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A small number of start-ups are developing novel specilalty-focused diagnostics that capture drug-like revenues and margins without taking drug-like development and regulatory risks. Questions about the business model abound, since most companies need multiple tests to reach profitability and a changing regulatory climate may force these companies to seek FDA approval for their tests, dramatically increasing development risk and cost.
VCs won't go near traditional diagnostics. But some are starting to bet on biomarkers that expedite drug R&D and commercialization. Only one problem: they've yet to come up with the right business model
The FDA sees pharmacogenomics as a key tool for optimizing both the development and clinical utility of drugs. But most of the visible examples to date of pharmacogenomics have been in specialty areas like oncology and virology. The Vioxx situation raises an inevitable question as Pharma looks to improve R&D efficiency and clinical utility. What is the role of pharmacogenomics in assessing the safety and efficacy of primary care drugs?
The history of the IIb/IIIa inhibitor Integrilin touches on many of the challenges of cardiology marketing, including how to move a member of a new class of drugs into a complex, rapidly evolving treatment pattern. Having established Integrilin as the most-used drug in its class, its marketer must now deal with the impact on IIb/IIIa use of Angiomax, a potential replacement for heparin. Imagine the scene five years from now: A combination of Angiomax and low-molecular-weight heparin has replaced unfractionated heparin, and the addition of statins and possibly vascular protectants has turned the current triple therapy regimens of anti-coagulants, anti-thrombins, and anti-platelet drugs into a quartet. Physicians attending scientific meetings may well still be puzzling over the proper role of IIb/IIIa inhibitors, and asking themselves the extent to which long-term results from trials initiated early in the 21st century have meaning.
In Vitro Diagnostics
- Therapeutic Drug Monitoring