ANNA LISA SOMERA MS, MBA, MPH CHICAGO INNOVATION EXCHANGE OCTOBER 30, 2014 Introduction to Grant Funds SBIRs & STTRs 1 Professional Background Early stage start-up experience: 10 years MS, MBA, MPH Technology transfer OTM at UIC Venture Capital co-managed life science portfolio of IllinoisVentures, LLC Co-founder of OrthoAccel Technologies, Inc. Director of Quality, Regulatory Affairs, and Operations at Diagnostic Photonics Chicago Innovation Mentor Heartland Angels Advisor 2 Grant Successes $6M+ in federal and state grant funding Consulted to multiple life science companies NIH: Phase I, Phase II, and Fast Track SBIR and STTRs grants AND contracts (NCI, NHLBI, NIDDK, NIDCR) DOD: Phase I SBIR Ranked #1 in topic area NSF: Phase I SBIR First-time PI became an NSF reviewer Competitions: Business Plan Competitions, MedTech Innovator and Get in the Ring 3 Agenda Overview of SBIR and STTR programs Agency participants NIH SBIR/STTR overview SBIR/STTR submission schedule Grant application tips Resources Questions and answers 4 The SBIR & STTR Programs SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM Set-aside program created by Congress in 1982 for small business concerns to engage in Federal R&D with potential for commercialization SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM Set-aside program created in 1992 to facilitate cooperative R&D between small business concerns and U.S. research institutions with potential for commercialization 2.8% FY % FY2013 5 SBIR STTR Stimulate technological innovation Use small business to meet Federal R&D needs Foster and encourage participation by minorities and disadvantaged persons in technological innovation Increase private-sector commercialization innovations derived from Federal R&D Stimulate and foster scientific and technological innovation through cooperative research and development carried out between small business concerns and research institutions. Foster technology transfer between small business concerns and research institutions SBIR/STTR Purpose and Goals 6 Organized as for-profit U.S. business Small: 500 or fewer employees, including affiliates PD/PIs primary employment must be with small business concern at time of award and for duration of project period Greater than 50% U.S.- owned by individuals and independently operated OR Greater than 50% owned and controlled by other business concern/s that is/are greater than 50% owned and controlled by one or more individuals OR (NIH ONLY) Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these SBIR Eligibility Criteria 7 Organized as for-profit U.S. business with 500 or fewer employees, including affiliates Is more than 50% U.S.-owned and independently Operated PD/PIs primary employment must be with small business concern or non-profit research institution Formal Cooperative R&D Effort Minimum 40% by small business concern Minimum 30% by U.S. research institution U.S. Research Institution College or university; other non-profit research org STTR Eligibility Criteria 8 SBIR/STTR Budgets by Agency, FY 2013 Agencies with SBIR and STTR Programs Department of Defense (DOD)$ 1.0 B Department of Health and Human Services: National Institutes of Health (NIH) $697.0 M Department of Energy (DOE), including ARPA-E $183.9M National Science Foundation (NSF)$153.0 M National Aeronautics and Space Administration (NASA) $ M Agencies with SBIR Programs U.S. Department of Agriculture (USDA) $18.4M Department of Homeland Security (DHS): Science and Technology Directorate (S&T) and Domestic Nuclear Detection Office (DNDO) $15.7 M Department of Education (ED)$13.4 M Department of Transportation (DOT) $7.6 M Department of Commerce: National Oceanic and Atmospheric Administration (NOAA) and National Institute of Standards and Technology (NIST) $7.4 M Environmental Protection Agency (EPA) $3.8 M ~ $2.3B in FY13 Across all agencies 9 SBIR/STTR Programs The largest, most accessible source of SEED CAPITAL in the nation for innovative small businesses Over 2 Billion $$$$ in FY 14 10 Advantages and Benefits 11 Evaluation is based scientific and technical merit, firms