1. Overview of the NIH SBIR/STTR Program “Lab to Life”
National Institutes of Health
Susan Pucie
National Heart, Lung, and Blood Institute, NIH

2. NIH SBIR/STTR Program Coordinator
For More Information
Dr. Matthew Portnoy
NIH SBIR/STTR Program Coordinator
Phone:
Dr. Lenka Fedorkova
NIH SBIR/STTR Program
Phone:

3. Infrastructure Programs Translational Sciences
Organizational Structure of NIH
Office of Research
Infrastructure Programs
Office of the Director
National Institute
on Aging
National Institute
on Alcohol Abuse
and Alcoholism
National Institute
of Allergy and
Infectious Diseases
National Institute
of Arthritis and
Musculoskeletal
and Skin Diseases
National Cancer
Institute
National Institute
of Child Health
and Human
Development
National Institute on
Deafness and Other
Communication
Disorders
National Institute
of Dental and
Craniofacial
Research
National Institute
of Diabetes and
Digestive and
Kidney Diseases
National Institute
on Drug Abuse
National Institute
of Environmental
Health Sciences
National Eye
Institute
National Institute
of General
Medical Sciences
National Heart,
Lung, and Blood
Institute
National Human
Genome Research
Institute
National Institute
of Mental Health
National Institute
of Neurological
Disorders and
Stroke
National Institute
of Nursing Research
National Institute
on Minority Health
and Health
Disparities
National Center
for Complementary
and Alternative
Medicine
Fogarty
International
Center
National Center
for Advancing
Translational Sciences
National Library
of Medicine
National Institute
of Biomedical
Imaging
and
Bioengineering
NIH Clinical Center
Center for
Information
Technology
Center for
Scientific Review
No funding
authority

4. NIH Mission
Improve human health through biomedical and behavioral research,
research training and communications.

5. SBIR/STTR Mission through the investment of federal research funds
Supporting scientific excellence and technological innovation
through the investment of
federal research funds
in critical American priorities
to build a strong national economy…
one small business at a time.
So on to the basics of the NIH SBIR/STTR programs. The SBIR/STTR program mission is to support scientific excellence and technological innovation through the investment of federal research funds in critical American priorities to build a strong national economy …one small business at a time.

6. Bridging the Discovery to Development Gap
SBIR/STTR Programs Are Fully Integrated With the NIH Research Mission
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
The SBIR and STTR programs are fully integrated with the NIH research agenda. That is they are meant to:
Improve human health through prevention, detection, diagnosis and treatment of disease or disability
Speed the process of discovery
Reduce the cost of medical care
Improve research tools and reduce the cost of research
And increase the health knowledge base.
So, the SBIR and STTR programs are not only integral to NIH’s mission, but unlike NIH’s traditional research programs, for instance those that fund regular investigator-initiated research project (R01 type) grants, the SBIR and STTR programs exist to move a great idea, perhaps your great idea, to a commercially viable product, process, or service that meets a recognized need.
NIH SBIR/STTR Program Specifics

7. SBIR Purpose and Goals 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
Small Business Innovation Development Act of 1982
P.L Re-Authorizes program through FY2017

8. STTR Purpose and Goals
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
Small Business Research and Development
Enhancement Act of 1992
P.L Re-Authorizes program through FY2017

9. SBIR Eligibility Criteria
Subject to change per new SBA Policy Directive pending
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
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

10. STTR Eligibility Criteria
Applicant is 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

11. SBIR and STTR: Critical Differences
Research Partner
SBIR: Permits partnering
33% Phase I and 50% Phase II
STTR: Requires partnering with Research Institution
Small business (40%) and U.S. research institution (30%)
Principal Investigator
SBIR: Primary (>50%) employment must be with small business concern
STTR: PI may be employed by either research institution or small business concern
Award is always made
to Small Business Concern

12. NIH SBIR/STTR: 3-Phase Program
PHASE I Feasibility Study
Budget Guide: $150K (SBIR); $150K (STTR) Total Costs
Project Period: 6 months (SBIR); 1 year (STTR)
PHASE II Full Research/R&D
$1M (STTR), $1M (SBIR) over two years
PHASE II Competing Renewal/R&D
Clinical R&D; Complex Instrumentation/Tools to FDA
Many, but not all, ICs participate
Varies ~$1M/year; 3 years
PHASE III Commercialization Stage
NIH, generally, not the “customer”
Consider partnering and exit strategy early

13. NIH INSTITUTE/CENTER SBIR/STTR BUDGET ALLOCATIONS (FY2011)
NIMHD
Extramural R&D Set-Asides:
SBIR = 2.5%
STTR = 0.3%
FY 2011 SBIR/STTR
Budget Allocations to NIH ICs:
$609 M (SBIR)
$ 73 M (STTR)
Total: $682 M
FY2012-pending
Go to Rob at end
NIGMS
NIDDK

