National Institutes of Health Office of Extramural Research
Overview of the NIH SBIR/STTR Programs April 11, 2014
2014 Kentucky SBIR/STTR Conference R b t Vinson Robert Vi NIH SBIR/STTR Program Analyst Office of Extramural Research Research, NIH 1
National Institutes of Health Office of Extramural Research
SBIR/STTR Programs Overview
S SMALL BUSINESS US SS INNOVATION O O RESEARCH (SBIR) PROGRAM 2.8% Set-aside program for small business concerns to engage in Federal R&D – with potential for commercialization
SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM 0.40% Set-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions – with potential for commercialization
National Institutes of Health Office of Extramural Research
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 private sector commercialization innovations derived from Federal R&D Small Business Innovation Development Act of 1982 P.L. 112-81 Re-Authorizes program through FY2017
National Institutes of Health Office of Extramural Research
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. 112-81 Re-Authorizes program through FY2017
SBIR/STTR Budgets y g y, by Agency, FY 2012
National Institutes of Health Office of Extramural Research
NASA
DOE
NSF
All Oth Others
NIH
Agencies with SBIR and STTR Programs Department of Defense (DOD)
$ 1.1 B
Department of Health and Human Services: National Institutes of Health (NIH)
$717.0 M
National N i lA Aeronautics i and dS Space Administration (NASA)
$161 8 M $161.8
Department of Energy (DOE)
$188.3 M
National Science Foundation (NSF)
$ 150.6 M
Agencies with SBIR Programs
DOD
~ $2.4B in FY12 across all agencies
U.S. Department of Agriculture (USDA)
$19.3 M
Department of Homeland Security (DHS)
$12 6 M $12.6
Department of Education (ED)
$13.4 M
Department of Transportation (DOT)
$8.6 M
Department of Commerce: National Oceanic and Atmospheric Administration (NOAA) and National Institute of Standards and Technology (NIST)
$4.7 M
Environmental Protection Agency (EPA)
$4.8 M
National Institutes of Health Office of Extramural Research
NIH Mission
To seek fundamental knowledge about the nature t and db behavior h i off living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.
National Institutes of Health Office of Extramural Research Office of Research Infrastructure Programs
National Institutes of Health Office of the Director
http://www.nih.gov/icd
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 R Research h
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 Lung, Institute
National Human Genome Research Institute
National Institute of Mental Health
National Institute g of Neurological Disorders and Stroke
National Institute of Nursing Research
National N ti l Institute I tit t on Minority Health and Health Disparities
National Center for Complementary and Alternative Medicine
Fogarty International Center
National Center for Advancing Translational Sciences
NIH Clinical Center
Center for Information Technology
National Library of Medicine
Center for Scientific Review
National Institute of Biomedical Imaging and Bioengineering
No funding authority
National Institutes of Health Office of Extramural Research
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 F ll R Research/R&D h/R&D $1M (STTR), $1M (SBIR) over two years
PHASE IIB Competing C ti R Renewal/R&D l/R&D Clinical R&D; Complex Instrumentation/Tools to FDA Many all ICs participate Many, but not all, Varies ~$1M/year; 3 years
PHASE III Commercialization Stage NIH, generally, not the “customer” Consider partnering and exit strategy early
National Institutes of Health
SBIR Eligibility Criteria
Office of Extramural Research
Organized as for-profit U.S. business
S Small: 500 or fewer f employees, including affiliates ff
PD/PI’s primary employment must be with small business concern at time of award and for duration of project period Greater than 50% U.S.- owned by individuals and independently operated or Greater than 50% owned and controlled by other business concern/s that is/are greater than 50% owned and controlled by one or more individuals OR Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private it fifirms, or any combination bi ti off these th equity
National Institutes of Health Office of Extramural Research
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 U.S.
