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Seminar 2: SBIR and STTR: Federal Funding Mechanisms for Improving the Reach of Behavioral Science March 30, 2016 Patricia Weber, DrPH Program Director NCI SBIR Development Center @NCIsbir @NHLBI_SBIR

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Seminar 2:SBIR and STTR: Federal Funding Mechanisms

for Improving the Reach of Behavioral Science

March 30, 2016

Patricia Weber, DrPH

Program Director NCI SBIR Development Center

@NCIsbir@NHLBI_SBIR

No funding authority

Office of Research

Infrastructure Programs

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

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 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

Integrative Health

Fogarty

International

Center

National Center

for Advancing

Translational

Sciences

National

Library

of Medicine

National Institute

of Biomedical

Imaging and

Bioengineering

Office of the Director

NIH Clinical Center Center for Information

TechnologyCenter for Scientific Review

http://www.nih.gov/icd

National

Eye

Institute

National Institute

of Child Health

and Human

Development

3

• Provides seed funding for innovative technology development

• Provides recognition, verification and visibility

• Helps provide leverage in attracting additional funding or support

(e.g., venture capital, strategic partner)

Not a Loan

No repayment is required

Doesn’t impact stock or shares in any way (i.e., non-dilutive)

• Intellectual property rights retained by the small business

Reasons to Seek NIH Small Business Funding

44

Congressionally-Mandated Programs

Set Aside FY16

$877M annually at NIH

$137M annually at NCI

$95M annually at NHLBI

Small Business Innovation Research (SBIR)Set-aside program for small business concerns to engage in

Federal R&D with the potential for commercialization

Federal agencies with an extramural R&D budget > $100M

Small Business Technology Transfer (STTR)Set-aside program to facilitate cooperative R&D between small

business concerns and U.S. research institutions with the

potential for commercialization

Federal agencies with an extramural R&D budget > $1B

5

3.0%

0.45%

$31 BillionBasic and applied biomedical science

$877 MillionNon-dilutive funding just for small businesses

$137M annually at NCI

$95M annually at NHLBI

Small Business Mission and Program Goals

Both Small Business Innovation Research (SBIR) and

Small Business Technology Transfer (STTR) programs

Stimulate technological innovation.

Increase private-sector commercialization of innovations derived from

Federal R&D funding.

Small Business Innovation Development Act of 1982

Small Business Technology Transfer Act of 1992

SBIR STTR

• Meet Federal R&D needs.

• Foster and encourage

participation in innovation and

entrepreneurship by socially and

economically disadvantaged

persons.

• Foster technology transfer

through cooperative R&D

between small businesses and

research institutions.

7

Small Business Innovation Research (SBIR) vs.

Small Business Technology Transfer (STTR)

SBIR STTR

Program

Size 3.0% set aside 0.45% set aside

Partnering

Requirement

Permits partnering Requires a non-profit research

institution partner

Principal

Investigator

Primary employment (>50%)

must be with the small

business

PI may be employed by either

the research institution partner or

small business

Work

Requirement

Guidelines: May outsource up

to 33% (Phase I), 50% (Phase

II)

Minimum Work Requirements:

40% Small Business

30% Research Institution Partner

VC

Ownership

Majority ownership by

multiple VC ok; No single VC

majority ownership

Not allowed to be majority

owned by VC (single or multiple)

Award is always made to the small business

Phase IIICOMMERCIALIZATION

Phase IIDEVELOPMENT

Phase IFEASIBILITY

Phase II

•Research & Development• Commercialization plan required• $1.5 million over 2 years

• Commercialization stage• Use of non-SBIR/STTR funds

Fast Track ApplicationCombined Phase I & II

SBIR & STTR: Three-Phase Program

Phase I

•Proof-of-Concept study• $225,000 over

6 months (SBIR) or 1 year (STTR)

Direct to Phase II

(Skip Phase I)

9

Discovery Manufacturing/Delivery

Product Design

Proof of Concept

Product Development

Founder

Friends & Family

Angels

Angel Groups

Seed Funds

Venture Funds

Institutional Equity

Loans/Bonds

SBIR Ph I SBIR Ph II NCI & NHLBI Ph IIB Bridge SBIR Ph IIICROSSING THE

VALLEY OF DEATH

I-Corps @ NIH

Niche Assessment Program

Commercialization Assessment Program

Non-Federal Funds

Fast Track

Direct to Phase II(skip Phase I)*

10

SBIR & STTR: Three-Phase Program

Funding Opportunities

Investigator Initiated Grants

Omnibus Solicitations

Targeted Grant Funding Opportunities

Variety of topics, release and receipt dates

Contract Funding Opportunities

Annual NIH & CDC SBIR Contract Solicitation

Application process different from grants

11

$

12

Investigator-Initiated Grants

We encourage applications for any topic within the NIH mission

Read the “Program Descriptions and Research Topics”

Due January 5, April 5, September 5

• Omnibus Solicitations (Phase I, Phase II, FastTrack)• PA-15-269 (SBIR) and PA-15-270 (STTR)

