August 14, 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.
On Thursday September 12, 11 am EST, join former FDA commissioner Scott Gottlieb and our Chief Scientific Business Officer, Christopher Ung, for an in-depth conversation on the latest in regulatory and biomarker development.
The session will focus on the following key topics:
- The history and future of cell therapies, including discussion of Gottlieb’s forthcoming book, The Miracle Century: Making Sense of the Cell Therapy Revolution, and therapeutic evolutions such as T cell engagers.
- The FDA’s final rule to regulate lab-developed IVDs as medical devices
- The FDA’s new oncology IVD pilot program, including what it is and how it might be used
- T cell health in immune oncology and metabolic drug development
- How AI-powered digital pathology is revolutionizing cell therapy development, including the FDA’s view on AI-driven pathology in the clinic
Meet the Speakers
Scott Gottlieb
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
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.