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					Secrets of NIH SBIR & STTR Grant Applications                                                                                 Gregory Milman
February 23, 2010                                                                                                       gmilman@niaid.nih.gov


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                                                                                  SBIR
        Secrets of NIH Small Business Grant Applications
                                                                                  Small Business Innovation Research

                                                                                               Business applies for and receives award
                                                                                               2.5% of NIH extramural research budget
                            Gregory Milman                                                     About $550M in FY2008 NIH awards
                       National Institute of Allergy                                           Principal Investigator (PI) in single PI application must
                          and Infectious Diseases                                              be employed over 50% by company.
                                                                                               Multiple PI applications allowed
                        gmilman@niaid.nih.gov                                                   – Leadership plan required
                           February 23, 2010                                         SBIR       – Contact PI employed over 50% time by company.
                                                                                                – Academic PI allowed but not as a Contact PI
                                                                                               Subcontracting allowed but not required
                                                                                               Maximum subcontracting nominally
                                                                                                – 33% in Phase I
                                                                                                – 50% in Phase II
                                                                                                – actual amount somewhat flexible with justification




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        STTR
        Small Business Technology Transfer Research

                      Requires research institution partner that conducts a                            Funding Opportunities
                      minimum of 30% of the work (funds)                                SBIR &
                                                                                                        – Small Business Innovation Research (SBIR)
                      Business must conduct minimum of 40% of work                       STTR
                                                                                                        – Small Business Technology Transfer
                      Remaining funds, if any, can be used for consultants                                 Research (STTR)
                      or other subcontractors                                                          Eligibility
                      Business applies for and receives award                                          Receipt dates
                      Contact PI                                                                       Program descriptions and research Topics
           STTR
                       – Must commit 10% effort                                                        Electronic submission information
                       – Need not be employed by business                                              Application review process
                       – Full-time academic employee allowed                                           Policy information
                       – Need not receive salary from award                                            Grant preparation resources
                      0.3% of NIH extramural research budget                                           NIH Small Business Conference information
                      About $72M in FY2008 NIH awards




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        Revealing Secrets Levels the Playing Field                                Beware of Secrets


                                                                                               The secrets I share are my opinions.
                                                                                               Opinions are not facts.
                                                                                               My opinions are based on experience.
                                                                                               But, my opinions may not be shared by everyone
                                                                                               including reviewers and other NIH staff.
                                                                                               Caveat emptor applies.
                                                                                               My opinions are not official, so don’t quote me.




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Secrets of NIH SBIR & STTR Grant Applications                                                                                  Gregory Milman
February 23, 2010                                                                                                        gmilman@niaid.nih.gov


                                                                               7                                                                       8
        Agenda


                     Real budget and time limitations                                           Real budget and time limitations
                     Award rates for Phase I and II                                             Award rates for Phase I and II
                     My interpretations of NIH Review Criteria                                  My interpretations of NIH Review Criteria
                     My application advice                                                      My application advice
                      – Focus on a single narrow but significant problem                         – Focus on a single narrow but significant problem
                      – Decide on a single product to address the problem                        – Decide on a single product to address the problem
                      – Write your title first (On Line Exercise)                                – Write your title first (On Line Exercise)
                      – Limit your specific aims for Phase I                                     – Limit your specific aims for Phase I
                      – Describe approach including preliminary data,                            – Describe approach including preliminary data,
                        timeline, and anticipated results and problems                             timeline, and anticipated results and problems
                      – Explain access to resources important to project                         – Explain access to resources important to project
                      – Justify appropriate budget and fee                                       – Justify appropriate budget and fee
                      – Prepare exciting non-proprietary project summary                         – Prepare exciting non-proprietary project summary
                     More tips                                                                  More tips




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        SBIR and STTR Are Multiphase Programs                                      FY2008 NIH Phase I Applications


                     Application Guide budget information                                       Type         Received    Funded Award Rate
                      – SBIR Phase I normally $100K for 6 months
                      – STTR Phase I $100K for 1 year
                                                                                                SBIR All        3062        739       24.1%
                      – SBIR & STTR Phase II $750K for 2 years
                     FY2008 Awards                                                              Initial         2255        478       21.2%
                      – Average NIH Phase I $160K per Year for 1 or 2 years                     Revision         661        208       31.5%
                      – Average NIH Phase II $375 per Year for 2 or 3 years
                     Fast-Track – Combined Phase I/II application
                                                                                                STTR All         805        109       13.5%
                     Competing Phase II renewal for some Institutes
                      – For FDA related products
                                                                                                Initial          521         49        9.4%
                      – Compete with other Phase II applications                                Revision         222         38       17.1%
                      – Award up to $1M per year for 2 to 3 years
                     Phase III                                                                  R01 All       30624        5852       19.1%
                      – Remaining steps of commercialization
                      – Not funded by NIH. Funded by other sources, e.g.,
                         angels, venture capital, etc.




