Developing the Business of Technology

Developing the Business of Technology SBIR Proposal Preparation Tips: Granting Agencies 2018 Mid Atlantic SBIR/STTR & Commercialization Conference April 25, 2018 Becky Aistrup Managing Partner 734.930.9741 becky@bbcetc.com bbcetc.com / @BBC_etc 1

Granting Agency Proposal Prep SBIR/STTR Introduction & Eligibility Granting Agencies vs. Contracting Agencies Doing Your Homework Writing Your Proposal for a Granting Agency NSF & NIH What s different? What s similar? What is the SBIR/STTR Program? A $2.6 Billion+ Federal Funding Program SBIR: Small Business Innovation Research STTR: Small Business Technology Transfer Intended to: Stimulate technological innovation in the private sector Strengthen the role of small business in meeting Federal R&D needs Increase commercial application of Federally-supported research [Not an alternative source of funding basic research] 4 2

Goal of SBIR/STTR Programs What is SBIR/STTR. Mandated by legislation Current authorization through 2022 Separate legislation for SBIR and STTR Applies to agencies with extramural research budgets that exceed certain thresholds SBIR applicable to 11 Agencies STTR applicable to 5 of the 11 SBIR agencies Participation mandatory SBA oversees program implementation and compliance SBIR/STTR Policy Directive Small Business Size Regulations 6 3

4/25/2018 What Does SBIR/STTR Fund? Product Development What is the intended product? What applications will it be used for? Based on Technological Innovation What technological innovation will enable the product to achieve the desired performance? Is there risk of failure? Will the product be revolutionary or evolutionary? Credible Commercialization Strategy Is there a market identified? Competitive analysis done? How will the company generate revenue? What additional resources will be required to achieve commercialization? Have they been identified? Strategic Partners Sources of capital 7 Why SBIR/STTR? Debt Equity Non-Dilutive 4

Which Would You Choose? SBIR / STTR 9 months to funding 10% - 40% probability Don t need to know anyone Will fund early stage Don t take equity Don t take board seat $2 billion per year available Peer review Venture Capital 6-12 months to funding Low probability Need to know someone Unlikely to fund early stage Take equity (sometimes lots) Take a board seat (and sometimes control) 9 11 Participating Federal Agencies NSF NASA DoE HHS DoD TOTAL: ~$2.5 B FY 2015 GRANTS CONTRACTS *mostly 10 SBIR/STTR DOD - $1.4 B HHS* - $797 M DOE - $206 M NSF - $180 M NASA - $176 M SBIR Only USDA - $20 M DHS - $18 M DOT - $8 M DOC* - $8 M ED* - $8 M EPA - $4 M 5

Agency Differences Types of awards (grant or contract) $$$ (both their budgets and sizes of their awards) R&D topic areas Number & timing of annual solicitations Length of proposal Submission process Level of experimentation Proposal review process, i.e. internal vs. external Success rates The Basics of SBIR: 3 Phases 3 Years, ~$1,150,000+ Phase I: 6 Months, $150K Phase II: 2 Years, ~$1,000 K+ Phase III: Commercialization (no federal SBIR/STTR $$) 12 6

SBIR vs. STTR Relationship with a non-profit research institution: SBIR allows but does not require the involvement of a nonprofit research institution STTR requires the involvement of a non-profit research institution The Applicant Organization is always the Small Business! 13 SBIR vs. SBIR SBIR STTR Applicant is ALWAYS the Small Business Concern (SBC) Allows outsourcing* within the US Requires outsourcing* 1 subcontractor must be a non-profit research institution Maximum outsourcing limits 33% of Phase I 50% of Phase II PI must be employed by SBC > 50% of full time equivalent Minimum participation requirements 40% by SBC 30% by SBC 1 subcontractor PI may be employed by SBC or 1 Subcontractor > 50% of full time equivalent 10 % effort on project NSF always requires PI employment at SBC Company MUST have company controlled R&D facilities suitable to do work proposed 14 *outsourcing includes work done by subcontractors and consultants 7

Eligibility for Funding* Small business US owned and controlled < 500 employees For-profit Located in the U.S. R&D must be performed in the U.S. Company-controlled research space *at the time of award 15 SBIR & STTR Size Regulations* Ownership and Control >50% owned and controlled by: i. US citizens, permanent resident aliens and/or one or more domestic business concerns which themselves are >50% owned and controlled by US Citizens or permanent resident aliens..or. ii. Multiple domestic VCOCs, HFs, or PEFs, provided that no single such investor owns more than 50% (SBIR ONLY) *at the time of award 8

Facilities Requirement* The research work performed by the awardee must be conducted in: Company controlled Research space Suitable to do the work proposed 17 *at the time of award Do your Homework Understand eligibility and resource requirements Review agency-specific program information: Search past awards / Review closed solicitations Understand agency(s) funding cycles, timing, priorities Know how and by whom proposals are reviewed Contact agency program personnel and READ THE SOLICITATION!! 18 9

