Precision Medicine: U.S. Gov't Initiatives

President Obama, January 30, 2015

"The White House Cancer Moonshot Task Force, chaired by Vice President Joe Biden, will focus on making the most of federal investments, targeted incentives, private sector efforts from industry and philanthropy, patient engagement initiatives, and other mechanisms to support cancer research and enable progress in treatment and care."

"The FDA has published two draft guidances proposing methods to streamline oversight of Next Generation Sequencing (NGS)-based tests. These tests are capable of rapidly identifying or ‘sequencing’ large sections of a person’s genome and are important advances in the clinical applications of precision medicine. The new guidances provide adaptability and flexibility that test developers need to innovate in this dynamic field while still enabling the FDA to meet its mandate of ensuring that tests are safe and effective."

The Blue Ribbon Panel report presented to the National Cancer Advisory Board on September 7, 2016.

"CGCI supports cutting-edge genomics research on adult and pediatric cancers. Researchers develop and apply advanced sequencing and other genome-based methods to identify novel genetic abnormalities in tumors. The extensive genetic profiles generated by CGCI may inform better cancer diagnosis and treatment."

"CTD2 bridges the gap between the enormous volumes of data generated by genomic characterization studies and the ability to use these data for the development of human cancer therapeutics. It specializes in computational and functional genomics approaches critical for translating next-generation sequencing data, as well as high-throughput and high content small molecule and genetic screens."

"The National Cancer Institute's (NCI) Center for Cancer Genomics (CCG) unifies NCI's activities in cancer genomics by aiming to synthesize research in different fields of cancer genomics – structural, functional, and computational – to improve patient outcomes. CCG programs and collaborations generate cancer genomic and clinical data, and make these data available for widespread use by the research community."

"These listings include slide sets for clinicians, press launch materials, as well as other information about the trials.

"The Precision Medicine Initiative® (PMI) is a $215 million investment in President Obama’s Fiscal Year 2016 Budget to accelerate biomedical research and provide clinicians with new tools to select the therapies that will work best in individual patients. The PMI’s $70 million in funding for NCI is being used to advance the field of precision oncology."

"TARGET applies a comprehensive genomic approach to determine molecular changes that drive childhood cancers. Investigators form a collaborative network to facilitate discovery of molecular targets and translate those findings into the clinic. TARGET is managed by NCI’s Office of Cancer Genomics and Cancer Therapy Evaluation Program."

"The PMI Cohort Program will seek to extend precision medicine to all diseases by building a national research cohort of one million or more U.S. participants."

"TCCs for health disparities research exploring the potential for precision medicine to promote health equity and advance the science of minority health and health disparities."

"The Broad's Cancer Program is a scientific community focused on understanding the basic molecular mechanisms of cancer and applying this knowledge to transform the practice of cancer medicine."

Clinical Pharmacogenetics Implementation Consortium (CPIC) of the Pharmacogenomics Research Network and the Pharmacogenomics Knowledge Base (PharmGKB).

"The Personalized Medicine Coalition (PMC), representing innovators, scientists, patients, providers and payers, promotes the understanding and adoption of personalized medicine concepts, services and products to benefit patients and the health system."

"The TAPUR study is a non-randomized clinical trial that aims to describe the performance (both safety and efficacy) of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant."