11
Jo Anne GoodnightSBIR/STTR Program Coordinator
Office of Extramural Research, NIH
301.435.2688 [email protected]
““Lab to Life”Lab to Life”NIH SBIR/STTR Funding NIH SBIR/STTR Funding
Opportu“Opportu“NIHNIH”tie”tieSS
Nat
ion
al In
stit
ute
s o
f H
ealt
h
Presentation to the Monte Jade Science & Technology Association
October 22, 2008
22
Topics to Discuss Today
• SBIR/STTR Program OverviewSBIR/STTR Program Overview
• NIH SBIR/STTR Program SpecificsNIH SBIR/STTR Program Specifics
• Transitioning NIH SBIR/STTR Innovations to Transitioning NIH SBIR/STTR Innovations to the Marketplace the Marketplace
• Answer Your Questions!Answer Your Questions!
33
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
44
The largest, most accessible
source of SEED CAPITAL
for the nation’s innovative small businesses
$2.3 Billion in 2008
SBIR/STTR PROGRAMS
OFFICE OF EXTRAMURAL PROGRAMS: SBIR/STTR
…and
This capital is in the form ofgrants and contracts
no repaymentno debt service
no equity forfeiture no IP forfeiture
66
SBIR/STTR Program Overview
SMALL BUSINESS INNOVATION SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAMRESEARCH (SBIR) PROGRAMSet-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) PROGRAMSet-aside program to facilitate cooperative R&D between small businesses and research institutions -- with potential for commercialization.
2.5%
0.3%
The best way to predict the future… is to create it.
77
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
88
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
99
•PHASE II Full Research/R&D $750K and 2-year Award (SBIR & STTR) Pre-requisite: Phase I award
•PHASE III Commercialization Stage Must use 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
1010
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
500 or fewer employees, including affiliates
PI primarily employed with the small business
STTR: Formal collaboration between small business and research institution
SBIR/STTR Program Overview
1111
Topics to Discuss Today
• SBIR/STTR Program OverviewSBIR/STTR Program Overview
• NIH SBIR/STTR Program SpecificsNIH SBIR/STTR Program Specifics
• Transitioning NIH SBIR/STTR Innovations to Transitioning NIH SBIR/STTR Innovations to the Marketplace the Marketplace
1212
• 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 Development GapBridging the Discovery to Development Gap
1313
SBIR/STTR Set-Aside Amounts (FY1983-2008)
621
4052 61 66 71 73 79 86
118 130
182198
260281
325
373
435
499
557
631 639 641 650 649
0
100
200
300
400
500
600
700
1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
Fiscal Year
Do
llars
(m
illio
ns
)
.2 .6 1.0 1.25 1.5 2.0 2.5SBIR
STTR .05 .1 .15 0.3N/A
Set-aside %
Growth of the SBIR/STTR Budget Over 25 Years
NIH SBIR/STTR Program Specifics
1414
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
1515
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
1616
NIH SBIR Funding in FY2007 – Top 10 Awards and Dollars
State Awards Amount Awarded
CALIFORNIA 263 103,862,962
MASSACHUSETTS 206 74,503,651
MARYLAND 101 34,907,762
NEW YORK 83 31,156,040
PENNSYLVANIA 74 29,030,771
TEXAS 79 26,814,616
OHIO 53 19,964,206
OREGON 48 19,894,707
WASHINGTON 54 18,739,713
WISCONSIN 46 15,811,543NIH SBIR/STTR Program Specifics
1717
Number Of NIH Competing SBIR ApplicationsFY 1995 - 2007
5,380
36133,744
4,580
6,109
5,135
4,095
3,629
4,171
3,758
2,9643,1083,316
-
1,000
2,000
3,000
4,000
5,000
6,000
7,000
1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007
Phase 1 and Phase 2Phase 1 = All R43 and U43; Phase 2 = Other competing R44 and U44
-15%
-12%
-21%
NIH SBIR/STTR Program Specifics
1818
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
NIH SBIR/STTR Program Specifics
1919
• PHASE II (Full Research/R&D) Average $850K and 2-years; can be longer
• PHASE II+ (Competing Renewal/R&D) Clinical R&D; Complex Instrumentation/Tools Many, 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: Varies. Most awards on a 1-yr NCE
NIH SBIR/STTR: 3-Phase Program
2020
• NIH, CDC & FDA SBIR/STTR Grant Solicitation “Parent FOAs”
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 FOAhttp://grants.nih.gov/grants/guide/index.html
Solicitations and Due DatesSolicitations and Due Dateshttp://grants.nih.gov/grants/funding/sbir.htm
SBIR: PA-08-050 STTR: PA-08-051
NIH SBIR/STTR Program Specifics
2121
http://grants.nih.gov/grants/funding/sbir.htm
NIH SBIR/STTR Program Specifics
2222
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-08-050 and STTR: PA-08-051
NIH SBIR/STTR Program Specifics
2323
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 - FNIH SBIR/STTR Program Specifics
2424
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 Review Process
NIH SBIR/STTR Program Specifics
2525
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 NIH SBIR/STTR Innovations to the Marketplace
2626
NIH Technical Assistance Program: Understanding the “B” in SBIR
• A “menu” of technical assistance / training programs in:
• Strategic/business planning• FDA requirements• Technology valuation• Manufacturing issues• Patent and licensing issues
• Getting closer to the customer, the market, and the competition.
