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Needham, MA

February 2, 2010

SOLiD Gold: Dietrich Stephan on Ignite's Partnership with Life Technologies

Last year, Dietrich Stephan, the co-founder of personal genomics company Navigenics, announced his plans to build an ambitious new academic institute in Northern Virginia – the Ignite Institute for Individualized Health. In an eye-opening announcement earlier this week, Ignite is partnering with Life Technologies and acquiring 100 SOLiD 4 instruments, which can deliver $6000 human genome sequences. Kevin Davies spoke with Stephan about Ignite and his choice of sequencing partner.

Bio-IT World: You've just ordered 100 sequencing instruments from Life Technologies for your new Ignite Institute. Why so many, and why did you select SOLiD 4 sequencing system?

STEPHAN: We're really excited about this partnership. I feel really good about the SOLiD technology, its accuracy, price points and throughput. We had both SOLiDs and Illumina at TGen, but my group was using the Illumina platform. They're both great technologies... Having reviewed recent data, it looks like the SOLiD platform is extremely accurate. I really like that, because you don't have to sequence with as much '–fold' redundancy. The other aspect of it is that we're really creating a strategic partnership with Life Technologies to do co-development around the technology and understanding the interpretation in a clinical setting of the information. So it's more a strategic partnership that swayed the decision.

Why did we go big is maybe more relevant. The technology is robust across multiple vendors. I think we're finally approaching a price point for full-genome sequencing where we can realistically start to redo all the whole genome sequencing studies (GWAS) that have been backed up for the last five years waiting for this technology. You need some horsepower to do that, and we needed some infrastructure. That's on the research side.

We also started extending on my Navigenics days, putting the technology into a CLIA environment and using it in a clinical setting. So for example, is there a role for sequencing the entire cancer genome out of a diagnostic biopsy from someone newly diagnosed with cancer – so pull single sells out, sequence them, and try to understand if we can, to prioritize the standards of care, develop salvage therapies for the 50% of people who will eventually progress. So we want to start learning how to apply the technology in a clinical setting and how to interpret it.

So you feel it is worth revisiting all the GWAS data over the past few years but at the full sequence level?

I'm of the bent that all these heritable risk factors will be relevant in the aggregate. Common variants were extremely valuable in many cases, not only in risk assessment but as guideposts to uncover rare variants in those portions of the genome. But there's epigenetics and copy number variation that we can now capture with the current technologies. We're finally apt a point where we can, in a systematic way, go back and rip through all those case-control studies and get close to capturing the totality of heritable risk for complex genetic disease -- step 1 -- and then maybe even start to sub-classify those common, complex diseases, and name them.

What will be the focus of your sequencing efforts in the clinical realm?

It's an extension of Dan Van Hoff's work at Scottsdale Health Care, where he ran a beautiful clinical trial using expression profiles of patients. When someone presented with end-stage cancer and was asked to be assigned to a Phase I trial, Dan would randomly assign a Phase 1 trial, the other he would profile and then intelligently assign to a trial. He's presented beautiful data that he can improve response rates. So trying to use that same strategy but with the next evolution of technologies to see if we can't, for those individuals who progress through therapies. I would say it's more in a clinical research setting than as a clinical service. We're not going to be opening the doors to everyone.

Was there any hesitation in making such a big investment now when there are so many new technologies waiting in the wings?

There's always a danger, yes, but it's a stable technology that's available today, that we can get started on with great accuracy and great price points. In some ways, that's the purpose of a genome institute is to be able to have the horsepower that very few places have to take on very large projects. So why buy something now when in a year you could buy something else? Unfortunately, that's the life we have to lead.

You used the term 'genome institute.' How have your plans and ideas for Ignite evolved in the past year? It is, after all, called an institute for individualized health...

There's a couple of aspects in the Ignite model that we think are unique – that may not be true of course! One is the horsepower to drive out pure molecular subclasses of disease as a starting point for personalized medicine. So renaming complex genetic diseases according to nomenclature around molecular homogeneity. That's one strategic principle. The other is aligning the disease foci to the market needs out there in the world. Basically that means the most prevalent, intractable diseases will be the ones we start with.

The third aspect will be that we'll have commercialization infrastructure surrounding the genome institute so we can make early go/no-go decisions. We can model the economics of new tools and strategies. For example, who is going to pay for this when we turn it on?

Another aspect that may or may not be unique is that we've aligned it with a tier-one partner in terms of high-volume community healthcare system. So if you take a big genome institute, surround it with a commercialization infrastructure, and then stick that in close partnership with a healthcare system, hopefully you can build those trusted relationships to quickly move from a little biotech or drug company into a clinical setting quickly. We used to call the valley of death some scientist in a basement writing and publishing papers that no-one would read. .. A second valley of death is, once you have a little company like Navigenics, it takes years and tens of millions of dollars to educate doctors and get any of them to use it. So can we compress both of those valleys of death?

What's the status of settling on a permanent location for Ignite?

We're currently building out our temporary space, which will be ready shortly. We're in the weird upside-down pyramid building near Dulles Airport, it's a state-owned building. The state will put in some money to refurbish it, and we'll leave it behind as a biotech incubator for the commonwealth of Virginia. On the permanent site, we're still evaluating a couple of options [a search led by Nancy Kelley of Murphy-McManus] but it looks like we'll purchase a pre-existing shell so we can go in very rapidly refurbish floors of it.

What about the support you've received from local government?

It's been a true public-private partnership. The Commonwealth of Virginia has been spectacular, committing $25 million to the project. Fairfax County is committed to building us a building and letting us occupy that for a certain period of time for free. And we've got private sector partners like Life and the Innova Healthcare System, and academic partners like George-Washington University, which wants to make a name for itself in health care policy. We've got George Mason University around neurological diseases and Virginia Tech around bioinformatics and supercomputing. They just recruited the spectacular head of the Virginia Bioinformatics Institute [at Virginia Tech], Skip Garner (who worked on the 1000 Genomes Project). We're going to generate data and then collaboratively with them, we'll crunch it.

Ed Note: An expanded version of this interview will appear in the March-April issue of Bio-IT World.