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Kathleen Shino, MBA NIH SBIR/STTR Program

An In-Depth Look at the NIH SBIR and STTR Programs. Connecticut SBIR/STTR Conference April 2005. Kathleen Shino, MBA NIH SBIR/STTR Program. Issues Discussed. Review of NIH SBIR/STTR Nuances NIH Evaluation/Review/Selection Process Updates & Reminders

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Kathleen Shino, MBA NIH SBIR/STTR Program

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  1. An In-Depth Look at the NIH SBIR and STTR Programs Connecticut SBIR/STTR Conference April 2005 Kathleen Shino, MBA NIH SBIR/STTR Program

  2. Issues Discussed • Review of NIH SBIR/STTR Nuances • NIH Evaluation/Review/Selection Process • Updates & Reminders • Identifying Funding Opportunities • Communication & Other Tips • Technical Assistance Program • NIH Resources • Q&A

  3. NIH Mission IMPROVE HUMAN HEALTH through biomedical and behavioral research, research training and communications.

  4. Small Companies Can Help NIH meet its mission Conduct innovative R/R&D that results in product, process, or service that will... • Improve patient health • Speed process of discovery • Reduce cost of medical care/cost of research • Improve research & communication tools

  5. Program Descriptions and Goals Set-aside program for small business concerns to engage in federal R&D -- with potential for commercialization. Small Business Innovation Research (SBIR) • Stimulate technological innovation • Meet Federal R&D needs 2.5% • Foster and encourage participation by minorities and disadvantaged persons in technological innovation • Increase private-sector commercialization of innovations derived from Federal R&D Small Business Innovation Development Act of 1982

  6. Program Descriptions and Goals Set-aside program to facilitate cooperative R&D between small business concerns andU.S. research institutions -- with potential for commercialization. Small Business Technology Transfer (STTR) • Stimulate and foster scientific and technological innovation through cooperative research 0.30% • Foster technology transfer between small business concerns and research institutions Small Business Research and Development Enhancement Act of 1992

  7. SBIR PROGRAM ELIGIBILITY CHECKPOINTS • Organized for- profit U.S. business in U.S. • At least 51% U.S.- owned by individuals and independently operated or (2) SBIR it must be a for-profit business concern that is at least 51% owned and controlled by another SBC that is 51% U.S.- owned by individuals and independently operated & < 500 Employees • P.I.’s primary employment with SBC

  8. STTR PROGRAM ELIGIBILITY CHECKPOINTS • Applicantis Small Business Concern • Formal Cooperative R&D Effort • Minimum 40% by small business • Minimum 30% by U.S. research institution • U.S. Research Institution • College or University; other non-profit research organization; Federal R&D center • Intellectual Property Agreement • Allocation of Rights in IP and Rights to Carry out Follow-on R&D and Commercialization

  9. SBIR AND STTR PROGRAMSCRITICAL DIFFERENCES • Research Partner SBIR:Permitsresearch institution partners [Outsource ~ 33% Phase I and 50% Phase II R&D] STTR: Requiresresearch institution partners (e.g., universities) [40% small business concerns (for-profit) and 30% U.S. research institution (non-profit)] AWARD ALWAYS MADE TO SMALL BUSINESS

  10. SBIR AND STTR PROGRAMSCRITICAL DIFFERENCES • Principal Investigator SBIR: Primary (>50%) employment must be with small business concern STTR: Primary employment not stipulated [PI can be from research institution and/or from small business concern*] *DISCUSS WITH AGENCIES

  11. SBIR / STTR ELIGIBILITY OWNERSHIP AND CONTROL got questions? • Contact the SBA Size Specialists • Request an eligibility determination • http://www.sba.gov/size/indexcontacts.html

  12. Important Facts to Remember • Eligibility is determined at time of award • Noappendices allowed in Phase I • 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

