11

Overview of the NIH Overview of the NIH SBIR/STTR ProgramSBIR/STTR Program

“Lab to Life”“Lab to Life”

Nat

ion

al In

stit

ute

s o

f H

ealt

h

Susan Pucie

National Heart, Lung, and Blood Institute, NIH

pucies@nhlbi.nih.gov

22

For More Information

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

Dr. Lenka FedorkovaNIH SBIR/STTR Program

Phone: 301-435-0921

Dr. Matthew PortnoyNIH SBIR/STTR Program Coordinator

Phone: 301-435-2688

33

Office of the Director

National Institute on Minority Health

and Health Disparities

Organizational Structure of NIH

http://www.nih.gov/icd

National Instituteon Alcohol Abuseand Alcoholism

National Instituteof Arthritis andMusculoskeletal

and Skin Diseases

National CancerInstitute

National Instituteon Aging

National Instituteof Child Health

and HumanDevelopment

National Instituteof Allergy and

Infectious Diseases

National Instituteof Diabetes andDigestive and

Kidney Diseases

National Instituteof Dental andCraniofacial

Research

National Instituteon Drug Abuse

National Instituteof Environmental Health Sciences

National Institute onDeafness and Other

CommunicationDisorders

National EyeInstitute

National HumanGenome Research

Institute

National Heart,Lung, and Blood

Institute

National Instituteof Mental Health

National Instituteof NeurologicalDisorders and

Stroke

National Instituteof General

Medical Sciences

National Instituteof Nursing Research

National Libraryof Medicine

National Centerfor Complementary

and AlternativeMedicine

FogartyInternational

Center

National Centerfor Advancing

Translational Sciences

National Instituteof Biomedical

Imaging and

Bioengineering

No funding authority

Center for Information Technology

Center for Scientific Review

NIH Clinical Center

Office of Research Infrastructure Programs

44

NIH Mission

Improve human health through biomedical and

behavioral research, research training and

communications.

55

SBIR/STTR Mission

Supporting scientific excellence and Supporting scientific excellence and technological innovation technological innovation through the investment ofthrough the investment offederal research funds federal research funds

in critical American priorities in critical American priorities to build a strong national economy…to build a strong national economy…

oneone smallsmall businessbusiness atat aa timetime..

66

• Improve human health through prevention, detection, diagnosis and treatment of disease or disability• Speed process of discovery• Reduce cost of medical care• Improve research tools/ reduce cost of research• Increase health knowledge base

SBIR/STTR Programs Are Fully Integrated With the NIH Research Mission

Bridging the Discovery to Development Gap

NIH SBIR/STTR Program Specifics

77

SBIR Purpose and Goals

Small Business Innovation Development Act of 1982P.L. 112-81 Re-Authorizes program through FY2017

• 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

88

STTR Purpose and Goals

Small Business Research and Development Enhancement Act of 1992

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

• 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

99

SBIR Eligibility CriteriaSubject to change per new SBA Policy Directive pending

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

At least 51% U.S.- owned by individuals and independently operated or At least 51% owned and controlled by another (one) business concern that is at least 51% owned and controlled by one or more individuals

1010

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

STTR Eligibility Criteria

1111

• 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%)

Award is always made Award is always made to Small Business Concernto Small Business Concern

SBIR and STTR: Critical Differences

• 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

1212

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

PHASE II 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

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

NIH SBIR/STTR: 3-Phase Program

1313

NIH INSTITUTE/CENTER SBIR/STTR NIH INSTITUTE/CENTER SBIR/STTR BUDGET ALLOCATIONS (FY2011)BUDGET ALLOCATIONS (FY2011)

Extramural R&D Set-Asides:SBIR = 2.5%STTR = 0.3%

NIDDKNIGMS

FY 2011 SBIR/STTR Budget Allocations to NIH ICs:

$609 M (SBIR) $ 73 M (STTR)

Total: $682 MFY2012-pending

NIMHD

1414

NIH SBIR/STTR Success Rates

Fiscal Year SBIR/STTR PhaseNumber of

Applications Reviewed

Number of Applications

Awarded

Success Rate Total Funding

2010 SBIR Fast Track 430 67 15.6% $16,795,1502010 SBIR Phase 1 4,496 614 13.7% $129,218,3712010 SBIR Phase 2 734 246 33.5% $146,228,9592010 STTR Fast Track 47 11 23.4% $2,300,9712010 STTR Phase 1 539 109 20.2% $21,620,3992010 STTR Phase 2 92 32 34.8% $18,207,1132010 FY TOTAL 6,338 1,079 17.0% $334,370,9632011 SBIR Fast Track 409 42 10.3% $10,059,9042011 SBIR Phase 1 4,672 536 11.5% $123,802,0742011 SBIR Phase 2 681 203 29.8% $137,152,6872011 STTR Fast Track 42 4 9.5% $813,9002011 STTR Phase 1 508 80 15.7% $18,321,5162011 STTR Phase 2 103 37 35.9% $20,977,584

2011 FY TOTAL 6,415 902 14.1% $311,127,665

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Multiple Funding Opportunities

Annual SBIR/STTR Omnibus Grant Solicitation Release: January Receipt Dates: April 5, Aug 5, Dec 5 (non-AIDS)

May 7, Sept 7, Jan 7 (AIDS)

To be released soon for 2012

Targeted SBIR/STTR Grant Funding Opportunity Announcements (NIH Guide for Grants & Contracts)

Release: Weekly Various receipt dates

Annual SBIR Contract Solicitation (NIH, CDC) Release: August Receipt Date: Early November

1616

Electronic Submission

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

• Registrations are required!!!– Grants.gov (company)– eRA Commons (company and all PD/PIs)

http://era.nih.gov/ElectronicReceipt/index.htm

1717

Phase I Phase II Phase III

Gap FundingGap Funding

Phase I / Phase II Fast Track

Technical Assistance Programshttp://grants.nih.gov/grants/funding/nap.htm

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

Phase IIB Competing Renewals

Pipeline to Partnershipshttp://www.ott.nih.gov/p2p/

1818

Technical Assistance Programs

Commercialization Assistance

Business & strategic planning

Help help build strategic alliances and investor partnerships

(Phase II awardees)

Niche Assessment Identify other uses of technology

Determines competitive advantages

Develops market entry strategy

(Phase I awardees)

1919

http://grants.nih.gov/grants/funding/sbir.htmSolicitations and Due Dates

2020

Advice from Awardees

Don’t Don’t judge an Institute’s interests byits “name name ”

Understand an Institute’s mission & needs mission & needs

Get to know your Institute Program Program ManagerManager

Read solicitation and other funding opportunities and follow instructionsfollow instructions

2121

• Suggest potential awarding component(s)

• Request same or different Request same or different study sectionstudy section

• Suggest key areas of expertise Suggest key areas of expertise requiredrequired

• Indicate individual(s) or organization(s) in conflict

Cover Letter: A Valuable Tool

2222

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

2323

What Reviewers Say…Common Pitfalls with Applications

• Inadequately defined test of feasibility• Lack of sufficient experimental detail• Questionable reasoning in experimental approach• Failure to consider potential pitfalls and alternatives• Lack of innovation• Unconvincing case for commercial potential or societal

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

2424

TEXAS SBIR/STTR 55 Companies – Active Awardees

RESONANT SENSORS INC. ARLINGTON ATACTIC TECHNOLOGIES, INC. HOUSTON

AMBION DIAGNOSTICS, INC. AUSTIN BIOTEX, INC. HOUSTON

ASURAGEN, INC. AUSTIN COVALENT BIOSCIENCE, INC. HOUSTON

BIOO SCIENTIFIC CORPORATION AUSTIN HOUSTON PHARMACEUTICALS, INC. HOUSTON

CAISSON BIOTECH, LLC AUSTIN IONWERKS, INC. HOUSTON

MICROSURFACES, INC. Austin LC SCIENCES, LLC HOUSTON

MIRNA THERAPEUTICS, INC. AUSTIN NANOSPECTRA BIOSCIENCES, INC. HOUSTON

PLASTIPURE, INC. AUSTIN PHARMAREVIEW CORPORATION HOUSTON

RULES-BASED MEDICINE, INC. AUSTIN PULMOTECT, INC Houston

SAVARA, INC. Austin RADIANT CREATIVE GROUP, LLC HOUSTON

SELENIUM, LTD AUSTIN SYNTHECON, INC. HOUSTON

SERALOGIX AUSTIN TOMOWAVE LABORATORIES, INC. HOUSTON

SILICON AUDIO, LLC AUSTIN VIVID TECHNOLOGIES HOUSTON

XERIS PHARMACEUTICALS, INC. Austin LASER TISSUE WELDING, INC. HUMBLE

KJ BIOSCIENCES, LLC COLLEGE STATION BIO-SYNTHESIS, INC. LEWISVILLE

LYNNTECH, INC. COLLEGE STATION NOVOMEDICS, LLC Missouri City

POSITIVEMOTION, LLC COLLEGE STATION REBELLION PHOTONICS, INC. PEARLAND

STATACORP, LP COLLEGE STATION MARTINGALE RESEARCH CORPORATION Plano

CRO LABORATORIES, INC. DALLAS MICROFAB TECHNOLOGIES, INC. PLANO

DENTAL DESIGNS OF DALLAS DALLAS VITAL ART AND SCIENCE, INC. Richardson

IMAGINATION STATION, INC. Dallas ACCESSIBLE DESIGNS, INC. SAN ANTONIO

MICROTRANSPONDER, INC. DALLAS APPLIED HUMAN FACTORS, INC. SAN ANTONIO

RADIX THERAPEUTICS, LLC DICKINSON BIOMEDICAL DEVELOPMENT CORPORATION SAN ANTONIO

EP PHARMA, INC. EL PASO CARE TEAM SOLUTIONS, LLC SAN ANTONIO

ORGANIZATIONAL WELLNESS & LEARNING SYS FORT WORTH PROBETEX, INC. SAN ANTONIO

MAJESTECK BIOSCIENCE GALVESTON TELEHEALTH HOLDINGS, LLC SAN ANTONIO

AGENNIX, INC. HOUSTON NIMBIC SYSTEMS, INC. STAFFORD

AM BIOTECHNOLOGIES, LLC HOUSTON

2525

NHLBI SBIR/STTR online search using RePORT

25http://report.nih.gov

MRI

2008 & 2009

NHLBI

SBIR & STTR

2626

SBIR/STTR Grants With MRI Focus Funded by NHLBI in the Past Two Years

26http://report.nih.gov

2727

SBIR/STTR – NHLBI Funded Imaging Grants

27http://report.nih.gov

2828

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 and Contracts) Electronic Submission (grants only) Awards: Grants, Contracts, Cooperative Agreements

• Multiple Receipt Dates (Grants) April 5, August 5, December 5 May 7, September 7, January 7 (AIDS) Contracts: Early November

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

• External Peer Review Option to request review group Experts from Academia/Industry 5 Criteria: Significance, Approach, PI(s), Innovation, Environment Summary Statement for all applicants Revise & resubmit

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

• Technical Assistance Programs Technology Niche Assessment Commercialization Assistance Pipeline to Partnerships (P2P)

Summary

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Save the Date!

14th Annual NIH SBIR/STTR Conference

• May 30 to June 1, 2012• Louisville, Kentucky• Hosted by Kentucky Science and Technology Corporation • 2 day conference with optional workshop on June 1.

• Stay tuned to NIH SBIR website and listserv for details!

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Stay Informed…

Listserves NIH Guide for Grants and Contracts (weekly notification)

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

NIH SBIR/STTR Notification

Send email to LISTSERV@LIST.NIH.GOV with the following text in the message body:

subscribe SBIR-STTR your name.

OFFICE OF EXTRAMURAL PROGRAMS: SBIR/STTR

For More InformationFor More Information

Matthew Portnoy, PhDNIH SBIR/STTR Program Coordinator

Phone: 301- 435-2688Email: mportnoy@mail.nih.gov

Lenka Fedorkova, PhDSBIR/STTR Program Analyst

Phone: 301-435-0921Email: lenka@nih.gov

Subscribe to the SBIR/STTR List Serv: Email LISTSERV@LIST.NIH.GOV with the following text in the message body: subscribe SBIR-STTR your name

Robert VinsonSBIR/STTR Program Analyst

301-435-2713Email: vinsonr@mail.nih.gov