Introduction to SBIR and STTR Funding Opportunities

Transcription

1 @FreeMindGrp FreeMindGroup Introduction to SBIR and STTR Funding Opportunities FreeMind Group Webinar Meytal Waiss 1/34

2 FreeMind Group FreeMind Group, LLC Est Fulltime Employees Diverse Client Base: Academics, University Medical Centers, and Independent Research Institutes Industry Small Startups to Large Pharmaceutical Companies. ~400 Applications Annually 2/34

3 A Tool to Max. 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 3/34

4 In this webinar 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 4/26

5 Some Interesting Statistics Dollars Awarded $50B allocated annually to fund the life sciences The majority of that comes from the NIH 5/34

6 NIH 2016 Budget - $32.31B Res. Management & Support 1,692,585 5% All others $733,923 2% Intramural Research $3,581,878 11% Research & Develop. Contracts $2,995,825 10% Research Projects $17,820,973 55% Training $830,430 3% Other Research $2,010,924 6% ~$27,000,000,000 Research Centers $2,644,811 8% Adapted from the NIH Data Book, 6/34

7 Categorical Spending Cancer - ~$6B Neurosciences - ~$6B Infectious Diseases - ~$4B ~$27,000,000,000 Adapted from the NIH Data Book, 7/34

8 SBIR & STTR Programs SBIR / STTR Programs Congressionally-mandated set-aside programs (SBIR 3.1% and STTR 0.45% of the budget) For domestic small business concerns (SBCs) (see: Engage in R&D Potential for commercialization 8/34

9 SBIR & STTR Mission & Goals 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 9/34

10 SBIR vs. STTR Purpose SBIR Fuel growth in private sector And commercialization of innovations STTR Stimulate a partnership of ideas & technologies between innovative SBCs and non-profit research institutions 10/34

11 SBIR / STTR Eligibility Requirements Only US small businesses are eligible and 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! 11/34

12 SBIR vs. STTR Requirements 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 Must meet eligibility criteria at the time of award! 12/34

13 NIH Phased Program Phase I Phase II 13/34

14 NIH Phased Program SBIR / STTR Phase I 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 months STTRs normally do not exceed $225K total costs over 1 year Phase I Phase II 14/34

15 NIH Phased Program SBIR / STTR Phase II Phase II To continue the R&D efforts initiated in Phase I 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 Phase I Phase II 15/34

16 NIH Phased Program SBIR / STTR Phase IIB Phase IIB Competing renewal to bridge Phase II and commercialization Phase I Phase II Phase IIB 16/34

17 NIH Phased Program SBIR / STTR Fast-Track 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 Phase I Fast-TrackPhase II 17/34

18 Phased Program SBIR Direct to Phase II Direct to Phase II Receive 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 Phase I Phase II 18/34

19 Important SBIR & STTR Dates Dates Due Dates Phase I and Phase II Estimated Award Date April 5 September (2016) September 5 April (2017) January 5 July (2017) * Some have non-standard due dates 19/34

20 Some Interesting Statistics Awarded domestic, for-profit organizations 20/34

21 Funding Opportunities Funding Routes 1. Solicited Address a specific area of interest 2. Unsolicited Investigator Initiated awards 7610 unsolicited 21/34

22 SBIR / STTR Funding Opportunities NIH, CDC, FDA, ACF Next Application Deadline: April 5 th Parent Announcements Omnibus Solicitation of the NIH, CDC, FDA and ACF for Small Business Innovation Research Grant Applications (Parent SBIR PA ) 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 ) Phase I: up to $225,000 up to 1 year Phase II: up to $1.5 million up to 2 years 22/34

23 SBIR / STTR Funding Opportunities NIH Next Application Deadline: April 5 th Parent Announcements Direct Phase II SBIR Grants to Support Biomedical Technology Development (Parent SBIR PA ) Funding is up to $1.5 million over up to 2 years 23/34

24 NSF SBIR/STTR Programs NSF Application Window: June December Industrial Innovation and Partnerships (Parent SBIR Phase I NSF ) Funding: Phase I up to $150K for 6 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 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: 24/38

25 NSF SBIR Program Summary Deadline Funding PI Phase I Phase II Fast track SBIR June 2016 December 2016 Phase I: $150K, 6 months Phase II: $750K, 2 years Minimum 1 calendar month on the project STTR June 2016 December 2016 Phase I: $225K, 12 months Phase II: $750K, 2 years Minimum 2 calendar months on the project Feasibility and commercialization plan not available Prototype development not available 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 25/34

26 Grants vs. Contracts Application Deadline: April 5 th Solicitation of the NIH & CDC for SBIR Contract Proposals Scope of the proposal Questions during solicitation period? Funding Solicitations for SBIR Grants Investigator-defined within the mission of NIH May speak with any Program Officer Funding Solicitation for SBIR Contracts Defined by the NIH (focused) 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 Set-aside of funds for particular areas? One final report (Phase I); Annual reports (Phase II) NO Monthly or quarterly progress reports YES 26/34

27 Solicited SBIR/STTR Opportunities Solicited 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) 27/34

28 Major Challenges in Preparing SBIR/STTR Applications Challenges 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 28/34

29 NIH Review Process Risk Management Leadership Innovation Scientific Approach Environment Risk Strength Significance 29/34

30 Strategic Choices Beyond SBIR/STTR What Next? SBIR/STTR is a great mechanism and 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.) 30/34

31 Maximizing your Chances Key Issues Systematic Approach Know the interests of the Agency Present a complete, focused project Ask for what is necessary Leverage on research collaborations 31/34

32 Maximizing your Chances Key Issues Target the Right Mechanism Different pockets of money Different size of award/success rates Conduct a thorough strategic assessment Multi-Submission Granting Strategy 32/34

33 FMG Professional Process 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 33/35

34 Thank you! Contact Us! Meytal Waiss Director, Business Development (617) ext FreeMindGroup FreeMindGrp 34/34