• Systematic approach to developing business strategies.
• Individualized assistance/mentoring/consulting.
Menu:
Commercialization Assistance Program Technology Niche Analysis Program Manufacturing Assistance Program
Transitioning NIH SBIR/STTR Innovations to the Marketplace
2727
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)
ManufacturingAssistance
(Phase II awardees)
Partnership with NIST MEP Centers
Help make better manufacturing and operational decisions
Transitioning NIH SBIR/STTR Innovations to the Marketplace
2828
To (the) Market We Go
NIH Pipeline to Partnerships (P2P)
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)
Transitioning NIH SBIR/STTR Innovations to the Marketplace
2929
NIH Pipeline to Partnerships (P2P)http://www.ott.nih.gov/p2p/index.asp
3030
Pipeline to Partnerships (P2P)
Potential partner identifies technology of interest and contacts company's Web site.
Transitioning NIH SBIR/STTR Innovations to the Marketplace
3131
Pipeline to Partnerships (P2P)http://www.ott.nih.gov/p2p/index.asp
Transitioning NIH SBIR/STTR Innovations to the Marketplace
3232
Phase III Commercialization
An evaluation of NIH Ph II SBIR awardees (FY1992-2001) and regular updates document the continued achievements of SBIR awardees over time.
• Number of awardees with FDA-approved projects increased 51%, from 59 in 2002 to 89 in March 2007.
• Estimated cumulative sales to date increased over 200%, from $821 million to $1.95 billion in March 2007.
• Number of awardees receiving additional non-SBIR funding or capital increased 33%, from 281 in 2002 to 375 in March 2007.
A recent second evaluation of NIH Ph II SBIR awardees (FY2002-2006) show $395M for another 189 awardees.
3333
Top 10 Reasons
3434
Top 10 Reasons
10.10. Over $2.3 Billion available- annually
9.9. NOT A LOANNOT A LOAN - no repayment
8.8. Provides recognition, verificationand visibility
7.7. Potential leveraging tool to attract
venture capital/other sources of $$$
3535
5.5. Creates jobs / stimulates local and state economies – stronger National Economy
4.4. Provides seed money to fund high risk projects
6.6. Foster partnerships (universities, large niversities, large corporations)corporations) that that enhance
competitiveness ofof small businesses in marketplacesmall businesses in marketplace
Top 10 Reasons
3636
3.3. Intellectual property rights arenormally retained by the smallbusiness
2.2. Small business concerns are recognized as
a unique national resource of technological innovation – creating AND sustaining
Top 10 Reasons
3737
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
3838
SummarySummary
3939
Summary:Importance of NIH SBIR/STTR Funding
• Funds early-stage, high-risk projects for which private and public funds are not traditionally available– Establish feasibility of ideas with commercial
potential– Verify technology and leverage SBIR funds to
attract other funding
• Plays an important role is achieving NIH mission of improving human health– Develop tangible products and services resulting
from innovative R&D approaches to improving health
• Focuses on commercialization of the outcomes of research – a unique feature. – SBIR program supplements -- but does not
supplant or diminish -- the traditional research programs of NIH.
Summary
4040
NIH SBIR/STTR Program Key Features
• SBIR and STTR Program Single SBIR/STTR grant solicitation Investigator-initiated research ideas Supplemental Funding Opportunities (NIH Guide for Grants and Contracts) Electronic Submission 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 $100K/6 months (Ph I) $750K/2 yrs (Ph II) Deviations permitted where scientifically appropriate.
• 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 One resubmission (eff. Jan 2009)
• Gap Funding Programs No-Cost Extensions (NCE) Ph I/Ph II Fast Track Administrative Supplements
• Technical Assistance Programs Technology Niche Assessment Commercialization Assistance Pipeline to Partnerships (P2P)
Summary
4141
NIH SBIR/STTR Program Enhancements
• Project Director/Principal Investigator (PD/PI)
Multiple PD/PI allowed Waivers for 51% employment requirement
• Performance of Work Waivers for work outside U.S. Deviations from SBIR subcontract percentages (not for STTR)
• Budget and Project Period Deviations permitted Reasonable and scientifically appropriate for success of the project.
• SBIR-STTR Conversions (vice-versa) Phase I stage allowed
Summary
• Phase II Competing Renewal Up to $1M/year for 3 years Additional R&D to meet FDA regulatory requirements OR Complex instrumentation/clinical research tools/behavior interventions
• Program Evaluation Tool Performance Outcomes Database System (PODS) Regular updates Accessible to NIH staff
OFFICE OF EXTRAMURAL PROGRAMS: SBIR/STTR
Jo Anne GoodnightNIH SBIR/STTR Program Coordinator
Phone: 301-435-2688 Fax: 301-480-0146
Email: [email protected]
Kay EtzlerSBIR/STTR Program Analyst
Phone: 301-435-2713Fax: 301-480-0146
Email: [email protected]
http://grants.nih.gov/grants/funding/sbir.htm
Thank You!