Overview of the HHS SBIR/STTR Program - CTSI

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National Institutes of HealthOffice of Extramural Research

Overview of the HHS SBIR/STTR Program

19th Annual NIH SBIR/STTR ConferenceNovember 7-9, 2017Milwaukee, Wisconsin

Matthew Portnoy, Ph.D.SBIR/STTR Program Coordinator

Office of Extramural Research, NIH


Conference Goals

• Understand the HHS SBIR/STTR programs and funding opportunities

• Better understand the HHS application, review and award process

• Enable you to take advantage of one-on-one and networking opportunities

• Know we really ARE here to help you!

• Enjoy yourself!

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#InTheHeartland#HHSAnnual#19thAnnualSBIR#MilwaukeeSBIR#HHSAnnualSBIR

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Add these # to your tweets.

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Agenda

• SBIR/STTR Program Overview

• NIH SBIR/STTR Program Specifics

• Reauthorization Updates

• Solicitations and Funding Opportunities

• The NIH Peer-Review Process

• Transitioning to the Marketplace

• Question & Answer

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Most Important Piece of Advice

• Talk to an HHS Program Officer about your application and SUBMIT EARLY (days not hours and minutes)!

o Program Officer contact information found on the

HHS Agency Contact webpage

o Questions about who to contact? Email [email protected]

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NIH SBIR/STTR Website

http://sbir.nih.gov

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New to SBIR/STTR?

http://sbir.nih.gov/infographic


SBIR/STTR Program Overview

SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAMSet-aside program for small business concerns to engage in federal R&D -- with potential for commercialization

SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAMSet-aside program to facilitate cooperative R&D between small business concerns and US research institutions -- with potential for commercialization

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3.2%

0.45%

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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

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Small Business Innovation Development Act of 1982P.L. 114-328 Re-Authorizes program through FY2022


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

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Small Business Research and Development Enhancement Act of 1992

P.L. 114-328 Re-Authorizes program through FY2022

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DOD

HHS

DOENASA NSF All

Others

Agencies with SBIR and STTR Programs Budget

Department of Defense (DOD) $ 1.070 B

Department of Health and Human Services (HHS), including the National Institutes of Health (NIH)*

$797.0 M

Department of Energy (DOE), including Advanced Research Projects Agency – Energy (ARPA-E)

$206.1M

National Aeronautics and Space Administration (NASA)

$ 180.1 M

National Science Foundation (NSF) $176.0 M

Agencies with SBIR Programs Budget

U.S. Department of Agriculture (USDA) $25.3M

Department of Homeland Security (DHS): Science and Technology Directorate (S&T) and Domestic Nuclear Detection Office (DNDO)

$17.7 M

Department of Commerce: National Oceanic and Atmospheric Administration (NOAA) and National Institute of Standards and Technology (NIST)*

$8.4M

Department of Transportation (DOT) $7.9 M

Department of Education (ED) $7.5 M

Environmental Protection Agency (EPA) $4.2 M

SBIR/STTR Budgets by Agency FY2015

~ $2.5B in FY15 across all agencies

Grants

Contracts

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HHS Program Funding

2017 Budget SBIR STTR

NIH $861M $121M

CDC ~$11.0M N/A

ACL (NIDILRR)

~$3M N/A

FDA ~$1M N/A

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NIH SBIR/STTR3-Phase Program

Discovery

Phase I Feasibility StudyBudget Guide: $150K for SBIR and STTRProject Period: 6 months (SBIR); 1 year (STTR)

PhaseI

Development

Phase II Full Research/R&D$1M for SBIR and STTR, over two years

Phase IIB Competing Renewal/R&DClinical R&D; Complex Instrumentation/Tools to FDAMany, but not all, IC’s participateVaries~$1M per year; up to 3 years

PhaseII

Commercial-ization

Phase III Commercialization StageNIH, generally, not the “customer”Consider partnering and exit strategy early

PhaseIII

PhaseIIB

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SBIR Eligibility Criteria

• Organized as for-profit US business

• Small: 500 or fewer employees, including affiliates

• Work must be done in the US (with few exceptions)

• Individual Ownership: o Greater than 50% US-owned by individuals and independently operated

OR

o 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

o Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these (For FOAs after 1/28/2013 NIH; 7/10/14 CDC)

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Determined at Time of Award

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STTR Eligibility Criteria

• Applicant is a Small Business Concern

• Formal Cooperative R&D Efforto Minimum 40% by small businesso Minimum 30% by US research institution

• US Research Institutiono College or university; other non-profit research

organization; Federal R&D center

• Intellectual Property Agreemento Allocation of rights in IP and rights to carry out follow-on

R&D and commercialization

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SBIR and STTR Critical Differences

SBIR STTR

Partnering Requirement

Permits partnering Requires a non-profit research institution partner (e.g. university)

WorkRequirement

Guidelines: May outsource 33% (Phase I) 50% (Phase II)

Minimum Work Requirements: 40% small business 30% research institution partner

PrincipalInvestigator

Primary employment (>50%) must be with the small business

PI may be employed by either the research institution partner or small business

Award is always made to the small business

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Important Facts to Remember

• Eligibility is determined at time of award

• PD/PI is not required to have a Ph.D./M.D.

