Takin ’ Care of Business: SBIR/STTRs

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

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 CAPITALfor the nation’s innovative smallbusinesses$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 * 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 Small Business Innovation Development Act of 1982 P.L. 112-81 Re-Authorizes program through FY2017 SBIR/STTR Program Overview

7. STTR Purpose and Goals * 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 Small Business Research and Development Enhancement Act of 1992 P.L. 112-81 Re-Authorizes program through FY2017 SBIR/STTR Program Overview

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

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

10. PHASE I Feasibility Study • Budget Guide: $150K (SBIR); $150K (STTR) Total Costs • Project Period: 6 months (SBIR); 1 year (STTR) • 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 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. more EligibilityCheckpoints • 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 SBIR/STTR Program Overview

13. 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 Award is always made to Small Business Concern * Research Partner • SBIR:Permitspartnering 33% Phase I and 50% Phase II • STTR: Requirespartnering with Research Institution Small business (40%) and U.S. research institution (30%)

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

17. HHS/NIH Program Funding

18. Mt. “FDA” Gap Funding Programs PhaseIIBCompetingRenewalAward Phase I Phase II Phase III • No-Cost Extension • Phase I / Phase II Fast Track • Administrative / Competitive • Supplements NIH SBIR/STTR Program Specifics

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

20. Phase IIB Competing Renewals Purpose * 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) 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) “In-NIH-vative” Approaches

21. Phase IIB Competing Renewals Eligibility Contact NIH Program Staff to discuss * 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 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) “In-NIH-vative” Approaches

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

23. Solicitations & Due Dates http://grants.nih.gov/grants/funding/sbir.htm * 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: August Receipt Date: November Parent FOAs: SBIR: (PA-13-088) STTR: (PA-13-089) NIH (24 ICs) – SBIR & STTR FDA – SBIR only CDC – SBIR only ACF– SBIR only NIH SBIR/STTR Program Specifics

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

25. Cover Letter: A Valuable Tool • *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

26. Targeted SBIR/STTR FOA http://grants.nih.gov/grants/funding/sbir_announcements.htm * 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.

27. Electronic Submission http://era.nih.gov/ElectronicReceipt/index.htm • 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)

28. Important Application Changes (Effective January 25, 2010) Research Plan Background & Significance Preliminary Studies/Progress Report Research Design and Methods Research Strategy Significance Innovation Approach Guide Notice: NOT-OD-09-149 • 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

29. Updates • 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. • Resubmissions: Must be submitted no later than 37 months after initial receipt date. (NIH Guide Notice NOT-OD-10-140) • New Reporting Requirement:Transparency Act requires reporting on subawards over $25K & executive compensation (NIH Guide Notice NOT-OD-11-005) • Annotated forms: http://grants.nih.gov/grants/ElectronicReceipt/files/small_bus_annotated_app_form.pdf

30. Small Business Concern Applicant Initiates Research Idea Scientific Review Groups Evaluate Scientific Merit Advisory Council or Board Recommend approval IC Allocates Funds Application & Review Process Remember: First get registered in Grants.gov AND eRA Commons! NIH Center for Scientific Review Assign to IC and IRG Submits SBIR/STTR Grant Application to NIH Electronically ~2-3 months after submission ~2-3 months after review IC Staff Prepare funding Plan for IC Director Grantee Conducts Research NIH SBIR/STTR Program Specifics

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. Competing Successfully • ∙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.

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

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

35. 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 • * 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 • * 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) • * Technical Assistance Programs • Technology Niche Assessment • Commercialization Assistance • Pipeline to Partnerships (P2P) Summary

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

37. Eligibility CriteriaSubject 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

38. Ownership And AffiliationsSubject 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.

39. 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

40. 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

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

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

43. 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

44. 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

45. 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

46. 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

47. 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

48. 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.

49. Top 10 Reasons

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