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Location, Location, Location: New Institute Positioned to Heighten Personalized Rx's Profile Inside Beltway

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By Turna Ray

At the Ignite Institute, Dietrich Stephan's new effort to bring personalized medicine to the nation's capital, rubbing elbows with policy makers will be as much of a focus as rapid commercialization of drug/diagnostic combination products.

In a podcast hosted by Burrill & Co., Stephan acknowledged last week that the establishment of Ignite in Fairfax County, Va., was a calculated move to situate a personalized medicine research and development entity beside a major community healthcare provider, Inova Health System, and a stone's throw from the US Food and Drug Administration, the Capitol Building, and the White House. Ignite's founders are hoping that the institute's locale will not only allow for the adoption of its discoveries at a community healthcare center but also ensure access to decision makers who can "touch and feel what personalized medicine is all about."

"Our goal was to be near the nation's capital so we could influence regulatory approval of the new drugs and diagnostics, and policy making around changing the paradigm of healthcare from reactive and generalized to proactive and personalized," Stephan said during the podcast.

"In line with that, we looked for a clinical partnership that would allow us to abbreviate the time from discovery to clinical adoption," he added. "Inova is not only the premier provider in the national capital region, but it's also a community-based healthcare system … So, if we can solve how to drive new clinical tools and some strategies into a community-based healthcare setting [in an] abbreviated time frame, we can impact chronic diseases at a massive scale."

The introduction and acceptance of personalized medicine in the nation's capital will "trickle out to the rest of the providers nationally," said Stephan, who is co-founder and chief scientific officer of the direct-to-consumer genetics company Navigenics and formerly the deputy director of discovery research at the Translational Genomics Research Institute.

Ignite's launch announcement in November was accompanied by the news that the Commonwealth of Virginia plans to invest as much as $25 million into the establishment of the institute. So far, Governor Timothy Kaine has cleared $3 million in grants for the project. The rest of the $22 million will be doled out in increments of $5.5 million over a four-year period, contingent on how well Ignite contributes to job creation in the area, commitments of additional outside capital, and research collaborations with Virginia universities.

Inova, in addition to inking its partnership with Ignite, has also committed to a $25 million investment in the effort. As of Nov. 16, Ignite has raised $200 million in initial funding, through NIH grants, philanthropic giving, and foundation grants. Stephan estimates the institute will be a "$100 million a year enterprise."

While a permanent facility for Ignite is in the works, its temporary offices will be set up in the state-run Center for Innovative Technology in Herndon, Va. The research focus will be on developing drug/diagnostic combination products for personalizing treatments for chronic illnesses, such as heart disease, cancer, diabetes, stroke, and myocardial infarction.

"The institute will generate molecular subclasses of common diseases as a starting point for companion drug/diagnostic development and exposure epidemiology moving forward," Stephan said during the podcast. The technologies the institute will employ in its research efforts will include genome sequencing systems, a transcriptional profiling facility, a proteomics and metabolomics scanning facility, and facilities for molecular scanning.

As reported in PGx Reporter sister publication GenomeWeb Daily News, Ignite will launch in 2010 with a focus on neurological and mental health disorders. Later in the year, the institute will open its oncology and pediatrics departments. In subsequent years, Ignite will turn its research focus to cardiovascular and metabolic diseases.

In addition to research, Ignite also will be "surrounded by commercialization infrastructure" to bridge the "valley of death between academic research and commercial application" to get discoveries into companies, Stephan noted. "We'll hardwire that aspect to the outside of the institute."

The second "valley of death," according to Stephan, is the gap between commercialization and physician adoption. "We will put our institute right next to a high-volume clinical center but also build in the infrastructure to validate those discoveries, educate physicians, and teach them how to adopt it so we can abbreviate the time to clinical implementation of what we're building," he said.

Another benefit of setting up Ignite in the Beltway and its partnership with Inova is that it will allow the institute to demonstrate whether it is possible to lower healthcare costs through the application of personalized medicine strategies.

"The big need is that in 20 years it's anticipated that we'll be spending 40 percent of our national GDP to care for individuals who have chronic diseases, age-related diseases. And that's simply unsustainable," Stephen said. "So, with the institute we're trying to build the epicenter of a new movement, which will kick into play very shortly, where we will focus on personalized prevention as a solution to not only the cost burden but the suffering burden at the end of life.

"We're looking to put in the minimal investment at the front end of life, to see big benefits in the back end of life in terms of keeping people healthy and reducing the time they are sick," he noted.

Although Ignite's location is strategic, it doesn't mean there won't be plenty of barriers ahead for the institute in the effort to expand adoption of personalized medicine. The biggest hurdle for widespread acceptance of personalized healthcare, in Stephan's opinion, is the outdated reimbursement system.

"We need to engage the payor community," he noted. "I for one believe that Medicare is going to be the compressing force. If they don't step in and start subsidizing personalized preventative strategies in the front end of life – either subsidizing positive change or de-incentivizing those negative behaviors – then we will not see broad-based adoption of personalized medicine."

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