• PD/PI is required to have expertise to oversee project scientifically and technically

• Applications may be submitted to different agenciesfor similar work

• Awards may not be accepted from different agencies for duplicative projects

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Agenda








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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.

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No funding authority

Office of Research Infrastructure Programs

National Instituteon Aging

National Instituteon Alcohol Abuseand Alcoholism

National Instituteof Allergy and

Infectious Diseases

National Institute of Arthritis and

Musculoskeletal and Skin Diseases

National Cancer

Institute

National Instituteof Child Health

and HumanDevelopment

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 Instituteof EnvironmentalHealth Sciences

National Eye

Institute

National Institute of General

Medical Sciences

National Heart,Lung, and Blood

Institute

National HumanGenome Research

Institute

National Institute

of Mental Health

National Institute of Neurological

Disorders and Stroke

National Instituteof Nursing Research

National Instituteon Minority

Health and Health Disparities

National Center for Complementary and Integrative Health

Fogarty International

Center

National Centerfor Advancing

Translational Sciences

National Library

of Medicine

National Instituteof Biomedical Imaging and

Bioengineering

Office of the Director

NIH Clinical Center Center for Information Technology

Center for Scientific Review

National Institutes of Health

http://www.nih.gov/icd

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NIH SBIR/STTR Budget Allocations FY20173.2% SBIR $861.4M0.45% STTR $121.1MTotal FY17 $982.5MFY18 pending

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NIH 2016 SBIR/STTR Grants Success Rate by Phase

13% 13%

31%32%

17%

22%

15%14%

31%

Fast Track Phase I Regular Phase II Phase IIB Direct Phase II CRP

SBIR STTR STTR PHIIB: 1 Application and 1 Award

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NIH-wide SBIR/STTR Grant Success Rates 2016

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Success Rates Posted Online: http://report.nih.gov/success_rates/index.aspx

Fiscal Year SBIR/STTR PhaseNumber of

Applications Reviewed

Number of Applications

Awarded

Success Rate

Total Funding

2016 SBIR Phase I 4,178 526 12.6% $121,272,849

2016 SBIR Fast Track 512 67 13.1% $17,348,139

2016 SBIR Total Phase II 1,194 299 25.0% $240,205,166

2016 SBIR Regular Phase II 628 193 30.7% $146,728,352

2016 SBIR Direct Phase II 497 84 16.9% $74,799,524

2016 SBIR Phase IIB 69 22 31.9% $18,677,290

2016 SBIR CRP 67 15 22.4% $9,135,503

2016 STTR Phase I 1,341 191 14.2% $44,316,736

2016 STTR Fast Track 109 16 14.7% $4,866,290

2016 STTR Total Phase II 121 38 31.4% $29,964,963

2016 STTR Regular Phase II 120 37 30.8% $29,089,887

2016 STTR Phase IIB 1 1 100.0% $875,076

2016 FY TOTAL 7,522 1,152 15.3% $467,109,646


First Time Applications &Awards for SBIR/STTR

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35%32%

31% 30%

34%

38%36%

34% 33%35% 34%

38%

32%29% 30% 29%

31%33% 34%

32% 32%35% 33% 34%

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

Percentage of New Applicant Companies and New Awardee Companies

%New Applicant Companies % New Awardee Companies

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Goal: to match quality biomedical research project applications with the interest of funding agencies Private foundations

Pharmaceutical companies

Biotechnology companies

How it works?

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Submit abstract to OnPAR via

website

Reviews for potential

match

Invited to submit

application (if match found)

Makes decision to

fund

Unfunded Applicants

Leidos Unfunded Applicants

Participating Funding Agencies

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Current Participating Funding Agencies/Members

Breast Cancer Foundation

Epilepsy Foundation

Parent Project Muscular Dystrophy

Cystinosis Research Foundation

Adenoid Cystic Carcinoma Research Foundation

National Alopecia Areata Foundation

Children Tumor Foundation

EB Research

Cure Alzheimer Fund

JDRF

Daiichi Sankyo (pharma)

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* Membership continually growing

Contact

For more information about OnPAR visit Online Partnership to Accelerate Research (OnPAR)

email [email protected]

NIH specific questions, email [email protected]

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SBIR/STTR Reauthorizationupdate

• Congress passed a 5 year SBIR/STTR Reauthorization as part of S.2943, the 2017 National Defense Authorization Act (NDAA)

• SBIR/STTR programs reauthorized for 5 year FY18 through FY22

• Simple, one line reauthorization• No pilot programs extended, all expire 9/30/17

o Direct Phase IIo Commercialization Readiness Pilot Program (SB1)o 3% Agency SBIR Admin fundso NIH Phase 0 Proof of Concept Centers

• Bills circulating in Congress as we speak on these and other areas. – Stay tuned.

