Introduction to SBIR and STTR Funding...
Transcript of Introduction to SBIR and STTR Funding...
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Introduction to SBIR and STTR Funding Opportunities
FreeMind Group WebinarMeytal WaissFebruary 24, 2016
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FreeMindGroup
@FreeMindGrp
February 24, 2016
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FreeMind Group
FreeMindGroup, LLC Est. 1999
55 Fulltime Employees
Diverse Client Base:
• Academics, University Medical Centers, and Independent Research Institutes
• Industry – Small Startups to Large Pharmaceutical Companies.
~400 Applications Annually
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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
A Tool to Max. Your Funding Potential
FreeMindGroup, LLC
Non-Dilutive Funding – A Strategic Financial Tool
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In this webinar
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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 many SBIR and STTR funding opportunities
Other interesting information
on the SBIR and STTR mechanisms
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Dollars Awarded
Some Interesting Statistics
$50B allocated annuallyto fund the life sciences
The majority of that comes from the NIH
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NIH 2016 Budget - $32.31B
Adapted from the NIH Data Book, www.report.nih.gov
Research Projects $17,820,973
55%
Research Centers $2,644,811
8%
Other Research $2,010,924
6%
Training $830,430
3%
Research & Develop. Contracts $2,995,825
10%
Intramural Research $3,581,878
11%
Res. Management & Support 1,692,585
5%
All others $733,9232%
~$27,000,000,000
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Categorical Spending
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Adapted from the NIH Data Book, www.report.nih.gov
Cancer - ~$6BNeurosciences - ~$6BInfectious Diseases - ~$4B
~$27,000,000,000
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SBIR & STTR Programs
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Congressionally-mandated set-aside programs (SBIR 3.1% 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
SBIR / STTR Programs
February 24, 2016
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SBIR & STTR Mission & Goals
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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
February 24, 2016
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SBIRFuel growth in private sector And commercialization of innovations
STTRStimulate a partnership of ideas & technologies between innovative SBCs and non-profitresearch institutions
February 24, 2016
Purpose
SBIR vs. STTR
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SBIR / STTR Eligibility
Only US small businesses are eligibleand must meet all of the following:
For profit organizations
Located in the United States
No more than 500 employees
At least 51 percent US owned
VC backing: Either multiple or none
Must meet eligibility criteria at the time of award!
Requirements
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SBIR vs. STTR
SBIRPI must be primarily employed with the SBC
Permits (encourages) research partnerships
STTRPrimary employment of the PI is not stipulated
Requires formal collaborationwith a non-profit research institution
February 24, 2016
Requirements
Must meet eligibility criteria at the time of award!
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NIH Phased Program
February 24, 2016
Phase IIPhase I
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NIH Phased Program
Phase I Establish the technical merit, feasibility and commercial potential of the proposed R&D efforts
Awards for: SBIRs normally do not exceed $225K total costs over 6 monthsSTTRs normally do not exceed $225K total costs over 1 year
SBIR / STTR Phase I
February 24, 2016
Phase IIPhase I
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NIH Phased Program
Phase IITo continue the R&D efforts initiated in Phase IAwards 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
SBIR / STTR Phase II
February 24, 2016
Phase IIPhase I
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NIH Phased Program
February 24, 2016
Phase II
Phase IIBCompeting renewal to bridge Phase IIand commercialization
Phase IIB
Phase I
SBIR / STTR Phase IIB
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NIH Phased Program
February 24, 2016
Phase IIPhase I Fast-Track
Fast-Track Award
Both Phase I and Phase II grant applications are submitted and reviewed togetheras one application
The NIH Fast-Track mechanism can reduce or eliminate the funding gap between phases
SBIR / STTR Fast-Track
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Phased Program
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Direct to Phase IIReceive Phase II award even if they have not previously received a Phase I award
Must have performed the Phase I stage-type of research
Only SBIRs
SBIR Direct to Phase II
February 24, 2016
Phase IIPhase I
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Important SBIR & STTR Dates
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Due DatesPhase I and Phase II
Estimated AwardDate
April 5 September (2016)
September 5 April (2017)
January 5 July (2017)
Dates
* Some have non-standard due dates
February 24, 2016
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Some Interesting Statistics
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Awarded domestic, for-profit organizations
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Funding Opportunities
Funding Routes1. Solicited –
Address a specific area of interest
2. Unsolicited –Investigator Initiated
12549 awards7610 unsolicited
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SBIR / STTR Funding Opportunities
Next Application
Deadline:April 5th
NIH, CDC, FDA, ACF
February 24, 2016
Parent Announcements
Omnibus Solicitation of the NIH, CDC, FDA and ACF for Small Business Innovation Research Grant Applications (Parent SBIR PA-15-269)
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 Grant Applications (Parent STTR PA-15-270)
Phase I: up to $225,000 up to 1 year
Phase II: up to $1.5 million up to 2 years
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SBIR / STTR Funding Opportunities
NIH
Next Application
Deadline:April 5th
February 24, 2016
NIHParent Announcements
Direct Phase II SBIR Grants to Support Biomedical Technology Development(Parent SBIR PA-14-088)
Funding is up to $1.5 million over up to 2 years
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NSF SBIR/STTR Programs
Industrial Innovation and Partnerships(Parent SBIR Phase I NSF 14-603)
Funding: Phase I up to $150K for 6 monthsPhase 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 SMCs 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: http://www.nsf.gov/eng/iip/sbir/topics/Combined.pdf
Application Window:
JuneDecember
NSF
February 24, 2016
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NSF SBIR Program Summary
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STTRSBIR
June 2016
December 2016
June 2016
December 2016
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
February 24, 2016
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
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Grants vs. Contracts
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Funding Solicitations for
SBIR Grants
Funding Solicitation for
SBIR Contracts Scope of the proposal Investigator-defined
within the mission of NIH
Defined by the NIH (focused)
Questions during solicitation
period?
May speak with any Program
Officer
MUST contact the contracting officer
Receipt Dates 3 times/year for Omnibus Only ONCE per year
Basis for Award Based on score during peer review If proposal scores well during peer
review, must then negotiate to
finalize deliverables with NIH
Reporting One final report (Phase I);
Annual reports (Phase II)
Monthly or quarterly progress
reports
Set-aside of funds
for particular areas? NO YES
Solicitation of the NIH & CDCfor SBIR Contract Proposals
http://grants.nih.gov/grants/funding/SBIRContract/PHS2015-1.pdf
Application Deadline:April 5th
February 24, 2016
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Solicited
Solicited SBIR/STTR Opportunities
88 open solicitations
in the SBIR/STTR Programs across the NIH!
Examples:
Small Business Alzheimer's Disease Research (R43/R44)
Building Complex 3-Dimensional in Vitro Human Musculoskeletal and Skin Tissue Models (R43)
Imaging Diagnostics of Dental Diseases and Conditions (Caries, Periodontal Disease, Cracked
Teeth, and Pulp Vitality) (R43/R44)
Investigational New Drug (IND)-enabling Development of Medications to Treat Alcohol Use
Disorder and Alcohol-related Disorders (U44)
Novel Tools for Investigating Brain-derived GPCRs in Mental Health Research (R43/R44)
New Technologies for Viral Hepatitis STTR (R41/R42)
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Challenges
Major Challenges in Preparing SBIR/STTR Applications
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
February 24, 2016
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Risk Management
NIH Review Process
Scientific Approach
Leadership
Environment
Significance
Innovation
Risk
Strength
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What Next?
Strategic Choices Beyond SBIR/STTR
SBIR/STTR is a great mechanismand is considered by many as a gateway to larger awards
Submit as many as you can to increase your likelihood for success(no less than 3 and upwards of 6 )
Tap additional pockets of non-dilutive money(RO1, R21, U01, BAA etc.)
February 24, 2016
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Key Issues
Maximizing your Chances
Know the interests of the Agency
Present a complete, focused project
Ask for what is necessary
Leverage on research collaborations
Systematic Approach
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Key Issues
Maximizing your Chances
Different “pockets of money”
Different size of award/success rates
Conduct a thorough strategic assessment
Multi-Submission Granting Strategy
Target the Right Mechanism
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FMG Professional Process
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Core Service 1- Strategic Assessment
Long term Strategic approach Outline projects Tasks to be completed Link with existing pockets of money Solicited vs. Unsolicited Map of relevant funding opportunities
Core Service 2- Project Production Process
Project Management - coordinating Comprehensive templates Ongoing feedback and edits Budgets Converge information Final outcome – single coherent presentation
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Contact Us!
Thank you!
Meytal WaissDirector, Business Development
(617) 648-0340 ext. 215
www.freemindconsultants.com
FreeMindGroup FreeMindGrp