Amedio CMC Consulting LLC

John C. Amedio, PhD, Principal at Amedio CMC Consulting, assists emerging and established pharmaceutical and life science companies with the technical and regulatory CMC development of small molecules and peptides from the bench to the market.

John has a proven track record of delivering results on time. He provides leadership and guidance in drug development, regulatory affairs and quality programs. John has 25 years of experience in major and start-up pharmaceutical companies with expertise that spans organic chemistry, process research and development, analytical method development, formulation development, cGMP manufacture for drug substance and drug product (parenteral, lyophilized, ophthalmic, solid dosage forms). He has extensive knowledge in primary/packaging, labeling and supply chain/distribution activities and has performed several technology transfers to and from CMOs.

John has delivered numerous profitable and patented manufacturing processes for both drug substance and drug product. He has authored and reviewed CMC sections for multiple regulatory filings (INDs, Amendments, Annual Updates, Briefing Books and an NDA; IMPD documentation to EMA and Canadian authorities), participated in face-to-face FDA meetings (pre-IND, end-of-phase 1, end-of-phase 2 and pre-NDA), performed budget planning and forecasts, established hiring plans, and contributed to the overall strategic planning. He is a lead author or co-author of several peer-reviewed articles, publications and patents and has given many invited presentations.

John held positions as Vice President of Manufacturing and Process Development at Seaside Therapeutics, VP of Manufacturing and Process Development at ZIOPHARM Oncology, Executive Director, Chemical and Analytical Development, EPIX Pharmaceuticals and Unit Head, Chemical Development, at Sandoz Research Institute (currently Novartis).

Providing Excellence in Chemistry, Manufacturing and Controls (CMC) Consultation