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A National Agenda On Personalized Medicine

Last week’s State of the Union address included an important announcement: the Obama administration intends to re-focus its efforts to accelerate innovation in “precision” or personalized medicine. Last week, the White House gave more detail about what that focus would look like – the official press release includes information on a $215 billion investment that includes:

  • $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 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 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 ONC to support the development of interoperability standards and requirements that address privacy and enable secure exchange of data across systems.

The response from the patient advocacy community has been immediate: patients are ready and willing to do what it takes. As Kathy Giusti, head of the Multiple Myeloma Research Foundation (a Feinstein Kean Healthcare client) wrote in Fortune: “Though we have only scratched the surface of what is possible, the successes to date are life-changing for those who benefit, and have laid important groundwork for similar approaches across all cancers.”

PMWC-2015

At last week’s Personalized Medicine World Conference (PMWC) in Silicon Valley, some of the most prominent researchers, clinicians and executives shared this sentiment as they discussed ideas for improving the current state of personalized medicine — Feinstein Kean Healthcare was on the ground among them.

From dozens of impressionable PMWC presentations, the two that stuck out the most were from FDA Commissioner Margaret Hamburg, and 23andme founder Anne Wojcicki. Commissioner Hamburg spoke about the challenges of ensuring that regulation keeps up with the pace of innovation, without serving as a hindrance to it. She reminded the audience that the promise of personalized medicine is not just to generate information – but also to ensure that the information is accurate, reliable and actionable.

Ms. Wojcicki spoke passionately about what the opportunity of personalized medicine means to consumers and the desire for more information that can help guide their behaviour as a whole, not just their treatment options. She noted that consumers want information that can help them to “predict and prevent” just as much as they want information that will cure.

The link between these closing PMWC presentations is awareness that the future of personalized medicine should focus on the shift to personalized healthcare. This is what makes the White House’s Precision Medicine Initiative so exciting: it is focused on delivering more and better care, not just more and better innovation. As President Obama stated in his State of the Union address, the initiative is designed to “bring us closer to curing diseases like cancer and diabetes – and to give all of us access to the personalized information we need to keep ourselves and our families healthier.”

For a long time, the “person” in personalized medicine has been the researcher, or the lab technician, or even the physician – anyone but the patient. This paradigm has resulted in tremendous innovation – less than two decades after first mapping the human genome we can now offer DNA analysis for $99 – but it has failed to change healthcare for the vast majority of people.

National, bipartisan support for innovation in personalized medicine may be exactly what was needed to pull together not only the greatest minds in science, healthcare and technology, but importantly, the power of the patient. Imagine – an administration and an industry that is not just looking at the science behind personalized medicine, but instead at the medicine behind personalized healthcare. It looks like that dream is a bit closer to becoming a reality, and how we engage patients, researchers, clinicians and more will play a role in shaping the future of personalized medicine.