National Institutes of Health SMALL BUSINESS FUNDING OPPORTU“NIH”TIES Jo Anne Goodnight NIH SBIR/STTR Program Coordinator Phone: Fax:

The NIH NIH SBIR/STTR Program Features and Nuances

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

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

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

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

Office of the Director Largest SBIR/STTR set-asides National Center on Minority Health and Health Disparities National Institutes of Health / 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 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 cost of research  Improve research tools

“Never, ever, think outside the box.”

u DODSBIR/STTR u NASASBIR/STTR u DOESBIR/STTR u NSFSBIR/STTR u USDASBIR u DOCSBIR u EDSBIR u EPASBIR u DOTSBIR SBIR/STTR 2004 Budget Estimate HHS SBIR/STTR NIH: $ 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

NIH SBIR/STTR FUNDING RATES NIH SBIR/STTR FUNDING RATES FISCAL YEAR 2002 Success Rate (%) 27% 48% 33% 63% 25 17% $499 M SBIR/STTR

NIH SBIR/STTR FUNDING RATES NIH SBIR/STTR FUNDING RATES FISCAL YEAR 2003 Success Rate (%) 24% 44% 27% 43% 28% 22% $563 M SBIR/STTR (set aside $556M) 95 5

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

SBIR/STTR Award Amount l l Award Amount and Project Period  Phase I~$100,0006 months  Phase II~$750,0002 years Propose a Realistic and Appropriate Budget for the Research Take Home Message #1

SOLICITATION(S) and SOLICITATION(S) and RECEIPT DATES  SBIR/STTR Omnibus Grant Solicitation (NIH, CDC and FDA) Release: JanuaryReceipt: Apr 1, Aug 1, Dec 1  NIH SBIR Contract Solicitation Release: AugustNovember 14, 2003  NIH Guide for Grants and Contracts Release: WeeklyReceipt dates as noted

Angioscopes to Zebrafish NIH SBIR/STTR RESEARCH AREAS

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

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

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

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

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

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

NIH Guide for Grants and Contracts u NIH Scientific Initiatives – Program Announcements – Requests for Applications u NIH Policy and Administrative Information

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

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

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

Peer Review of SBIR/STTR Grant Applications

Formula for Grant Success

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 ~2-3 months after submission ~2-3 months after review NIH SBIR/STTR PROGRAM NIH SBIR/STTR PROGRAM Review Process for Research Grant

NIH 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

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

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

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

Common Problems with Applications l Inadequately defined test of feasibility l Diffuse, superficial, or unfocused research plan –Lack of sufficient experimental detail l Questionable reasoning in experimental approach –Uncritical approach –Failure to consider potential pitfalls and alternatives l Lack of innovation l Unconvincing case for commercial potential or societal impact l Lack of experience with essential methodologies l Unfamiliar with relevant published work l Unrealistically large amount of work proposed

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

u Human Subject Issues (OHRP)  IRB and Assurances u Animal Welfare Issues (OLAW)  IACUC (Animal Involvement) u EIN (Entity Identification Number) u Third Party Involvement  Contracts, Consortia, Consultants NIH SBIR/STTR AWARD PROCESS Avoid Delays

Phase IPhase IIPhase III Transitioning SBIR / STTR Projects to the Marketplace

NIH SBIR/STTR Program Gap 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!

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

NIH SBIR “FAST-TRACK” Best Option For Everyone? l Convincing preliminary data? l Clear, measurable, achievable milestones? l Well-conceived Commercialization Plan ? l Letters of Phase III support/interest? l Track record for commercializing? No! !

NIH SBIR/STTR Program Gap 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!

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

 - To take existing, promising compounds developed under a Phase II through the next step of drug discovery and development. Competing Continuation Phase II Award Purpose  Provide additional Phase II research support 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”

 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! Competing Continuation Phase II Award Eligibility

NIMH NICHD NCI NIAAA Competing Continuation Phase II Award Participating ICs Also see PHS SBIR/STTR Grant Solicitation

NHLBI NIAID NINDS NIDCD NIA Competing Continuation Phase II Award Participating ICs

SBIR / STTR Toolbox Information and Resources

INFORMATION and RESOURCES A GOOD STARTING POINT u NIH SBIR / STTR Grant Solicitation, Forms and Instructions u Contacts at NIH u National SBIR / STTR Resource Center

INFORMATION and RESOURCES HOW TO WRITE A GRANT APPLICATION u Grant Application Preparation

Updates INFORMATION and RESOURCES Updates u Commercialization Plan – Detailed Instructions u CORP -- Collaborations / Partnerships u Success Stories u SBIR Phase II Competing Continuation Awards u Sample Applications u Data Sharing Plan (>$500K d.c. / year) files/NOT-OD html files/NOT-OD html

u Revised Policy on Amended Applications htmlhttp://grants.nih.gov/grants/guide/notice-files/NOT-OD html u Data Sharing Plan (>$500K d.c. / year) files/NOT-OD html files/NOT-OD html Updates INFORMATION and RESOURCES Updates (cont.)

