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Vol. LXIII, No. 23
November 11, 2011
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Will Also Review SBIR/STTR
NIH Moves Forward on Main SMRB Recommendations

On the front page...

NIH director Dr. Francis Collins at SMRB meeting
NIH director Dr. Francis Collins at SMRB meeting
While a challenging budget outlook for NIH continues to cloud the horizon, members of the Scientific Management Review Board (SMRB) on Oct. 26 learned that progress is being made on the two most substantial recommendations it has yet made to NIH director Dr. Francis Collins: that NIH create a new National Center for Advancing Translational Sciences (NCATS) and that a single institute take the place of NIAAA and NIDA.

“We are all very energized by the potential of NCATS,” said Collins.

However, he offered a “reality check” on the NIH budget, which has essentially flattened following the doubling that occurred during 1998-2003 (excepting the one-time American Recovery and Reinvestment Act increase of $10.2 billion in 2009). “Our buying power is essentially the same as it was 10 years ago, even as scientific opportunities have expanded,” he said.

Continued...

“We are all very energized by the potential of NCATS,” said Collins.

However, he offered a “reality check” on the NIH budget, which has essentially flattened following the doubling that occurred during 1998-2003 (excepting the one-time American Recovery and Reinvestment Act increase of $10.2 billion in 2009). “Our buying power is essentially the same as it was 10 years ago, even as scientific opportunities have expanded,” he said.

Collins confers with Dr. Kathy Hudson, NIH deputy director for science, outreach and policy, at the SMRB meeting.
Collins confers with Dr. Kathy Hudson, NIH deputy director for science, outreach and policy, at the SMRB meeting.

The traditional NIH grant success rate of between 30-35 percent “has become far less healthy in the past 7 or 8 years,” Collins continued. “For fiscal year 2011, it seems it will be less than 20 percent for the first time in history,” he said. Rather than 1 in 3 applications being approved for funding, the new ratio will be closer to 1 in 6, he explained.

Collins noted that much depends on the deliberations of the congressional super-committee, which is charged with trimming trillions of dollars from the U.S. budget. Should the super-committee’s recommendations fail to win bipartisan approval, a mandatory process of budget “sequestration” would take place, the consequences of which, for NIH, “would be truly draconian,” Collins said. “These are not just stressful times, but potentially disastrous times…it’s hard to know what trajectory we are on.”

Meantime, plans to stand up NCATS are proceeding, according to Dr. Kathy Hudson, NIH deputy director for science, outreach and policy. The new center is included in Senate report language for FY 2012, at a mark of $582.4 million for NCATS, plus $20 million for its component Cures Acceleration Network. The House has not yet marked up a bill through its subcommittee, she reported.

“While we wait,” she said, NIH is currently soliciting applications for an NCATS director and designing pilot programs such as an NIH- DARPA-FDA collaboration to create a “tissue on a chip” to screen for safe and effective drugs, and “identifying a role NIH could play as a matchmaker for rescuing and repurposing compounds,” which applies the “crowd-sourcing” concept to potential drugs.

“We are eagerly awaiting the day that we can cut the ribbon” on the new center, Hudson said. She noted that President Obama “strongly supports the mission of the new center” and hopes he may even attend an eventual NCATS dedication ceremony.
In the foreground, Barbara McGarey (l) of the Office of General Counsel talks with Theodore Roumel, a management

In the foreground, Barbara McGarey (l) of the Office of General Counsel talks with Theodore Roumel, a management consultant formerly with NIH's Office of Technology Transfer, while at rear, Dr. Michael Gottesman (l), NIH deputy director for intramural research, converses with NIH alumnus Dr. Solomon Snyder.

NIH principal deputy director Dr. Lawrence Tabak reported that NIH has shifted back by 1 year the implementation plan for merging NIAAA and NIDA into what is at least temporarily known as the National Institute of Substance Use and Addiction Disorders.

“We are in the midst of completing a very detailed portfolio analysis among all the potentially relevant institutes and centers,” he said, including “a significant amount of intramural research.”

He continued, “A scientific strategic plan is now launched…It is not a reprise of ‘should we have a new institute or not?’” Rather, it is identifying gaps in knowledge and new opportunities that NISUAD might explore and is being conducted by NIH and relevant stakeholders, he explained.

“The group has met internally,” Tabak said, “but will begin to engage focus groups and town halls across the country. Our goal is to gain maximum input on scientific opportunity.”

A year from now, in fall 2012, NIH expects to release its portfolio integration plan and scientific strategic plan, both of which include public comment periods. NISUAD might then debut in October 2013 as part of the FY 2014 budget.

Tabak said the year’s delay in standing up the new institute is due to “the complexity of the portfolios, and to assure sufficient time for public comment and, particularly, to allow for review of scientific opportunities.”

