Medical Writing, Editing & Grantsmanship

An oddly titled (”Start-Ups Say Innovation Doesn’t Grow on Trees”) Washington Post column by Kim Hart laments the absence of a 2.8% set-aside for SBIR/STTR awards in the $10B the NIH received in ARRA funds and notes lobbying efforts for Congressional reauthorization of the small business set-aside program:

Cha-Mei Tang, chief executive of Potomac-based Creatv MicroTech, said she submitted a grant application last week to help hire more employees to gather patient samples and statistics in the development of a tool to detect chronic lymphocytic leukemia. She said past efforts to compete for funds that are not reserved for small businesses have been unsuccessful, so she is concerned that companies will not have much of a shot at stimulus money.

“Everything we sell is based on SBIR funding,” Tang said. She said she plans to visit lawmakers on Capitol Hill this week. The House is scheduled this week to take action to reauthorize the SBIR program, which expires at the end of July. The biggest issue in question is whether venture-backed firms should have access to SBIR grants.

Perhaps Creatv MicroTech should consider why they have been unsuccessful in competing for R&D funding and whether this reflects on the soundness of their science, study design, expertise, facilities, etc.

The Enhancing Small Business Research and Innovation Act of 2009 is being reviewed by the House Committee on Science and Technology, whose Chair Bart Gordon (D-Tenn) calls it “one of the most significant bills the Committee will likely address in this Congress”. Right now, the bill extends the life of SBIR/STTR only until 2011 (corresponding Senate bill, SBIR/STTR Reauthorization Act of 2009 [S. 1233], goes through 2023 and gradually increases the set-aside amount until it reaches 3.5% in 2020). Usually, the program is reauthorized for 8-year cycles.

Both bills increase the award levels, and the House also shortens the application review period. One presumes the NIH will be among those extending the 90-day deadline to 180 days recommended in the House report:

The section also directs Federal agencies to render a final decision on each proposal 90 days after the date a solicitation closes. A clear timeline will allow applicants to better forecast and prepare for receipt of potential SBIR awards. Recognizing that the agencies will not be able to meet with this directive in all cases, the section provides the agencies with the authority to extend the 90-day deadline to a 180-day deadline on a case-by-case basis.

With regard to ARRA small-business funding, apparently the recent RFAs — Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN) Pilot Program (RC3) ($35M) and Small Business Catalyst Awards for Accelerating Innovative Research (R43) ($5M) — which were not mentioned in the Post article, don’t count.

Regardless, Aprile Pilon of Clarassance, a Rockville-based biopharmaceutical company, “argues that small-business applications get tougher scrutiny than those from academic institutions, and she claims that the board reviewing the applications is largely made up of university representatives.”

What a shocker that the NIH would want to have qualified scientists review the science. Never mind that the paylines for SBIR/STTR grants are much higher than those for the basic biomedical research that will eventually become available for commercialization.

Oh, the Post piece notes that:

Cardin, Van Hollen and Edwards [all D-Md reps] sent a pointed letter to [acting NIH Director] Kington after the hearing [on the SBIR reauthorization bill], saying that his “absence sent a message of indifference.”

Hmm. Wonder what Ray might have on his plate that could possibly be more important than small-business set asides?

Now, not that I am against the NIH Small Business Research programs. Far from it. But when the NIH has to keep raising paylines because there aren’t enough scientifically outstanding and excellent applications competing for these Congressionally designated funds, perhaps industry should put as much effort into evaluating their research practices as lobbying for more federal set-asides.

In case you were not aware, you can browse NIH ARRA-funded awards by state (notice the nice distribution of push pins) or you can search RePORTER (think enhanced CRISP) using the swanky new query form, which includes a check box to “show only projects supported by NIH Recovery Act funds.” Each list of projects by state (scroll down below map) can be sorted by PI or organization name (click on the appropriate column heading) to find those of most interest.

<I’ll pause a moment while feverish fingers check out the success of rivals.>

Notice upon searching RePORTER that you will be given tabs that list award description (abstract), details (including $ amounts), results (publications), history (renewals, supplements – interesting for long-standing awards especially), and subprojects. I’ll add that the new query portal layout and functionality is a very welcome improvement over the CRISP query page.

You can also view an interactive graph to monitor how much of the ARRA monies have been committed to FOAs.

As more and more of you become stimulated by ARRA funding, you might consider whether you have a “success story” to share with your funding IC. NIAID has created an ARRA Success Stories Website, and I assume at least some – if not all – other ICs will follow suit. NIAID will eventually have a Web-form through which you can submit your anecdotes, but in the meantime, please send niaidarraimpact@mail.nih.gov the following information:

• Grant number, project title, PI name
• How ARRA funding has helped you (1,000 words or fewer)

Another NIAID page suggests what you might report:

Share your successes, both big and small, with us and your community. For example, your personal stories can illustrate how the funds enabled you to keep your lab intact, hire a promising young scientist, expand your research, or advance science.

Maybe even salvage a tenure application. Good luck to you all in getting your sliver (à la mode, of course) of the stimulus pie!

No.

An impact score of 80 at the 59th percentile means either the study section discussed all proposals, or someone took an interest in your otherwise triage-destined application and advocated for its discussion.

The new scoring range is from 10-90, with impact scores under 20 most likely to be funded … perhaps under 25 since ARRA has relieved the system of some of the backlog of potentially fundable applications. Percentiles issued in this round reflect only the current study section in which the application was reviewed (assuming the study section had 25 or more applications under review … if fewer than 25, then pooled with either all CSR or all IC applications, as appropriate to the review group’s affiliation).

You can find details on the scoring procedure and interpretation as well as reviewer guidelines by mechanism at the Enhancing Peer Review Website.

I’m guessing NIAID will be the first to update their paylines accordingly, and I’ll post updates as the ICs provide them here in the main blog and on the NIH Paylines & Resources page.

What is Toni Scarpa smoking? He recently told The Chronicle of Higher Education that

The numbers [of RC1s] are causing concern for the present, as each application requires an average of three reviewers working 12 hours apiece, Dr. Scarpa told agency representatives.

Everyone out there who is spending 12 hours reviewing their Challenge Grants, raise your hand. Based on conversations I’ve had with investigators here at BICO (& warmer environs elsewhere) in a wide range of disciplines, they uniformly find these proposals, shall we say, unchallenging, to be kind. I’m sure Comrade PhysioProf can provide the appropriate color commentary. The minimal time needed to assess these is a good thing given that I also know of faculty who just last week unexpectedly found as many as 5 RC1 applications sitting in their eRA Commons account with reviews due June 12. Twelve hours per application? Ooooooh yaaaaaa.

And this apparently is after the NIH removed about 8% of applications that were deemed to be unresponsive/noncompliant … I think noncompliant with the laws of science more than the FOA policies. Many are apparently recycled ideas that weren’t funded the first time as R01s/R21s etc., so novelty will not be a common term used in the truncated summary statements (unless to point out the distinct lack of). It could be that the most novel proposals achieve this distinction due to their basis in woo.

Anyone experiencing review nirvana out there?

But, Toni is most grateful:

“Our scientists and their staff are unsung heroes, managing twice as many applications in a very compressed time with great professionalism and excellence,” said CSR Director Dr. Toni Scarpa. “The response by the scientific community also has been tremendous. The help is particularly gratifying because it shows the value and respect that scientists have for NIH peer review.”

I am glad Toni decided to issue a press release about the number of applications (nearly 21K) and reviewers (18K+) involved. The sheer numbers will hopefully serve as a wake up call that the NIH base appropriation needs to be restored and maintained in a responsible manner – not in irregular spikes guaranteed to stimulate irrational exuberance followed by a musical chairs, survival of the fittest (& richest) scramble for the crumbs that remain after the feast.

Indeed, The Chronicle article concludes:

Mr. Obama’s proposal, if approved by Congress, would set the agency’s baseline budget 4.7% higher than its final budget under President George W. Bush in 2008. But the biology federation said the increase proposed by Mr. Obama for the NIH in fiscal 2010 is only 1.45% higher than the fiscal 2009 level, excluding the stimulus money, raising questions about the federal government’s commitment to sustain biomedical research.

I know you’ve been waiting on the edge of your seat for the HHS Agency-Wide Recovery Implementation Plan, and I’m thrilled to say the wait is over.

The section on Strengthening Scientific Research and Facilities includes 4 PDF files laying out how the NIH will spend $8.2B on Scientific Research (only $122M used intramurally); $1B on Extramural Lab Construction & Renovation; $300M on Shared Instrumentation; and $500M on Buildings & Facilities (intramural).

The Scientific Research plan again notes the plan to support Signature Initiatives, the only mechanism (or strategy) not yet announced for funding – and not mentioned in the implementation timeline. On page 4 of the plan, there is an interesting table laying out how the $8.2B will be distributed by grant type. I was puzzled to see, for example, 525 awards totaling $39M going toward institutional training grants. Meritoriously scored pick-ups and supplements?

The table on page 6 is of interest as it gives target quotas for the number of new and competing RPGs, administrative supplements, and competitive revision awards to be made … plus an empty row for number of jobs created/retained. The numbers jump considerably between the original and revised targets for each, especially in FY09, giving a nice incremental change (increase) in performance:

• 9,842 -> 16,564 RPGs
• 1,369 -> 3,445 administrative supplements
• 37 -> 576 competitive revision awards

Oddly, the NIH had no original target for extramural construction awards, despite knowing money had specifically been designated for this purpose. For FY09, their revised award target is 58, with 174 awards to be made in FY10. The Shared Instrumentation plan shows a bigger jump in FY10 (124 -> 544 awards) than in FY09 (123 -> 198).

Intramurally, the NIH’s big projects include the John Edward Porter Neuroscience Research Center Phase II (PNRCII) ($266 million), Building 10 (original clinical research hospital) F Wing Renovations ($134 million), Build-Out of Building 3 (offices) ($21 million), and Conversion of Building 7 (Rocky Mountain Laboratories) ($7 million).

A separate section on Supporting Comparative Effectiveness Research includes 3 very uninformative PDF files: NIH ($400M), AHRQ ($300M), and Office of Secretary. None of them have any original or revised targets in terms of numbers of awards, though the Office of the Secretary plan notes that $1.5M went for a CER study by the IOM and another $1.1M to provide logistical support to the new Federal Coordinating Council for Comparative Effectiveness Research.

Also of interest in the Office of the Secretary plan is a table on page 4 showing output measure targets, which I bring up in consideration of RC2 applicants, who need to provide measurable outcomes to assess whether they are making the most of their grand opportunity. The AHRQ CER plan provides another model for such a table on pp 4-5.