national institutes of health office of extramural research 1 overview of the nih sbir/sttr program...

National Institutes of HealthOffice of Extramural Research

1

Overview of the NIH SBIR/STTR Program

Texas SBIR/STTR Summit

June 12, 2013

Matthew Portnoy, Ph.D.

SBIR/STTR Program Coordinator

Office of Extramural Research, NIH


DOD

NIH

NASA

DOE NSFAll Others

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 Aeronautics and Space Administration (NASA)

$161.8 M

Department of Energy (DOE) $188.3 M

National Science Foundation (NSF) $ 150.6 M

Agencies with SBIR Programs

U.S. Department of Agriculture (USDA) $19.3 M

Department of Homeland Security (DHS) $12.6 M

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

SBIR/STTR Budgets by Agency, FY2012

~ $2.4B in FY12across all agencies


NIH Mission

To seek fundamental knowledge about the

nature and behavior of living systems and the

application of that knowledge to enhance

health, lengthen life, and reduce illness and

disability.


Office of the Director

National Institute on Minority Health

and Health Disparities

National Institutes of Health

http://www.nih.gov/icd

National Instituteon Alcohol Abuseand Alcoholism

National Instituteof Arthritis and

Musculoskeletaland 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 Advancing

Translational Sciences

National Instituteof Biomedical

Imaging and

Bioengineering

No funding authority

Center for Information Technology

Center for Scientific Review

NIH Clinical Center

Office of Research Infrastructure Programs


PHASE II Full Research/R&D $1M (STTR), $1M (SBIR) over two years

PHASE IIB 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

PHASE I Feasibility Study Budget Guide: $150K (SBIR); $150K (STTR) Total Costs Project Period: 6 months (SBIR); 1 year (STTR)

NIH SBIR/STTR3-Phase Program

NCI

NIAID

NHLBINIGMSNIDDKNINDS

NIMH

NICHD

NIA

NIDA

NEINCATS

NIEHS

NI-AMS

NHGRI

NI-AAA

NIDCD

NIDCR

NIBIB NIMHD ORIP NINR NCCAMNLM

NIH SBIR/STTR Budget Allocations FY20132.7% SBIR $617M0.35% STTR $80MTotal FY2013 $697M


NIH-wide SBIR/STTR Success Rates

Fiscal Year SBIR/STTR PhaseNumber of

Applications Reviewed

Number of Applications

AwardedSuccess

Rate Total Funding

2011 SBIR Fast Track 409 42 10.3% $10,059,9042011 SBIR Phase 1 4,672 536 11.5% $123,802,0742011 SBIR Phase 2 681 203 29.8% $137,152,6872011 STTR Fast Track 42 4 9.5% $813,9002011 STTR Phase 1 508 80 15.7% $18,321,5162011 STTR Phase 2 103 37 35.9% $20,977,5842011 FY TOTAL 6,415 902 14.1% $311,127,6652012 SBIR Fast Track 358 57 15.9% $13,985,8022012 SBIR Phase 1 4,287 667 15.6% $154,237,8902012 SBIR Phase 2 557 222 39.9% $153,650,1622012 STTR Fast Track 32 11 34.4% $2,840,6322012 STTR Phase 1 542 110 20.3% $23,857,7002012 STTR Phase 2 71 28 39.4% $18,240,418

2012 FY TOTAL 5,847 1,095 18.7% $366,812,604


Texas Success Rates FY2010-12

Fiscal Year

SBIR or

State

All SBIR/STTR Phases

STTRNumber of

Applications Reviewed

Number of Applications

AwardedSuccess Rate Total Funding

2010 SBIR TEXAS 264 35 13.3% $9,542,456

2010 STTR TEXAS 47 12 25.5% $3,411,215

2011 SBIR TEXAS 238 28 11.8% $8,592,046

2011 STTR TEXAS 30 4 13.3% $1,584,769

2012SBIR TEXAS 227 41 18.1% $13,919,585

2012STTR TEXAS 40 7 17.5% $1,610,460


HHS/NIH Program Funding

2013 Budget SBIR STTR

NIH (2013) $617M $80M

CDC FDAACF

$8.3M$1.382 M

~350KN/A

Phase I $150K*6 months*

$150K*1 year*

Phase II $1M* 2 years*

$1M* 2 years*


NIH Website Reauthorization pages

http://sbir.nih.gov

Standard Due Dates:Apr 5; Aug 5; Dec 5

http://sbir.nih.gov/


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

NIH Website Reauthorization pages

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

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


Key Re-Authorization Provision

FY Set-aside SBIR Set-aside STTR

2011 2.5% 0.30%

2012 2.6% 0.35%

2013 (current) 2.7% 0.35%

2014 2.8% 0.40%

2015 2.9% 0.40%

2016 3.0% 0.45%

2017 3.2% 0.45%

Set aside requirements for Agencies will increase


• NIH, CDC, FDA, & ACF SBIR/STTR Grant Solicitation **

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 2013 close date

• NIH Guide for Grants and ContractsRelease: Weekly Receipt dates specified in each FOA