NIH director Dr. Francis Collins, CFC vice chair, demonstrates DNA’s double helix structure. The gesture is also known in sign language as “love.”

NIA director Dr. Richard Hodes (r) makes a point while Collins and Dr. Gail Cassell of the SMRB listen.

Photos: Ernie Branson

Three stakeholders commenting on the proposed merger called for a consensus conference that would explore funding issues and more sharply define the range of “excessive behaviors” that could be studied, including gambling, obesity and smoking.

One other SMRB recommendation—that the Clinical Center be funded as a line item in the Office of the Director budget, rather than via a management fund contributed to by all user ICs—also hit a bump in the road. NIAMS director Dr. Stephen Katz, who chairs the CC governance board, said the hospital would continue to be funded internally in FY 2012 and 2013 because implementation of the SMRB recommendation “is more legally complex than anticipated.”

The CC will, however, proceed with plans to broaden its Bench-to-Bedside Program to include extramural investigators, provided that outside teams include an intramural collaborator.

Collins concluded the meeting by giving the SMRB a new charge: recommend ways to optimize and make more effective the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, both of which are managed by the Office of Extramural Research and depend on IC taps for their funding.

The SBIR, extant since 1982, is funded through a 2.5 percent set-aside for each user IC, or $609 million in 2011; the STTR, founded in 1992, gets a 0.3 percent set-aside, or $73 million in 2011.

“Some institutes consider [these programs] an incredible asset, while others ask, ‘What is this?’ Some institutes want to spend more [than what is allotted] and some, frankly, don’t want to spend any,” Collins said. “I want to look at the flexibilities we have and perhaps find some more effective approaches. These programs can be fine-tuned to capture the very best and most promising science.”

The SMRB accepted the charge and NIH alumnus Dr. Solomon Snyder, now at Johns Hopkins University, will chair the SBIR/STTR working group.

SMRB’s next scheduled meeting is Dec. 21, by which time Collins said the budget picture should be clearer.

Budget Worries Occupy Advisors

At each gathering of the Scientific Management Review Board, NIH director Dr. Francis Collins delivers a “state of the NIH” address, which updates the SMRB on agency activities.

His Oct. 26 presentation included four avenues that NIH is either already pursuing or planning to keep budget pain at a minimum: make the case for NIH, trim spending across the board, evaluate and perhaps rearrange the research portfolio (“You should never let a crisis go to waste,” quipped Collins, paraphrasing Chicago Mayor Rahm Emanuel) and change how NIH resources are managed, including potentially limiting the number of R01 grants individual investigators may hold.

Collins said he welcomes any useful suggestions the scientific community may have and offered an email address for ideas: NIHResourceManagement@nih.gov.

NIH director Dr. Francis Collins, CFC vice chair, demonstrates DNA’s double helix structure. The gesture is also known in sign language as “love.”

Snyder (l), who accepted leadership of a SMRB working group on SBIR/STTR operations, talks with Dr. Arthur Rubinstein, dean of the University of Pennsylvania School of Medicine. Rubinstein thinks his peers in academic medicine have misjudged the seriousness of the current budget situation.

Two SMRB members, however, added their own assessments of the current budget climate.

“This is my third downturn,” said Dr. William Brody, former president of Johns Hopkins University, alumnus of the advisory committee to the NIH director and currently president of the Salk Institute for Biological Studies. “This one feels worse than the others.”

Brody says the extramural world “is in denial.” Many institutions continue to build up their medical campuses, as if it were true that you could “build it and they will come.”

He thinks the current slump in scientific funding will persist indefinitely, noting, “I think the system has to wash out some people.”

During a recent limousine ride in New York City, he asked the driver how long he’d been a chauffeur. “He said, ‘Four months.’ Before that, he had been a pharmaceutical chemist for 31 years.”

Also commenting was Dr. Arthur Rubinstein, dean of the University of Pennsylvania School of Medicine. “There’s this unreal feeling that ‘it’s not going to affect my institution.’ I keep saying that there are going to be millions and millions less for university research. But they laugh at me when I preach, at my institution.”

Collins said that whatever austerities may be introduced, NIH is “not going to issue a mandate and say ‘Live with it.’ It will be a community-generated response.”

He mused about potential cost-savings if, for example, effort-reporting audits were no longer required, or if fewer IRBs needed to approve individual studies. “There may be some tasks we could unload, or reorganize some administrative burdens,” he said.

Observed SMRB chairman Norman Augustine, retired chairman and CEO of Lockheed Martin Corp., who has witnessed large layoffs at his company, “People can stand change, but they can’t stand uncertainty…You don’t cut the cat’s tail off an inch at a time.” NIHRecord Icon


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