Benjamin Stevens

Ben Stevens is a Senior Director of Regulatory Affairs CMC Policy and Advocacy at Alnylam Pharmaceuticals and has nearly two decades of experience spanning drug discovery, global regulatory CMC strategy, and CMC policy development. His career sits at the intersection of public policy, pharmaceutical innovation, and regulatory science, and involves key matters spanning small molecules, peptides, oligonucleotides, biologics, combination products, and emerging technologies. At Alnylam, Ben provides strategic leadership on global CMC policy and advocacy, supporting development and lifecycle management of RNAi-based therapeutics. Previously, he served as Senior Director of Regulatory CMC Policy and Advocacy at GSK, where he led industry-facing policy initiatives across biologics, cell and gene therapies, oligonucleotides, and AI/ML-based advanced manufacturing platforms, and represented the company in numerous trade and professional associations. At Alnylam, Ben also led the clinical regulatory CMC development of vutrisiran prefilled syringe in over 30 countries, and initial US NDA and EU MAA submissions. Ben served as an Acting Branch Chief in the FDA’s Office of New Drug Products (CDER), where he worked closely with policy divisions (OPPQ, ORP), collaborated with CDRH on combination product reviews, and served as a government liaison to the U.S. Pharmacopeia. Prior to FDA, he spent seven years in medicinal chemistry R&D at Pfizer and Merck, contributing to early drug discovery and development programs. In addition to his industry roles, Ben is an active contributor to professional and academic communities through speaking engagements, advisory roles, and workforce development initiatives. He holds a PhD in Chemistry from the University of Pittsburgh and an MPH from the Johns Hopkins Bloomberg School of Public Health, is a co author of 30+ scientific publications and patents.