NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

Former Pfizer Executive and FDA Division Director Brian Harvey, MD, PhD Joins NDA Partners

Rochelle, Virginia (October 5, 2015) - Dr. Carl Peck, MD, Chairman of NDA Partners LLC announced today that Brian E. Harvey, MD, PhD, has joined the firm as a Premier Expert consultant. NDA Partners Premier Experts are top tier consultants whose expertise and professional stature enable them to bring extraordinary value to the company's clients. Premier Experts collaborate to design and implement critical solutions to help clients successfully develop their medical products, pursue optimal regulatory pathways, build companies that are attractive to professional investors, and initiate access to global markets. Dr. Harvey has more than 30 years of experience in biomedical research, clinical medicine, drugs, biologics, medical devices, and combination product development, including pre-market regulatory evaluation. He specializes in FDA regulatory science policy development, biosimilars, orphan products/ rare disease treatments, and gastroenterology/liver disease treatments.

Dr. Harvey held several senior roles at FDA. As Director of the Division of Gastroenterology Products (CDER), he headed the regulatory review team for submissions and chaired FDA meetings with the regulated industry. Of note, as Director, he created the Inborn Errors of Metabolism Team within the GI division to focus on Rare Disease FDA approvals. He also led multidisciplinary regulatory teams for NDA reviews and developed a range of regulatory experience associated with drug development and approvals while Deputy Director for the Office of Drug Evaluation 5 (CDER). In addition to his extensive FDA experience, Dr. Harvey served as Vice President of US Regulatory Strategy at Pfizer, Vice President of US Regulatory Policy at Sanofi-Aventis and currently is the Executive Vice President, Scientific and Regulatory Affairs at the non-profit Global Liver Institute (GLI).

"Dr. Harvey’s firsthand knowledge of FDA regulations, guidance and procedures, in addition to his extensive management, clinical trials and regulatory submission experience in a broad range of therapeutic areas, make him a high-value addition to our team and a highly sought-after expert by our clients”, said Dr. Peck. “We are very pleased to welcome him to NDA Partners.”

Dr. Harvey received a BA in Biology/Chemistry from Middlebury College, PhD in Biochemistry from the University of Connecticut and then enrolled in the University of Connecticut, School of Medicine, where he earned his MD degree. He received post-MD training at Beth Israel/Harvard, followed by Johns Hopkins Hospital and is a licensed physician in the State of Maryland.

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 two former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; an international team of approximately 40 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, 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.

Earle Martin, General Manager
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