1 Chris Sasiela PhD RAC chrissasielanihgov S mall business E ducation and E ntrepreneurial D evelopment office Office of Extramural Research NIH SB program Local investment ID: 1034379
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1. NIH Small Business Programs1Chris Sasiela, PhD, RACchris.sasiela@nih.govSmall business Education and Entrepreneurial Development officeOffice of Extramural Research, NIH
2. SB program = Local investment2>$31M Awarded to Bay Area companies. San Francisco area $31.6 MLA/OC area$26.1 MSan Diego area$60.6 MSource: NIH RePORTERIn FY18, CA small businesses received >$200M in NIH SBIR/STTR funding.
3. STTR Innovation 3Breaking News! Amprion Receives FDA Breakthrough Device Designation For Detection of Alpha-Synucleinhttps://www.amprionme.com20 yrs, 56 projects, >$37M in NIH supportIncluding 6 STTR awards >$4.5MProfessor, Department Of NeurologyChief Scientific Officer, Co-founderClaudio Soto, PhD
4. SBIR/academic innovation4Dr. Ricardo Olcese16 yrs academic research on calcium channel modulation5 NIH SB awards (10 yrs) STTR: NIDDKSBIR: NIAMS, NHLBISBIR Phase I award: in silico modelling of calcium channel moderatorsSBIR Phase II award: medicinal chemistry lead development and preliminary efficacy testingData Driven Drug Design ®
5. SBIR/STTR Program PhasesDiscovery Phase I Feasibility Study Budget Guide: $252K for SBIR and STTR Project Period: 6 months (SBIR); 1 year (STTR) 6 page research planPhaseIDevelopment Phase II Full Research/R&D $1.68M for SBIR and STTR, over two years 12 page research plan 12 page commercialization plan Phase IIB Competing Renewal/R&D Clinical R&D; Complex Instrumentation/to FDA Many, but not all, IC’s participate Varies~$1M per year; up to 3 yearsPhaseIICommercialization Phase III Commercialization NIH, generally, not the “customer” Consider partnering and exit strategy earlyPhaseIIIPhaseIIB
6. Types of applicationsPhase I proof of conceptPhase II following Phase IFast Track combined Phase I and II (12 page research plan)Direct to Phase II (SBIR only) Phase I equivalent work completed without SB fundingBudget Waiver TopicsCommercialization Readiness Pilot (Phase 2 awarded)6
7. SBIR or STTR?SBIR (3.2%, $1B)STTR (0.45%, $144M)Partnering RequirementPermits partneringRequires a non-profit research institution partner (e.g. university)Work RequirementGuidelines: May outsource 33% (Phase I) 50% (Phase II)Minimum Work Requirements: 40% small business 30% research institution partnerPrincipal InvestigatorPrimary employment (>50%) must be with the small business May be employed by either the research institution partner or small businessAward is always made to the small business
8. Omnibus Grant SolicitationsNIH, CDC, & FDA SBIR/STTR Grant Solicitation “Parent” FOAs:https://sbir.nih.gov/funding#omni-sbirClinical Trial RequiredSBIR: PA-19-273 STTR: PA-19-271Clinical Trial Not Allowed SBIR: PA-19-272 STTR: PA-19-270 Release Date: May 7, 2019Receipt Dates: January 6, April 6 (2020)
9. Does your study…Involve one or more human participants?Prospectively assign human participant(s) to intervention(s)?Intend to evaluate the effect of an intervention on human participantsHave a health-related biomedical or behavioral outcome? If “yes” to ALL of these questions, your study is considered a clinical trialClinical Trial Interactive Decision Tree: https://grants.nih.gov/ct-decision/index.htm9Clinical Trial?Is Your Study an NIH-defined Clinical Trial
10. Annual Contract SolicitationNIH / CDC SBIR Contract Solicitationhttps://sbir.nih.gov/sites/default/files/PHS2020-1.pdf NIH participation: NCATS, NCI, NHLBI, NIAAA, NIAIDCDC participation: NCCDPHP, NCEH, NCEZID, NCIRDReceipt Date: October 23, 2019 5:00pm EDT
11. Commercialization ReadinessPilot Program (Phase II predicate)Technical Assistance and Late Stage Development Clinical Trial Not AllowedSBIR: PAR-19-333 Technical Assistance and Late Stage DevelopmentClinical Trial RequiredSBIR: PAR-19-335 Technical Assistance Clinical Trial Not Allowed SBIR: PAR-19-334 Not all IC’s participate; no uniform budget limit; no additional TABACompetitive Revision/Supplement to an active Phase II/IIB award OR a renewal of a closed Phase II/IIB award.
12. Application FundingReceiptDateScientificReviewCouncilReviewAward Date(earliest)April 5th Sept 5thJan 5thMay/JuneOct/NovFeb/MarAug/SeptJan/FebMay/JuneOctoberMarchJuly
13. Super Important Piece of AdviceTalk to a HHS Program Officer at least a month before a deadline for application specific advice.
14. NIH SBIR/STTR Website14https://sbir.nih.gov
15. Application ResourcesSmall Business Program ManagersSF424 Application Guide How to apply for SBIR STTR from NIHAnnotated Form SetWhat to put into each form fieldNIAID Sample ApplicationsThese projects got fundedNHLBI Small Biz HangoutsResearch Plan tipsCommercialization Plan tips Understanding Peer ReviewManaging Your Award15
16. NIH Technical Assistance ProgramsNiche Assessment Program-Foresight S&T(Phase I Awardees)Commercialization Accelerator Program - Larta, Inc.(Phase II Awardees)Helps jump start commercialization effortsDetermines competitive advantagesDevelops market entry strategyTechnical Assistance/Training in:Strategic/business planningFDA requirementsTechnology evaluationManufacturing issuesPatent and licensing issuesHelps build strategic alliances Facilitates investor partnershipsIndividualized mentoring/consulting
17. Investor ForumTechnology Development Programs (open to eligible awardees from participating ICs)I-CorpsTM at NIHEntrepreneurial Immersion12 Participating ICs + CDCFacilitating PartnershipsConcept to Clinic Commercializing Innovation c3i program6 Participating ICs academic PIs and small businesses
18. NIH Entrepreneurs in Residence18https://sbir.nih.gov/resources/entrepreneurs-in-residence/index.htmEthel Rubin, PhDJohn Sullivan, MBA
19. Stay in the know!Subscribe to the SBIR/STTR Listserv: Email LISTSERV@LIST.NIH.GOV with the following text in the message body: subscribe SBIR-STTR your name NIH Guide for Grants and Contracts (weekly notification) Follow us on Twitter: @NIHsbir
20. Ask us!Robert VinsonSBIR/STTR Program ManagerPhone: 301-435-2713Email: vinsonr@mail.nih.gov 20Nita Basu, PhDSBIR/STTR Program ManagerPhone: 301-451-7768Email: dipanwita.basu@nih.gov JP Kim, JD, MBA, MScSBIR/STTR Program ManagerPhone: 301-435-0189Email: jpkim@nih.govBo Yeon Lee, PhDSBIR/STTR Program ManagerPhone: 301-451-7784Email: boyeon.lee@nih.gov sbir@od.nih.gov