September 10, 2024
The drug development landscape is rapidly evolving, with new regulatory guidance, novel therapy types, and exciting AI-powered technologies altering the face of clinical testing.
In this webcast, Scott Gottlieb, former FDA commissioner, joins Christopher Ung, our Chief Scientific Business Officer, for an in-depth conversation on the latest in regulatory and biomarker development.
Key topics discussed in this webcast:
- The history and future of cell therapies
- The FDA’s final rule to regulate lab-developed IVDs as medical devices
- How to navigate the FDA’s new oncology IVD pilot program
- T cell health in immune oncology and metabolic drug development
- How AI-powered digital pathology is revolutionizing cell therapy development
Dr. Gottlieb is a physician and served as the 23rd Commissioner of the U.S. Food and Drug Administration. Dr. Gottlieb’s work focuses on advancing public health through developing and implementing innovative approaches to improve medical outcomes, reshape healthcare delivery, and expand consumer choice and safety. He is currently a partner at the venture capital firm New Enterprise Associates; a resident fellow at the American Enterprise Institute; a contributor to CNBC; and a board member to Pfizer, Inc. and Illumina, Inc.
Christopher Ung is CellCarta’s Chief Scientific Business Officer and has served in the companion diagnostics field since its inception. He is one of the original pioneers of the personalized medicine field. Mr. Ung currently leads the development and execution of CellCarta’s strategic and business initiatives, leveraging the company’s solid tumor and anatomic pathology services.