Key Lessons from Manufacturing Cell-Based Immunotherapies to Accelerate Development and Process

Dr. Carmen is the Vice President of Business Development for Kincell Bio, a contract development and manufacturer (CDMO) focused on cell therapies. She has over 20 years of experience in the cell and gene therapy industry. Previously, she was Executive Vice President of Science & Technology at Adjuvant Partners; supporting companies in the cell and gene therapy space with their strategy, partnering, and business development needs. In a consulting capacity, she has supported the business development team at Oxford Biomedica, a manufacturer of clinical and commercial viral vectors. She has a broad technical knowledge base in cell and gene therapies with deep understanding of manufacturing of these innovative medicines and unique insights into the commercialization of tools and services to support the manufacture of these therapies. In her prior roles she has been responsible for out-licensing a non-viral enabling technology for cellular engineering at MaxCyte. She also has been responsible for establishing partnerships with developers of cell-based medicines in order to expand the cell therapy contract manufacturing business at Lonza. Dr. Carmen has been instrumental in the establishment of the Standards Coordinating Body for Regenerative Medicines and is currently serving as Vice President of the Board of Directors. She has been a member of the Science and Technology Committee of the Alliance for Regenerative Medicine and has served on the Commercialization Committee for the International Society of Cellular Therapy. Dr. Carmen earned a Doctorate from the Johns Hopkins University School of Public Health and a Bachelor of Science from the University of Florida.

TBA

Shishir Gadam, PhD, joined CARGO Therapeutics as CTO in January 2022. He is a seasoned biotechnology leader with over 25 years of experience and brings a wealth of CMC experience across vaccines, biologics and cell therapy modalities. Dr Gadam is passionate about building strong technical teams and accelerating development and commercialization of new products and technology. Most recently, Dr Gadam was Vice President of Global Cell Therapy Manufacturing Science and Technology at BMS (acquired Celgene, which acquired Juno Therapeutics, his previous company). He played an instrumental role in the global licensure and launch of the CAR T-cell products Breyanzi® (lisocabtagene maraleucel) and Abecma® (idecabtagene vicleucel) and built a global technical organization responsible for product life cycle management, commercialization, technology transfers and support of internal and external manufacturing. Prior to BMS, Dr Gadam spent 12 years at Genentech/Roche in various global leadership roles in Biologics Technical Development and Operations focused on CMC life cycle management, manufacturing science, new facility startup, technology transfers and Site Operations. Dr Gadam established technical teams in multiple countries and interacted with global health authorities to support Roche’s Biologics portfolio, including critical new launches of Actemra® (tocilizumab), Perjeta® (pertuzumab), Ocrevus® (ocrelizumab) and Tecentriq® (atezolizumab). Prior to Genentech, he was at Merck and Company’s Vaccine/Bioprocess Technical Development Organization and played a key role in the development and approval of critical vaccines including Gardasil® (Human Papillomavirus Quadrivalent Vaccine, Recombinant). Dr Gadam earned a PhD in Chemical Engineering from Rensselaer Polytechnic Institute, a Masters in Chemical Engineering from West Virginia University and a BS in Chemical Engineering from the Institute of Chemical Technology in India. In 2017, he was inducted to the AIMBE College of Fellows for his outstanding contributions in developing, scaling up, designing and starting up manufacturing processes and factories, along with defining the product technology lifecycle strategy for multiple products.

Arvind Natarajan, PhD, MBA, is Senior Vice President of Process and Analytical Development at Iovance, where he has worked on development and commercialization of tumor infiltrating lymphocytes (TIL) therapy, lifileucel, for melanoma and other solid tumor indications. He has 25 years of CMC experience in cell and gene therapies, biologics, and vaccines. Prior to joining Iovance, Dr Natarajan was Global Head of Program Management and Strategy, Cell & Gene Technical Development and Manufacturing at Novartis. Prior to that, he was the Global CMC Lead for Kymriah, the first FDA-approved CAR-T therapy. Prior to Novartis, Dr Natarajan worked at Merck and Co for 15 years. While at Merck, he worked in biologics on tech transfer and approval of Keytruda, and in vaccines, supporting development, approval, and commercial manufacturing of Zostavax, ProQuad, and Varivax. Dr Natarajan earned an MBA from Wharton, a PhD in Chemical Engineering from University of Minnesota, a Masters in Microbial Engineering from University of Minnesota, and a Masters in Biology and BE in Electronics and Electrical Engineering from Birla Institute of Technology and Science (BITS) Pilani in India.

Greg Russotti, PhD, is Chief Technology and Manufacturing Officer at Century Therapeutics. Prior to joining Century, Dr Russotti served as Vice President of Cell Therapy Development and Operations at Celgene. At Celgene, he guided chemistry, manufacturing and control efforts for five different cell therapy products to clinical-stage development. Dr Russotti was also a leader in establishing in-house clinical manufacturing at Celgene, and in building Celgene’s first commercial CAR T manufacturing facility. Earlier, he held various leadership roles at Merck Research Laboratories, developing vaccines and monoclonal antibodies for clinical and commercial manufacturing. He received his BS and MS degrees in Chemical Engineering from Rensselaer Polytechnic Institute, and his PhD in Chemical and Biochemical Engineering from Rutgers University. Dr Russotti has held a visiting professorship in Rutgers Biomedical Engineering department since 2008. He also serves as Industrial Executive Board Member of the Marcus Center for the Commercialization of Cell Therapies at Georgia Tech, and as an Executive Committee member of the National Science Foundation-funded Center for the Manufacturing of Advanced Therapeutics at Georgia Tech.

Bruce Levine, PhD, is the Barbara and Edward Netter Professor in Cancer Gene Therapy, is the Founding Director of the Clinical Cell and Vaccine Production Facility (CVPF) in the Department of Pathology and Laboratory Medicine and the Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania. He received a BA (Biology) from Penn and a PhD in Immunology and Infectious Diseases from Johns Hopkins. First-in-human adoptive immunotherapy trials include the first use of a lentiviral vector, the first infusions of gene edited cells and the first use of lentivirally-modified cells to treat cancer. Dr Levine is co-inventor of the first FDA approved gene therapy (Kymriah), chimeric antigen receptor T cells for leukemia and lymphoma, licensed to Novartis. Dr Levine is co-inventor on 29 issued US patents and co-author of >200 manuscripts and book chapters with a Google Scholar citation h-index of 98. He is a Co-Founder of Tmunity Therapeutics, and of Capstan Therapeutics both spinouts of the University of Pennsylvania. Dr Levine is a recipient of the William Osler Patient Oriented Research Award, the Wallace H. Coulter Award for Healthcare Innovation, the National Marrow Donor Program/Be The Match ONE Forum 2020 Dennis Confer Innovate Award, serves as President of the International Society for Cell and Gene Therapy and serves on the Board of Directors of the Alliance for Regenerative Medicine. He has written for Scientific American and Wired and has been interviewed by the NY Times, Wall Street Journal, Washington Post, NPR, Time Magazine, National Geographic, Bloomberg, Forbes, BBC and other international media outlets.