Welcome Overview of the NIH SBIR STTR Programs by NIHhealth

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									 6th Annual NIH SBIR/STTR
         Conference

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

      Bethesda, MD – June 23-24, 2004
          Conference Goals
1. Learn the basics and nuances of the
   SBIR/STTR Programs
2. Understand the NIH application, review
   and award process
3. Meet NIH staff during One-on-One
   sessions
4. Network with attendees
5. Enjoy yourself!
       Conference Reminders
1. Cell phone options: Off, Silent or Vibrate
2. NIH, CDC and FDA staff: Yellow Badges
3. Notebooks:
   • Agenda
   • Logistics
   • One-on-One Schedules: Refer to chart
   • Presentations included for speakers
   • Panel discussions -- Note-taking pages
   • Attendance List
4. Message Board in lobby
5. Enjoy yourself!
     Research Opportunities
   Reserved for Small Business



SMALL BUSINESS INNOVATION
 RESEARCH (SBIR) PROGRAM

SMALL BUSINESS TECHNOLOGY
 TRANSFER (STTR) PROGRAM

                             Updated 05/22/04 (JG)
       SBIR/STTR
A Three Course Overview
            Course 101
         SBIR/STTR Basics

             Course 102
 NIH SBIR/STTR Features and Nuances

              Course 103
   Transitioning to the Marketplace

             Final Exam
  Course 101

  SBIR / STTR:
Learn the Basics

 General Features
       and
 Agency Nuances
    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.
      Program Descriptions and Goals
Small Business Innovation Research (SBIR)
 Set-aside program for small business concerns to engage
 in federal R&D -- with potential for commercialization.
      Stimulate technological innovation
2.5%  Meet Federal R&D needs
      Foster and encourage participation by
       minorities and disadvantaged persons in
       technological innovation
      Increase private-sector commercialization
       of innovations derived from Federal R&D

    Small Business Innovation Development Act of 1982
       Program Descriptions and Goals
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.
       Stimulate  and foster scientific and
0.30%
        technological innovation through
        cooperative research
       Foster technology transfer between small
        business concerns and research
        institutions
         Small Business Research and Development
                 Enhancement Act of 1992
  SBIR / STTR Participating Agencies

                      DOD    SBIR/STTR
                      HHS    SBIR/STTR
                      NASA   SBIR/STTR
                      DOE    SBIR/STTR
                      NSF    SBIR/STTR
                      DHS    SBIR        New
                      USDA   SBIR
                      DOC    SBIR
                      ED     SBIR
                      EPA    SBIR
TOTAL ~ $2.0 + B      DOT    SBIR        New
    FY 2004           HUD
  SBIR/STTR: 3-Phase Program
PHASE I
   Feasibility Study
   $100K and 6-month (SBIR)
      or 12-month (STTR) Award
PHASE II
   Full Research/R&D
   $750K and 2-year Award
    (SBIR/STTR)

PHASE III
   Commercialization Stage
   Use of non-SBIR/STTR Funds
      SBIR PROGRAM
 ELIGIBILITY CHECKPOINTS
 Organized for- profit U.S. business
 At least 51% U.S.- owned by
individuals and independently operated

 Small Business located in the U.S.
 500 or fewer employees
 P.I.’s primary employment with small
    business during project
         STTR PROGRAM
    ELIGIBILITY CHECKPOINTS
 Applicant is Small Business Concern
 Formal Cooperative R&D Effort
      Minimum 40% by small business
      Minimum 30% by U.S. research institution
   U.S. Research Institution
      College or University; other non-profit research
        organization; Federal R&D center
   Intellectual Property Agreement
     Allocation of Rights in IP and Rights to Carry out
      Follow-on R&D and Commercialization
 SBIR / STTR ELIGIBILITY
OWNERSHIP AND CONTROL

             got questions?
• Contact the SBA Size Specialists
• Request an eligibility determination

http://www.sba.gov/size/indexcontacts.html
    SBIR AND STTR PROGRAMS
     CRITICAL DIFFERENCES
   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)]

    AWARD ALWAYS MADE TO SMALL BUSINESS
    SBIR AND STTR PROGRAMS
     CRITICAL DIFFERENCES
   Principal 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*]


