By:
Alice B. Borrelli, Global Director for Healthcare Policy, Intel
Kathleen Lynch, Senior Director, Global Government Affairs & Public Policy, Illumina
DNA sequencing is advancing faster than nearly any other technology in history—and it’s setting off the next global space race. Nations that come out on top in precision medicine will be the ones to lead the world in curing disease, delivering high-quality healthcare services, and creating a healthier, more productive population. Precision medicine’s leaders will also be better positioned to drive economic growth based on biomedical innovation. They’ll gain in national competitiveness and prestige.
With programs such as the Cancer Moonshot and the Precision Medicine Initiative (PMI), the United States has taken significant steps toward precision medicine. But other nations are also moving aggressively. More than 20 countries are developing precision medicine initiatives, many of them based on whole genome sequencing (WGS). China has announced a five-year, USD 3 billion precision medicine initiative that demonstrates the country’s intent to dominate the field. China says it plans to sequence at least one million individuals and to incorporate genomics into a range of clinical and research applications.
Policies to Accelerate Progress
US progress in precision medicine has been slowed by a wide range of policy issues. To accelerate progress in this crucial area, Intel and Illumina developed a whitepaper that surveys these policy issues and identifies practical changes that can help align policies with evolving requirements. Illumina is the global leader in genomic sequencing and analysis products, and Intel powers much of the world’s bioinformatics and data analytics infrastructure.
Among our suggestions:
• Advance legislation to support biomedical research and innovation
• Continue federal funding for strategic health initiatives such as the Cancer Moonshot, Precision Medicine Initiative, and the Veterans Administration’s Million Veteran Program (MVP), and ensure that genomics and next-generation sequencing (NGS) are essential parts of these programs
• Move toward collecting comprehensive genomic data via whole genome sequencing, which offers great power to drive exploration, discovery, and innovation
• Facilitate the sharing of genomic data while protecting patient privacy
• Establish a standardized, machine-readable consent form for sharing genomic data, in alignment with standards work being done by the international genomics community
• Bring industry and government stakeholders together to clarify and streamline the regulatory environment while ensuring efficacy, access, and patient safety
• Provide incentives to promote the adoption of genomics for diagnostics in clinical settings
• Create a glide path to flexible standards of care for precision medicine
• Facilitate the integration of genomic data into electronic health records (EHRs) and continue to improve EHR interoperability
Policy modernization is a key step to bringing Americans the benefits of precision medicine and keeping the US competitive in this strategic arena. Through comprehensive efforts to increase agility in the regulatory environment, advance the collection of next-generation sequencing data, and facilitate the use of precision medicine, policymakers have opportunities to spur a cycle of biomedical innovation that can improve health, transform healthcare, extend the nation’s life sciences leadership, boost the US economy—and win the next global space race.
Learn More See how policy modernization can promote US leadership in precision medicine. Read the whitepaper: Transforming Healthcare with Next-Generation Genome Sequencing: Policy Issues for Precision Medicine.
Contact the authors:
Alice Borrelli: alice.b.borrelli@intel.com
Kathleen Lynch: klynch@illumina.com
[1] White House, Office of the Press Secretary, Investing in the National Cancer Moonshot, February 1, 2016. https://www.whitehouse.gov/the-press-office/2016/02/01/fact-sheet-investing-national-cancer-moonshot
[2] Fact Sheet: Administration Announces New Actions to Advance the President’s Precision Medicine Initiative. https://www.whitehouse.gov/the-press-office/2016/07/06/fact-sheet-administration-announces-new-actions-advance-presidents
[3] George W. Russell, China Plans Leading Role in “Precision Medicine” Field, JMSC Reporting Health and Medicine, April 2016. http://jmsc.hku.hk/reportinghealth2016/2016/04/06/china-plans-leading-role-in-precision-medicine-field/
[4] US Department of Veterans Affairs, VA Funds New Studies Using Million Veteran Program Data, July 7, 2015. http://www.va.gov/opa/pressrel/pressrelease.cfm?id=2717
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