introduction to sbir and sttr funding opportunities · • nih strokenet small business innovation...
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FreeMindGroup
@FreeMindGrp
FreeMind Group
Introduction to SBIR and STTRFunding Opportunities
Shira Aharoni Machluf
Director, Business Development
July 5, 2017
FreeMind Group, LLCJuly 5, 2017 2
FreeMind Group
FreeMind Group, LLC
Est. 1999
60 Fulltime Employees
Diverse Client Base:
• Academics, University Medical Centers, and Independent Research Institutes
• Industry – Small Startups to Large Pharmaceutical Companies
~500 Applications Annually
FreeMind Group, LLCJuly 5, 2017 3
A Tool to Maximize Your Funding Potential
FreeMind Group, LLC
• Identify the most relevant funding opportunities
• Strategize to maximize the application’s chance of success
• Manage complex project production processes
• Lead joint application writing
• Support final contract negotiations
Non-Dilutive Funding – A Strategic Financial Tool
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Adapted from the NIH Data Book, www.report.nih.gov
NIH 2017 Budget - $34B
$28,000,000
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Categorical Spending
Adapted from the NIH Data Book, www.report.nih.gov
Cancer - ~$6BNeurosciences - ~$6BInfectious Diseases - ~$4B
FreeMind Group, LLC
Small Business Innovation Research (SBIR)
Small Business Technology Transfer (STTR)
Features of the SBIR and STTR programs (Differences and similarities)
Eligibility criteria for SBIR and STTR applicants
Review various SBIR and STTR funding opportunities
Additional interesting information on the SBIR and STTR mechanisms
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SBIR / STTR
FreeMind Group, LLC
Congressionally-mandated set-aside programs (for 2017 SBIR 3.2% and STTR 0.45% of the budget).
• For domestic small business concerns (SBCs)
(see: www.sba.gov/size)
• Engage in R&D
• Potential for commercialization
The DoD, CDC, FDA, and NSF also have SBIR & STTR programs.
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SBIR & STTR Programs
SBIR / STTR Programs
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Mission
“To support scientific excellence & technological innovation through the investment of Federal research funds in critical American priorities to build a strong national economy.”
Goals
• Stimulate technological innovation
• Meet Federal R&D needs
• Commercialization of innovations
• Small business growth & development
• Socially and economically disadvantaged SBCs and women-owned business
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SBIR & STTR Mission and Goals
FreeMind Group, LLC
SBIR
• Fuel growth in private sector
• Commercialization of innovations
STTR
• Stimulate a partnership of ideas and technologies between innovative SBCs and non-profit research institutions
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SBIR vs. STTR
Purpose
FreeMind Group, LLC
Only US small businesses are eligible and must meet
all of the following:
• For profit
• Located in the United States
• No more than 500 employees
• At least 51 percent US owned
• VC / Private Equity ownership ok, as long as no one owns more than 50%
July 5, 2017 10
SBIR & STTR Requirements
Requirements
FreeMind Group, LLC
SBIR
• PI must be primarily employed with the SBC
• Permits (encourages) research partnerships
STTR
• Primary employment of the PI is not stipulated
• Requires formal collaboration with a non-profit research institution
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SBIR vs. STTR
Requirements
Must meet eligibility criteria at the time of award!
FreeMind Group, LLC
Phase I
• Establish the technical merit, feasibility and commercial potential of the proposed R&D efforts
• Proof-of-Concept
Awards for:
SBIRs normally do not exceed $225K total costs for 6 months
STTRs normally do not exceed $225K total costs for 1 year
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NIH Phased Program
SBIR / STTRPhase I
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Phase II
• To continue R&D efforts initiated in Phase I
• Commercialization plan required
Awards for:
SBIRs normally do not exceed $1.5M total costs over 2 years
STTRs normally do not exceed $1.5M total costs over 2 years
July 5, 2017 13
NIH Phased Program
SBIR / STTRPhase II
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Phase IIB or Phase IIB Bridge Award
• To address the funding gap, known as the "Valley of Death," between the end of the Phase II award and the subsequent round of financing needed for commercialization
July 5, 2017 14
NIH Phased Program
SBIR / STTRPhase IIB
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Direct to Phase II SBIR
• Receive Phase II award even if they have not previously received a Phase I award
• Must have performed work equivalent to a Phase I
• Not available for STTRs
July 5, 2017 15
NIH Phased Program
SBIRDirect to Phase II
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Fast-Track Award
• Both Phase I and Phase II grant applications are submitted and reviewed together as one application
• The NIH Fast-Track mechanism can reduce or eliminate the funding gap between phases
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NIH Phased Program
SBIR / STTRFast Track
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NEW TIMELINE GOAL: Funding of > 50% of applications within 6 months!
* Some mechanisms have non-standard due dates
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Important NIH SBIR / STTR Dates
Dates Due DatesPhase I and Phase II
Estimated AwardDate
January 5 July
April 5 Sept or Dec
September 5 March (2018)
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Funding Routes
1. Solicited –
Address a specific area of interest
2. Unsolicited –
Investigator Initiated
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Funding Opportunities
2016 NIH Total Awards
Unsolicited % Unsolicited
1,847 1,244 67%
$817.7m $521.9m 64%
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Parent AnnouncementsOmnibus Solicitation of the NIH, CDC, FDA, and ACF for Small Business Innovation Research Grant Applications
(Parent SBIR PA-16-302)
Phase I: Up to $225,000 up to 6 months
Phase II: Up to $1.5 million up to 2 years
Omnibus Solicitation of the NIH for Small Business Technology Transfer Research Grant Applications
(Parent STTR PA-16-303)
Phase I: Up to $225,000 up to 1 year
Phase II: Up to $1.5 million up to 2 years
July 5, 2017 19
SBIR / STTR Funding Opportunities
NIH, CDC,FDA, ACF
Next Application Deadlines:
September 5
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NSF SBIR / STTR
NSF
Deadlines:December, June
Directorate for Engineering, Industrial Innovation and Partnerships
(Parent SBIR Phase I NSF 17-544)
Funding: Phase I up to $225K for 6-12 months
Phase II up to $750K over 2 years
Scope: Early-stage R&D, for small businesses, based on innovative,
transformational technology with potential for great commercial and/or societal
benefits. The program invites proposals from SBCs across a broad range of
science and engineering disciplines.
Selected Topics: Advanced Materials and Instrumentation (MI), Biological
Technologies (BT), Smart Health (SH), Biomedical Technologies (BM)
See: https://www.nsf.gov/pubs/2017/nsf17544/nsf17544.pdf
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NSF SBIR Program Summary
STTRSBIR
December 2017
June 2018
December 2017
June 2018
Deadline
Phase I: $225K, 12 months
Phase II: $750K, 2 years
Phase I: $150K, 6 months
Phase II: $750K, 2 years
Funding
Minimum 2 calendar months* on
the project
Minimum 1 calendar month* on
the project
PI
Feasibility and commercialization planPhase I
Prototype developmentPhase II
not availablenot availableFast track
*Calendar Month= Amount of time dedicated to working on this project 10% over 12 months = 1.2 calendar months; 10% over 6 months = 0.6 calendar months
FreeMind Group, LLC
Currently, 79 open SBIR/STTR solicitations from the NIH
Examples:
• NIDDK Exploratory Clinical Trials for Small Business (R44)
• NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44)
• Development and Commercialization of Technologies to Create, Characterize or Improve Animal Models of Human Disease (R43/R44)
• Novel Genomic Technology Development (R43/R44)
• New Technologies for Viral Hepatitis STTR (R41/R42)
• Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System (U44)
• NIH StrokeNet Small Business Innovation Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U44)
• Novel Tools for Investigating Brain-derived GPCRs in Mental Health Research (R41/R42)
• Advancing Research on Alzheimer's Disease (AD) and Alzheimer's-Disease-Related Dementias (ADRD) (R41/R42)
July 5, 2017 22
Solicited SBIR / STTR Opportunities
Solicited
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• Overcoming limitations of the SBIR/STTR program – virtual companies
SBIR Phase I at least 67% in house
Phase II at least 50% in house
STTR 40% by Company and
30% by Academic collaborator
• Product development driven – Milestones!
• Atypical Sections: Commercialization plan, Consortium,
multi PI, etc.
• One consolidated, coherent, and responsive application
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Major Challenges in Preparing SBIR / STTR Applications
Challenges
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NIH Review Process
Risk Management
Scientific Approach
Leadership
Environment
Significance
Innovation
Risk
Strength
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Turn NDF into a Strategic Source of Funding
Strategic Approach
Maximize the Company’s
Funding Potential
VCs
NDFAngels
FreeMind Group, LLC
Systematic Approach
Conduct a thorough strategic assessment
Identify ALL relevant funding opportunity
Seek insight into the interests and goals of the funding agencies
Correlate the granting strategy with your long term R&D plan
Target the Right Mechanism
Different “pockets of money”
Different size of award/success rates
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Maximize Your Chances for Award
Strategic Approach
NDF
Plan and execute a long-term,
multi-submission granting
strategy
FreeMind Group, LLC
Lower the Risk
Know your weaknesses
Find the right partners (if necessary)
Know the interests of the agency/mechanism
Address the “non-important” admin parts
Establish yourself both as a top researcher as well as an experienced manager
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Maximizing Your Chances for Award
Risk Management
NDF
FreeMind Group, LLC
Maximize Funding Potential
July 5, 2017 28
FreeMind Group, LLC
What do we do?
1. Identify ALL relevant funding opportunities
2. Create a multi-submission granting strategy
3. Submit as many top quality applications as possible
FreeMind Group, LLCJuly 5, 2017 29
Thank you!
Contact Us!
Watch past presentations and webinars online on our YouTube Channel
Join our LinkedIn network and follow us on Twitter for updates and announcements relating to non-dilutive funding
www.freemindconsultants.com
FreeMindGroup
@FreeMindGrp
FreeMind Group
Shira Aharoni MachlufDirector, Business Development
+1 (617) 648-0340 ext 285