           *DISCUSS WITH AGENCIES
     STTR RESEARCH
  INSTITUTION PARTNER
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
         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
              FEE/PROFIT
Up to 7% of total direct and F&A costs may
be requested for fee
 Must be REQUESTED/JUSTIFIED in
  application
 Does not need to be negotiated
 Only SBC eligible; no contracts, consortium
  or other third party are eligible for fee
 Not direct or indirect cost
       PERFORMANCE of
     RESEARCH ACTIVITIES
“All research/R&D must be performed in
its entirety in the U.S.”
Rare cases to conduct testing of specific
   patient populations outside U.S. is allowable
Travel to scientific meeting in foreign
  country allowable
Foreign consultants/collaborators allowable,
  but must perform consulting in U.S.
    Important Facts to Remember
   Eligibility is determined at time of award
   No appendices allowed in Phase I
   The PI is not required to have a Ph.D. or M.D.
   The 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
       Course 102

The NIH SBIR/STTR Program

  Features and Nuances
THE NIH SBIR/STTR PROGRAM
    FEATURES and NUANCES
 NIH Mission      Research Topics
 What’s New?      Application Process
 Budget and       Gap Funding
   Award Amount    Funding Rates
 Award Type       Website
 Solicitations    Resource Toolbox
 Receipt Dates    Success Story
         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
                         National Institutes of Health
                                               http://www.nih.gov/icd/
                                                          Office of the Director



                                                                          National Institute                         National Institute
                          National Institute       National Institute
 National Institute                                                        of Arthritis and    National Cancer        of Child Health
                          on Alcohol Abuse          of Allergy and
     on Aging                                                             Musculoskeletal          Institute            and Human
                           and Alcoholism        Infectious Diseases
                                                                         and Skin Diseases                             Development



National Institute on     National Institute      National Institute
                                                                                               National Institute
Deafness and Other         of Dental and          of Diabetes and        National Institute                             National Eye
                                                                                               of Environmental
  Communication             Craniofacial           Digestive and          on Drug Abuse                                   Institute
                                                                                                Health Sciences
     Disorders                Research            Kidney Diseases



                                                                                               National Institute
 National Institute        National Heart,        National Human                                                      National Institute
                                                                         National Institute     of Neurological
    of General            Lung, and Blood        Genome Research                                                    of Nursing Research
                                                                         of Mental Health       Disorders and
 Medical Sciences             Institute               Institute
                                                                                                    Stroke




National Center on        National Center                                                                            National Institute
                                                       Fogarty            National Center
 Minority Health        for Complementary                                                        National Library     of Biomedical
                                                    International          for Research
    and Health            and Alternative                                                          of Medicine           Imaging
                                                       Center               Resources
    Disparities              Medicine                                                                                      and
                                                                                                                      Bioengineering


Largest SBIR/STTR
    set-asides
                         National Institutes of Health
                                               http://www.nih.gov/icd/
                                                          Office of the Director

                           Use SBIR/STTR Help NIH
                                                                          National Institute                         National Institute
 National Institute
     on Aging                  Meet Its Mission
                          National Institute
                          on Alcohol Abuse
                           and Alcoholism
                                                   National Institute
                                                    of Allergy and
                                                 Infectious Diseases
                                                                           of Arthritis and
                                                                          Musculoskeletal
                                                                         and Skin Diseases
                                                                                               National Cancer
                                                                                                   Institute
                                                                                                                      of Child Health
                                                                                                                        and Human
                                                                                                                       Development

              Conduct innovative R/R&D that results in
               product, process, or service that will...
National Institute on
Deafness and Other
                          National Institute
                           of Dental and
                                                  National Institute
                                                  of Diabetes and        National Institute
                                                                                               National Institute
                                                                                               of Environmental
                                                                                                                        National Eye
  Communication             Craniofacial           Digestive and          on Drug Abuse                                   Institute
                                                                                                Health Sciences
     Disorders                Research            Kidney Diseases


               Improve human health                                                           National Institute

               Speed process of discovery
 National Institute        National Heart,        National Human                                                      National Institute
                                                                         National Institute     of Neurological
    of General            Lung, and Blood        Genome Research                                                    of Nursing Research
                                                                         of Mental Health       Disorders and
 Medical Sciences             Institute               Institute
                                                                                                    Stroke

