Rochelle, Virginia (July 18, 2016) – NDA Partners Chairman Carl Peck, MD, announced today that Roger Williams, MD, a clinical pharmacology and global regulatory expert, has been appointed a Partner in the firm. Dr. Williams has worked with NDA Partners as an Expert Consultant since December 2014. He was formerly Chief Executive Officer and Chair of the Council of Experts at the US Pharmacopeial Convention (USP), and Director of the Office of Generic Drugs (OGD) within the FDA Center for Drug Evaluation and Research (CDER).
In addition to his role in the FDA as Director of OGD, Dr. Williams served as Deputy Center Director and Director, Office of Pharmaceutical Science, and Acting Director for New Drug Chemistry (now Office of New Drug Product Quality). He held leadership roles nationally and internationally at the World Health Organization, the Pan American Health Organization, and, as the lead FDA representative to the International Conference on Harmonization. He has contributed to many important initiatives, including a WHO guidance, which supported interchangeable multisource medicines, and numerous guidances on the topics of safety, efficacy, quality, and regulatory communications at ICH.
“Dr. Williams’ expertise in global regulatory strategy, generic drug development, and clinical pharmacology greatly enhances our ability to provide our clients with world class strategic advice and guidance”, said Dr. Peck. “We are pleased to welcome him as a Partner in the firm.”
Dr. Williams received a BA in Chemistry-Zoology from Oberlin College (Ohio), an MD from the University of Chicago School of Medicine, and completed a fellowship in clinical pharmacology at the University of California, San Francisco. He received a Doctor of Science degree, honoris causa, from Long Island University and has authored or coauthored more than 200 publications on topics related to applied regulatory and compendial science as well as national and international 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.
Earle Martin, Chief Executive Officer