SBIR Information: SBIR.gov Links to all 11 agencies Search past awards Current/past solicitations 19 What has SBIR funded in your field? www.sbir.gov 10

Past Awards 11

Search Past Awards (agency websites) Agency Differences Receipt dates, number & timing of solicitations Type of award (grant or contract) Proposal review process R&D topic areas $ of award (both Phase I and II s) Proposal success rates Profit or fee allowed Gap funding provided (competing continuation grants) Payment types & schedules 24 12

SBIR/STTR Deadlines www.bbcetc.com SBIR/STTR Deadlines www.bbcetc.com 13

Registrations Required Registration Type Agency NIH DoD NSF NASA DoE USDA DoT EPA DoC DoEd DHS EIN X X X X X X X X X X X DUNS X X X X X X X X X X X SBIR.gov (company registration)* X X X X X X X X X X X SAM (System of Award Management) X X** X X X X X X X X X Grants.gov X X X X ecommons X FastLane X dodsbir.net X PAMS (DOE Office of Science Portfolio Analysis & Mgmt System) X ASAP X FedConnect X EHB (Electronic Handbook) X *SAM registration is not required to complete SBIR.gov registration **DoD does not require SAM registration until time of award but encourages it before submission Registrations Allow 8 weeks! All organizations submitting proposals to any agency must have the following: Prerequisites: EIN Employee Identification Number (IRS) DUNS Data Universal Number (D&B) Bank Account SAM* System for Award Management SBIR.gov Company Registry *NOTE: SAM registration and renewal now requires that a notarized letter be sent (effective 3/22/2018). 28 14

Grants vs. Contracts. 29 Agency Differences -- Grants vs. Contracts Grants Assistance Project/proposal is welldefined, but no formal agreement Progress/final reports Broad topics funded Agency contact unlimited No Phase III opportunities Contracts Procurement Well-defined, legally binding statement of work, obligations, responsibilities Specific deliverables defined Topic Specific Response Agency contact limited Phase III opportunities 30 15

Grants vs. Contracts Grants Investigator Initiated Topics HHS (95% $$), NSF, USDA, DOE, ED Some agencies might have topic areas (aka buckets ) Open communications with Agency personnel External peer review Contracts Agency-specified topics DoD, NASA, DHS, EPA, DOT, DOC, ED, HHS (5% $$) Must respond to a topic Limited time to prepare ( 8-12 weeks) Limited communications once solicitation opens Internal review Examples of Phase I Proposal Requirements SBIR/STTR Agency Proposal Commercial Section Department of Defense <20 page 1 page Health & Human Services <7 pages ½ page Department of Energy <15 pages 3-5 pages NASA <23 pages ½-1 page National Science Foundation <15 pages 7-10 pages 16

Granting Agencies Differences Between Granting Agencies Program focus and priorities Frequency and timing of solicitations Timing until funding decision Registration and submission processes Phase I and Phase II duration and budget limits What can (and cannot) be included in the budget Peer review recruitment Review criteria Research Strategy/Project Description sections required Emphasis on Commercialization Plan in Phase I Formatting requirements 17

DOE SBIR/STTR Program 35 Key Points About DOE Both SBIR and STTR programs Can apply to both simultaneously Two Phase I deadlines annually, different topics each time Release 1 due in mid-october Release 2 due in early February Issues topics similar to a Contracting Agency, but not a Phase III buyer Only Agency that requires a Letter of Intent prior to submission 36 18

DOE Project Structure Phase I Phase II 9 months $150,000 $225,000 24 months $1,000,000 $1,500,000 Feasibility Development Phase III????? Commercialization 37 Strategize for DOE SBIR or STTR? Note you can apply to both (if you meet the requirements) Release 1 Offices Advanced Scientific Computing Research Basic Energy Sciences Biological and Environmental Research Nuclear Physics Release 2 Offices Defense Nuclear Nonproliferation Electricity Delivery and Energy Reliability Energy Efficiency and Renewable Energy Environmental Management Fossil Energy Fusion Energy Sciences High Energy Physics Nuclear Energy 19

DOE Documents DOE Topics You must select a Topic and a sub-topic: 20

DOE Phase I Letter of Intent is Required 41 Template available to BBC customers National Science Foundation 42 21

Mission of NSF to promote the progress of science; to advance the national health, prosperity, and welfare; and to secure the national defense. 43 What Does NSF SBIR/STTR Fund? 44 High Degree of Technical Risk Has never before been attempted or successfully done Is still facing technical hurdles Potential for Significant Commercial Impact A product-market fit validated by customers Can potentially disrupt target market segment Presents competitive barriers-to-entry Offers potential societal benefits via commercialization That demonstrate strategic partnerships with research collaborators, customers, industry partners, and equity investors 22

