NDA Partners Expert Consultant Vinod Shah, PhD, receives AAPS…

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I am deeply honored to receive this award for my contributions to the development of methodology and standards for dissolution/drug release of drug products to assure product quality and performance, and for my work to establish a scientific basis for the Biopharmaceutics Classification System.

NDA Partners Chairman Carl Peck, MD, announced today that one of the firm’s most prominent Expert Consultants, Dr. Vinod Shah, was recently honored as the recipient of the 2017 Distinguished Pharmaceutical Scientist award conferred by the American Association of Pharmaceutical Scientists (AAPS). The award was presented to Dr. Shah at the AAPS Annual meeting held in San Diego, California on November 12-15, 2017. The Distinguished Pharmaceutical Scientist award is intended to recognize the accomplishments of an individual that have been outstanding because of the impact of his or her work in the pharmaceutical sciences. The work must have significantly moved the frontier of the field and advanced basic concepts of important scientific significance which have stimulated research investigations by others. Dr. Shah was recognized for his contributions to the development of methodology and standards for dissolution/drug release of various types of drug products to assure product quality and performance.

Dr. Shah was formerly a Senior Research Scientist in the Office of Pharmaceutical Sciences at the US Food & Drug Administration (FDA). During his 30-year tenue at the FDA, he developed several regulatory guidelines with “How to Information” in the area of bioanalytical method validation, dissolution, bioavailability/bioequivalence, scale-up and post approval changes (SUPAC), and led efforts to establish the scientific basis for the Biopharmaceutics Classification System (BCS).

“I am deeply honored to receive this award for my contributions to the development of methodology and standards for dissolution/drug release of drug products and to assure product quality and performance and for my work to establish a scientific basis for the Biopharmaceutics Classification System. I hope my work will continue to make an impact in this field,” said Dr. Shah.

Dr. Shah joined NDA Partners as an Expert Consultant in 2016. In addition to his thirty years of experience at the FDA, he is a former Biopharmaceutics Expert Committee member of U.S. Pharmacopeial Convention (USP), where he was Co-Chair of USP’s Advisory Panel on Dosage Form Performance – Topical/Dermal, and Distinguished Pharmaceutical Scientist/Consultant at USP in Biopharmaceutics. He is a member of the Steering Committee of Non-Biological Complex Drugs (hosted at Lygature, The Netherlands), and Founder and Chairman of the Society of Pharmaceutical Dissolution Science (SPDS) International. Dr. Shah has authored more than 300 scientific papers and four books. His honors include the AAPS Presidency and the AAPS Distinguished Service Award, and the Pharmaceutical Sciences World Congress (PSWC) Research Achievement Award. He is a recipient of International Pharmaceutical Federation (FIP) Lifetime Achievement Award in Pharmaceutical Sciences and holds an Honorary Doctorate from Semmelweis University and from the University of Medicine and Pharmacy Carol Davila, Bucharest, Romania.

About AAPS

The American Association of Pharmaceutical Scientists (AAPS) is a professional, scientific organization of approximately 9,000 members employed in academia, industry, government, and other research institutes worldwide. Founded in 1986, AAPS advances the capacity of pharmaceutical scientists to develop products and therapies that improve global health.

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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