Precision Medicine Initiative

On January 30, 2015, the Precision Medicine Initiative was announced by President Obama. Many in our field, researchers and clinicians alike, recognize that such a program would bring additional funding into our space to design, develop and implement new diagnostic tests that are aiding physicians in their practice of precision medicine. Here is what we know.

Led by the National Institutes of Health (NIH), the President’s initiative intends to fund research and facilitate collaborative public-private efforts to leverage advances in genomics. It would involve stakeholders in healthcare as well as the Food and Drug Administration (FDA), Health and Human Services (HHS) and the Office of the National Coordinator for Health Information Technology (ONC). It also intends to recruit expertise from multiple sectors and forge partnerships with existing research cohorts, patient groups and the private sector to capitalize on existing genomic discoveries as well as work currently under way.

As it stands the funding would get divided four ways.

The NIH would receive $130 million to:

• Launch a national “patient-powered” research cohort consisting of scientists and a million volunteers. This “Mega Study” would give us the statistical power needed to conduct research on rare diseases.
• Share and mine research data hopefully yielding new breakthrough insights and scientific results.

The FDA would receive $10 million to:

• Better understand and assess next-generation sequencing technologies
• Determine which genetic changes are important to patient care
• Ensure test accuracy and reliability
• Advance the development of high quality, curated databases to support the regulatory structure

The Office of the National Coordinator for Health Information Technology (ONC) would receive $5 million to:

• Develop interoperability standards to ensure privacy during secure exchange of data across systems
• Empower patients and clinicians
• Advance individual, community and population health

The National Cancer Institute (NCI) would receive $70 million to scale up efforts to identify genomic drivers in cancer, and then apply that knowledge to develop more effective cancer treatments. This would include:

• Supporting expansion of genetically based clinical trials in partnership with drug companies
• Establishing a national “cancer knowledge network” that generates and shares new knowledge to fuel scientific discovery and guide treatment approaches
• Testing therapy combinations that target a tumor’s molecular structure
• Developing solutions to drug resistance
• Developing approaches to assessing therapy response and resistance
• Developing new tumor cell models to help clinicians predict response to drug combinations and define mechanisms of resistance

Many likened this initiative to Kennedy’s mission to the moon. And Obama’s call to action might be just as impactful and transformative. In the next few weeks and months I plan to cover the following key success factors for Precision Medicine to become a reality:

• Regulatory Issues
• Tailoring diagnostic and therapeutic strategies
• Reimbursement & Cost
• Education
• Bioinformatics & Infrastructure
• Patient and Health Care Professionals Adoption

In this series, I will leverage our insights working with hundreds of organizations in this field. I also plan to share with you how we at Golden Helix are positioned to play a role in Precision Medicine. Please check in with us soon.