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Jo Anne GoodnightSBIR/STTR Program Coordinator

Office of Extramural Research, NIH

301.435.2688 jg128w@nih.gov

AdvaMed2008Entering the North American

MarketNIH Funding Opportu”NIH”ties

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COMMON SOURCES CAPITAL TO JUMP-START YOUR START-UP

Personal savingsCredit cardsSelling assets (boats & other toys)Second mortgagesLoans & investments from family, friends and …..Suppliers, vendors, other businessesCommercial bank loansPrivate investors, AngelsGovernment GrantsVenture Capital

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Topics to Discuss Today:Government Grants

SBIRSmall Business Innovation Research

STTRSmall Business Technology Transfer

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The largest, most accessible source of

SEED CAPITAL for the nation’s innovative

small businesses$2.3 Billion in 2008

SBIR/STTR PROGRAMS

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…and

This capital is in the form ofgrants and contracts

no repaymentno debt service

no equity forfeiture no IP forfeiture

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SBIR/STTR PROGRAM HIGHLIGHTS

• National competition sponsored by 23 NIH Institutes and Centers (11 Federal agencies total)

• R&D funding set-aside for small businesses to develop innovative products and services (2.5% SBIR / 0.3% STTR)

• Supports R&D aligned with our agency mission and technology needs

• Stimulates innovation and job creation in the Nation’s small business sector

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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

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NIH INSTITUTE/CENTER SBIR/STTR NIH INSTITUTE/CENTER SBIR/STTR BUDGET ALLOCATIONS (FY2008)BUDGET ALLOCATIONS (FY2008)

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

FY 2008 SBIR/STTR Budget Allocations to NIH ICs:

$580 M (SBIR) $ 70 M (STTR)

Total: $650 M

NIDDKNIGMS

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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

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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- idea with commercial

potential • $100K and 6-month (SBIR) or 12-month

(STTR) Award

SBIR/STTR: COMPETITIVE 3-PHASE PROGRAM

NIH permits deviations where scientifically justified

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SBIR/STTR ELIGIBILITY CRITERIA

U.S. small business organized for-profit

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

PD/PI primarily employed with small business

STTR: Formal collaboration between small business and research institution

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SOLICITATIONS AND DUE DATES AND DUE DATES

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Biodefense

Biosensors

Nanotechnologies

Bioinformatics

Diagnostic and Therapeutic Devices

Telehealth

Biosilicon devices

Biocompatible materials

Acousto-optics / opto-electronics

Imaging devices

Proteomics / Genomics

*Examples from 200+ pages of topics!

Parent SolicitationsSBIR: PA-08-050 and STTR: PA-08-051

Our Research Topic Ideas*

NIH SBIR/STTR RESEARCH TOPICS

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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 (cont)

Keyword search the Solicitation

Ctrl - F

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NUMBER OF COMPETING SBIR APPLICATIONS BY PHASE

2,503

3,173

3,582

2,972

3,411

4,384

5,299

4,511

3,723

2,947

461 585 589 657 684 751 810 869 857666

0

1,000

2,000

3,000

4,000

5,000

6,000

1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

Fiscal Year

Nu

mb

er o

f Ap

plic

atio

ns

Phase I Phase II

INFORMATION

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49% 48%

39%

53%

49%

44%

28% 28% 26%

30%27%

24%

20% 18%20%

24%

37%36%

41% 42%

0%

10%

20%

30%

40%

50%

60%

1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

Fiscal Year

Su

cc

es

s R

ate

Phase I Phase II

SUCCESS RATES OF COMPETING SBIR APPLICATIONS

INFORMATION

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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

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TECHNICAL ASSISTANCE PROGRAMS

Commercialization Assistance

Business & strategic planning

Build alliances and investor partnerships(Phase II awardees)

Niche Assessment Identify other uses of technology

Determine competitive advantages

Develop market entry strategy

(Phase I awardees)

ManufacturingAssistance(Phase II awardees)

Partnership with NIST MEP Centers

Help make better manufacturing and operational decisions

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TRANSITIONING TO THE MARKETPLACE

NIH Pipeline to Partnerships

Technology Showcase

Potential partners search for technologies of interest

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

(Ph I and Ph II awardees)

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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.

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PIPELINE TO PARTNERSHIPS (P2P)

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

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SBIR/STTR SUCCESS ABOUNDS!

PediSedateTM

Design Continuum, Inc.

Percutaneous Ventricular Assist DeviceCardiac Assist, Inc.

Intralase Corporation

Xilas Medical, Inc.

HIT SystemTM Simbex, LLC.

Next Generation BiotherapeuticsGlycoFi, Inc. (Sold to Merck)

SonicareTM Toothbrush Optiva Corp.

Cyberkinetics Neurotechnology Systems, Inc. -- BrainGateTM

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How Can You How Can You Qualify for and Compete Successfully for NIH 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.

SUMMARY

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STAY INFORMED…

• NIH SBIR/STTR Web site

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

• NIH Guide for Grants and Contracts (weekly notification)

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

• NIH SBIR/STTR Notification

LISTSERV@LIST.NIH.GOV: Subscribe SBIR-STTR your name

• Contact NIH Program Staff:

Listed in Solicitations under each IC

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http://grants.nih.gov/grants/oer.htm

Jo Anne GoodnightNIH SBIR/STTR Program Coordinator

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

Email: jg128w@nih.gov

THANK YOU!