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Jo Anne GoodnightSBIR/STTR Program Coordinator
Office of Extramural Research, NIH
301.435.2688 [email protected]
AdvaMed2008Entering the North American
MarketNIH Funding Opportu”NIH”ties
Nat
ion
al In
stit
ute
s o
f H
ealt
h
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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
[email protected]: 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: [email protected]
THANK YOU!