Monday, January 28, 2013

The challenge of companion diagnostics, FDA approval & reimbursement

Companion diagnostics offer a lot when paired with a drug, but most Pharma companies are having troubles bringing the diagnostics to market.  These test that are used that are likely to identify whether or not a person will respond to a treatment once they receive a drug.  Companies often have to work together to develop the diagnostic at the same time as the drug, but partnering does not often last throughout the development process, and then affordability developing a test to determine this diagnostic.

The reason for this, according to PharmExec is:
Timing is also key. The Tufts report emphasizes that collaborations between drug companies and companion diagnostics developers need to take into account the basic discrepancies in their business models. This is true not only within the context of effectively co-developing these products, but in maintaining harmony and pace between both entities to ensure the drug and diagnostics components are ready at the same time for review and approval before the regulatory bodies.

This May at the 2nd Annual Future of Companion Diagnostics Commercialization Summit, during the presentation Commercial Considerations that Must Factor into your Companion Diagnostic Partnership Decisions Andrea Lauber, of Bristol-Myers Squibb will be on hand to discuss the important things to consider when selecting a partner in developing a companion diagnostic. If you'd like to find out more about this session and the rest of the program, download the agenda. If you'd like to join us in Boston this May 22-23, 2013, as a reader of this blog, you'll save 15% off the standard rate when you register and mention code XP1812BLOG.

No comments: