Commercializing Autologous Cell Therapy: Bridging Clinical and Large-Scale Manufacturing

Pascal Touchon

Pascal Touchon serves as global strategy advisor to RoslinCT and board director, bringing over four decades of international experience in the biopharmaceutical industry, combining operational leadership with strategic vision to accelerate the development of transformative therapies for patients worldwide. He has held senior roles across large pharmaceutical companies and biotech innovators, with a consistent focus on harnessing cutting-edge science to deliver meaningful clinical impact.

Formerly global head of strategy and business development, as well as global head of the cell & gene unit at Novartis Oncology, Pascal played a pivotal role in the development and global launch of Kymriah®, the first approved cell and gene therapy in the U.S. He later served as CEO, and most recently chairman, of Atara Biotherapeutics, where he led the company through the first ever approval of an allogeneic T cell therapy, Ebvallo®. He currently sits on the boards of Ipsen (IPN) Medincell (MEDCL), Catalym, Xylocor and CDR-Life, and is an operating partner at Jeito Capital, bringing strategic insight and operational expertise to support sustainable value creation.

Pascal holds a doctorate in veterinary medicine from Paul Sabatier University and an MBA from INSEAD. He has lived and worked extensively across Asia, Europe, and the United States, bringing a truly global perspective to his board and advisory roles.

Heath Coats

Heath Coats has over 35 years of industry and consulting experience including a stint in the Division of Manufacturing and Product Quality (DMPQ) in U.S. FDA’s CBER. There, he gained extensive knowledge of administrative and regulatory review procedures for INDs and CMC sections of biologics license applications. During his time at the agency, he reviewed applications and supplements for cell therapy products, HPC cord blood, plasma fractionated products, vaccines, allergenics, aseptic processing, and in vitro diagnostics. Prior to the FDA, he managed the validation program for a cell therapy contract manufacturing company that also manufactured endotoxin detection products and cell culture media. He also has over ten years of industrial experience in manufacturing biologically active proteins.

Dean Morris

Dean Morris has over twenty-five years of experience leading a broad range of operational functions including commercial manufacturing operations, capital investment programs, process development, engineering, validation, and quality for various clinical and commercial biologics and advance therapy medicinal products.

As chief operations officer of RoslinCT Boston, Dean is responsible for enabling the rapid growth of the business and for all aspects of the company’s operations including manufacturing, supply chain, facilities, and information technology. Dean is responsible for ensuring the operations are maintained in full quality and regulatory compliance while upholding a culture of safety, sustainability, and driving continuous improvement and operational excellence initiatives.

Dean has experience on both the sponsor/innovator and CDMO sides of the industry, joining from his most recent role as vice president of operations and site head for ReciBioPharm where he led operational teams dedicated to the production of clinical phase products across a broad range of modalities for multiple client programs.

Dean previously served as the head of commercial operations for second-generation products at Sanofi’s Bio-Campus in Framingham, MA, and has also served as the program director for new manufacturing investments, managing the design, construction, and commercial start-up of the new multi-product manufacturing facility. Over the course of ten years at Sanofi, Dean held key roles in manufacturing science and technology and quality.

Dean holds a degree in chemical engineering from the University of Massachusetts at Amherst.

Gregory Russotti, PhD

Gregory Russotti, PhD, is the chief technology and manufacturing officer at Century Therapeutics, a company developing iPSC-derived, allogeneic cell therapy products for type 1 diabetes, hematology/oncology, and autoimmune indications. Before joining Century in January 2020, Greg was vice president of cell therapy development and operations at Celgene. During his 13-year tenure at Celgene, he guided CMC efforts for six different cell therapy products to IND and clinical stage development. Greg was also a leader in establishing in-house clinical manufacturing at Celgene and in building Celgene’s first commercial CAR T manufacturing facility. Prior to Celgene, Greg held various leadership roles at Merck Research Laboratories, developing vaccines and monoclonal antibodies for clinical and commercial manufacturing. Greg received his BS and MS degrees in chemical engineering from Rensselaer Polytechnic Institute and his PhD in chemical and biochemical engineering from Rutgers University.

Jay Kang, PhD

Jay Kang, PhD, is currently the executive director of CMC and External Manufacturing at Legend Biotech. He joined Legend in early 2020 as the global CMC lead for Carvykti. He led the internal and joint team in the successful development, process validation, global submission, commercial approval and launch of Carvykti. His team also led the tech transfer of Carvykti to a CMO and managed the strategic collaboration and day-to-day activities in the CMO for commercial cell therapy manufacturing. Carvykti has become the best-selling cell therapy product and serves over 10,000 patients worldwide.

Before Legend, he has over 15 years of experience in the pharmaceutical/biotech industry, starting as a bench scientist and growing into leadership roles in the areas of CMC development and regulatory strategy, clinical and commercial manufacturing, and CMO/partnership management.

Jay holds a PhD in pharmaceutical sciences from Peking University and had his postdoctoral training at the University of Michigan. He is the author of over twenty publications in peer-reviewed journals and the inventor of several patents. He is Regulatory Affairs Certified and a frequent conference speaker.