIA) and the Scientific Board for National Addictions Vigilance Intervention and Prevention Program (NAVIPPRO™).