In the PMWC 2017 discussion, Dr. Tenenbaum focused on the question: When faced with certain death, is it 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 the session, he described a plan that 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.”
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.
Update 3-1-17: A video of this event has now been released. Watch it below.
This year’s Precision Medicine World Conference in Mountain View, California, was well-attended by many members of Cancer Commons, who shared in the scientific discoveries that will lead the way to more personalized, accurate, and effective cancer care. Precision medicine is a rapidly evolving field with many breakthroughs in science, technology, and diagnosis that is transforming the way cancer care is practiced at the bedside.
A special session was co-chaired by Cancer Commons board member Larry Marton and Lincoln Nadauld, director of the personalized oncology program at Intermountain Healthcare in Utah. The session also featured Cancer Commons medical director Kevin Knopf, Mountain View oncologist Edmund Tai, and Tim Collins, who is corporate vice president of operations and research at Scripps Health in San Diego. Continue reading…
Every year, scientists, doctors, and representatives from pharmaceutical, diagnostics, and technology companies gather in Silicon Valley to talk shop at the Personalized Medicine World Conference (PMWC). For 2 days, they discuss the triumphs and challenges of diagnosing and treating diseases based on patients’ distinct genetic characteristics.
This year, the PMWC status quo was interrupted by a not-so-unlikely guest: the patient. Cancer Commons joined the event’s organizers to cohost a series of informative presentations for patients and advocates, delivered by doctors and researchers, as well as patients and advocates themselves. Continue reading…
Personalized oncology is changing the cancer treatment landscape. Increasingly, patients are treated according to the distinct genetics of their tumors. To realize the full benefits of this shift, cancer patients and advocates must be engaged and informed. Cancer Commons has joined the Personalized Medicine World Conference (PMWC) to co-host a special two-day track for cancer patients and advocates. Attendees will have the opportunity to discuss personalized medicine with each other and with researchers, clinicians, and industry leaders. Distinguished speakers will present the latest advances in personalized oncology and discuss its promise for the future.
PMWC is the largest and most established global conference on personalized medicine. It provides a platform for clinical, scientific, industry, and mobile health stakeholders to collaborate and catalyze further change. Cancer patients and advocates can register for the Patient & Advocate Program (Track 4) at a discounted fee.
PMWC 2014 will take place January 27-28, 2014, at the Computer History Museum in Mountain View, CA.
The 6th annual PMWC conference in Silicon Valley runs Jan 27–28. It brings together leaders from multiple sectors—including business, government, healthcare-delivery, research and technology—to learn from each other and further the field of personalized medicine. Dr. Tenenbaum’s panel discussion is at 11 am on the main-stage. General registration is available through Jan 24.