qualifications, commercial potential and societal benefits Not a loan - requires NO REPAYMENT of monies received grant or contract Requires NO EQUITY sacrifice Intellectual property rights remain with the small business Challenges The game is VERY competitive The rules may be hard to interpret Good proposals are hard to write Funding decisions are subjective The money doesnt flow quickly even in between phases When you take Government money you are subject to scrutiny and audits 12 Agency Differences Each agency is unique Different solicitation schedules Different R&D Topic Areas -- (Broad vs. Focused) Different funding levels Different proposal outlines Different evaluation processes Different attitudes Different kinds of commercialization assistance Department of Defense National Institutes of Health National Science Foundation Department of Energy Tip: Dont judge an agencys interests by its name. Cheat sheet:13 Granting Agencies (SBIR/STTR) Investigator initiates approach Less-specified topics Assistance mechanism More flexibility DOD HHS/NIH NASAED EPADOT DOC Contracting Agencies (SBIR) Agency establishes plans, protocols, requirements Highly focused topics More fiscal and reporting requirements HHS/NIH NSF ED USDA DOE Agency Differences 14 All R&D must be performed in its entirety in the U.S. Rare cases to conduct testing of specific patient populations outside of the U.S. Travel to scientific meetings in foreign countries is allowable Foreign consultants/collaborators are allowable, but must perform consulting in the U.S. ALSO: Avoid purchase of any foreign goods or services outside of the US. While the NIH does allow the use in exceptional cases but the process involved is very onerous, time- consuming and requires multiple permissions (including clearance from the state department & Fogarty International Institute). Performance of Research Activities 15 27 Separate Institutes & Centers (IC) each with different: missions & priorities budgets ways of deciding which grants to fund NIGMS Clinical Center International Center National Institutes of Health 16 2.8% SBIR $617M 0.4% STTR $80M Total FY2013 $697M NIH SBIR/STTR Budget Allocations FY Fiscal YearSBIR/STTRPhase Number of Applications Reviewed Number of Applications Awarded Success Rate Total Funding 2012SBIRFast Track %$13,985, SBIRPhase 14, %$154,237, SBIRPhase %$153,650, STTRFast Track %$2,840, STTRPhase %$23,857, STTRPhase %$18,240, FY TOTAL 5,8471, %$366,812, SBIRFast Track %$13,981, SBIRPhase I3, %$114,040, SBIRPhase II %$136,348, STTRFast Track %$2,542, STTRPhase I %$24,138, STTRPhase II %$10,985, FY TOTAL 5, %$302,036,519 Success Rates Posted Online:18 NIH SBIR/STTR Success Rates PHASE II Full Research/R&D $1M (SBIR), $1M (STTR) over two years PHASE IIB Competing Renewal/R&D Clinical R&D; Complex Instrumentation/Tools to FDA Many, but not all, ICs participate Varies ~$1M/year; 3 years PHASE III Commercialization Stage NIH, generally, not the customer Consider partnering and exit strategy early PHASE I Feasibility Study Budget Guide: $150K (SBIR); $150K (STTR) Total Costs Project Period: 6 months (SBIR); 1 year (STTR) NIH Grant Phases 19 Technical Assistance Programs Phase I Phase II Phase III Mt. FDA ??? Commercialization Assistance Program Niche Assessment Program Helping Companies Through the Valley of Death 20 Commercialization Assistance Menu of technical assistance/training programs in: Strategic/business planning FDA requirements Technology valuation Manufacturing issues Patent and licensing issues Helps build strategic alliances Facilitates investor partnerships Individualized mentoring/consulting (Phase II or IIB awardees) Niche Assessment Identifies other uses of technology Determines competitive advantages Performs market research (Active Phase I awardees) NIH Technical Assistance Programs 21 Gap Funding Programs More NIH Gap Funding Programs No-cost extension Extends project period by 6 months or 1 year Direct to Phase II Fast-track application One application for Phase I and Phase II that is submitted and reviewed together Phase IIB awards $1M per year for up to 3 years; not offered by all ICs Always talk to a Program Officer! 