               Reduce cost of medical care/
 Minority Health
    and Health
                cost of research
National Center on        National Center
                        for Complementary
                          and Alternative
                                                       Fogarty
                                                    International
                                                                          National Center
                                                                           for Research
                                                                                                 National Library
                                                                                                   of Medicine
                                                                                                                     National Institute
                                                                                                                      of Biomedical
                                                                                                                         Imaging
                                                       Center               Resources
    Disparities              Medicine                                                                                      and
                                                                                                                      Bioengineering



               Improve research tools
Largest SBIR/STTR
    set-asides
     NIH SBIR/STTR Program
          What’s New?
 Register in NIH Commons: See Website
 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
 Technical Assistance Programs
 EO 13329: Encouraging Innovation in
  Manufacturing
       NIH SBIR/STTR Program
             Reminders
 Similar, Essentially Identical or Identical
  Applications to NIH awarding components (ICs)
  NOT allowed
 Submission Dates: Postmark Date acceptable for
  applications submitted in response to PHS 2004-2
 Commercialization Plan: ALL Phase II


 Details in PHS 2004-2 SBIR/STTR Grant Solicitation
   Budget and Award Amount
                 SBIR          STTR
2004 Budget     $563.3M       $67.6M
     NIH               $630.9
     CDC          ~8.1M
  ****Propose a Realistic and Appropriate
     FDA           the Research****
        Budget for~0.8M            N/A
    AHRQ Take Home Message #1
                  ~2.0M
   Phase I        $100K*        $100K*
                6 months*        1 year*
   Phase II       $750K*        $750K*
                 2 years*       2 years*
  Types of SBIR / STTR Awards
~95%  GRANTS: you decide the research and
        product to be designed or developed (SBIR /
        STTR)

~4-5%  CONTRACTS: The government decides the
        research and general product to fill their
        perceived need (SBIR only)

<1%    COOPERATIVE AGREEMENTS: Similar to
        grants, but awarding IC has substantial
        involvement in carrying out the project's
        activities.
SOLICITATION RECEIPT DATES
           SBIR/STTR Omnibus Grant
           Solicitation (NIH, CDC and FDA)
           Release: January
           Receipt: Apr 1, Aug 1, Dec 1

           Contract Solicitation
           Release: August
           Receipt: November (~2nd Friday)

           NIH Guide
           Release: Weekly
           Receipt : Dates as noted
 NIH SBIR/STTR
RESEARCH AREAS


  Angioscopes
  to Zebrafish
           NIH SBIR/STTR
      RESEARCH GRANT TOPICS
Our ideas ….(examples)
   Biodefense                 Biosilicon devices
   Biosensors                 Biocompatible materials
   Nanotechnologies           Acousto-optics /opto-electronics
   Bioinformatics             Imaging technologies
   Behavioral research        Genetically engineered proteins
   Computational Biology      Proteomics / Genomics
   Telehealth              Complementary and Alternative
                            Medicine
                               …
         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
 DOES MY TECHNOLOGY
     “FIT” IN NIH?

See Mission Statement!
       Solution to…
     Real Problem….
 that affects Real People!
NIH Guide for Grants & Contracts
Special SBIR/STTR Opportunities
    http://grants.nih.gov/grants/guide/index.html

                             Go Beyond the
                           SBIR/STTR Omnibus
                              Solicitation….
NIH GUIDE: PAs and RFAs
  SBIR/STTR Opportunities
SBIR/STTR : “Tip of the R&D Iceberg”
                                            --Joe Henebury
                                            DOT Prog. Mgr
                SBIR/STTR




                                    2.8%
                                                  NIH Budget
                                                  SBIR STTR

Other
Research
                        NIH Extramural Research Budget
Opportunities
 NIH Roadmap




http://nihroadmap.nih.gov
Grant Application
    Process
    NIH SBIR/STTR PROGRAM
Application Process for Research Grant
Small Business            Applicant Initiates
                            Research Idea       Contact NIH Staff
  Concern
                                   or
                          Identifies PA/RFA



                                                Discuss: Project
                                                  IC Relevance
                         Review Solicitation         Budget




                                                     Submit
NIH Center for Scientific Review                SBIR/STTR Grant
     Assign to IC and IRG                       Application to NIH
 Grant Application
   Assignment:

