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.”
In a recent Xconomy article on cancer DNA testing, Cancer Commons medical director Kevin Knopf shares his perspective:
“To help all patients we think an open-source database has the most utility,” says Knopf. Instead of current tests that list a patient’s mutations and potential drugs to use, a report should rank therapies the way online travel sites rank best options.
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.”
Since the beginning of high school, Cancer Commons supporter Sheri Sobrato Brisson has been working with families facing pediatric illness. “As soon as I was 16, I started volunteering in hospitals with kids with cancer, not knowing that I would grow up one day to be one of those patients myself,” she says.
At the age of 24, Sheri faced her own diagnosis: a brain tumor. Now a long-term survivor—Sheri celebrates 30 years of survivorship on May 7—she continues to dedicate her time, energy, and resources to helping children with serious diseases and their families. Continue reading…
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.
Ask MIT Neuroscientist Dr. Nancy Kanwisher what the most fascinating discovery about the human brain is in her eyes; she’ll tell you there’s a part of our brain that is selectively turned on only when we’re thinking about what other people are thinking about us. Though it was Dr. Kanwisher’s student and now colleague who made this discovery, she considers it the “coolest” of discoveries about how various areas or regions of our brains contribute to our perception of the world.
Dr. Kanwisher is a professor in the Department of Brain and Cognitive Sciences and an investigator at the McGovern Institute for Brain Research, where she earned her Bachelor of Science degree in biology and PhD in brain and cognitive sciences. At MIT, Dr. Kanwisher uses brain imaging and behavioral testing to understand the mechanisms that underline the human experience. She says that in 1981, while working as a psychologist and studying for her PhD, she read an article about brain imaging, and was hooked on learning more and uncovering the magnificent mystery of the human brain. Continue reading…
Volunteers are essential members of the Cancer Commons community. We are deeply grateful to those who have generously donated their time to helping us change the way the world treats cancer.
This month, we celebrate the contributions of Cancer Commons volunteer Connor Sweetnam, who uses his engineering background to extract insights from our interactions with patients so they can be leveraged to help other patients. To learn more about his work, I interviewed Connor via email.
Can you tell me a bit about yourself?
I am the oldest of three boys and have come to call the Bay Area home. I graduated with a degree in biomedical engineering from the University of Southern California in May 2016 and now work as the Facilities Assistant for a cancer immunotherapy start-up named Alexo Therapeutics. I thoroughly enjoy reading, building things, watching college football, sports, snowboarding, backpacking, scuba diving, and traveling. As a next step, I’m thinking of going to graduate school in a field related to biotechnology or engineering.
How did you find out about Cancer Commons, and what made you want to volunteer?Continue reading…
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…