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SBIRSTTR Overview.ppt

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SBIRSTTR Overview.ppt Powered By Docstoc
					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
      Research Opportunities
    Reserved for Small Business



 SMALL BUSINESS INNOVATION
  RESEARCH (SBIR) PROGRAM

SMALL BUSINESS TECHNOLOGY
 TRANSFER (STTR) PROGRAM
                              Updated 01/17/2006 JG)
                     Agenda

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

 • Small Business Innovation Research (SBIR)
2.5%   Set-aside program for small business
       concerns to engage in federal R&D --
       with potential for commercialization.

 • Small Business Technology Transfer (STTR)
0.3% Set-aside program to facilitate cooperative
     R&D between small business concerns
     and U.S. research institutions -- with
     potential for commercialization.
   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 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)]
    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*]
     SBIR PROGRAM
ELIGIBILITY CHECKPOINTS

 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

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
            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 Participating Agencies

                   •   DOD    SBIR/STTR
                   •   HHS    SBIR/STTR
                   •   NASA   SBIR/STTR
                   •   DOE    SBIR/STTR
                   •   NSF    SBIR/STTR
                   •   DHS    SBIR
                   •   USDA   SBIR
                   •   DOC    SBIR
                   •   ED     SBIR
TOTAL ~ $2.2 + B   •   EPA    SBIR
   FY 2006         •   DOT    SBIR
DHHS Budget and Award Amount
                                 STTR
 2006 Budget     SBIR

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


    IMPROVE HUMAN HEALTH
through biomedical and behavioral
    research, research training
       and communications.
                                            NIH Organization
                                                        Office of the Director
                                                                                          http://www.nih.gov/icd
                                                                        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
            Examples of
    Cross-Cutting Areas of Interest
   Nanotechnologies
   Bioinformatics
   Biodefense
   Proteomics / Genomics
   Genetically engineered proteins
   Biosensors
   Biosilicon devices
   Biocompatible materials
   Acousto-optics and opto-electronics
   Imaging technologies
   Education/communication tools
   Computational biology
   Behavioral research
       Small Companies Can Help
         NIH Meet its Mission

Conduct innovative R/R&D that results in
product, process, or service that will...

   Improve patient health
   Speed process of discovery
   Reduce cost of medical care/cost of
    research
   Improve research & communication tools
                      Our Ideas…
• SBIR/STTR Omnibus Grant Solicitation
  (NIH, CDC, and FDA) = Parent FOA
  Release: January       April 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: August           November 6, 2006 receipt date


• NIH Guide for Grants and Contracts
  Release: Weekly           Various receipt dates
      http://grants.nih.gov/grants/funding/sbir.htm
            Your Ideas …


 Investigator-initiated R&D
 Research projects related to the NIH
  mission
 “Other” areas of research within the
   mission of an awarding component
       NIH SBIR/STTR PROGRAM
     Review Process for Research Grant
                           Submits           NIH Center for Scientific Review
                      SBIR/STTR Grant             Assign to IC and IRG
Small Business
                      Application to NIH
   Concern
                        Electronically

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
       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
      Phase II Review Criteria
   Same as Phase I
   Demonstrated Feasibility in Phase I
   Commercialization Plan
   High Degree of Commercial Potential
    based on plan
    … Protection of Human Subjects
    … Animal Welfare
    … Budget
         SBIR “FAST-TRACK”
 Standard application, review, award process
                                                 7-9 months
Phase I 7-9 months
                                      Phase II
                     6 months
                                                       24 months

Fast-Track review option
 Phase I + Phase II 7-9 months              Satisfactory Phase I
                                                Final Report
  Simultaneous                   6 months
submission/review
                       Phase II
 DOES MY TECHNOLOGY
     “FIT” IN NIH?

See Mission Statement!
       Solution to…
      Real Problem….
 that affects Real People!
Entrepreneurial Research Institutions




  Universities / Industry Partnerships
                   and
         Cultural Differences
   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
UNIVERSITY AND INDUSTRY:
    Two diverse cultures

  Industry Researchers
    are from MARS


  University Researchers
    are from Venus
UNIVERSITY AND INDUSTRY:
         Two diverse cultures

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

Industry culture
   Mission toward research / R&D /
      commercialization
   Quick-paced
   Solve problems - develop new products  profit
   Maintain control of science to explore full
     potential of discovery (initially)
   Economic impact: Jobs, societal benefit
      CULTURAL DIVERSITY
 That was then…
                        This is now…

University - Industry Partnerships
Critical dimension of the new
“Knowledge-based Economy”
   Universities are establishing creative and
                 is KEY!
      entrepreneurial environments for the
      commercialization of university
      intellectual property
   Universities and Industry learning to
     work together
Entrepreneurial Research Institution
             Key Ingredients

    Develop common goals between
     faculty-initiated business and
     mission of research institution
    Create environment that enables
     innovation and entrepreneurship
    Protect IP assets of university
    Establish policies to manage, reduce
     or eliminate conflict of interest (COI)
Examples of Successful Entrepreneurial
        Research Institutions


• The Ohio State University          • Texas A&M University
• Purdue University                  • Penn. State University
• University of Wisconsin            • UC San Diego
• N.C. State University              • University of Utah
• Georgia Tech                       • Carnegie Mellon University
• Virginia Tech                      • Stanford University

 Source: Innovation U. “New University Roles in A Knowledge Economy”
   Southern Technology Council and Southern Growth Policies Board
 Examples of Successful Entrepreneurial
     Research Institutions (cont.)


• 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

   http://www.purdueresearchpark.org
 Examples of Successful Entrepreneurial
     Research Institutions (cont.)

• 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
                 SUCCESS STORY

• Endocyte, Inc. (Purdue Research Park)
     Researcher, Philip Low, discovered way to diagnose,
      potentially cure, ovarian cancer using vitamin folate
     Sell technology or start own company to develop and
      market treatment????
     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
STTR ELIGIBILITY CRITERIA

 Applicant Organization
 Research Institution Partner
 Principal Investigator

  Yellow Lights….

             Red Lights
         STTR
APPLICANT ORGANIZATION


 Small Business Concern ALWAYS
 the applicant/awardee organization
     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
      STTR RESEARCH
   INSTITUTION PARTNER


Formal collaborative relationship with SBC
Perform minimum of 30% of the
 research/R&D (maximum 60%)
         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
            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
           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
             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
               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

Subcontracts       Phase I      < 33.3%      < 60%
                   Phase II     < 50%        < 60%
Research Partner              Not Required   > 30%
Business Employment of PI       >50%          n/a
      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
Questions?

				
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