Part IV: The NIH Phased Program


There are 3 phases to SBIR/STTR awards.

Phase I: to establish the technical merit, feasibility, and commercial potential of the proposed R&D efforts. The awards to both SBIR/STTR generally do not exceed $225K; though for SBIR this amount is for 6 months, and for STTR, this amount is for 1 year. Waivers exist for several institutions increasing the max budget allowed.

Phase II: to continue the R&D efforts initiated in phase I. This is why it is recommended to submit a phase II application immediately after submitting phase I. The funding is based on the result achieved in phase I and the scientific merit and commercial potential of the project proposed in phase II. Only phase I awardees are eligible for phase II.

The awards generally do not exceed $1.5M over 2 years, but as with phase I, waivers exist for some institutes to allow for increased budgets.

Phase IIB: can be awarded to continue a phase II project. This award is not as well known, but is not a new award, it has actually been available for several years. The purpose is to support the next stage of development for federally funded SBIR phase II projects, and overcome the “Valley of Death” funding gap between the end of phase II award and the subsequent round of financing needed for commercialization. It usually requires matching funds.

Fast Track Program: incorporates a submission and review process in which both phase I and phase II are submitted and reviewed together as a single application. The fast-track mechanism can reduce or even eliminate the funding gap between phases. This is not offered by the NSF.

Look for PART V next week!


Part III: Eligibility


Only US-based small businesses are eligible and must meet all of the following criteria at the time of award to get funded:

  • For-profit organization
  • Located in the US
  • No more than 500 employees, including affiliates
  • At least 51% US-owned and controlled by individuals who are citizens or permanent residents
  • SBIR-only: Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern

These requirements must be met at the time of the award. All work must be done in the US.

Look for PART IV next week!


Part II: What’s the difference between SBIR and STTR?


SBIRs are intended to fuel growth in the private sector and commercialization of innovations derived from federally funded R&D. This is done by funding small businesses seeking to commercialize innovative biomedical technologies.

STTRs are intended to stimulate a “partnership of ideas and technologies” between small businesses and non-profit research institutions through federally funded R&D. In other words, the small businesses collaborate with a research institution in phase 1 and 2. However, the STTR must also be product and market oriented.

SBIRs and STTRs differ in two major ways:

  1. The PI (Principal Investigator) – For SBIRs, the PI must be primarily employed by the SBC for the duration of the research and at the time of the award (unless waiver is granted). The PI must spend more than half of his time at the company or must not be a full-time employee of another organization. This is not required for STTR, where the PI may also come from the Research Institution partner.
  2. Location of the Work – At least two-thirds of the work must be in-house (at the SBC) for the SBIR; but the STTR requires that only > 40% of the work is done by STTR

Look for PART III next week!


Part I: What are SBIRs/STTRs?


The total pocket of non-dilutive funding from the US government is around $50B annually. Most of the non-dilutive funding for life sciences, biotech and medtech comes from the National Institutes of Health (NIH) – around $28B in 2018 (against a total budget of $37B). Through the 24 funding institutes at the NIH, numerous indications can be funded. So, no matter your field, the NIH can potentially fund your project.

One mechanism for non-dilutive funding from the NIH is SBIR (small business innovation research)/STTR (small business technology transfer). These are congressionally-mandated programs – money must be set aside each year – whose goal is to strengthen the role of innovative small businesses in federally funded R&D: “support scientific excellence and technological innovation through the investment of federal research funds in critical American priorities to build a strong national economy.”

Any institute with an extramural R&D budget over $100M must allocate 3.2% of that budget for SBIR and institutes with an extramural R&D budget over $1B must allocate for 0.45% for STTR each year. SBIR is available for domestic (US-based) small business concerns (SBCs). While the goal is to help small business engage in R&D – the NIH specifically looks for those with potential for commercialization.

Look for An Intro to SBIR/STTR Part II next week!


  • Know Your Audience

Know your audience – the institute from which you are applying for a grant. Your project should address their areas of interest. To identify these areas, check the institute’s website, review the study section description, and look at the rosters of previous meetings as well as previous awards made.

  • Create Bite-Sized Pieces

Plan your research strategically by creating bite-size pieces. Define a singular, focused goal that encompasses the research aims under a single concept. The research can also be divided into several distinct proposals, submitted either simultaneously or one-by-one.

  • Find the Middle Ground

Innovation is a double-edged sword – pioneering work can significantly advance a research field, but involves a lot of risk. Review groups tend to be conservative, and so to win, you need to find the middle ground. Your research should be novel but also grounded with supporting literature.

  • Establish a Reputation

Your name should be synonymous with the research at hand. Publish your work, attend conferences, establish networks with others in the field and working relationships with relevant laboratories and institutions.

  • Assemble Experts

Reviewers need to know that you can undertake the proposed tasks, even if unforeseen snags arise. Choose collaborators to complement your capabilities; if necessary, recruit a consultant, collaborate with a laboratory, or subcontract a CRO. The governmental grantor itself may be available for collaboration or contribution of human or laboratory resources.

  • Dedicate the Time

Writing a grant proposal is a complex process that requires a significant time commitment. Set aside several weeks or months for the process; depending on the size of the project and level of preparedness. It will require several drafts, and the more you review the drafts, the more you can edit, and the better your final proposal will be.

  • Ask for Help

It is always best to turn to others to review your application and offer unbiased input. These can be colleagues, supervisors, current or former employees. Consultancy firms, such as the FreeMind Group, with years of experience writing grants, familiarity with funding agencies, and the benefit of an unbiased view, are a valuable source of guidance.

  • Get Their Attention – and Keep It!

Your proposal will likely be read at 10 PM, after a full day’s work and along with seven other 80-page proposals. Of a 20-30-member panel only 3-4 will read your application in full, while others skim it for important points. Write the proposal in a reader-friendly manner: break the text into sections with informative titles; stress important points; keep paragraphs short; and change sentence structure. Pictures, figures, graphs, and flowcharts are also helpful.

  • Details, details, details

A grant proposal should paint the most complete picture possible of the research. The reviewers must understand exactly what you want to do and how you intend to do it. You need to guide them through the preliminary data, hypothesis, research design, methods, interpretation, and future directions. Any gap will have the reviewers doubting your ability to complete that step.

  • Have No Fear

Don’t fear rejection; it’s in your best interest to submit as many high-quality applications as your research will support. It’s not easy money, but it is an excellent source of funding. If at first you don’t succeed, try, try again.

NIH and VC Funding; Growth Engines for the Life Science Industry; Exploring Similarities, Differences, and Overall Objectives. A panel discussion at the 14th Annual Non-Dilutive Funding Summit featuring: Ram May-Ron, Managing Partner, FreeMind Group | B. Christopher Kim, Managing Partner, Novatio Ventures | Dr. Matthew Portnoy, Director, Division of Special Programs – Office of Extramural Research, NIH

 

Adam Ruben

doi:10.1126/science.caredit.a1600164

‘Twas the night before grant deadline, 7:15.
Many creatures were stirring, thanks to caffeine.
The comments accepted, the references done,
In hopes someone might fund my first R01.

I wrote like a showman. My prose was terrific.
My font was New Roman. My aims were specific.
I showed prior data and new innovation—
I even nailed my budget justification.

The footnotes were hung like superscript pendants,
Each at the end of a well-crafted sentence.
I sighed with relief; it had all turned out fine,
And I dreamed of the day when I’d hear the pay line.

I’d labored for months while my spouse gazed with pity:
This would have to influence my tenure committee.
The time and the effort I’d spent really showed.
Now the grant was complete; it was time to upload.

When what should my wondering eyes chance to scan
But the tiniest typo in my research plan?
Then more and more errors came as I read through!
And I knew it would never survive peer review.

So quickly I rose from my chair made of vinyl
And opened the files I’d all labeled “FINAL.”
“Sweet merciful Darwin!” I cried to the heavens.
“There’s no Figure 6! There are two Figure 7s!”

My spacing was shrunk and my margins too wide!
My titles and headings were right-justified!
Even the sections I’d thought in grand shape
Had been converted from portrait to landscape!

What fate had befallen my grant so idyllic?
The tables were merged—and is that Cyrillic?
So many errors! Oh, how could this be?
All I did was convert from Mac to …

Uh-oh.

Now swiftly I read one line to the next,
Putting symbols back in and repairing the text,
Fixing all of the words over which I had sweated,
The objects and worksheets that now were embedded.

“But it’s science!” I screamed, my heart pitter-patting.
“Why must I spend all my time on formatting?
Why would anyone panic? Why would they care if
My spacing was close, or my font had a serif?”

When all of a sudden, there came such a din
That I ran to the door—and then he walked in.
“Cease your worry!” said he, in his bold way of talking.
“All good scientists get a grant in their stocking.

You’ve done all the research that one could deem prudent.
(Well, not you—your postdocs and graduate student.)
Your grant is the greatest thing since streptomycin!”
And I knew right away he was Neil deGrasse Tyson.

He was dressed in a blazer; his elbows were patched.
And, like most astronomers, none of it matched.
His mustache, so bushy! His loafers, how dirty!
His visage, so kind, and his necktie, how nerdy!

“Oh please, Dr. Tyson!” I then interrupted.
“The grant is due soon, and my file’s corrupted!
If my department chair sees that I’ve flunked,
I might be demoted to teaching adjunct!”

With a wink and a nod and a friendly high-five,
He placed in my hand a USB drive.
The files it held were my own grant, but better!
He even provided a new cover letter!

As I marveled and gawked at my mended submission,
With every page break in its proper position,
He climbed in his sleigh. (Why a sleigh? Don’t ask me.)
He took up the reins, and he shouted with glee:

“Now funding! Now finance! Now tech transfer offers!
On private foundations! On government coffers!
Now sit back and watch as your budget increases
For keeping your postdocs on H1-B visas!”

“Oh, thank you!” I yelled, “for each PDF’d page!
My lab techs will cheer at their new living wage!
On supplies and equipment we’ll run up a tab.
My undergrads won’t have to sleep in the lab!”

I dreamed of results from the money we’d spend,
Professional meetings we now could attend,
The safety routines we’d bring up to compliance,
The last-author papers I’d publish in Science.

For grant applications are vaguely abusive;
Funding is fleeting and tenure elusive.
In science, we struggle for basic support.
I guess we’re less vital than, say, a sport.

He pointed his sleigh toward a twinkling star,
Then flew off to help with an SBIR.
And I heard him exclaim, in a voice to enchant,
“Merry deadline to all! Now go start your next grant.”

 

Read online

Amber Dance

Nature 540, 471–473 doi:10.1038/nj7633-471a

Published online 14 December 2016

This article was originally published in the journal Nature

Nervous about your grant application’s chance of success? Get help to make every word count.

Read article online

Jiri Lukas’ research centre was at a crossroads four years ago. Bankrolled by the Novo Nordisk Foundation, the organization was facing a mid-term evaluation, and its funding was at risk. Lukas, executive director of the Center for Protein Research at the University of Copenhagen, wanted to apply for a grant extension, but was worried that his efforts would be wasted. It was rare at the time for foundations that award grants for biomedical research to further their support beyond one-time, limited-term funding.

A colleague told Lukas that the science in his application was strong, but that the application itself didn’t make the best case for the societal impact and unique nature of the centre. The colleague advised Lukas to consult with scientific-communication specialists at Elevate Scientific in Malmö, Sweden. “The rest was kind of a fairy tale,” Lukas says. With help from Elevate, the centre won the extension.

When it comes to seeking either government or private funding, grant writers and editors are a useful resource for scientists in both academia and industry. Scientists call on them for a variety of reasons. Some simply don’t have time to do it themselves. Others know that they aren’t good writers, or lack a sufficient command of English. Some are struggling to get funding. Grant writers can help with finding the right organizations to fund a project, as well as with writing the application. They can hone and focus the message, ensure consistency between sections drafted by different authors and assure adherence to strict page limits. Grant writers and editors help with everything that isn’t the science, yet can still significantly affect a proposal’s chance of success.