14. NIH SBIR/STTR Success Rates
Fiscal Year
SBIR/STTR
Phase
Number of Applications Reviewed
Number of Applications Awarded
Success Rate
Total Funding
2010
SBIR
Fast Track
430 67
15.6%
$16,795,150
Phase 1
4,496
614
13.7%
$129,218,371
Phase 2
734
246
33.5%
$146,228,959
STTR 47 11
23.4%
$2,300,971
539
109
20.2%
$21,620,399 92 32
34.8%
$18,207,113
FY TOTAL
6,338
1,079
17.0%
$334,370,963
2011
409 42
10.3%
$10,059,904
4,672
536
11.5%
$123,802,074
681
203
29.8%
$137,152,687 4
9.5%
$813,900
508 80
15.7%
$18,321,516
103 37
35.9%
$20,977,584
6,415
902
14.1%
$311,127,665

15. Multiple Funding Opportunities
Annual SBIR/STTR Omnibus Grant Solicitation
Release: January Receipt Dates: April 5, Aug 5, Dec 5 (non-AIDS)
May 7, Sept 7, Jan 7 (AIDS)
To be released soon for 2012
Targeted SBIR/STTR Grant Funding Opportunity Announcements (NIH Guide for Grants & Contracts)
Release: Weekly Various receipt dates
Annual SBIR Contract Solicitation (NIH, CDC)
Release: August Receipt Date: Early November

16. Electronic Submission
SBIR/STTR grant applications must be submitted electronically. SBIR contract proposals still in paper form.
Registrations are required!!!
Grants.gov (company)
eRA Commons (company and all PD/PIs)

17. Gap Funding Phase I Phase II Phase III Phase I / Phase II Fast Track
Phase IIB Competing Renewals
Pipeline to Partnerships
Phase I
Phase II
Phase III
Technical Assistance Programs

18. Technical Assistance Programs
Niche Assessment
Identify other uses of technology
Determines competitive advantages
Develops market entry strategy
(Phase I awardees)
Business & strategic planning
Help help build strategic alliances and investor partnerships
Commercialization
Assistance
(Phase II awardees)

19. Solicitations and Due Dates

20. Advice from Awardees Don’t judge an Institute’s interests by
its “name ”
Understand an Institute’s mission & needs
Get to know your Institute Program
Manager
Read solicitation and other funding opportunities and follow instructions
When trying to determine which agency to apply to, many awardees advise that you don’t judge an agency’s interests by its name. It’s important to understand an agency’s mission and needs, to get to know your agency program manager, and of course to read the published solicitations and follow the instructions.

21. Cover Letter: A Valuable Tool
Suggest potential awarding component(s)
Request same or different study section
Suggest key areas of expertise required
Indicate individual(s) or organization(s) in conflict
A valuable tool to submit with your application is a cover letter. This cover letter will allow the NIH Center for Scientific Review to see the applicant’s suggestion for potential awarding components, study sections, and areas of expertise. Also the letter allows the applicant to indicate individuals and organizations that are in conflict.

22. Review Criteria Overall Impact Score
Scored Review Criteria (score 1-9)
Significance (Real Problem/Commercial Potential)
Investigators (PI and team)
Innovation (New or Improved?)
Approach (Research Design, Feasible)
Environment (Facilities/Resources)
Additional Review Criteria (not scored individually)
Protection of Human Subjects
Inclusion of Women, Minorities & Children
Vertebrate Animals
Biohazards

23. Common Pitfalls with Applications
What Reviewers Say…
Common Pitfalls with Applications
Inadequately defined test of feasibility
Lack of sufficient experimental detail
Questionable reasoning in experimental approach
Failure to consider potential pitfalls and alternatives
Lack of innovation
Unconvincing case for commercial potential or societal impact
Lack of experience with essential methodologies
Unfamiliar with relevant published work
Unrealistically large amount of work proposed
There are a number of common pitfalls with applications that the reviewers regularly come across (see list on slide 34).