   What if I cannot
determine which IC is
 most appropriate?
       Application Assignments
Institutes/Centers                   Scientific Review Groups
NIH Center for Scientific Review     NIH Center for Scientific Review
RECEIPT and REFERRAL STAFF           RECEIPT and REFERRAL STAFF refer
refer applications to Institute or   applications to an Initial Review Group
Center as the potential funding
component:                           and Study Section:

 – Match between research               -- Match between research and
   proposed and IC’s mission            scientific review group within IRG

 – Multiple IC assignments when         -- Scientific expertise/specialization
   technologies cross-cut more
   than one IC
                                        -- Special Emphasis Panels
                                           Ad hoc; Not Chartered
   Applications Submitted to NIH
    Center for Scientific Review
REGARDLESS 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
       NIH SBIR/STTR PROGRAM
     Review Process for Research Grant
                                             NIH Center for Scientific Review
                           Submits                Assign to IC and IRG
Small Business
                      SBIR/STTR Grant
  Concern
                      Application to NIH

Applicant Initiates
                                               Scientific Review Groups
 Research Idea                                 Evaluate Scientific Merit
                           ~2-3 months
                         after submission

                                               Advisory Council or Board
                                ~2-3             Recommend approval
                              months
                            after review
                                     IC      IC Staff Prepare funding Plan
 Grantee Conducts                Allocates           for IC Director
     Research                     Funds
Peer Review of SBIR/STTR
   Grant Applications
      Streamlined Procedures of
     NIH Grant Application Review
   Reviewers
    – Rate applications: “upper” half and “lower” half
    – Discuss at review applications identified
      between 100 and 300
    – “Triage”/ UNscore applications between
       300-500…. generally
   Applicants: ALL
    – Automatically receive essentially verbatim
       written critiques (Summary Statement)
       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
            HINT!

 Research Plan should include
answers to questions described
    under Review Criteria!

       (See Solicitation)
       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
Phase II Commercialization Plan
       Included in ALL Phase II applications.
           Detailed instructions provided.
 1.   Value of the SBIR/STTR Project, Expected Outcomes,
      and Impact
 2.   Company Description
 3.   Market, Customer, and Competition
 4.   Intellectual Property (IP) Protection
 5.   Finance Plan
 6.   Production and Marketing Plan
 7.   Revenue Stream
      Post Review: Next Steps


 Read the summary statement
 Re-read the summary Statement
 Contact your Program Director
    – Guidance and advice
    – Discuss options
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
        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
       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
NIH SBIR/STTR APPLICATION PROCESS
                     TIMELINE
                        2-tiered review process
SBIR/STTR       Scientific/Technical   Adv Council    Est.Award
Receipt Dates   Peer Review            Board Review      Date
Apr 1           June/July              Sept/Oct          Dec
Aug 1           Oct/Nov                Jan/Feb           Mar
Dec 1           Feb/March              May/June          July

                   ~7 – 9 months
           90-Day pre-award costs are allowable:
                    At your own risk…..
NIH SBIR/STTR FUNDING RATES
        FISCAL YEAR 2003
              327               18          $563 M
   45
   40         44%               43%
                                            SBIR/STTR
   35                                       (set aside $556M)
                                       5
   30                     95
        981
   25                61               28%       Phase I
                          27%
   20   24%                                     Phase II
   15               22%                         Fast-Track
   10
    5
    0
          SBIR              STTR
NIH SBIR/STTR AWARD PROCESS

      Congratulations!
 The check is “in the mail…”




         (almost)
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
   DUNS Number
       https://eupdate.dnb.com/requestoptions.html
   Third Party Involvement
      Contracts, Consortia, Consultants
 Gap Funding Options




Phase I           Phase II
      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       New!
  Maximum of $1M/yr for 3 years
  Response to IC-specific PA
        NIH SBIR/STTR FAST-TRACK
                 Bridging the Funding Gap
 Phase I + Phase II         7-9 months
 (Simultaneous submission
                                                Phase I
 and Concurrent review)
                                          6 month award (SBIR)
                                         12 month award (STTR)



                                                Phase I
                                              Completed:
                                           Submit satisfactory
                Funding Gap                Phase I Final Report
   Phase II     Reduced/Eliminated
2 –year award

