Ali R Siahpush, Ph.D.
Dr. Siahpush has over 29 years of cell therapy and biologics development and commercialization experience. Since founding Pharmefex in 2014, Dr. Siahpush has advised numerous cell and gene therapy clients on a vast array of CMC topics including development, technology transfer, CMO selection, validation, comparability, regulatory submissions and interactions, and CMC strategy. Prior to creating Pharmefex, Dr. Siahpush was Vice President of Product Development and Manufacturing Science at Dendreon, a pioneer in cell therapy development and commercialization, where he was responsible for early and late stage product development, and support of Dendreon’s commercial manufacturing for Provenge®. Prior to joining Dendreon, Dr. Siahpush spent nearly 20 years at Amgen in a number of capacities spanning process development, product development, technology transfer, supply chain management, program management, acquisition integration and organizational redesign culminating as Executive Director of global process development. Dr. Siahpush also has hands on experience in protein formulation and fill/finish, lyophilization, downstream development, protein derivatization, Quality investigations, NC/CAPA’s, and risk analysis and has presided over transfer, validation and approval of numerous products both within and outside of the contiguous United States. He holds a Ph.D. in Biochemical Engineering from University of Michigan, Ann Arbor.