NSF SBIR/STTR Does NOT fund Basic research Evolutionary optimization of existing products and processes or modifications to broaden the scope of an existing product, process or application Analytical or market studies of technologies 45 NSF SBIR/STTR Award Guidelines NSF Award Amounts Goal Program Max Budget Duration Ph I Feasibility SBIR/STTR $225,000 6-12 months Ph II Development SBIR/STTR $750,000 2 years Ph III Commercialization non-sbir???? NSF Award Timelines Program Release Date Accept Proposals Decision Period Project Start Release 1 Mar May-Jun 4-6 months Jan Release 2 Sep Nov- Dec 4-6 months Jul 23

NSF SBIR Program Interests Twelve Broad Topics* Advanced Manufacturing and Nanotechnology (MN) Advanced Materials and Instrumentation (MI) Biological Technologies (BT) Biomedical Technologies (BM) Chemical & Environmental Technologies (CT) Educational Technologies & Applications (EA) Electronic Hardware, Robotics & Wireless Technologies (EW) Information Technologies (IT) Internet of Things (I) Other Topics (OT) Semiconductors (S) & Photonic (PH) Devices & Materials Smart Health (SH) *https://seedfund.nsf.gov/portfolio/ Current NSF FOAs 48 24

NSF Decision Making Process Minimum of 3 outside reviewers Each deliver a written review & a rating Meet as a panel led by the Program Director Discuss and rank your proposal Provides guidance to the Program Director Program Director makes final decision on whether to recommend for funding 50 25

NSF Review Process Merit Review Criteria What is the intellectual merit of the proposed activity? What are the broader impacts of the proposed activity? 51 NSF Review Process Intellectual Merit Reviewer Instructions Does the plan establish a sound approach for establishing technical and commercial feasibility? To what extent are unique or ingenious concepts or applications explored? How well-qualified is the team to conduct the project? Is there sufficient access to needed resources? Is state-of-the-art reflected in the proposed activities? Are advancements in state-of-the-art likely? 52 26

NSF Review Process Broader Impacts Reviewer Instructions What may be the commercial and societal benefits? Will the outcome lead to a marketable product? Does the proposal lead to enabling technologies for further discoveries? Evaluate the competitive advantage vs. alternative technologies Is the project positioned to attract further non-sbir funding? Has the Company successfully commercialized previous SBIR technology? 53 NSF SBIR/STTR Application Required Format 54 1) Cover Sheet and Certification 2) Project Summary (3 boxes; 4,600 characters MAX) 3) Project Description (maximum 15 pages) 4) References Cited 5) Biographical Sketches 6) Budget, Sub-budgets, and Budget Justification 7) Current and Pending Support of PI and Senior Personnel 8) Facilities, Equipment, and Other Resources 9) Supplementary Docs a. Letters of Support for Technology (3 max provide market validation!) b. SBA company registry c. Data management plan d. Company commercialization history e. Post doc mentoring plan f. Human subjects and vertebrate animals 27

Project Description The Commercial Opportunity (2 to 4 pages) Describe the market and the addressable market How have you validated this opportunity? Describe your customers and your business model Describe the competition; how will it change? What are your key market risks? What support/resources will you need from outside partners? 57 Project Description The Innovation (1 to 3 pages) Describe the innovation (briefly) Describe the technical challenges and risks Status of any intellectual property Does the technology have NSF lineage? 58 29

Project Description The Company/Team (1 to 3 pages) Describe the founders or key project participants Company vision and five-year impact Revenue history for last 3 years Describe any project consultants or subcontractors 59 Project Description Technical Discussion and R&D Plan (5 to 7 pages) Describe the innovation in more technical depth Describe the key objectives for Phase I What critical technical milestones must be met to get to market? Describe the R&D plan 60 30

NIH SBIR/STTR Program 61 National Institutes of Health The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services Composed of 27 Institutes and Centers. NIH s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce the burdens of illness and disability. 62 31

NIH SBIR/STTR Budget Allocations FY2017 NIAMS NIEHS NEI NCATS NIDCD NIAAA NHGRI NIMHD NIBIB NIDCR ORIP NINR NCCIH NLM NCI 3.2% SBIR $814M 0.45% STTR $114M Total FY17 $928M NIA NIDA NIAID NICHD NIMH NHLBI NINDS NIDDK NIGMS NIH SBIR/STTR 3-Phase Program Discovery Phase I Development Phase II Competing Renewal Award Phase IIB Commercialization Phase III $3M for up to 3 years Feasibility Up to $225K 6-12 months Full R/D Up to $1.5M 2 years Additional R/D Only Some ICs Participate NIH is not usually the end customer Phase I Phase II Fast-Track 64 32

NIH SBIR/STTR Fast-Track Discovery Phase I Development Phase II Competing Renewal Award Phase IIB Commercialization Phase III $3M for up to 3 years 65 Feasibility Up to $225K 6-12 months Phase I Fast-Track Full R/D Up to $1.5M 2 years Phase II Additional R/D Only Some ICs Participate NIH is not usually the end customer Simultaneous submission and review of Phase I & II Phase I is awarded Milestones/aims of Phase I are assessed by program staff prior to Phase II award 2018 Omnibus Funding Opportunities New Omnibus released in Jan 2018 Apr 5, 2018 due date Sep 5, 2018, Jan 5, 2019, Apr 5 2019 33

SBIR Omnibus Solicitation FOA 34

SBIR Omnibus Solicitation PA-18-574: Non-CT You must find a fit! SBIR Omnibus Solicitation FOA 35

SBIR Omnibus Solicitation PA-18-573: CT Required You must find a fit! If I/C not listed: Review SBIR/STTR Solicitations Review I/C website Contact I/C SBIR/STTR program manager Program Descriptions and Research Topics 36

Program Descriptions and Research Topics Program Descriptions and Research Topics Initial contact person: 37

Budget limit is $150-225K unless.. 75 76 38

Talk to NIH! Center for Scientific Review Single receiving point for all NIH applications Assigns applications to the Scientific Review Groups (aka Study Section) Assigns applications to the Institute/Center that is the potential funding component 39

NIH Review Process Applicant initiates research idea Small Business Concern confirms Eligibility Submits SBIR/STTR grant application to NIH electronically NIH Center for Scientific Review assigns to IC and IRG 1-2 Months 3 Months IC staff prepare funding plan for IC Director 2-4 Months Advisory Council or Board recommend Approval Scientific Review Group evaluates scientific merit IC allocates funds Grantee conducts research Timeline: New Applications Due Date Scientific Review Council Review Award Date (earliest) Sept 5 Oct/Nov Jan/Feb March Jan 5 Feb/Mar May/June July April 5 June/July Aug Sept or Dec 40

NIH Review Criteria Significance Significant Science Significant Product Significant Commercial Opportunity Investigators Innovation Approach Environment IMPACT 81 NIH Funding Decisions Ratings from scientific/technical evaluation Overall Impact scores of 1 to 9 (best to worst) Rank Priority Discussion All applications receive written summary statement Areas of high program relevance Program balance among areas of research Available funds Extent of commercialization status >15 Phase II awards in prior 5 fiscal years 82 41

Components of an NIH SBIR/STTR Project Summary/Abstract (30 lines) Public Health Relevance Statement/Narrative Bibliography and Refs Cited Facilities & Other Resources Equipment Biographical Sketches (5 pg ea.) Project Budget Subaward Budget Introduction to Application (resubmission only -1pg) Specific Aims (1 pg) Research Strategy (6 or 12 pg) Significance Innovation Approach Progress report/publication List (Phase II only) Vertebrate Animals Select Agent Research Multiple PD/PI Leadership Plan Consortium/Contractual Arrangements Letters of Support Resource Sharing Plans Authentication of Key Biological and/or Chemical Resources Appendix Cover Letter Commercialization Plan (12 pg; Ph II & Fast Track only) PHS Assignment Request PHS Human Subjects and Clinical Trials Information NIH Research Strategy Sections Significance Innovation Approach Phase I: 6 pages Phase II: 12 pages 84 42

4/25/2018 Grant Proposal Preparation 85 Planning the Project Your Definition of Feasibility Define the Technical Objective(s) What must be proved in order to establish feasibility? Will depend on the technology and the ultimate product to be developed 86 43

Planning the Project Select Technical Objective(s)/Aims Identify the Critical Tasks How long will each task take? By whom and where will they be done? Define criteria for acceptance Measurable performance goal Do not be too aggressive 87 Preliminary Budget SBIR Example Critical Task Team Member Hours Price Design & assemble prototype SubWorks Corp 400 $40,000 Confirm key features Awardee Tech, LLC 750 $37,500 Produce test samples Awardee Tech, LLC 1,200 $60,000 = $70K Produce control samples Midwest Univ 100 $25,000 Measure tensile strength Breakit Labs, Ltd. 50 $2,000 Perform statistical analysis Dr. John Consult 72 $5,400 Materials & supplies - $6,000 Travel & indirect costs - $33,250 Fee (profit) - $14,700 Total $223,850 $70k/$223K = 31% 88 44

Writing the SBIR Proposal Primary Questions to be Answered What you are going to do? Why is it worth doing? Who is going to do the work? Where are you going to do the work? How much will it cost? How are you getting it to market? Which sections? What you are going to do? Why is it worth doing? NIH: Specific Aims Section Research Strategy Commercialization Plan NSF: Project Description Commercialization Plan 45

NSF Project Description Outline Limited to 15 pages 1) Elevator Pitch (recommended 1 page) 2) The Commercial Opportunity (2 to 4 pages) 3) The Innovation (1 to 3 pages) 4) The Company/Team (1 to 3 pages) 5) Technical Discussion and R&D Plan a. Minimum 5 pages; recommended 5 to 7 pages 91 Project Description Outline Elevator Pitch ( 1 page) The Customer Describe your expected customer What customer need are you addressing? The Value Proposition Key differentiator of your product/technology What are the benefits to the customer? The Innovation What is the innovation? What aspects are novel, disruptive, transformative? 92 46

Project Description Outline The Commercial Opportunity (2 to 4 pages) Describe the market and the addressable market Market drivers and business economics How have you validated this opportunity? Describe your customers and your business model Describe the competition; how will it change? What are your key market risks? What support/resources will you need from outside partners? Plan and timetable to secure this support 93 Project Description Outline The Innovation (1 to 3 pages) Describe the innovation (briefly) What stage of technical development? Describe the technical challenges and risks Which of these will be addressed in the Phase I project? Status of any intellectual property How do you plan to protect future IP? Does the technology have NSF lineage? 94 47

Project Description Outline The Company/Team (1 to 3 pages) 95 Describe the founders or key project participants Level of effort within Company Background and commercialization experience Company vision and five-year impact How does the project fit into current operations? Revenue history for last 3 years Any government funding and/or private investment? Describe any project consultants or subcontractors Affiliation and expertise Role on the project? Project Description Outline Technical Discussion and R&D Plan (5 to 7 pages) 96 Describe the innovation in more technical depth Include any necessary background information Describe the key objectives for Phase I What questions must be answered to determine the technical and commercial feasibility? What critical technical milestones must be met to get to market? Describe the R&D plan Introduce the plan with a description of the general approach to the Phase I project Technical objectives and the experiments, tests, computations, etc. necessary to reach those objectives 48

4/25/2018 NSF Technical Discussion-outline 97 <Objective Restated> Rationale Why is this objective necessary to establish feasibility? Experimental Design & Methods Describe what tasks/experiments (in detail) will be conducted, what methods will be used, and what type of data will be generated Data Analysis & Interpretation How will you will analyze the data and draw conclusions? Potential Pitfalls / Alternative Approaches What could go wrong and how will you compensate if it does? Expected Outcomes What do you expect to happen? NIH Specific Aims Page Single and most important page of application An Executive Summary of the Proposal One page sets the tone for the reviewer Is the project compelling? Are the outcomes significant? Will the project have impact? Is it well written? Do I want to read more? 98 49

Specific Aims Outline Phase I The Company Significance Problem to be solved Gap in knowledge The Product Technological Innovation Impact Long Term Goal Rationale for the goal Phase I Project: Phase I Hypothesis Specific Aim 1 Criteria for acceptance Specific Aim 2 Criteria for acceptance Expected Outcomes Proof of Feasibility Plans for Phase II Commercial Application PAGE LIMIT: One PAGE NIH Research Strategy Significance Significant product Significant science/technological innovation Significant commercial opportunity Innovation Clearly state the technological innovation Will success improve the State-of-the-art, establish new research directions, change clinical practice? Approach Do experiments relate to the Specific Aims? Are the end-points/milestones clearly defined? 100 50

NIH Research Strategy BBC Outline Significance 101 Problem to be solved Product to be developed Impact of proposed product to provide a solution Impact of product/innovation on state of the science/technology Value of the solution to the problem Commercial Potential Market analysis Competition (competing technologies and competitors) Commercialization strategy Other applications of the technology Research Strategy BBC Outline Innovation The technological innovation (describe) Relevance to current state of the science Why is it innovative? How does it move the field forward? What future advancements will this innovation enable? Phase II remember to update literature and market searches to reflect CURRENT state of the science and state of the market 102 51

4/25/2018 NIH Approach Phase I Preliminary Data/Prior Work are not required for Phase I applications (but if you don t have any, get some) should support the proposed Phase I aims Demonstrates that the investigator has: mastery of (and/or access to) the required techniques ability to manage and work with collaborators/partners sufficient attention to important details (i.e. accurate, carefully assembled figures, tables, graphs) Reviewers will not look anything up! Provide sufficient, relevant details for an informed judgment 103 NIH Research Strategy BBC Outline Approach Prior work/preliminary Studies Rationale Aims of the preliminary studies Results and conclusions Summary (how does the prior work apply to this SBIR/STTR) Specific Aim (Repeat for each aim) Rationale Experimental Design & Methods Data Analysis & Interpretation Potential Pitfalls / Alternative Approaches Expected Outcomes 104 52

Aims/Objectives vs. Tasks Aims/Objectives = Achievements/Goals/Outcomes Do not yield results/data Have desired, measurable end points Specific criteria for acceptance Tasks = Activities Make up your work plan They are performed or carried out Yield results/data 105 Planning the Project Tasks To study To experiment To test To optimize Aims/Objectives To demonstrate To prove To establish To complete To achieve 106 53

Quantitative Milestones for Specific Aims Detect one cancer cell in 106 normal blood cells. Increase the therapeutic index of an agent >3-fold by nanoparticle-based therapeutic solution relative to the non-nanoparticle bound agent. Achieve >95% selectivity in targeting mixed cell populations in vitro Technical Objective with Success Criterion #1: To demonstrate that a semi-automated process is capable of producing high-quality ceramics Success Criterion: samples will have an average tensile strength equivalent to those produced by the current state-of-the-art process Critical Task Team Member 1 Design and assemble the prototype SubWorks Corp. 2 Confirm key functions Awardee Tech, LLC 3 Produce 100 samples using with each each Awardee Tech, LLC process 4 Test tensile strength of samples Breakit Laboratories, Ltd. 5 Perform statistical analysis Dr. John Consult 108 54

Writing the SBIR Proposal Primary Questions to be Answered What you are going to do? Why is it worth doing? Who is going to do the work? Where are you going to do the work? How much will it cost? How are you getting it to market? Which sections? Who is going to do the work? Where will the work be done? How much will it cost? Both NIH and NSF: Biographical Sketches Facilities and Resources Letters of Support Budget and Budget Justification 55

Key Personnel: Build a Strong TEAM! Your (the SBC* s) employees Includes the PI if SBIR If STTR should have at least 1 (may include PI) Subcontractor s employees Consultants Other Significant Contributors e.g. advisors ; 0% effort on project (think ahead to Phase II and commercialization) 111 *SBC = Small Business Concern Consultants and Subcontractors Build a strong and diverse team Keep the crucial work in-house Consultants and subcontractors should be used for clearly defined, support functions Project review Product testing Specific experimental operations or data collection If you are farming everything out, why should the agency fund you in the first place? 112 56

4/25/2018 NSF SBIR/STTR Application Format 113 1) Cover Sheet and Certification 2) Project Summary (3 boxes; 4,600 characters MAX) 3) Project Description (maximum 15 pages) 4) References Cited 5) Biographical Sketches 6) Budget, Sub-budgets, and Budget Justification 7) Current and Pending Support of PI and Senior Personnel 8) Facilities, Equipment, and Other Resources 9) Supplementary Docs a. Letters of Support for Technology (3 max provide market validation!) b. SBA company registry c. Data management plan d. Company commercialization history e. Post doc mentoring plan f. Human subjects and vertebrate animals NSF Biographical Information Maximum 2 pages each: PI & Key Persons* Education Institution, Location, Major/Concentration, Degree, Year Relevant Experience Technical and/or Commercial experience in reverse chronological order Products Patents Publications 5 closely related to the project, 5 other significant publications Synergistic Activities 5 examples of broader impact in integration and transfer of knowledge *Consultant info uploaded with Budget Justification 57

NSF Project Description Limited to 15 pages 1) Elevator Pitch (recommended 1 page) 2) The Commercial Opportunity (2 to 4 pages) 3) The Innovation (1 to 3 pages) 4) The Company/Team (1 to 3 pages) 5) Technical Discussion and R&D Plan a. Minimum 5 pages; recommended 5 to 7 pages 115 Project Description The Company/Team (1 to 3 pages) Describe the founders or key project participants Level of effort within Company Background and commercialization experience Company vision and five-year impact Revenue history for last 3 years Describe any project consultants or subcontractors Affiliation and expertise Role on the project? 116 58

Components of an NIH SBIR/STTR Project Summary/Abstract (30 lines) Public Health Relevance Statement/Narrative Bibliography and Refs Cited Facilities & Other Resources Equipment Biographical Sketches (5 pg ea.) Project Budget Subaward Budget Introduction to Application (resubmission only -1pg) Specific Aims (1 pg) Research Strategy (6 or 12 pg) Significance Innovation Approach Progress report/publication List (Phase II only) Vertebrate Animals Select Agent Research Multiple PD/PI Leadership Plan Consortium/Contractual Arrangements Letters of Support Resource Sharing Plans Authentication of Key Biological and/or Chemical Resources Appendix Cover Letter Commercialization Plan (12 pg; Ph II & Fast Track only) PHS Assignment Request PHS Human Subjects and Clinical Trials Information NIH Biosketch Personal Statement why experience and qualifications make the applicant particularly well-suited for role in the project how you are qualified for your assigned role on study how your formal education, training & experience contribute to feasibility of work your access to resources/collaborations 118 59

Position where you will be doing the work CRITICAL!*** Make sure to list the small business for all personnel that will be working there at the time of award If not already employed add not to be implemented at time of award 119 Personal Statement ***Make it easy for the reviewer! Used to establish why this person is qualified to have this specific role on this project. Therefore start this paragraph out with 1-2 sentences as follows: In my role as {-------------} I will be responsible for {-------- -----}. I am qualified because.. 120 60

Don t forget relevant items such as patents or other product development accomplishments All key persons should include You may cite up to 5 contributions Up to 4 relevant publications or research products 121 Full publication list can be cited here: 122 Template, instructions and samples can be found at: http://grants.nih.gov/grants/forms/biosketch.htm 61

NSF SBIR/STTR Application Format 123 1) Cover Sheet and Certification 2) Project Summary (3 boxes; 4,600 characters MAX) 3) Project Description (maximum 15 pages) 4) References Cited 5) Biographical Sketches 6) Budget, Sub-budgets, and Budget Justification 7) Current and Pending Support of PI and Senior Personnel 8) Facilities, Equipment, and Other Resources 9) Supplementary Docs a. Letters of Support for Technology (3 max provide market validation!) b. SBA company registry c. Data management plan d. Company commercialization history e. Post doc mentoring plan f. Human subjects and vertebrate animals Components of an NIH SBIR/STTR Project Summary/Abstract (30 lines) Public Health Relevance Statement/Narrative Bibliography and Refs Cited Facilities & Other Resources Equipment Biographical Sketches (5 pg ea.) Project Budget Subaward Budget Introduction to Application (resubmission only -1pg) Specific Aims (1 pg) Research Strategy (6 or 12 pg) Significance Innovation Approach Progress report/publication List (Phase II only) Vertebrate Animals Select Agent Research Multiple PD/PI Leadership Plan Consortium/Contractual Arrangements Letters of Support Resource Sharing Plans Authentication of Key Biological and/or Chemical Resources Appendix Cover Letter Commercialization Plan (12 pg; Ph II & Fast Track only) PHS Assignment Request PHS Human Subjects and Clinical Trials Information 62

Facilities and Resources include: Company s Research Facility(s) Subcontractors Research Facilities Other R&D Resources Other Significant Contributors (e.g., Scientific Advisory Board) Commercialization Resources Management Strategic Partners Funding Regulatory/Reimbursement 125 NSF SBIR/STTR Application Format 126 1) Cover Sheet and Certification 2) Project Summary (3 boxes; 4,600 characters MAX) 3) Project Description (maximum 15 pages) 4) References Cited 5) Biographical Sketches 6) Budget, Sub-budgets, and Budget Justification 7) Current and Pending Support of PI and Senior Personnel 8) Facilities, Equipment, and Other Resources 9) Supplementary Docs a. Letters of Support for Technology (3 max provide market validation!) b. SBA company registry c. Data management plan d. Company commercialization history e. Post doc mentoring plan f. Human subjects and vertebrate animals 63

Components of an NIH SBIR/STTR Project Summary/Abstract (30 lines) Public Health Relevance Statement/Narrative Bibliography and Refs Cited Facilities & Other Resources Equipment Biographical Sketches (5 pg ea.) Project Budget Subaward Budget Introduction to Application (resubmission only -1pg) Specific Aims (1 pg) Research Strategy (6 or 12 pg) Significance Innovation Approach Progress report/publication List (Phase II only) Vertebrate Animals Select Agent Research Multiple PD/PI Leadership Plan Consortium/Contractual Arrangements Letters of Support Resource Sharing Plans Authentication of Key Biological and/or Chemical Resources Appendix Cover Letter Commercialization Plan (12 pg; Ph II & Fast Track only) PHS Assignment Request PHS Human Subjects and Clinical Trials Information Letters of Support* Validate your resources & commercial opportunity Consultants (required); must include: Role, Rate Time Subcontractors Other Significant Contributors Research Resources, e.g. Facilities, equipment not on budget or owned by company Commercialization Resources (critical for Phase II) Strategic Partners Investors Key Customers Potential Licensees Key Opinion Leaders 128 *Contingent Commitment 64

Supplementary Documents Letter(s) of Support Should be from knowledgeable stakeholders (e.g., prospective investors, strategic partners, customers) Validate the commercial opportunity Demonstrate that applicant has initiated dialog with market players Letters must contain affiliation and contact information for the signatory 129 Letters of Support Inclusion of letters of support for the technology within the proposal is strongly encouraged. Letters of support act as an indication of market validation for the proposed innovation and add significant credibility to the proposed effort. Letters of support should demonstrate that the company has initiated dialog with relevant stakeholders (potential customers, strategic partners, or investors) for the proposed innovation and that a real business opportunity exists, should the technology prove feasible. The letter(s) must contain affiliation and contact information of the signatory stakeholder. 130 65

NSF SBIR/STTR Application Format 131 1) Cover Sheet and Certification 2) Project Summary (3 boxes; 4,600 characters MAX) 3) Project Description (maximum 15 pages) 4) References Cited 5) Biographical Sketches 6) Budget, Sub-budgets, and Budget Justification 7) Current and Pending Support of PI and Senior Personnel 8) Facilities, Equipment, and Other Resources 9) Supplementary Docs a. Letters of Support for Technology (3 max provide market validation!) b. SBA company registry c. Data management plan d. Company commercialization history e. Post doc mentoring plan f. Human subjects and vertebrate animals Components of an NIH SBIR/STTR Project Summary/Abstract (30 lines) Public Health Relevance Statement/Narrative Bibliography and Refs Cited Facilities & Other Resources Equipment Biographical Sketches (5 pg ea.) Project Budget Subaward Budget Introduction to Application (resubmission only -1pg) Specific Aims (1 pg) Research Strategy (6 or 12 pg) Significance Innovation Approach Progress report/publication List (Phase II only) Vertebrate Animals Select Agent Research Multiple PD/PI Leadership Plan Consortium/Contractual Arrangements Letters of Support Resource Sharing Plans Authentication of Key Biological and/or Chemical Resources Appendix Cover Letter Commercialization Plan (12 pg; Ph II & Fast Track only) PHS Assignment Request PHS Human Subjects and Clinical Trials Information 66

