1. 11 Matthew Portnoy, PhD SBIR/STTR Program Coordinator Office of Extramural Research, NIH “Lab to Life” NIH SBIR/STTR Funding Opportu“NIH”tieS National Institutes of Health NIH Regional Seminar April 2012 Indianapolis, IN

2. 22 Topics to Discuss Today NIH SBIR/STTR Program Specifics NIH SBIR/STTR Program Specifics Partnering Incentives for Research Institutions and Industry through SBIR/STTR Red Lights and Yellow Lights Red Lights and Yellow Lights Answer Your Questions! Answer Your Questions!

3. 33 Registration Open! 14 th Annual NIH SBIR/STTR Conference May 30 to June 1, 2012 Louisville, Kentucky Hosted by Kentucky Science and Technology Corporation 2 day conference with optional workshops on June 1. http://nih.kysbir.com/

4. 44 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

5. 55 And…. This capital is in the form of grants and contracts no repayment no debt service no equity forfeiture no IP forfeiture

6. 66 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. 2.6%* 0.35%* The best way to predict the future… is to create it.

7. 77 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

8. 88 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

9. 99 NIH Mission Improve human health through biomedical and behavioral research, research training and communications.

10. 10 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

11. 11 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

12. 12 SBIR 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

13. 13 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 SBIR/STTR Eligibility Checkpoints SBIR/STTR Program Overview

14. 14 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 SBIR and STTR: Critical Differences 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

15. 15 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

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

17. 17 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

18. 18 HHS/NIH Program Funding 2012 BudgetSBIR STTR NIH$632M$85M CDC FDA ACF $8.3M $1 M ~350K N/A Phase I$150K* 6 months* $150K* 1 year* Phase II$1M* 2 years* $1M* 2 years*

19. 19 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

20. 20 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

21. 21 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 Renewal Award “In-NIH-vative” Approaches

22. 22 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 Renewal Award “In-NIH-vative” Approaches

23. 23 http://grants.nih.gov/grants/funding/sbir.htm Solicitations and Due Dates

24. 24 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 and Due Dates Parent FOAs: SBIR: (PA-12-088) STTR: (PA-12-089) NIH SBIR/STTR Program Specifics http://grants.nih.gov/grants/funding/sbir.htm NIH (24 ICs) – SBIR & STTRFDA – SBIR onlyCDC – SBIR onlyACF– SBIR only

25. 25 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 SBIR/STTR Program Descriptions and Research Topics Investigator-initiated R&D l Research projects related to the NIH mission l “Other” areas of research within the mission of an awarding component Keyword search the Solicitation Ctrl - F

26. 26 l Suggest potential awarding component(s): NIH Institutes/Centers l Request SBIR/STTR study section l http://www.csr.nih.gov/Roster_proto/sbir_section.asp l Suggest key areas of expertise required l Indicate individual(s) or organization(s) in conflict l For resubmission, indicate review history l Justify your requests Cover Letter: A Valuable Tool

27. 27 Targeted SBIR/STTR Funding Opportunity Announcements NIH Guide for Grants and Contracts –High priority areas for ICs –Various IC participation –Nuances: Various due dates Additional review criteria Limited funds and project duration periods Etc. http://grants.nih.gov/grants/funding/sbir_announcements.htm

28. 28 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

29. 29 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

30. 30 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

31. 31 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 NIH Application and Review Process NIH SBIR/STTR Program Specifics Remember: First get registered in Grants.gov AND eRA Commons!

32. 32 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

33. 33 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

34. 34 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: your research idea. outcome of your review. challenges and opportunities. Competing Successfully for SBIR/STTR Funding

35. 35 Phase IPhase IIPhase III NIH Technical Assistance Program Mt. “FDA” ??? Commercialization Assistance Program Niche Assessment Program Helping Companies cross the “Valley of Death” “In-NIH-vative” Approaches

36. 36 Technical Assistance Programs Understanding the “B” in SBIR 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)

37. 37 NIH SBIR/STTR Program 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

38. 38 Topics to Discuss Today NIH SBIR/STTR Program Specifics NIH SBIR/STTR Program Specifics Partnering Incentives for Research Institutions and Industry through SBIR/STTR Red Lights and Yellow Lights Red Lights and Yellow Lights Answer Your Questions! Answer Your Questions!