(http://grants.nih.gov/grants/guide/index.html)

Solicitations and Due Dates

“Parent” FOAs: SBIR: PA-13-234 STTR: PA-13-235

http://grants.nih.gov/grants/guide/pa-files/PA-13-234.html

http://grants.nih.gov/grants/guide/pa-files/PA-13-235.html


Important changes in this year’s Omnibus Grant Solicitations

• See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-071.html for details.

• New SBIR/STTR award budget HARD caps in placeProgram Phase I Phase II

SBIR $150,000 $1,000,000

STTR $150,000 $1,000,000

Award Guidelines

Award Hard Caps – cannot exceed

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-071.html




Important changes in this year’s Omnibus Grant Solicitations

• Technical Assistance option• NIH offers distinct technical assistance programs to

SBIR Phase I and Phase II awardees (Niche & CAP)• Applicants wishing to utilize their own technical

assistance vendor are required to include this in your budget and provide a detailed budget justification.

• Please note, if funds are requested to utilize your own technical assistance vendor and an award is made, the awardee is not eligible to apply for the NIH-provided technical assistance program for the phase of their award.

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


New provisions implemented in this year’s Omnibus Grant Solicitations

• VC-backed companies (VCOC, Hedge fund, private equity firm) CAN NOW apply at this time (NIH SBIR only).

• SBIR/STTR applicants must register at the SBA Company registry at SBIR.gov.


New provisions NOT implemented in this year’s Omnibus Grant Solicitations at this time

1. No Switching mechanisms at Phase II• Applicants cannot apply for Phase II SBIR funding based on a

Phase I STTR award or conversely a Phase II STTR based on a Phase I SBIR award. Similarly, applicants cannot apply for a Phase IIB SBIR or STTR based on a Phase II STTR or SBIR award, respectively.

2. No Direct Phase II applications (pilot FOAs when implemented)

Why not? NIH is currently updating its electronic systems and forms for these provisions.


Biodefense

Biosensors

Nanotechnologies

Bioinformatics

Diagnostic and Therapeutic Devices

Telehealth

Proteomics / Genomics

Biosilicon devices

Biocompatible materials

Acousto-optics / opto-electronics

Health IT

Imaging devices

Genetically engineered proteins

…

Our Ideas: Suggested topic areas*

SBIR/STTR ProgramDescriptions and Research Topics


Biodefense

Biosensors

Nanotechnologies

Bioinformatics

Diagnostic and Therapeutic Devices

Telehealth

Proteomics / Genomics

Biosilicon devices

Biocompatible materials

Acousto-optics / opto-electronics

Health IT

Imaging devices

Genetically engineered proteins

…

Our Ideas: Suggested topic areas*

SBIR/STTR ProgramDescriptions and Research Topics

Your Ideas: Investigator-initiated R&D

Research projects related to the NIH mission

“Other” areas of research within the

mission of an awarding component Keyword search the Solicitation

Ctrl - F


Targeted SBIR/STTR Funding Opportunity Announcements

• NIH Guide for Grants and Contracts– High priority areas for ICs– Various IC participation– Nuances:

• Various due dates• Additional review criteria• Limited funds • Varying project periods• Etc.

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


Electronic Submission

• SBIR/STTR grant applications must be submitted electronically. SBIR contract proposals still in paper form.

