Capitalizing on Collaboration – The President’s Precision Medicine Initiative

29 February 2016 Personalized Medicine Bulletin Blog

Last week President Obama marked the one year anniversary of his Precision Medicine Initiative (“PMI”) by holding a web-accessible panel discussion where he and interested stakeholders discussed his PMI initiative, its progress and future direction. The President also announced a series of awards, funded by the National Institutes of Health (“NIH”), to build the infrastructure and data collection tools necessary to support the voluntary research cohort who will share health, familial and genetic information. (For more information on the voluntary research cohort, see my prior post of January 26, 2016).

Private-Public Partnerships

The PMI initiative is not limited to the public sector. The President announced that more than 40 private-sector organizations made commitments to PMI. Several public-private partnerships were announced to advance the PMI:

Vanderbilt University in collaboration with Verily (formerly Google Life Sciences) received a grant to lay the foundation for a national community of 1 million or more U.S. volunteers who will partner with researchers to share personal health data;

The NIH and the Health Resources and Services Administration will partner with several health centers to develop, pilot, and refine approaches to engaging underserved and underrepresented individuals, families, and communities to ensure diversity in the data collected to support PMI;

The NIH and the Office of the National Coordinator for Health IT will create “Sync for Science” pilots through an open standards development process with electronic health record developers Allscripts, athenahealth, Cerner, drchrono, Epic and Mckesson;

The Office of the National Coordinator for Health IT and the National Institute of Standards and Technology (NIST), will develop a precision medicine-specific guide to the NIST Cybersecurity Framework to obtain individual input on best practices in security and data management for precision medicine;

The Department of Veterans Affairs and the Department of Defense will expand a participant-driven research cohort with more than 450,000 veteran enrollees; and

The Food and Drug Administration announced the launched its first precisionFDA challenge, which will use the new precisionFDA platform to encourage the genomics community to advance quality standards and achieve more consistent and accurate DNA test results.

Progress for Personalized Medicine

The President’s PMI received additional commitments from the private sector to enable patient-access to and the sharing of their data. Several notable examples include, for example: Allscripts, athenahealth, Cerner, crchrono, Epic and Mckesson reported that they will pilot the use of open, standardized application programming interface (“API’) to allow patient’s access to their own electronic health records;

Carolinas Healthcare System will use a new mobile application that allows patients to view their data from multiple devices. Get My Data is a newly formed not-for-profit group organized to raise public awareness of the right of individuals to access and control their data;

The University of California Health System announced its commitment to giving patients the tools to download their health data from any of the five UC Health medical systems;

Foundation Medicine also announced it is releasing the world’s largest, real-world genomics dataset of common and rare pediatric cancers to help develop targeted therapies specifically for pediatric cancer;

IBM and New York Genome Center committed to creating a comprehensive, open cancer data repository, using cognitive insights from IBM’s Watson computer system to accelerate cancer research and scale access to precision medicine. The project will begin with a pilot to sequence tumors from 200 cancer patients and compare how different types of sequencing inform and improve cancer care;

Inova Health System, a non-profit healthcare system serving more than 2 million people per year, announced that it will set up a new venture investment fund in excess of $100 million focused exclusively on precision medicine;

Intel also announced a precision medicine initiative, the Precision Medicine Acceleration Program, to develop and release an open source proof of concept for data center infrastructure to support processing, storage, and analysis of large precision medicine data sets; and

Microsoft reported that by the end of this year, it will host large, open genomics data sets on the Microsoft Azure cloud platform at no cost.

Clinical Adoption of Precision Medicine

Progress is not limited to enabling tools for precision medicine. Several significant clinical programs were announced. The Multiple Myeloma Research Foundation (MMRF), announced the MMRF Patient Journey Initiative to educate tens of thousands of patients and their families on the critical steps in the patient journey and the actions they can take to maximize their precision care from diagnosis through the course of their disease. St. Elizabeth Healthcare plans to assess and operationalize the use of a precision medicine pharmacogenomics test to identify the specific type and dosage of medicine to prescribe based on the patient’s genetic profile.

Stanford Medicine announced its plant to launching a consultative pharmacogenetics practice in 2016 so that physicians can refer patients with unusual drug responses or with a family history of unusual responses. University of Arizona Health Sciences (UAHS) committed to $22 million to expand the clinical utility of its open-source, patient-centric analytic methods to aid physicians in interpreting disease-associated gene expression changes arising from patients’ own DNA blueprint. UAHS also announced the three new precision medicine initiatives. The first is an on-demand “case-based reasoning” system that intelligently searches and analyzes entire databases of electronic medical records. The second is the development of genetic assays to predict an individual’s response to therapy and prevention of adverse reactions. The third is a partnership with five other institutions to advance the Sanford Pediatric Genomics Consortium to improve health care decision-making through better understanding and integration of genomic evidence.

And There’s More…

Many additional programs were announced by the White House that support and promote the President’s initiative. A full summary of the initiatives is found on the White House web page, accessible here. The initiative’s scope, depth and commitments from the public and private sectors virtually ensure its success to the benefit of our nation’s future health.

This blog is made available by Foley & Lardner LLP (“Foley” or “the Firm”) for informational purposes only. It is not meant to convey the Firm’s legal position on behalf of any client, nor is it intended to convey specific legal advice. Any opinions expressed in this article do not necessarily reflect the views of Foley & Lardner LLP, its partners, or its clients. Accordingly, do not act upon this information without seeking counsel from a licensed attorney. This blog is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Communicating with Foley through this website by email, blog post, or otherwise, does not create an attorney-client relationship for any legal matter. Therefore, any communication or material you transmit to Foley through this blog, whether by email, blog post or any other manner, will not be treated as confidential or proprietary. The information on this blog is published “AS IS” and is not guaranteed to be complete, accurate, and or up-to-date. Foley makes no representations or warranties of any kind, express or implied, as to the operation or content of the site. Foley expressly disclaims all other guarantees, warranties, conditions and representations of any kind, either express or implied, whether arising under any statute, law, commercial use or otherwise, including implied warranties of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Foley or any of its partners, officers, employees, agents or affiliates be liable, directly or indirectly, under any theory of law (contract, tort, negligence or otherwise), to you or anyone else, for any claims, losses or damages, direct, indirect special, incidental, punitive or consequential, resulting from or occasioned by the creation, use of or reliance on this site (including information and other content) or any third party websites or the information, resources or material accessed through any such websites. In some jurisdictions, the contents of this blog may be considered Attorney Advertising. If applicable, please note that prior results do not guarantee a similar outcome. Photographs are for dramatization purposes only and may include models. Likenesses do not necessarily imply current client, partnership or employee status.