White House Seeks $215 MM for Precision Medicine Initiative


From DCAT Value Chain Insights (VCI)

By Regulatory News posted 01-30-2015 14:28

  

Following up on his recent announcement in the State of the Union Address, President Barack Obama provided details about the Precision Medicine Initiative, a new research effort to facilitate the development of personalized medicine approaches. The President's Fiscal Year 2016 Budget calls for $215 million in funding to the National Institutes of Health (NIH), together with the Food and Drug Administration (FDA), and the Office of the National Coordinator for Health Information Technology (ONC) to support the initiative.

The budget request calls for the following:

  • $130 million to NIH for development of a voluntary national research cohort of a million or more volunteers to propel our understanding of health and disease and set the foundation for a new way of doing research through engaged participants and open, responsible data sharing.
  • $70 million to the National Cancer Institute (NCI), part of the NIH, to scale up efforts to identify genomic drivers in cancer and apply that knowledge in the development of more effective approaches to cancer treatment.
  • $10 million to the FDA to acquire additional expertise and advance the development of high quality, curated databases to support the regulatory structure needed to advance innovation in precision medicine and protect public health.
  • $5 million to the ONC to support the development of interoperability standards and requirements that address privacy and enable secure exchange of data across systems.

In a statement, the White House outlined the key objectives of the Precision Medicine Initiative:

  • More and better treatments for cancer: The NCI will accelerate the design and testing of effective, tailored treatments for cancer by expanding genetically based clinical cancer trials, exploring fundamental aspects of cancer biology, and establishing a national “cancer knowledge network” that will generate and share new knowledge to fuel scientific discovery and guide treatment decisions.
  • Creation of a voluntary national research cohort: The NIH, in collaboration with other agencies and stakeholders, will launch a national, patient-powered research cohort of one million or more Americans who volunteer to participate in research. Participants will be involved in the design of the Initiative and will have the opportunity to contribute diverse sources of data—including medical records; profiles of the patient’s genes, metabolites (chemical makeup), and microorganisms in and on the body; environmental and lifestyle data; patient-generated information; and personal device and sensor data. The cohort will be broadly accessible to qualified researchers and will have the potential to inspire scientists from multiple disciplines to join the effort and apply their creative thinking to generate new insights.The ONC will develop interoperability standards and requirements to ensure secure data exchange with patients’ consent and advance individual, community, and population health.
  • Commitment to protecting privacy: To ensure from the start that this Initiative adheres to rigorous privacy protections, the White House will launch a multi-stakeholder process with the US Department of Health and Human Services and other federal agencies to solicit input from patient groups, bioethicists, privacy, and civil liberties advocates, technologists, and other experts in order to identify and address any legal and technical issues related to the privacy and security of data in the context of precision medicine.
  • Regulatory modernization: The Initiative will include reviewing the current regulatory landscape to determine whether changes are needed to support the development of this new research and care model, including its critical privacy and participant protection framework. As part of this effort, the FDA will develop a new approach for evaluating next-generation sequencing technologies—tests that rapidly sequence large segments of a person’s DNA, or even their entire genome. The new approach will facilitate the generation of knowledge about which genetic changes are important to patient care and foster innovation in genetic sequencing technology, while ensuring that the tests are accurate and reliable.
  • Public-private partnerships: The Administration said it will seek to forge strong partnerships with existing research cohorts, patient groups, and the private sector to develop the infrastructure that will be needed to expand cancer genomics and to launch a voluntary million-person cohort. The Administration said it will call on academic medical centers, researchers, foundations, privacy experts, medical ethicists, and medical product innovators to lay the foundation for this effort, including developing new approaches to patient participation.

Source: The White House

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