Conference Presentation, Panel
The Promise of the Cancer Moonshot
Milken InstituteKathy Hudson, Anna Barker, L. Michelle Bennett, Robert Bradway, Louis DeGennaro, Isla Garraway, Lou DiGennaro, Greg Simon, Tom Caleo, Jackie Brandwin, Greg Zuckerman, Laura Kalmos Nasser, Mike Hiltik, Noah Crafts
- The Vice President intends to spend the next 15 months driving progress, with the President aiming to establish the Cancer Moonshot foundation in the administration's final months.
- A proposal to allocate one billion dollars for the Cancer Moonshot is directed toward Congress for fiscal year 2017.
- The initiative aims to dismantle bureaucratic inertia dating back to the 1950s by shifting medical research culture and integrating patient preferences early in the research process.
- Efforts will address geographic health disparities by bringing trials to patients rather than requiring patients to travel, potentially catalyzing a decade or two of productivity similar to the Human Genome Project.
- New clinical trial models like iSpy2 and MATCH are projected to graduate drugs to Phase 3 trials in a timeframe significantly shorter than the 25 years typically required by previous methods.
- Regulators are expected to eventually waive control arms in cancer development trials, allowing patient enrollment in treatment arms with potential advantages over existing options.
- Project Data Sphere is anticipated to advance the field more rapidly than was possible without it, while the FDA is expected to incorporate diverse data sources, including real-world data, into evaluations.
- A new Partnership for Advancing Cancer Therapeutics will be created involving the government, private sector, and patient groups to convene academic, biotech, pharma, regulator, payer, and patient stakeholders.
- The Blue Ribbon Panel plans to generate two to three ideas per topic area to present ten candidates to the National Cancer Advisory Board, with a report to be finalized by year-end.
- The Genomic Data Commons is scheduled to launch on June 1st to aggregate NCI-funded trial data, with future plans to integrate data from Fitbits and electronic medical records (EMRs) and allow individuals to donate their EMR data.
- A citable data entity mechanism aims to alter academic reward structures to incentivize data sharing, with aggregate data sharing requirements for NIH-funded trials slated for implementation this summer.
- Statistical plans for preclinical research proposals will become mandatory to ensure robustness, and data from failed experiments will be unlocked to prevent the repetition of errors.
- Drug approvals and therapy combinations are expected to increase, following a baseline of 15 drug approvals in the prior year, with telemedicine-based trials predicted as a major advancement within the next five to 10 years.
- The initiative seeks to align goals across stakeholders to accelerate therapy development and adopt audacious metrics, such as driving sequencing costs to $1,000, comparable to those set by the Human Genome Project.
- Focus is placed on "exceptional opportunities" like glioblastoma multiforme (GBM), while basic science investments from the 1970s continue to drive long-term advances in a "marathon" approach.
- Compliance rates for sharing aggregate clinical trial data, currently described as "embarrassing," are expected to improve, and an open forum will be created to discuss experiment replication challenges.
- The strategy involves bringing in entities outside the United States to expedite the transition from idea to proof of concept and expanding the definition of real-world data to include sources like SEER to identify discrepancies between trial and real-world outcomes.