2014_04-11 National Institutes of Health (NIH)

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

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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

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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

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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

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• 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

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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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More Information

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Questions and Answers!