The eventual impact of personalized diagnostics and medicine on the pharmaceutical industry will signal a definitive change in patient therapy. In fact, that change may already have begun.
That theory was discussed at an hour-long conference titled “Pharmacogenomics: the Convergence of Diagnostics and Therapeutics,” at the Thomas Weisel Partners Healthcare Tailwinds Conference in Boston. Moderator David Lewis posed several questions to the panelists, each of whom delivered answers from the perspective of their companies as well as from an industry-wide standpoint.
Anu Saad, chairman and CEO of Impath Inc., of New York, said collaborative efforts between genomic, technology and diagnostic companies “have led to some federation” that will bring a better understanding of the pharmacogenomics process, efficiently delivering drugs to the marketplace.
Lewis questioned whether big pharmaceutical companies would embrace the idea of personalized medicine.
“Some are under the impression that the rise of pharmacogenomics, or targeted therapeutics, is going to kill the idea of the blockbuster drug and create a new revolution of small-market drugs,” he said.
Jay Mohr, president and chief business officer of Variagenics Inc., of Cambridge, Mass., whose molecular diagnostics company has entered a number of collaborations with big pharmaceutical companies, weighed in on the issue.
“I would agree with that statement, but I think that there’s more to the story than that,” he said. “I think pharmaceutical companies have really turned the corner, to a certain extent, with respect to pharmacogenomics. It’s clear that most [regard] a strategic effect for the role of pharmacogenomics, and then make recommendations to senior management to implement, perhaps on a pilot basis, the utility and application of pharmacogenomics in their own program.”
Mohr also pointed to the developing role of the FDA in merging pharmacogenomics with traditional pharmaceuticals, “not only in the area of drug safety, but also in the area of drug efficacy.”
Saad said pharmacogenomics could help companies with products already on the market predict responses to drugs or their side effects. But none of the panelists believe the blockbuster drug will disappear.
Lewis also questioned the reluctance on the part of the large pharmaceutical companies to strike deals with genomics companies, especially if the FDA is driving pharmacogenomics testing into the clinical trial process.
Kenneth Conway, president of predictive medicine at Millennium Pharmaceuticals Inc., of Cambridge, Mass., said his company worked in such a way with New York-based Bristol-Myers Squibb Co. But, he said, the deal came about only after a fair amount of internal debate at Bristol-Myers.
“The debate really was, This is a great business today. Why should we change anything? Let’s wait for the market to change and then do it,’” Conway said. But, he said, the company decided to go ahead and add the pharmacogenomics approach, in part, to “know more about their patients than anybody else, which would allow them to [better] market their products.”
Saad said another application for big pharmaceutical companies would be to modify diagnostics to fit the drug candidate during the clinical trial process.
“Pharma companies do not want to tie the pricing of their drugs to one specific guideline for one particular trial, because what if the following year this better technology comes out that better predicts response to a drug?” she said. The companies would then have to return to the FDA. “We really do need to come up with a way to identify patients for clinical trials, and therefore get the drugs to market faster, have a diagnostic in a loose way associated with that drug and help to identify the patients with that diagnostic.”