Get Up to $2M in
Biotech Research Funding
NIH SBIR/STTR grants for biotech startups. $1.2B Seed Fund for therapeutics, medical devices, diagnostics, and drug discovery. Zero equity required.
✓ 3 application deadlines yearly • ✓ Fast-Track available • ✓ Non-dilutive funding
Biotech & Life Sciences Grant Programs
Federal and state funding for therapeutics, medical devices, diagnostics, drug discovery, and biomedical innovation.
Biomedical Innovation
- Drug discovery & therapeutics development
- Medical devices & diagnostics platforms
- Preclinical research (80% of grants)
- 3 deadlines: Jan 5, Apr 5, Sep 5
R&D Advancement
- 24 months development timeline
- Clinical trials & regulatory prep
- IND/IDE filing support included
- Commercialization pathway focus
Additional Funding
- FDA Orphan Drug grants available
- State life sciences centers funding
- Rare disease research priority
- Tax credits & regulatory incentives
Biotech Technologies That Qualify
NIH SBIR/STTR and FDA grants support biomedical innovations across therapeutic areas.
Therapeutics
Small molecules, biologics, gene therapy, cell therapy, immunotherapy, antibodies
$295M infectious disease
Medical Devices
Implantables, wearables, surgical tools, imaging systems, monitoring devices
Class II/III priority
Diagnostics
IVD, point-of-care, biomarkers, liquid biopsy, molecular diagnostics, companion diagnostics
Fast-Track eligible
Drug Discovery
High-throughput screening, target discovery, lead optimization, ADME/Tox, formulation
80% preclinical focus
Rare Diseases
Orphan drugs, ultra-rare conditions, genetic disorders, FDA designation benefits
Tax credits available
Digital Health
Software as medical device, remote monitoring, digital therapeutics, clinical decision support
Growing NIH focus
Vaccines & Biologics
mRNA platforms, viral vectors, adjuvants, immunization technologies, pandemic prep
NIH priority area
Research Tools
Assay development, reagents, lab automation, CRISPR tools, sequencing technologies
Enabling technologies
What's New in Biotech Funding 2026-2027
Recent NIH investments and program updates for biotech entrepreneurs
$1.2B NIH Seed Fund Active
NIH continues investing $1.2 billion annually through SBIR/STTR programs supporting early-stage biomedical R&D. Non-dilutive funding for small businesses nationwide.
Preclinical Research Priority
Over 80% of SBIR/STTR grants awarded for drugs at preclinical and discovery stages. $1.1B between 2020-2024 supporting early-stage biotech innovation.
Infectious Disease Leadership
Infectious disease remains top therapy area with $295M in preclinical/discovery grants (2020-2024). CNS follows with $241M. Strong therapeutic focus areas.
Fast-Track Expedited Review
NIH Fast-Track allows simultaneous Phase I and Phase II submission for scientifically meritorious projects with high commercialization potential. Faster funding decisions.
Complete Biotech Grant Program Details
Everything you need to know about NIH SBIR/STTR, FDA Orphan Drug programs, and state life sciences funding.
Program Overview
Phase I Focus Areas:
- Drug Discovery: Target validation, lead optimization, preclinical studies
- Medical Devices: Proof-of-concept, prototype development, biocompatibility
- Diagnostics: Assay development, clinical validation, sensitivity/specificity
- Biologics: Gene therapy vectors, cell therapy protocols, manufacturing
Biotech Success Stories
Gene Therapy Breakthrough
$306K Phase I → validated novel AAV vector for rare genetic disorder → demonstrated safety in animal models → $2M Phase II → advanced to Phase 1 clinical trial → partnered with major pharma for $50M upfront.
Medical Device Innovation
$306K Phase I → developed implantable cardiac monitor → animal studies successful → $2M Phase II → completed pivotal trial → FDA 510(k) clearance → commercial launch → $100M+ annual revenue.
Application Strategy & Requirements
Eligibility
- • US small business <500 employees
- • For-profit company (any structure)
- • Principal Investigator commitment
- • Biomedical R&D focus
Application Process
- • Review Program Descriptions
- • Identify relevant NIH institute
- • Contact Program Officer early
- • Submit via grants.gov portal
Success Factors
- • Strong scientific rationale
- • Preliminary data included
- • Clear commercialization path
- • Experienced team credentials
Program Details
Phase II supports continued R&D for therapeutics, devices, and diagnostics moving toward clinical trials, regulatory submissions (IND/IDE), and commercialization. Combined Phase I + II provides ~$2.3M total non-dilutive funding.
Phase II Objectives
Development Milestones:
- Clinical Advancement: IND/IDE filing, Phase 1 trial initiation, safety data
- Regulatory Prep: FDA interactions, quality systems, manufacturing scale-up
- Partnerships: Pharma collaborations, licensing deals, investor relations
- Commercialization: Business plan, reimbursement strategy, market access
FDA Orphan Drug Program
Orphan Drug Designation Benefits:
- • 7 years market exclusivity post-approval
- • Tax credits for clinical trial costs (25%)
- • Waived FDA user fees (~$3.2M savings)
- • Regulatory assistance & protocol guidance
- • Grant funding opportunities available
- • Fast Track & priority review eligibility
Eligibility:
Diseases affecting <200,000 US patients or no reasonable expectation of cost recovery. Over 900 orphan drug approvals since 1983 program launch.
State Life Sciences Centers
Massachusetts Life Sciences Center
SBIR matching grants, capital equipment, internship programs, tax incentives. Over $1B invested in 600+ companies since 2008.
California Life Sciences
CalSEED grants ($50K-$225K), CIRM stem cell funding, biotech incubators, UC partnership programs, R&D tax credits.
Pennsylvania & New York
Innovation grants, life sciences accelerators, hospital partnerships, commercialization support, early-stage capital access.
Biotech Grant Application Success Strategies
Proven tactics to increase your chances of winning NIH SBIR/STTR and FDA funding.
Include Strong Preliminary Data
Provide proof-of-concept data, in vitro results, animal studies, or clinical pilot data. NIH reviewers prioritize de-risked projects with demonstrated feasibility and clear path forward.
Contact Program Officers Early
Reach out to NIH institute Program Officers before submission. They provide valuable feedback on fit, identify relevant funding opportunities, and can strengthen your application approach.
Target High-Priority Therapy Areas
Infectious disease ($295M), CNS ($241M), rare diseases, and cancer are top-funded areas. Align your innovation with NIH priorities and demonstrate unmet medical need clearly.
Develop Clear Regulatory Strategy
Outline FDA pathway (IND, IDE, 510(k), PMA), regulatory milestones, clinical trial plans. Show understanding of development timeline and realistic commercialization roadmap.
Weak Commercialization Plan
Vague market strategy without specific reimbursement pathway, competitive analysis, or revenue projections. NIH requires clear path to patient impact and financial sustainability.
Insufficient Scientific Rationale
Missing mechanism of action, poor hypothesis, or weak scientific justification. Include strong scientific background, literature review, and explain how innovation advances field.
Unrealistic Timelines
Overpromising deliverables in Phase I (6-12 months) or Phase II (24 months). Be realistic about development milestones, technical challenges, and regulatory timelines.
Ignoring Fast-Track Option
Missing opportunity for simultaneous Phase I/II review if you have strong preliminary data and commercialization potential. Fast-Track accelerates funding timeline significantly.
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Comprehensive PDF with NIH SBIR/STTR templates, FDA Orphan Drug info, state programs, and winning strategies.
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