22 Governmental agencies follow-on non-SBIR funded R&D or production contracts for products, processes or services intended for use by the U.S. Government. Corporations Venture capitalist firms/individual Angel investors Phase III Funders 23 Direct Costs Including fringe benefits Indirect Costs Usually 40% for small businesses Fee/Profit Up to 7% of the total direct and F&A costs. Must be requested in the proposal to be eligible. Not all costs are allowable What Do SBIR/STTR Grants Pay For? 24 Research Partner SBIR: Permits partnering SBC Effort: 33% Phase I & 50% Phase II STTR: Requires partnering with research institution. Effort: SBC (40%) and U.S. research institution (30%) Award is always made to the Small Business Concern Principal Investigator SBIR: Primary (>50%) employment must be with small business concern at the time of award and during project STTR: PI may be employed by either research institution or small business concern NIH SBIRs vs STTRs 25 PD/PI Eligibility on NIH STTRs PD/PI is not required to be employed by SBC PD/PI at RI must establish contract between RI and SBC describing PD/PIs involvement PD/PI must commit a minimum of 10% effort PD/PIs signature on application is agreement to conforming to Solicitation requirements 26 NIH Funding Opportunity Announcements SBIR/STTR Omnibus Solicitation NIH SBIR Direct Phase II Targeted FOAs NIH SBIR Contract Solicitation Located on the NIH SBIR/STTR Homepage: sbir.nih.gov 27 Targeted FOAsOver 60 IC Specific Targeted FOAs 28 NIH Reauthorization Changes Reauthorization required that budgets over the hard cap ($225,000 for Phase I and $1,500,000 for Phase II) Agencies (not applicants) apply for waiver from SBA SBA has recently approved a topics list, which allows budgets to exceed the hard caps as long as the project topics are on the list The approval is good for the 2014 SBIR/STTR Omnibus, and any FOA that falls on the topic list, including the Direct Phase II FOA 29 Small Business Concern Applicant Initiates Research Idea Grantee Conducts Research IC Staff Prepare funding Plan for IC Director NIH Center for Scientific ReviewAssign to IC and IRG Scientific Review Groups Evaluate Scientific Merit Advisory Council or Board Recommend approval IC Allocates Funds Submits SBIR/STTR Grant Application to NIH Electronically ~2-3 months after submission ~2-3 months after review Application & Review Process NIH Grant Application & Review Process 30 DueDate April 5 August 5 December 5 Scientific Review July November March Council Review October January May Award Date (earliest) December April July NIH Timeline for New Grants 31 NIH Facts to Remember Eligibility is determined at time of award The PI is not required to have a Ph.D. The PI is required to have expertise to oversee project scientifically and technically Applications may be submitted to different agencies for similar work Awards may not be accepted from different agencies for duplicative projects 32 Consortium/Contractual Arrangements Letters of Support Resource Sharing Plans Appendix Bibliography and Refs Cited Project Summary/Abstract (30 lines) Public Health Relevance Statement/Narrative Senior/Key Person Profiles Biographical Sketches (4 pg ea.) Facilities & Other Resources Equipment Project Budget Subaward Budget Cover Letter Commercialization Plan (12 pg; Ph II & Fast Track only) Forms Introduction to Application (1pg) Specific Aims (1 pg) Research Strategy (6 pg Ph I or 12 pg for Ph II and Fast Tracks) Significance Innovation Approach Inclusion Enrollment Report Progress report/Publication List (Phase II proposals only) Protection of Human Subjects Inclusion of Women and Minorities Targeted/Planned Enrollment Table Inclusion of Children Vertebrate Animals Select Agents Multiple PD/PI Plan Components of an NIH SBIR/STTR FAST-TRACK Grant Standard application, review, award process Fast-Track review option Satisfactory Phase I Final Report Phase I 7-9 months Simultaneous submission/review Phase I + Phase II 7-9 months Phase II 6 months 24 months 6 months Phase II 7-9 months 34 NIH SBIR FAST-TRACK Best Option For Everyone? No! Convincing preliminary data? Clear, measurable, achievable milestones? Well-conceived Commercialization Plan? Letters of Phase III support/interest? Track record for commercializing? Grant track record? Speak with Program Staff Prior to Submission 35 Gap Funding Programs Phase IIB Competing Renewals Phase I/Phase II Fast Track Administrative Supplements SBIR and STTR Program Single SBIR/STTR grant solicitation Investigator-initiated research ideas Special Funding Opportunities (NIH Guide for Grants & Contracts) Electronic Submission (grants only) Awards: Grants, Contracts, Cooperative Agreements Budget and Project Period $150K/ months (Phase I) $1M/2 years (Phase II) External Peer Review Option to request review group Experts from academia/industry Five Criteria: Significance, Approach, PI(s), Innovation, Environment Summary statement for all applicants Revise & resubmit Technical Assistance Programs Technology Niche Assessment Commercialization Assistance Multiple Receipt Dates (Grants) April 5, August 5, December 5 May 7, Sept 7, Jan 7 (AIDS) Contracts: November NIH SBIR/STTR Program Summary of Key Features 36 NIH Fast Track (Phase I and II combined) Direct to Phase II NSF Phase IB (1:2 match to $30K) Phase IIB (NSF will match 1:3 to $500K) Commercialization assistance Department of Defense National Institutes of Health National Science Foundation Department of Energy Grant and Contract Variations 37 Next Steps Youve convinced me to apply NOW WHAT?!?! 38 Where to Start Searching Online 39 SBIR website: Information on both SBIR and STTR programs Handbook for proposal preparation State award information Agency contacts & more! Grants.gov Run by DHHS Search for open and closed solicitations SBIR Gateway: Links to the agency SBIR/STTR sites Agency solicitation release/proposal due dates agency Key word search on topics search both open and closed solicitations Conference information NIH Reporter: Search the RePORTER database for funded proposals that are similar to yours. What was the scope of work? What were their aims? And importantly, how much money were they awarded? This will give you an idea of what constitutes a fundable project SBIR Schedule Department of Defense: (solicitations typically posted at least 30 days prior to opening) 1. DoD DoD DoD May Sep Dec Jun Oct Jan Dept of Health & Human Services (NIH, CDC, FDA): 1. PHS/NIH (grants) (AIDS- related topics due 7th of following month) 2. PHS/NIH (contracts) 17 Jan Aug Apr Aug Dec Nov OPEN DATE CLOSE DATE GRANTS! CONTRACTS! 40 SBIR Schedule NASA 14 Nov Jan NSF May Nov Jun Dec OPEN DATE CLOSE DATE Complete SBIR schedule can be found here:41 STTR Schedule Complete SBIR schedule can be found here:AGENCY OPENS CLOSES Department of Defense 2014-A 2014-B March 5, 2014 August 22, 2014 April 9, 2014 October 22, 2014 Department of Energy November 24, 2013 Aug 11, 2014 February 3, 2015 October 14, 2014 Department of Health & Human Services (AIDS- related topics due on 7th of following month) January 17, 2014 April 7, 2014 August 5, 2014 December 5, 2014 Homeland Security Dropped STTR NASA November 14, 2014January 28, 2015 NSF May 11, 2014 November 4, 2014 June 11, 2014 December 4, Understand Each Agencys Culture What are its distinct missions and needs ? What are the lines of communication? when (when not) to call, who to call, why you are calling How does the review and award process operate? Who are the reviewers internal, external, or both ? Who makes the final award selection ? What are the types of awards (contract or grant) ? Are there funding gap programs ? Does the agency offer a technical assistance program ? How can the agency support a firms: commercialization program ? as a Phase III customer by providing external contacts Ten Grant Application Tips 1. Start your registrations early 2. Talk to a program officer 3. Assemble your A-Team 4. Create a schedule 5. Follow the grant solicitation instructions 6. File a provisional patent prior to submission 7. Use the fewest words to communicate a well-designed research procedure 8. Create a viable commercialization plan 9. Focus on achievable goals 10. Ask a colleague to read/edit the final draft 44 Most Importantly (10+1) Know the grant review criteria. Also submit an excellent and compelling proposal that: Excites reviewers compelling Is innovative Meets a need and provides a solution Remember: Not all great ideas are funded! 45 Start Your Registrations Early! SBIR/STTR grant applications must be submitted electronically. SBIR contract proposals still in paper form. Registrations are required!!! DUNS Number (Company) System for Award Management (SAM) Grants.gov (Company) eRA Commons (Company and all PD/PIs) SBA Company Registry at SBIR.gov For NSF: Fastlane 46 Contact Program Staff for Pre-Application Guidance Optional, but HIGHLY suggested Be prepared with an executive summary of the company, abstract and specific aims. Be prepared with specific questions such as agency fit or project scope. If applicable, ask if your project is more suited for a fast track or direct to phase II application. Do not be annoying! Do notor call every other day. Program Officer contact information found in the NIH SBIR/STTR Solicitation on47 Assemble Your A-Team Choose your PI wisely! PIs should have a grant track record, if not build your team around them PI should be an expert in the field of your proposal First time PIs on SBIR/STTRs will have an uphill battle Supplement your team with the collaborators and consultants you need in order to convince the reviewers that you have all the expertise that is necessary to complete the work you propose 48 Create a Schedule Work backwards from the due date Plan to have everything nearly finished at least 2 weeks before the deadline Assign tasks and due dates for each section Hold weekly walls with your grant team Tip: Things that take time include documents that are somewhat out of your control Anything that needs to be approved by the university Letters of support 49 File a Provisional Patent Prior to Submission This protects your idea against competitors. Additionally, abstracts of funded proposals are made public, which means you will not be able patent your idea at that point. Reviewers look for strong IP around a technology and often ask about freedom to operate. 50 Follow the Grant Solicitation Instructions Important information on the first page of the solicitation: Clarifications and Changes Bold-Face Type Instructions "Type Size" Specifications Page Limitations Budget Section: Justification Biosketch rules Human Subjects/Vertebrate Animals: Definitions, Assurances, Exemptions Other Grant and Contract Support Revisions and Resubmission of Grant Applications Receipt Deadlines 51 Use the Fewest Words to Communicate a Well- Designed Research Procedure Write clearly. Organize your ideas and experiments. Never assume reviewers will "Know what you mean!" Support your ideas using references to literature or similar work done by the PI or others. 52 Focus on Achievable Goals Do not become overambitious. State specific aims explicitly. Present specific aims in a logical order and discuss why each aim is important. 53 Ask a Colleague to Read/Edit the Final Draft Ask both a technical and a business person in your field to review your application. Typographical errors? Missing figures? Missing biographical sketches, letters from consultants, and budget justification? 54 NIH Review Criteria Significance Significant Science Significant Product Significant Commercial Opportunity Investigators Innovation Approach Environment IMPACT 55 Most Common Reasons For Not Recommending Further Consideration Lack of Innovative Ideas Lack of Sufficient Experimental Data Lack of Knowledge of Published Relevant Work Lack of Experience in Essential Methodology Uncertainty Concerning Future Directions Questionable Reasoning in Experimental Approach Unfocused, Diffuse or Superficial Research Plan Absence of Acceptable Scientific Rationale Overambitious Weak Team 56 Resources: SBIR.gov57 Resources: NSF Webinars 58 Resources: NSF YouTube Channel 59 Resources: DOE 60 Save the Date 61 Save the Date 62 Questions and Answers! Contact Information: Anna Lisa Somera 63