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Dr. Dietrich Stephan, founder of Ignite, has a vision of bringing together all of the components needed to make personalized medicine a reality, and putting it into action for real people at the community level — in the environment where most people get their health care. A human geneticist who has identified genes that predispose to autism, cardiovascular disease, and sudden infant death syndrome, Dr. Stephan has made significant contributions to identifying the molecular basis of disease.
In this interview from October 2009, Dr. Stephan shares his insights on personalized medicine, on the urgency of investing in this new approach now, and the role that Ignite hopes to play.
A: Personalized medicine really stems from our understanding that all human diseases have both a molecular and an environmental component to them. If we can truly understand an individual's hardwiring in terms of what they are at risk for early in life, we could then tailor the environmental variables (lifestyle, treatments, etc.) to reduce that risk and improve their overall health.
If we could diagnose diseases earlier or anticipate onset, that would lead to better outcomes. Once someone has a disease, we can put them on the right drug at the right dose to make sure they have the best chances of getting well. So my vision for personalized medicine is really a lifelong strategy that starts very early and involves close interaction and coaching between a person and their physician to minimize the chances of you getting a disease.
Just to put everything in context, by 2030, it is anticipated that we are going to be spending up to 40 percent of our nation's GDP caring for individuals with chronic disease. That is simply unsustainable, and it means we only have a few years in which to achieve dramatic changes in the way we practice and pay for health care. We have to start right now, and that is why Ignite is so exciting.
A: We've heard a lot about personalized medicine over the last five years or so, but we finally have the ability to put it into action. Ignite is a unique non-profit institute that will span the entire spectrum from the discovery of new personalized medicine treatments, to diagnostics that identify responding subpopulations. It will facilitate the commercialization of these tests and treatments. We'll also be looking at how to navigate the regulatory process in a shortened timeframe, and what policy changes we need to make to encourage clinical application. We will be educating physicians and finding ways to incentivize their adoption of personalized medicine. And we will look at how consumers interface with these treatments.
When we actually have a successful system for personalized medicine in practice, we will replicate this model across the country. We hope to spread this new paradigm for medical care that we think will become the foundation for a more efficient, effective, and affordable health care system.
A: In order to achieve change in health care delivery, we need a fully integrated system that is firing on all cylinders. We need to open the channels of communication between doctors and researchers. We have to help researchers chaperone their discoveries into the commercial sector; and we need to assist regulatory agencies to deal with the new data and find ways to regulate them fairly and get them to the patient in a timely fashion. Ignite is the only organization that will be putting all of the critical pieces together to turn this into a reality.
We are placing a strong emphasis on clinical practice, and completing the connection between the search for new treatments and the patient. Without that link, your ability to deliver the latest and greatest discoveries to patients is hindered. From day one, our researchers will be working on real clinical problems, and the clinicians will be coaching those researchers as to how to frame their experimental questions.
A: We need to address policy issues related to the structural barriers to personalized medicine, but also the regulatory barriers, the economic barriers, and the information technology barriers. For example, we still need robust genetic nondiscrimination laws at the federal and state level. We have some protection around health insurance discrimination, but still no protections around life-insurance or employer discrimination. That is a critical gap that needs to be filled.
We also need to understand how payers will interact with institutes and medical centers practicing personalized medicine so we can drive adoption in a quicker timeframe. For example, what role does Medicare play in creating an environment where we can use personalized preventive strategies early in life, well before Medicare kicks in, so we can reap the benefits of driving down the cost of care later in life?
By addressing these issues at the policy level, we hope to attain a more robust health care ecosystem in which Ignite can thrive.
View of the Expert posted October 2009