2. National Institutes of Health SMALL BUSINESS FUNDING OPPORTU“NIH”TIES Jo Anne Goodnight NIH SBIR/STTR Program Coordinator Phone: 301-435-2688 Fax: 301-480-0146 Email: jg128w@nih.gov

3. Research Opportunities Reserved for Small Business Reserved for Small Business SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM Updated 01/17/2006 JG)

4. Agenda Basics of the SBIR & STTR programs NIH SBIR/STTR programs  Overview  What’s new  Latest funding opportunities  University participation/involvement

5. SBIR / STTR Program Mission Supporting scientific excellence and technological innovation through the investment of Federal research funds in critical American priorities to build a strong national economy… one small business at a time.

6. Small Business Innovation Research (SBIR) Set-aside program for small business concerns to engage in federal R&D -- with potential for commercialization. Small Business Technology Transfer (STTR) Set-aside program to facilitate cooperative R&D between small business concerns and U.S. research institutions -- with potential for commercialization. Program Descriptions 2.5% 0.3%

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

8. SBIR AND STTR PROGRAMS CRITICAL DIFFERENCES Research Partner Research Partner SBIR: Permits research institution partners [Outsource ~ 33% Phase I and 50% Phase II R&D] STTR: Requires research institution partners (e.g., universities) [40% small business concerns (for-profit) and 30% U.S. research institution (non-profit)]

9. Principal InvestigatorPrincipal 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*] SBIR AND STTR PROGRAMS CRITICAL DIFFERENCES

10. Organized for- profit U.S. business 500 employees or fewer, including affiliates PI’s primary employment must be with the small business concern at the time of award and for the duration of the project period. SBIR PROGRAM ELIGIBILITY CHECKPOINTS ELIGIBILITY CHECKPOINTS

11. Small business concern must be: At least 51% U.S.- owned by individuals and independently operated or At least 51% owned and controlled by another (one) for-profit business concern that is at least 51% owned and controlled by one or more individuals SBIR PROGRAM ELIGIBILITY CHECKPOINTS ELIGIBILITY CHECKPOINTS

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

13. DODSBIR/STTR HHSSBIR/STTR NASA SBIR/STTR DOE SBIR/STTR NSF SBIR/STTR DHSSBIR USDASBIR DOCSBIR EDSBIR EPASBIR DOTSBIR SBIR / STTR Participating Agencies TOTAL ~ $2.2 + B FY 2006 $640M in FY2006

14. 2006 BudgetSBIR STTR NIH$571M$69M CDC FDA AHRQ ~8.1M ~0.8M ~2.0M N/A Phase I$100K* 6 months* $100K* 1 year* Phase II$750K* 2 years* $750K* 2 years* DHHS Budget and Award Amount $640M ****Propose a Realistic and Appropriate Budget for the Research****

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

16. Office of the Director Largest SBIR/STTR set-asides National Center on Minority Health and Health Disparities NIH Organization 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 Research Resources National Institute of Biomedical Imaging and Bioengineering

17. Examples of Cross-Cutting Areas of Interest l Nanotechnologies l Bioinformatics l Biodefense l Proteomics / Genomics l Genetically engineered proteins l Biosensors l Biosilicon devices l Biocompatible materials l Acousto-optics and opto-electronics l Imaging technologies l Education/communication tools l Computational biology l Behavioral research

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

19. SBIR/STTR Omnibus Grant Solicitation (NIH, CDC, and FDA) = Parent FOA Release: JanuaryApril 5, Aug 5, Dec 5 receipt dates (AIDS/AIDS-related: May 1, Sept 1, Jan 2 receipt dates) SBIR: http://grants.nih.gov/grants/guide/pa-files/PA-07-180.html STTR: http://grants.nih.gov/grants/guide/pa-files/PA-07-181.html SBIR Contract Solicitation (NIH, CDC) Release: AugustNovember 6, 2006 receipt date NIH Guide for Grants and Contracts Release: WeeklyVarious r eceipt dates http://grants.nih.gov/grants/funding/sbir.htm Our Ideas… Our Ideas…

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

21. 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 SBIR/STTR PROGRAM NIH SBIR/STTR PROGRAM Review Process for Research Grant

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

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

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

25. DOES MY TECHNOLOGY “FIT” IN NIH? See Mission Statement! Solution to… Real Problem…. that affects Real People!

26. Universities / Industry Partnerships and Cultural Differences Entrepreneurial Research Institutions

27. UNIVERSITY-BUSINESS 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

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

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

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

31. CULTURAL DIVERSITY University - Industry Partnerships University - Industry Partnerships Critical dimension of the new “Knowledge-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 This is now… That was then… is KEY!

32. u Develop common goals between faculty-initiated business and mission of research institution u Create environment that enables innovation and entrepreneurship u Protect IP assets of university u Establish policies to manage, reduce or eliminate conflict of interest (COI) Entrepreneurial Research Institution Key Ingredients

33. 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

34. Purdue Research Park Purdue University: Purdue Research Park  3 business incubators  Companies benefit from shared office concept, flexible leases, attractive rental rates, and more...  Gateways Program  Financial assistance Examples of Successful Entrepreneurial Research Institutions (cont.) http://www.purdueresearchpark.org

35. Purdue University  Environment for business to have frequent and mutually beneficial interactions with University  Policies / Procedures to address COI -- not to eliminate, but to minimize and manage Examples of Successful Entrepreneurial Research Institutions (cont.)

36. Endocyte, Inc. (Purdue Research Park) l Researcher, Philip Low, discovered way to diagnose, potentially cure, ovarian cancer using vitamin folate l Sell technology or start own company to develop and market treatment???? l Resisted VC offers: wanted control of science Now exploring use of folate in arthritis  ADVICE: Hire experienced CEO to handle all but science  BENEFIT: Purdue retains talent SUCCESS STORY

37. STTR ELIGIBILITY CRITERIA  Applicant Organization  Research Institution Partner  Principal Investigator Yellow Lights…. Red Lights

38. STTR APPLICANT ORGANIZATION Small Business Concern ALWAYS the applicant/awardee organization

39. STTR RESEARCH INSTITUTION PARTNER  U.S. 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

40. STTR RESEARCH INSTITUTION PARTNER  Formal collaborative relationship with SBC  Perform minimum of 30% of the research/R&D (maximum 60%)

41. PI Eligibility on STTR  Formal collaborative relationship: PI at RI establishes contract between RI and SBC describing PI’s involvement  PI is NOT required to be employed by SBC  Minimum 10% effort  PI and co-investigator must be paid at either SBC or RI, but NOT BOTH  PI’s signature on Face Page is agreement to conforming to Solicitation requirements

42. 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 See instructions for Multiple PI requirements

43. PI Role on STTR  PI also business official for SBC?  Type of appointment does 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

44. 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

45. SBIR vs STTR UNIQUE FEATURES SBIR STTR Set-Aside of Agency Budget 2.5% 0.30% FY06 SBIR / STTR Budget$571M $69M Award Guidelines Phase I $100K/6mos $100K/12 mos. Phase II $750K/2 yrs $750K/ 2 yrs Business Employment of PI >50% n/a SubcontractsPhase I < 33.3% < 60% Phase II < 50% < 60% Research Partner Not Required > 30%

46. For More Information http://grants.nih.gov/grants/funding/sbir.htm Jo Anne Goodnight NIH SBIR/STTR Program Coordinator Phone: 301-435-2688 Fax: 301-480-0146 Email: jg128w@nih.gov Kay Etzler SBIR/STTR Program Analyst Phone: 301-435-2713 Fax: 301-480-0146 Email: etzlerk@od.nih.gov

47. Questions?