1. Robert Vinson, Jr. Assistant Program Manager NIH SBIR/STTR Program Office NIH Regional Seminar on Program Funding & Grants Administration June 27-28, 2013 Baltimore, MD

2. Topics to Discuss Today * NIH SBIR/STTR Program Specifics * Red Lights and Yellow Lights * Answer Your Questions!

3. The largest, most accessible source of SEED CAPITAL for the nation’s innovative small businesses $2.5 Billion in FY 2012 SBIR/STTR Programs NIH SBIR: $632 M NIH STTR: $ 85 M Total: $717M

4. and…. This capital is in the form of grants and contracts no repayment no debt service no equity forfeiture no IP forfeiture

5. SBIR/STTR Program Overview SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM Set-aside program for small business concerns to engage in Federal R&D -- with potential for commercialization. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM Set-aside program to facilitate cooperative R&D between small businesses and research institutions -- with potential for commercialization. 2.7%* 0.35%* The best way to predict the future…is to create it.

6. SBIR Purpose and Goals Small Business Innovation Development Act of 1982 P.L. 112-81 Re-Authorizes program through FY2017 * 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 SBIR/STTR Program Overview

7. STTR Purpose and Goals Small Business Research and Development Enhancement Act of 1992 P.L. 112-81 Re-Authorizes program through FY2017 * Stimulate and foster scientific and technological innovation through cooperative research and development between small business concerns and research institutions * Foster technology transfer between small business concerns and research institutions SBIR/STTR Program Overview

8. NIH Mission Improve human health through biomedical and behavioral research, research training and communications.

9. Office of the Director National Institute on Minority Health and Health Disparities Organizational Structure of NIH http://www.nih.gov/icd National Institute on Alcohol Abuse and Alcoholism National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute on Aging National Institute of Child Health and Human Development National Institute of Allergy and Infectious Diseases National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Dental and Craniofacial Research National Institute on Drug Abuse National Institute of Environmental Health Sciences National Institute on Deafness and Other Communication Disorders National Eye Institute National Human Genome Research Institute National Heart, Lung, and Blood Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of General Medical Sciences National Institute of Nursing Research National Library of Medicine National Center for Complementary and Alternative Medicine Fogarty International Center National Center for Advancing Translational Sciences National Institute of Biomedical Imaging and Bioengineering No funding authority Center for Information Technology Center for Scientific Review NIH Clinical Center Office of Research Infrastructure Programs

10. PHASE II Full Research/R&D  $1M (STTR), $1M (SBIR) 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 SBIR/STTR: 3-Phase Program

11. SBIR/STTR Eligibility Criteria Subject to change per new SBA Policy Directive pending Organized as for-profit U.S. business Small: 500 or fewer employees, including affiliates PD/PI’s primary employment must be with small business concern at time of award and for duration of project period At least 51% U.S.- owned by individuals and independently operated or At least 51% owned and controlled by another (one) business concern that is at least 51% owned and controlled by one or more individuals

12. STTR: Formal collaborative effort means: * Minimum 40% by small business * Minimum 30% by U.S. research institution STTR: Intellectual Property Agreement Needed Allocation of Rights in IP and Rights to Carry out Follow-on R&D and Commercialization SBIR/STTR: Applicant is Small Business Concern SBIR/STTR: All of the work must be done in the US more Eligibility Checkpoints SBIR/STTR Program Overview

13. SBIR and STTR: Critical Differences * Research Partner  SBIR: Permits partnering 33% Phase I and 50% Phase II  STTR: Requires partnering with Research Institution Small business (40%) and U.S. research institution (30%) Award is always made to Small Business Concern * Principal Investigator Employment  SBIR: Primary employment (>50%) must be with small business concern  STTR: PI may be employed by either research institution or small business concern  Multiple PD/PI allowable

14. Important Facts to Remember * Eligibility is determined at time of award * No appendices allowed in Phase I * The PD/PI is not required to have a PhD/MD * The PD/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

15. NIH SBIR/STTR Budget Allocations FY2012 2.6% SBIR $632M 0.35% STTR $85M Total FY2012 $717M

16. NIH SBIR/STTR Success Rates Fiscal YearSBIR/STTRPhase Number of Applications Reviewed Number of Applications Awarded Success Rate Total Funding 2010SBIRFast Track4306715.6%$16,795,150 2010SBIRPhase 14,49661413.7%$129,218,371 2010SBIRPhase 273424633.5%$146,228,959 2010STTRFast Track471123.4%$2,300,971 2010STTRPhase 153910920.2%$21,620,399 2010STTRPhase 2923234.8%$18,207,113 2010FY TOTAL 6,3381,07917.0%$334,370,963 2011SBIRFast Track4094210.3%$10,059,904 2011SBIRPhase 14,67253611.5%$123,802,074 2011SBIRPhase 268120329.8%$137,152,687 2011STTRFast Track4249.5%$813,900 2011STTRPhase 15088015.7%$18,321,516 2011STTRPhase 21033735.9%$20,977,584 2011FY TOTAL 6,41590214.1%$311,127,665

17. HHS/NIH Program Funding 2012 BudgetSBIR STTR NIH$632M$85M CDC FDA ACF $8.3M $1M ~350K N/A Phase I$150K* 6 months* $150K* 1 year* Phase II$1M* 2 years* $1M* 2 years*

18. Phase IPhase IIPhase III Gap Funding Programs Mt. “FDA” No-Cost Extension Phase I / Phase II Fast Track Administrative / Competitive Supplements Phase IIB Competing Renewal Award NIH SBIR/STTR Program Specifics

19. Bridging the Phase I - II Funding Gap (Simultaneous Submission and Concurrent Review) SBIR/STTR Phase I + Phase II Phase I Award 7-9 months Completion of Phase I Phase I Final ReportProgram Staff assess completion of specific aims and milestones Phase II award Aims/Milestones Met Phase II award Aims/Milestones NOT Met Go? No Go? NIH Phase I/Phase II Fast-Track “In-NIH-vative” Approaches

20. * To take existing, promising compounds or devices developed under a Phase II through the next step of drug discovery / medical device refinement and development (see SBIR/STTR Solicitation) Purpose or…NCI, NHLBI, NINDS specific announcements, ex: * Competing Renewal Awards of SBIR Phase IIB Grants for Brain and Behavior Tools (R44) (see PA-11-135) Phase IIB Competing Renewals “In-NIH-vative” Approaches

21. * SBIR/STTR Phase II awardee * Promising pharmacologic compound identified in original Phase II * Device prototype developed in original Phase II * Instrumentation/Interventional technologies not subject to FDA regulatory approval but require extraordinary time/effort to develop Contact NIH Program Staff to discuss Eligibility Parameters * Maximum of $1M/year for up to 3 years * IC must accept Competing Renewal applications (NIA, NIAAA, NIAID, NICHD, NIDA, NIDCD, NIDDK, NIGMS, NEI, NHLBI, NIMH, NINDS, NCI, NCATS, and ORIP) Phase IIB Competing Renewals “In-NIH-vative” Approaches

22. http://sbir.nih.gov Solicitations & Due Dates

23. * NIH, CDC, FDA & ACF Omnibus Solicitation for SBIR/STTR Grant Applications Release: January Due Dates: April 5, Aug 5, Dec 5 (AIDS: May 7, Sept 7, Jan 7) * NIH & CDC SBIR Contract Solicitation Release: AugustReceipt Date: November Solicitations & Due Dates Parent FOAs: SBIR: (PA-13-088) STTR: (PA-13-089) NIH SBIR/STTR Program Specifics http://grants.nih.gov/grants/funding/sbir.htm NIH (24 ICs) – SBIR & STTRFDA – SBIR onlyCDC – SBIR onlyACF– SBIR only

24. Biodefense Biosensors Nanotechnologies Bioinformatics Diagnostic and Therapeutic Devices Telehealth Biosilicon devices Biocompatible materials Acousto-optics / opto- electronics Imaging devices Genetically engineered proteins Proteomics / Genomics… Suggested topic areas Descriptions & Research Topics Investigator-initiated R&D * Research projects related to the NIH mission * “Other” areas of research within the mission of an awarding component Keyword search the Solicitation Ctrl - F

25. *Suggest potential awarding component(s): NIH Institutes/Centers * Request SBIR/STTR study section http://www.csr.nih.gov/Roster_proto/sbir_section.asp * Suggest key areas of expertise required * Indicate individual(s) or organization(s) in conflict * For resubmission, indicate review history * Justify your requests Cover Letter: A Valuable Tool

26. Targeted SBIR/STTR FOA * NIH Guide for Grants and Contracts - High priority areas for ICs - Various IC participation - Nuances: a) Various due dates b) Additional review criteria c) Limited funds and project duration periods d) Etc. http://grants.nih.gov/grants/funding/sbir_announcements.htm