       Discuss Fast-Track option with Program Director
     NIH SBIR “FAST-TRACK”              No!
                                         !
     Best Option For Everyone?
 Convincing preliminary data?
 Clear, measurable, achievable milestones?
 Well-conceived Commercialization Plan?
 Letters of Phase III support/interest?
 Track record for commercializing?
      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       New!
  Maximum of $1M/yr for 3 years
  Response to IC-specific PA
          Course 103

Transitioning to the Marketplace
“Lab to Life”

                Mt. “FDA”
                ???????
     Commercialization Issues
 Phase  II to Phase III: Pier or Mountain?
 Clinical evaluation and FDA approvals
 cGMP and GLP Facilities
 Partnerships and Strategic Alliances
  – Drugs and Biologics require vast amounts of
    time and $$$
      Average of 8.5 years
       (lab research/animal testing to clinical trials)
      Average of $1.6M
http://www.fda.gov/cder/handbook/Develop.gif




                               NDA Contains:
                               •Pre-clinical studies
                               •Human clinical studies
                               •Manufacturing Details
                               •Labeling Info
                               •Other Info
     In”NIH”ovative Solutions to
      Commercialization Issues



       Competing Continuation
          Phase II Award

“From the Test Tube to the Medicine Cabinet”
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 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
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!
Competing Continuation Phase II Award
          Participating ICs
NIMH
http://grants.nih.gov/grants/guide/pa-files/PA-02-173.html
NICHD
http://grants.nih.gov/grants/guide/pa-files/PA-03-085.html
NCI
http://grants.nih.gov/grants/guide/pa-files/PAR-03-074.html
NIAAA
http://grants1.nih.gov/grants/guide/pa-files/PA-03-129.html
      Also see PHS 2004-2 SBIR/STTR Grant Solicitation
Competing Continuation Phase II Award
          Participating ICs
NHLBI
http://grants.nih.gov/grants/guide/pa-files/PA-04-028.html
NIAID
http://grants1.nih.gov/grants/guide/rfa-files/RFA-AI-04-005.html
NINDS
http://grants.nih.gov/grants/funding/sbirsttr1/2003-2_SBIR-STTR-topics.pdf
NIDCD
http://grants.nih.gov/grants/funding/sbirsttr1/2003-2_SBIR-STTR-topics.pdf
NIA
http://grants.nih.gov/grants/funding/sbirsttr1/2003-2_SBIR-STTR-topics.pdf
 SBIR / STTR
  Toolbox


Information and
   Resources
 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
     INFORMATION and RESOURCES
         FINDING A PARTNER
   CRISP Award Database

    http://crisp.oit.nih.gov

   NIH Collaboration Opportunities and Research
    Partnerships

    http://grants1.nih.gov/grants/funding/corp.htm

   NIH Office of Technology Transfer

    http://ott.od.nih.gov/
(cont)
   INFORMATION and RESOURCES
       FINDING A PARTNER
 Federal   Laboratory Consortium for Technology
   Transfer
   www.federallabs.org/

 State   SBIR/STTR Support

  grants1.nih.gov/grants/funding/sbirsttr_resources.htm#st
  ate
               State SBIR/STTR Reps here today!
      Key to the
NIH Application, Review,
  and Award Process

    Communication



  Take-home Message # 4
http://www.nih.gov




    Visit the NIH Small Business
   Funding Opportunities Website
http://grants.nih.gov/grants/funding/sbir.htm
             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


Application        Review            Award
             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
              If at first you don‟t succeed….
                                   Revise and resubmit
Application                Review                        Award
           Contact NIH Staff
             Review Staff
Scientific Review Administrator….
 Point of contact during review process
 Recruitment/Assignment of Reviewers
 Concerns about I/C Assignment or Review



                Review
       Contact NIH Staff
    Grants Management Staff

 Pre-Award Steps
 Post-Award Advice Guidance




                               Award
                                     BodPod
            CONTACT ME!
  NIH SBIR/STTR Program Coordinator




