Get most biotech executives talking about the FDA, and they usually tiptoe around with diplomatic sound bites, or maybe they’ll grumble about what they consider unreasonable burdens and arbitrary decisions by the U.S. drug regulatory agency.
The guys at Menlo Park, CA-based Optivia Biotechnology have a completely different take.
“The tougher the FDA gets, the better our business gets,” says Peter Milner, Optivia’s co-founder and executive vice president of corporate development.
Optivia, a company started four years ago with only about $500,000 in seed capital to date, has grown from one man’s idea in a garage into a profitable company with about 30 employees and a roster of 50 customers from Big Pharma, biotech, and academic research labs. Optivia has grown up based on a proprietary lab test that looks at transporter proteins that shuttle drugs, nutrients, and other substances in and out of cells. The field of research was pretty obscure when CEO Yong Huang got the company started in his garage (literally), but it has encountered some good fortune over the past year as the FDA has become increasingly vigilant in asking drugmakers to study the effect their compounds have on certain transporter proteins.
The FDA is particularly interested in how these transporters can be involved in drug-drug interactions, which can lead to dangerous side effects that sometimes only appear after a treatment has been taken by thousands or millions of people, on the market. Biologists say there are about 300 to 400 of these transporters that act as cellular gatekeepers. The FDA is trying to learn more about them, to avoid new cases like the debacle with Bayer’s cholesterol-lowering drug cerivastatin (Baycol). That drug was withdrawn from the market after reports of a fatal muscle disorder were discovered in patients who got the drug along with another compound known as gemfibrozil—through what was determined to be a bad transporter reaction.
Drug regulators have long required companies to run tests that shown how their drugs get metabolized, or washed out of the body, usually through certain enzyme pathways in the liver. Doctors and pharmacists use that information to make sure they don’t prescribe too many different drugs that get metabolized through the same pathway, which could create a traffic jam of sorts, causing too much of the drug to remain in the bloodstream or tissues for too long. Transporter proteins also play an important role in drug metabolism, but the FDA has only recently begun to step up its requests for lab studies about them. That’s because transporters are complex protein structures that have been harder to study than enzymes, Huang says.
The FDA has singled out transporter biology as one area of research that could help improve the drug development process, as Janet Woodcock, a senior FDA official, described in this review article in Nature a year ago. Optivia isn’t the only company running tests of
