National Institutes of Health SMALL BUSINESS FUNDING OPPORTU “NIH” TIE S

1. National Institutes of HealthSMALL BUSINESS FUNDINGOPPORTU“NIH”TIES Jo Anne Goodnight NIH SBIR/STTR Program Coordinator Phone: 301-435-2688 Fax: 301-480-0146 Email: jg128w@nih.gov

2. The NIH SBIR/STTR Program Features and Nuances

3. NIH SBIR/STTR ProgramWhat’s New? • PHS 398/2590: Undergoing revision • Submission Dates: CDC will use same 3 standard receipt dates as NIH and FDA • Type 2 Competing Continuation Ph II Awards • Clarification of Instructions for Preparing Human Subjects Section of Research Plan • Sample SBIR Applications • FDA Resources and Useful Websites

4. THE NIH SBIR/STTR PROGRAM FEATURES and NUANCES • NIH Mission • SBIR/STTR Budget • Award Type • Award Amount • Solicitations • Receipt Dates • Research Topics • Application Process • Review Process • Gap Funding • Funding Rates • Award Process • Website • Resource Toolbox

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

6. AN ADDED DIMENSION TO THE NIH “CULTURE” “The National Institutes of Health needs to work much more closely with industry to find cures for disease and improve global health and will ‘aggressively’ seek out partnerships with private companies.” -- Dr. Elias Zerhouni NIH Director

7. National Institutes of Health Use SBIR/STTR Help NIH Meet Its Mission Conduct innovative R/R&D that results in product, process, or service that will... • Improve human health • Speed process of discovery • Reduce cost of medical care/ cost of research • Improve research tools http://www.nih.gov/icd/ Office of the Director 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 Center 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 Research Resources National Library of Medicine Largest SBIR/STTR set-asides

8. “Never, ever, think outside the box.”

9. SBIR/STTR 2004 Budget Estimate • DOD SBIR/STTR • NASA SBIR/STTR • DOE SBIR/STTR • NSF SBIR/STTR • USDA SBIR • DOC SBIR • ED SBIR • EPA SBIR • DOT SBIR • HHS SBIR/STTR NIH: $ 563.3 M SBIR $ 67.6 M STTR $630.9 M Total CDC: ~ $ 8.0 M SBIR FDA: ~$ 0.8 M SBIR AHRQ:~$ 2.1 M SBIR

10. NIH SBIR/STTR FUNDING RATESFISCAL YEAR 2002 29 $499 M SBIR/STTR 335 63% 48% 81 Success Rate (%) 880 33% 44 27% 25 0 17%

11. NIH SBIR/STTR FUNDING RATESFISCAL YEAR 2003 327 18 $563 M SBIR/STTR (set aside $556M) 44% 43% 5 95 981 61 28% Success Rate (%) 27% 24% 22%

12. Types of SBIR / STTR Awards ~95% • GRANTS: you decide the research and product to be designed or developed (SBIR / STTR) • CONTRACTS: The government decides the research and general product to fill their perceived need (SBIR only) • COOPERATIVE AGREEMENTS: Similar to grants, but awarding IC has substantial involvement in carrying out the project's activities. ~4-5% <1%

13. SBIR/STTR Award Amount • Award Amount and Project Period • Phase I ~$100,000 6 months • Phase II ~$750,000 2 years Propose a Realistic and Appropriate Budget for the Research Take Home Message #1

14. SOLICITATION(S) and RECEIPT DATES • SBIR/STTR Omnibus Grant Solicitation (NIH, CDC and FDA)http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf Release: January Receipt: Apr 1, Aug 1, Dec 1 • NIH SBIR Contract Solicitation Release: August November 14, 2003 • NIH Guide for Grants and Contracts • Release: Weekly Receipt dates as noted • http://grants.nih.gov/grants/guide/index.html

15. NIH SBIR/STTR RESEARCH AREAS Angioscopes to Zebrafish

16. NIH SBIR/STTR Solicitation(s) Omnibus Grant Solicitation • Mission statement • General areas of research • Research Topics • “Other” Research Within the Mission of the IC (a.k.a. “Your Ideas”)

17. NIH SBIR/STTR RESEARCH GRANT TOPICS Our ideas ….(examples) • Biodefense • Biosensors • Nanotechnologies • Bioinformatics • Osteoarthritis Markers • Behavioral research • Computational Biology • Biosilicon devices • Biocompatible materials • Acousto-optics /opto-electronics • Imaging technologies • Genetically engineered proteins • Telehealth technologies • Proteomics / Genomics • …

18. NIH SBIR/STTR RESEARCH GRANT TOPICS Your ideas... • Investigator-initiated R&D • Research topics related to the NIH mission • “Other” areas of research within the mission of an awarding component • … Take-home Message #2

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

20. Grant Application Assignment:What if I cannot determine which IC is most appropriate?

21. Assignment to Institutes/Centers Applications are referred to an Institute or Center as the potential funding component: • Assignment based on match between the research proposed and the overall mission of the Institute or Center • Where appropriate for more than one Institute or Center, multiple assignments are made

22. NIH Guide for Grants and Contracts http://www.nih.gov • NIH Scientific Initiatives • Program Announcements • Requests for Applications • NIH Policy and Administrative Information

23. Requests for Applications (RFA) • Announcement describing an institute initiative in a well-defined scientific area • Invitation to the field to submit research grant applications for a one-time competition • Set-aside of funds for a certain number of awards • Applications generally reviewed within the issuing institute

24. Program Announcement • Invites grant applications in a given research area • May describe new or expanded interest in a particular extramural program • May be a reminder of a continuing interest in a particular extramural program • Generally has no funds set aside • Applications reviewed in CSR along with unsolicited grant applications

