In March, we wrote about the “Cancer Moonshot” Initiative that was announced as part of President Obama’s 2016 State of the Union Address. Headed by Vice President Joe Biden, the aim of the initiative was to facilitate collaboration in cancer research, treatment, detection and prevention and to facilitate a decade’s worth of advances over the next five years.
At the end of June, Vice President Biden convened a one-day “Cancer Summit” to encourage support for this effort, with dozens of regional summits held at the same time. As part of the event, a number of new and ongoing projects were discussed aimed at furthering collaboration, improving and streamlining regulatory oversight, and increasing patient and oncologist information and access to clinical trials. Some of key developments that are underway include:
- The FDA Center for Excellence in Oncology. Right now, cancer drugs and proteins fall under jurisdiction of one FDA division; cell therapies and viruses, another; and diagnostics and medical devices, a third. The overall structure and goals of the new Center for Excellence, which will be led — at least initially — by Dr. Richard Pazdur, director of the office of oncology drug products, have yet to be set. But regulatory power over all of these product approaches as they affect the diagnosis and treatment of cancer, including data-enabled devices, will be consolidated under this new umbrella at FDA.
- Giving Researchers Better Access to Investigational Drugs. The National Cancer Institute is working with pharmaceutical and biotechnology companies to give researchers faster access to investigational drugs for combination studies through one pre-approved “formulary,” rather than requiring researchers to negotiate with individual drug developers for drug access. NCI has reportedly already met with over 20 companies and hopes to have the arrangement in place by year-end.
- Giving Patients and Oncologists Better Access to Knowledge and Clinical Trials. A number of programs are in development or underway to make it easier for patients and oncologists to find information on potential useful therapies and appropriate clinical trials.
The NCI is redesigning the search function on its Cancer.Gov site, making it easier to look for appropriate studies. A number of regional efforts to improve clinical trial access are also underway, such as that of the Oncology Precision Network, whose initial members include Intermountain Healthcare, Stanford Cancer Institute, Providence Health & Services, and Syapse. Their aim is to share data, including cancer genomics data, with a goal of bringing new cancer treatment insights to patients and physicians and increasing access to clinical trials. The current data sharing and trial information extends across 11 states, 79 hospitals and 800 clinics, and their aim is to add 5 new healthcare systems over the coming year to expand access to additional geographic regions.
Additionally, IBM is loading its “Watson for Genomics Technology” to the U.S. Department of Veteran’s Affairs to analyze the genomes of 10,000 cancer patients, to better bring precision oncology approaches and access to clinical trials to cancer patients within the VA medical system.
Collaborations within the “Moonshot” are also being broadened internationally. On July 16, Vice President Biden announced three Memoranda of Understanding (MOU) signed between the NCI and several leading Australian research institutions aimed at sharing an international dataset from more than 8,000 U.S. patients and 50,000 Australians by 2021. These agreements will establish a new collaboration to facilitate the sharing of cancer‐associated clinical research data, genetic and other molecular information (DNA, RNA, and protein), targeted tests, and the subsequent public dissemination of products and data to the research community. Cancer Research UK has also announced an effort to team with NCI and University of Southern California (USC) to develop new liquid biopsy approaches capable of detecting lung and bowel cancers at an earlier stage.
Here at Bionest, we are looking forward to seeing how these initiatives will shape the future oncology landscape. We believe that information sharing – from genomic data to patient empowerment and education – will be a key driver of growth and innovation within oncology.