1 Natalia Kruchinin Ph . - PowerPoint Presentation

1. 1Natalia Kruchinin Ph.D.NIAID SBIR/STTR Program CoordinatorRTSP, DEA Overview of the NIH SBIR/STTR ProgramSeptember 30, 2016

2. Talk to an HHS Program Officer about your application and SUBMIT EARLY (days not hours and minutes)! Program Officer contact information found on the HHS Agency Contact webpagehttps://sbir.nih.gov/engage/ic-contactsQuestions about SBIR/STTR NIH? Email sbir@od.nih.gov Questions about SBIR/STTR NIAID? Email NIAIDSBIR@mail.nih.gov2Most Important Piece of Advice

3. 3NIH SBIR/STTR Website https://sbir.nih.gov

4. 4Confirm Your SBC Meets Eligibility RequirementsDevelop an Innovative Research IdeaFive Required RegistrationsNIH FOAs SBIR/STTR Omnibus (PA-15-269 & PA-15-270) Targeted SBIR/STTR FOAsSubmit your grant application ElectronicallyNIH Center for Scientific Review evaluate your grantSBIR/STTR Application Process Infographichttps://sbir.nih.gov/infographicFunding decisions and awards are madeAwardee Conducts Research

5. NIH SBIR/STTR FOAshttps://sbir.nih.gov/funding 31

6. 6NIAID SBIR/STTR web sitehhttps://www.niaid.nih.gov/grants-contracts/small-businessesNIAID SBIR/STTR High-Priority Areas of Interesthttps://www.niaid.nih.gov/grants-contracts/areas-interest-small-businessNIAID Current Small Business F​unding Opportunitieshttps://www.niaid.nih.gov/grants-contracts/grants-contracts?title=&=Search&term_node_tid_depth%5B%5D=131

7. 7NIAID SBIR/STTR Sample ApplicationsSBIR NIH office “Samples of SBIR/STTR applications from NIAID are one of our most requested resources” https://www.niaid.nih.gov/grants-contracts/sample-applications#r43r44

8. Congressionally Mandated ProgramsSMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAMSet-aside program for small business concerns to engage in federal R&D -- with potential for commercializationSMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAMSet-aside program to facilitate cooperative R&D between small business concerns and US research institutions -- with potential for commercialization3.2%.45%3.0%.45%SET ASIDE(FY16)(FY16)(FY17)(FY17)

9. SBIR Purpose and GoalsStimulate technological innovationUse small business to meet federal R&D needsFoster and encourage participation by minorities and disadvantaged persons in technological innovationIncrease private-sector commercialization innovations derived from federal R&D9Small Business Innovation Development Act of 1982P.L. 112-81 Re-Authorizes program through FY2017

10. STTR Purpose and GoalsStimulate and foster scientific and technological innovation through cooperative research and development carried out between small business concerns and research institutionsFoster technology transfer between small business concerns and research institutions10Small Business Research and Development Enhancement Act of 1992P.L. 112-81 Re-Authorizes program through FY2017

11. 11FYSBIR Set-asideSTTR Set-aside20112.5%0.30%20122.6%0.35%20132.7%0.35%2014 2.8%0.40%20152.9%0.40%2016 3.0%0.45%20173.2%0.45%Set-aside for Agencies is IncreasingFYSBIR/STTR NIHSBIR/STTR NIAID2016$877 $132 2015$786 $121 2014$758 $118

12. SBIR Eligibility CriteriaOrganized as for-profit US business Small: 500 or fewer employees, including affiliatesWork must be done in the US (with few exceptions)Individual Ownership: Greater than 50% US-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 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 (For FOAs after 1/28/2013 NIH; 7/10/14 CDC) 12Determined at Time of Award

13. STTR Eligibility CriteriaApplicant is a Small Business ConcernFormal Cooperative R&D EffortMinimum 40% by small businessMinimum 30% by US research institutionUS Research InstitutionCollege or university; other non-profit research organization; Federal R&D centerIntellectual Property AgreementAllocation of rights in IP and rights to carry out follow-on R&D and commercialization13Determined at Time of Award

14. SBIR and STTR Critical DifferencesSBIRSTTRPartnering 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 PI may be employed by either the research institution partner or small businessAward is always made to the small business 16

15. Important Facts to RememberEligibility is determined at time of awardPD/PI is not required to have a Ph.D./M.D.PD/PI is required to have expertise to oversee project scientifically and technicallyApplications may be submitted to different agencies for similar workAwards may not be accepted from different agencies for duplicative projects15

