So why create a new center now? “As Will Rogers once
said, ‘Even if you’re on the right track, you’ll get run
over if you just sit there,’” said Collins. “There has
been a deluge of discoveries of potential new targets,”
he explained, and the “genomics revolution” has also
offered a tempting array of possible therapeutic avenues
that are going unexploited.
The proposed NCATS, said Collins, would
“serve as a catalyst to enhance NIH’s longstanding
involvement” in translational
research and drug development. “This is not
an effort to turn NIH into a drug development
company,” he warned. The goal is to
move promising products far enough along
that drug companies would take over development
eventually, resulting in what Collins
called a triple-win situation: NIH pioneers
new therapeutics, pharma takes the
ball over the goal line and the public benefits
from better medicines.
|The goal is to move promising products far enough along that drug companies would take over development eventually, resulting in a triple-win situation: NIH pioneers new therapeutics, pharma takes the ball over the goal line and the public benefits from better medicines.
The morning SMRB session, the 9th meeting
of that body, primarily served to describe
how three working groups are determining
how NCATS will be assembled and how
the National Center for Research Resources
will be abolished as its major programs are
either absorbed by NCATS or transferred to other institutes
or the Office of the Director.
The first working group, composed of senior leadership
across NIH and co-chaired by NIMH director Dr. Thomas
Insel and NHGRI director Dr. Eric Green, is charged with
outlining the mission and function of NCATS; its report
was due Mar. 1 to Collins.
The second group, a subset of the advisory committee to
the NIH director chaired by Dr. Maria Freire of the ACD, is
examining how NCATS can best partner with the private
sector. This group held its first all-day meeting Feb. 4.
The third group, the NCRR task force co-chaired by NIH
principal deputy director Dr. Lawrence Tabak and NICHD
director Dr. Alan Guttmacher, offered “final interim recommendations”
that assigned NCRR ’s programs, including
the Clinical Translational Science Awards (CTSAs,
which fund 55 research centers nationwide), to new
homes. These were posted Feb. 22 at http://feedback.nih.gov/index.php/ncats/task-force-recs/.
One SMRB member, Dr. Thomas Kelly of the Sloan-Kettering
Institute, acknowledged “a fair amount of angst
out there over the redistribution of NCRR programs” and
elimination of the center, and said he didn’t think the
board had adequately discussed the repercussions. Why
not leave NCRR intact and simply move the CTSA program
elsewhere?, he wondered.
Tabak said the first thing his task force considered was
determining whether that solution might work, but
concluded that the “coat of many colors” that NCRR
has evolved into over time is not the optimum arrangement,
given new scientific opportunities. Tabak also
said his group had conducted a thorough analysis of the
“At no time was there ever an intention to eliminate
extant NCRR programs,” he said. All programs will be
maintained, but moved around organizationally, he said,
“to enhance scientific opportunities, based on adjacency.”
Insel said his group, the IC directors NCATS working
group, had met seven times since Jan. 4, including a Feb.
4 joint meeting with Freire’s group. He predicted the new
center will serve “as a catalyst for translation.” Especially
strengthened will be the field of clinical pharmacology,
which has been languishing, he added.
Eight individuals spoke up during the public comment
portion of the SMRB meeting; virtually all applauded
the proposed new center. Said Amy Comstock Ricks of
the Parkinson’s Action Network, “A dried-up pipeline of
new therapies is unacceptable.”
At a 50-minute press telebriefing a half-hour after the
SMRB session ended, Collins said the NCATS mission
“has been embraced by the institute directors” and said it
would herald a new era of collaboration with FDA, pharma,
biotech, advocacy groups, non-profits and academia.
He hoped that the President’s FY 2012 budget, which
includes $100 million to start the Cures Acceleration
Network, wins passage; CAN is to be part of the proposed
NCATS. Collins also hopes that NCATS, by bringing
a raft of new therapies across the so-called “Valley of
Death,” would turn into “a valley that leads to life.”
In responses to questions from seven reporters, Collins
said: the NCATS budget would be around $700 million
(not including possible CAN funding) and will require
a budget amendment from the White House; NIH will
soon advertise globally for an NCATS director-designate;
intellectual property issues arising out of NCATS
will follow a model already in place; and CAN could
potentially have “a DARPA-like authority” (the Defense
Advanced Research Projects Agency begat both the
Internet and GPS technology, Collins noted).
In conclusion, Collins emphasized that he “understands
that people are unsettled by change…The goal is not to
diminish the importance of programs but to empower
them. I am optimistic that the impression [of standing
up NCATS so rapidly] will improve.
“This is not an attempt to replace, but to augment
what the ICs have done traditionally,” he continued.
“Five years ago, this [undertaking] would have been
premature; 5 years from now, it would be a missed
opportunity. The time is right…maybe especially in a
difficult budget environment.”.