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The C-Path Institute s Ray Woosley on Group s Role and First Projects

Ray Woosley
C-Path Institute

Name: Ray Woosley

Background: President, C-Path Institute, since 2005; Vice President for the University of Arizona Health Sciences Center, 2001 — the present; Associate Dean and Dean, University of Arizona College of Medicine, 2001 — the present; Chairman, Department of Pharmacology, Georgetown University, 1988 — 2001

Education: PhD, Pharmacology, University of Louisville, 1967; MD, University of Miami, 1971

Age: 62

The C-Path Institute opened in February to promote research and education in the service of streamlining safe drug development, and it has spent the intervening time planning research projects involving pharma and its founding institutions: the University of Arizona; SRI International; and the US Food and Drug Administration.

At the end of the month, the independent, non-profit institute will begin funding those programs, and Pharmacogenomics Reporter felt it was a good time to check in with the institute's president, Ray Woosley.

The Critical Path Institute is working on several projects to streamline drug development, and today you have a conference call concerning a toxicogenomics cross validation consortium. Can you tell me a little more about it?

It's a very early discussion of a group of scientists from the FDA and the pharmaceutical industry, SRI, and C-Path to begin exploring how we might leverage some expertise in ways that move drug development forward.

The concept is — most drug companies have developed internal methods for safety screening, but few of these have been validated to the degree that they could be submitted to the FDA as evidence supporting decisions or non-decisions. And the goal here would be to see if companies would be willing to share their methods — and it looks like they are certainly willing to discuss that — and C-Path could create a neutral forum for them to present those different methods. Then the idea would be that one company would validate another company — A would do B and B would do C — and at the end of the day, you would have an outside body test the method to see if they get the same results that the innovator company obtained, submit it back to the Critical Path Institute for independent review. A report would be written, and the FDA would have access to that report, and at the end of the day, the goal would be to have these tests become validated. And any company using those methods could submit data on their drugs — these are safety methods, so there shouldn't be much proprietary here — and expedite their drug development.

The FDA can't physically validate [this kind of data] for a company — why would they pick one over the other? Well, this creates a forum where they can work with multiple companies and not exclude anybody, so it's going to be a very open process. Any company that has biomarkers within a specific area would be able to participate.

Are you talking about both safety and efficacy biomarkers?

So far we're only talking about safety because the proprietary issues don't arise there. Or fewer of them.

There's so much work to do — we're going to go to those areas where there should not be proprietary issues.

What are you discussing on the call? Just how to set this up?

Yeah — what are the logistics of it? How do we keep it open? Who are the kinds of scientists that have the kind of expertise that we can bring in? Prioritizing certain areas — where do we start? Is there one type of toxicity screen that we should do first?

What drug makers are involved?

I shouldn't say yet. I would say most of the major companies are represented.

When do you hope to launch?

C-Path is ending its planning phase July 1. [The Insitute] involves no commercial-interest funding, it's all private donors and the city, the county, the state. Those checks are being written right now. We've got a bank account that's growing, and July 1 we'll start funding these programs.

This is one of the very first ones, so this phone planning will probably set the stage for our first investment.

How much do you expect this to cost, and how long until the project is finished?

It's too early to be very quantitative on that. It will cost a lot, because these are very expensive laboratory techniques — they're very complex scientifically and the validation of one of these is rigorous. But the good news is that the companies themselves will bear most of the cost for each other. While they're spending money on another company's method, somebody else is out there working for them.

The funding for the process will come mostly from our seed funding. At some point we'd like to operate the way the food industry does — about 15 years ago it set up a facility at the Illinois Institute of Technology, and the companies contribute money to the core activities. It's like a consortium companies that pool money for areas that they all declare, and the FDA declares, are of common interest and value to the industry and the public. The FDA puts something like 32 people there, and they put in some money, but most of it comes from this consortium-type funding.

So we're going to seed it, but what we hope to do is demonstrate the principle of companies working on developing their tools, and in the long run we hope to develop other sources of funding.

There is another project on drug safety monitoring that involves genomic and proteomic technologies, can you tell me about it?

In the UK, and in Europe in general, 20 years ago drugs were first tested there, and we would get them in the US after they'd been on the market for a year or two. So they developed early warning systems. The UK started with the Yellow Card system, now it's the general practitioners' practice network, where they actually get data on every patient who gets a new drug. In France, they have 30-something pharmacovigilance centers, where they actually get medical records for people who've gotten new treatments.

Now new drugs are being tested first here. But we don't have that system. So, we're working with Paul Seligman in the [FDA] Office of Drug Safety and the community of Southern Arizona to see if we can create a pilot network that would give us that same early warning system, to give us that same denominator. With our current system, we only get one out of one hundred serious events reported. So we'd like to get all of them, and know the denominator, and equally important, have a comparator.

Problems like Vioxx — you're worried about a heart attack, well heart attacks occur every day. How many of them are due to the drug? Well, without a comparator or a very good control group, you will never really know if it's real or not.

Are you going to correlate that with genotypes and other markers?

Yes indeed. And that's getting back to why you do surveillance. You don't do it to take drugs off the market. You may end up having to take them off the market, but if we had an early warning system that ideally was suspecting that there might be a problem out there, and get DNA, so that as soon as you know you've got a signal, you know the genotype of the people who generated that signal, you can have a gene test to say, 'OK, we've found a problem, and here's the way we're going to deal with it — we're not going to give this drug to anybody at risk of having the adverse event.' And yes, it can then stay on the market.

Ideally we'd like to have DNA available from anybody who gets a new drug.

With the Amplichip approved, and we'll have many more of those, and far cheaper. I think the pharmacy of the future is a place where you go to get your cheek swabbed, and learn about how to take your medicine safely.

When does that project start?

This summer. We've actually got a group of people right now doing the very first studies of feasibility — what happens in the drug store right now, what would have to change for them to be able to gather this data.

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