Biotech Connector Speaker Series May 2020: Cell Therapy
Topic 1: A New Paradigm: Commercial Cell Therapy Manufacturing
Kite Pharma is currently building a new commercial manufacturing facility in Frederick, MD to add capacity to its manufacturing network. Unlike many other biotechnology processes, commercial cell therapy manufacturing requires scaling out manufacturing rather than scaling up. In this talk, I will give a summary of the cell therapy manufacturing process, challenges we face, and what the future of cell therapy manufacturing may hold.
Presenter: Brian Stamper is the Director of Manufacturing at the Kite Cell Therapy Manufacturing Facility in Frederick, MD. Prior to Kite, he accumulated 20 years of experience in the biotechnology field including positions at Eli Lilly, MedImmune/AstraZeneca, and Lonza in roles including process development, clinical and commercial manufacturing, and Manufacturing Sciences & Technology. Brian has degrees from Indiana University, Purdue University, and Johns Hopkins University, and has lived in Middletown, MD with his wife and three daughters since 2009.
Topic 2: Clinical Production of CD33 CAR-T cell therapy at the Frederick National Labs
The treatment of cancer patients with autologous T cells expressing a chimeric antigen receptor (CAR) is one of the most promising adoptive cellular therapy approaches. The Biopharmaceutical Development Program (BDP) at the Frederick National Laboratories for Cancer Research (FNLCR) was recently tasked with the setting up of a facility to manufacture clinical grade cell therapy products with an objective of meeting NCI clinical trial needs. This presentation briefly presents the progress made at the BDP in the development and GMP manufacture of the CD33 CAR T cell therapy for the treatment of children and adolescents/young adults (AYAs) with CD33+ relapsed/refractory acute myeloid leukemia (AML).
Presenter: Vinay Vyas, PhD, is a senior scientist at the Biopharmaceutical Development Program (BDP) at the Frederick National Laboratories for Cancer Research (FNLCR) where he has led teams in the development and clinical manufacture of cytokines, therapeutic proteins, nanoparticle vaccines and lentiviral/retroviral vectors for cell therapy. More recently, he spearheaded the establishment of BDP’s cGMP CAR-T Cell Therapy Facility enabling the FNLCR to rapidly become a manufacturing site for NCI’s clinical trials. Prior to joining the FNLCR, he was a scientist at the Center for Advanced Research in Biotechnology (CARB/IBBR, UMD) and at the Biochemical Engineering Research and Process Development Center at the Institute of Microbial Technology, CSIR, India. He graduated with degrees in Chemical Engineering (BS) and Chemistry (MS) from BITS, Pilani, India and PhD in Biochemical Engineering/Biotechnology from Panjab University, India. He has over 25 years of progressive experience in bioprocess development and translational research.
Topic 3: Therapeutic Cell Manufacturing Matters - How Bioprocessing Innovations are Laying the Foundation for a Sustainable Regenerative Medicine Industry
Presenter: Jon Rowley, PhD, is the Founder and Chief Product Officer of RoosterBio Inc and has a personal goal of making significant contributions to the commercial translation of living cellular technologies. Jon holds a PhD from the University of Michigan in Biomedical Engineering and has authored over 35 peer reviewed manuscripts and 20 issued or pending patents related to biomaterials development, tissue engineering, and cellular therapy. He is alumni of BD, Aastrom and Lonza, and currently resides in Walkersville, MD with his wonderful wife and their 3 awesome children. Jon is also on the Board of Directors of FITCI, Frederick’s local technology incubator.