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        FY2008 NIH Phase II Applications                                           Ways Academics Can Tap into SBIR and STTR Grants


                     Type         Received Funded Award Rate                                    Consultant on small business grant
                                                                                                Subcontractor on small business grant
                     SBIR All         675        269        39.9%                               Principal investigator on small business grant
                     Initial          401        161        40.1%                                – Contact PI on STTR grant
                     Revision         196         76        38.8%                                – Non-Contact PI on Multiple PI SBIR grant
                                                                                                Start a small business with grant funds
                     STTR All         130          43       33.1%
                     Initial           73          24       32.9%
                     Revision          37          10       27.0%

                     R01 All        30624       5852        19.1%




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Secrets of NIH SBIR & STTR Grant Applications                                                                                            Gregory Milman
February 23, 2010                                                                                                                  gmilman@niaid.nih.gov


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        My Interpretations of NIH Application Review Criteria                        Application Components Relating to Review Criteria

                    Five Core Review Criteria                                        Pages   Section
                     – Significance – How important is the problem?                   N/A    Title (Significance and Innovation in 81 characters)
                     – Investigators – How qualified are the investigators?           N/A    Project Summary/Abstract (All Criteria)
                                                                                       1     Introduction – Resubmitted or New Applications Only
                     – Innovation – How important is the product?
                                                                                       1     Specific Aims (Significance, Innovation, Approach)
                     – Approach – How well designed is the research?                   6     Research Strategy
                     – Environment – How critical are the collaborators and                     a. Significance
                       the facilities?                                                          b. Innovation
                                                                                                c. Approach
                    Overall Impact: The overall impact of proposed research
                                                                                                     • Preliminary Studies for New Applications
                    is not an average of five Core Review Criteria.
                                                                                                     • Progress Report for Renewal/Revision Applications
                    Significance and Innovation are the most important                               • Research Design: Strategy, Methodology, Analyses
                    criteria!                                                         N/A    Facilities and Other Resources – Environment. Explain how resources
                                                                                             contribute to project.
                                                                                       4     Biographical Sketch – Investigators, Environment
                                                                                                a. Personal Statement –Qualifications for Project
                                                                                                b. Publications – No More than 15 Relevant to Project




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        Significance (Public Health Problem)                                         Focus On One Product, Not On Your Technology


                      Single narrow disease is best because the application                            Core technology builds a business.
                      will be assigned to a reviewer who knows and cares                               A single use of core technology makes an SBIR/STTR
                      about that disease.                                                              application.
                      What are the number and composition of the                                       Advantages of focus on single use:
                      population affected?                                                              – Meets needs of specific problem
                      What discoveries are needed? (gaps, roadblocks, etc.)                             – Targets committed reviewers
                                                                                                        – Demonstrates business acuity
                                                                                                        – Allows additional applications using same core
                                                                                                           technology
                                                                                                        – Directs different uses of your technology to
                                                                                                           different ICs and different review groups
                                                                                                       Describe the public health and financial significance of
                                                                                                       your product.




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                                                                                     Title – One Product and One Problem in 81 Characters
        Innovation (Product)
                                                                                     (Innovation and Significance )

                      Why is your product innovative (better, faster, at                               Title should convey two pieces of information.
                      lower cost, etc.)?                                                                – What is your product? (Innovation)
                      What are the public health implications?
                                                                                                        – What is the public health problem? (Significance)
                      What are the product's financial projections?
                                                                                                       Decide on your title before you write your application!
                      After Phase II, what additional steps will be necessary
                      before your company can realize a profit?                                        The remaining sections of your application are just
                                                                                                       details.




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Secrets of NIH SBIR & STTR Grant Applications                                                                                       Gregory Milman
February 23, 2010                                                                                                             gmilman@niaid.nih.gov


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        Titles of Real Phase I SBIR Applications                                       Limit Your Specific Aims for Phase I
        Do these include both a product and a problem?                                 Larger Balloons Are More Likely to Be Popped

        1.  Development of Antimicrobial Peptides
        2.  Antigen Detection Assay for the Diagnosis of Visceral Leishmaniasis
        3.  Enteric-coated Vector Microparticles for Oral Vaccination
        4.  Coupled Enzyme Reporter Assay for Proteases                                            Review Committee
        5.  An Immunoadhesin Therapy for Gastrointestinal Anthrax
        6.  Proteolytic Antibodies for Treatment of Psoriasis
        7.  A Dynamic Web-based Geospatial Data Visualization and
            Distribution System
        8. Virus-like Particle (VLP) Vaccine for RSV
        9. Molecular Screen for Antiviral Agents
        10. Multi-antigen Peptide Assay for the Serodiagnosis of Lyme Disease


                                                                                                                                   Your Application




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        Specific Aims
                                                                                       Approach – Preliminary Studies/Progress Report
        (All Criteria)

