The Role of Public-Private Partnerships in the Cancer Moonshot: How PACT can Transform Cancer Immunotherapy Clinical Trials

By David Wholley, M.Phil, Senior Vice President of Research Partnerships at the Foundation for the National Institutes of Health (FNIH).

September 21, 2018 - Today, Vice President Joe Biden and Dr. Jill Biden are hosting the national Biden Cancer Summit in Washington, D.C. This event is one of more than 350 Biden Cancer Community Summits convening across the country to bring together patients and caregivers with the scientific community to help promote new solutions for tackling cancer and share stories of the tremendous resilience and strength shown by those who have been touched by the disease and remain #CancerFIERCE. As head of Research Partnerships at the Foundation for the National Institutes of Health (FNIH), I am delighted to be a part of the Biden Cancer Summit and share details of the Partnership for Accelerating Cancer Therapies (PACT) —an extraordinary collaboration that has brought together academia, government, not-for-profits and industry to accelerate the development of new cancer immunotherapy treatments.

Cancer is personal to so many of us: almost every one of us knows someone who has been affected by this devastating disease. According to the National Institutes of Health (NIH), cancer remains the leading cause of death worldwide. In the United States alone, about 1.7 million new cases of cancer will be diagnosed, and more than 609,000 people will die from the disease in 2018. While tremendous advances in knowledge and treatment have occurred, they have been accompanied by an explosion of relevant scientific data and an increasingly complex treatment landscape.

Recently, for example, new immunotherapies have resulted in very promising responses to treatment in certain types of cancer, leading to a dramatic increase in the number of immunotherapy clinical trials. However, emerging data suggest that each of these new therapies—whether immunotherapy, monotherapy or a combination therapeutic approach—will only be efficacious in specific patient populations. Discovery of which immunotherapy to pair with each patient population is complicated by the sheer number of possible combinations, high biologic complexity and the need for new biomarkers and assays to guide which patients should receive a combination. Ultimately, the development and standardization of biomarkers to understand how immunotherapies work in some patients and to predict their response to treatment are urgently needed if these therapies are to be used most effectively for the patients that need them. This in turn requires the timely generation and rigorous analysis of substantial data from clinical trials, and the consensus of scientists from all corners of the cancer research world on the significance of the results.

A scientific and organizational challenge as complex as this cannot be addressed effectively by any one organization acting alone. It requires the energy and intellectual and financial resources of multiple partners working together in close collaboration. At the Summit, I will have the honor of meeting with Vice President Biden to discuss PACT. In February 2018, the NIH, the FNIH and 12 pharmaceutical companies* launched PACT to identify and develop robust, standardized biomarkers and assays that will support selection and clinical testing of promising immune-oncology (IO) and combination therapies. This $220 million pre-competitive research partnership is managed by the FNIH, with the Food and Drug Administration.

PACT includes a $160 million Cancer Moonshot investment by National Cancer Institute (NCI) to create Cancer Immune Monitoring and Analysis Centers (CIMACs) at four nationally recognized cancer research centers and to establish a central database, the Cancer Immunologic Data Commons (CIDC), at the Dana-Farber Cancer Institute. It will also support NCI clinical trial networks where patients can participate in cutting-edge immunotherapy trials. The FNIH has raised an additional $60 million for the partnership from industry, which will be used to expand on the capabilities funded through NIH. Working together, the partners in PACT promise to develop robust, systematic, uniformly conducted clinical biomarker tests that enable researchers and clinicians to better understand mechanisms of response and resistance to IO agents. This includes standardizing existing biomarker assays and developing new, exploratory markers and assays so they can be used effectively in clinical trials conducted anywhere in the cancer field. PACT also is providing scientific coordination by sharing results and information across the IO field and aligning investigative approaches to avoid duplication of effort, share resources, and enable the conduct of more relevant high-quality trials.

PACT is a significant step forward in ensuring that new immunotherapies find their way to patients that will benefit the most and to developing even more powerful treatments that harness the immune system and that target specific molecular pathways to attack cancer. We are proud to be working as partners to leverage the collective expertise, capabilities and resources necessary to make these promising advances in cancer research, and hopefully transform the lives of cancer patients.

 

*AbbVie, Amgen, Boehringer-Ingelheim Pharma GmbH & Co. KG, Bristol-Myers Squibb, Celgene Corporation, Genentech (a member of the Roche Group), Gilead, GlaxoSmithKline plc, Janssen Pharmaceutical Companies of Johnson & Johnson, Novartis Institutes for Biomedical Research, Pfizer Inc and Sanofi.

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