- Posted by ISPE Boston
- On June 7, 2018
In October 2017, the NIH and 11 leading biopharmaceutical companies launched PACT (the Partnership for Accelerating Cancer Therapies), a five-year public-private research collaboration totaling $215 million as part of the Cancer Moonshot. PACT will initially focus on efforts to identify, develop and validate robust biomarkers — standardized biological markers of disease and treatment response — to advance new immunotherapy treatments that harness the immune system to attack cancer. The partnership will be managed by the Foundation for the National Institutes of Health (FNIH), with the FDA serving in an advisory role.
New immunotherapies have resulted in dramatic responses in certain cancer cases. They have also been the focus of intense investment by biopharmaceutical companies seeking to provide new options for patients who do not respond to other cancer therapies, but they don’t work for all patients. Development and standardization of biomarkers to understand how immunotherapies work in some patients, and predict their response to treatment, are urgently needed for these therapies to provide benefit to the maximum number of people.
“We have seen dramatic responses from immunotherapy, often eradicating cancer completely for some cancer patients,” said NIH Director Francis S. Collins, M.D., Ph.D. “We need to bring that kind of success — and hope — for more people and more types of cancers, and we need to do it quickly. A systematic approach like PACT will help us to achieve success faster.”
PACT will facilitate systematic and uniform clinical testing of biomarkers to advance our understanding of the mechanisms of response and resistance to cancer therapy. The research conducted under the partnership will also integrate immune and other related oncology biomarkers into clinical trials by defining a set of standardized biomarkers to be tested across a variety of studies. This approach will allow for consistent generation of data, uniform and harmonized assays to support data reproducibility, comparability of data across trials, and discovery and validation of new biomarkers for immunotherapy and related combinations. PACT will also facilitate information sharing by all stakeholders to better coordinate clinical efforts, align investigative approaches, reduce duplication and enable more high-quality trials to be conducted.
PACT partners include AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Genentech, Gilead Sciences, GlaxoSmithKline, Janssen Pharmaceutical, Novartis and Pfizer. Additional support has been provided by the Pharmaceutical Research and Manufacturers Association (PhRMA). The 11 partner organizations will contribute up to $1 million per year for five years through the FNIH for a total private sector contribution of $55 million. NIH will contribute $160 million over the five years of the partnership, pending availability of funds. (Source: NIH Website, 12 October, 2017)