National Institutes of Health Office of Extramural Research 1 Do Your Research – What you need to know about the business of Small Business Innovation

National Institutes of HealthOffice of Extramural Research

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Do Your Research – What you need to know about the business of Small Business Innovation

Research (SBIR)

June 30, 2014

NIH Industry Day

Matthew Portnoy, Ph.D.

SBIR/STTR Program Coordinator

Office of Extramural Research, NIH


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SBIR/STTR Programs Overview

• SMALL BUSINESS INNOVATION • RESEARCH (SBIR) PROGRAM• Set-aside program for small business concerns to

engage in Federal R&D – with potential for commercialization

• SMALL BUSINESS TECHNOLOGY • TRANSFER (STTR) PROGRAM• Set-aside program to facilitate cooperative R&D between

small business concerns and U.S. research institutions – with potential for commercialization


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SBIR Purpose and Goals

• Stimulate technological innovation• Use small business to meet Federal R&D needs• Foster and encourage participation by minorities

and disadvantaged persons in technological innovation

• Increase private-sector commercialization innovations derived from Federal R&D

Small Business Innovation Development Act of 1982

P.L. 112-81 Re-Authorizes program through FY2017


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STTR Purpose and Goals (cont.)

• Stimulate and foster scientific and technological innovation through cooperative research and development carried out between small business concerns and research institutions

• Foster technology transfer between small business concerns and research institutions

Small Business Research and Development

Enhancement Act of 1992

P.L. 112-81 Re-Authorizes program through FY2017


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SBIR/STTR in Your Portfolio

• Capital is in the form of grants and contracts

• Strategic Investment in Innovation• Non-diluted funding:

– No repayment– No debt service– No equity forfeiture– No IP forfeiture


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SBIR/STTR Budgets by Agency FY2013

Agencies with SBIR & STTR Programs:• Department of Defense (DOD) = $1.0 B• Department of Health & Human Services:

National Institutes of Health (NIH) = $697.0 M• Department of Energy (DOE),including ARPA-E

= $183.9 M• National Science Foundation (NSF) = $153.0 M• National Aeronautics & Space Administration

(NASA) = $148.8 M


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SBIR/STTR Budgets by Agency FY2013 (continued)

Agencies with SBIR Programs:• U.S. Department of Agriculture (USDA) = $18.4 M• Department of Homeland Security (DHS): Science and Technology

Directorate (S&T) and Domestic Nuclear Detection Office (DNDO) = $15.7M

• Department of Education (ED) = $13.4 M• Department of Transportation (DOT) = $7.6 M• Department of Commerce: National Oceanic & Atmospheric

Administration (NOAA) and National Institute of Standards & Technology (NIST) = $7.4 M

• Environmental Protection Agency (EPA) = $3.8 M

~ $2.3B in FY13 across all agencies


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NIH Mission

To seek fundamental knowledge about the nature and behavior of living systems and

the application of that knowledge to enhance health, lengthen life, and reduce illness and

disability.


National Institutes of Health

NIH Institutes, Centers and Offices

http://www.nih.gov/icd


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NIH SBIR/STTR3-Phase Program

PHASE I Feasibility Study • Budget Guide: $150K (SBIR); $150K (STTR) Total Costs • Project Period: 6 months (SBIR); 1 year (STTR)

PHASE II Full Research/R&D• $1M (STTR), $1M (SBIR) over two years

PHASE IIB Competing Renewal/R&D• Clinical R&D; Complex Instrumentation/Tools to FDA• Many, but not all, ICs participate• Varies ~$1M/year; 3 years

PHASE III Commercialization Stage• NIH, generally, not the “customer”• Consider partnering and exit strategy early


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SBIR Eligibility Criteria

• Organized as for-profit U.S. business • Small: 500 or fewer employees, including affiliates• PD/PI’s primary employment must be with small business concern

at time of award and for duration of project period• Greater than 50% U.S.- owned by individuals and independently

operated or• Greater than 50% owned and controlled by other business

concern/s that is/are greater than 50% owned and controlled by one or more individuals or

• 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


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STTR Eligibility Criteria

Applicant is Small Business Concern

Formal Cooperative R&D Effort • Minimum 40% by small business• Minimum 30% by U.S. research institution

U.S. Research Institution • College or university; other non-profit research organization;

Federal R&D center

Intellectual Property Agreement • Allocation of rights in IP and rights to carry out follow-on R&D and

commercialization


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PD/PI Eligibility on STTR

• PD/PI is not required to be employed by SBC

• PD/PI at RI must establish contract between RI and SBC describing PD/PI’s involvement

• PD/PI must commit a minimum of 10% effort

• PD/PI’s “signature” on application is agreement to conforming to Solicitation requirements


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SBIR and STTR Critical Differences

• Research Partner SBIR: Permits partnering

33% Phase I and 50% Phase II STTR: Requires partnering with research institution.

Small business (40%) and U.S. research institution (30%)

• Principal Investigator SBIR: Primary (>50%) employment must be with small business

concern STTR: PI may be employed by either research institution or small

business concern

Award is always made

to Small Business Concern


NIH SBIR/STTR Budget Allocations FY2014

• 2.8% SBIR $663M• 0.4% STTR $95M• Total FY2014 $758M

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HHS/NIH Program Funding

2014 BudgetNIH SBIR = $663M; STTR = $95M

CDC SBIR = $8.97M; STTR = n/a

FDA SBIR = $1.29M; STTR = n/a

ACF SBIR = $81K; STTR = n/a

Phase I SBIR = $150K*, 6 months*; STTR = $150K*, 1 year*

Phase II SBIR = $1M*, 2 years*; STTR = $1M*, 2 years*


Success Rate of SBIR/STTR 2012 and 2013 by Phase

SBIRFast Track: 2012 = 15.9%

2013 = 15.7%

Phase 1:2012 = 15.6%

2013 = 13.2%

Phase II: 2012 = 39.9%

2013 = 32.8%

STTRFast Track: 2012 = 34.4%

2013 = 28.6%

Phase 1:2012 = 20.3%

2013 = 18.7%

Phase II: 2012 = 39.4%

2013 = 26.4%

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NIH-wide SBIR/STTR Success Rates

Success Rates are Posted Online:

Fiscal Year SBIR/STTR PhaseNumber of

Applications Reviewed

Number of Applications

AwardedSuccess

Rate Total Funding

2012 SBIR Fast Track 358 57 15.9% $13,985,8022012 SBIR Phase 1 4,287 667 15.6% $154,237,8902012 SBIR Phase 2 557 222 39.9% $153,650,1622012 STTR Fast Track 32 11 34.4% $2,840,6322012 STTR Phase 1 542 110 20.3% $23,857,7002012 STTR Phase 2 71 28 39.4% $18,240,4182012 FY TOTAL 5,847 1,095 18.7% $366,812,6042013 SBIR Fast Track 313 49 15.7% $13,981,3862013 SBIR Phase I 3,738 495 13.2% $114,040,1572013 SBIR Phase II 542 178 32.8% $136,348,8462013 STTR Fast Track 42 12 28.6% $2,542,1282013 STTR Phase I 583 109 18.7% $24,138,6292013 STTR Phase II 72 19 26.4% $10,985,3732013 FY TOTAL 5,290 862 16.3% $302,036,519

http://report.nih.gov/success_rates/index.aspx


NIH SBIR/STTR Webpage

SBIR/STTR Webpage

Standard Due Dates:Apr. 5; Aug. 5; Dec. 5

http://sbir.nih.gov/


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New sbir.nih.gov!


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Solicitations and Due Date

• NIH, CDC, FDA, & ACF SBIR/STTR Grant Solicitation “Parent” FOAs: SBIR: PA-14-071 STTR: PA-14-072

New SBIR Direct to Phase II FOA PAR-14-088

Release: January

Standard Due Dates: April 5, August 5, December 5

(AIDS/AIDS-related: May 7, September 7, January 7)

• SBIR Contract Solicitation (NIH, CDC)Release: August November 2014 close date

• NIH Guide for Grants and ContractsRelease: Weekly Receipt dates specified in each FOA

http://grants.nih.gov/grants/guide/index.html


Reauthorization Changes – Budget Hard Caps

• Reauthorization required that budgets over the hard cap ($225,000 for Phase I and $1,500,000 for Phase II) Agencies (not applicants) apply for waiver from SBA

• SBA has recently approved a topics list, which allows budgets to exceed the hard caps as long as the project topics are on the list

• Pre-approved topics list is Appendix A in regular topics document

• The approval is good for the 2014 SBIR/STTR Omnibus, and any FOA that falls on the topic list, including the Direct Phase II FOA

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http://1.usa.gov/1iUa5Kh


Other Reauthorization Changes

• Majority-owned venture capital provision

• Switching between SBIR and STTR

• SBIR Direct Phase II

Full list of changes located at the Grants & Funding website.

Questions? – Talk to your NIH IC Program Officer!

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http://grants.nih.gov/grants/funding/sbir/reauthorization.htm


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Venture Capital Companies

• Small business concerns that are majority-owned by multiple venture capital operating companies (VCOCs), hedge funds and/or private equity firms ARE NOW ELIGIBLE to apply (NIH SBIR only).

• See NOT-OD-13-071

• SBIR and STTR VCOC forms are available

• *Note: SBIR VCOC form also used for SBIR contracts

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-071.html

http://grants.nih.gov/grants/forms.htm#sbir

http://grants.nih.gov/grants/forms.htm#sbir


Switching between SBIR and STTR

NIH SBIR/STTR applicants may now ‘switch’ programs at Phase II or Phase IIB to any active NIH SBIR or STTR solicitation.

Which means:• Phase I STTR Awardees may apply for NIH SBIR or STTR Phase II• Phase I SBIR Awardees may apply for NIH SBIR or STTR Phase II• Phase II STTR Awardees may apply for NIH SBIR or STTR Phase IIB• Phase II SBIR Awardees may apply for NIH SBIR or STTR Phase IIB

Note that not all NIH Institutes and Centers accept Phase IIB applications. Check the Omnibus Topics document for listing.

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http://grants.nih.gov/grants/funding/sbirsttr1/2014-2_SBIR-STTR-topics.pdf


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Helpful Tips:

• Must follow program rules (PI, % effort, sub-contracting, etc.)

• No special instructions or requirements from applicants

• NOT-OD-14-048

• Applicants are strongly advised to discuss this option with their program officer well in advance of any due date.

Switching between SBIR and STTR (cont.)

http://1.usa.gov/1nWAsjg


Direct to Phase II SBIR FOA

• Allows small businesses that are ready for the Phase II stage of development to bypass applying for a Phase I grant.

• The SBC must already have a technology prototype, and must have tested its feasibility (i.e. completed Phase-I-type R&D) to move directly into a Phase-II-type R&D.

• Pilot SBIR Direct to Phase II Solicitation – it’s own SEPARATE FOA: PAR-14-088.

• Note: Not all ICs will accept Direct Phase IIs – only the ones listed on the solicitation. SBCs cannot apply for a Phase II and Direct Phase II for the same research project.

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http://grants.nih.gov/grants/guide/pa-files/PAR-14-088.html


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• All ICs on the Direct Phase II FOA will accept technology on anything within their mission. Note: NINDS has a few exceptions listed within the FOA.

• Applicants are strongly advised to talk to their SBIR Program Officer before applying.

• Some ICs may issue their own separate Direct Phase II FOA/s in the future.

Direct to Phase II SBIR FOA (2)


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• A Direct Phase II is not a Phase IIB!

• No due dates past 12/5/2016 standard date.

• The Direct-to-Phase II authority is not available to the STTR program and not available for the CDC, FDA, and ACF SBIR programs.




How is a Direct Phase II different than a fast-track?

• A FT incorporates a submission and review process in which both Phase I and Phase II grant applications are submitted and reviewed together as one application

• Intended to reduce or eliminate the funding gap between phases

Which one is right for you? • Talk to your SBIR Program Officer!

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What is the review process?

• Application goes to NIH Center for Scientific Review.

• Application is assigned a small business study section.

• Review staff have guidance on the new FOA,

• It’s too early to know the volume or the success rate!

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http://1.usa.gov/1eL6koM

http://1.usa.gov/1eL6koM


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SBIR/STTR Program Descriptions & Research Topics

Our Ideas: Suggested topic areas*Biodefense

Biosensors

Nanotechnologies

Bioinformatics

Diagnostic and Therapeutic Devices

Telehealth

Proteomics / Genomics

Biosilicon devices

Biocompatible materials

Acousto-optics / opto-electronics

Health IT

Imaging devices

Genetically engineered proteins


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SBIR/STTR Program Descriptions & Research Topics (cont.)

Your Ideas:

Investigator-initiated R&D • Research projects related to the NIH

mission• “Other” areas of research within the

mission of an awarding component

Keyword search the Solicitation Ctrl - F


Electronic Submission

SBIR/STTR grant applications must be submitted electronically. SBIR contract proposals still in paper form.

Registrations are required!!!

System for Award Management (SAM)Grants.gov (company) eRA Commons (company and all PD/PIs)SBA company registry at SBIR.gov


Most Important Piece of Advice

• Talk to an NIH Program Officer about your application and SUBMIT EARLY (days not hours and minutes)!

– Program Officer contact information found in the NIH SBIR/STTR Solicitation

– Questions about who to contact? Email [email protected]



mailto:[email protected]


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Application & Review Process

1. Small Business Concern (Applicant Initiates Research Idea)

2. Submits SBIR/STTR Grant Application to NIH Electronically

3. NIH Center for Scientific Review Assign to IC and IRG

4. Scientific Review Groups Evaluate Scientific Merit – (~2-3 months after submission)

5. Advisory Council or Board Recommend approval – (~2-3 months after review)

6. IC Staff Prepare funding Plan for IC Director

7. IC Allocates Funds

8. Grantee Conducts Research


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Review Criteria

Overall Impact Score

Scored Review Criteria (score 1-9) Significance (Real Problem/Commercial Potential) Investigators (PI and team) Innovation (New or Improved?) Approach (Research Design, Feasible) Environment (Facilities/Resources)

Additional Review Criteria (not scored individually) Protection of Human Subjects Inclusion of Women, Minorities & Children Vertebrate Animals Biohazards


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Timeline: New Applications

Entire Process = 6-9 months Due Date - April 5

Scientific Review – July

Council Review – October

Award Date (earliest) – December Due Date - August 5

Scientific Review – November

Council Review – January

Award Date (earliest) – April Due Date - December 5

Scientific Review – March

Council Review – May

Award Date (earliest) – July


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Common Application Problems

• No Significance Unimportant problem, unconvincing case for commercial

potential or societal impact

• Inadequately defined test of feasibility• Lack of innovation • Diffuse, superficial, or unfocused research plan• Questionable reasoning in experimental approach

Failure to consider potential pitfalls and alternatives

• Lack of experience with essential methodologies• Unfamiliar with relevant published work• Unrealistically large amount of work proposed


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Competing Successfully for SBIR/STTR Funding

• Understand our mission• Review Funding Opportunity Announcements (FOAs)• Propose innovative ideas with significance as well as

scientific and technical merit• Give yourself ample time to prepare application• Communication, Communication, Communication• Contact NIH Staff to discuss

– your research idea– outcome of your review– challenges and opportunities


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NIH SBIR/STTR: 3-Phase Program Plus Gap Funding

• Phase I – Feasibility• Phase II – Full R&D

(Phase I Phase II Fast Track)

Phase II Competing Renewal Award

($3M/3 years)• Phase III


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NIH Phase I/Phase II Fast-Track

SBIR/STTR Phase I + Phase II(Simultaneous Submission and Concurrent Review)

7-9 months to Phase I Award

Completion of Phase IPhase I Final Report

Program Staff assess completion of specific aims and milestones

Go? Aims/Milestones Met = Phase II award

No Go? Aims/Milestones NOT Met = Phase II no award


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Phase IIB Competing Renewal Award

Parameters• SBIR/STTR Phase II awardee• Promising pharmacologic compound identified in original Phase II• Device prototype developed in original Phase II• Instrumentation/Interventional technologies not subject to FDA regulatory

approval but require extraordinary time/effort to develop

• Awards up to $1M/year for up to 3 years • IC must accept Competing Renewal applications

(NIA, NIAAA, NIAID, NICHD, NIDA, NIDCD, NIDDK, NEI, NIGMS, NHLBI, NIMH, NINDS, NCATS, ORIP, NCI, NHLBI, NINDS)

Contact NIH Program Staff to discuss!


Niche Assessment Program

• Provides active Phase I awardees with market research, and consumer and competition analysis

• Helps small businesses complete their commercialization plans as part of their Phase II applications

• Learn more at the Niche Assessment Program website

http://grants.nih.gov/grants/funding/nap.htm


Commercialization Assessment

• Trains Phase II awardees to:– Develop tailored market entry strategies; – Build strategic partnerships;– Develop FDA regulatory and reimbursement

paths; and– Identify financing strategies and expertise on

intellectual property matters

– Learn more at the Commercialization Assistance Program (CAP) website

http://grants.nih.gov/grants/funding/cap/

http://grants.nih.gov/grants/funding/cap/


NIH SBIR/STTR Program Summary of Key Features

SBIR and STTR Program• Single SBIR/STTR grant solicitation• Investigator-initiated research ideas• Special Funding Opportunities (NIH Guide for Grants & Contracts)• Electronic Submission (grants only)• Awards: Grants, Contracts, Cooperative Agreements

External Peer Review• Option to request review group• Experts from academia/industry• Five Criteria: Significance, Approach, PI(s), Innovation, Environment• Summary statement for all applicants• Revise & resubmit

Multiple Receipt Dates (Grants)• April 5, August 5, December 5• May 7, Sept. 7, Jan. 7 (AIDS)• Contracts: November


NIH SBIR/STTR Program Summary of Key Features (cont.)

Gap Funding Programs • Phase IIB Competing Renewals• Phase I/Phase II Fast Track • Administrative Supplements

Budget and Project Period• $150K/6 - 12 months (Phase I)• $1M/2 years (Phase II)

Technical Assistance Programs • Technology Niche Assessment• Commercialization Assistance

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For More Information

Matthew Portnoy, PhDNIH SBIR/STTR Program Coordinator

Phone: 301- 435-2688

Email: [email protected]

Lenka Fedorkova, PhDSBIR/STTR Asst. Program Manager

Phone: 301-435-0921


Robert VinsonSBIR/STTR Asst. Program Manager

Phone: 301-435-2713


Betty RoysterSBIR/STTR Communications Specialist

Phone: 301-402-1632


Julie Beaver

SBIR/STTR Statistician

Phone: 301-496-8807

Email: julie.beaver@nih

.





mailto:julie.beaver@nih


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More Information

Get Connected!

• Subscribe to the SBIR/STTR Listserv:

Email [email protected] with the following text in the message body: subscribe SBIR-STTR your name

• NIH Guide for Grants and Contracts (weekly notification)

• Follow us on Twitter: @NIHsbir

• Submit your SBIR/STTR Success Story

• Email: [email protected]


http://grants.nih.gov/grants/guide/listserv.htm




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Save the Date

16th Annual NIH SBIR/STTR Conference

• October 21 – 23, 2014

• Albuquerque, New Mexico

• Host: University of New Mexico Health Sciences Center

• Early Bird Registration $350 through 8/22/14

http://sbir2014.com/


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Questions

Questions and Answers!

Documents

National Institutes of Health Office of Extramural Research 1 Do Your Research – What you need to know about the business of Small Business Innovation