Former FDA Director Eric B. Sheinin, PhD, joins NDA Partners as Expert Consultant

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NDA Partners Chairman Carl Peck, MD, announced today that Eric B. Sheinin, PhD, a 30-year veteran of the FDA in the Center for Drug Evaluation and Research (CDER), who was formerly Deputy Director, Office of Pharmaceutical Science; Director, Office of New Drug Chemistry, Office of Pharmaceutical Science; and Director, Division of New Drug Chemistry III, Office of New Drug Chemistry, has joined the firm as an Expert Consultant.

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Dr. Sheinin’s extensive experience at FDA and USP, in addition to his expertise in issues relating to the drug approval and regulatory process in the US and internationally, will greatly benefit our clients in the early-stage drug development process.

NDA Partners Chairman Carl Peck, MD, announced today that Eric B. Sheinin, PhD, a 30-year veteran of the FDA in the Center for Drug Evaluation and Research (CDER), who was formerly Deputy Director, Office of Pharmaceutical Science; Director, Office of New Drug Chemistry, Office of Pharmaceutical Science; and Director, Division of New Drug Chemistry III, Office of New Drug Chemistry, has joined the firm as an Expert Consultant.

In addition to his FDA experience, Dr. Sheinin served as Vice President, Pharmaceutical Ingredient Verification Program, and Vice President and Chief Scientific Officer at the United States Pharmacopeia (USP). He is an expert in CMC review and issues relating to the drug approval and regulatory processes both in the US and internationally.

“Dr. Sheinin’s extensive experience at FDA and USP, in addition to his expertise in issues relating to the drug approval and regulatory process in the US and internationally, will greatly benefit our clients in the early-stage drug development process. He is a welcome addition to our team of Expert Consultants, and we are very pleased that he has joined NDA Partners,” said Dr. Peck.

Dr. Sheinin earned his doctorate degree in Organic Chemistry from the University of Illinois at the Medical Center in Chicago, in addition to a bachelor’s degree in Zoology from the University of Illinois. He is a charter member of the American Association of Pharmaceutical Scientists and member of the USP Nomenclature and Labeling Expert Committee. He has authored or co-authored 40 scientific publications and over 200 presentations.

About NDA Partners:

NDA Partners is a strategy consulting firm specializing in expert product development and regulatory advice to the medical products industry and associated service industries such as law firms, investment funds and government research agencies. The highly experienced Principals and Premier Experts of NDA Partners include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and virtual product development teams.

Contact:
Earle Martin, Chief Executive Officer
Office: 540-738-2550
MartinEarle(at)ndapartners(dot)com

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Earle Martin
NDA Partners LLC
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