How much funding is going to go into this?
The White House has called for almost $1 billion to kick-start the initiative — $195 million available immediately for the National Institutes of Health, or NIH, and $755 million requested in the Fiscal Year 2017 budget proposal for the NIH and the U.S. Food and Drug Administration.
But Biden also has talked about other ways to speed progress besides funding. Describing himself as a “convener” and a relationship-builder, he wants to focus on:
- Breaking down silos and encouraging collaboration among researchers in different academic disciplines and different institutions as well as among researchers, patients and drug companies. One example Biden has used: Two different drug companies make two different drugs that treat the same cancer. Clinicians think the two would be most effective if combined —but getting approval to do so “is like … getting a nuclear deal with Iran.”
- Clearing regulatory red tape, with more efforts like the FDA’s Breakthrough Therapy Designation, which fast-tracks review and approval of promising treatments. As part of the initiative, the FDA will develop a virtual Oncology Center of Excellence to expedite the development of novel drugs and devices, including novel combination treatments.
So where are we now in the process?
In late January, the White House created a Cancer Moonshot Task Force chaired by Biden and made up of the heads of the NIH, the National Cancer Institute, the National Science Foundation, the FDA, the Defense and Veterans Administration departments and other federal agencies.
Even before the State of the Union announcement, Biden had met with almost 200 cancer researchers, physicians, patients and philanthropists. Since January, he has visited the University of Pennsylvania’s Abramson Cancer Center in Philadelphia to launch the moonshot and discuss immunotherapy, the Duke Cancer Institute and Duke University School of Medicine in Durham, North Carolina, to talk about standardizing data and increasing access to clinical trials, the Huntsman Cancer Institute in Salt Lake City to discuss big data and the UC San Francisco/Helen Diller Family Comprehensive Cancer Center in San Francisco for a round table on precision medicine. He has also talked tactics for sharing data and recruiting clinical trial participants at the World Economic Forum in Davos, Switzerland.
On Monday, Biden will meet with Fred Hutch President and Director Dr. Gary Gilliland and with Hutch and other Seattle researchers.
When will we see an 'action plan'?
If the moonshot initiative as announced was high on aspiration but short on details, the listening tour and other meetings are intended to guide Biden and the task force toward specific goals.
A still-to-be-named advisory panel of scientific experts is expected to produce detailed recommendations on how to accelerate cancer prevention, treatments and cures, improve patient access, support greater access to data and research, reduce regulatory barriers, ensure optimal investment of federal research dollars and promote public-private partnerships. Those recommendations are due in June.
But as far as Biden is concerned, the effort won’t stop there. In his blog post about the initiative, he wrote, “I want you to know that I’ll be focusing the rest of the time I have in office — and the rest of my life — on this effort.”
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