  13. SBIR/STTR Participating Agencies TOTAL ~ $2.0 B FY 2005 NIH: $ 571 M SBIR $ 69 M STTR $640 M Total CDC: $ 8.0 M SBIR FDA: ~ $ 0.8 M SBIR AHRQ: ~$ 2.1 M SBIR • DOD SBIR/STTR • NASA SBIR/STTR • DOE SBIR/STTR • NSF SBIR/STTR • DHS SBIR • USDA SBIR • DOC SBIR • ED SBIR • EPA SBIR • DOT SBIR • HHS SBIR/STTR

  14. NIH SBIR/STTR FUNDING RATESFISCAL YEAR 2004 (Preliminary) $631 M SBIR/STTR 32 44% 49.2% 49% 15 302 215 37% 39% 37% Success Rate (%) 973 59 20% 18%

  15. National Institutes of Health http://www.nih.gov/icd/ Office of the Director National Center on Minority Health and Health Disparities

  16. SBIR/STTR: 3-Phase Program PHASE I • Feasibility Study • $100K and 6-month (SBIR) or 12-month (STTR) Award PHASE II • Full Research/R&D • $750K and 2-year Award (SBIR/STTR) PHASE III • Commercialization Stage • Use of non-SBIR/STTR Funds

  17. NUANCES NIH SBIR & STTR Programs • SBIR and STTR Program • Multiple Award Mechanisms • Multiple Receipt Dates • Budget Guidelines ~$100K/ $750K • External Peer Review Critiques sent to all applicants • Revise & Resubmit • Single Solicitation • ~ 95% Awards are grants • April 1, Aug 1, Dec 1 • Realistic & appropriate • Academia and industry • Original + 2 amendments

  18. Our Ideas … SBIR/STTR Omnibus Grant Solicitation (NIH, CDC, and FDA)Release: January April 1, Aug 1, Dec 1 receipt dates SBIR Contract Solicitation (NIH, CDC) Release: August Early November receipt date NIH Guide for Grants and Contracts Release: Weekly Various receipt dates http://grants.nih.gov/grants/funding/sbir.htm

  19. Your Ideas … Investigator-initiated R&D • Research projects related to the NIH mission • “Other” areas of research within the mission of an awarding component

  20. 7-9 months 7-9 months Phase I Phase II 6 months 6 months 24 months Satisfactory Phase I Final Report 7-9 months Phase I + Phase II Simultaneous submission/review Phase II SBIR “FAST-TRACK” Standard application, review, award process Fast-Track review option

  21. No!! NIH SBIR “FAST-TRACK”Best Option For Everyone? • Convincing preliminary data? • Clear, measurable, achievable milestones? • Well-conceived Commercialization Plan? • Letters of Phase III support/interest? • Track record for commercializing?

  22. NIH SBIR/STTR ProgramGap Funding Options • Phase I / Phase II Fast Track Simultaneous submission / concurrent review • No-Cost Extension (Ph I or Ph II) Extension in time with no additional funds • Administrative / Competitive Supplements Discuss with Program Director • Phase II Competing Continuation Maximum of $1M/yr for 3 years Response to IC-specific PA

  23. Phase II Competing Continuations • Goal: Provide additional research funds to move already identified drugs or devices requiring regulatory approval into clinical trials • Stipulations: • Available only to Phase II grantees preparing for clinical trials • Focus -- Diagnostics, devices, tissue engineering, drug development, biologics • Funding level: Maximum $1M per year for maximum of 3 years • IC must have announced the opportunity Speak with Program Staff Prior to Submission

  24. Peer Review of SBIR/STTR Grant Applications

  25. NIH Center for Scientific Review Assign to IC and IRG Small Business Concern Applicant Initiates Research Idea Scientific Review Groups Evaluate Scientific Merit Advisory Council or Board Recommend approval IC Allocates Funds NIH SBIR/STTR PROGRAM Review Process for Research Grant Submits SBIR/STTR Grant Application to NIH ~2-3 months after submission ~2-3 months after review IC Staff Prepare funding Plan for IC Director Grantee Conducts Research

  26. APPLICATION, REVIEW, and AWARD TIMELINE SBIR/STTR Scientific/Technical Adv Council Awd Receipt Dates Peer Review Board Review Date Apr 1 June/July Sept/Oct Nov Aug 1 Oct/Nov Jan/Feb Mar Dec 1 Feb/March May/June July 7 to 9 months 90-Day pre-award costs are allowable: At your own risk…..

