Developing the Business of Technology

Developing the Business of Technology Developing the Business of Technology SBIR/STTR Proposal Development Focus on NIH October 21-22, 2015 University of Connecticut Presenter: Lisa M. Kurek Managing Partner 734.930.9741 lisa@bbcetc.com Training & Consulting, LLC Training & Consulting, LLC 1

BBC Team Lisa M Kurek, MS Managing Partner Michael P. Kurek, PhD, MBA Partner Andrea Johanson, PhD Principal Consultant Becky Aistrup, Principal Consultant Kris Bergman Consultant, Grants and Contract Management Kristin Burgard, Principal Consultant Jayne Berkaw Director, Marketing and Outreach 3 What We Do BBC works with technology-based entrepreneurs and companies on strategies to advance R&D efforts to commercialization. Through training courses and one-onone counseling, the BBC team coaches clients in: Technology Assessment Commercialization Planning SBIR/STTR/Other Research Grant Assistance Entrepreneurial Training Grant/Contract Management Tech-Based Economic Development Programs The BBC team is nationally recognized for its success in helping clients win federal funding through the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, and use it tactically to propel growth. Training & Consulting, LLC 2

Now about you Where are you from. University? Industry? Government? Other? What is your technology? How will your technology become a product? Who will purchase this product when commercialized? Already submitted grants or contracts SBIR/STTR? NIH, NSF, Other? Planning to submit? 5 Why SBIR/STTR? We just need a little seed money. 6 Training & Consulting, LLC 3

Where does SBIR/STTR Fit? Component of a Funding Strategy Debt Equity Non-Dilutive 7 What are SBIR * and STTR **? $2.5 billion of federal funding to: Support small business to: Stimulate technological innovation to Develop products with commercial merit * Small Business Innovation Research ** Small Business Technology Transfer Training & Consulting, LLC 4

Goal of SBIR/STTR Programs a.k.a. Come Back When Source: SBIR and the Phase III Challenge of Commercialization: Report of a Symposium. NAS, 2007. What is SBIR/STTR. Mandated by legislation (NDAA FY2012) Current authorization for 6 years through 2017 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 10 Training & Consulting, LLC 5

10/12/2015 Participating Federal Agencies Others, 3% NSF, 5% DoE, 7% DoD, 49% TOTAL: ~$2.3 B FY 2015 NASA, 8% HHS, 28% SBIR and STTR DOD - $1,200 m HHS - $690 m NASA - $204 m DOE - $164 m NSF - $124 m SBIR Only USDA - $19 m DOT - $4 m EPA - $7 m DOC - $9 m DoED - $8 m DHS - $23 m 11 Key Questions The Project What do you need the money for? The Company (there has to be one ) Who owns it? What resources does it have? Facilities People Where will it get what it needs? 12 Training & Consulting, LLC 6

The Project: What Does SBIR/STTR Fund? PRODUCT Development Based on technological innovation high risk Credible Commercialization Strategy 13 The Project QUESTIONS: $ for PRODUCT Development What is the intended product? What applications will it be used for? What has been done to date? How much is left to do? 14 Training & Consulting, LLC 7

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 $$) 15 Three Phases of SBIR/STTR Details Agency Dependent Phase I Feasibility* 6 months 1 year $80k 225k Phase II - Expand results, pursue further development* 2 years $750k - $1.5m Phase III Commercialization Your own $$ ( ie - no government $!) *Phase I and II supplements available at some agencies 16 Training & Consulting, LLC 8

The Project QUESTIONS: Based on technological innovation What is the technological innovation that will enable the product to achieve the desired performance? How certain are you that it will work? Is there risk of failure? Will the product be revolutionary or evolutionary? 17 Commercialization There is no such thing as the Build it and they will come Business Model 18 Training & Consulting, LLC 9

10/12/2015 The Project QUESTIONS: Credible Commercialization Strategy Is there a market identified? Has a competitive analysis been done? How will the company generate revenue? What additional resources will be required to achieve commercialization? Have sources of those resources been identified? Strategic partners Sources of capital 19 SBIR/STTR Programs Learn the Rules! 20 Training & Consulting, LLC 10

The Company QUESTIONS: A for-profit entity? Who owns the company? May need to refer to cap table Who controls the company? Does the company have its own research facilities? Is there a qualified PI with primary employment at the company? 21 2012 Reauthorization SBA Documents Small Business Size Regulations Final Rule Published 12/27/2012 https://www.federalregister.gov/articles/2012/12/27/2012-30809/small-business-size-regulations-small-businessinnovation-research-sbir-program-and-small-business Effective Jan 28, 2013 Training & Consulting, LLC 11

Eligibility for Funding Small business For-profit U. S. owned and controlled < 500 employees Located in the U.S. R&D must be performed in the U.S. 23 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) Training & Consulting, LLC 12

SBIR & STTR Size Regulations Size and Affiliation Under 500 employees for SBIR applicant and its affiliates including: Full-time, part-time or other basis Employees obtained from a temporary employee agency, PEO or leasing concern Based on average of number of employees for each pay period in the preceding 12 months SBIR & STTR Size Regulations Size and Affiliation Affiliation exists when one business controls or has the power to control another or when a third party controls or has the power to control both businesses Training & Consulting, LLC 13

SBIR & STTR Size Regulations Timing of Size Certifications Size and eligibility certified at the time of award If awardee grows to > 500 employees during the time of the award it may continue to perform activities covered by the award If awardee merges or is acquired it may only continue for the current funding period and then will have to recertify Facilities Requirement The research work to be performed by the awardee is to be conducted in: Company controlled Research space Suitable to do the work proposed 28 Training & Consulting, LLC 14

SBIR vs. STTR SBIR and STTR are two separate programs Not all agencies with both SBIR and STTR programs give you the choice of mechanism Separate set-asides SBIR: 2.6% (3.2% in 2017) STTR: 0.35% (0.45% in 2017) SBIR vs. STTR Primary difference is in the relationship with a non-profit research institution: SBIR allows but does not require the involvement of a non-profit research institution STTR requires the involvement of a non-profit research institution However in either case: The Applicant Organization is always the Small Business! 30 Training & Consulting, LLC 15

SBIR vs. STTR: Who does the work? ** APPLICANT IS ALWAYS THE SMALL BUSINESS** Subcontract percentages SBIR: no more than 33% in a Phase I and 50% in a Phase II STTR: at least 40% at small business and at least 30% at partner non-profit research institution 31 SBIR vs. STTR Facilities Requirement Therefore the company must do: 67% of the SBIR Phase I work and 50% of the Phase II work or 40% of the STTR Phase I and II work in** **Company controlled research space suitable to do the work proposed! 32 Training & Consulting, LLC 16

SBIR vs. STTR: Where is the PI? Principal Investigator rules SBIR: Primary employment* (>50%) at small business STTR: ** APPLICANT IS ALWAYS THE SMALL BUSINESS** Primary employment* (>50%) at EITHER the small business OR the non-profit research institution Minimum 10% effort on the project at the institution where they PI has his/her primary employment *at the time of, and for the duration of, the award 33 STTR Applications - Extra Requirements Company & its University partner must sign intellectual property (IP) agreement (JIT) Budget and Certification of Research Institution form required Virtual companies do not qualify Be conscious of conflict of interest issues (Both of the above apply equally to SBIRs that include a subcontract to a non-profit research institution) 34 Training & Consulting, LLC 17

How do you choose? Does the agency offer STTR? Is the relevant technology area/specific topic offered under both mechanisms? If yes to both above: Do a resource inventory people and facilities What do I have What do I need Where will I fill the gaps? Talk to the Agency 35 University Participation Faculty Roles* Faculty member can own small company & identify someone else (well-qualified) as PI Faculty member can be PI (i.e., with appropriate leave of absence) Subcontracts to academic institution Faculty member can be PI s of subcontracts Faculty member can provide analytical and other support services Faculty member can be a consultant *subject to institution-specific policies 36 Training & Consulting, LLC 18

Common Misconceptions Universities can apply for STTRs If a University is involved you have to do an STTR If the IP comes from a University you have to do an STTR If the inventor and/or key scientist is faculty you have to do an STTR If the PI of an STTR is at the University it is the University s grant/contract All of the work of an STTR can be done at the University 37 Critical watch-outs Make sure that: The company has company-controlled research facilities If the PI of an SBIR also maintains a faculty appointment that they reduce their effort appropriately You accurately represent the company s resources 38 Training & Consulting, LLC 19

DO YOUR HOMEWORK 39 SBIR/STTR Terminology Solicitation Funding Opportunity Announcement (FOA) Request for Proposal (RFP) Request for Application (RFA) Submission Proposal Application Award Grant Contract Training & Consulting, LLC 20

SBIR Information: SBIR.gov Links to all 11 agencies Search past awards Current/past solicitations www.sbir.gov 41 Search Past Awards https://www.sbir.gov/sbirsearch/award/all Training & Consulting, LLC 21

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 44 Training & Consulting, LLC 22

SBIR/STTR Deadlines 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 46 Training & Consulting, LLC 23

Agency Differences -- Grants vs. Contracts Grants Investigated Initiated Topics HHS (95% $$), NSF, USDA, DOE, ED Some agencies might have topic areas (aka buckets ) Open communications External peer review Contracts Agency-specified topics DoD, NASA, DHS, EPA, DOT, DOC, ED, HHS (5% $$) Must respond to a topic Limited time to prepare ( 8-12 weeks) Limited communications during open solicitation Internal review Agency Differences -- Review Process Internal Review DoD, NASA, DHS Review panels composed of Agency personnel External Review NIH, NSF Review panels composed of leading experts in the field Agency personnel do not score/rank applications, but manage the process 48 Training & Consulting, LLC 24

contract For More Agency Information NIH SBIR/STTR Conference October 27-29, 2015 Seattle, WA National SBIR/STTR Conferences December 1-3, 2015 Co-located with Defense Energy Innovation Summit Austin, TX 49 contract How to be Competitive in SBIR/STTR Understand the philosophy of the Agency Understand the review process Understand the psychology of the reviewers Develop and follow a strategic plan Follow the rules Complete your registrations Submit Early! 50 Training & Consulting, LLC 25

NSF SBIR Program 51 Mission of NSF The mission of The National Science Foundation is to promote the progress of science; to advance the national health, prosperity, and welfare; and to secure the national defense. 52 Training & Consulting, LLC 26

What Does NSF SBIR Fund? We fund high-risk, high-payback innovations With the potential for commercialization That demonstrate strategic partnerships with research collaborators, customers, industry partners, and equity investors We do 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 53 54 http://www.nsf.gov/eng/iip/sbir/home.jsp Training & Consulting, LLC 27

Read me NSF SBIR Program Interests Ten Broad Topics* Educational Technologies & Applications (EA) Information Technologies (IT) Internet of Things (I) Semiconductors (S) & Photonic (PH) Devices & Materials Electronic Hardware, Robotics & WirelessTechnologies (EW) Advanced Manufacturing and Nanotechnology (MN) Advanced Materials and Instrumentation (MI) Chemical & Environmental Technologies (CT) Biological Technologies (BT) Smart Health (SH) and Biomedical (BM) Technologies http://www.nsf.gov/eng/iip/sbir/topicshome.jsp Training & Consulting, LLC 28

Program Director listed with each topic Training & Consulting, LLC 29

NSF SBIR Program Interests Projects Considered Non-Responsive Demonstrations of technology Technical assistance Literature surveys Market research Patent application or patent litigation costs Training & Consulting, LLC 30

NSF SBIR Project Attributes Proposers must: Provide evidence of a commercially viable product, process, or system Meet an important social or commercial need Projects must: Show high potential commercial payback Show high risk effort Projects may also address: Research tools which meet significant commercial market needs Applications that result in multipurpose commercially viable functions NSF SBIR/STTR Proposals PLEASE NOTE Focus on near-term commercialization Letters of support from commercialization partners are required Communication with Program Officer is strongly encouraged Provide a brief 1-2 page executive summary with background on the: 1. Company/team 2. Market opportunity, value proposition, customers 3. Technology/innovation and 4. Competition Training & Consulting, LLC 31

NSF Application Review Process Submission Date Project Start Date Dec xx, 2014 Recruit Jul 1, 2015 expert reviewers Compliance Review Internal: NSF Program Staff Merit Review External: 4-5 peer reviewers per proposal Programmatic Review Internal: NSF Program Staff Funding Recommendation & Decision Internal: NSF Program Staff & Division Director Funding Commitment Internal: Division of Grants and Agreements (DGA) NSF SBIR & STTR BEFORE you write, complete these tasks: Register in FastLane Review topic descriptions and select a single topic and subtopic to respond to Select either the SBIR or the STTR program (if appropriate) Communicate your Executive Summary to the cognizant NSF Program Director Complete a preliminary work plan for Phase I feasibility and a preliminary budget Training & Consulting, LLC 32

Department of Defense SBIR/STTR Contracts 65 Objectives of DoD SBIR Program Stimulate technological innovation in DoD's Critical Technology Areas, Strengthen role of small business in meeting DoD R&D needs, Encourage participation by minority and disadvantaged persons in technological innovation, Increase commercial application of DoD-supported R&D results. 66 Training & Consulting, LLC 33

http://www.acq.osd.mil/osbp/sbir/ Training & Consulting, LLC 34

DoD Critical Technology Areas Air Platforms Chemical/Biological Defense Information Systems Technology Ground & Sea Vehicles Technology Materials / Processes Biomedical Sensors, Electronics, Electronic Warfare Space Platforms Technology Human Systems Weapons (Conventional, Directed Energy) Nuclear Technology Battlespace Environments 69 DoD SBIR/STTR by Component ($1.1 Billion) DoD Budgets FY11 FY12 SBIR $1,041M $1,016 M STTR $117M $127M $1,158M $1,143M SOCOM DTRA DARPA OSD MDA $113M DLA CBD DMEA NGA Army $231M DHP AF $315M Navy $302M http://www.acq.osd.mil/osbp/sbir/ 70 Training & Consulting, LLC 35

DoD s SBIR/STTR focus Primary focus on the warfighter Some additional service requirements Topics across many technologies & products Topics and rules are Component-Specific DARPA seeks most advanced technologies SOCOM wants quick deployment of practical technologies Other services seek technology development in between Navy has the most successful Phase III transition DoD Three-Phase Program Each component has unique guidelines and rules Phase I awards Total $100,000 - $150,000 $80-150K Base + (if applicable) $50-70K Option Total 6 to 18 months 6-7 mo. Base + (if applicable) 4-6 mo. Option Phase I Option (not used by all components) May be exercised to fund interim Phase I activities while a Phase II contract is being negotiated Only Phase I efforts selected for Phase II awards are eligible to have the Phase I Option exercised Technical proposal, Cost proposal & Timeline must separate the Base and Option periods It is VITAL to demonstrate feasibility within the Base period 72 Training & Consulting, LLC 36

DoD Three-Phase Program Each component has unique guidelines and rules Phase II awards (*Reauthorization Change- no longer by invitation only for 13.1 & 13.A and later) Awarded on the basis of results of Phase I scientific, technical, and commercial merit of Phase II proposal Typically $1,000,000 Generally ~ 24 months (subject to negotiation) Expected to produce well-defined deliverable prototype 73 DoD Three-Phase Program Phase II continuation funding is to encourage transition of SBIR research into DoD acquisition programs Phase II Enhancement/Phase II Plus SBIR/STTR matching investment funds the company obtains from non-sbir/non-sttr sources such as DoD acquisition programs or private sector Can extend Phase II contract up to 1 yr. and match up to $500K of non-sbir/non-sttr funds FastTrack no longer available after 2013.1/2013.A Sequential Phase II Phase II contractor may receive up to one additional, sequential Phase II award for continued work on the project, up to $500K TALK TO YOUR TPOC DURING Phase II 74 Training & Consulting, LLC 37

DoD Three-Phase Program (cont d) Phase III Commercialization phase Derives from, extends or logically concludes efforts performed under prior SBIR/STTR funding agreements from any agency Must be funded by sources outside of SBIR/STTR (private sector and/or non-sbir Government) Develop prototype into viable product/service for sale in military and/or private sector markets Within DoD, often initial customer is prime contractor for a major weapon system or program of record, not DoD directly DoD Solicitation Schedule* You may communicate directly with the Topic Author or TPOC (Technical Point of Contact) ONLY during this window. After that, questions must be posted to DoD s SBIR/STTR Interactive Topic Information System (SITIS). www.dodsbir.net/sitis *http://www.acq.osd.mil/osbp/sbir/sb/schedule.shtml Training & Consulting, LLC 38

TPOC/Topic Author Technical Point of Contact Responsible for monitoring the technical performance of a contract Often the author of the topics that appear in solicitations; Topic Author is sometimes synonymous with TPOC Can be an excellent champion for the small business http://www.acq.osd.mil/osbp/sbir/solicitations/sbir20153/index.shtml Training & Consulting, LLC 39

DoD Solicitation Topics Only proposals submitted in response to topics in solicitation accepted! DoD scientists and engineers author solicitation topics Awarding Component Component-specific instructions Unique topics DoD SBIR 2015.1 Solicitation Topics 80 Training & Consulting, LLC 40

10/12/2015 DoD SBIR Solicitation Topic Examples Talking to the TPOC in the open period Understand the DoD and component needs stated in the solicitation Do your research before you call Develop a brief as a quad chart or white paper to summarize how your technology addresses the need Email the TPOC and request a phone discussion Attach the brief you ve prepared Questions to ask Where/how did the topic originate? Is our approach to your problem responsive to the topic solicitation? Is there an identified acquisition program? If not, how do you see this project transitioning to Phase III? What group/lab leads this research topic within the Component? Training & Consulting, LLC 41

DoD Homework Look for topics Look for background from past solicitations and awards Understand the component(s) of interest Prepare for your conversation with the TPOC in the open period Keep track of questions and revisions posted at SITIS Influencing future topics Insert Topic Title/# Here Designate Focus Area(s) here PI: Insert PI name here Org: Insert performing organization name here Problem, Hypothesis and Military Relevance State the problem to be studied, or State the hypothesis to be tested Concisely outline the rationale for the research project Describe military relevance (relationship to selected focus area(s) in announcement) Describe why your company/technology is appropriate Proposed Solution Describe objectives of the proposed research project Summarize the specific aims Concisely identify anticipated study outcomes including TRL expected at each Phase Brief description of why your company is uniquely qualified to conduct the project You may reduce font size if needed, but 12 point minimum is recommended Insert a picture or graphic here that represents the proposed work Timeline and Cost Activities FY 11 12 13 14 Enter description of major activity or phase 1; insert or delete rows as needed Enter description of major activity or phase 2; insert or delete rows as needed Enter description of major activity or phase 3; insert or delete rows as needed Estimated Budget ($K) xxx xxx xxx xxx Training & Consulting, LLC 42

DoD Registration Register your firm online: www.dodsbir.net/submission/signin.asp Other items: Federal Tax ID DUNS Number CAGE Code (CCR) NOTE: these three items are needed at time of award; NOT to submit a proposal Designate a Point of Contact (POC) for your firm Upon completion of the registration form You will receive an on-line confirmation page: DOD SBIR Updates Subscribe to the DOD SBIR/STTR Listserv Send an email to: sbirlist@listserv.dodsbir.net Put SUBSCRIBE in the subject line Training & Consulting, LLC 43

NIH SBIR/STTR Program 87 Strategic Planning BEFORE you start to write your proposal: Understand NIH Structure Find a Solicitation Understand the Review Process Define your project Understand how to work with NIH 88 Training & Consulting, LLC 44

HHS Program Funding 2015 2015 Budget SBIR STTR NIH $691 M $95 M CDC ACL (NIDILRR) FDA ACF $7.0 M $2.7 M $1.5 M $ 88 K N/A ACL=Institute for Community Living (NIDILRR moved from DoED) ACF=Administration for Children and Families 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. 90 Training & Consulting, LLC 45

NIH Institutes Differ in Funding 20 institutes & 7 centers at NIH 23 of 27 make SBIR awards Separate budgets (extramural funding) Do some intelligence work first 91 NIH is organized into: 27 Separate Institutes & Centers (IC) each with different: Missions & priorities Budgets Ways of deciding which grants to fund NIGMS International Center Clinical Center Training & Consulting, LLC 46

Where does SBIR/STTR Fit at NIH? Award Mechanisms Research Grants Traditional R01 Small R03 Exploratory/Development R21 Program Project P01 Research Center P41, P30, P50 Large Project/Program Planning P20 Clinical Trial Planning R34 Small Business R41, R42, R43, R44 Academic Research Enhancement Award (AREA) R15 http://grants.nih.gov/grants/funding/funding_program.htm Purpose of NIH SBIR/STTR Program Stimulate technological innovation New technologies Refinement of existing technologies New applications for existing technologies Increase the commercial application of NIH supported research New medical or biological products Improved value Improved efficiency Improved costs Training & Consulting, LLC 47

NIH SBIR/STTR3-Phase Program Discovery Phase I Phase I Feasibility Study Budget Guide: $150K for SBIR and STTR Project Period: 6 months (SBIR); 1 year (STTR) Development Phase II Phase IIB Phase II Full Research/R&D $1M for SBIR and STTR, over two years Phase IIB Competing Renewal/R&D Clinical R&D; Complex Instrumentation/Tools to FDA Many, but not all, IC s participate Varies~$1M per year; up to 3 years Commercialization Phase III Phase III Commercialization Stage NIH, generally, not the customer Consider partnering and exit strategy early NIH SBIR/STTR: 3 Phases Phase I (Feasibility Study) Guideline = $150k; Cap = $225k** Phase II (Full Research R&D) Guideline = $1mil; Cap = $1.5mil** PHASE II+ (Competing Renewal/R&D) Clinical R&D; Complex Instrumentation/Tools Many, but not all, ICs participate $1M/year; 3 years Phase III (Commercialization) You must raise non-sbir/sttr funds ** preapproved exceptions by Institute per Application Guide Appendix A Training & Consulting, LLC 48

Success Rate SBIR/STTR 2013 & 2014 SBIR 40.5% STTR 42.5% 32.8% 21.6% 18.0% 15.7% 13.2% 28.6% 18.7% 20.3% 26.4% 2013 2014 8.3% Fast Track Phase I Phase II Fast Track Phase I Phase II 97 NIH SBIR/STTR Budget Allocations FY2015 NIAMS NIEHS NIAAA NHGRI NIMHD NIDCR ORIP NIDCD NIBIB NINR NCCIH NLM 2.9% SBIR $691M 0.40% STTR $95M Total FY15 $786M NCATS NEI NCI NIDA NIA NIAID NICHD NIMH NHLBI NINDS NIDDK NIGMS Training & Consulting, LLC 49

www.nih.gov 99 Training & Consulting, LLC 50

NIH -- Get Connected 101 How Does NIH Solicit Applications? Federal Opportunity Announcements (FOA) published: The NIH Guide At grants.gov Parent Announcements cover basic mechanisms Investigator-initiated applications Special Opportunities to fill gaps Requests for Applications (RFAs) a one time call with set aside funds Program Announcements (PA) highlights areas of focus Program Announcement with Special Review (PAR) for special consideration and protected review Program Announcement with Set Aside (PAS) essentially an RFA with multiple receipt dates Training & Consulting, LLC 51

NEW NIH SBIR/STTR WEBSITE! Training & Consulting, LLC 52

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2015 Omnibus Funding Opportunities SBIR Omnibus Solicitation FOA September 5, 2015 NEW Omnibus Cycle 1 January 5, 2016- NEW Omnibus Cycle 2 April 5, 2016- NEW Omnibus Cycle 3 Training & Consulting, LLC 54

SBIR Omnibus Solicitation FOA You must find a fit! Program Descriptions and Research Topics Training & Consulting, LLC 55

Program Descriptions and Research Topics NIH SBIR/STTR Special Solicitations RFA Request for Applications Specific program purpose Funds set aside for the competition Generally identify a single application receipt date Unique receipt dates PA Program Announcement Requesting applications in the stated scientific areas Money is not set aside Standard receipt dates 112 Training & Consulting, LLC 56

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Do your homework @ NIH Which Institute? Which Mechanism? Scope? Timing? NIH Strategic Planning DIRECT YOUR PROPOSAL! Find a home Search Reporter Talk to Program Staff Ensure appropriate review Review CSR Study Sections Tailor your project Training & Consulting, LLC 58

NIH Reporter projectreporter.nih.gov 118 Training & Consulting, LLC 59

NIH SBIR & STTR Grant Codes R41 R42 R43 R44 Small Business Technology Transfer (STTR) Grants - Phase I Small Business Technology Transfer (STTR) Grants - Phase II Small Business Innovation Research Grants (SBIR) - Phase I Small Business Innovation Research Grants (SBIR) - Phase II 119 Decoding Your NIH Grant Number Application Type Activity Code Institute Code Serial Number Support Year Extension 1 R41 EB 12345 01 A1 1 = new 2 = renewal 3 = supplement 5 = noncompeting continuation 7 = Change of Grantee Institution 9 = Change of NIH awarding institute or division R = Research project P = Program project or Center T = Training (institutional) F = Fellowship (individual) K = Career Development U = Cooperative agreement AA = NIAAA AG = NIA AI = NIAID AR = NIAMS AT = NCCAM CA = NCI DA = NIDA DC = NIDCD DE = NIDCR DK = NIDDK EB = NIBIB ES = NIEHS EY = NEI GM = NIGMS HD = NICHD Unique, up to six digits HG = NHGRI HL = NHLBI LM = NLM MD = NCMHD MH = NIMH NR = NINR NS = NINDS RR = NCRR TW = FIC Years of Continuous Funding A1 = resubmission S1 = supplement Training & Consulting, LLC 60

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Talk to NIH! Grant Writing 101: Understand the Review Process a.k.a.- make the reviewers job easy... 128 Training & Consulting, LLC 64

The Peer Review Process 129 130 Training & Consulting, LLC 65

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 131 CSR Division of Receipt and Referral Electronic SF424 R&R submitted through grants.gov CSR Referral Office assigns the application to a study section (SRG) o Conduct review o Write critique o Assign impact score to an NIH Institute (IC) o Make Funding Decision Application assessed for completeness & eligibility Notice of assignment available in era Commons in 4 weeks. 1 st Month 2 nd Month Training & Consulting, LLC 66

133 http://public.csr.nih.gov/pages/default.aspx Who are the NIH Reviewers? Review panels are assembled on an ad hoc basis for each meeting; therefore designations and scientific emphasis may change with each review cycle. 134 Training & Consulting, LLC 67

CSR SBIR /STTR Study Sections 135 Training & Consulting, LLC 68

The Review Process at CSR Assignment The Division of Receipt and Referral (DRR) assigns each application to a review group and to one or more Institutes/Centers for funding consideration. Referral staff have access to the entire application, not just the title and Abstract. In many cases, they concentrate on the Abstract and Specific Aims. Requests made by investigators and the assignment of previous applications are also considered. An Institute or Center (IC) is identified for primary assignment for funding. Applications may also receive dual IC assignments. The grant application is assigned for review to the CSR or to one of the other IC Review groups. Training & Consulting, LLC 69

