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1 1 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR NIH SBIR/STTR Funding Funding Opportu Opportu “NIH” “NIH” tie tie $ $ National Institutes of Health 11 th Annual NIH SBIR/STTR Conference June 30 – July 1, 2009 Omaha, Nebraska

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Page 1: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

11

Jo Anne GoodnightSBIR/STTR Program Coordinator

Office of Extramural Research, NIH

NIH SBIR/STTR NIH SBIR/STTR Funding Funding

OpportuOpportu“NIH”“NIH”tietie$$

Nat

ion

al In

stit

ute

s o

f H

ealt

h

11th Annual NIH SBIR/STTR ConferenceJune 30 – July 1, 2009

Omaha, Nebraska

Page 2: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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CONFERENCE GOALSCONFERENCE GOALS

We really ARE here to help you Understand NIH SBIR/STTR Program and Funding Opportunities Understand NIH application, review and award process better More confident about submitting a competitive application Take advantage of the one-on-one and networking opportunities Enjoy yourself!

Page 3: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

OFFICE OF EXTRAMURAL PROGRAMS: SBIR/STTR

Topics to DiscussTopics to Discuss

• SBIR/STTR Program Overview SBIR/STTR Program Overview • NIH SBIR/STTR Program SpecificsNIH SBIR/STTR Program Specifics• Solicitations and Funding Opportunities Solicitations and Funding Opportunities • The NIH Peer-Review Process The NIH Peer-Review Process • Industry- University Partnership Industry- University Partnership OpportunitiesOpportunities• Gap-Funding Programs Gap-Funding Programs • Transitioning to the MarketplaceTransitioning to the Marketplace

Page 4: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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SBIR/STTR Program Overview

SMALL BUSINESS INNOVATION SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAMRESEARCH (SBIR) PROGRAM

Set-aside program for small business concerns to engage in Federal R&D -- with potential for commercialization.

SMALL BUSINESS TECHNOLOGY SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAMTRANSFER (STTR) PROGRAM

Set-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions -- with potential for commercialization.

2.5%

0.3%

SBIR/STTR Program Overview

Page 5: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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SBIR Purpose and Goals

Small Business Innovation Development Act of 1982P.L. 106-554 (Signed 12/21/2000 extends program through 09/30/2008)

• 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

“We in government must work in partnership with small businesses to ensure that technologies and processes are readily transferred to commercial applications.” – Ronald Reagan, July 22, 1982.

SBIR/STTR Program Overview

Page 6: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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SBIR Program Extended Temporarily Until July 31, 2009

P.L. 111-10 temporarily extends programs authorized under the Small Business Act and the Small Business Investment Act of 1958. (Extension includes SBIR)

-- signed into law on March 19, 2009

SBIR/STTR Program Overview

SBIR Program Update

Page 7: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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• S.1233: A bill to reauthorize and improve the SBIR and STTR programs and for other purposes. Introduced Jun 10, 2009

• H.R. 2747: To amend the Small Business Act to improve outreach and support activities and to increase award recipients from rural areas with respect to the Small Business Innovation Research Program and the Small Business Technology Transfer Program, and for other purposes. Introduced Jun 8, 2009

• H.R. 2769: Commercializing Small Business Research and Development Act Introduced Jun 9, 2009

• H.R. 2767: Investing in Tomorrow's Technology Act

Introduced Jun 9, 2009• H.R. 2772: SBIR and STTR Enhancement Act

Introduced Jun 9, 2009

•  

SBIR Legislative Update

SBIR/STTR Program Overview

Page 8: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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STTR Purpose and Goals

Small Business Research and Development Enhancement Act of 1992

P.L. 107-50 (Program reauthorized through 09/30/2009)

• 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

SBIR/STTR Program Overview

Page 9: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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The largest, most accessible source of

SEED CAPITAL for the nation’s innovative

small businesses~$2.3 Billion in 2009

SBIR/STTR Programs25 years later…

DOD SBIR/STTRHHS SBIR/STTRNASA SBIR/STTRDOE SBIR/STTRNSF SBIR/STTRDHS SBIRUSDA SBIRDOC SBIRED SBIREPA SBIRDOT SBIR

$670M

Page 10: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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…and

This capital is in the form ofgrants and contracts

no repaymentno debt service

no equity forfeiture no IP forfeiture

SBIR/STTR Program Overview

Page 11: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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•PHASE II Full Research/R&D $750K and 2-year Award (SBIR & STTR) Pre-requisite: Phase I award

•PHASE III Commercialization Stage Use of non-SBIR/STTR Funds

• PHASE I Feasibility Study $100K and 6-month (SBIR) or 12-month (STTR)

Award

SBIR/STTR: 3-Phase Program

SBIR/STTR Program Overview

Page 12: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

1212 SBIR/STTR Program Overview

Page 13: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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SBIR Eligibility Criteria

Applicant must be a Small Business Concern

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 (unless a waiver is granted)

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

SBIR/STTR Program Overview

Page 14: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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Applicant must be a 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

SBIR/STTR Program Overview

Page 15: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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STTR Research Institution Partner

• U.S. non-profit organization owned and operated exclusively for scientific or educational purposes

• U.S. non-profit medical and surgical hospitalseligible as partner as long as these

institutions are exclusively engaged in scientific research and/or application of scientific principles and techniques

SBIR/STTR Program Overview

Page 16: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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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

SBIR/STTR Program Overview

Page 17: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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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 Face Page is agreement to conforming to Solicitation requirements

SBIR/STTR Program Overview

Page 18: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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• Research Partner SBIR: Permits partnering

STTR: Requires partnering with Research Institution

Small Business Concern is ALWAYSSmall Business Concern is ALWAYSApplicant/Awardee OrganizationApplicant/Awardee Organization

SBIR vs STTR: Which Program is Best for You?

Consider major differences• Principal Investigator SBIR: Primary employment

must be with small business concern

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

SBIR/STTR Program Overview

Page 19: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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Important Facts to Remember

• Eligibility is determined at time of award

• PD/PI is not required to have a Ph.D./M.D.

• PD/PI is required to have expertise to oversee project scientifically and technically

• Applications may be submitted to different agencies for similar work

• Awards may not be accepted from different agencies for duplicative projects

SBIR/STTR Program Overview

Page 20: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

OFFICE OF EXTRAMURAL PROGRAMS: SBIR/STTR

Topics to Discuss TodayTopics to Discuss Today

• SBIR/STTR Program Overview SBIR/STTR Program Overview • NIH SBIR/STTR Program SpecificsNIH SBIR/STTR Program Specifics• Solicitations and Funding Opportunities Solicitations and Funding Opportunities • The NIH Peer-Review Process The NIH Peer-Review Process • Industry- University Partnership Industry- University Partnership OpportunitiesOpportunities• Gap-Funding Programs Gap-Funding Programs • Transitioning to the MarketplaceTransitioning to the Marketplace

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NIH Mission:Improve Human Health

Science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability—from the rarest genetic disorder to the common cold.

NIH SBIR/STTR Program Specifics

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• 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 Within NIH Research Agenda

Bridging the Discovery to Bridging the Discovery to Development GapDevelopment Gap

NIH SBIR/STTR Program Specifics

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Office of the Director

National Center 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 ResearchResources

National Instituteof Biomedical

Imaging and

Bioengineering

No funding authority

Page 24: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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NIH Institute/Center SBIR/STTR Budget Allocations (FY2009)

$600 M (SBIR) $ 72 M (STTR)

Total: $672 M

NIDDKNIGMS

NIH SBIR/STTR Program Specifics

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

Page 25: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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• PHASE II Full Research/R&D Average $850K and 2-years

• PHASE II Competing Renewal/R&D Clinical R&D; Complex Instrumentation/Tools Some, but not all, ICs participate $1M/year; 3 years

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

• PHASE I Feasibility Study Average award: $170K Project Period: Most awards on a 1-yr NCE

NIH SBIR/STTR: 3-Phase Program

NIH SBIR/STTR Program Specifics

Page 26: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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Phase I Phase II Phase III

Gap Funding Programs

Mt. “FDA”

• No-Cost Extension• Phase I / Phase II Fast Track• Administrative / Competitive Supplements

Phase II Competing Renewal Award

NIH SBIR/STTR Program Specifics

Page 27: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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(Simultaneous Submission and Concurrent Review)

SBIR/STTR Phase I + Phase II

Phase I Award

7-9 months

Completion of Phase I Phase I Final Report Program Staff assess completion of specific aims and milestones

Phase II award

Aims/Milestones Met

Phase II award

Aims/MilestonesAims/MilestonesNOT MetNOT Met

Go?

No Go?

NIH Phase I/Phase II Fast-Track

NIH SBIR/STTR Program Specifics

Page 28: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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Important Considerations• Convincing preliminary data

• Clear, measurable, achievable milestones

• Well-conceived Commercialization Plan

• Letters of Phase III support/interest?

• Track record for commercializing?

• Discussed with NIH Program Staff?

NIH Phase I/Phase II Fast-Track

NIH SBIR/STTR Program Specifics

Page 29: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

OFFICE OF EXTRAMURAL PROGRAMS: SBIR/STTR

Topics to Discuss TodayTopics to Discuss Today

• SBIR/STTR Program Overview SBIR/STTR Program Overview • NIH SBIR/STTR Program SpecificsNIH SBIR/STTR Program Specifics• Solicitations and Funding Opportunities Solicitations and Funding Opportunities • The NIH Peer-Review Process The NIH Peer-Review Process • Industry- University Partnership Industry- University Partnership OpportunitiesOpportunities• Gap-Funding Programs Gap-Funding Programs • Transitioning to the MarketplaceTransitioning to the Marketplace

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• NIH, CDC & FDA SBIR/STTR Grant Solicitation

Release: January Standard Due Dates: April 5, Aug 5, Dec 5(AIDS/AIDS-related: May 7, Sept 7, Jan 7)

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

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

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

Solicitations and Due Dates

“Parent” FOAs: SBIR: PA-09-080 STTR: PA-09-081

Solicitations and Funding Opportunities

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

Page 31: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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Small Businesses can apply for NIH Recovery Act funding opportunities:

Challenge Grants (RC1) Grand Opportunities [“GO” Grants] (RC2) Administrative Supplements Competing Supplements (“Revisions”) Biomedical Research, Development and Growth [BRDG-SPAN] (RC3) Catalyst Awards (R43)

SBIR/STTR and ARRA

NIH Recovery Act Funding Opportunities:http://grants.nih.gov/recovery/

Solicitations and Funding Opportunities

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

NIH SBIR/STTR Web Site

Solicitation and Funding Opportunities

Page 33: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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NIH SBIR/STTR Solicitation Research Topics

Our IdeasOur Ideas**

Biodefense

Biosensors

Nanotechnologies

Bioinformatics

Diagnostic and Therapeutic Devices

Telehealth

Biosilicon devices

Biocompatible materials

Acousto-optics / opto-electronics

Imaging devices

Genetically engineered proteins

Proteomics / Genomics

*Examples from 200+ pages of topics!

Parent SolicitationsSBIR: PA-09-080 and STTR: PA-09-081

Page 34: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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Investigator-initiated IdeasInvestigator-initiated Ideas(a.k.a. “I can’t find a topic match”)(a.k.a. “I can’t find a topic match”)• Research projects related to NIH mission• “Other” areas of research within mission of an awarding component

NIH SBIR/STTR Research Topics

Keyword search the Solicitation

Ctrl - FSolicitations and Funding Opportunities

Page 35: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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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

Lack of sufficient experimental detail• 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

Solicitations and Funding Opportunities

Page 36: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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• Identifying Funding Opportunities• Electronic Submission Using Grants.gov and the NIH eRA Commons

Solicitations and Funding Opportunity Announcements

Solicitations and Funding Opportunities

Page 37: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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Small Business Concern

Applicant Initiates

Research Idea

Grantee Conducts Research

IC Staff Prepare funding Planfor IC Director

NIH Center for Scientific ReviewAssign to IC and IRG

Scientific Review GroupsEvaluate Scientific Merit

Advisory Council or BoardRecommend approval

IC Allocates

Funds

SubmitsSBIR/STTR Grant Application to NIH

Electronically

~2-3 monthsafter submission

~2-3 months

after review

NIH Application and Review Process

Solicitations and Funding Opportunities

Page 38: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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Timeline: New Applications

DueDueDateDate

April 5April 5

August 5August 5

December 5December 5

ScientificReview

July

October

March

CouncilReview

October

January

May

AwardDate (earliest)

December

April

July

2.52.5 1.71.7 2.22.2

<……………….……6-9 months…………………….>

Solicitations and Funding Opportunities

Page 39: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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• An In-Depth Look at the NIH SBIR/STTR Receipt, Referral, and Review Process • All You Ever Wanted to Know About the Electronic Submission Process

NIH Application Submissionand Review Process

Solicitations and Funding Opportunities

Page 40: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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05

101520253035404550

SBIR STTR

Phase I

Phase II

Fast-Track

NIH SBIR/STTR Success Rates:FY 2008

Su

cces

s R

ate

(%) $650 M

SBIR/STTR

739

288

46

66

109

48.3%

32%

16%

39%

9.5%

27.2%4

Solicitations and Funding Opportunities

Page 41: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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• Preparing a Successful Application• Pre-Award and Post Award Issues• Indirect Cost Rates and Accounting Systems: Workshop

Solicitations and Funding Opportunities

Page 42: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

OFFICE OF EXTRAMURAL PROGRAMS: SBIR/STTR

Topics to Discuss TodayTopics to Discuss Today

• SBIR/STTR Program Overview SBIR/STTR Program Overview • NIH SBIR/STTR Program SpecificsNIH SBIR/STTR Program Specifics• Solicitations and Funding Opportunities Solicitations and Funding Opportunities • The NIH Peer-Review Process The NIH Peer-Review Process • Industry- University Partnership Industry- University Partnership OpportunitiesOpportunities• Gap-Funding Programs Gap-Funding Programs • Transitioning to the MarketplaceTransitioning to the Marketplace

Page 43: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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SBIR/STTR Historical Relationships

1997

FederalGovernment

SmallBusinesses

1982

Industry-University Partnerships

Page 44: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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Quasi-Government Corporations Economic Development Entities Technology Centers State Venture Funds

StateGovernment

19981982

SmallBusinesses

FederalGovernment

SBIR/STTR Historical Relationships

Industry-University Partnerships

Page 45: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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SBIR/STTR Historical Relationships

2000- 20091982

SmallBusinesses

Academia University Research Parks Faculty & Graduate Students Technology Incubators Research Foundations University Start-Ups

Quasi-Government Corporations Economic Development Entities Technology Centers

StateGovernmentFederal

Government

Industry-University Partnerships

Page 46: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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University Start-Ups:Roles in the SBIR/STTR Programs

• University is the intellectual capital of scientific and engineering knowledge

• Small Business is a vehicle forchanneling scientific discovery to thebenefit of society

• Partnership between the University and the Small Business benefitsBOTH

Industry-University Partnerships

Page 47: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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University-Business Partnership Opportunities

• Own small firms (assign someone else PI)

• Principal Investigator (with official permission from university)

• Senior Personnel on SBIR/STTR

• Consultants on SBIR/STTR

• Subcontracts on SBIR/STTR

• University facilities provide analytical and other service support

Industry-University Partnerships

Page 48: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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University and Industry:Two diverse cultures

Industry Researchers Industry Researchers

are from MARS!are from MARS!

University Researchers University Researchers

are from Venus!are from Venus!

Industry-University Partnerships

Page 49: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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University cultureUniversity culture

• Research, discover, educate and train future

workforce• Pace is slower - aligned to academic cycle

• Mission = basic and applied research• Technology transfer activities are companion

to applied research mission

• Fertile ground for economic development

University and Industry:Two diverse cultures

Industry-University Partnerships

Page 50: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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Industry cultureIndustry culture

• Mission toward research/R&D/commercialization

• Quick-paced

• Solve problems - develop new products profit

• Maintain control of science to explore full potential of discovery (initially)

• Economic impact: Jobs, societal benefit

University and Industry:Two diverse cultures

Industry-University Partnerships

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Cultural Diversity

University - Industry PartnershipsUniversity - Industry Partnerships Critical dimension of the new “Innovation-based Economy”

Universities are establishing creative and entrepreneurial environments for the commercialization of university intellectual property

Universities and Industry learning to work together

is KEY!

Industry-University Partnerships

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• Develop common goals between faculty-initiated business and mission of research institution

• Create environment that enables innovation and entrepreneurship

• Protect IP assets of university

• Establish policies to manage, reduce or eliminate conflict of interest (COI)

Entrepreneurial Research Institution

Key Ingredients

Industry-University Partnerships

Page 53: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

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• The Ohio State University

• Purdue University

• University of Wisconsin

• N.C. State University

• Georgia Tech

• Virginia Tech

Examples of Successful Entrepreneurial

Research Institutions• Texas A&M University

• Penn. State University

• UC San Diego

• University of Utah

• Carnegie Mellon

University

• Stanford University

Source: Innovation U. “New University Roles in A Knowledge Economy”Southern Technology Council and Southern Growth Policies Board

http://www.southern.org/pubs/pubs_pdfs/iu_report.pdf

Industry-University Partnerships

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• Texas A&M

Allows commercialization of faculty research to be considered in the granting of tenure to faculty at A&M System universities.

Examples of Successful Entrepreneurial Research

Institutions (cont.)

Industry-University Partnerships

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Endocyte, Inc. (Purdue Research Park)

Researcher, Dr. Philip Low, discovered way to diagnose, potentially cure, ovarian cancer using vitamin folate

Sell technology or start own company to develop and market treatment????

Resisted VC offers initially…. wanted control of science Also exploring use of folate in arthritis

University Start-Up Success Story

Industry-University Partnerships

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• Faculty entrepreneur Dr. Phil Low , along with CEO, Ron Ellis, and angel investor Jack Clawson found Endocyte 

• NIH SBIR Funding

•  $1.63 M from NCI + 1.95M from Indiana 21st Century Res & Technology Fund

• Multiple rounds of financing received

• Collaborations with Bristol-Myers Squibb

• Endocyte has a strong pipeline with a number of products in various stages of clinical and preclinical development.

BENEFIT: Purdue retained his talent.

ADVICE: Hire experienced CEO to handle all but science.

Unversity Start-Up Success Story (cont)

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• Ivory Tower Innovation & University Start-Ups • Tools for Building and Facilitating Partnerships

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OFFICE OF EXTRAMURAL PROGRAMS: SBIR/STTR

Topics to Discuss TodayTopics to Discuss Today

• SBIR/STTR Program Overview • NIH SBIR/STTR Program Specifics• Solicitations and Funding Opportunities • The NIH Peer-Review Process • Industry- University Partnership Opportunities• Gap-Funding Programs Gap-Funding Programs • Transitioning to the MarketplaceTransitioning to the Marketplace

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Phase I Phase II Phase III

Challenges for Biotech Firms: Navigating the Peaks and Valleys

Unusually long

development times (5-12

yrs)

High & intense

capital needs (>$1B)

Exceptionally high burn rate for investment

funds

Multiple rounds of financing required

Transitioning to the Marketplace

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In-NIH-vative Approaches to Overcoming Commercialization

Challenges

• Phase II Competing Renewal Awards

• BRDG-SPAN Awards • Technical Assistance Program

• Finding a Partner

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Phase I Phase II Phase III

Mt. “FDA”????

Phase II Competing Renewal Awards

Gap Funding and Transitioning to the Market

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• To take existing, promising compounds or devices developed under a Phase II through the next step of drug discovery / medical device refinement and development (see Solicitation)

Purpose

OR….

• To support complex instrumentation, clinical research tools, behavior interventions/treatments (http://grants.nih.gov/grants/guide/pa-files/PA-08-115.html)

Phase II Competing Renewal Award

Gap Funding and Transitioning to the Market

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• SBIR 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

Contact NIH Program Staff to discussContact NIH Program Staff to discuss

Eligibility

Parameters

• Maximum of $1M/year for up to 3 years • IC must accept Competing Renewal applications (NIA, NIAAA, NIAID, NIDA, NIDCD, NIDDK, NEI, NHLBI, NIMH, NICHD, NINDS, NIGMS and NCRR)

Phase II Competing Renewal Award

Gap Funding and Transitioning to the Market

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Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies

(BRDG-SPAN) Pilot Program

Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN) Pilot Program

Application Due Date:  September 1, 2009 

Activity Code: RC3 (Not SBIR/STTR)

Purpose: To address the funding gap between promising research and development (R&D) and transitioning to the market -- often called the “Valley of Death -- by contributing to the critical funding needed to pursue the next appropriate milestone(s) toward ultimate commercialization; i.e., to carry out later stage research activities necessary to that end.

Budget/Project Period: $1 million total costs per year for a maximum of three years.   

Eligible Institutions/Organizations. A U.S.-owned, for-profit enterprise/commercial organization doing a majority of its business in the United States.