Guidance and Advice...…. Success Stories
 I’m from the
 Government,
and I’m here to
 help you….
  Final Take-home Message
                                                                                          National Institute                             Fogarty
                     National Institute                                                   of Environmental                            International
                         on Aging                                                          Health Sciences                               Center
                                                        National Institute
                                                        of Diabetes and
                                                         Digestive and
                                                        Kidney Diseases                             National Institute
  National Cancer                                                                                    of Child Health
      Institute                                                                                        and Human
                                                                                                                                National Institute
                                                                                                      Development
                                               National Eye                                                                      of Biomedical
                                                 Institute             National Institute                                           Imaging
                  National Institute                                    on Drug Abuse                                                 and
                   of Dental and                                                                                                 Bioengineering
                    Craniofacial
                      Research
                                                                                                      National Human
                                                                                                     Genome Research
  National Institute
                                                                                                          Institute
   of Arthritis and            National Institute
  Musculoskeletal                 of General             National Institute
 and Skin Diseases             Medical Sciences          of Mental Health
                                                                                                                 National Institute
                                                                                                               of Nursing Research        National Center
                                                                                                                                           for Research
                                                                              National Heart,                                               Resources
                                                                             Lung, and Blood
                                                                                 Institute
  National Institute on
                                                                                                                           National Institute
  Deafness and Other                            National Institute
                                                                                                                            of Allergy and
    Communication                                of Neurological
                                                                                                                         Infectious Diseases
       Disorders                                 Disorders and
                                                     Stroke
National Center on                                                                               National Library
 Minority Health                                                                                   of Medicine
    and Health                     National Institute
    Disparities                    on Alcohol Abuse
                                    and Alcoholism
                                                                                      National Center
                                                                                    for Complementary                                 New!
Largest SBIR/STTR                                                                     and Alternative
                                                                                         Medicine
    set-asides
                     National Institutes of Health
                          http://www.nih.gov/icd/
                               Office of the Director




National Center on
 Minority Health
    and Health
    Disparities
    Final Exam




The Top 10 List
       Top 10 Reasons to Seek
 SBIR / STTR Funding Opportunities
10. $2.0 Billion available

 9. NOT A LOAN - no repayment
 8. Provides recognition, verification
    and visibility
 7. Potential leveraging tool to attract
    venture capital/other sources of $$$
      Top 10 Reasons to Seek
SBIR / STTR Funding Opportunities
6. Fosters partnerships (e.g., large
   corporations, academia)
5. Stimulates local and state
   economies = stronger national
   economy
4. Provides seed money to fund high
   risk projects
      Top 10 Reasons to Seek
SBIR / STTR Funding Opportunities
3. Intellectual property rights are
   normally retained by the small
   business
2. Small business concerns are
   recognized as a unique national
   resource of technological
   innovation
      Top 10 Reasons to Seek
SBIR / STTR Funding Opportunities

 1. To make economic and societal
     contributions to America



                    NIH + Army
       Real Solutions…..
Real Problems…. Real People…


    Seeing is Believing…
Corneal Surgery with Femtosecond Lasers
    Dr. Ronald Kurz and Dr. Tibor Juhasz
        Intralase Corporation (CA)
                 National Eye Institute
             SBIR: EY012340, EY014301
    Entrepreneurial Audacity

     Discovery of Penicillin….

     First step on the moon…

Invention of the personal computer…

        And now the first…
 Implantable Replacement Heart
                Dr. Robert Kung
            Abiomed Corporation (MA)
             National Heart, Lung, and Blood Institute
                             HV038128




AbioCorTM
               Artificial Skin
   Drs. Naughton, Bartel, Riley, Hollister and Ratner
 Advanced Tissue Sciences, Inc., U.Michigan and U. Wash.
                National Institute of Neurological Disorders and Stroke
                  SBIR: AR 40121, AR 41110, CA 057161, DK041968,
                               BRP: HL064387 , DE013608




Post-Burn Day 1                       Post-Burn Day 21
Technology Entrepreneurship

     Intellectual Rigor
              +
         Hard Work
              +
          Passion
              +
           Mission
        Real Solutions…..
 Real Problems…. Real People…

           “Lab to Life”
 Today’s Ideas

                 Tomorrow’s Discoveries

A Better Future for All Americans
        Jo Anne Goodnight
NIH SBIR/STTR Program Coordinator
       Phone: 301-435-2688
         Fax: 301-480-0146
      Email: jg128w@nih.gov

               or

            Kay Etzler
     NIH SBIR/STTR Program
       Phone: 301-435-2713
    Email: etzlerk@od.nih.gov

								
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