The Review Process at CSR Review Prior to the meeting reviewers are assigned to your application Your Scientific Review Officer (SRO) will analyze the content of your application, check for completeness and compliance with policies, and decide which reviewers can best evaluate it. Reviewers have access to your application approximately 6 weeks before the Study Section meeting. Each application is assigned to three or more reviewers, and at least two of them provide full written critiques. These assigned reviewers lead the discussions at the meeting. Before the Study Section meets, reviewers confidentially submit preliminary critiques. Reviewers also assign preliminary scores for each review criterion and for the overall impact of the application. The Review Process at CSR Review The SRO uses the preliminary overall impact scores to order the reviews. Applications in the lower half are not typically discussed. Study sections convene for 1 to 2 days. Assigned reviewers present their evaluations and mail reviews are read. After a general discussion, reviewers privately submit overall impact scores to CSR. Relevant NIH program staff are encouraged to attend, but do not participate. The Advisory Council of the funding institute will then consider the study section s recommendations. Training & Consulting, LLC 70

NIH Review Criteria Significance Significant Science Significant Product Significant Commercial Opportunity Investigators Innovation Approach Environment IMPACT 141 NIH Review Process Preliminary Impact Score of 1-9 (best to worst) Each criterion also scored; unrelated to impact score Preliminary scores used to determine which are discussed Rank order discussion process Final impact score by each panel member for those discussed Overall impact score = mean x 10 (range from 10-90) All applications receive written summary statement Streamlined applications receive scores on each criterion in addition to critiques 142 Training & Consulting, LLC 71

Significance / Impact Overall Impact Score: assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved. 143 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 144 Training & Consulting, LLC 72

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 NIH Review Process Small Business Concern Submits SBIR/STTR Grant Application to NIH Assign to IC and IRG Applicant Initiates Research Idea Scientific Review Groups Evaluate Scientific Merit Score of >??? Resubmission? Score of 10 -?? Advisory Council or Board Recommend approval Grantee Conducts Research IC Allocates Funds Assurances are met IC Staff Prepare funding Plan for IC Director Training & Consulting, LLC 73

Summary Statements 147 Summary Statements 148 Training & Consulting, LLC 74

Review Criteria Significance Technical merit Commercial value Investigators Innovation Approach Environment 149 Significance: Merit of Project Does this study address an important problem? Will the Specific Aims be reached when experiments are completed? If so, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? 150 Training & Consulting, LLC 75

Significance: Commercial Value How strong is the commercial potential of the project in terms of leading to a marketable product or process? What may the product or process be worth? Will the technology have a competitive advantage over existing or alternative technologies in meeting the market needs? 151 Investigators Knowledgeable Investigators appropriately trained and well suited to carry out this work? Skilled Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Are the investigators productive? Persistent, Passionate, Focused Does the investigative team bring complementary and integrated expertise to the project? 152 Training & Consulting, LLC 76

Innovation Is the project original and innovative? Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? 153 Quality of Approach Is there a solid hypothesis to be tested? Sound experimental design & methods Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 154 Training & Consulting, LLC 77

Environment Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? 155 Strategic Planning BEFORE you start to write your proposal: Understand NIH Structure Find a Solicitation Understand the Review Process Define your project Understand how to work with NIH Proposal Preparation 156 Training & Consulting, LLC 78

NIH SBIR/STTR Proposal Preparation Key Planning Steps Acquire preliminary data Conduct scientific literature search and market research Plan experiments/r&d activities Develop commercialization strategy Convene the technical team Secure facilities and other resources Writing the 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? Training & Consulting, LLC 79

Components of an NIH SBIR/STTR Introduction to Application (1pg) Specific Aims (1 pg) Research Strategy (6 or 12 pg) Significance Innovation Approach Inclusion Enrollment Report Progress report/publication List (Phase II proposals only) Protection of Human Subjects Inclusion of Women and Minorities Targeted/Planned Enrollment Table Inclusion of Children Vertebrate Animals Select Agents Multiple PD/PI Plan Consortium/Contractual Arrangements Letters of Support Resource Sharing Plans Appendix Bibliography and Refs Cited Project Summary/Abstract (30 lines) Public Health Relevance Statement/Narrative Biographical Sketches (5 pg ea.) Facilities & Other Resources Equipment Project Budget Subaward Budget Cover Letter Commercialization Plan (12 pg; Ph II & Fast Track only) Forms NIH SBIR/STTR Proposal Preparation Specific Aims Section (1 page): A summary of. 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? Training & Consulting, LLC 81

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? 163 Importance of Specific Aims Criteria by which success of Phase I will be judged Q: Did you demonstrate feasibility? A: Did you accomplish the specific aims? 164 Training & Consulting, LLC 82

Hypothesis-Driven Research 165 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 166 PAGE LIMIT: One PAGE Training & Consulting, LLC 83

Specific Aims Outline Phase II The Company Significance Problem to be solved Gap in knowledge The Product Technological Innovation Impact Long Term Goal Rationale for the goal Phase I Outcomes Demonstrate feasibility Phase II Project: Phase II Hypothesis Specific Aim 1 Criteria for acceptance Specific Aim 2 Criteria for acceptance Expected Outcomes Commercial Application 167 PAGE LIMIT: One PAGE Aims vs. Activities Specific Aims = Objectives Either achieved or not Do not yield results/data Have measurable, desired end points (e.g., criteria for acceptance ) Tasks = Activities Steps to achieve your aims/objectives Make up your work plan They are performed or carried out Yield results &/or data Training & Consulting, LLC 84

The Specific Aims Support a significant, testable hypotheses appropriate for the Phase of development Should be stated succinctly in one sentence each Aims test the hypothesis Experiments (as described in the research strategy section) support aims Should be independent Should be achievable within the budget and time frame Should have criteria for acceptance so that you will know when you ve achieved them and the reviewers therefore know that you will know! 169 Components of an NIH SBIR/STTR Introduction to Application (1pg) Specific Aims (1 pg) Research Strategy (6 or 12 pg) Significance Innovation Approach Inclusion Enrollment Report Progress report/publication List (Phase II proposals only) Protection of Human Subjects Inclusion of Women and Minorities Targeted/Planned Enrollment Table Inclusion of Children Vertebrate Animals Select Agents Multiple PD/PI Plan Consortium/Contractual Arrangements Letters of Support Resource Sharing Plans Appendix Bibliography and Refs Cited Project Summary/Abstract (30 lines) Public Health Relevance Statement/Narrative Biographical Sketches (5 pg ea.) Facilities & Other Resources Equipment Project Budget Subaward Budget Cover Letter Commercialization Plan (12 pg; Ph II & Fast Track only) Forms Training & Consulting, LLC 85

Research Strategy Significance Innovation Approach 171 Significance Explain the importance of the problem or critical barrier to progress in the field. How will the proposed project improve scientific knowledge, technical capability, and/or clinical practice. Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the aims are achieved. Describe the commercial potential of the project to lead to a marketable product, process or service. 172 Training & Consulting, LLC 86

Significance Demonstrate: Significant product Significant science Significant need in the market Significant commercial opportunity Use references! 173 Innovation Clearly state the technological innovation. Explain how the application challenges and seeks to shift current research or clinical practice paradigms. Describe any novel theoretical concepts, approaches or methodologies, instrumentation or intervention(s) to be developed or used, and any advantage over existing methodologies, instrumentation or intervention(s). Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation or interventions. 174 Training & Consulting, LLC 87

Innovation How will this effort shift current research or clinical practice paradigms? Is the proposed work new? Creative? Describe any novel theoretical concepts, approaches or methodologies, instrumentation or interventions(s) to be developed. How will the results direct/inform future research/product development? Will success improve the State-of-the-art, establish new research directions, change clinical practice? 175 Approach Describe the overall strategy, methodology, and analyses to be used. Include how data will be collected, analyzed, and interpreted. Discuss potential problems, alternative strategies, and benchmarks for success. Describe the strategy to establish feasibility, and address the management of any high risk aspects of the proposed work. Point out any procedures, or materials that may be hazardous to personnel and precautions to be exercised. Include information on Preliminary Studies. Discuss the PD/PI s preliminary studies, data, and/or experience pertinent to this application. 176 Training & Consulting, LLC 88

Approach Do experiments relate to the Specific Aims? Provide an overview and conceptual framework Are the experiments logical and well-integrated? Why are the proposed methods the best way to go? Be sure this study is not a technology looking for a problem! Less detail needed for established techniques Alternatives for high risk elements add to the feasibility Are the end-points/milestones clearly defined? Is the appropriate statistical analysis included? Is there a sensible timeline? 177 Approach Data Planning Provide information on the number of observations (experiment runs, human subjects, animals ) that need to be made to obtain statistically significant findings Describe how the data will be analyzed to verify scientific validity. 178 Training & Consulting, LLC 89