39. 39 University Roles in SBIR/STTR Programs Universities are the intellectual capital of scientific and engineering knowledge. Small Businesses are a vehicle for channeling scientific discovery to the benefit of society. Partnerships between the University and the Small Business benefits BOTH.

40. 40 Research Institution Partnership Opportunities Own small firms (assign someone else PI) Principal Investigator (with official permission from university) Senior Personnel on SBIR/STTR Consultants on SBIR/STTR Subcontracts on SBIR/STTR University facilities provide analytical and other service support

41. 41 UNIVERSITY AND INDUSTRY: Two diverse cultures Industry Researchers are from MARS are from MARS University Researchers University Researchers are from Venus

42. 42 University culture Research, discover, educate and train future workforce Pace is aligned to academic cycle Mission = basic and applied research Technology transfer activities are companion to applied research mission Fertile ground for economic development UNIVERSITY AND INDUSTRY: Two diverse cultures

43. 43 Industry culture Mission toward research / R&D / commercialization Quick-paced Solve problems - develop new products  profit Maintain control of science to explore full potential of discovery (initially) Economic impact: Jobs, societal benefit UNIVERSITY AND INDUSTRY: Two diverse cultures

44. 44 CULTURAL DIVERSITY University - Industry Partnerships University - Industry Partnerships Critical dimension of the new “Innovation-based Economy” u Universities are establishing creative and entrepreneurial environments for the commercialization of university intellectual property u Universities and Industry learning to work together

45. 45 Synergistic goals between faculty- initiated business and mission of research institution Environment that enables innovation and entrepreneurship Agreement on IP issues Policies to manage, reduce or eliminate conflict of interest (COI) Entrepreneurial Research Institution Key Ingredients

46. 46 The Ohio State University Purdue University University of Wisconsin N.C. State University Georgia Tech Virginia Tech Examples of Successful Entrepreneurial Research Institutions Texas A&M University Penn. State University UC San Diego University of Utah Carnegie Mellon University Stanford University Source: Innovation U. “New University Roles in A Knowledge Economy” Southern Technology Council and Southern Growth Policies Board

47. 47 “Land” of Opportunities Providing incubator facilities on university property Taking equity position (e.g., 5%) in commercial ventures Investing funds in new companies Providing technical and business services to new firms (e.g., alumni, business school) Entering into joint ventures with private entities Modernizing the tenure process

48. 48 Case Study: Texas A&M

49. 49 Topics to Discuss Today NIH SBIR/STTR Program Specifics NIH SBIR/STTR Program Specifics Partnering Incentives for Research Institutions and Industry through SBIR/STTR Red Lights and Yellow Lights Red Lights and Yellow Lights Answer Your Questions! Answer Your Questions!

50. 50 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

51. 51 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.

52. 52 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

53. 53 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 with SBC precludes full-time employment at another organization Eligibility is determined at the time of award

54. 54 STTR Eligibility Criteria Applicant Organization Research Institution Partner Project Director/Principal Investigator

55. 55 STTR Applicant Organization Small Business Concern is ALWAYS the applicant/awardee organization

56. 56 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

57. 57 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

58. 58 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

59. 59 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

60. 60 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

61. 61 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.

62. 62 Top 10 Reasons

63. 63 Top 10 Reasons 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 $$$

64. 64 5. 5. Creates jobs / stimulates local and state economies – stronger National Economy 4. 4. Provides seed money to fund high risk projects 6.niversities, large 6. Foster partnerships (universities, large corporations) that corporations) that enhance of small businesses in competitiveness of small businesses in marketplace marketplace Top 10 Reasons

65. 65 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

66. 66 Top 10 Reasons 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

67. 67 Save the Date! 14 th Annual NIH SBIR/STTR Conference May 30 to June 1, 2012 Louisville, Kentucky Hosted by Kentucky Science and Technology Corporation 2 day conference with optional workshops on June 1. http://nih.kysbir.com/

68. OFFICE OF EXTRAMURAL PROGRAMS: SBIR/STTR For More Information Matthew Portnoy, PhD NIH SBIR/STTR Program Coordinator Phone: 301- 435-2688 Email: mportnoy@mail.nih.gov Lenka Fedorkova, PhD SBIR/STTR Program Analyst Phone: 301-435-0921 Email: lenka@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 SBIR/STTR Program Analyst Phone: 301-435-2713 Email: vinsonr@mail.nih.gov