  27. Scientific Review Group Match between proposed research and review groups for scientific/technical merit Center for Scientific ReviewReceipt & Referral Office Application Assignments Institutes/Centers Match between proposed research and IC’s mission for funding

  28. REVIEW CRITERIA (Phase I) • Significance (Real Problem/Real People) • Approach (Research Design, Feasible) • Innovation (New or Improved?) • Investigators (PI and team) • Environment (Facilities/Resources) … Protection of Human Subjects … Animal Welfare … Budget

  29. Phase II Review Criteria • Same as Phase I • Demonstrated Feasibility in Phase I • High Degree of Commercial Potential based on Commercialization Plan … Protection of Human Subjects … Animal Welfare … Budget

  30. Phase II Commercialization Plan Included in ALL Phase II applications. Detailed instructions provided. • Value of the SBIR/STTR Project, Expected Outcomes, and Impact • Company Description • Market, Customer, and Competition • Intellectual Property (IP) Protection • Finance Plan • Production and Marketing Plan • Revenue Stream

  31. WHAT HAPPENS IN A STUDY SECTION MEETING? • Closed • Orientation • Streamlining • Application by application discussion • Every member scores every application • Assignment of gender, minority, and • children codes, human subjects codes; • Recommended changes to budget

  32. SCIENTIFIC REVIEW GROUP • Scientific Review Administrator • Recruits and selects reviewers • Insures review that is competent, thorough and fair (unbiased) • Proper review criteria used to evaluate application • Reviewers • All ad hoc reviewers • Scientists with appropriate expertise • High professional profiles • Dependable, reasonable, open minded • Grants Technical Assistant • Mails material to reviewers • Handles paperwork • Organizes meeting room • Enters scores and codes • Assists with summary statements

  33. Criteria for Selection of Peer Reviewers • Demonstrated Scientific Expertise • Doctoral Degree or Equivalent • Mature Judgment • Work Effectively in a Group Context • Breadth of Perspective • Impartiality • Interest in Serving • Diversity (Women and Minority Scientists) • Business skills/experience You can be a reviewer too!!!

  34. Scientific Review Group or Study Section Actions • Scored, Scientific Merit Rating (priority scores 100 to 300, typically) • Unscored (lower half; priority scores 301-500) • Deferral STUDY SECTIONS DO NOT FUND! INSTITUTES FUND!

  35. NIH Allows Amended Applications An opportunity to revise and improve your application • Two amended applications allowed • Generally half of the reviewers are new • Request for change of reviewers must be supported

  36. What Reviewers Say… Common Pitfalls with Applications • Inadequately defined test of feasibility • Lack of sufficient experimental detail • Questionable reasoning in experimental approach • Failure to consider potential pitfalls and alternatives • Lack of innovation • Unconvincing case for commercial potential or societal impact • Lack of experience with essential methodologies • Unfamiliar with relevant published work • Unrealistically large amount of work proposed

  37. What Reviewers Say About Outstanding Phase II Applications • “principals … highly experienced in their respective roles” • “ detailed Ph I Final Report was included” • Ph I effort was substantial and addressed reservations of the Ph I review solidly” • “…product promises to fill a long-felt need in neuroscience and in the larger community” • “… resources are outstanding” • “limitations of the project have been realistically addressed”

  38. What Reviewers Say About Outstanding Phase II Applications • “A prototype has been developed… pre-tested in Phase I… good feasibility results • “…well-defined goals presented in the work plan… to address required improvements that arose during testing in Phase I” • “clearly stated rationale for developing such a program is a major strength” • “commercialapplications for the … are significant” • “innovative with high promise of producing a major advance in…”

  39. Update: 2005 SBIR/STTR NIH Omnibus Solicitation Changes • Modular budget no longer applicable to SBIR/STTR • Fonts – Must use Helvetica or Arial, 11 points or larger • Review criteria updated (interdisciplinary, translational, clinical projects) • Final reports format changed PHS 398 Forms Required after May 9, 2005

  40. Reminders • Similar, Essentially Identical or Identical Applications to NIH awarding components (ICs) NOT allowed • Submission Dates: Postmark Date acceptable for applications submitted in response to PHS 2005-2

  41. Funding Opportunities SBIR/STTR Omnibus Grant Solicitation (NIH, CDC, and FDA)Release: January April 1, Aug 1, Dec 1 receipt dates SBIR Contract Solicitation (NIH, CDC) Release: August Early November receipt date NIH Guide for Grants and Contracts Release: Weekly Various receipt dates http://grants.nih.gov/grants/funding/sbir.htm

  42. Latest Funding Opportunities (Samples)http://grants.nih.gov/grants/funding/sbir_announcements.htm • RFA-06-005: Innovative Technologies for Molecular Analysis of Cancer • PA-04-156: Bioengineering Approaches to Energy Balance and Obesity • PAR-03-119: Innovations in Biomedical Computational Science and Technology • PA-04-161: Manufacturing Processes of Medical, Dental, & Biological Technologies • PA--05-014: Molecular Libraries Screening Instrumentation

  43. PAR-03-119: Innovations in Biomedical Computational Science and Technology Objective: To support research and development of tools and approaches for computing on data Unique Features: • Special receipt dates (Oct ’04, Feb ’05, Oct ’05, Feb ’06) • Trans-NIH opportunity • Flexible budget and project durations Phase I: 2 yrs, $100K direct costs each year Phase II: 3 yrs, no official budget limit • Parallel Announcement (PAR-03-106)

  44. RFA-AT-05-005: Improving Measurement Tools for Sternal Skin Conductance & Hot Flashes Objective:To improve measurement tools or devices for sternal skin conductance. Unique Features: • Special receipt date (Jan 25, 2005) • Letter of Intent Receipt Date: (Dec 20, 2004) • Only SBIR Phase I apps. accepted • Flexible budget and project durations 1 yr, $200K total costs • Multiple IC participation (NCCAM, NIA, NIBIB)

  45. Tips/Suggestions Key to the NIH Application, Review, and Award Process Communication

  46. Contact NIH Staff Program Staff : Pre- Application Assess the “fit” What’s New: PAs/RFAs Assist in finding collaborators Review Issues: Dos and Don’ts Define product and focus application Application Review Award Identification Tools: Solicitation Part II & CRISP Database

  47. Contact NIH Staff Program Staff : Post Review • Discuss outcome of peer review • Review Summary Statement • What the rating means (numeric vs. **) • Strengths and weaknesses • Likelihood of funding • Next steps If at first you don’t succeed…. Revise and resubmit Application Review Award Identification Tool: Summary Statement

  48. Contact NIH Staff Review Staff • Scientific Review Administrator…. • Point of contact during review process • Recruitment/Assignment of Reviewers • Concerns about I/C Assignment or Review Review Identification Tool: Grant Receipt Notice

  49. Contact NIH Staff Grants Management Staff • Pre-Award Steps • Budget, Eligibility, Submission • Post-Award Advice Guidance • Prior approval requirements • Changes in PI, organization, scope • Final reporting requirements Award Identification Tools: Solicitation Part I & Notice of Grant Award

  50. Tips/Suggestions • READ Solicitation INSTRUCTIONS--MOST important • Submit to multiple agencies to increase chances of winning • Submit multiple INDEPENDENT grants to support one product • Be cautious of 25-page limitation • Include well-designed graphics, tables, figures • Be persistent – revise and resubmit • Get help • Don’t miss the deadline • Don’t leave $$$$ on the table

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