Can Sponsors Respond by Finding Non-Responders?
This article was originally published in RPM Report
Executive Summary
One way to get a more favorable review from FDA is to find products that work on a well-defined, under-served patient populations. Wyeth R&D head Robert Ruffolo has some questions about how difficult it will be for sponsors to find those populations. Here is what he had to say about the difficult time-frame for taking a non-responder strategy.
You may also be interested in...
US Price Negotiation Hearing Lays The Groundwork For Future Improvements
The pharma industry is hoping that litigation might end Medicare price negotiation before it begins. But a House hearing also starts the process of developing legislative improvements that might be viable in years to come – starting with trying to restore the lifespan of small molecules.
As Sickle Cell Gene Therapies Move To Market, Health Inequities Could Help Pricing Debate
Positive tandem ICER reviews for bluebird bio’s and Vertex/CRISPR’s gene therapies show the impact that concerns about addressing racial inequities could create a favorable context for products as they enter pricing and coverage discussions.
The Evolving Door? What Having A ‘Big Data’ Commissioner Might Mean For US FDA
Robert Califf’s nomination to return as FDA commissioner will raise protests about a ‘revolving door’ pathway between industry and agency. But, in this case, it may be more apt to talk about how Califf’s time outside FDA led to evolving views on the role of big data in drug regulation.