11 jo anne goodnight sbir/sttr program coordinator office of extramural research, nih 301.435.2688...

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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

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Presentation to the Monte Jade Science & Technology Association

October 22, 2008

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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

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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

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

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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.

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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.


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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


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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 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


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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

500 or fewer employees, including affiliates

PI primarily employed with the small business

STTR: Formal collaboration between small business and research institution


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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

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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 Development GapBridging the Discovery to Development Gap

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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

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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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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

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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%


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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


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• 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

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• 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


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


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


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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 - FNIH SBIR/STTR Program Specifics

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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 Review Process


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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 NIH SBIR/STTR Innovations to the Marketplace

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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


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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


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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)


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

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Pipeline to Partnerships (P2P)

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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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.

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Top 10 Reasons

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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 $$$

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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

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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

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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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SummarySummary

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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

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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

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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!

11 jo anne goodnight sbir/sttr program coordinator office of extramural research, nih 301.435.2688...

Documents

sbirsttr budget

small business sttr

goals small business

sbirsttr eligibility

small business concerns

month sttr award sbirsttr

nih research agenda

marketplace slide