Jon Clark, Former Vice President of USP, Joins NDA Partners as Expert Consultant

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NDA Partners announced today that Jon Clark, the former Vice President of Industry Standards Collaborations at the US Pharmacopeia (USP), has joined the firm as an Expert Consultant. In addition to his experience at USP, Mr. Clark served as a CMC reviewer at the US Food & Drug Administration, and was a founding member of ICH eCTD standard and medicinal go-to-market standards.

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“Mr. Clark’s scientific knowledge in drug substance processes, practical experience in drug development, and regulatory expertise in GMP and CMC will provide an outstanding resource to our clients and to our growing CMC Practice.”

NDA Partners Chairman Carl Peck, MD, announced today that Jon Clark has joined the company as an Expert Consultant. Mr. Clark was formerly a Vice President with US Pharmacopeia, where he was responsible for industry collaborations and managing the development of small molecule monographs based on analytical methods. NDA Partners Expert Consultants are top tier consultants whose expertise and professional stature enable them to bring extraordinary value to the company's clients. 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.

Mr. Clark worked at the FDA as Associate Director, Program Policy and GMP, Pharmaceutical Science (CDER), where he developed and published 25 FDA Guidance Documents, participated in 10 ICH Expert Working Groups, and was a founding member of ICH Electronic Common Technical Document (eCTD) and the Cumulative Table of Contents (CTD) standards. His work with CMC Guidance Development and foundational working group activity lead to the establishment of the FDA Office of Policy for Pharmaceutical Quality (OPPQ). Mr. Clark also served as a CMC Electronic Submissions Expert, Office of Information Management (OIM) and a Review Chemist in Office of Generic Drugs (OGD).

“Mr. Clark’s scientific knowledge of creating drug substance processes for antimicrobials, practical experience in drug product development, and regulatory expertise in GMP and CMC will provide an outstanding resource to our clients and to our growing CMC Practice”, said Dr. Peck. “We are very pleased to welcome him to NDA Partners.”

Jon Clark earned a MS in chemistry from Rutgers University and a BS in chemistry from University of Michigan. He holds five US Patents and is the author of numerous FDA Guidance Documents.

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 Expert Consultants at 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 approximately 60 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.

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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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