Why Don't Big Pharmas Buy Pharmacogenomics?
Pharmacogenomics has disappointed advocates who saw the opportunity to apply a discovery tool to the near-term goal of increasing approval chances and marketability for late-stage and marketed compounds. In return, they hoped to take a percentage of the highest-cost segment of the pharmaceutical budget. But Big Pharma is by and large not using pharmacogenomics for late-stage and marketed compounds: senior executives don't believe there's enough evidence it works and are afraid of limiting the marketability of the products by segmenting broad target populations into niches. Some also worry about uncovering potential side-effects that non-pharmacogenomic trials wouldn't reveal. Nonetheless, pharmacogenomics has made it to Big Pharma: most companies, for example, are banking samples from clinical trials to be pharmacogenomically tested retrospectively, thereby informing future trials. Not that this means the pharmacogenomics specialists will be able to sign high-value deals with the commercial side of drug companies, who believe that pharmacogenomic analysis is available from a number of sources, including internal ones, and feel they own the key assets for creating meaningful programs: compounds and patient samples. Instead, pharmacogenomics will find its place first as a discovery technology, integrated with other methods for finding, validating and prioritizing targets. That means that to succeed selling pharmacogenomics, biotechs will have to combine their pharmacogenomic assets with other discovery technologies, perhaps through mergers. An alternative: use their technologies to find drug products that they can themselves develop, perhaps later out-licensing them.
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Pharmacogenomics: Promises and Problems
So far, pharmacogenomics, the study of the effects of an individual's genetic makeup on their response to drugs, has not produced the hoped-for revolution in the pharmaceutical industry, due primarily to lagging approvals and the high cost of molecular testing. Nevertheless, the promise of personalized medicine is very real, and several exciting products have received FDA approval.
Xanthus Life Sciences Inc.
Xanthus is pursuing personalized medicine in a way quite different from pharmacogenomics players: rather than exclude patients from treatment, this start-up aims to optimize drug dosing for everyone--beginning with anti-cancer compounds. Instead of relying on genes that may or may not be activated, Xanthus is gauging phenotypic factors, traits that are already physically manifest.
Shaking Up the FDA
To improve regulatory predictability, Mark McClellan has plans to reduce multiple-cycle reviews. In addition, he is in the midst of adopting best review practices and developing clearer guidances in therapeutic areas where progress has been slow and in certain emerging areas. While such plans potentially offer good news for the brand-name drug companies--though the benefits will be slow to accrue since the regulatory efficiencies will take years to fully materialize--they won't lower overall system costs since lower development expenses won't necessarily lead to lower average prices. Thus the FDA is focusing on two areas in which it has direct influence on drug costs and reimbursement: speeding the approval of generics and forcing OTC switches. McClellan's desire to impose a cost-benefit mindset on the agency attempts to balance the needs of the drug industry with the needs of reimbursers, particularly the Federal government as it prepares to shoulder the new burden of Medicare outpatient drug costs.