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

Brian Harvey, MD, PhD

Practice Area Focus

  • Regulatory Submissions
  • Development Strategy
  • Regulatory Strategy
  • Biologicals
  • Biosimilars
  • Combination Products
  • Devices & Drugs
  • Orphan Designation
  • Therapeutic Proteins


Dr. Harvey joined NDA Partners as an Expert consultant in 2015. He has over 30 years of experience in biomedical research, clinical medicine, drug, biologic product, medical device and combination product development and pre-market regulatory evaluation. Dr. Harvey served in several executive roles at the US Food & Drug Administration including Director, Division of Gastroenterology Products (CDER); Deputy Director, Office of Drug Evaluation 5; Acting Director, Division of Anti-Inflammatory, Analgesic and Ophthalmologic Drug Products (CDER); Associate Director Regulatory Policy, Office of Therapeutics Research and Review; and Medical Officer, CDRH. During his term in the CDER Gastroenterology Division, he organized the Inborn Errors of Metabolism Team to focus on Rare Disease FDA approvals. In addition to his FDA experience, Dr. Harvey served as Vice President of US Regulatory Strategy at Pfizer and Vice President of US Regulatory Policy at Sanofi-Adventis. /p>

Dr. Harvey regularly makes presentations of FDA policy and regulatory issues at academic, professional and government sponsored meetings and has also served as a congressional fellow working with Senate staff on Health committee initiatives.