Changing the development paradigm
National Institutes of Health
When Francis Collins took over at the National Institutes of Health in 2009, the scientific community was abuzz with the fact that he's a practicing Christian. Soon after, the chatter moved beyond science and religion and into the polarized politics of today's United States, with a renewed debate over stem cell research. Now, Collins has achieved something that not only defies controversy, but also stands to change the way treatments are discovered and adopted. He persuaded Congress to create a new National Center for Advancing Translational Sciences, and got it funded to the tune of $575 million.
Yes, that's less than the $1 billion he asked for. But it's also more than half a billion dollars, at a time when deficit is a dirty word. That's partly because the center is a difficult project to argue against. Who wouldn't want to find ways to speed a revolutionary new treatment's trip from lab to bedside?
"Patients suffering from debilitating and life threatening diseases do not have the luxury to wait the 13 years it currently takes to translate new scientific discoveries into treatments," Collins said the day President Barack Obama signed the NCATS bill into law.
The new center couldn't come at a better time for pharma; R&D productivity stats are dismal, so faster development would be a godsend for the industry. One of NCATS new grant programs, the Cures Acceleration Network, is aimed directly at helping promising drugs overcome bureaucratic obstacles, the journal Nature reports.
Critics question NCATS' chances at smoothing drug, device and diagnostics development when Big Pharma hasn't--and Big Pharma spends up to 14 times that amount with limited success.
But several recent R&D successes--new drugs that won FDA approval in record time--are examples of another Collins credo, personalized medicine. Using genetic markers of disease to create new treatments and select the patients for them is not only something Collins has championed for years, but promises to streamline development, too. From Phase II trials directly to approval, as one Roche drug achieved, is a shortcut NCATS might well decide to study.