Convey impact with less detail Focus on your strategy, rather than detailing all experiments. Detail experiments that let you shine. Limit your aims Know when detail is needed: Give preliminary data to show you are on the right track. Give more detail for unique or new methods. Cite refs & use Biosketch statement. Research Strategy BBC Outline Significance 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 180 Training & Consulting, LLC 90

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? 181 Research Strategy BBC Outline Approach Phase I 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 (separate section for each aim) Rationale Experimental Design & Methods Data Analysis & Interpretation Potential Pitfalls / Alternative Approaches Expected Outcomes 182 Training & Consulting, LLC 91

10/12/2015 Research Strategy BBC Outline Approach Phase II Phase I Progress Report Beginning and ending dates of Phase I Summarize Phase I Aims Results and conclusions (achievement of aims) Describe any significant changes to aims/new directions Summary Specific Aim (separate section for each aim) Rationale Experimental Design & Methods Data Analysis & Interpretation Potential Pitfalls / Alternative Approaches Expected Outcomes 183 Approach - Outline For Each Specific Aim: [Restate the Aim] Rationale Give the reasoning behind the aim Experimental Design & Methods Lay out what experiments (in detail) will be conducted to complete the aim and methods to be employed in each experiment Data Analysis & Interpretation How will you will analyze the data? Potential Pitfalls / Alternative Approaches What could go wrong and how will you compensate if it does? Expected Outcomes What do you expect to happen? 184 Training & Consulting, LLC 92

10/12/2015 Summary Tell the reviewers: What (Specific Aims) Why (Significance, Innovation, Prior Work) How (Research Strategy) Summarize who, when and where: Gantt Chart Detailed timeline for project Details who will be responsible for completion of each aims Where the work will be done (company, subcontractor etc.) 185 Gantt Chart (who, when, where?) Specific Aims Specific Aim 1 Month 1 2 3 4 5 6 Experiment 1 A. Scientist, Ph.D. NewCo. Labs Experiment 2 A.N. Scientist, Ph.D. NewCo. Labs Specific Aim 2 Experiment 1 A. Engineer, M.S. MidWest University Specific Aim 3 Experiment 1 A.N. Scientist, Ph.D. Research Co. 2 Training & Consulting, LLC 93

Components of an NIH SBIR/STTR Introduction to Application (1pg) Specific Aims (1 pg) Research Strategy (6 or 12 pg) Significance Innovation Approach Inclusion Enrollment Report Progress report/publication List (Phase II proposals only) Protection of Human Subjects Inclusion of Women and Minorities Targeted/Planned Enrollment Table Inclusion of Children Vertebrate Animals Select Agents Multiple PD/PI Plan Consortium/Contractual Arrangements Letters of Support Resource Sharing Plans Appendix Bibliography and Refs Cited Project Summary/Abstract (30 lines) Public Health Relevance Statement/Narrative Biographical Sketches (5 pg ea.) Facilities & Other Resources Equipment Project Budget Subaward Budget Cover Letter Commercialization Plan (12 pg; Ph II & Fast Track only) Forms Human Subjects If you have human subjects You must upload 5 pdf attachments: Inclusion Enrollment Report Protection of Human Subjects (includes Data & Safety Monitoring Plan) Inclusion of Women and Minorities Targeted/Planned Enrollment Table Inclusion of Children 188 Training & Consulting, LLC 94

Where to get help on Human Subjects The NIH SBIR/STTR Application Guide (Part II: Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan) The National Institutes of Health (NIH) Human Research Protections Program (HRPP) http://ohsr.od.nih.gov Research Involving human subjects http://grants.nih.gov/grants/policy/hs/ Vertebrate Animals Address the following five key points Describe the proposed use of the animals in the work outlined e.g. species, strains, ages, sex, numbers Justify the use of animals, the choice of species, and the numbers to be used. Information on veterinary care. Describe the procedures for ensuring that discomfort, distress, pain, and injury will be limited. Describe any method of euthanasia to be used and the reasons for its selection. 190 Training & Consulting, LLC 95

Components of an NIH SBIR/STTR Introduction to Application (1pg) Specific Aims (1 pg) Research Strategy (6 or 12 pg) Significance Innovation Approach Inclusion Enrollment Report Progress report/publication List (Phase II proposals only) Protection of Human Subjects Inclusion of Women and Minorities Targeted/Planned Enrollment Table Inclusion of Children Vertebrate Animals Select Agents Multiple PD/PI Plan Consortium/Contractual Arrangements Letters of Support Resource Sharing Plans Appendix Bibliography and Refs Cited Project Summary/Abstract (30 lines) Public Health Relevance Statement/Narrative Biographical Sketches (5 pg ea.) Facilities & Other Resources Equipment Project Budget Subaward Budget Cover Letter Commercialization Plan (12 pg; Ph II & Fast Track only) Forms Bibliography & References Cited Include the names of all authors the article and journal title, book title, volume number, page numbers, and year of publication. Include only bibliographic citations. Follow scholarly practices in providing citations for source materials relied upon when preparing any section of the application. Should include any references cited in the Research Plan Component. Should be limited to relevant and current literature. Don t forget important conversations, correspondence. No page limitation, but be concise and select only those literature references pertinent to the proposed research. 192 Training & Consulting, LLC 96

Project Summary/Abstract (30 lines) A summary of the proposed activity suitable for dissemination to the public. A succinct/accurate description of the proposed work when separated from the application. State the application s long-term objectives and specific aims, refer to the health relatedness of the project. Describe concisely the research design and methods for achieving the stated goals. Understandable to a scientifically literate lay reader. No proprietary/confidential information. < 30 lines of text. 193 Phase I Abstract - outline Introduction Problem to be addressed Product Technological Innovation Long-Term Goal Phase I Summary Phase I Hypothesis Specific Aims for Phase I Phase II Objectives Commercial Opportunity 194 Training & Consulting, LLC 97

Phase II Abstract - outline Introduction Problem to be addressed Product Technological Innovation Long-Term Goal Phase I Outcomes (e.g., feasibility) Phase II Summary Phase II Hypothesis Specific Aims for Phase II Commercial Opportunity 195 Public Health Relevance For NIH and other PHS agencies applications, this attachment will reflect the second component of the Project Summary relevance. Using no more than two or three sentences, describe the relevance of this research to public health. In this section, be succinct and use plain language that can be understood by a general, lay audience. 196 Training & Consulting, LLC 98

Components of an NIH SBIR/STTR Introduction to Application (1pg) Specific Aims (1 pg) Research Strategy (6 or 12 pg) Significance Innovation Approach Inclusion Enrollment Report Progress report/publication List (Phase II proposals only) Protection of Human Subjects Inclusion of Women and Minorities Targeted/Planned Enrollment Table Inclusion of Children Vertebrate Animals Select Agents Multiple PD/PI Plan Consortium/Contractual Arrangements Letters of Support Resource Sharing Plans Appendix Bibliography and Refs Cited Project Summary/Abstract (30 lines) Public Health Relevance Statement/Narrative Senior/Key Person Profiles Biographical Sketches (5 pg ea.) Facilities & Other Resources Equipment Project Budget Subaward Budget Cover Letter Commercialization Plan (12 pg) Ph II & Fast Track only Forms NIH Commercialization Plan Value of SBIR/STTR project Company information Market, Customer, Competition Intellectual Property Protection Finance Plan Production and Marketing Plan Revenue Stream No more than 12 pages 200 Training & Consulting, LLC 100

Which sections? Who is going to do the work? Where will the work be done? How much will it cost? Biographical Sketches Facilities and Resources Letters of Support Budget and Budget Justification The Team Key Persons vs. Non-Key Persons 202 Training & Consulting, LLC 101

Key Personnel Your (the SBC s) employees Subcontractor s employees Consultants Other Significant Contributors 203 Components of an NIH SBIR/STTR Introduction to Application (1pg) Specific Aims (1 pg) Research Strategy (6 or 12 pg) Significance Innovation Approach Inclusion Enrollment Report Progress report/publication List (Phase II proposals only) Protection of Human Subjects Inclusion of Women and Minorities Targeted/Planned Enrollment Table Inclusion of Children Vertebrate Animals Select Agents Multiple PD/PI Plan Consortium/Contractual Arrangements Letters of Support Resource Sharing Plans Appendix Bibliography and Refs Cited Project Summary/Abstract (30 lines) Public Health Relevance Statement/Narrative Biographical Sketches (5 pg ea.) Facilities & Other Resources Equipment Project Budget Subaward Budget Cover Letter Commercialization Plan (12 pg; Ph II & Fast Track only) Forms Training & Consulting, LLC 102

Biographical Sketches NEW FORMAT November 2014 207 http://grants.nih.gov/grants/funding/424/index.htm Biosketch Personal Statement 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 Training & Consulting, LLC 104

Position where you will be doing the work Make sure to list the small business for all personnel that will be working there at the time of award 209 Don t forget relevant items such as patents or other product development accomplishments NEW NOVEMBER 2014: Replaces publications 210 Training & Consulting, LLC 105

211 Consortium/Contractual Arrangements Explain the programmatic, fiscal, and administrative arrangements to be made between the applicant organization and the consortium organization(s). Explain why the applicant organization, rather than the ultimate performer of the activities, should be the grantee. List any subcontracts or enter Not applicable Write a paragraph on what the deliverables will result from the arrangement. 212 Training & Consulting, LLC 106

