Session Chair Profile
Ph.D., Founder & Chairman, Cancer Commons
Marty Tenenbaum is a renowned computer scientist, Internet entrepreneur and cancer warrior. He is the Founder and Chairman of Cancer Commons, a non-profit network of physicians, scientists, and patients that Newsweek dubbed the “LinkedIn of Cancer.” He began his career in AI, leading elite research groups at SRI International and Schlumberger Ltd. Later, as an Internet commerce pioneer, he founded or co-founded five successful startups. Dr. Tenenbaum is a fellow and former board member of the American Association for Artificial Intelligence, a former Director of Commerce One, the Public Library of Science (PLoS) and Patients Like Me, and a former consulting professor of Computer Science at Stanford. He currently serves as a Director of CommerceNet and Efficient Finance. Dr. Tenenbaum holds B.S. and M.S. degrees in Electrical Engineering from MIT, and a Ph.D. from Stanford, and has received numerous awards for his contributions to AI and his work as a patient advocate.
Is An Additional Path to FDA Approval Possible?
This talk will explore the question: When faced with certain death, it is acceptable to accept less than 100% proven safety and efficacy? Patients with glioblastoma and certain other cancers with dire prognoses do not have the time to wait for new treatments to be fully approved by the FDA. Is it time to add “conditional approval” as an additional pathway to approval for these patients? In this session, a plan will be proposed by which the FDA could conditionally approve a treatment that has been proven safe in a clinical trial(s) with at least 25 patients, and has demonstrated biologic activity. Therefore, this treatment could not be denied by insurance as being “experimental”. However, the requires patients using these drugs to participate in a registry through which their physicians submit details on the treatments, side effects and outcomes. The FDA’s periodic review of the registry data would lead to a range of outcomes from full approval to the conditional approval being revoked.
Session Synopsis: Patient advocacy plays an increasingly critical part in today’s health care delivery system. This session will facilitate a discussion that focuses on two examples of how patient involvement is shaping the course of therapies and decisions: driving the 21st Century Cures Act from concept to the finish line, and as a second example, expediting “conditional approval” of treatments that have been proven safe in clinical trials.