Part VI: Funding Opportunities

These can be divided into 2 categories: solicited and unsolicited

Unsolicited opportunities, also known as investigator-initiated or omnibus solicitations, or parent announcements are when investigators submit a solicitation with no specific solicitation. Many NIH institutes participate in the parent announcements. Approximately, two-thirds of all awards are unsolicited; even if you can’t find an exact solicitation for your project, utilize the unsolicited mechanism.

The deadlines and budget are standard for parent announcements. Recently, the NIH separated the parent announcements for clinical trials allowed and clinical trials not allowed.

Solicited opportunities, are specific opportunities for specific indications. As of 2018, there were 92 open from the NIH alone.

Part V: Standard Due Dates for SBIR/STTR Applications

The due dates for SBIR/STTR applications are cyclic:

  • January 5
  • April 5
  • June 5
  • September 5

It takes ~2 months from submission until review and score. It can take another 3-4 months to be awarded. The NIH has been working on reducing the amount of time it takes to award funds.   

It’s important to remember that some of the solicitations have non-standard due dates. Carefully read each solicitation.

Look for PART VI next week!

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!