24. TEXAS SBIR/STTR 55 Companies – Active Awardees
RESONANT SENSORS INC.
ARLINGTON
ATACTIC TECHNOLOGIES, INC.
HOUSTON
AMBION DIAGNOSTICS, INC.
AUSTIN
BIOTEX, INC.
ASURAGEN, INC.
COVALENT BIOSCIENCE, INC.
BIOO SCIENTIFIC CORPORATION
HOUSTON PHARMACEUTICALS, INC.
CAISSON BIOTECH, LLC
IONWERKS, INC.
MICROSURFACES, INC.
Austin
LC SCIENCES, LLC
MIRNA THERAPEUTICS, INC.
NANOSPECTRA BIOSCIENCES, INC.
PLASTIPURE, INC.
PHARMAREVIEW CORPORATION
RULES-BASED MEDICINE, INC.
PULMOTECT, INC
Houston
SAVARA, INC.
RADIANT CREATIVE GROUP, LLC
SELENIUM, LTD
SYNTHECON, INC.
SERALOGIX
TOMOWAVE LABORATORIES, INC.
SILICON AUDIO, LLC
VIVID TECHNOLOGIES
XERIS PHARMACEUTICALS, INC.
LASER TISSUE WELDING, INC.
HUMBLE
KJ BIOSCIENCES, LLC
COLLEGE STATION
BIO-SYNTHESIS, INC.
LEWISVILLE
LYNNTECH, INC.
NOVOMEDICS, LLC
Missouri City
POSITIVEMOTION, LLC
REBELLION PHOTONICS, INC.
PEARLAND
STATACORP, LP
MARTINGALE RESEARCH CORPORATION
Plano
CRO LABORATORIES, INC.
DALLAS
MICROFAB TECHNOLOGIES, INC.
PLANO
DENTAL DESIGNS OF DALLAS
VITAL ART AND SCIENCE, INC.
Richardson
IMAGINATION STATION, INC.
Dallas
ACCESSIBLE DESIGNS, INC.
SAN ANTONIO
MICROTRANSPONDER, INC.
APPLIED HUMAN FACTORS, INC.
RADIX THERAPEUTICS, LLC
DICKINSON
BIOMEDICAL DEVELOPMENT CORPORATION
EP PHARMA, INC.
EL PASO
CARE TEAM SOLUTIONS, LLC
ORGANIZATIONAL WELLNESS & LEARNING SYS
FORT WORTH
PROBETEX, INC.
MAJESTECK BIOSCIENCE
GALVESTON
TELEHEALTH HOLDINGS, LLC
AGENNIX, INC.
NIMBIC SYSTEMS, INC.
STAFFORD
AM BIOTECHNOLOGIES, LLC

25. NHLBI SBIR/STTR online search using RePORT
MRI
SBIR & STTR
Here is the URL for the REPORT. REPORT is a powerful tool for searching NIH grants. For example – One can search for a keyword. Here I am using “MRI” as the key word. You can restrict the search to “SBIR/STTR” grants. Here you can select one or more or all of the NIH institutes – I am restricting this search to grants funded by “NHLBI”. You can choose one or more FY – here I am restricting grants to the past three FY. You can choose one or more states or entire United States like I have done. Thus I am searching for SBIR/STTR grants with MRI focus funded by NHLBI in the past three FY.
2008 & 2009

26. SBIR/STTR Grants With MRI Focus Funded by NHLBI in the Past Two Years
Here is the URL for the REPORT. REPORT is a powerful tool for searching NIH grants. For example – One can search for a keyword. Here I am using “MRI” as the key word. You can restrict the search to “SBIR/STTR” grants. Here you can select one or more or all of the NIH institutes – I am restricting this search to grants funded by “NHLBI”. You can choose one or more FY – here I am restricting grants to the past three FY. You can choose one or more states or entire United States like I have done. Thus I am searching for SBIR/STTR grants with MRI focus funded by NHLBI in the past three FY.

27. SBIR/STTR – NHLBI Funded Imaging Grants
Now I can see the grant#, Project title, the PI’s name, an abstract and the duration of the project. This is a powerful tool to search for the funded grants. Note this is a search mechanism for any type of NIH grant and not just for SBIR/STTRs. Also I would like to emphasize that the small businesses are not restricted to apply only to SBIR/STTR grants.

28. NIH SBIR/STTR Program Summary of Key Features
SBIR and STTR Program
Single SBIR/STTR grant solicitation
Investigator-initiated research ideas
Special Funding Opportunities
(NIH Guide for Grants and Contracts)
Electronic Submission (grants only)
Awards: Grants, Contracts,
Cooperative Agreements
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
Revise & resubmit
Gap Funding Programs
Phase II Competing Renewals
Ph I/Ph II Fast Track
Administrative Supplements
Multiple Receipt Dates (Grants)
April 5, August 5, December 5
May 7, September 7, January 7 (AIDS)
Contracts: Early November
Budget and Project Period
$150K/6 -12months (Ph I)
$1M/2 yrs (Ph II)
Technical Assistance Programs
Technology Niche Assessment
Commercialization Assistance
Pipeline to Partnerships (P2P)
Summary

29. Save the Date! 14th Annual NIH SBIR/STTR Conference
May 30 to June 1, 2012
Louisville, Kentucky
Hosted by Kentucky Science and Technology Corporation
2 day conference with optional workshop on June 1.
Stay tuned to NIH SBIR website and listserv for details!

30. Stay Informed… Listserves
NIH Guide for Grants and Contracts (weekly notification)
NIH SBIR/STTR Notification
Send to with the following text in the message body:
subscribe SBIR-STTR your name.

31. For More Information Matthew Portnoy, PhD
NIH SBIR/STTR Program Coordinator
Phone:
Lenka Fedorkova, PhD
SBIR/STTR Program Analyst
Phone:
Robert Vinson
SBIR/STTR Program Analyst
Subscribe to the SBIR/STTR List Serv:
with the following text
in the message body: subscribe SBIR-STTR your name