• College or university; other non-profit research organization; Federal R&D center
Intellectual Property Agreement
• Allocation ocat o o of rights g ts in IP a and d rights g ts to ca carry y out follow-on R&D and commercialization
National Institutes of Health Office of Extramural Research
PD/PI Eligibility on STTR
• PD/PI is not required to be employed by SBC • PD/PI at RI must establish contract between RI and SBC describing PD/PI’s involvement • PD/PI must commit a minimum of 10% effort • PD/PI’s “signature” on application is agreement to conforming to Solicitation requirements
National Institutes of Health Office of Extramural Research
• Research Partner
SBIR and STTR C t ca Differences e e ces Critical
• Principal Investigator
SBIR: Primary (>50%) employment must be with 33% Phase I and 50% Phase small business concern II
SBIR: Permits partnering
STTR: Requires partnering STTR: PI may be employed with research institution. by either research institution S ll business Small b i (40%) and d or small business concern U.S. research institution ((30%))
Award is always made to Small Business Concern
NIH SBIR/STTR Budget Allocations FY2013 NIAAA NIAMS NIEHS NCATS
NHGRI
NIDCR
NIBIB ORIP NINR NCCAM
NIDCD NIMHD
NLM
2.7% SBIR $617M 0.35% STTR $80M Total FY2013 $697M
NCI
NEI NIDA NIAID
NIA NICHD NIMH NHLBI
NINDS NIDDK
NIGMS
NIH-wide SBIR/STTR Success Rates
National Institutes of Health Office of Extramural Research
Fiscal Year
SBIR/STTR
Phase
2012 2012 2012 2012 2012 2012 2012 2013 2013 2013 2013 2013 2013 2013
SBIR SBIR SBIR STTR STTR STTR FY TOTAL SBIR SBIR SBIR STTR STTR STTR FY TOTAL
Fast Track Phase 1 Phase 2 Fast Track Phase 1 Phase 2 Phase 2 Fast Track Phase I Phase I Phase II Fast Track Phase I Phase I Phase II
Number of Applications Reviewed
Number of Applications Awarded
Success Rate
Total Funding
358 4,287 557 32 542 71 5,847 313 3 738 3,738 542 42 583 72 5,290
57 667 222 11 110 28 1,095 49 495 178 12 109 19 862
15.9% 15.6% 39.9% 34.4% 20.3% 39 4% 39.4% 18.7% 15.7% 13 2% 13.2% 32.8% 28.6% 18 7% 18.7% 26.4% 16.3%
$13,985,802 $154,237,890 $ $153,650,162 $2,840,632 $23,857,700 $18 240 418 $18,240,418 $366,812,604 $13,981,386 $114 040 157 $114,040,157 $136,348,846 $2,542,128 $24 138 629 $24,138,629 $10,985,373 $302,036,519
Success Rates Posted Online: http://report.nih.gov/success_rates/index.aspx
National Institutes of Health Office of Extramural Research
Kentucky Success Rates Kentucky SBIR/STTR Phases
Fiscal SBIR or State # of Apps # of Apps Year STTR Reviewed Awarded
Success Rate
Total Funding
2011
SBIR
KY
65
8
12.3%
$2,383,334
2011
STTR
KY
16
2
12.5%
$2,029,977
2012
SBIR
KY
54
10
18.5%
$3,631,806
2012
STTR
KY
21
5
23.8%
$1,353,544
2013
SBIR
KY
53
11
20.8%
$3,364,373
2013
STTR
KY
23
3
13.0%
$1,249,509
National Institutes of Health Office of Extramural Research
HHS/NIH Program Funding
2013 Budget NIH
SBIR $ $617M
CDC FDA ACF Phase I
$8.4M $8 4M $1.4M $233K $150K* $150K 6 months* $1M* 2 years*
Ph Phase II
STTR $ $80M
N/A $150K $150K* 1 year* $1M* 2 years*
National Institutes of Health
NIH Reauthorization Webpage
Office of Extramural Research
http://sbir.nih.gov
Standard Due Dates: Apr 5; Aug. Apr. Aug 5; Dec. Dec 5
National Institutes of Health Office of Extramural Research
Solicitations and Due Dates
• NIH, CDC, FDA, & ACF SBIR/STTR Grant Solicitation “Parent” FOAs: SBIR: PA-14-071 PA 14 071 STTR: PA-14-072 PA 14 072 Release: January Standard Due Dates: April 5, 5 August 5, 5 December 5 (AIDS/AIDS-related: May 7, September 7, January 7)
• SBIR Contract Solicitation (NIH, CDC) Release: August g
November 2014 close date