Consortium/Contractual Arrangements (STTR) Certification showing the cooperative R&D arrangement between the small business concern and the research institution requested prior to an award. The single partnering research institution must certify that > 30% of the work of the STTR project will be performed by the research institution. The signature of the authorized representative of the research institution affirming certifications made by the research institution must be included in a letter: 213 Consortium/Contractual Arrangements (STTR) The small business concern and the research institution certify jointly that: The project will be conducted jointly by the small business concern and the research institution in which > 40 % of the work will be performed by the small business concern and > than 30 % of the work will be performed by the research institution The small business concern will be the primary party that will exercise management direction and control of the performance of the project. 214 Training & Consulting, LLC 107

Letters of Support** (**Contingent Commitment) Consultants (required) Subcontractors (include in contractual arrangements section) Contingent Resources, e.g.: Company research pace Leaves of absence R&D Resources Commercialization Resources, e.g.: Funding Strategic Partners Key Customers 215 Letters of Support** (**Contingent Commitment) Required from each consultant Prepared on the letterhead of the consultant and addressed to the Small Business Concern (SBC). Letter should: Refer to the specific project by name Verify the consultant s commitment to the project Confirm his/her role in the project. Acknowledge the PD/PI as the lead on the project Specify what assets or services the consultant will contribute (e.g. expertise, number of hours/ percent of effort) Quantify the consultant s remuneration Biographical sketch 216 Training & Consulting, LLC 108

Components of an NIH SBIR/STTR Introduction to Application (1pg) Specific Aims (1 pg) Research Strategy (6 or 12 pg) Significance Innovation Approach Inclusion Enrollment Report Progress report/publication List (Phase II proposals only) Protection of Human Subjects Inclusion of Women and Minorities Targeted/Planned Enrollment Table Inclusion of Children Vertebrate Animals Select Agents Multiple PD/PI Plan Consortium/Contractual Arrangements Letters of Support Resource Sharing Plans Appendix Bibliography and Refs Cited Project Summary/Abstract (30 lines) Public Health Relevance Statement/Narrative Biographical Sketches (5 pg ea.) Facilities & Other Resources Equipment Project Budget Subaward Budget Cover Letter Commercialization Plan (12 pg; Ph II & Fast Track only) Forms Facilities and Other Resources Not just a cut-and-paste list! Address how the (scientific) environment will contribute to probability of success, unique features of environment, etc. Other aspects of the environment can include: Scientific Advisory Board Management Team Community Support Training & Consulting, LLC 109

Facilities and Other Resources To assess the capability of the resources available to perform the effort proposed. Identify the facilities to be used (Lab, Animal, Computer, Office, Clinical and Other). Indicate capacities, capabilities, relative proximity, extent of availability to the project. Describe only resources directly applicable to the work Provide any information describing the Other Resources available to the project. All research by the small business and its collaborators must be in U.S. facilities available to and under the control of each party. 219 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 220 Training & Consulting, LLC 110

Equipment List major items of equipment already available for this project and, if appropriate identify location and pertinent capabilities. 221 Components of an NIH SBIR/STTR Introduction to Application (1pg) Specific Aims (1 pg) Research Strategy (6 or 12 pg) Significance Innovation Approach Inclusion Enrollment Report Progress report/publication List (Phase II proposals only) Protection of Human Subjects Inclusion of Women and Minorities Targeted/Planned Enrollment Table Inclusion of Children Vertebrate Animals Select Agents Multiple PD/PI Plan Consortium/Contractual Arrangements Letters of Support Resource Sharing Plans Appendix Bibliography and Refs Cited Project Summary/Abstract (30 lines) Public Health Relevance Statement/Narrative Biographical Sketches (5 pg ea.) Facilities & Other Resources Equipment Project Budget Subaward Budget Cover Letter Commercialization Plan (12 pg; Ph II & Fast Track only) Forms Training & Consulting, LLC 111

Budget limitations NEW: Reauthorization Impacts 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 Appendix A Talk to program staff! REMINDER: Outsourcing Limits SBC (applicant organization) must do required minimum (% of direct + indirect) SBIR - Phase I - 67% SBIR - Phase II - 50% STTR - Phase I & II - 40% Therefore total of Consultants + Subcontractor Costs must be: SBIR - Phase I - <33.3% SBIR - Phase II - <50% STTR - Phase I & II - 30% for primary subcontractor; <30% for all other consultants + subcontractors Training & Consulting, LLC 112

Budgets Direct Costs Indirect Costs (F&A) Fee 40% Phase I, 40% Phase II or be prepared for an IDC rate negotiation Basis is total direct costs A rate of 40% of total direct costs is requested. This amount is appropriate to cover the company s current projected indirect costs and is consistent with NIH s policy for Phase I SBIR proposals when the company does not already have a previously negotiated indirect cost rate. A fee of 7% of total costs (direct and indirect) is requested. This fee contributes to the growth of the small business concern by allowing expansion of resources and personnel development. The fee is consistent with a normal profit margin provided for research and development work. Unallowable Costs Budget approach When a cap or restriction is enforced Work backwards to determine the direct dollars If Budget Cap = $225,000 Direct Costs = $150,000 Indirect Costs = $150,000 x 40% $60,000 Fee = ($150,000 + $60,000) x 6.99% $14,679 TOTAL: Direct + Indirect + Fee $224,679 Therefore design your project to fit $150k directs Training & Consulting, LLC 113

Budget Figures Plan For This Phase I Phase II Direct $ 150,000 $ 1,000,000 Indirect@40% $ 60,000 $ 400,000 Fee@7% $ 14,679 $ 97,860 Total $ 224,679 $ 1,497,860 Budget Justification A budget justification is required for each budget submitted. Written justification for each dollar requested Provide detail Stand alone document Be convincing Training & Consulting, LLC 114

Budget Justification Every line item in your budget should have a subheading and corresponding paragraph in the Budget Justification. Include all justification information for all years in the same file. List the names, employment status, project role, calendar months (% effort), and salary for ALL project personnel. If the application includes a subaward/consortium budget, a separate budget justification is submitted for that budget. Should be a stand-alone document. 229 Budget Best Practices** 1. Develop your budget early 2. Make sure that your direct costs are consistent with the work proposed 3. Request indirect costs 4. Request fee 5. Understand the difference between direct costs, indirect costs and fee! **Refer to BBC June 2012 Pursuit Newsletter 230 Training & Consulting, LLC 115

Components of an NIH SBIR/STTR Introduction to Application (1pg) Specific Aims (1 pg) Research Strategy (6 or 12 pg) Significance Innovation Approach Inclusion Enrollment Report Progress report/publication List (Phase II proposals only) Protection of Human Subjects Inclusion of Women and Minorities Targeted/Planned Enrollment Table Inclusion of Children Vertebrate Animals Select Agents Multiple PD/PI Plan Consortium/Contractual Arrangements Letters of Support Resource Sharing Plans Appendix Bibliography and Refs Cited Project Summary/Abstract (30 lines) Public Health Relevance Statement/Narrative Biographical Sketches (5 pg ea.) Facilities & Other Resources Equipment Project Budget Subaward Budget Cover Letter Commercialization Plan (12 pg; Ph II & Fast Track only) Forms The Cover Letter Include a cover letter! Application title PA or RFA title, if you are responding to an NIH initiative Request of an assignment and referral to a particular IC (NIH makes the final determination.) List of people (e.g., competitors) who should not review your application and why Disciplines involved, if multidisciplinary NOT OPTIONAL! 232 Training & Consulting, LLC 116

Components of an NIH SBIR/STTR Introduction to Application (1pg) Specific Aims (1 pg) Research Strategy (6 or 12 pg) Significance Innovation Approach Inclusion Enrollment Report Progress report/publication List (Phase II proposals only) Protection of Human Subjects Inclusion of Women and Minorities Targeted/Planned Enrollment Table Inclusion of Children Vertebrate Animals Select Agents Multiple PD/PI Plan Consortium/Contractual Arrangements Letters of Support Resource Sharing Plans Appendix Bibliography and Refs Cited Project Summary/Abstract (30 lines) Public Health Relevance Statement/Narrative Biographical Sketches (5 pg ea.) Facilities & Other Resources Equipment Project Budget Subaward Budget Cover Letter Commercialization Plan (12 pg; Ph II & Fast Track only) Forms Introduction to Application Only if you are submitting a Resubmission. An introduction that summarizes the substantial additions, deletions, or changes. Must include responses to the criticisms and issues raised in the Summary Statement. Identify the changes in the Research Design and Methods section clearly by bracketing, indenting, or changing typography, unless the changes are so extensive as to include most of the text. One page. 234 Training & Consulting, LLC 117

Proposal Format Read the solicitation! NIH Font and Page limits (PA-15-269, PA-15-270) Arial, Helvetica, Palatino Linotype or Georgia (in black) 11 point or greater ½ inch or greater margins No headers or footers Follow instructions for marking confidential information Graphics Think of the reviewer! Convert all documents to.pdf before submission File names <50 characters; do not use &; only 1 space between words and it counts as a character; 235 236 Training & Consulting, LLC 118