Many researchers still go it alone in preparing grant applications, but the funding landscape has changed, and scientists are now less hesitant to ask for help, says Sheila Cherry, president of Fresh Eyes Editing in Dayton, Ohio. Many funders expect applicants to seek assistance. The written guidelines from the US National Institutes of Health (NIH), for example, make that clear: “If writing is not your forte, seek help!”

There should be no shame in asking for guidance, says Anders Tunlid, a microbial ecologist at Lund University in Sweden who has reviewed grants for the European Research Council. “We need to accept that this is the way we all do it,” he says. “I don’t think that everyone has written their proposals themselves.” Colleagues may be willing to review an application’s scientific content — but they are typically too busy to spare the hours needed for fine-tuning.

“Everyone needs a little bit of help, if only to find typos,” points out David O’Keefe, senior grant writer at the Salk Institute in La Jolla, California.

The Salk offers the service for free to its researchers, but external help comes at a price: basic editing services can run from US$500 to thousands of dollars, depending on the application. “It’s an investment, for sure,” says Stefano Goffredo, a marine ecologist at the University of Bologna in Italy. But after spending months on a proposal, he thinks it’s worth opening his wallet to get a professional polish.

Without that polish, it’s all too easy for reviewers to quickly discount an application, says Laura Hales, principal of the Isis Group, a scientific consulting and communications service in Cambridge, Massachusetts. She has served as a reviewer herself and can attest to the fact that first impressions count for everything. “You have,” she says, “one chance.”

Independent data are essentially non-existent on how professional grant-writing services affect success rates. Companies’ claims for success range from more than three times the average rate for NIH grants to six times the average rate for the European Union’s Horizon 2020 grants. But the companies themselves concede that they can offer no guarantees. “Just because I know the formula doesn’t mean I’m going to get every one,” says Hales.

Find your match

Institutions might pay for support for a junior scientist’s first few grants, says Susan Marriott, president of BioScience Writers in Houston, Texas, but the support can be useful for mid- to later-stage-career researchers, too. Working with Elevate Scientific was a “humbling” experience, says Lukas, even as a senior scientist. The editors identified unclear sections, improved graphics and strengthened the logic in the proposal to communicate the message more effectively.

Senior researchers in a collaboration may also use a grant editor as a project manager to ensure that all the pieces come together in a neat package by the submission deadline. It was just such a multi-investigator project that led Bruce Johnson to call in Fresh Eyes Editing. Every author tends to use their own formatting for elements such as headings and references, he notes, and editors can give the document a consistent style. “It makes it look so much more professional,” says Johnson, chief clinical research officer at the Dana Farber Cancer Institute in Boston, Massachusetts.

Editors also catch inconsistencies and redundancies in the content. For example, a large document on lung cancer does not need to repeat in every author’s section that it’s the leading cause of cancer deaths in the United States. And one scientist might cite a statistic that 15% of people with lung cancer have a certain mutation, whereas another might write 25%. That inconsistency could cause reviewers to think that the collaborators aren’t talking to one another, Johnson says, which would not inspire a sense of confidence that the team could carry out the project together.

Grant helpers vary in the assistance they provide, and at different stages of the proposal process. Some get involved at the very start, strategizing about where to apply for funding. “It’s not only about how you write an application,” says Ram May-Ron, managing partner with the FreeMind Group in Boston. “The search starts with identifying which funding opportunity is the best one for a particular part of a research project.

Scientists may have heard of big funding initiatives, such as Horizon 2020, but there might be other opportunities they should consider, says Eran Har-Paz, vice-president for sales at Sunrise Projects in Rosh Ha’Ayin, Israel. “We try to build a strategy, a few alternatives to submit to,” he says. “Don’t put all your eggs in one basket.”