27. Electronic Submission SBIR/STTR grant applications must be submitted electronically. (SBIR contract proposals still in paper form) Registrations are required!!! –Grants.gov (company) –eRA Commons (company and all PD/PIs) http://era.nih.gov/ElectronicReceipt/index.htm

28. Important Application Changes (Effective January 25, 2010) Research Plan Restructure Page Limits –Introduction (resubmission or revision) – 1page –Specific Aims – 1page –Research Strategy Phase I – 6 pages Phase II – 12 pages Phase II Commercialization Plan – 12 pages Research Plan Background & Significance Preliminary Studies/Progress Report Research Design and Methods Research Strategy Significance Innovation Approach Guide Notice: NOT-OD-09-149

29. Updates 1.Error correction window: Eliminated effective January 25, 2011. (NIH Guide Notice NOT- OD-10-123) Until January 25, 2011, two business days to correct errors and warnings. 2.Resubmissions: Must be submitted no later than 37 months after initial receipt date. (NIH Guide Notice NOT-OD-10-140) 3.New Reporting Requirement: Transparency Act requires reporting on subawards over $25K & executive compensation (NIH Guide Notice NOT-OD-11-005) 4.Annotated forms: http://grants.nih.gov/grants/ElectronicReceipt/files/small_bus_annotated_app_form.pdf

30. Small Business Concern Applicant Initiates Research Idea Grantee Conducts Research IC Staff Prepare funding Plan for IC Director NIH Center for Scientific Review Assign 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 SBIR/STTR Program Specifics Remember: First get registered in Grants.gov AND eRA Commons!

31. Review Criteria Overall Impact Score Scored Review Criteria (score 1-9)  Significance (Real Problem/Commercial Potential)  Investigators (PI and team)  Innovation (New or Improved?)  Approach (Research Design, Feasible)  Environment (Facilities/Resources) Additional Review Criteria (not scored individually)  Protection of Human Subjects  Inclusion of Women, Minorities & Children  Vertebrate Animals  Biohazards

32. Timeline: New and Resubmission Applications Due Date April 5 August 5 December 5 Scientific Review July November March Council Review October January May Award Date (earliest) December April July 2 2 4 4 5 5 Solicitations and Funding Opportunities

33. ∙ Understand our mission. ∙ Review Funding Opportunity Announcements (FOAs). ∙ Propose innovative ideas with significance as well as scientific and technical merit. ∙ Give yourself ample time to prepare application. ∙ Communication, Communication, Communication! ∙ Contact NIH Staff to discuss: a) your research idea. b) outcome of your review. c) challenges and opportunities. Competing Successfully

34. Phase I Phase II Phase III Technical Assistance Programs Mt. “FDA” ??? Commercialization Assistance Program Niche Assessment Program Helping Companies cross the “Valley of Death” “In-NIH-vative” Approaches

35. Technical Assistance Programs 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 awardees) Niche Assessment Identifies other uses of technology Determines competitive advantages Develops market entry strategy (Phase I awardees)

36. Summary of Key Features * SBIR and STTR Program  Single SBIR/STTR grant solicitation  Investigator-initiated research ideas  Special Funding Opportunities (NIH Guide for Grants and Contracts)  Electronic Submission (grants only)  Awards: Grants, Contracts, Cooperative Agreements * Multiple Receipt Dates (Grants)  April 5, August 5, December 5  May 7, September 7, January 7 (AIDS)  Contracts: Early November * Budget and Project Period  $150K/6 -12months (Ph I)  $1M/2 yrs (Ph II) * External Peer Review  Option to request review group  Experts from Academia/Industry  5 Criteria: Significance, Approach, PI(s), Innovation, Environment  Summary Statement for all applicants  Revise & resubmit * Gap Funding Programs  Phase IIB Competing Renewals  Ph I/Ph II Fast Track  Administrative Supplements * Technical Assistance Programs  Technology Niche Assessment  Commercialization Assistance  Pipeline to Partnerships (P2P) Summary

37. Topics to Discuss Today * NIH SBIR/STTR Program Specifics * Red Lights and Yellow Lights * Answer Your Questions!

38. Eligibility Criteria Subject to change * Ownership: US-owned, independently operated * Affiliations: Research Institutions, Foundations, Foreign “Parents” * Size: 500 employees maximum * Business Structure: Inc., LLP, LLC,... * Principal Investigator: Employment

39. Ownership And Affiliations Subject to change Eligibility of wholly-owned subsidiary * Owners of the SBIR organization must be "individuals" who are "citizens of, or permanent resident aliens in, the United States." * The regulations nowhere provide that corporations or artificial entities may qualify as "individuals" who are U.S. citizens.

