Partnership for Accelerating Cancer Therapies (PACT)

Overview

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 MoonshotSM Research Initiatives. PACT is focused on efforts to identify, develop and validate robust biomarkers to advance new therapies and treatments that harness the immune system to attack cancer. The FNIH manages the partnership, with FDA serving in an advisory role.

Immune therapies have been effective in treating certain cancers. Biopharmaceutical companies have focused investments in these therapies, seeking to provide new options for patients who do not respond to other cancer therapies – yet these immune treatments do not work for all patients. Development and standardization of biomarkers to understand how immunotherapies work in some patients, and thus to predict patient responses to treatment, are urgently needed for these therapies to benefit the maximum number of people.

PACT facilitates systematic and uniform clinical testing of biomarkers to advance understanding of the mechanisms of treatment response and resistance to these immunotherapies. The research conducted under the partnership also defines a set of standardized assays to be tested across a variety of studies, aiming to integrate immune and other related oncology biomarkers into clinical trials. This approach supports harmonization of assays and allows for consistent generation of data to enable data reproducibility and comparison of data across trials, and fosters discovery and validation of new biomarkers for immunotherapy and related combinations. PACT also facilitates information sharing by stakeholders across government, academia and industry to better coordinate clinical efforts, align investigative approaches, eliminate duplicative efforts and support execution of more high-quality trials.

CIMAC-CIDC Network

The CIMAC-CIDC Network is a key 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 – use analytically validated and standardized platforms to conduct a wide range of cutting-edge analyses for genomic, phenotypic and functional characterization of patient responses during early-phase clinical trials. The Cancer Immunologic Data Commons (CIDC), hosted by Dana-Farber Cancer Institute, provides bioinformatics support, optimizes data collection methodologies suitable for immune-related biomarkers, integrates data for the network and establishes a biomarker database for secondary use by the larger immune oncology research community.

• CIMAC-CIDC Website

PACT Partnership Goals

• Provide a set of basic biomarker modules for uniform clinical application.
• Establish a network of core laboratories to coordinate, conduct, validate and standardize biomarker assays. 
• Fund the development of standardized biomarkers for immune profiling and highly relevant exploratory biomarker assays.
• Incorporate biomarkers and data collection standards into selected clinical trials and coordinate the broader adoption of these biomarkers and standards across the immuno-oncology community.
• Create a comprehensive database that integrates biomarker and clinical data to enable pre-competitive correlative biomarker analyses.
• Facilitate information sharing by stakeholders across government, academia and industry to better coordinate clinical efforts, align investigative approaches, eliminate duplicative efforts and support execution of more high-quality trials.