Last week, Cancer Commons founder Marty Tenenbaum spoke at the Precision Medicine World Conference (PMWC) in Durham, NC. He presented a proposal to significantly accelerate patient access to promising investigational drugs, using a new pathway to approval by the U.S. Food and Drug Administration (FDA).
The proposed Conditional Approval pathway aims to help cancer patients who may have exhausted existing options access new, promising treatments.
“It’s an idea whose time has come, and the conference provided strong validation, including some personal communications from several prominent FDA officials (past and present) who were in attendance,” Marty says. “We are currently in discussions with the FDA, and hope to be able to pilot Conditional Approval in brain cancer where the prognosis is dire.”
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.
Oncologist and Cancer Commons Medical Director Kevin Knopf, MD, will speak next month at TiEcon 2017, a technology conference in Santa Clara, CA. He’ll join three other experts to discuss the future of personalized medicine. From the program:
A new era of personalized medicine has made its way into the world of healthcare. We will discuss novel approaches for designing disease treatment and prevention that integrates with an individual’s genetic profile, environment and lifestyle.The future is here — let’s hear from industry luminaries on how digital health entrepreneurs and the healthcare industry as a whole are preparing for massive disruption.
Kevin’s presentation will take place on May 5 at 3:00 pm. For more information, visit the TiEcon website.
Cancer Commons founder Marty Tenenbaum, PhD, recently visited Microsoft’s Richmond, CA, office to give a presentation entitled “How to Beat Cancer.”
Because of “a convergence of recent developments in genomics, big data informatics, social networks, and personalized medicine that is transforming the landscape of cancer research and treatment,” Marty says, “we are now on the threshold of being able to give each individual the knowledge, resources, and tools needed to successfully treat the one disease that matters most to them.”