• NIH Guide for Grants and Contracts Release: Weekly Receipt dates specified in each FOA (http://grants.nih.gov/grants/guide/index.html)
National Institutes of Health Office of Extramural Research
Reauthorization Changes – g Hard Caps p Budget
• Reauthorization required that budgets over the hard cap ($225 000 for Phase I and $1 ($225,000 $1,500,000 500 000 for Phase II) Agencies (not applicants) apply for waiver from SBA • SBA has h recently tl approved d a topics t i list, li t which hi h allows ll budgets to exceed the hard caps as long as the project topics are on the list • Pre-approved topics list is Appendix A in regular topics document: http://1.usa.gov/1iUa5Kh • The approval is good for the 2014 SBIR/STTR Omnibus, Omnibus and any FOA that falls on the topic list, including the Direct Phase II FOA 19
National Institutes of Health Office of Extramural Research
Other Reauthorization Changes
• Majority-owned venture capital provision • Switching between SBIR and STTR • SBIR Direct Phase II • SBA Company Registry Full list of changes located here: http://grants.nih.gov/grants/funding/sbir/reauthorization .htm Questions? – Talk to your NIH IC Program Officer! 20
National Institutes of Health Office of Extramural Research
SBIR/STTR Program Descriptions p & Research Topics
Our Ideas: Suggested topic areas* Biodefense
Biosilicon devices
Biosensors
Biocompatible materials
Nanotechnologies
Acousto-optics / optoelectronics l i
Bioinformatics Diagnostic and Therapeutic Devices Telehealth
Health IT Imaging devices Genetically engineered proteins
Proteomics / Genomics ‌
SBIR/STTR Program p and Research Descriptions Topics
National Institutes of Health Office of Extramural Research
O Ideas: Id S t i areas** Our Suggested topic Y t d Id Your Ideas:
g Biosilicon devicesR&D & Biodefense Investigator-initiated related to the NIH Biocompatible materials Biosensors Research projects mission Acousto-optics / optoNanotechnologies “Other” areas electronics of research within the Bioinformatics IT component mission of an Health awarding Diagnostic and Keyword search the Solicitation Imaging devices Therapeutic Devices Telehealth Proteomics / Genomics
Genetically engineered proteins Ctrl -F …
National Institutes of Health Office of Extramural Research
Electronic Submission
SBIR/STTR grant applications must be submitted b itt d electronically. l t i ll SBIR contract t t proposals still in paper form. Registrations are required!!! System for Award Management (SAM) G t Grants.gov ( (company) ) eRA Commons (company and all PD/PIs) SBA company registry at SBIR.gov http://era.nih.gov/ElectronicReceipt/index.htm
National Institutes of Health
Most Important Piece of Advice
Office of Extramural Research
• Talk to an NIH Program Officer about your application and SUBMIT EARLY (days not hours and minutes)! – Program Officer contact information found in the NIH SBIR/STTR Solicitation on http://sbir.nih.gov http://sbir nih gov – Questions about who to contact? Email sbir@od.nih.gov
National Institutes of Health Office of Extramural Research
Small Business Concern
Applicant Initiates Research Idea
Application & Review Process
Submits SBIR/STTR Grant Application to NIH Electronically
NIH Center for Scientific ReviewAssign to IC and IRG
Scientific Review Groups Evaluate Scientific Merit
~2-3 2-3 months after submission
~2-3 months after review
Grantee Conducts Research
IC Allocates Funds
Advisory Ad i C Council il or Board B d Recommend approval
IC Staff Prepare funding Plan for IC Director
National Institutes of Health Office of Extramural Research
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) E i Environment t (F (Facilities/Resources) iliti /R )
