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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!

 

NIH alone awards roughly $6B annually to Cancer related R&D grants and contracts. The scope of funding support covers much of the R&D cycle, from basic research, through pre-clinical activities and early phase clinical trials.

In this webinar, we discuss key cancer related opportunities, focusing on the new set of solicitations from the National Cancer Institute (NCI) and the soon to be released CDMRPs (DoD) that are available for life science organizations.

 

View Slide Deck

Dr. Charles Cywin of the National Institute of Neurological Disorders and Stroke spoke about the programs available to support neuroscience translational research.

View Slide Deck

Dr. Matthew Portnoy of the National Institutes of Health gave updates on the Small Business Innovation Research and Small Business Technology Transfer Programs.

View Slide Deck

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.”

 

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