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NIH SBIR/STTR FOAs

https://sbir.nih.gov/funding

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Solicitations and Due Dates

• NIH, CDC, FDA, & ACF SBIR/STTR Grant Solicitation “Parent” FOAs: SBIR: PA-17-302 STTR: PA-17-303Release: June 5, 2017Standard Due Dates: September 5th, January 5th

o These FOAs are being issued with limited due dates to accommodate the transition from FORMS-D to FORMS-E application packages.

o HHS expects to re-issue these Omnibus after the January 5, 2018 due date.

• SBIR Contract Solicitation (NIH, CDC) – Program Solicitation PHS 2018-1 (SBIR Only) NIH Guide Notice NOT-OD-17-089Release: July 18, 2017, Due date: October 20, 2017 5PM EDT

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


Institutes NOT accepting Clinical Trials under current Omnibus

• National Eye Institute (NEI)• National Human Genome Research Institute (NHGRI)• National Institute of Allergy and Infectious Diseases (NIAID)• National Institute of Arthritis, Musculoskeletal and Skin Diseases (NIAMS)• National Institute of Dental and Craniofacial Research (NIDCR)• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)• National Institute of Environmental Health Sciences (NIEHS)• National Institute of Neurological Disorders and Stroke (NINDS)• National Library of Medicine (NLM)• National Center for Advancing Translational Sciences (NCATS)• Division of Program Coordination, Planning and Strategic Initiatives, Office

of Research Infrastructure Programs (ORIP)• U.S. Food and Drug Administration (FDA)• If your proposed work includes an NIH-defined clinical trial that would be

assigned to one of these NIH Institutes/Centers, you should contact relevant program staff to discuss alternatives for support of those studies.

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Targeted SBIR/STTRFunding Opportunity Announcements

NIH Guide for Grants and Contracts

• High priority areas for ICs• Various IC participation• Nuances:

o Various due dateso Additional review criteriao Limited funds o Varying project periodso Etc

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http://sbir.nih.gov/funding#targeted


Omnibus vs Targeted FOAs

Omnibus TargetedDue Dates Standard Due Dates Standard or

Customized Due Dates

Review SBIR/STTR panels at CSR SBIR/STTR panels at CSRORSBIR/STTR panel at IC

Application Instructions

Follow SF424 R&RSBIR/STTR Application Guide & Annotated Form Set

Follow SF424 R&RSBIR/STTR Application Guide & Annotated Form SetANDany additional instructions in FOA

Read FOA very carefully!

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NIH SBIR/STTR3-Phase Program

Feasibility

Discovery

Phase I

Full R/D

Phase I Phase II

Fast-Track

$3M for up to 3 years

Development

Phase IICommercialization

Phase IIICompeting Renewal Award

Phase IIB

Only Some ICs Participate

Direct to Phase II


Commercialization Readiness Pilot (CRP)

Congressionalauthority expired

Congressionalauthority expired


NIH SBIR/STTRFast-Track

Feasibility

Discovery

Phase I

Full R/D

Phase I Phase II

Fast-Track


Development


Phase IIICompeting Renewal Award

Phase IIB

Additional R/D

Direct to Phase II

• Simultaneous submission and review of Phase I and II

• Phase I is awarded• Milestones/aims of Phase I

are assessed by program staff BEFORE Phase II is awarded

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Phase IIB CompetingRenewal Award

Discovery

Phase I


Development


Phase IIICompeting Renewal

Phase IIB

• SBIR/STTR Phase II awardee• Technologies that require extraordinary time/effort to develop,

and often require FDA regulatory approval• 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!


Electronic Submission

SBIR/STTR grant applications and SBIR contract proposals must be submitted electronically.

Registrations are required!!!

o DUNS Number (Company)

o System for Award Management (SAM)

o Grants.gov (Company)

o eRA Commons (Company and all PD/PIs)

o SBA Company Registry at SBIR.gov

• Helpful NIH Grants Registration Infographic

• For contracts, submit proposals with electronic Contract Proposal Submission (eCPS) website

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Submit via ASSIST

Adobe Forms going AWAY AFTER 1/5/18 deadline. Use ASSIST or Workspace.