• Direct to Phase II Solicitation• PAR-14-088 (SBIR only)

2007 2008 2009 2010 2011 2012 2013 2014 2015

17%

25% 24%

33%35%

31%

24%

SBIR Contracts vs. Grants

SBIR Grants SBIR Contracts

Scope of the proposal Investigator-defined within NIH mission Defined (narrowly) by the NIH

Receipt Dates 3 times/year for Omnibus Only ONCE per year

Peer Review Locus NIH Center for Scientific Review (CSR)At the Institute (NCI / NHLBI)

(target 50% business reviewers)

Basis for AwardPeer review score/ Program

assessment

Peer review score/negotiation of

technical deliverables, budget

ReportingOne final report (Phase I);

Annual reports (Phase II)

Kickoff + Final presentation

Quarterly progress reports

Final report and Commercial Plan

Program Involvement Low High

NCI SBIR contracts(thousands)

% of total NCI SBIR

Fiscal Year

$38,174

13%

8%

$37,418

$29,257

NIH/NCI 342: Validation of Mobile Technologies for Clinical Assessment, Monitoring, and Intervention

Budget: Phase I $225,000 for 9 months; Phase II $1.5M for 2 yearsNumber of Anticipated Awards: 2-3Phase I proposals not accepted. Fast-Track proposals not accepted.Direct-to-Phase-II proposals accepted.

Goal: support validation of mobile technologies for clinical assessment, screening, diagnostics, monitoring or intervention delivery focused on cancer prevention, and control objectives. This topic in not intended to support the development of new technologies.

Responses to this topic are expected to address one or more of the following areas of mobile/wireless health research:• Evaluation of the reliability of mobile screening, diagnostic, assessment or

monitoring technologies & methods• Evaluation of the validity of mobile screening, diagnostic, assessment or monitoring

technologies & methods• Evaluation of the efficacy and effectiveness of mobile technology and systems for

behavioral analytics, clinical decision support, or intervention delivery.

What is NIH Looking for?

Innovative solution to significant unmet need

Solution that has significant commercial potential

Projects that leverage company/founder expertise

Start-up company too early for private investment

Established small business pursuing a new project

Case: Chrono Therapeutics

SmartStop™The world’s first programmable nicotine replacement therapy

Personalized Treatment• Synchronized with cravings• Offers a higher dosage before cravings• Easy compliance -- automated optimal delivery and behavioral

support

NCI’s SBIR/STTR Portfolio

17

Therapeutics39%

Devices for Cancer Therapy

7%

Imaging19%

In Vitro Diagnostics21%

Tools for Basic Research

8%

Health IT & Software Tools

6%

Program Staff

Andrew J. Kurtz, PhD

Lead Program Director

Biologics, Small Molecules, Nanotherapeutics,

Molecular Diagnostics, Bridge Award

Greg Evans, PhD

Lead Program Director

Cancer Biology, E-Health, Epidemiology, Research

Tools

Michael Weingarten, MA

Director

NCI SBIR Development Center

Jian Lou, PhD

Program Director

In-Vitro Diagnostics, Theranostics, early-stage drug

development , Bioinformatics, FRAC Workshop

Todd Haim, PhD

Program Director

Small Molecules, Biologics, Immunotherapeutics,

Theranostics, SBIR Investor Forum, FRAC Workshop

Patricia Weber, DrPH

Program Director

Digital Health, Therapeutics, Biologics, SBIR

Investor Forum, FRAC Workshop

Deepa Narayanan, MS

Program Director

Cancer Imaging, Clinical Trials, Radiation Therapy, SBIR

Investor Forum, FRAC Workshop

Amir Rahbar, PhD, MBA

Program Director

In-Vitro Diagnostics, Biologics, Therapeutics, Proteomics,

SBIR Investor Forum

Ming Zhao, PhD

Program Director

Cancer Diagnostics & Therapeutics, Cancer Control &

Prevention, Molecular Imaging, Bioinformatics,

Stem Cells

Christie Canaria, PhD

Program Manager

Cancer/Biological Imaging, Research Tools, Devices,

Scientific Communications, and I-Corps at NIH

Jonathan Franca-Koh, PhD, MBA

Program Director

Cancer Biology, Biologics, Small Molecules, Cell Based

Therapies

Kory Hallett, PhD

AAAS Science & Technology Policy Fellow

Monoclonal Antibodies, Immunotherapy, Biologics, and

Program Analysis

[email protected] @NCIsbir

NCI SBIR Development Center

[email protected]

Phone: 240.276.5300

http://sbir.cancer.gov

Patricia Weber, [email protected]

@NCIsbir

Small Business Funding &

Resources at NHLBI & NIH

Jennifer C. Shieh, PhD Small Business Coordinator, NHLBI

[email protected]

