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New Study Addresses Key Issues and Requirements Shaping the Adoption of Pharmacogenomics Testing

Click the title to purchase "Successful Pharmacogenomics Business Models"

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January 5, 2004/Newton Upper Falls, MA/Cambridge Healthtech Institute announces the publication of Successful Pharmacogenomics Business Models, a new report that provides a theoretical framework to evaluate pharmacogenomics initiatives within pharmaceutical companies.

Emerging pharmacogenomics technologies are presenting the drug discovery and development community with the promise of targeted therapies and potential new revenue streams. Pharmacogenomics is also creating new opportunities for diagnostic companies to develop tests that can be used to determine patient response to a drug and screen out inappropriate candidates.

In an interview with CHI, Dr. Stephen Little, CEO of DxS Ltd., a leading provider of pharmacogenomics services, discusses the market opportunities, challenges, and outlook for pharmacogenomic tests.

“Ultimately, I think we will see three factors which will drive personalized medicine forward. The first is regulatory pressure. The second is that we need one or two more good examples which demonstrate that a targeted therapy can also be a profitable therapy. Certainly current therapies such as Herceptin and Gleevec which have a companion diagnostic are generating significant sales, but a few more successes would be very helpful. It may well be the case that more innovative drug companies push ahead with diagnostic/therapeutic combinations to get their drugs to the people who need it. Finally, the diagnostic industry can work independently of the pharmaceutical sector to bring pharmacogenomic tests to market.”

The key—and challenge—to the widespread adoption of pharmacogenomic testing will be to successfully navigate the evolving regulatory requirements and commercial challenges to formulate business models that will enable diagnostic companies to forge mutually beneficial partnerships with drug companies. Dr. Little comments on the possible business models for diagnostics companies to use their tests in combination with therapeutics.

“There are two distinct opportunities for using diagnostics in combination with therapeutics. On the one hand, there are diagnostic tests that will allow the selection of one of several therapies; on the other, there is a diagnostic test that is a prerequisite to prescribing a therapy… In this case, the diagnostic is the gateway to the therapy and the drug industry will have a great interest in ensuring that these tests are readily available. Furthermore, drug companies will have a different view of these tests than diagnostic companies. For them the priority is not to maximize diagnostic revenue but rather to minimize the chance of the diagnostic delaying the launch or hampering drug sales. The key issues will be timing, availability, convenience for the doctor, and regulatory compliance. If that means accepting a lower return on the diagnostic for an increased drug sale that is exactly what will happen.”

Dr. Little also comments on the concern of some pharmaceutical companies that targeted medicines will mean reduced market sizes.

“Will pharmacogenomics mean the end of blockbuster drugs? I doubt it…If you have a diagnostic that improves both the chances of getting a drug through development so that its development costs are lower, and at the same time improves its performance so that more doctors are willing to prescribe it, it may well be the case that you don’t need to have such huge drug sales to still have a very profitable product, particularly if the treatment commands a premium price.”

Click to view TOC "Successful Pharmacogenomics Business Models"

Click the title to purchase "Successful Pharmacogenomics Business Models"
 

 

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