• Registrations are required!!!System for Award Management (SAM)Grants.gov (company) eRA Commons (company and all PD/PIs)SBA company registry at SBIR.gov

http://era.nih.gov/ElectronicReceipt/index.htm


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 Application and Review Process


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

National Institutes of HealthOffice of Extramural Research Timeline: New Applications

DueDate

April 5

August

5

December 5

ScientificReview

July

November

March

CouncilReview

October

January

May

AwardDate (earliest)

December

April

July

2 2 4 4 5 5

<……………….……6-9 months…………………….>


Common Application Problems

• No Significance Unimportant problem, unconvincing case for

commercial potential or societal impact• Inadequately defined test of feasibility• Lack of innovation • Diffuse, superficial, or unfocused research plan• Questionable reasoning in experimental approach

Failure to consider potential pitfalls and alternatives• Lack of experience with essential methodologies• Unfamiliar with relevant published work• Unrealistically large amount of work proposed


• Understand our mission. • Review Funding Opportunity Announcements (FOAs).• Propose innovative ideas with significance as well as

scientific and technical merit. • Give yourself ample time to prepare application.• Communication. Communication. Communication.• Contact NIH Staff to discuss

• your research idea.• outcome of your review.• challenges and opportunities.

Competing Successfully for SBIR/STTR Funding


Phase III

NIH SBIR/STTR: 3-Phase Program Plus Gap Funding

(Phase I-Phase II Fast-Track)

Phase I

Feasibility

Phase II

Full R/D

$3M/3 years

Mt. “FDA”

Phase II Competing Renewal Award


(Simultaneous Submission and Concurrent Review)

SBIR/STTR Phase I + Phase II

Phase I Award

7-9 months

Completion of Phase I Phase I Final Report Program Staff assess completion of specific aims and milestones

Phase II award

Aims/Milestones Met

Phase II award

Aims/MilestonesNOT Met

Go?

No Go?

NIH Phase I/Phase II Fast-Track

NIH SBIR/STTR Program Specifics


• SBIR/STTR Phase II awardee• Promising pharmacologic compound identified in original Phase

II• Device prototype developed in original Phase II• Instrumentation/Interventional technologies not subject to FDA

regulatory approval but require extraordinary time/effort to develop

• Awards up to $1M/year for up to 3 years • IC must accept Competing Renewal applications(NIA, NIAAA, NIAID, NICHD, NIDA, NIDCD, NIDDK, NEI, NIGMS NHLBI, NIMH, NINDS, NCATS, ORIP, NCI, NHLBI, NINDS)

Contact NIH Program Staff to discuss

Parameters

Phase IIB Competing Renewal Award

NIH SBIR/STTR Program Specifics


Phase I Phase II Phase III

NIH Technical Assistance Program

Mt. “FDA”???Commercialization Assistance Program

Niche Assessment Program

Helping Companies cross the “Valley of Death”

“In-NIH-vative” Approaches


NIH Technical Assistance Programs

• Commercialization Assistance Program (CAP) (Humanitas Inc and Larta Inc)

• 75 Phase II SBIR/STTR companies per year

• Business & strategic planning (9 month hands-on program)

• Help build strategic alliances and investor partnerships

• 125 recent Phase I SBIR/STTR companies per year

• Vendor prepares Technology Niche AnalysesTM

• Identifies alternative uses for technology, competitive advantage, market entry strategy

• Niche Assessment Program (Foresight S&T)


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

• 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)

• 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 IIB Competing Renewals Ph I/Ph II Fast Track Administrative Supplements

• Technical Assistance Programs Technology Niche Assessment Commercialization Assistance

Summary


Stay Informed…

NIH Guide for Grants and Contracts (weekly notification)

http://grants.nih.gov/grants/guide/listserv.htm

NIH SBIR/STTR Notification

Send email to [email protected] with the following text in the message body:

subscribe SBIR-STTR your name.


Save the Date!

15th Annual NIH SBIR/STTR Conference

• October 28-30, 2013• Sioux Falls, South Dakota• Hosted by University of South Dakota Research Park,

Inc.

• Stay tuned to NIH SBIR website and listserv for details!

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

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


For More Information

Matthew Portnoy, PhDNIH SBIR/STTR Program Coordinator

Phone: 301- 435-2688Email: [email protected]

Lenka Fedorkova, PhDSBIR/STTR Program Analyst

Phone: 301-435-0921Email: [email protected]

Subscribe to the SBIR/STTR List Serv: Email [email protected] with the following text

in the message body: subscribe SBIR-STTR your name

Robert VinsonSBIR/STTR Program Analyst

Phone: 301-435-2713Email: [email protected]

[email protected]

Follow us @NIHsbir

mailto:[email protected]

http://twitter.com/NIHsbir

http://twitter.com/NIHsbir

national institutes of health office of extramural research 1 overview of the nih sbir/sttr program...

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