Success Stories Updates (cont.) Success Stories u Recognition and visibility u Leverage SBIR / STTR funds Post Your SBIR / STTR Commercialization Success Stories!

Change in PHS Policy on Humane Care and Use of Laboratory Animals Updates (cont.) Change in PHS Policy on Humane Care and Use of Laboratory Animals As of October 1, 2002 receipt date, IACUC approval information may be provided “just-in-time” NIH Guide, August 8, files/NOT-OD html

Revised Policy on Submission of Amended Applications Updates (cont.) Revised Policy on Submission of Amended Applications u Limit of 2 revised applications remains in effect u Applies to all NIH extramural funding mechanisms NIH Guide, May 7, htmlhttp://grants.nih.gov/grants/guide/notice-files/NOT-OD html There is no longer any time limit on the submission of revised applications.

Other Support u NIH requires complete and up-to-date other support information before an award can be made u Grantees must report changes in other support as part of the annual progress report NIH Guide, February 13, Reminder

Invention Reporting Reminder u Grantees must report inventions u Interagency Edison

Beginning with December 2002 start dates grantees use website to identify progress reports duehttp://era.nih.gov/userreports/pr_due.cfm NIH Guide Notice: August 13, OD htmlhttp://grants2.nih.gov/grants/guide/notice-files/NOT- OD html Last pre-printed “hard copy” Face Pages mailed in June 2002 for November 2002 start dates Reminder Non-competing Continuation Grant Progress Report

FINDING A PARTNER INFORMATION and RESOURCES FINDING A PARTNER u CRISP Award Database u NIH Collaboration Opportunities and Research Partnerships u NIH Office of Technology Transfer

FINDING A PARTNER INFORMATION and RESOURCES FINDING A PARTNER u Federal Laboratory Consortium for Technology Transfer Transfer u State SBIR/STTR Supporthttp:// (cont)

Tissue Banks and Repositories INFORMATION and RESOURCES Tissue Banks and Repositories u NCI Research Resources u NIAID Reference Reagent Repository u NIDA Drug Discovery / Drug Development

FDA Technical Assistance Human Drug Products: Center for Drug Evaluation and Research (CDER) Telephone Number: Fax Number: Fax-On-Demand: or CDER Home Page: Address:

Each Component of FDA has an Office to Provide Technical Assistance to Manufacturers: FDA Technical Assistance Human Drug Products Biological Products Animal Drugs and Devices Food Products and Cosmetics

FDA Technical Assistance Biological Products: Center for Biologics Evaluation and Research (CBER) Telephone Number: or Fax Number: Fax-On-Demand: or CBER Home Page: Address: a. Manufacturers Assistance and Technical Training Team: b. Consumer & Health Professional Assistance:

FDA Technical Assistance Animal Drugs and Devices: Center for Veterinary Medicine (CVM) Telephone Number: Fax Number: CVM Home Page: Address:

FDA Technical Assistance Food Products and Cosmetics: Center for Food Safety and Applied Nutrition (CFSAN) Telephone Number: Fax Number: CFSAN Home Page: Address:

Key to the NIH Application, Review, and Award Process Take-home Message # 4 Communication

funding/sbir.htm Visit the NIH Small Business Funding Opportunities Website Solicitations, Forms and Instructions Collaborative Opportunities and Research Partnerships Receipt Dates SBIR and STTR Award Data Policy and Grantsmanship Information Invention Reporting Requirements Other Small Business Sites of Interest Conferences Success Stories Information For New Grantees Financial Questionnaire Review Committees

Contact NIH Staff Program Staff : Pre- Application Assess the “fit” What’s New: PAs/RFAs Assist in finding collaborators Review Issues: Dos and Don’ts Define product and focus application ApplicationReviewAward

Contact NIH Staff Program Staff : Post Review Discuss outcome of peer review  Review Summary Statement  What the rating means (numeric vs. **)  Strengths and weaknesses  Likelihood of funding  Next steps ApplicationReviewAward If at first you don’t succeed…. Revise and resubmit

Contact NIH Staff Review Staff Scientific Review Administrator…. u Point of contact during review process u Recruitment/Assignment of Reviewers u Concerns about I/C Assignment or Review Review

Contact NIH Staff Grants Management Staff u Pre-Award Steps u Post-Award Advice Guidance Award

CONTACT ME! NIH SBIR/STTR Program Coordinator Guidance and Advice...…. Success Stories BodPod

I’m from the Government, and I’m here to help you…. Final Take-home Message

National Institute on Alcohol Abuse and Alcoholism National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute 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 Aging National Institute of Child Health and Human Development 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 National Institute of Allergy and Infectious Diseases Fogarty International Center National Center for Research Resources Largest SBIR/STTR set-asides National Institute of Biomedical Imaging and Bioengineering National Center on Minority Health and Health Disparities New!

National Institutes of Health Office of the Director Largest SBIR/STTR set-asides National Center on Minority Health and Health Disparities /

Jo Anne Goodnight NIH SBIR/STTR Program Coordinator Phone: Fax: or Kay Etzler NIH SBIR/STTR Program Phone:

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