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

Jon Clark

Practice Area Focus

  • Drugs
  • Dietary Supplements
  • OTC
  • CMC
  • Expert Witness
  • Quality Systems
  • Regulatory Submissions

Biography

Jon Clark joined NDA Partners as an Expert Consultant in 2016. He has more than 35 years of experience in the pharmaceutical industry in drug development, R&D processes, FDA CMC reviewer, founding member of ICH eCTD standard, and medicinal go-to-market standards.

Mr. Clark was previously 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. Prior to USP, Mr. Clark worked at the FDA as Associate Director, Program Policy and GMP, FDA Office of 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). In Mr. Clark’s early career, he was a Senior Chemist/API Synthesis at Schering-Plough Research Institute and a Chemist and Manufacturing Support at Beecham Laboratories.