40. Ownership and Affiliations * Parent of wholly-owned subsidiary is FOREIGN * Sum TOTAL of ALL employees more than 500 (parent + subsidiary) * Sharing of officers on Board of Directors

41. PD/PI Eligibility on SBIR * PI must have primary employment with SBC (unless waiver is granted) * More than 50% of PI’s time spent in employ of SBC * Primary employment w/SBC precludes full-time employment at another organization Eligibility is determined at the time of award

42. STTR Eligibility Criteria * Applicant Organization * Research Institution Partner * Project Director/Principal Investigator

43. STTR Applicant Organization Small Business Concern is ALWAYS the applicant/awardee organization

44. STTR Research Institution Partner * Must establish formal collaborative relationship with SBC * Must perform minimum of 30% of the research/R&D (maximum 60%) * Non-profit organization owned and operated exclusively for scientific or educational purposes * Non-profit medical and surgical hospitals eligible as partner as long as these institutions are exclusively engaged in scientific research and/or application of scientific principles and techniques

45. PD/PI Eligibility on STTR * PD/PI: Not required to be employed by SBC * PD/PI: Must commit 10% effort (minimum) * PD/PI at RI: Must establish contract between RI and SBC describing PD/PI’s involvement PD/PI’s “signature” on Face Page represents agreement to conforming to Solicitation requirements

46. PD/PI Role on STTR BUDGET PAGE * PI must be on SBC or RI budget, but NOT BOTH * PI and co-PI must be paid at either SBC or RI, but NOT BOTH * PI oversees all research activities on behalf of SBC

47. PD/PI Role on STTR * Is PD/PI also business official for SBC? * Type of appointment does PD/PI have at RI? * If Owner/Business Official, s/he should also appear as employee of SBC (co-Investigator) and forego RI appointment during Phase II

48. PI Role on STTR * NIH requires documentation from original employer/RI confirming change in employment status (e.g., sabbatical) for duration of SBIR/STTR project * PI cannot serve as consultant on same project

49. Tips for Potential Applicants * Explore the OER website – a wealth of information there! http://grants.nih.gov/grants/oer.htm * Explore Institute/Center (IC) websites - to find the most likely home for your project * Explore the CSR website - identify potential study sections http://cms.csr.nih.gov/PeerReviewMeetings/CSRIRGDescription/ * Contact appropriate program staff – they can help you! * Include a cover letter with your application - to request IC and study section assignments * Be persistent and don’t get discouraged: NIH extramural staff are your links with the ICs and are there to help you.

50. Top 10 Reasons

51. 10. 10. Over $2.5 Billion available annually 9.NOT A LOAN 9. NOT A LOAN - no repayment 8. 8. Provides recognition, verification and visibility 7. 7. Potential leveraging tool to attract venture capital/other sources of $$$$$

52. 5. 5. Creates jobs / stimulates local and state economies – stronger National Economy 4. 4. Provides seed money to fund high risk projects 6. 6. Foster partnerships (universities, large corporations) that enhance competitiveness of small businesses in marketplace Top 10 Reasons

53. 3. 3. Intellectual property rights normally retained by the small business 2. 2. Small business concerns recognized as a unique national resource of technological innovation Top 10 Reasons

54. Cardiac Assist, Inc. Intralase Corporation Xilas Medical, Inc. Cyberkinetics Neurotechnology Systems, Inc. Merck pays $400 million in cash for small New Hampshire company … largest sum ever reported for a privately held biotech. GlycoFi, Inc. Altea Therapeutics Corporation Design Continuum, Inc. America 1. Opportunity to improve the health of America

55. For More Information Matthew Portnoy, PhD NIH SBIR/STTR Program Coordinator Phone: 301-435-2688 Email: mportnoy@mail.nih.gov Lenka Fedorkova, PhD Assistant Program Manager Phone: 301-435-0921 Email: fedorkoval@mail.nih.gov Subscribe to the SBIR/STTR List Serv: Email LISTSERV@LIST.NIH.GOV with the following text in the message body: subscribe SBIR-STTR your name Robert Vinson, Jr. Assistant Program Manager Phone: 301-435-2713 Email: vinsonr@mail.nih.gov