seminar 2: sbir and sttr: federal funding … 2: sbir and sttr: federal funding mechanisms for...
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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
• 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.
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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)
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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
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
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
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
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
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
Twitter @NHLBI_SBIR
Website www.nhlbi.nih.gov/funding/sbir
Listserv http://bit.ly/NHLBI-SBIR-Updates
36