Consultant Connect: Ask the Experts Forum

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. 

Brian Tamashiro has 25 years of industry experience and proven leadership in the areas of Drug Substance and Drug Product development and manufacturing. He has subject matter expertise in the areas of tech transfer (local and international), CDMO partnership/external manufacturing oversight, and late-stage commercialization strategy and has in-depth experience in the following areas: Stainless and single-use platforms, microbial and mammalian modalities, monoclonal and bispecific antibodies, fusion proteins, and AAV.  Brian has worked for AGC Biologics, Amgen, and ICOS and holds a BS Microbiology from Washington State University. 

As a founding partner and senior project leader at Kanopy Group International, Kurt Voelker holds 20 years of experience in supporting and leading capital projects for biopharma manufacturing clients. His passions lie in coaching talent, developing strong teams, and improving project execution performance by continuously seeking process improvements. Kanopy Group is highly motivated to deliver complex and challenging projects that maximize the return on investment for our clients, while ensuring safety, quality, and compliance. Kanopy has built a team of respected professionals who share our vision and values, and who have the skills and experience to meet the technical and commercial requirements of any project. Kanopy is mentoring and developing the next generation of project leaders, while fostering a competitive culture of continuous improvement and innovation.  He previously worked for Sanofi Pasteur and holds a bachelor's degree in Mechanical Engineering from Penn State University.