Clinical Trials New Reforms & Initiatives

All Research Involving Human

Participants

New forms to collect human subjects information

Use of a single Institutional Review Board (IRB) for domestic multi-site studies

Research that Meets the NIH Definition of a Clinical Trial

Training in Good Clinical Practice (GCP)

Clinical trial-specific Funding Opportunity Announcements (FOAs)

New review criteria

Expanded registration and results reporting in ClinicalTrials.gov

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NIH Definition of a Clinical Trial

• Definition was clarified in October 2014

• Encompasses a wide range of types of trials, including:

o Mechanistico Exploratoryo Pilot/Feasibilityo Behavioral

• With broader definition, many more studies are classified as clinical trials

Notice: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html


NIH Definition of a Clinical TrialA research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

Learn more at https://grants.nih.gov/policy/clinical-trials/definition.htm

NIH Definition of a Clinical Trial

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WOSB and SDB Definitions

What is a Women-Owned Small Business (WOSB)?

• A firm must be at least 51% owned and controlled by one or more women, and primarily managed by one or more women (who must be US citizens)

• The firm must be “small” in its primary industry in accordance with SBA’s size standards for that industry

• SBCs self certify on the SF 424 (R&R) Form

What is a Socially and Economically Disadvantaged Business (SDB)?

• The firm must be 51% or more owned and control by one or more disadvantaged persons

• The disadvantaged person or persons must be socially disadvantaged and economically disadvantaged

• The firm must be small, according to SBA’s size standards

• You must self-certify by registering your business in the System for Award Management

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NIH Application & Review Process

Applicant initiatesresearch idea

Small Business Concern confirms eligibility

Submits SBIR/STTRgrant application toNIH electronically

NIH Center for Scientific Reviewassigns to IC and IRG

Scientific Review Group evaluates scientific merit

Advisory Council or Board recommend approval

IC staff prepare funding plan for IC Director

IC allocates funds

Grantee conductsresearch

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Timeline: New Applications

Sept 5

Jan 5

April 5

Oct/Nov

Feb/Mar

June/July

Jan/Feb

May/June

Aug

March

July

Sept or Dec

Due DateScientificReview

CouncilReview

Award Date(earliest)

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SBIR/STTR JIT Help Module

https://grants.nih.gov/grants/sbir_jitt/story.html


Checklist

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Identify Research Subjects


Option 1

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Most Important Piece of Advice

• Talk to an HHS Program Officer about your application and SUBMIT EARLY (days not hours and minutes)!

o Program Officer contact information found on the

HHS Agency Contact webpage

o Questions about who to contact? Email [email protected]

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NIH Technical Assistance Programs

Helping companies cross the “Valley of Death”

Phase I Phase II Phase III

Commercialization AcceleratorProgram (CAP)

Niche Assessment

Program (NAP)

Valley of

Death

Phase IIB

Market-Ready

Technology

Early-StageTechnology

?

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NIH Technical Assistance Programs

Niche Assessment Program Foresight S&T(Phase I awardees)https://sbir.nih.gov/nap

Commercialization Accelerator Program Larta, Inc.(Phase II awardees)https://sbir.nih.gov/cap

• Identifies other uses of technology

• Determines competitive advantages

• Develops market entry strategy

• “Menu” of technical assistance/training programs in:

o Strategic/business planning

o FDA requirements

o Technology valuation

o Manufacturing issues

o Patent and licensing issues

• Helps build strategic alliances

• Facilitates investor partnerships

• Individualized mentoring/consulting

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Investor Forum

Multi-IC Technology Development Programs (open to eligible Awardees from participating ICs)

I-CorpsTM at NIHAn intensive Entrepreneurial Immersion course for scientists

https://sbir.cancer.gov/programseducation/icorps

Facilitating Partnerships


More Information

Get Connected!

• Subscribe to the SBIR/STTR Listserv:

o Email [email protected] with the following text in the message body: subscribe SBIR-STTR your name

• NIH Guide for Grants and Contracts (weekly notification)

• Follow us on Twitter: @NIHsbir

• Read our NIH SBIR/STTR Notable Successes

• Connect with Us

• Email: [email protected]

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For More Information

Matthew Portnoy, PhD NIH SBIR/STTR Program Coordinator Phone: 301-435-2688Email: [email protected]

Robert VinsonSBIR/STTR Program ManagerPhone: 301-435-2713Email: [email protected]

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Patricia SwayneSBIR/STTR CommunicationsSpecialistPhone: 301-402-1632Email: [email protected]

Julie Beaver, MD, MSSBIR/STTR StatisticianPhone: 301-496-8807Email: [email protected]

JP Kim, JD, MBA, MScSBIR/STTR Program ManagerPhone: 301-435-0189Email: [email protected]

Documents

Overview of the HHS SBIR/STTR Program - CTSI