At this level, grant helpers may reach out to programme officers, says May-Ron. For example, they might ask whether an agency has funded similar research recently, and whether they’re at all interested in doing so again. “If you go to the right place, you’re already in a better position,” he points out.

This full-scale service comes at a price, of course. Har-Paz estimates that the simplest proposal might cost a few thousand euros, with the cost escalating to 20,000 (US$21,414) or more for elaborate applications. That includes not only the strategizing, but also writing the majority of the application.

Some scientists already hand off much of the writing to others. Cath Ennis, a project manager and grant writer in Vancouver, Canada, might contribute an abstract, literature review, impact statement or budget, depending on the scientists’ needs — but never the research plan itself. “Our role is to take all the jobs that we can from the principal investigator, so they can focus more on the research,” she says.

Other grant professionals stick to editing — but that’s more than just dotting i’s and crossing t’s. Grant editors consider content, clarity, logic and flow.

Grant professionals can be found in a variety of places: some work for a company and others as freelancers whereas some institutions have in-house specialists (see ‘How to become a grant writer’). “Start talking early,” advises Marriott, who is also a virologist at Baylor College of Medicine in Houston. “Even if you don’t have a grant ready yet, even if you don’t know what you’re going to write.” It’s beneficial to get on an editor’s calendar as early as possible, because by the time the deadline rolls around, they could have many scientists clamouring for their attention. Later on, editors may be still able to help, but in a more limited fashion, she says.

Scientists tend to look for someone with a PhD and the right technical expertise. But the match doesn’t have to be exact. “I’ve edited grants about nuclear physics,” says Ennis, whose background is in cancer biology. “I can still catch a typo when someone’s put ‘proton’ instead of ‘photon’.”

Equally important, Ennis says, is to look for editors who specialize in the kind of grant one’s after — say, NIH, Horizon 2020 or foundation grants. Every programme has its own requirements, and the professional should know those inside out.

With candidates in mind, the next step is to get to know them. Ask a potential editor or writer about their process, and the services they do and don’t provide, advises Cherry. “It’s a lot more than just, ‘What’s your fee and how soon can you get this done?’” she says.

Timing and costs are, nonetheless, key questions. It’s best to get an estimate in advance to avoid a surprise charge later. One should also ask for a confidentiality clause in the contract.

Then, be prepared for plenty of back-and-forth. “Remember that it’s a collaborative process,” says Cherry. “Don’t be afraid to bring up concerns and make sure you’re really collaborating.”

 

 

A tough and ever-changing question.

Perhaps a quick personal historical overview might help shed light on the statement above. When I started out in this field in many years ago, there was a “three strike” policy. That basically meant that you could submit an original proposal, and then two revisions. If you didn’t get the award you had to change direction. In some cases, this caused some of our clients to regard the original as a type of “feeler” to send out before getting down to things in the following proposals. Others, correctly, took every proposal seriously. But however you looked at it, you were out after three tries.

After a few years, the NIH, presumably trying to reduce reviewer workload, if I recall correctly, changed this to a two-strike policy. That means that you had the original and a single try at a resubmission before you were “out of there” with the research idea. This caused general unhappiness in the field, because having just one chance to resubmit was kind of harsh. Researchers really didn’t like having to change projects, after getting an almost-funded 17 percentile for example. I also personally believe this didn’t make much sense when the paylines are so competitive. I mean, the difference between awarded and not-awarded is sometimes negligible in terms of score, and in the very-subjective range of reviewers’ decisions.

The surprising next move was that the NIH did an almost complete 180 degree turn in terms of concept. After a few years of having the rough two-strike policy, they went with the complete opposite, and this is what we currently have now. Yes, you can now still only resubmit (revise) your proposal once for each original, but can then go ahead and continue the cycle as many times as you like: Original – resubmission – original – resubmission and on and on. No formal limits. We may note here that the second “original” is also referred to as a “virtual A2” by the NIH itself (A2 refers to a second resubmission).

Joel Knopf
Manager of Consulting Services

 

In our next resubmission posts we will discuss: