Secrets of NIH Small Business Grant Applications September 21, Gregory Milman

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1 Secrets of NIH Small Business Grant Applications 1 Beware of Secrets 2 National Institute of Allergy and Infectious Diseases 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. Besides, I would prefer my opinions remain secret. Particularly important Information is highlighted in red NIH Small Business Research Funding Opportunities 3 SBIR/STTR Company Eligibility Rules 4 Funding Opportunities Small Business Innovation Research (SBIR) Small Business Technology Transfer Research (STTR) Eligibility Receipt dates Program descriptions and research Topics Electronic submission information Application review process Policy information Grant preparation resources NIH Small Business Conference information Satisfy U.S. ownership requirement. Principal place of business in U.S. SBIR/STTR funded research must be conducted entirely in the U.S. Control research facilities where SBIR/STTR research will be conducted. Small = 500 or fewer employees in the small business and all its affiliates. Opportunities for foreign and VC-owned companies. Collaboration Ownership under 50% SBIR and STTR Are Multiphase Programs 5 Propose Just Enough Work in Phase I to Get to Phase II Larger Balloons Are More Likely to Be Popped 6 Phase I Awards (1 or 2 years) SBIR Phase I Median Award $199K/year (FY2010) STTR Phase I Median Award $174K/year (FY2010) Awards to about 12.5% of applications (FY2010) Phase II Awards (2 or 3 years) SBIR Phase II Median Award $529K/year (FY2010) STTR Phase I Median Award $562K/year (FY2010) Awards to about 29.6% of applications (FY2010) Fast-Track Combined Phase I/II application Competing Phase II (renewal) For FDA related products Awards up to $1M per year for 2 to 3 years Phase III Remaining steps of commercialization Not funded by government. Funded by other sources Review Committee Review Committee Your Application Page 1

2 Potential NIAID SBIR Funds Per Project (Total Cost) SBIR Collaboration for Academic Investigators 7 Ways Academics Can Tap into SBIR and STTR Grants 8 Grant Years per Year Total Subcontract* Phase I 2 $0.3M $0.6M $0.3M Phase II 3 $1.0M $3.0M $1.5M Renewal 3 $1.0M $3.0M $1.5M Total 8 $6.6M $3.3M Average $825K $413K Consultant on small business grant Subcontractor on small business grant Principal investigator on small business grant Contact PI on STTR grant Non-Contact PI on Multiple PI SBIR grant Start a small business with grant funds Shift careers with NIH SHIFT Award * Subcontract could be to an academic investigator Median competing R01 = $381K/year (Total Cost) SHIFT Award: Small Businesses Helping Investigators to Fuel the Translation of Scientific Discoveries (R43/R44) 9 SHIFT Connector: Bringing Academic Investigators and Companies Together 10 PI SHIFT requirement At time of application, contact PI must be primarily employed by research institution. At time of award, contact PI must be primarily employed by small business. No new investigator advantage or disadvantage. NIAID hosts pilot SHIFT Connector site to help investigators and businesses connect for SHIFT award applications. Academic investigators describe product-oriented research topics Businesses describe their diseases and products Networking sponsors provide network contact information Budget Higher than "Normal" Phase I up to $200K/year for 1 or 2 years Phase II up to $750K/year for 2 or 3 years Topics Any within the mission of the twelve participating Institutes and Centers Receipt, Review, and Award Dates 11 SBIR/STTR Funding Timeline Example December Receipt Date 12 Awards Within Payline ~ 33% ~ 33% ~ 33% Receipt (AIDS) Apr 5 (May 7) Aug 5 (Sep 7) Dec 5 (Jan 7) Review Jun-JulJul Oct-Nov Feb-Mar Council Sep-Oct Jan-Feb May-Jun Estimated Award Nov Mar Jul Phase I Dec 2007 Submit Phase I application Jun 2008 Application reviewed Sep 2008 Grant Funded $600K/2yr Aug 2009 Complete Phase I Sp. Aims Phase II Dec 2009 Submit Phase II application Jun 2010 Application reviewed Sep 2010 Grant funded for $3M/3yr --- Dec 2012 Submit Phase II renewal Jun 2013 Application review Sep 2013 Grant funded for $3M/3yr --- Sep 2014 Seek venture funding, licensing or acquisition SBIR/STTR Funding Timeline EXAMPLE: Optimal 50% Awarded ~Apr ~Jun ~Aug Page 2

3 Characteristics of an Outstanding Small Business Grant Application 13 Deciphering NIH Grant Numbers 14 Addresses a significant problem Leads to an innovative product Has an impact on the problem Offers high financial reward for business Exit strategy can be achieved in reasonable time Reasonable likelihood of success judged by Investigators prior accomplishments Approach and experimental design Preliminary data Company and collaborator resources Milestones achieved in Phase I 1R43AI A1 Type: 1=new, 2=renewal, and 5=continuing noncompeting Activity: Letter and two numbers, R=research, K=training, U=cooperative agreement Institute or Center (IC): Two letter code Grant number: Five numbers that are IC dependent Funding year: Two numbers A1 or A2: If present, an amended (revised) application Grant numbers do not provide FOA information. SBIR (R43 and R44) Small Business Innovation Research 15 STTR (R41 and R42) Small Business Technology Transfer Research 16 Business applies for and receives award 2.5% of NIH extramural research budget About $599M in competing and noncompeting FY2010 NIH awards Principal Investigator (PI) in single PI application must be employed over 50% by company. Multiple PI applications allowed One as Contact PI Leadership plan required 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 Business applies for and receives award 0.3% of NIH extramural research budget About $83M in competing and noncompeting FY2010 NIH awards Requires research institution partner that conducts a minimum of 30% of the work (funds) Business must conduct minimum of 40% of work Remaining funds, if any, can be used for consultants or other subcontractors Contact PI Must commit 10% effort Need not be employed by business Full-time academic employee allowed Need not receive salary from award Advantages of SBIR and STTR Awards 17 FY2010 NIH Phase I Applications 18 SBIR over STTR No research institution partner necessary Flexibility to increase or decrease subcontracting Academic scientist consultant fees on top of salary STTR over SBIR Company lacks credible PI Contact PI role essential to academic scientist Potentially better access to academic facilities, intellectual property and support Higher percent Phase I subcontract possible. Changes between SBIR and STTR are not permitted from Phase I to Phase II (may change) Type Received Funded Award Rate SBIR All % Initial % Revisions % Median Award/Yr $199K STTR All % Initial % Revisions % Median Award/Yr $174K R01 New % Median Award/Yr $374K Page 3

4 FY2010 NIH Phase II Applications 19 Budget and Fee SBIR/STTR Advice 20 Type Received Funded Award Rate SBIR All % Initial % Revisions % Median Award/Yr $529K STTR All % Initial % Revisions % Median Award/Yr $562K R01 Competing % Median Award/Yr $376K Request and justify Phase I for 2 years and $ K/year (STTR) or K/year (SBIR). Complete one year or more of Phase I research prior to Phase I funding. Charge up to 90 days pre-award research to grant. Apply for Phase II grant during first year of Phase I. Do not exceed the salary cap. A fee up to 7% can be used for expenses not allowed on your grant. Patent costs Market research Expenses outside the U.S. SBIR/STTR Application Review Panels 21 My Interpretations of NIH Application Review Criteria 22 The percent of reviewers affiliated with companies varies from about 20% to 60%. Only a few reviewers are your application's Subject Matter Experts. They greatly influence your score. Reviewers read, discuss, and give an Impact score to applications they think belong among the best 50%. The rest are not discussed and not scored (triage). The average Impact score is multiplied by 10 to give a final score of between 10 and 90 (10=best). Five Core Review Criteria Significance Is the problem important? Innovation Will the product make a difference? Investigators Are you qualified for the work? Approach Are your studies well designed? Environment Do you have the essential resources and collaborators? Impact Score: The overall impact of proposed research is not an average of five Core Review Criteria. Significance (Health Problem In People) 23 Focus On A Product, Not On Your Technology 24 Single narrow disease is best because the application will be assigned to a reviewer who knows and cares about that disease. What are the number and composition of the population affected? What discoveries are needed? (gaps, roadblocks, etc.) Core technology builds a business. A single use of core technology makes an SBIR/STTR application. Advantages of focus on single use: Meets needs of specific problem 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. Page 4

5 Innovation (Product) 25 Title One Product and One Problem in 81 Characters (Innovation and Significance ) 26 Why is your product innovative (better, faster, at lower cost, etc.)? What are the public health implications? What are the product's financial projections? After Phase II, what additional steps will be necessary before your company can realize a profit? Title should convey two pieces of information. What is your product? (Innovation) What is the public health problem? (Significance) Decide on your title before you write your application! The remaining sections of your application are just details. Titles of Real Phase I SBIR Applications Do these include both a product and a problem? 27 Specific Aims (All Criteria) 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 5. An Immunoadhesin Therapy for Gastrointestinal Anthrax 6. Proteolytic Antibodies for Treatment of Psoriasis 7. ADynamicWebbased 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 Paragraph 1 Problem and its significance Current solutions, gaps, roadblocks Paragraph 2 Your product Why it is an innovative solution to the problem Specific Aims (two or three with bullets for each) No more than necessary to justify Phase II Timeline Environment contribution if applicable Easily assessed by a review committee End point specific aims as opposed to a best effort A best effort specific aim is "to evaluate a number of potential drug candidates." An end point specific aim is "to select the best drug candidate for Phase II study." Due Diligence Online Tools 29 Select an SBIR/STTR Study Section 30 A. Small Business Research Funding Opportunities B. NIH Center for Scientific Review (CSR) C. PubMed D. NIH Research Portfolio Online Reporting Tools 1. Strategic Plans and Visions 2. Success Rates 3. NIH RePORTer E. Scopus (Elsevier Subscription) SEP = Special Emphasis Panel Page 5

6 SBIR/STTR Study Sections Topic Example: Malaria Peptide Vaccine 31 Small Business Non-HIV Microbial Vaccines Topic Example: Malaria Peptide Vaccine 32 [IMM-N Roster] Choose your study section in application cover component Study Section Rosters 33 ZRG1 IMM-N Reviewer Information 34 NIH Research Portfolio Online Reporting Tools (RePORT) 35 NIH RePORTer: NIH Funding Reports 36 Campbell A. Page 6

7 Active Grants for A. Stewart Campbell Description of Campbell's Active Grant "Evaluation Vaccine in Severe Anemia Models of Malaria" Details of Campbell's Active Grant 39 Similar SBIR and STTR Projects 40 NIH RePORTer: NIH Funding Reports 41 Search Results Malaria Peptide Vaccine Funded R01 Grants 42 Malaria Peptide Vaccine R01 Page 7

8 PubMed: Biomedical Literature Citations 43 PubMed Advanced Search Example: Malaria Peptide Vaccine and Scopus 45 Scopus 46 Deciphering Funding Opportunity Announcements SEPs Always Review SBIR and STTR Applications 47 Stick to the Omnibus Solicitation Master the Beginner Slopes First 48 PA Program Announcement reviewed by NIH Center for Scientific Review (CSR), with some advance review committee information. PAR Program Announcement Reviewed by IC usually with singlemeeting review committee. PAS Program Announcement Reviewed by IC with set-aside (dedicated) funds and single-meeting review committee. RFA Request for Applications Reviewed by IC with set-aside funds usually one-time solicitation and single-meeting review committee. NIH Guide: Fast-Track Other FOAs Omnibus Solicitation Page 8

9 Patents on Intellectual Property 49 Just-in-Time Our Time, Not Yours 50 Do not submit a grant application until you have applied for patents on your intellectual property just good practice, not an NIH requirement. Patent protection is an absolute requirement for a business. Describe your strategy if existing patents block the market for your product. Core technology must be protected (patented, patent pending, or provisional patent pending). Company must own title to patent or have exclusive license to it. Provisional Patent Application Allows one year to file full application Not examined on merits Should be prepared by professional Other support data for PI and all key personnel Lease agreement PI and applicant institution eligibility verification Human subjects Federalwide Assurance (FWA) number Institutional review board (IRB) approval certification date Human subjects education certification Institutional animal care and use committee (IACUC) assurance number and approval date NIH Offers More Than Funds 51 Collaboration with NIH Scientists Your Resources or Funds Go to NIH 52 Material transfer agreements (MTA), licenses, and cooperative research and development agreements (CRADA) (Buy from NIH) Pipeline to Partnerships (P2P) partnership and licensing information (Get resources) Technical assistance programs (TAP) (Get consultation) Market research assistance Presentation assistance (dog & pony show) Manufacturing assistance Material Transfer Agreement (MTA) Research purposes only. Licenses purchase of rights to use intellectual property for commercial purposes. Cooperative Research And Development Agreement (CRADA) with NIH Scientists. Collaboration over substantial period of time. Both parties contribute t resources NIH Pipeline to Partnerships (P2P) Contact an Angel (Investor)? 53 NIH SBIR Technical Assistance Program (TAP) Competitive, So Apply Early! 54 Registration open to NIH licensees and NIH SBIR/STTR awardees. Registrants describe Disease category Product type Product application Product status Partnership opportunities sought NIH provides searchable database and links to registrants web information. Disclaimer Submissions not endorsed or recommended by NIH but monitored by NIH staff Niche Assessment Program (NAP) for NIH Phase I awardees Market analyses of technology Strategic planning for technology Commercialization Assistance Program (CAP) for NIH Phase II awardees Free 10 month program (except travel) to develop company's investor presentation Presentation at venture forum Page 9

10 Links to More Information 55 Alerts and Funding News Advice on SBIR and STTR Applications Ph. D. Division of Extramural Activities NIAID, NIH, DHHS 6700-B Rockledge Drive; Room 2130 Bethesda, MD Tel (301) Fax (301) Page 10