Monday, September 14, 2009

Executive Spotlight: Mickey Urdea, Ph.D., Chairman, CEO and Founder of Tethys Bioscience

Mickey Urdea, Ph.D., co-founder, chairman and CEO of Tethys Bioscience, is a true Renaissance man, with interests not just in improving medical care through early detection and prevention of chronic diseases, but in raising carnivorous plants and learning about classical music. In the early 1980s Urdea was one of the first employees at Chiron where he directed the nucleic acids chemistry group and began the molecular diagnostics efforts. He led the development of quantitative RNA and DNA assays, including the introduction of the first HIV and HCV viral load tests. He became head of the Nucleic Acid Diagnostics business unit at Chiron. In 1998, he joined Bayer Diagnostics as senior vice president of Nucleic Acid Diagnostics and acting-chief scientific officer of Bayer Diagnostics. He left Bayer in 2000 and co-founded Tethys Bioscience in 2002. Urdea received his doctorate in biochemistry at Washington State University and held a National Institutes of Health postdoctoral fellowship at the University of California San Francisco with William J. Rutter. He has published more than 185 articles and book chapters, and is an inventor on more than 100 issued and pending patents.

Q: Where will your patients be in five years? How many will have diabetes? Tell me about this statement, which appears on Tethys’ homepage.
The dilemma that we try to deal with at Tethys is the fact that in chronic diseases, we know there are people that are at risk, but we don’t have a good tool for determining which portion of the population actually has the highest risk. Our belief is that if we look at the biology of the diseases carefully, we’re likely to find that a small portion of the population harbors most of the risk. The doctor’s dilemma is that he has this room of people who are at a somewhat elevated risk, but not a very high risk and what does he do? What we’re doing is taking that large population of individuals and paring it down to three groups—a high-risk group, a moderate-risk group and an low-risk group. In fact, the high-risk group, which is about 10 percent of the population, does harbor most of the risk where we see about a 500 percent increased risk versus the pretest probability. So there are really big differences in risk in different parts of the population. Now, what the doctor can do is focus his efforts on those individuals that have the highest risk.

Q: Tell me about Tethys’ products and what’s in the pipeline. How does the test work?
The PreDx Diabetes Risk Score is a simple blood test using blood samples that ship to our laboratory here in Emeryville. The test is performed using standard amino assay analyzers. The turnaround time is about 72 hours. Our whole idea was that if we take a look at proteins and lipids in blood, that should reflect the biological changes that are occurring very early on in chronic disease, making prevention possible. Genetics has not been as useful, at least so far. In some diseases, of course, genetics is useful, but in chronic diseases, we find so many different genetic variants that will lead to basically the same phenotype. So what we’re looking at, I think, is something much closer to the actual phenotype based on the protein and lipid biology. Those changes are occurring early in the disease state.

The other two products we have are still in R&D. One will be used for predicting primary myocardial infarction with a five-year risk score using both proteins and lipids in blood. The other one is for osteroporotic fractures; specifically, we’re looking at hip fractures and vertebral fractures in postmenopausal women. Our major interest there is in the so-called pre-osteoporotic or osteopenic woman where most of the fractures occur. Our initial studies indicate that we’re getting very good predictability in that population.

Q: Why do we need this test? It’s been written about as a “tool to change fate,” which may save upwards of tens of thousands of dollars per patient. How is that?

A: The way we approach the markets in which we work is that we do the health economic studies first to determine whether the test would be cost-effective or preferably cost-saving. Most recently we conducted a diabetes study with Shawn Sullivan at University of Washington and we presented a paper at the American Diabetes Association meeting this past June. We will be publishing the results fairly soon. What we were able to show is that the test is initially cost-effective and with time becomes cost-saving relative to the standards of an approach using fasting glucose alone, where it is not cost-effective. I can’t think of a more potentially cost-saving thing to do than to prevent chronic diseases where we spend most of our healthcare dollars.

Q: How many people work at Tethys and how many locations do you have?

A: We have 85 people working at two major locations; one here in Emeryville and the second in West Sacramento. Last year, we acquired a company called Lipomics Technologies and that was the site of their headquarters. We’ve kept them there.

Q: Which companies do you view as your main competitors and what are your main competitive advantages?
Right now I would say probably Metabolon and BG Medicine. They are the ones that have said they’re working on similar tests. We’re much further along than I believe they are at this point. A lot of companies are working on so-called insulin-resistance assays, but what we are doing is quite different. We’ve been working in this for nearly four years now and have generated considerable intellectual property. I think we’ve done a very good job hiring a group of veterans of the diagnostics industry who have created markets before. We’ve done a very thorough job in the clinical studies. We’ve worked with a large number of thought leaders to make sure that we’re doing it right, that this is what people need and that the science is strong.

Q: What types of partnerships do you seek out?
Primarily, partners in manufacturing the diagnostic kits that we’re using. We look for partnerships with the large commercial reference laboratories. We look for partnerships with diabetes nurse educators. We look for partnerships with people in integrated healthcare systems, employers, all those people who have a specific interest in the development and delivery of diagnostic tests for prevention.

Q: What changes can we expect in your industry in the coming years?

A: Well, what we want to see happen, and we’re working very hard on it, is that people start recognizing that prevention is so important that they start reimbursing people for education, for the tests, that the FDA approves the products, that prevention becomes the most important thing that we’re doing. Sen. Daschle has been quoted saying, “we need to make prevention hot and wellness cool.” I love it.

Q: What do you hear from customers about your products?
That it’s made a big change in their practice. We’ve had a few doctors tell us that they drive home at night feeling better because they’re making a difference with people. They’ve had this dilemma of having all these people at low risk for so long and now being able to tell someone they’re actually at a much higher risk than they realize and they need to do something about it is very helpful. They’re seeing their patients lose weight and asking to get into wellness programs. The patients are being more careful about diet, exercise and blood pressure—all the things that they should be worrying about, but didn’t. People just need to understand that the risk is higher than they realize and there is something they can do about it.

Q: What keeps you up at night?
Trying to get into the market as fast as we can. I feel as though we have proven the clinical utility of this product. My biggest concern is having enough money to get to profitability.

Q: What do you do to relax?
I work out religiously at least six times a week. I raise carnivorous plants believe it or not. I have two greenhouses at home and I own part of a nursery.

Q: If your house were on fire, what would you grab?
Besides my wife and son, probably my computer.

Q: When you were young, what did you aspire to be as an adult?
I wanted to be a scientist ever since I was a kid. I took a science course when I was 12 years old, a summer course, and it just totally turned me on. I remember the teacher, Mr. Stark. He took us on nature walks; we did experiments; we talked about astronomy—all the stuff that I had never been exposed to.

Q: What are you reading?
I’m reading a book, “1491”, by Charles Mann, about the New World before Columbus. I’m reading “Winesburg, Ohio” by Sherwood Anderson, and then I’m taking a course on “The Chamber Music of Mozart” by Robert Greenberg from The Teaching Company.

Q: How do you want people remember you?
That I never made the same mistake twice.

CHI-Advancing California biomedical research and innovation

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