Partnership for Accelerating Cancer Therapies (PACT)

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PACT RFA | Clinical Trial Submission


About 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 is nitially focusing 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.


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.



  • 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

Scientific Publications

The Partnership for Accelerating Cancer Therapies. Baker R, Hoos, A, Adam S, Wholley, D et al. The Cancer Journal. 2018 May/June; 24(3).180036 doi:10.1097/PPO.0000000000000321 


Trends in Cancer (February 2019): It Is a Capital Mistake to Theorize Who to Treat with Checkpoint Inhibitors before One Has Data.

Cancer Discovery (October 5, 2018): A Rethink for IO Biomarkers

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


  FNIH RFA #2018-PACT001 - Novel Biomarkers - CLOSED

Release Date: December 15, 2019

Deadline for Submissions: The deadline for RFA submission has passed.

PACT, through the FNIH, is soliciting proposals in support of the development of novel exploratory biomarker assays, which can utilized within PACT and across the research community. This RFA will assist in driving promising novel biomarkers and assays toward analytical and clinical validation and eventually regulatory approval. This first RFA is targeted to very focused areas within the fields of liquid biopsy, tumor microenvironment, and the microbiome that can assist clinicians in accurately predicting response to immuno-oncology interventions. Deadline for submissions has passed.

Clinical Trial Submissions
PACT Clinical Trial Intake Form 
Appendix A - Additional Guidance
Appendix B - PACT Assays List
Appendix C - PACT Policies
Appendix E - PACT Specimen Collection and Processing

FNIH RFA #2020-PACT001 - Call for Clinical Trials

Release Date: March 5, 2020
Final Deadline for Submissions: January 31, 2022
Call for Trials RFA

PACT, through the FNIH, is soliciting clinical trials to partner with the PACT initiative to provide biospecimens for exploratory deep immunoprofiling analysis with the CIMAC-CIDC Network. The data from this immunoprofiling, along with the necessary de-identified clinical data from the trials, will be placed into the CIDC to continue to build a large body of standardized immunoprofiling data that can be used to validate existing biomarkers for clinical trial and regulatory use, and importantly, to develop new validated biomarkers for these purposes. Development and validation of these biomarkers will allow the immuno-oncology field to more accurately pair patients with novel immunotherapies being developed. Review of clinical trial applications will be held on a rolling basis, with a final deadline for submission of January 31, 2022.

Documentation Required for Submission

PACT Clinical Trial Intake Form
Trial Informed Consent Form

Additional Information

Appendix A - Additional Guidance
Appendix B - PACT Assays List
Appendix C - PACT Policies
Appendix D - PACT Guidelines
Appendix E - Umbrella Specimen Collection and Processing Protocol


Public-Sector Partners
National Cancer Institute (NCI)
National Institutes of Health (NIH)
U.S. Food and Drug Administration (FDA)

Private-Sector Partners
AbbVie Inc*
Boehringer-Ingelheim Pharma GmbH & Co. KG*
Bristol-Myers Squibb*
Celgene Corporation*
Genentech, a member of the Roche Group*
GlaxoSmithKline plc*
Janssen Research & Development LLC*
Novartis Institutes for BioMedical Research, Inc.*
Pfizer Inc*

*Provides financial or in-kind support for this program

FNIH Contacts

Stacey Adam, Ph.D., Director, Cancer, Research Partnerships,

Jenny Peterson-Klaus, M.S, Senior Scientific Project Manager, Cancer,

Courtney Southard, Scientific Project Manager, Cancer,