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. 237 238 Training & Consulting, LLC 119

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) 239 Components of an NIH SBIR/STTR 1. Introduction to Application (1pg) 2. Specific Aims (1 pg) 3. Research Strategy (6 or 12 pg) Significance Innovation Approach 4. Inclusion Enrollment Report 5. Progress report/publication List (Phase II proposals only) 6. Protection of Human Subjects 7. Inclusion of Women and Minorities 8. Targeted/Planned Enrollment Table 9. Inclusion of Children 10. Vertebrate Animals 11. Select Agents 12. Multiple PD/PI Plan 13. Consortium/Contractual Arrangements 14. Letters of Support 15. Resource Sharing Plans 16. Appendix Bibliography and Refs Cited Project Summary/Abstract (30 lines) Public Health Relevance Statement/Narrative Senior/Key Person Profiles Biographical Sketches (4 pg ea.) Facilities & Other Resources Equipment Project Budget Subaward Budget Cover Letter Commercialization Plan (12 pg; Ph II & Fast Track only) Forms Training & Consulting, LLC 120

NIH PHS 2015-02 Omnibus Solicitation 241 Grant Application Package Make sure you have the correct application package. FOA information is automatically populated and not editable. Save the package locally. Mandatory Grants.gov fields highlighted yellow with red box. 242 Training & Consulting, LLC 121

Instructions Application Guide 243 Company Subcontractors Consultants Others Introduction (resub)? Project Narrative Abstract Specific Aims Research Strategy? Human Subjects? Vertebrate Animals? Bibliography?? Budget? Budget Justification Biographical Sketches? Facilities & Resources? Equipment? Select Agents? Subcontactor Arrangements Letters of Support? Cover Letter Commercialization Plan (PH II)? Forms Training & Consulting, LLC 122

System Capability Issues 1 - Adobe Reader www.grants.gov/web/grants/support/technical-support/recommended-software.html 2 Browser: Use Internet Explorer to be safe! Registrations All organizations submitting proposals to NIH must have the following: Prerequisites: EIN Employee Identification Number (IRS) DUNS Data Universal Number (D&B) Bank Account SAM System for Award Management Three required registrations: 1. Grants.gov registration 2. NIH Electronic Research Administration (ecommons) registration 3. SBIR.gov Company registry Training & Consulting, LLC 123

NIH Help Resources FIVE registrations SIX to EIGHT weeks Overview of Electronic Application @ NIH PI downloads announcement & forms PI completes application & sends to company AOR who submits to Grants.gov era retrieves application from Grants.gov, checks for compliance PI and AOR/SO track status & view assembled application in era Commons. 248 Training & Consulting, LLC 124

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 250 Training & Consulting, LLC 125

Grantsmanship There is no grantsmanship that will turn a bad idea into a good one, but there are many ways to disguise a good one. 251 Where s my money? Just-in-time Information Assurances Financial Information 3rd party involvement Subcontracts, consultants 252 Training & Consulting, LLC 126

JIT Just in Time Information This is NOT a notice of grant award Financial Statements Line of Credit Chart of accounts Demonstrate the ability to record costs by project Time & Reporting Internal Controls Procurement Policy Travel Policy Conflict of Interest Lab notebooks Update Other Support (all key persons) Human Subjects Assurance Number IRB Approval Document of required education of human subjects IACUC verification/letter SBIR/STTR Verification Budget Signed lease Success Notice of Award Document Training & Consulting, LLC 127

SBIR/STTR Grants: Commercialization Plans 25 Training & Consulting, LLC 128

Assumption #1: A good idea is necessary but not sufficient. 25 Assumption #2: SBIR/STTR does not fund science fair projects 25 Training & Consulting, LLC 129

Assumption #3 You will need a combination of technical AND business expertise e.g. (e.g., You can not possibly know everything ) 25 Assumptions #4a and 4b: A Market Analysis is NOT a Commercialization Plan Large Market Commercialization 26 Training & Consulting, LLC 130

Assumption #5: There is no such thing as the Build it and they will come Business Model 26 Assumption # 6: This is NOT a feasible business model: Technology Training & Consulting, LLC 131

What is Commercialization? Ability to provide a solution to a problem in exchange for money Targeted and Differentiated Solution Important Problem Viable Business Model 26 Risk Evaluate risk A good planning process is crucial for commercial success! 26 Training & Consulting, LLC 132

Can we talk about RISK?? Technical Market Management And how about Value 26 Create Value How Investors View Risk Team Risk Engineering Risk Technical Risk IP Risk Science Risk From David Wells, Kleiner Perkins 26 Execution Risk Adoption Risk Market Risk Financial Risk Scale-up Risk Remove Risk Training & Consulting, LLC 133

Most Common Pitfalls Product Development Business Development Year 1 Year 2 Year 3 Year 4 Naïve Planning process Product Development Business Development Year 1 Year 2 Year 3 Year 4 Product Development and Business Development go hand in hand Knowing your customer helps develop both simultaneously 26 What are you doing? We are developing a that is (. faster, better, cheaper) and can do,,. 26 Training & Consulting, LLC 134

What do you have? (scenario b) There is an important problem. If, then. The technological innovation under development ( ) would enable thereby addressing this gap in technology. Upon successful reduction to practice the product that will be developed ( ) will address this problem better than because. 26 The Philosophy of Commercialization Life is sales! 27 Training & Consulting, LLC 135

The Philosophy of Commercialization Know thy customer 27 Chickens and Eggs: Where did you start?...what do you have? a) A product THE SOLUTION or b) A market THE PROBLEM 27 Training & Consulting, LLC 136

The Planning Process Describe the problem Identify the target customer Define the market (e.g., size, growth rate, distribution) List alternative solutions (i.e., competition) Define the value proposition Describe the business model 273 The Planning Process Where to Start?? External Problem Customer Market Internal Technology Product Company 27 Training & Consulting, LLC 137

What s the Opportunity? Where to Start?? Problem Technology Customer Market Product Company What s the Opportunity? Focus on the Problem Not the Solution! 27 Training & Consulting, LLC 138

The Planning Process Important Problem Who has the Problem? Customer How do they deal with it? Competition How do we compare? How many with the problem? Value Proposition Market 277 The Commercialization Plan 27 Training & Consulting, LLC 139

Business Plan Covers ALL products/services Defines the business model Provides extensive financials & assumptions Identifies milestones and risks for the company May be a request for funding --or-- May be an internal operating guide 279 Business Plan Tell Your Story Executive Summary Company Product Market Management Operations Financials 280 Training & Consulting, LLC 140

10/12/2015 Commercialization Plan Covers a SPECIFIC product or technology Defines the commercialization model (i.e. route to market) Identifies milestones and risks related to commercialization of the product or service Provides financial information related to the product (i.e. cost, price, sales projections, margin) 281 Commercialization Plan Plan will include: Competitive analysis (both companies & products) Plan may include: Research, development & engineering plans Product specifications; alpha, beta testing, in vitro, in vivo (animal/clinical) studies Regulatory plans FDA, labeling, clinical trials, ISO, GMP, CE mark Production (how, where, who?) Marketing, distribution, service 282 Training & Consulting, LLC 141

Sage Advice? (for what it s worth...) THE PLANNING PROCESS IS MORE VALUABLE THAN THE PLAN ITSELF 283 Commercialization Plan Elements SBA SBIR (old) Policy Directive: Company Information Customer and Competition Market Intellectual Property Financing Assistance and Mentoring 284 Training & Consulting, LLC 142

Commercialization Plan Elements NIH Proposed Layout Value of SBIR/STTR project Company information Market, Customer, Competition Intellectual Property Protection Finance Plan Production and Marketing Plan Revenue Stream No more than 12 pages 285 Commercialization Plan Elements 1 - Value of this SBIR/STTR project 286 Training & Consulting, LLC 143

1 Value of THIS SBIR Lay description of key technology objectives (features & benefits) Need addressed weakness in state of the art What are the potential commercial applications? What is the innovation? Advantages compared to competing products, technologies or services Societal, educational, scientific benefits Non-commercial impact How does project integrate into Company business plan? 287 Story ReceptorPro: Part I 28 Training & Consulting, LLC 144

Commercialization Plan Elements 2. Company information 289 2 Company Information Corporate objectives Core competencies Size Annual sales Number, type of employees Track record Identify products with significant sales History of previous Federal and non-federal funding Subsequent commercialization Succinct history of the company Vision for future How will you fill management needs How will you become a successful commercial entity 290 Training & Consulting, LLC 145

The Company Brief History Mission What will you look like in 5 years? 291 Entrepreneurial Opportunities Critical Success Factors Combination of technical & business expertise Customer focus with a welldefined target segment Proven business model 29 Training & Consulting, LLC 146

Business Models License Joint development Fully integrated manufacturing, marketing, distribution OEM Contract Manufacturing Distribution Management Team Executive Officers Scientific Advisory Board Board of Directors Business Advisors Regulatory Experience Recruiting Plans 294 Training & Consulting, LLC 147