NSF Budget limitations Firm Budget Limits $225,000 Phase I, $750,000 Phase II Salaries must be justified based upon pay scales from Bureau of Labor Statistics: city (http://www.bls.gov/ncs/ocs/compub.htm) or state (http://www.bls.gov/oes/current/oessrcst.htm) Use NSF SBIR Salary Validation Guide http://www.nsf.gov/eng/iip/sbir/documents/sbir_salary_validation_ Guide.pdf NIH Budget limitations Guidelines: $150,000 Phase I, $1,000,000 Phase II Limits max 150% of guidelines, therefore: $225,000 Phase I, $1,500,000 Phase II NIH 2018 Topics eligible for budget waiver Read the solicitation carefully: NIH has a salary cap ($189,600) be real in your request 67

Budgets Direct Costs E.g., Salaries, supplies, equipment, travel, consultants fees, subcontract costs Indirect Costs (F&A) Fee Understand your company s indirect costs Ratio between total indirect costs and direct cost base Know your agency s policies re. capturing indirect costs <=7% of total costs (direct and indirect) Know your agency s policies Unallowable Costs Budget Direct Costs Indirect Costs FEES 136 68

NIH Budget approach When a cap or restriction is enforced IF Budget Cap = $1,500,000 Direct costs $1,000,000 Indirect costs* = $1,000,000 x ~40% $400,000 Fee = ($1,000,000 + $400,000) x 7% $98,000 TOTAL: Direct + Indirect + Fee $1,498,000 *Maximum NIH Indirect cost without rate determination = 40% Therefore design your project to fit $1m directs NSF Budget Approach Category $ Budget $ % Total Remaining Total Budget Available - $750,000 100% Fee (profit) ( 7%) $52,000 $698,000 6.93% Indirect Costs* $250,000 $448,000 33.3% Direct Costs $448,000 0 59.7% *Indirect + Fringe = Maximum of 150% of total direct salaries 69

NSF Phase I SBIR Budget Typical Costs in Each Category Direct Costs Project personnel Subcontractors and consultants Travel Materials & supplies Purchased services Fee (Profit) Indirect Costs Employee fringe benefits Rent Admin/clerical Utilities Insurance No Equipment 139 140 70

Think of the reviewer Headings. Make it easy for reviewers to find information. Keep it short and simple. State the key points directly e.g. use Scientific American as a model for the non-technical parts. Guide reviewers with helpful graphics. Graphics can help reviewers grasp a lot of information quickly and easily, and they break the monotony. Edit adn prooff your propsal. Reviewers assess science, BUT they are influenced by the writing and appearance of your application. 141 71

Grammar and punctuation are important. 143 144 72

Style tips Be concise & precise No emotion or exaggeration Use proper technical writing Provide necessary detail Avoid jargon & abbreviations Avoid use of first person (I/we) 145 Planning an SBIR Grant Submission? Get an Early Start Register your company (SBA, SAM, grants.gov, FastLane, ecommons, etc.) Collect the documents you ll need Communicate with the appropriate Agency Program Director Search previous awards in your technology area Develop a preliminary project plan Prepare proposal sections considering the review criteria 146 73

Tell a Story With Your Proposal Messages There s an important problem Current solutions are inadequate Our approach is innovative There s a viable commercial opportunity Why is it important? Important to whom? What are the alternatives? What are their shortcomings? What is the approach? How is it different? What is the product? Who is the target customer? Why will you win? 147 148 Tips from Peer Reviewers Propose something significant Good ideas don t always sell themselves Don t assume too much about reviewers expertise Don t be overly ambitious in scope of work (most common mistake!) Focus your preliminary data Don t cram your application like a suitcase Know your audience & pitch your proposal to it Communicate with Program Managers before-and afterreview From Insider s Guide to Peer Review for Applicants, http://public.csr.nih.gov/aboutcsr/newsandpublications/publications/pages /InsidersGuide.aspx 74

Writing tips (from NIH) Don t wait until the last minute Organize to communicate Follow instructions EXACTLY Proof a hard copy Get a critique Ask people at NIH for help Submit again Analyze the critique Don t give up 149 SBIR Proposal Preparation Tips: Granting Agencies 2018 Mid Atlantic SBIR/STTR & Commercialization Conference April 25, 2018 Becky Aistrup Managing Partner 734.930.9741 becky@bbcetc.com bbcetc.com / @BBC_etc 75