Cancer Commons founder Marty Tenenbaum, Ph.D., will speak at the upcoming Precision Medicine World Conference (PMWC) in Durham, NC, which runs May 24–25. Marty, who founded Cancer Commons after his own battle with melanoma, will discuss the organization’s ongoing efforts to address challenges to knowledge-sharing in precision oncology.
Read the synopsis of Marty’s presentation, entitled “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.
Marty’s talk takes place on May 24 at 2:45 pm. For more information, visit the PMWC website.