September 22, 10:15 – 10:45 AM EST
Cell & Gene Therapy Development: Ecosystem Challenges for CDMOs
Founder and Principal Consultant
In the rapidly advancing realm of Cell and Gene Therapy (CGT) development, pharmaceutical contract development and manufacturing organizations (CDMOs) stand at the forefront of innovation. This presentation delves into the intricate ecosystem challenges these CDMOs face, spotlighting their pivotal role in navigating complex regulatory landscapes, optimizing Chemistry, Manufacturing, and Controls (CMC) development processes, and ensuring the seamless translation of groundbreaking therapies from lab to market. From personalized treatments to regulatory compliance, scalability, and patient-centric approaches, this discussion underscores how CDMOs can strategize and innovate to surmount multifaceted hurdles, ultimately shaping the future of CGT and its transformative potential in modern medicine.
Gautam Ranade, Ph.D., is an active consultant to the pharmaceutical industry and a member of several Technical Advisory Boards. He was a Senior Director (Pharmaceutical Sciences) at Pfizer Worldwide R&D, where he directed the development of multiple commercial, parenteral dosage forms; and managed the GMP sterile manufacturing facility for small molecules and biologics. He is well-versed in cell and gene therapy (CGT) product development, dosage form development, novel drug delivery and outsourcing. He is a member of the ASGCT, the ISCT and AAPS. He is the inventor for 19 US patents related to pharmaceutical product development.