By Megan Anderson Brooks, Senior Policy Associate and Lindsey Trischler, Public Policy Fellow
This week the National Institutes of Health (NIH) officially kicks off the Precision Medicine Initiative by hosting a workshop on Building a Precision Medicine Research Cohort. The Initiative, announced by President Obama during his State of the Union Address, promises to advance precision medicine, also known as personalized medicine, to equip patients and health care providers with better tools, knowledge, and therapies to select the most effective treatments. The Initiative will involve a large scale effort to increase discoveries made in genomics as well as emerging methods for managing and analyzing large data sets. During the two day workshop, thought leaders in the many disciplines and sectors surrounding the ambitious project will begin exploring the opportunities and challenges related to one of the Initiative’s major goals - building a large research cohort of the genetic information of one million or more American volunteers.
President Obama deepened his commitment to the Precision Medicine Initiative by allocating $215 million to its efforts in his 2016 budget. While Congress has yet to confirm that it would appropriate this amount to the project, if the President’s plan is accepted, then NIH would receive the largest portion of the investment. A predesignated $130 million would specifically go to the establishment of the national research cohort. Through collaboration with other agencies and stakeholders, this cohort will work to broaden our understanding of disease while laying the cornerstones for a new approach toward engaging patients in both research and open and responsible data sharing.
NIH Director Francis Collins noted while outlining the NIH’s portion of the President’s budget request that “…there is still a whole lot of information to work out. We are building on what we know. We need to test precision therapies. When drug resistance happens, why is that? Are there ways to predict tumor recurrence? We plan to expand all this knowledge in the longer term.”
The cohort will utilize already existing clinical and research networks while continuing to build research models that enable patients to be active participants in the search for better treatments. Increased data sharing also requires an increased commitment to protect patient privacy. Collaborative efforts between several federal agencies, including the NIH, will seek input from patient groups, bioethicists, privacy and civil liberties advocates, technologists and a variety of other experts to identify and address issues of legality when it comes to privacy and security of data.
In the near term, a great deal of resources will be devoted to cancer research with the hope of identifying new cancer subtypes and therapeutic targets, test precision therapies, and expanding understanding of therapeutic response. The President requested $70 million for the National Cancer Institute (NCI) to invest in this work. Researchers will have the opportunity to take a more in-depth look at the genomic drivers in cancer, and apply this insight to create more effective treatments. By expanding their genetically-based cancer clinical trials, NCI will work to accelerate the design and testing of successful individualized treatments for cancer. Additionally, the establishment of a “cancer knowledge network” aims to produce and share this new knowledge to fuel more scientific discovery while guiding treatment decisions.
The Food and Drug Administration (FDA) would use its $10 million allotment of the President’s request to increase the development of high quality databases that support the regulatory structure necessary to continue the advancement of innovation in precision medicine while protecting public health. FDA is already planning to create a new way to evaluate Next Generation Sequencing (NGS) technologies, which allow a large portion of a person’s DNA or the entire genome to be quickly sequenced. FDA will host a workshop on February 20 to discuss its approach to genetic tests.
The remaining $5 million would go to the Office of the National Coordinator for Health Information technology (ONC) for the development of interoperability standards which address patient privacy and establish a secure exchange of data across systems.
The NIH workshop this week marks the beginning of the Initiative’s plans to cultivate strong partnerships among already established cohorts, patient groups, and the private sectors to bring more effective treatments to patients. Upon the President’s budget release, Administration vowed to carefully consider its approach to advancing the field of precision medicine. Many entities and interests will have to come together to ensure that the genetic information of such a large cohort can be safely and accurately studied while protecting the privacy of patients in a way that empowers individuals and families to invest in this opportunity to better our approach to medicine.