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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 NHLBINHLBI_SBIR@mail.nih.gov

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

LISTSERV@LIST.NIH.GOVwith the following text in the message body: subscribe SBIR-STTR your name

• @NIHsbir

• Email: sbir@od.nih.gov

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Get Connected!• NHLBI Small Business

Inquiry

• @NHLBI_SBIR

• Email: NHLBI_SBIR@mail.nih.gov