Biden, Cancer Groups Call for Collaboration to Hasten Advancesby and
Vice president introduces genetic database; asks for openness
Cancer groups push for more coordination in FDA reviews
Vice President Joe Biden called on cancer researchers and health organizations to set aside individual goals in treatment and research to work together on fighting the second-leading cause of death in the U.S.
Advances against the disease that kills more than half a million Americans every year will come faster if doctors, researchers and groups like the American Society of Clinical Oncology pool their efforts, Biden said at the annual meeting of ASCO, the largest gathering of cancer doctors in the world. Breakthroughs in detection and treatment are among the goals of the National Cancer Moonshot Initiative that Biden announced in January after the death of his son Beau from brain cancer. Earlier Monday, he announced a public database at the University of Chicago to compile “vast troves” of genomic data to improve research and individual patient outcomes.
“No single oncologist or cancer researcher can find the answers on his or her own,” Biden said in a speech at the conference in Chicago. “It requires somewhat of a change in mindset. It requires a lot more openness: open data, open collaboration, and above all, open minds.”
Cancer advocacy groups including ASCO focused their support on Biden’s call to create an Oncology Center for Excellence at the U.S. Food and Drug Administration that would speed drug development by promoting collaboration within the agency.
Personalized treatments often target genetic mutations in individual patients that must be identified with diagnostic devices, which can lengthen FDA reviews, cancer advocacy groups said in a letter to FDA Commissioner Robert Califf. They urged the agency to coordinate its reviews to move valuable products to market more quickly.
Separate FDA centers -- for chemical drugs, biologic drugs and devices -- use their own policies, application types and tracking systems that can create additional work and make communication difficult, the groups said in the letter. While the agency established an office in 2002 to coordinate its centers’ work, the Moonshot’s Oncology Center of Excellence aims to create a “one-review” process that would streamline product evaluations.
The 27 groups that signed the letter include ASCO, the American Cancer Society Cancer Action Network, and Friends of Cancer Research.
“The science is so complicated today, and the issue is to really have a much more rapid, much more integrated approach -- to have the disease experts work together,” Ellen Sigal, founder and chairwoman of Friends of Cancer Research, said in an interview.
The Oncology Center of Excellence will help FDA and industry eliminate redundancies in the application process for a new treatment, try out new clinical trial designs and develop new ways to measure the patient experience, the groups wrote. Companies developing diagnostic devices as companions to drugs would have earlier access to FDA’s cancer experts, allowing drugs and diagnostics to reach the market together, Sigal said.
Other Disease Types
Planning meetings have begun internally among top officials at the FDA on the center, and the agency is holding sessions to gain input from advocacy groups and pharmaceutical and device manufacturers, said Sarah Peddicord, an agency spokeswoman.
The effort may also be a jumping off point where eventually the coordinated approach could be used for other areas including cardiovascular and neurodegenerative diseases.
Cancer comes hundreds of different variations, and each of them is unique and frightening in its own manner, Biden said. Still, as doctors learn what works and what doesn’t, the collective approach will make the biggest difference, he said.
“There has to be a better way,” Biden said. “The answer has to come from you.”
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