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Technical Assistance Programs

Commercialization Assistance

Business & strategic planning

Builds alliances and investor partnerships(Phase II awardees)

Niche Assessment Identify other uses of technology

Determines competitive advantages

Develops market entry strategy

(Phase I awardees)

ManufacturingAssistance(Phase II awardees)

Partnership with NIST MEP Centers

Help make better manufacturing and operational decisions

Transitioning to the Marketplace

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NIH Pipeline to Partnerships(Ph I and Ph II awardees)

Finding a Partner

• Showcase of SBIR/STTR and NIH-licensed technologies

• Facilitates matchmaking between NIH SBIR/STTR awardees and potential strategic partners and investors

• Searches by application category (diagnostics, therapeutic, tool, etc.) and/or disease

Gap Funding and Transitioning to the Market

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Pipeline to Partnerships (P2P)http://www.ott.nih.gov/p2p/index.asp

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Pipeline to Partnerships (P2P)

http://www.ott.nih.gov/p2p/index.asp

Potential partner identifies technology of interest and contacts company's Web site.

Transitioning to the Marketplace

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Pipeline to Partnerships (P2P)http://www.ott.nih.gov/p2p/index.asp

Gap Funding and Transitioning to the Market

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Pipeline to Partnerships (P2P)

Potential partner identifies technology of interest and contacts company's Web site.

Gap Funding and Transitioning to the Market

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Pipeline to Partnerships (P2P)

http://www.ott.nih.gov/p2p/index.asp

Gap Funding and Transitioning to the Market

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Pipeline to Partnerships (P2P)

Gap Funding and Transitioning to the Market

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Phase I Phase II Phase III

NIH Technical Assistance Program

Mt. “FDA”???Commercialization Assistance Program

Niche Assessment Program

Helping Companies cross the “Valley of Death”

“In-NIH-vative” Approaches

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• Business Planning Basics• Strategies for Commercialization• Life Science Venture Funds and Angels• Building Corporate Alliances & Partnerships• Commercialization of Behavioral Services Interventions and Products• Moving from R&D to Manufacturing • Commercializing Your Healthcare/IT/Media Product

To Market We Go

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Top 10 Reasons

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Top 10 Reasons

10. Over $2.3 Billion available- annually

9. NOT A LOAN - no repayment

8. Provides recognition, verificationand visibility

7. Potential leveraging tool to attract venture capital/other sources of $$$

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5. Creates jobs / stimulates local and state economies – stronger National Economy

4. Provides seed money to fund high risk projects

6. Foster partnerships (universities, large corporations) that enhance

competitiveness of small businesses in marketplace

Top 10 Reasons

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3. Intellectual property rights arenormally retained by the smallbusiness

2. Small business concerns are recognized as a unique national resource of technological innovation – creating AND sustaining

Top 10 Reasons

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BrainGateTM SystemCyberkinetics Neurotechnology Systems, Inc.

Percutaneous Ventricular Assist DeviceTM

Cardiac Assist, Inc.

Next Generation TherapeuticsTM

GlycoFi, Inc.

Intralase CorporationFemtosecond LaserIntralase Corporation

PediSedateTM

Design Continuum, Inc.

1. Opportunity to make important contributions

to the health of AmAmerericaica

Top 10 Reasons

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Stay Informed…

NIH Guide for Grants and Contracts (weekly notification)

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

NIH SBIR/STTR Notification

Send email to [email protected] with the following text in the message body:

subscribe listname your name.

ListServes

Page 81: 11 Jo Anne Goodnight SBIR/STTR Program Coordinator Office of Extramural Research, NIH NIH SBIR/STTR Funding Opportu“NIH”tie$ National Institutes of Health

OFFICE OF EXTRAMURAL PROGRAMS: SBIR/STTR

For More InformationFor More Information

www.nih.govwww.nih.govhttp://grants.nih.gov/grants/funding/sbir.htm

Jo Anne GoodnightNIH SBIR/STTR Program Coordinator

Phone: 301- 435-2688 Fax: 301- 480-0146

Email: [email protected]

Kay EtzlerSBIR/STTR Program Analyst Email: [email protected]

Lenka FedorkovaSBIR/STTR Program Analyst

Email: [email protected]

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Thank You!

Questions?