Archive for February, 2010

Health Care Reform: What Will It Take?

February 26, 2010

Like you, I’m wondering what Congress will do now with health reform. After months of debate and negotiation culminating in yesterday’s Presidential Health Summit, it is still unclear whether we will be stuck with a broken health care system or if aspects of the current bills will ultimately be implemented.

Even as health reform stalls, science marches on and is telling us how to turn our sick-care system into a system that proactively preserves health and turns a one-size-fits-all model to a more personalized approach.  The science behind medicine has already shown us it is possible to diagnose disabling health issues early, identify the best treatment for specific groups of patients and even reverse the progress of disease.  We can now see the light at the end of the tunnel: health professionals will no longer need to practice medicine by trial and error.

To fully capitalize on the emerging research however, our health delivery system must adapt.  We have a disjointed system that does not allow us to track disease effectively, identify which treatments work best for which patients or deploy the most up-to-date scientific knowledge in a coordinated way.  We can transform our health care system and give patients access to the latest breakthroughs that are right for them.  But only if an infrastructure that can support personalized care is put into place. What will it take?

At the core are incentives which must be adjusted to align with the concept of delivering the right care for the right person at the right time. And that will not be enough without an integrated, electronic information network that can support a “learning” health care system – where patient  outcomes are effectively utilized  to accelerate research and generate better treatment decisions.  Joining the best science with an efficient and knowledge-based delivery system is the only way to achieve the healthier outcomes we deserve.

Latest Developments at FDA Very Promising for Personalized Medicine

February 24, 2010

Today HHS Secretary Kathleen Sebelius, NIH Director Francis Collins, and FDA Commissioner Margaret Hamburg hosted a joint press conference to announce an unprecedented collaboration between FDA and NIH aimed at accelerating the research to regulatory approval timeline for promising new therapies.  To assist in this effort, the initiative has established a joint leadership council that will seek to align biomedical research planning with the most pressing public health issues.  To learn more about the joint initiative, take a look at the press release from FDA or view the videocast of the joint press conference.

The collaboration between these two government agencies has great potential to advance personalized medicine, and as an article published today in MIT Technology Review indicates, advancing personalized medicine through regulatory streamlining is on the agenda for FDA.  According to the article, FDA is seeking to adjust current drug approval processes to better align with personalized medicine.  FDA expects to begin this process by developing guidelines that will enable the side-by-side approval of a drug and the companion diagnostic that will identify which population of patients is most likely to benefit from it.

We are very pleased that Dr. Hamburg, FDA Commissioner, is joining us as the keynote speaker tomorrow at the Sixth Annual State of Personalized Medicine Luncheon.  We look forward to hearing more from her on these exciting developments, and the opportunity they present to introduce a logical approval process for personalized medicine products.

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