Office of Translational Alliances and Coordination

Division of Extramural Research Activities

@NHLBI_SBIR

#4

Stroke

Health Challenges in the NHLBI Mission

#3

Chronic Lung

Disorders

#1

Heart Disease

National Vital Statistics Reports (CDC) Vol. 61(6) October 10, 201221

Disability

Quality of life

$350 Billion

Find Funding Opportunities

22

http://bit.ly/NHLBI-SBIR-funding

Funding Opportunities

Investigator Initiated Grants

Omnibus Solicitations

Targeted Grant Funding Opportunities

Variety of topics, release and receipt dates

Contract Funding Opportunities

Annual NIH & CDC SBIR Contract Solicitation

Application process different from grants

23

$

Small Business Topics of Special Interest

http://bit.ly/NHLBI-SBIR-TOSI

24

HLS16-05 E-medicine Apps for patients and medical

professionals to improve the management of and reduce the

impact of non-malignant blood diseases

HLS16-12 Develop smart phone apps and other

communication tools to increase accessibility and evaluation

of the latest educational materials and trial research on

cardiovascular, nutritional and physical activity information for

medical professionals and patients (English and non-English

speakers)

HLS16-17 Develop innovative technology and/or service

delivery model or design targeted at increasing the

adoption, uptake, and sustainability of evidence-based

guideline recommendation for the management of heart, lung,

blood, and sleep disorders, that include multi-level (health

systems, provider, and patient) facets and benefit ethnic/racial

minority groups, rural populations, and low socioeconomic

groups.

25

Examples of Recent NHLBI Contract Topics

073 Evaluating Obstructive Sleep Apnea Dental Device

Treatment Compliance

Goals: Adapt therapeutic oral appliances used to maintain an open

airway during sleep with electronic and sensor technologies to

quantitatively monitor and evaluate patient adherence and the

effectiveness of treatment.

086 Tools for Educating Children about Clinical Research

Goals: To develop innovative and validated tools tailored to children

that will increase awareness of pediatric clinical research among

children and adolescents; enhance knowledge, empathy and

acceptance of pediatric research participants; and educate about

general clinical research information in an engaging, culturally

sensitive and age-appropriate way.

Collaborative Aging (in Place) Research

using Technology (CART)

http://www.nhlbi.nih.gov/research/reports/trans-nihinteragency-workshop-use-and-

development-assistive-technology-aging-population-and-people

27

Gary Robinson Business Development Advisor

Steve Flaim Investor-In-Residence

Chris Sasiela Regulatory Strategist

Jennifer Shieh Small Business Coordinator

Kurt MarekDeputy Director

Eric PadmoreProgram Analyst

Jodi BlackActing Director (2011-2015)

Kathleen RouscheNCAI Program Director

Office of Translational Alliances and Coordination (OTAC)

Matt McMahonDirector

Ethel Rubin Entrepreneur-In-Residence

http://www.nhlbi.nih.gov/otac

28

Gary Robinson Business Development Advisor

Steve Flaim Investor-In-Residence

Chris Sasiela Regulatory Strategist

Jennifer Shieh Small Business Coordinator

Advisory Experts at NHLBI:

Not Your Typical NIH Office

Ethel Rubin Entrepreneur-In-Residence

[email protected]

http://bit.ly/SmallBizHangouts

29

Regulatory

Navigating the FDA Website

"First Contact" with FDA

Finding the Right Regulatory Consultant

Developing a Target Product Profile

Commercialization

Writing your Phase II Commercialization Plan -

http://bit.ly/Ph2CommPlanHangout

Identifying and Connecting With Your Customer

How Pharma Evaluates New Therapeutic Opportunities

Intellectual Property

Intellectual Property Basics for the New Innovator

Making Your Mark: The Use and Care of Trademarks

Patent Litigation: Basics, Defense, and Offense – Parts 1 & 2

Fast-Track,

Phase II,

Direct to Phase II

“We’re scaling up the National Science Foundation’s successful Innovation Corps program at six more federal agencies so we can help more of our scientists move their ideas out of the lab and into the marketplace.”

– President Obama (August 4, 2015)

https://www.whitehouse.gov/the-press-office/2015/08/04/remarks-president-white-house-demo-day

White House Demo Day

From I-Corps™ at NIH

31

From I-Corps™ at NIH

32

“ Product-Market Fit ”

NIH SBIR Investor Forums (National)

20

UCI Applied Innovation

Irvine, CA

Financial support and mentoring for awardees

presenting at investor and partnering events

Innovation Showcase Partnerships

2016

2015

2015

20152016

34

1. http://sbir.nih.gov

2. Read the FOA

3. Search Previous Awards

http://projectreporter.nih.gov

4. Contact SBIR Program Staff Early

5. Register Early

6. Understand Review

http://csr.nih.gov

7. Read the SF424 Application Guide

7 Tips on Applying

35

Thank you

[email protected]

Twitter @NHLBI_SBIR

Website www.nhlbi.nih.gov/funding/sbir

Listserv http://bit.ly/NHLBI-SBIR-Updates

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