16. No funding authorityOffice of Research Infrastructure Programs National Instituteon AgingNational Instituteon Alcohol Abuseand AlcoholismNational Instituteof Allergy andInfectious DiseasesNational Institute of Arthritis and Musculoskeletal and Skin DiseasesNational CancerInstituteNational Instituteof Child Healthand HumanDevelopmentNational Institute on Deafness and Other Communication DisordersNational Institute of Dental and Craniofacial ResearchNational Institute of Diabetes and Digestive and Kidney DiseasesNational Instituteon Drug AbuseNational Instituteof Environmental Health SciencesNational EyeInstituteNational Institute of General Medical SciencesNational Heart,Lung, and BloodInstituteNational HumanGenome ResearchInstituteNational Instituteof Mental HealthNational Institute of Neurological Disorders and StrokeNational Instituteof Nursing ResearchNational Institute on Minority Health and Health DisparitiesNational Center for Complementary and Integrative HealthFogarty International CenterNational Centerfor Advancing Translational SciencesNational Library of MedicineNational Instituteof Biomedical Imaging and BioengineeringOffice of the DirectorNIH Clinical CenterCenter for Information TechnologyCenter for Scientific ReviewNational Institutes of Healthhttp://www.nih.gov/icd20

17. 17NIAID SBIR/STTR Program: The Second Largest at NIHFY16 Extramural Research Budget Set-Aside: 3% SBIR / 0.45% STTRSBIR/STTR Combined Budget (FY16) -           NIH-wide: $877million | NIAID: $132 million

18. Phase I FEASIBILITY18SBIR & STTR: Three-Phase Program Proof-of-Concept study SBIR/STTR Phase IIDEVELOPMENTPhase IIICOMMERCIALIZATION Commercialization stageUse of non-SBIR/STTR fundsDirect To Phase IIResearch & DevelopmentCommercialization plan requiredPhase II BFast-Track ApplicationCombined Phase I & II

19. NIH SBIR/STTR Fast-TrackFeasibilityDiscoveryPhase IFull R/DPhase I Phase IIFast-Track$3M for up to 3 yearsDevelopmentPhase IICommercializationPhase IIICompeting Renewal AwardPhase IIB Additional R/DDirect to Phase IISimultaneous submission and review of Phase I and IIPhase I is awardedMilestones/aims of Phase I are assessed by program staff BEFORE Phase II is awarded

20. NIH SBIR/STTR Direct to Phase IIFeasibilityDiscoveryPhase IFull R/DPhase I Phase IIFast-Track$3M for up to 3 yearsDevelopmentPhase IICommercializationPhase IIICompeting Renewal AwardPhase IIB Additional R/DDirect to Phase IISBIR onlyBypass Phase I grantMust have completed Phase-I-type R&D (i.e. feasibility) to move directly into a Phase-IISEPARATE FOAs: https://sbir.nih.gov/funding#phase2 Not all ICs Participate

21. Phase IIB Competing Renewal AwardDiscoveryPhase I$3M for up to 3 yearsDevelopmentPhase IICommercializationPhase IIICompeting Renewal AwardPhase IIB SBIR/STTR Phase II awardeeTechnologies that require extraordinary time/effort to develop, and often require FDA regulatory approvalAwards up to $1M/year for up to 3 years IC must accept Competing Renewal applications (NIA, NIAAA, NIAID, NICHD, NIDA, NIDCD, NIDDK, NEI, NIGMS NHLBI, NIMH, NINDS, NCATS, ORIP, NCI, NHLBI, NINDS)Contact NIH Program Staff to discuss!

22. DiscoveryPhase I$3M for up to 3 yearsDevelopmentPhase IICommercializationPhase IIICompeting Renewal AwardPhase IIB Webinar materials available at sbir.nih.govContact NIH Program Staff to discuss!$3M for up to 3 yearsCommercialization Readiness Pilot (CRP)PAR16-026: Technical AssistancePAR16-027: Technical Assistance and Late Stage DevelopmentCommercialization Readiness Pilot Program (CRP) – NEW!

23. Commercialization Readiness Pilot Program (CRP) – NEW!CRP may fund work that is not typically supported through SBIR/STTR Phase II or Phase IIB awards, including:Preparation of documents for a Food and Drug Administration (FDA) submissionDevelopment of an intellectual property strategyInvestigational New Drug (IND)-enabling studiesClinical studiesManufacturing costsRegulatory assistanceSubcontracted work to other institutions, including contract research organizations (CRO)A combination of servicesHHS CRP Informational Webinar (December 2, 2015)Webinar, slides, transcript @ http://grants.nih.gov/CRP%20Webinar23

24. Switching between SBIR and STTRNIH SBIR/STTR applicants may now ‘switch’ programs at Phase II or Phase IIB to any active NIH SBIR/STTR solicitation.Which means:Phase I STTR Awardees may apply for NIH SBIR or STTR Phase IIPhase I SBIR Awardees may apply for NIH SBIR or STTR Phase IIPhase II STTR Awardees may apply for NIH SBIR or STTR Phase IIBPhase II SBIR Awardees may apply for NIH SBIR or STTR Phase IIBNote that not all NIH Institutes and Centers accept Phase IIB applications.24

25. Venture Capital CompaniesSmall business concerns that are majority-owned by multiple venture capital operating companies (VCOCs), hedge funds and/or private equity firms ARE NOW ELIGIBLE to apply to NIH and CDC SBIRSee NOT-OD-13-071 SBIR and STTR VCOC forms available online *Note: SBIR VCOC form also used for SBIR contracts25

26. Grant Success Rate of SBIR/STTR 2015 by Phase26

27. NIH-wide SBIR/STTR Grant Success Rates 201527Fiscal YearSBIR/STTRPhaseNo. Applications ReviewedNumber Applications AwardedSuccess RateTotal Funding2015SBIRFast Track3376619.6%$18,157,5452015SBIRPhase I3,42551415.0%$117,110,5552015SBIRTotal Phase II82324129.3%$179,946,7272015SBIR Regular Phase II44216336.9%$113,088,1502015SBIR Direct Phase II3476518.7%$55,150,3632015SBIR Phase IIB341338.2%$11,708,2142015STTRFast Track611016.4%$2,171,9092015STTRPhase I91114916.4%$33,782,2242015STTRTotal Phase II873135.6%$21,597,1832015STTR Regular Phase II873135.6%$21,597,1832015FY TOTAL 5,6441,01117.9%$372,766,143Success Rates Posted Online: http://report.nih.gov/success_rates/index.aspx

28. 28NIAID Organization

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30. See NOT-OD-13-071 for details New SBIR/STTR award budget HARD caps in placeProgram Phase IPhase IISBIR$150,000$1,000,000STTR$150,000$1,000,000Award GuidelinesAward Hard Caps – cannot exceedBudget Hard CapsProgram Phase IPhase IISBIR$225,000$1,500,000STTR$225,000$1,500,00026

31. Budget Hard Cap WaiverAgencies (not applicants) must apply for a waiver from the SBA for budgets over the hard cap ($225,000 for Phase I and $1,500,000 for Phase II)SBA has approved a topics list, which allows budgets to exceed the hard caps as long as the project topics are on the listPre-approved topics list is Appendix A in regular topics document The approval is good for the 2016 SBIR/STTR Omnibus, and any FOA that falls on the topic list, including the Direct Phase II FOAs31

32. 32If you wish to request a budget over $225,000 for Phase I or over $1.5M for Phase II, please make sure your project is covered by one of the waiver topicsNIAID - Specific topics are listed for each Division, but satisfying any topic from any Institute or Center is sufficient to consider budget requests that exceed the hard capsNIAID will allow Phase I applications with budgets of up to $300,000 total costs per year for up to 2 years; and Phase II or Phase IIB applications with budgets of up to $1,000,000  total costs per year for up to 3 yearsThese requests must be very well justified in the “Budget Justification” attachment to the Research and Related Budget form and be consistent with the scope of the proposalBudget Hard Cap Waiver

33. Solicitations and Due DatesNIH, CDC, FDA, & ACF SBIR/STTR Grant Solicitation “Parent” FOAs: SBIR: PA-16-302 STTR: PA-16-303 Release: June 3, 2016 Standard Due Dates: September 5, January 5, April 5SBIR Contract Solicitation (NIH, CDC) – Program Solicitation PHS 2017-1 (SBIRs Only) NIH Guide Notice NOT-OD-16-123 Release: August 1, 2016 Close: October 21, 2016 (5pm EDT)NIH Guide for Grants and Contracts Release: Weekly receipt dates specified in each FOA

34. Omnibus vs Targeted FOAsOmnibusTargetedDue DatesStandard Due DatesStandard or Customized Due DatesReviewSBIR/STTR panels at CSRSBIR/STTR panels at CSRORSBIR/STTR panel at ICApplication InstructionsFollow SF424 R&R SBIR/STTR Application Guide & Annotated Form SetFollow SF424 R&R SBIR/STTR Application Guide & Annotated Form SetANDany additional instructions in FOARead FOA very carefully!36

35. Targeted SBIR/STTR Funding Opportunity AnnouncementsNIH Guide for Grants and ContractsHigh priority areas for ICsVarious IC participationNuances:Various due datesAdditional review criteriaLimited funds Varying project periodsEtc35http://sbir.nih.gov/funding#targeted

36. New SBIR/STTR Standard Due DatesSee NOT-OD-15-038Old SBIR/STTR Standard Due Dates36Cycle I Due Date Cycle II Due Date Cycle III Due Date April 5August 5December 5Current SBIR/STTR Standard Due Dates * Effective September 5, 2015, (no AIDS standard due dates)Cycle I Due Date Cycle II Due Date Cycle III Due Date September 5January 5April 5

37. Timeline: New ApplicationsSept 5Jan 5April 5Oct/NovFeb/MarJune/JulyJan/FebMay/JuneAugMarchJulySept or DecDue DateScientificReviewCouncilReviewAward Date(earliest)51

38. Electronic SubmissionSBIR/STTR grant applications and SBIR contract proposals must be submitted electronically.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.govHelpful NIH Grants Registration Infographic For contracts, submit proposals with electronic Contract Proposal Submission (eCPS) website38

39. 39ASSISTASSIST is optional, not required! http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-156.htmlASSIST – A New Submission Option  On-line system for the preparation, submission and tracking of grant applications through Grants.gov to NIH

40. NIH Application & Review Process Applicant initiatesresearch ideaProgram StaffSmall Business Concern confirms EligibilityProgram Staff/SBASubmits SBIR/STTRgrant application toNIH electronicallyeRA/Grants.gov HelpdeskScientific Review Group evaluates scientific meritScientific Review OfficerAdvisory Council or Board recommend ApprovalProgram StaffIC staff prepare funding plan for IC DirectorProgram StaffGrants ManagementIC allocates fundsGrantee conductsresearchNIH Center for Scientific Reviewassigns to IC and IRGReferral Office

41. 4141Key DocumentsOmnibus SBIR/STTR 2016 Solicitation: SBIR: PA-16-302 STTR: PA-16-303Note that the forms have recently been updated to FORMS-D use New SBIR/STTR Application Guide SF424 http://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/sbir-sttr-forms-d.pdf

42. 42NIH RePORTERhttp://projectreporter.nih.gov

43. 43Search Previous Awards29 hits

44. 44NIH RePORTERMatchmakerEnter abstracts or other scientific text and Matchmaker will return a list of 100 similar projects from RePORTER. These matches are based on the terms and concepts used in the submitted text. Up to 15,000 characters are permitted

45. 45Unfunded application, what is the next step?ResubmissionNew application -expected to be substantially different in content and scopeCannot change the scope or aims of the grant: When an unfunded Investigator-Initiated proposal is subsequently submitted in response to an RFA, it should be prepared as a new application.http://grants.nih.gov/grants/guide/notice-files/not-od-09-100.html If an unfunded application that was previously reviewed for a one activity code is submitted for a different grant activity code, it is to be prepared as a new application.  http://grants.nih.gov/grants/guide/notice-files/not-od-09-100.htmlApplications may be submitted to different  agencies for similar work  http://grants.gov/

46. 46Check “A Pilot Partnership to Find Private Support for Unfunded Applications” Accelerating Medicines Partnership (AMP)AMP - public-private partnership between the National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA), 10 biopharmaceutical companies and multiple non-profit organizations to transform the current model for developing new diagnostics and treatments by jointly identifying and validating promising biological targets for therapeutics.https://www.nih.gov/research-training/accelerating-medicines-partnership-ampOnPAR -Matchmaker between unfunded NIH applicants and private research funders- Private Business Venture, operated by Leidos Life Sciences,https://onpar.leidosweb.com/OnPAR FAQhttps://onpar.leidosweb.com/faq/Unfunded application, what is the next step?

47. 47NIH Technical Assistance Programs Transition to Phase IIINIH offers the I-Corps TM and the Niche Assessment Program for Phase I awardees, and the Commercialization Accelerator Program (CAP) for Phase II awardeesNIH SBIR/STTR Niche Assessment Program (NAP)Provides active Phase I awardees with market research, and consumer and competition analysis. https://sbir.nih.gov/napNIH SBIR/STTR Commercialization Accelerator Program (CAP)Trains Phase II awardees on how to be market ready. https://sbir.nih.gov/cap

48. 48“Innovation Corps (I-Corps™) at NIH Program for NIH and CDC Phase I Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grantees (administrative supplement) Intensive Entrepreneurial training program aimed at providing teams with skills and strategies to reduce commercialization riskFunding opportunity announcement: PA-16-414 Open Date: October 1, 2016 Application Due Date(s): November 1, 2016; January 9, 2017 Earliest Start Date: February 5, 2017; April 23, 2017http://grants.nih.gov/grants/guide/pa-files/PA-16-414.htmlInnovation Corps (I-Corps™) Program at NIH

49. Register Now!Register Now! http://bit.ly/OrlandoSBIR

50. Email LISTSERV@LIST.NIH.GOV with the following text in the message body: subscribe SBIR-STTR your name Email  LISTSERV@LIST.NIH.GOV  with the following text in the message body:  subscribe NIAID-SBIR your nameNIH Guide for Grants and Contracts (weekly notification) Follow on Twitter: @NIHsbir Read NIH SBIR/STTR Notable Successes Connect with Us Email: sbir@od.nih.gov NIAIDSBIR@mail.nih.gov50 Get Connected! Email Listserve

51. 51THANK YOU!