Comparing U.S. and U.K. Programs
Wisely, NCATS expanded participation to multiple drug developers, since more pharmas will mean more compounds for researchers to study. Also, NCATS will review applications from researchers from academia, industry, and nonprofit institutes, while MRC’s program is limited to academic and research institute applicants.
NCATS reasons that working with industry offers a greater chance of advancing the compounds. “The goal is simple: To see whether we can teach old drugs new tricks,” said U.S. Health and Human Services Secretary Kathleen Sebelius.
MRC’s applications may include collaborations with commercial third parties under agreements that must be in place before submission of full applications. Over eight weeks, MRC received more than 100 proposals from researchers at 37 institutions, said Donald Frail, vp of science within AstraZeneca’s new opportunities innovative medicines unit.
MRC’s program will award up to £10 million (about $15.6 million) in two- or three-year grants, with announcement of awards to come in October. Where MRC has said its awards will not be value limited, NCATS envisions awards of more than $2 million each—eight awards totaling $20 million—during the pilot program’s first year. NCATS awards will be announced in April or May 2013.
The $20 million sum is likely to rise over the second and third years, Dr. Hudson said, reflecting the expectation that some of NIH’s 27 institutes and centers will contribute additional research funding for projects affecting their specialties and the greater expense of clinical vs. preclinical studies.
NIH will be challenged to maintain, let alone increase, spending, however. Congress faces two sobering options soon after the November presidential election: Cut at least $1.2 trillion in spending over the coming decade or absorb across-the-board spending cuts of 7.8% or more for NIH.
Even if budget were no issue, NCATS faces another challenge in ramping up the new-therapeutic-purpose program: the willingness of NIH’s other centers and institutes to help the translational medicine center. As late as 2007, NIH acknowledged an agency culture where “research projects are normally managed by an individual institute or center.” Then-director Elias A. Zerhouni, M.D., sought to reverse this culture by creating interdisciplinary research consortia.
While the new program is disease-agnostic, NIH director Francis S. Collins, M.D., Ph.D., said that neurological disorders “would certainly be an area where we would hope there would be a lot of activity.” Four of the MRC program’s 22 compounds have neuro indications: two for schizophrenia, and two for anxiety, one of which was also indicated for depression.
The CNS disease focus for NCATS could reverse years of retrenchment by big pharma in CNS disease. AstraZeneca, Pfizer, GlaxoSmithKline, and Novartis closed research facilities, while Merck & Co. and Sanofi reduced research spending. Those moves followed the failure of numerous clinical trials.