Webinar and Q&A

Presented by: Eva Garland, Ph.D., CEO, and Angie Pollard, Ph.D., VP of Scientific Consulting

Session Overview

In this session, EGC experts, Eva Garland, Ph.D., CEO, and Angie Pollard, Ph.D., VP of Scientific Consulting, discuss strategies for adapting National Institutes of Health (NIH) Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) proposals to be competitive for other government and private funding sources amid the hold on SBIR/STTR reauthorization.

Session Recap

  • SBIR/STTR expired on Sept. 30, 2025, unexpectedly after decades of continuous authorization.

  • Reauthorization is expected, and advocacy efforts are underway; community engagement matters.

  • During the lapse, no new SBIR/STTR proposals are being accepted, and solicitations are paused.

  • DoW guidance indicates that once reauthorized, current deadlines will be extended ~30 days—so keep preparing.

  • NIH (and HHS broadly) is operating normally under the Continuing Resolution at FY25 levels.

  • SBIR/STTR funds (~3% of NIH extramural funding) are on hold, but:

    • Proposals submitted by Sept. 5 are still under review.

    • Study sections are meeting; proposals are being scored.

    • NIH adjusted review: top third discussed, middle third competitive but not discussed, bottom third not eligible.

  • Once reauthorized, NIH is expected to issue SBIR/STTR awards quickly.

  • ~$100B/year in U.S. non-dilutive life sciences funding exists.

    • Only ~$1B is NIH SBIR/STTR~99% remains available.

  • Additional sources:

    • ~$10B from private foundations

    • ~$5B from global programs

    • ~$1B from state and local funding

  • The challenge is strategic alignment, not lack of money.

  • Don’t sit on a ready NIH SBIR proposal—reposition it.

  • Start with NIH mechanisms outside SBIR/STTR, then expand to other agencies.

  • Diversifying funding sources can strengthen your overall development strategy, not weaken it.

  • Phase I–like scope:

    • R21 (~$275K direct): parent + many targeted solicitations

    • R03: small, fast funding for preliminary or single-aim work

  • Phase II / Fast-Track–like scope:

    • R01, U01 (often better via targeted solicitations)

    • R61/R33, UG3/UH3 (milestone-driven, translational)

    • R34 for clinical trial planning

  • Key tips:

    • Confirm IC participation and clinical trial eligibility

    • Request indirect costs (not capped like SBIR)

    • Talk to program officers, especially for larger budgets

    • Request an appropriate study section

  • FDA: ~$275M budget per year; rare disease, biomarkers, outcomes, orphan products.

  • ARPA-H:

    • Funds bold, game-changing ideas

    • Early engagement encouraged; submit abstracts and solution summaries

    • Budgets range from $3M to $100M+

  • BARDA:

    • ~$645M budget per year for biodefense, diagnostics, antivirals, vaccines

    • Best for more mature technologies

    • Requires TechWatch meetings and strong program alignment

  • DoW:

    • ~$2B budget per year in healthcare funding

    • Key players: USAMRDC, SOCOM, DARPA, CDMRP

    • Pre-applications and program officer conversations are critical

    • CDMRP solicitations expected in Q2 2026

  • MTEC:

    • Military Health Consortium

    • Targeted solicitations + $50K–$100K seed loans