Tufts Center: Approval Times Have Dropped, But Is It Enough?

For those of us who work in and follow the drug industry, winter is always made a bit brighter and warmer with the coming of the annual Outlook paper by the Tufts Center for the Study of Drug Development. The Tufts report is one of the definitive measures of where we are, where we're heading, and what hoops we have to jump through to get there.

This year's report (here's the Center's summary; the full Outlook 2010 will be made available to non-subscribers this spring) has plenty to chew on, but here are a few of the more relevant points that drug developers and QbD professionals need to consider:

--Few drugs make it to market, but it's important to remember that of those that do, only 3 of 10 generate enough revenue to sustain R&D.
--Drug developers don't just need to improve time to market, they need to dramatically change what they're doing--to "transform the way they conduct research and development over the medium and longer term to be more efficient and productive."
--Collaboration is critical. R&D success will depend upon how developers engage their partners at critical points in the product lifecycle.
--Risk management will continue to balloon in importance. With FDA and global regulators limited in their resources, it will be left up to developers to show expertise via Risk Evaluation and Mitigation Strategies (REMS)
--Biotech products will boom, but take longer to get to market due to increased clincial trial requirements.

Just a few thoughts to warm your winter.