Additional dd t o a Review e e Criteria C te a ((not ot scored sco ed individually) d dua y)
Protection of Human Subjects Inclusion of Women, Minorities & Children Vertebrate Animals
Biohazards
Timeline: New Applications
National Institutes of Health Office of Extramural Research
<……………….……6-9 months…………………….> 2
4
5
Due Date
Scientific Review
Council Review
Award Date (earliest)
April 5
July
October
D December b
August 5
November
January
A il April
December 5
March
May
July J l
National Institutes of Health Office of Extramural Research
Niche Assessment Program
• Provides active Phase I awardees with market research, and consumer and competition analysis • H Helps l smallll businesses b i complete l t th their i commercialization plans as part of their Phase II applications li ti • Learn more: http://grants.nih.gov/grants/funding/nap.htm
National Institutes of Health
Commercialization Assessment Program
Office of Extramural Research
• Trains Phase II awardees to: – Develop tailored market entry strategies; – Build strategic partnerships; – Develop FDA regulatory and reimbursement paths; and – Identify financing strategies and expertise on i t ll t l property intellectual t matters tt – Learn more: http://grants.nih.gov/grants/funding/cap/
National Institutes of Health Office of Extramural Research
SBIR and STTR Program Single SBIR/STTR grant solicitation Investigator initiated research ideas Investigator-initiated Special Funding Opportunities (NIH Guide for Grants & Contracts) Electronic Submission (grants only) Awards: Grants, Contracts, Cooperative Agreements
NIH SBIR/STTR Program y of Key y Features Summary External Peer Review Option to request review group Experts from academia/industry Five Criteria: Significance, Approach, PI(s), Innovation, Environment Summary statement for all applicants Revise & resubmit
Multiple Receipt Dates (Grants) April 5, August 5, December 5 May 7, Sept. 7, Jan. 7 (AIDS) Contracts: November
Gap Funding Programs Phase IIB Competing Renewals Phase I/Phase II Fast Track Administrative Supplements
Budget and Project Period $150K/6 - 12 months (Phase I) $1M/2 years (Phase II)
Technical Assistance Programs Technology Niche Assessment Commercialization Assistance Summary
National Institutes of Health
For More Information
Office of Extramural Research
Matthew Portnoy, PhD NIH SBIR/STTR Program Coordinator Phone: 301- 435-2688 Email: mportnoy@mail.nih.gov
Lenka Fedorkova, PhD
Robert Vinson
SBIR/STTR Program Analyst Phone: 301-435-0921 Email: lenka@nih.gov
SBIR/STTR Program Analyst Phone: 301-435-2713 Email: vinsonr@mail.nih.gov
Betty Royster SBIR/STTR Communications Specialist Phone 301-402-1632 Phone: 301 402 1632 Email: roysterbr@mail.nih.gov
Julie Beaver SBIR/STTR Statistician Phone: 301-496-8807 Email: julie.beaver@nih.gov
National Institutes of Health Office of Extramural Research
More Information
Get Connected! • Subscribe to the SBIR/STTR Listserv: • Email LISTSERV@LIST.NIH.GOV with the following text in the message body: subscribe SBIR-STTR SBIR STTR your name • NIH Guide for Grants and Contracts (weekly notification) htt // http://grants.nih.gov/grants/guide/listserv.htm t ih / t / id /li t ht •
Follow us on Twitter: @NIHsbir
• Submit your SBIR/STTR Success Story at: http://sbir.nih.gov p g • Email: sbir@od.nih.gov
National Institutes of Health Office of Extramural Research
Save the Date
2014 NIH SBIR/STTR Annual Conference • October 21 – 23, 2014 • Albuquerque, New Mexico • Host: H t U University i it off N New M Mexico i Health H lth Sciences Center • Stay tuned – details to come!
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Office of Extramural Research
Questions and Answers!