Partnership for Accelerating Cancer Therapies (PACT)

The Partnership for Accelerating Cancer Therapies (PACT) is a five-year public-private research collaboration totaling $220 million launched by the National Institutes of Health, the FNIH and 12 leading pharmaceutical companies 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 FNIH, with the Food and Drug Administration 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 do not 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.

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.

Goals

  • Providing a set of basic biomarker modules for uniform clinical application.
  • Establishing a network of 3–5 core laboratories to coordinate, conduct, validate, and standardize biomarker assays. Funding the development of standardized biomarkers for immunoprofiling and exploratory biomarker assays of high relevance.
  • Incorporating biomarkers and data collection standards into trials prioritized through PACT and coordinating their adoption broadly across the IO research community.
  • Creating a comprehensive database that integrates biomarker and clinical data to enable pre-competitive correlative biomarker analyses.
  • Provide scientific coordination by facilitating information sharing by all stakeholders to better coordinate clinical/translational oncology programs, align investigative approaches, avoid duplication of effort, share resources, and enable more relevant high-quality trials to be conducted.

Results & Accomplishments

Media

FNIH Announcement (Sept. 21, 2018): The Role of Public-Private Partnerships in the Cancer Moonshot: How PACT can Transform Cancer Immunotherapy Clinical Trials 

NIH Press Release (Oct. 12, 2017): NIH partners with 11 leading biopharmaceutical companies to accelerate the development of new cancer immunotherapy strategies for more patients

Project Resources

The CIMAC-CIDC Network is a critical component of the PACT project. The four Cancer Immune Monitoring and Analysis Centers (CIMACs), at Dana-Farber Cancer Institute, Stanford University, MD Anderson, and Mount Sinai, will be responsible for providing a wide range of state-of-the-art analyses for genomic, phenotypic and functional characterization of responses of patients in early phase clinical trials using analytically-validated and standardized platforms.The Cancer Immunologic Data Commons (CIDC), hosted by Dana-Farber Cancer Institute, will serve the bioinformatics needs of the network, optimization of data collection methodologies suitable for immune-related biomarkers, data integration and building a biomarker database for the secondary use by the large immuno-oncology community.

CIMAC-CIDC Website

Partners

AbbVie
Amgen
Boehringer-Ingelheim Pharma GmbH & Co. KG
Bristol-Myers Squibb
Celgene Corporation
Genentech, a member of the Roche Group
Gilead
GlaxoSmithKline plc
National Cancer Institute
National Institutes of Health
Janssen Pharmaceutical Companies of Johnson & Johnson
Novartis Institutes for Biomedical Research
Sanofi
Pfizer Inc
U.S. Food and Drug Administration

Contacts

Please contact the FNIH Development Office at Development@fnih.org.