Dr. John Amedio is a highly accomplished professional with an impressive 32-year track record in major and start-up pharmaceutical companies. Currently serving as the Principal Consultant at Amedio CMC Consulting, he plays a pivotal role in guiding emerging and established pharmaceutical and life science companies through the intricacies of technical and regulatory Chemistry, Manufacturing, and Controls (CMC) development for small molecules and peptides, ultimately steering them toward market success.
Prior to joining the ESTERN Medical CRO Life Sciences Corporate & Scientific Advisory Board, Dr. Amedio held various significant leadership positions, including Acting Chief Manufacturing Officer at Samus Therapeutics, Inc., Vice President of CMC & Commercial Manufacturing at Corbus Pharmaceuticals, Senior Vice President of Technical Operations at ArQule, and Vice President of Manufacturing & Process Development at ZIOPHARM Oncology, Inc. His earlier roles encompassed serving as the Executive Director of Analytical and Chemical R&D at EPIX Pharmaceuticals Inc. and as the Unit Leader in the Chemical Research and Development Department at Sandoz Research Institute (currently Novartis Pharmaceuticals).
Demonstrating a proven track record of delivering results on time, Dr. Amedio provides invaluable leadership and guidance in drug development, regulatory affairs, and quality programs. His expertise spans organic chemistry, process research and development, analytical method development, formulation development, and cGMP manufacturing for drug substances and drug products, including parenteral, lyophilized, and solid dosage forms. Dr. Amedio possesses extensive knowledge in primary/packaging, labeling, and supply chain/distribution activities, having successfully executed several technology transfers to and from Contract Manufacturing Organizations (CMOs).
Dr. Amedio’s contributions extend to delivering numerous profitable and patented manufacturing processes for both drug substances and drug products. He actively participates in face-to-face FDA meetings, including pre-IND, end-of-phase 1, end-of-phase 2, and pre-NDA discussions. Additionally, he plays a key role in budget planning and forecasts, establishes hiring plans, and contributes to overall strategic planning. Dr. Amedio is a lead author or co-author of several peer-reviewed articles, publications, and patents and has been a featured speaker at numerous invited presentations.
On the academic front, Dr. Amedio holds a Post-Doctoral degree in Natural Product Synthesis/Organic Chemistry from the State University of Oregon. He completed his Ph.D. in Organic Chemistry, specializing in the synthesis and isolation of natural products and transition metals, at the University of Delaware. Dr. Amedio earned his B.S. in Chemistry from Manhattan College in New York.
Dr. John Amedio’s comprehensive experience, strategic leadership, and commitment to advancing pharmaceutical manufacturing solidify his standing as a respected and influential figure in the field, making substantial contributions to the success and innovation of the companies he has served.
