Barron is the unemotional scientist when he switches to talk of personalized medicine, seeing it as a possible cure for what ails the industry as it promises to make clinical trials more efficient. “If you really want to make a significant dent in the cost of development, one way is to improve the success rate,” he says.

 

Herceptin remains the only example in the company’s roster of a product married to a diagnostic. But its success has spurred a big change at Genentech. The company now seeks to develop companion diagnostics for all of its drugs. One of the 2006 corporate goals set by Genentech’s leadership was for drug development groups to create a diagnostics plan for each new product. The idea was to use pre-clinical research to identify biomarkers.

 

Even if a companion diagnostic is not developed for a drug, using biomarkers has several benefits. It can accelerate drug development by helping weed out drugs that will be unsuccessful before large, expensive late-stage trials are launched. It can also help to refine the clinical trial population so that a drug is tested on people most likely to benefit. The approach can rescue a valuable targeted therapy from failure and control the size and cost of clinical trials.

 

Herceptin itself is a case in point. Genentech says if the drug’s late-stage clinical trial had used a general breast cancer population rather than HER2-positive patients, it would have had to enroll 2,000 patients over 10 years to show a statistically significant benefit. By narrowing the focus to a smaller population more likely to benefit, the trial included just 400 patients over 18 months. As a result, the drug was on the market helping to save lives a lot faster.

 

But finding biomarkers that actually tell researchers what they need to know can be tricky. A biomarker selected in preclinical research can turn out to be useless in the clinic. And tissue samples may be difficult to obtain for diagnostic use, which raises the challenge of finding blood tests or using imaging to obtain the desired information. Diagnostics has become part of Genentech’s “daily bread and butter,” says Sara Kenkare-Mitra, a senior director and head of Genentech’s development sciences. “Today, I don’t even look at diagnostics as something add-on. It’s woven into everything we do.”

 

But while Genentech may be culturally ahead of some of its big pharma brethren in its focus on biomarkers, it still has much to figure out beyond the science. While Kenkare-Mitra says that Genentech is working closely with a number of diagnostic companies, there are still “healthy tensions.” The biggest hurdle, she says, is the upfront payment diagnostic companies still demand as these companies try to determine the risk of developing a diagnostic to be paired with a drug that could be years away from approval—and may never win it at all. “We’re still working on these with a number of different companies to figure out what’s the best way to do this,” she says.

 

The problem, according to Ed Abrahams, executive director of the Personalized Medicine Coalition, a Washington, D.C.-based industry advocacy group, is that pharmaceutical companies are accustomed to expensive development cycles that extend 10 years or more. Diagnostic companies, meanwhile, have shallower pockets and seek to bring products to market in two years or less. “The developers of therapies aren’t so interested or willing to share the value with the diagnostic company, so there is some tension between them,” says Abrahams. “Those business models don’t comport very easily. That’s an issue.”

 

Such business issues are important sticking points. Diagnostic companies working alone have developed molecular diagnostics to determine the appropriateness or dosage of a therapy. But momentum for pairing diagnostics and therapeutics is building. Regulators worried about drug safety and governments and insurance companies concerned about rising healthcare costs want to see more drugs tied to diagnostics. This way, they hope, it will be clearer whether costly treatments are the right ones for the right patients. To do so will require closer relationships between drug and diagnostic makers.