                         Paragraph 1                                                                Phase I applications – Preliminary studies (Investigators)
                          – Problem and its significance                                             – Omnibus Solicitation states “Preliminary data are not
                          – Current solutions, gaps, roadblocks                                        required.”
                                                                                                     – But, most applications present preliminary data.
                         Paragraph 2
                                                                                                     – Reviewers want to see preliminary data.
                          – Your product
                                                                                                     – Preliminary data should support your proposal and
                          – Why it is an innovative solution to problem                                the feasibility of Phase I and Phase II.
                         Specific Aims (two or three with bullets for each)                          – Preliminary data may consist of publications by you
                          – No more than necessary to justify Phase II                                 and your collaborators and your unpublished data.
                          – Timeline                                                                 – Interpret preliminary data critically and evaluate
                          – Environment contribution if applicable                                     alternative meanings.
                          – Easily assessed by a review committee                                   Phase II applications – Phase I progress report
                                                                                                     – Milestones proposed
                                                                                                     – Milestones achieved




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        Facilities and Resources
                                                                                       Budget and Fee
        (Environment)

                         Company current or tentatively leased research                             Request and justify Phase I for 2 years and
                         facilities                                                                 $200-250K/year (STTR) or 250-300K/year (SBIR).
                         Company research resources necessary for project                           Complete one year or more of Phase I research prior
                         Unique company capabilities                                                to Phase I funding.
                         Not a virtual company                                                      Charge up to 90 days pre-award research to grant.
                         Research resources of collaborating laboratories and                       Apply for Phase II grant before first year of Phase I.
                         institutions                                                               Do not exceed the salary cap.
                         Subcontractor R&D Resources                                                A fee up to 7% can be used for expenses not allowed
                         New – Explain why resources are important to project                       on your grant.
                                                                                                     – Patent costs
                                                                                                     – Market research
                                                                                                     – Expenses outside the U.S.




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Secrets of NIH SBIR & STTR Grant Applications                                                                                          Gregory Milman
February 23, 2010                                                                                                                gmilman@niaid.nih.gov


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        Project Summary/Abstract
                                                                                    More Tips
        (All Criteria)

                     All reviewers read your abstract.                                               Goal of Phase I is to get to Phase II
                     Compose it after you complete rest of application.                              Select project best for your company
                     Concisely summarize application.                                                 – Apply to Omnibus Solicitation
                     Include no proprietary information.                                              – No need to search through Funding Opportunity
                     Write a few sentences on each:                                                      Announcements (FOAs)
                      – Public health problem                                                         – FOA success rate not any better than Omnibus
                      – Issues with current solutions
                                                                                                     Have patent protection before submission
                      – How your product addresses unmet needs
                                                                                                     Have little time for "Just-In-Time" information
                      – Summary of approach
                                                                                                     Wait for an award is longer than you think
                      – Collaborators and unique resources and
                          capabilities
                      – Phase I specific aims
                      – How anticipated results justify Phase II and further
                          product development




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        All NIH FY2008 SBIR Phase I & II Awards
                                                                                    Receipt, Review, and Award Dates
        Receipt and Award Dates


                                                                                                                                  Awards Within Payline
                                NIH Budget Approved                                                                           ~ 33%          ~ 33%           ~ 33%

                                            All Scores                                                   Receipt (AIDS)    Apr 5 (May 7)   Aug 5 (Sep 7)   Dec 5 (Jan 7)
                                             Are In

                                                                                                            Review            Jun-Jul        Oct-Nov         Feb-Mar



                                                                                                            Council          Sep-Oct         Jan-Feb         May-Jun


                                                                                                           Estimated
                                                                                                                               Nov             Mar              Jul
                                                                                                             Award

                                                                                                         50% Awarded           ~Apr           ~May            ~Aug


                                                   FY2009 Applications




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        Expand Your Horizon                                                         Links to More Information

                                                                                    Email Alerts and Funding News
                                             NIH                                    http://www.niaid.nih.gov/ncn/newsletters/default_subscribe.htm
                     DOD                                      NASA
                                            $645M                                   Narrated Animated Advice on SBIR and STTR Applications
                    $1270M                                    $115M                 http://www.niaid.nih.gov/ncn/sbir/pres.htm



                                                                                                                      CONTACT ME FOR LIVE PRESENTATION
                                                            DOE                                                       Gregory Milman, Ph. D.
                                                           $115M                                                      Division of Extramural Activities
                                                                                                                      NIAID, NIH, DHHS
                                                                                                                      6700-B Rockledge Drive; Room 2130
                                                                                                                      Bethesda, MD 20892-7610
                        SBIR/STTR                                                                                     Tel (301) 496-8666
                          FUNDS                                 NSF                                                   Fax (301) 402-0369
                                                                                                                      Email gmilman@niaid.nih.gov
                           $2.3B                               $95M




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