25. Applications Submitted to NIH Center for Scientific ReviewREGARDLESS OF INSTITUTE/CENTER TOPIC “LINKAGE” Cover Letter: A Valuable Tool • Suggest potential awarding component(s) • Discuss areas of expertise appropriate for the application’s review • Indicate individual(s) or organization(s) in conflict

26. Peer Review of SBIR/STTR Grant Applications

27. $ NIH $ NIH GRANT$ Formula for Grant Success + + = + + +

28. 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

29. NIH 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

30. NIH REVIEW CRITERIA (Phase II) • See Previous Slide • Demonstrated Feasibility in Phase I • Commercialization Plan • High Degree of Commercial Potential based on Commercialization Plan … Protection of Human Subjects … Animal Welfare … Budget

31. NIH REVIEW CRITERIA (Amended Applications) • See Previous Slide(s) as appropriate • Responses to comments from the previous review • Appropriateness of improvements in the revised application

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

33. Common Problems with Applications • Inadequately defined test of feasibility • Diffuse, superficial, or unfocused research plan • Lack of sufficient experimental detail • Questionable reasoning in experimental approach • Uncritical 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

34. NIH SBIR/STTR AWARD PROCESS Congratulations!The check is “in the mail…” (almost)

35. NIH SBIR/STTR AWARD PROCESS Avoid Delays • Human Subject Issues (OHRP) • IRB and Assurances http://ohrp.osophs.dhhs.gov/index.htm • Animal Welfare Issues (OLAW) • IACUC (Animal Involvement) http://grants.nih.gov/grants/olaw/olaw.htm • EIN (Entity Identification Number) http://www.irs.gov • Third Party Involvement • Contracts, Consortia, Consultants

36. Transitioning SBIR / STTR Projects to the Marketplace Phase I Phase II Phase III

37. 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 New!

38. Phase I + Phase II 7-9 months (Simultaneous submission and Concurrent review) Phase I 6 month award (SBIR) 12 month award (STTR) Funding Gap Reduced/Eliminated Phase II 2 –year award NIH SBIR/STTR FAST-TRACKBridging the Funding Gap Phase I Completed: Submit satisfactory Phase I Final Report Discuss Fast-Track option with Program Director

39. 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 New!

40. R. Magritte Le pont d’Heraclite, 1935 “A dense cloud creates the illusion that the bridge is incomplete”

41. Competing Continuation Phase II Award Purpose • - To take existing, promising compounds developed under a Phase II through the next step of drug discovery and development. • Provide additional Phase II researchsupport to continue assessing and improving devices or conducting preclinical studies of drugs or devices that ultimately require: • clinical evaluation • approval of a Federal regulatory agency • refinements to durable medical equipment (DME) designs “From the Test Tube to the Medicine Cabinet”

42. Competing Continuation Phase II Award Eligibility • SBIR Phase II awardee: • Promising pharmacologic agents or devices have already been identified (or developed) and some preclinical pharmacology has been conducted. • Response to an NIH Program Announcement • Generally, $750k-$1M/year for up to 3 years Contact your Program Director to discuss!

43. Competing Continuation Phase II Award Participating ICs NIMH NICHD NCI NIAAA http://grants.nih.gov/grants/guide/pa-files/PA-02-173.html http://grants.nih.gov/grants/guide/pa-files/PA-03-085.html http://grants.nih.gov/grants/guide/pa-files/PAR-03-074.html http://grants1.nih.gov/grants/guide/pa-files/PA-03-129.html Also see PHS 2004-2 SBIR/STTR Grant Solicitation

44. Competing Continuation Phase II Award Participating ICs NHLBI NIAID NINDS NIDCD NIA http://grants.nih.gov/grants/guide/pa-files/PA-04-028.html http://grants1.nih.gov/grants/guide/rfa-files/RFA-AI-04-005.html http://grants.nih.gov/grants/funding/sbirsttr1/2003-2_SBIR-STTR-topics.pdf http://grants.nih.gov/grants/funding/sbirsttr1/2003-2_SBIR-STTR-topics.pdf http://grants.nih.gov/grants/funding/sbirsttr1/2003-2_SBIR-STTR-topics.pdf

45. SBIR / STTR Toolbox Information and Resources

46. INFORMATION and RESOURCES A GOOD STARTING POINT • NIH SBIR / STTR Grant Solicitation, Forms and Instructions http://grants1.nih.gov/grants/funding/sbir.htm#sol • Contacts at NIH http://grants1.nih.gov/grants/contacts.htm • National SBIR / STTR Resource Center http://www.sbirworld.com

47. INFORMATION and RESOURCES HOW TO WRITE A GRANT APPLICATION http://grants1.nih.gov/grants/grant_tips.htm http://www.niaid.nih.gov/ncn/grants/ http://deainfo.nci.nih.gov/EXTRA/EXTDOCS/gntapp.htm http://chroma.med.miami.edu/research/Ellens_how_to.html http://www.cfda.gov/public/cat-writing.htm • Grant Application Preparation

48. INFORMATION and RESOURCESUpdates • Commercialization Plan – Detailed Instructions • CORP -- Collaborations / Partnerships http://grants.nih.gov/grants/funding/corp.htm • Success Storieshttp://grants.nih.gov/cfdocs/success/add.htm • SBIR Phase II Competing Continuation Awards • Sample Applications http://grants1.nih.gov/grants/funding/sbir.htm#sol • Data Sharing Plan (>$500K d.c. / year) http://grants.nih.gov/grants/guide/notice- files/NOT-OD-03-032.html

49. (cont.) INFORMATION and RESOURCESUpdates • Revised Policy on Amended Applications http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-041.html • Data Sharing Plan (>$500K d.c. / year) http://grants.nih.gov/grants/guide/notice- files/NOT-OD-03-032.html