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The NIH SBIR/STTR Programs
Mike Pieck, PhDSmall Business Program Coordinator
National Heart, Lung, and Blood Institute (NHLBI)
No SBIR/STTR funding authority
Office of Research Infrastructure Programs
National Instituteon Alcohol Abuseand Alcoholism
National Instituteof Allergy and
Infectious Diseases
National Institute of Arthritis and
Musculoskeletal and Skin Diseases
National CancerInstitute
National Instituteof Child Health
and HumanDevelopment
National Institute on Deafness and
Other Communication
Disorders
National Institute of Dental and Craniofacial
Research
National Institute of Diabetes and Digestive and
Kidney Diseases
National Institute
on Drug Abuse
National Instituteof EnvironmentalHealth Sciences
National Eye
Institute
National Institute of General
Medical Sciences
National Heart,Lung, and
BloodInstitute
National HumanGenome ResearchInstitute
National Instituteof Mental Health
National Institute of Neurological
Disorders and Stroke
National Instituteof Nursing Research
National Instituteon Minority
Health and Health Disparities
National Center for Complementary and
Integrative Health
Fogarty International
Center
National Centerfor Advancing Translational
Sciences
National Library
of Medicine
National Instituteof Biomedical Imaging and
Bioengineering
Office of the Director
NIH Clinical Center Center for Information Technology Center for Scientific Review
http://www.nih.gov/icd
National Instituteon Aging
National Institutes of Health: 27 Institutes and Centers
Congressionally Mandated
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Small Business Innovation Research (SBIR) Set-aside program for small business concerns to engage in federal R&D -- with potential for commercializationFederal agencies with an extramural R&D budget > $100M
Small Business Technology Transfer Research (STTR) Set-aside program to facilitate cooperative R&D between small business concerns and US research institutions --with potential for commercializationFederal agencies with an extramural R&D budget > $1B
3.2%
0.45%
SET ASIDE
(FY20)
(FY20)
NIH SBIR/STTR Budget Allocations FY2019
SBIR $1BSTTR $141MTotal $1.14 B
NHLBI: ~$115M
SBIR/STTR Eligibility
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✓ Organized for-profit U.S. business
✓ 500 or fewer employees, including affiliates
✓ Work must be done in the US (with few exceptions)
✓ ˃ 50% U.S.- owned by individuals and independently operatedOR
˃ 50% owned and controlled by another (one) business concern that is ˃ 50% owned and controlled by one or more individuals
OR (SBIR ONLY)˃ 50% owned by multiple venture capital operating companies, hedge
funds, private equity firms, or any combination of these
Award always made to
small business
Why Seek SBIR/STTR Funding
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Basic ResearchDiscovery
Proof of Concept
Research and Development
Scale-up andManufacturing
Sales andDistribution
Research Grants
Friends, Family, and Founders
Angel Investors
Venture CapitalCompany Formed Strategic Partners
• Provides seed funding for innovative technology development • One of the largest funding sources of early stage life sciences in the US• No repayment required; Not a loan = non-dilutive capital• IP rights are normally retained by the small business• Provides recognition, verification, and visibility• Can provide leverage to attract other funding and collaboration (e.g., venture capital,
strategic partner)
Critical Differences
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SBIR STTR
Partnering Permits partnering Requires a non-profit research institution partner
PrincipalInvestigator
Primary employment (>50%) must be with the small business
PI may be employed by either the research institution partner or small business
WorkRequirement
Guidelines:May outsource up to 33% (Phase I), 50% (Phase II)
Minimum Work Requirements: 40% Small Business 30% Research Institution Partner
Phased Program
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Feasibility
Discovery
Phase I
Full R/D
Phase I Phase II
Fast-Track
$3M for up to 3 yearsRequires matching $$
Development
Phase IICommercialization
Phase IIICompeting Renewal Award
Phase IIB
Direct to
Phase II
~ $3M for up to 3 years
Commercialization Readiness Pilot (CRP)
Only Some ICs Participate
NIH SBIR/STTR Funding Opportunities
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Investigator Initiated Grants: Omnibus Solicitation
January 5, April 5, September 5
Annual SBIR Contract Solicitation:Targeted solicitations with specified deliverables
only some ICs participate, Milestone-driven, NHLBI-specific topicsOne application date per year
Targeted Funding Opportunities:Funding Opportunity Announcements (FOAs) for focused priority areas
Application dates vary
sbir.nih.gov sbir.nih.gov/nhlbi/funding
Timeline: Application to Award
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Applicant initiatesresearch idea
Small Business Concern confirms
Eligibility
Submits SBIR/STTRgrant application
toNIH electronically
Scientific Review Group evaluates scientific merit
Advisory Council recommend Approval
IC staff prepare funding plan for
IC Director
IC allocates funds Just-in-Time
OGA Review and NOA
NIH Center for Scientific Review
assigns to IC and IRG
1-2 Months
2 Months
1-2 Months
1-2 Months
Application Cycles
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Due Dates Review meetings
Advisory Council Round
Earliest Project Start Date
January 5 March May July
April 5 June August September
September 5 November January April
SBIR Review Criteria (5 scored)
Does the product address an important problem, and have commercial potential? Is there a market pull for the proposed product?
How novel is the technology/product and the approaches proposed to test itsfeasibility? What is the competitive advantage?
Are the investigators, collaborators and consultants appropriately trained and capable of completing all project tasks?
Are design and methods well-developed and appropriate? Are problem areas addressed? Are potential pitfalls and alternative approaches provided?
Does the scientific environment contribute to the probability of success? Facilities? Independence?
Significance
Innovation
Investigator
Approach
Environment
SBIR Review Criteria (5 scored)
Does the product address an important problem, and have commercial potential? Is there a market pull for the proposed product?
How novel is the technology/product and the approaches proposed to test itsfeasibility? What is the competitive advantage?
Are the investigators, collaborators and consultants appropriately trained and capable of completing all project tasks?
Are design and methods well-developed and appropriate? Are problem areas addressed? Are potential pitfalls and alternative approaches provided?
Does the scientific environment contribute to the probability of success? Facilities? Independence?
Significance
Innovation
Investigator
Approach
Environment
Commercialization Is the company’s business strategy one that has a high potential for success?
NIH 2018 SBIR/STTR Funding Rates
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20.1%18.4%
42.2%
38.1%
20.9% 20.9%
34.6%
0.0%
Fast Track Phase I Phase II Phase IIB
SBIR STTR
FY13-17 SBIR and STTR Success Rates
0%
5%
10%
15%
20%
FY13 FY14 FY15 FY16 FY17
NIH SBIR Phase I
0%5%
10%15%20%25%30%35%40%45%
FY13 FY14 FY15 FY16 FY17
NIH SBIR Phase II
16.7%
34.8%
Phase I Phase II
FY13-17 STTR SUCCESS RATES
Phase Applications Reviewed
Applications Awarded
Success Rate
NIHPhase I 4,672 778 16.7%
Phase II 454 158 34.8%
Not just $$: Commercialization Support
Phase I: Market Analysis:Niche Assessment Program (NAP)
Entrepreneurial Assistance/ TrainingNIH I-CorpsTM and C3i Programs
Phase II/IIB: Technical Assistance/Training: Commercialization Accelerator Program (CAP) • Technical assistance/training in the
commercialization process (e.g., FDA, manufacturing, patenting)
Pre-SBIR/STTR: Applicant Assistance Program • Phase I Preparation Support and Review• Specific Aims Page Review and Advice• Submission Process Coaching• Only some Institutes participate
Investor Forum
Partnering Opportunities:Sponsored/Discounted Attendance at Events/Conferences and Pitch Coaching
NIH Entrepreneurs in Residence (EIRs)Various other Institute-specific
programs/resources
Expanded Technical and Business Assistance
• Limits for Technical and Business Assistance funding in SBIR/STTR proposals increased in 2019 – Phase I $6,500/year (up from $5,000/year)– Phase II $50,000/project (up from $5,000/year)– SBC hire own vendor or use agency-provided
services• Either use NIH Niche Assessment Program (NAP, Phase I) or
Commercialization Assistance Program (CAP, Phase II) or hire own vendor
• Must be included in the application when it is submitted
The NHLBI Small Business Program
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Innovative and commercially-promising products to prevent, treat and diagnose heart, lung, blood, and sleep-related diseases
(In Vitro,12%)
(Other, 19%)
Research Tools, 5%Health IT, 7%
Devices, 16%
Diagnostics, 31%
Therapeutics, 40%
The NHLBI Small Business Program
~$115MApproximate annual non-dilutive funds
~257 Active
projects
Advisory Experts at NHLBI
ProgramOfficer Regulatory
Small BusinessCoordinator
BusinessDevelopment
Investor-In-Residence
Entrepreneur-In-ResidenceIntellectual
Property
sbir.nih.gov/nhlbi
Small Business Inquiry Form
Catalyze Program Enhancing Support for Translational Research
Our Vision Derisking early stage technologies through a comprehensive suite of funding and services
InitiativesProduct
DefinitionEnabling
Technologies and Transformative
platforms
PreclinicalDevelopment
Technology Development funding and Professional Services Milestone-Driven Project Management https://www.nhlbi.nih.gov/grants-and-training/funding-opportunities-and-contacts/NHLBI-Catalyze-Program
Catalyze Program Funding Opportunities
https://www.nhlbi.nih.gov/grants-and-training/funding-opportunities-and-contacts/NHLBI-Catalyze-Program
Enabling Technologies and Transformative Platforms for HLBS Research (RFA-HL-20-022)
Product Definition for Small Molecules and Biologics • Target Identification and Validation, and Preliminary Product/Lead Series
Identification (RFA-HL-20-023)• Preliminary Product/Lead Series Identification (RFA-HL-20-027)
Product Definition for Devices• Prototype Design and Testing, Diagnostic Disease Target Identification and Assay
Development, and Research Tool Development (RFA-HL-20-024)• Prototype Testing and Design Modification, Diagnostic Disease Target Assay
Development and Design Characterization, and Research Tool Testing and Validation (RFA-HL-20-028)
Deadline March 9, 2020
Resources and Tips for Applicants
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Resources Sample SBIR Grant Applications
- NIAID SBIR Sample Application https://www.niaid.nih.gov/grants-contracts/sample-applications#r43r44
Annotated Form Set for NIH SBIR Grant Applicationshttps://grants.nih.gov/grants/ElectronicReceipt/files/Annotated_Forms_SmallBus_FORMS-E.pdf
SBIR/STTR Application Process Infographic- https://sbir.nih.gov
NIH RePORTER: Databases of NIH-supported Research- Matchmaker: find similar projects or program officials
Resources and Tips for Applicants
NHLBI Small Biz Hangouts
Intellectual Property
Regulatory
Navigating the FDA Website "First Contact" with FDA Finding the Right Regulatory Consultant Developing a Target Product Profile
Commercialization
Writing your Phase II Commercialization Plan Identifying and Connecting With Your Customer How Pharma Evaluates New Therapeutic
Opportunities
Intellectual Property Basics for the New Innovator Making Your Mark: The Use and Care of Trademarks Patent Litigation: Basics, Defense, and Offense –
Parts 1 & 2
http://bit.ly/SmallBizHangouts
Budget Specifics
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SBIR Budgets are defined by total cost and subcontracting is limited. Know the rules and the criteria.
Check Budget allowance in each FOA
Can request a 7% Fee• Company Profit• Of total budget
Phase I Phase IIGuidelines $150K/6-12 months $1M/2 yearHard Cap $252K/6-12 months $1.68M/2 yearIC-specific Waiver >252K >1.68M
https://sbir.nih.gov/sites/default/files/NIH_Topics_for_Budget_Waivers.pdf
Fee for Service (*Can Vary by IC): CRO-type activities can count as small business costs providing that:1. It is a commercially available service2. All analysis is done by small business3. Fee per basis (no indirect costs by fee for
service providers)
Application Tips
Start Early 5 registrations must be
completed in order to submit
Some have to be renewed every year
Read the instructions Different FOAs have
different requirement, Different institutes in the same FOA may have different rules
Don’t wait until the last minute to submit.
Reach out to program staff before you submit [email protected]
http://nhlbi-smallbiz-inquiry.force.com/InquiryForm
Other ICshttps://sbir.nih.gov/engage/ic-contacts
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How to Connect With NIH
Get Connected!• LISTSERV: Email
[email protected] the following text in the message body: subscribe SBIR-STTR your name
• @NIHsbir
• Email: [email protected]
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Get Connected!• NHLBI Small Business
Inquiry
• @NHLBI_SBIR
• Email: [email protected]
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