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Tufts University School of Medicine

Paul Beninger

Associate Professor of Public Health and Community Medicine
​Director, MD/MBA & MBS/MBA Programs
Department: Public Health & Community Medicine
Programs: Public Health

Paul Beninger

Associate Professor of Public Health and Community Medicine
​Director, MD/MBA & MBS/MBA Programs
Department: Public Health & Community Medicine
Programs: Public Health

Phone ​617-636-4057

Biography

Dr. Beninger is Associate Professor of Public Health & Community Medicine at Tufts University School of Medicine, where he is the Director of the MD/MBA and MBS/MBA Programs.

He began his career in drug development in 1987 at the US Food and Drug Administration, first as a reviewer and manager for drugs against HIV/AIDS and opportunistic infections and then as a division director for medical devices. He joined Merck & Company in 1995 and developed experience in regulatory affairs, medical affairs and drug safety in the areas of anti-infective drug and biological products, vaccines, anti-diabetic drug products and oncology drug products, before joining Genzyme as vice-president of pharmacovigilance in 2006; Genzyme was acquired by Sanofi in 2011. Dr. Beninger retired from Genzyme-Sanofi in April, 2017.

Dr Beninger trained in internal medicine and infectious diseases. He received his MD from the University of California, Davis, his BA from Claremont McKenna College in Claremont, California, his MBA from St Joseph’s University in Philadelphia, Pennsylvania, and his graduate certificate in epidemiology from Tufts. He has published and spoken extensively on regulatory science, drug and vaccine safety, and pharmacovigilance, and he is a fellow of the American College of Physicians and the Infectious Disease Society of America.

Education

  • ​MD: University of California, Davis, School of Medicine
  • MBA: Haub School of Business, St. Joseph’s University, Philadelphia

Research synopsis

Development process of new drugs, biologics, vaccines, and medical devices • Pharmacovigilance, including signal management and benefit-risk management • Regulatory science

Publications

  • Beninger P, Boumil M, Berman H, Getz K, Klapholtz H, Jotwani R, Salem D. Bridging the Academia/Industry Chasm: Proposed Solutions. Journal Clinical Pharmacology 56(12):1457-1460; 2016.
  • Beninger P, Boumil M, Jotwani Rohan. Medical Schools' Competition for Clinical Training Sites [Letter]. Academic Medicine. 91:1588; 2016.
  • Beninger P. Pharmacovigilance in the New Millennium (Editorial). Clinical Therapeutics 38:2512-2513; 2016.
  • Beninger P, Ibara M. Pharmacovigilance and Biomedical Informatics: A Model of Future Development. Clinical Therapeutics 38:2514-2525; 2016.
  • Beninger P. Pharmacovigilance: Work in Progress. Pharmaceutical Medicine 30 (1):1-5; 2017.
  • Beninger P. Opportunities for Collaboration at the Interface of Pharmacovigilance and Manufacturing. Clinical Therapeutics 39:672-674; 2017.
  • Beninger P. Risk Communication in a Pharmacovigilance Environment (Editorial). Clinical Therapeutics 39:702-712; 2017.
  • Jotwani R, Boumil M, Salem D, Wetterhahn M, Beninger P. Theranos exposes weaknesses in FDA regulatory discretion. Clinical Pharmacology in Drug Development. 6: 433-438; 2017.
  • Beninger P, Connelly J, Natarajan C. Data sharing in the pharmaceutical industry: the genie’s out of the bottle. Clinical Therapeutics 39 (9): 1191-1199; 2017.
  • Beninger, P. Pharmacovigilance: An overview. Clinical Therapeutics. 40 (12): 1991-2004; 2018
  • Beninger, P. Pharmacovigilance: Challenges in getting from here to there (Editorial). Clinical Therapeutics. 40 (12): 1964-1966; 2018.
  • Beninger P. Civic engagement: A physician’s perspective. J Health Politics, Policy and Law. 44 (1): 147-156; 2019.
  • Beninger P. Li D, Baaj A. Entrepreneurship for a meaningful clinical experience. BMJ Innovation. 10.1136/bmjinnov-2018-000295. February 16, 2019. 
  • Beninger P. Signal management in pharmacovigilance: review of processes and case studies. Clinical Therapeutics. 42 (6): 1110-1129; 2020. 
  • Beninger P. Covid-19: The regulatory landscape of medicinal and medical device products for human use. Clinical Therapeutics. 42 (8): 1444-1450; 2020. 
  • Nam K, Larholt K, Hirsch G, Beninger P, Fritsche D, Shoda D, Ferguson J, Bourgeois FT, Palmer D, Katz K, Courtney MW. Dynamic Dossier in the Cloud – An Architecture for a Real-time and Metrics-based Data Tracking System with Gene and Cell Therapies as a Case Study. Therapeutic Innovation & Regulatory Science, 2020. (Accepted for Publication: October 8)