Track Record Applicant organization s record of successfully commercializing SBIR or other research, if applicable Existence of Phase III funding commitments from private sector $ Description of products/services with significant sales Presence of other indicators of the commercial potential of the subject research 295 Company Vision How will you grow your business? How will you maintain that growth? Where will you go to attract management talent? Describe hurdles your foresee as the company becomes a commercial entity Propose solutions! 296 Training & Consulting, LLC 148

2 Company Information - Recap 297 Corporate objectives Core competencies Size Annual sales Number, type of employees Track record Identify products with significant sales History of previous Federal and non-federal funding Subsequent commercialization Succinct history of the company Vision for future How will you fill management needs How will you become a successful commercial entity Commercialization Plan Elements 3. Market, Customer, Competition 298 Training & Consulting, LLC 149

3 - Market, Custom, Competition per NIH RFP Target market Customer profile Positioning (ie product advantages) Hurdles to overcome to gain acceptance (ie barriers to entry) Strategic alliances, partnerships, licensing agreements To get FDA approval To market and sell Marketing and sales strategy Competitive analysis 299 Why a Marketing Plan? Foundation of Your Business Primary Communication Tool inside & outside the company Source of company goals, milestones, and measures of progress 300 Training & Consulting, LLC 150

Do your homework a.k.a. MARKET RESEARCH For the computer savvy For the socially adept 30 What you need to know... The Market Market size and growth Customer profile Sales and market share projections Pricing and margin analysis Competitors Market trends 30 Training & Consulting, LLC 151

Story XYZ Technologies: Beseech Them.. 30 Developing the Total Marketing Plan 1. Understand your customer 2. Analyze your market & competition 3. Select a market niche 4. Develop your marketing message 5. Choose your marketing medium 6. Set marketing and sales goals 7. Develop your marketing budget 30 4 Training & Consulting, LLC 152

Market Definition Adopt standard definitions used by the leading companies and by market analysts Compare and contrast with your own definition of the market Estimating sizes of specific market segments will be easier using standard definitions If possible, always size your market in terms of units, before projecting to dollar sizes Search government reports, trade associations, and professional societies for relevant numbers 305 Market intelligence. For the computer savvy: Associations Non-profit disease-focused (i.e., ADA, ACS, AHA) Generic non-profit health (i.e., AMA) Industry trade (i.e., PMA.; BIO ) Third-party health insurance carriers Industry reports Stock analysts & commercial market research 306 Training & Consulting, LLC 153

Government Sources 30 Trade Associations Training & Consulting, LLC 154

10/12/2015 Market Research Reports - Table of Contents 30 Chemical Sensors to 2008 : Liquid, Gas & Biosensors - Market Size, Market Share, Market Leaders, Demand Forecast, Sales, Company Profiles, Market Research, Industry Trends Bharat Book Bureau, 2004 III. TECHNOLOGY Basic Sensor Technology Chemical Sensor Technology Electrochemical Optical Infrared Biomimetic Photoionization Emergent Technologies Semiconductor Catalytic Pellistor Other Biosensors MEMS & Other Microsystems Nanotechnology Electronic Noses & Tongues Electronic Noses Electronic Tongues VI. MARKETS Medical/Diagnostic Glucose Tests Diabetes Trends Products Suppliers Other Diagnostic Tests Cardiac Risk/Cholesterol Renal/UTI & Other Patient Monitoring Equipment Industrial Motor Vehicles Oxygen Sensors Other Process Industries HVAC & Other Equipment Environmental Monitoring Industrial Safety & Emissions Portable & Fixed Safety Systems Emissions Monitoring Water & Wastewater Home Safety & Security Automobile Emissions Testing Other Environmental Monitoring Other Markets Company Profiles Abbott Laboratories Alphasense Limited AMETEK Incorporated Analytical Sensors Incorporated ATMI Incorporated Bayer AG Biacore AB Draegerwerk AG e2v technologies Limited Emerson Electric Company International Biomedical Incorporated Johnson & Johnson Marconi Corporation plc Optical Sensors Incorporated Osmetech plc Polymer Technology Systems Incorporated Quantum Group Incorporated RAE Systems Incorporated Roche Holding Limited Sensorex Siemens AG Spectris plc Teledyne Technologies Incorporated Texas Instruments Incorporated TheraSense Incorporated Market Research Reports - Follow-on Information Google the author s name Look for articles in trade publications that summarize key data from the market research study Note the names of publicly-traded companies in the target market Review their latest 10K reports to SEC (www.sec.gov/edgar/searchedgar/companysearch.html) 310 Training & Consulting, LLC 155

Corporate 10K Reports to SEC 31 1 www.edgar.gov Corporate 10K Reports to SEC Often contain sales by market segment, product line and geography Analyze reports over a 5-6 year period to develop an overview of the Company s sales history, pricing strategy, and market trends For larger companies it might be difficult to extract detailed data on specific products unless they represent a significant fraction of the total business Note report of new strategic alliances or equity investments that might signal new business initiatives 312 Training & Consulting, LLC 156

Investor Presentations 31 3 Investor Presentations For public companies they often contain more detail than annual reports PPTs often downloadable from the company s investor website For private companies these presentations might be the only source of detailed product information Search for presentations made at Venture Capital conferences 314 Training & Consulting, LLC 157

Trade Publications 31 Trade Publications From public company websites, get the names of the stock analysts that cover their industry Search for articles in trade publications by these analysts Look for year-in-review issues that ranklist the top companies in the market Use these rankings to target additional searches 316 Training & Consulting, LLC 158

SBIR Awardees 31 Market Intelligence. For the socially adept: End users and customers Trade shows Scientific meetings 318 Training & Consulting, LLC 159

Market Analysis 31 Market Analysis Potential Addressable Accessible 32 Training & Consulting, LLC 160

Product Positioning 1: No need Unique Product 2: Big Need Many Products 3: No Need Many Products Big Need Unique Product Product Uniqueness 1 3 2 Customer Needs 321 Market Analysis To Verify the Problem Complete These Steps Test your understanding of the problem Write your description of the problem and its costs Talk to more people Modify your description as needed Ask them what else they need List their needs Rank them 322 Training & Consulting, LLC 161

Market Analysis Now for the Solution What are the customer s current alternatives to solve the problem? Include doing nothing How does your solution compare? Performance, convenience, price Cost of switching 323 Put your product description through the so what test 324 Training & Consulting, LLC 162

Competitive Analysis 325 Competitive Products What are the alternatives? How are these products sold now? What is their price? How big is their market share? What is their intellectual property position? 326 Training & Consulting, LLC 163

Competitive Companies Who are they? How large are they? Are they developing something new? Are they a potential partner? How do you intend to compete? 327 3 - Market, Custom, Competition Target market Customer profile Positioning (ie product advantages) Hurdles to overcome to gain acceptance (ie barriers to entry) Strategic alliances, partnerships, licensing agreements To get FDA approval To market and sell Marketing and sales strategy Competitive analysis 328 Training & Consulting, LLC 164

Commercialization Plan Elements 4. Intellectual Property Protection 32 4. Patent / IP Status List and describe importance to THIS project Clearly explain the company s right to use the intellectual property Discuss how the IP fits into the broader base of IP in the competitive landscape Detail the plan to protect any subsequent IP HOW DOES YOUR IP ENABLE YOUR BUSINESS STRATEGY?? 330 Training & Consulting, LLC 165

Rights to Commercialize If you are an academic or employed elsewhere: READ and KNOW your institution s Intellectual Property Rights Policy Assume the institution owns the IP unless proven otherwise Beware of public disclosure Beware of conflict of interest issues Transfer is based on negotiation and a viable business opportunity 331 Rights to Commercialize Two other pieces of good advice: Hire a good attorney Read the Bayh-Dole Act The Bayh-Dole Act requires a grantee institution to disclose an invention to the granting agency (NIH) Read NOT-95-003: A "20-20" VIEW OF INVENTION REPORTING TO THE NATIONAL INSTITUTES OF HEALTH http://grants1.nih.gov/grants/guide/notice-files/not95-003.html 332 Training & Consulting, LLC 166

Commercialization Plan Elements 5. Finance Plan 33 33 Training & Consulting, LLC 167

Finance Plan How much $ is necessary to develop the product? When will the $ be required? Where will the money come from? How much $ is necessary to commercialize? When will the $ be required? Where will the money come from? 335 Finance Plan What are your plans to raise $ for commercialization in Phase III? Letters of commitment of funding Letters of intent, evidence of negotiations In-kind commitment Letters of support Detailed steps to secure funding 336 Training & Consulting, LLC 168

Financing Sources $ SBIR/STTR firm itself $ Private investors or "angels" $ Venture capital firms $ Investment companies $ Joint ventures, R&D limited partnerships, Strategic alliances $ Research contracts $ Sales of prototypes (built as part of this project) $ Public offering $ State finance programs $ Non SBIR-funded R&D or production commitments from a Federal agency with the intention that the results will be used by the United States government $ Other industrial firms 337 Funding for Commercialization Equity: $ Angel investment $ Venture capital $ Corporate investment Debt: $ Corporate investment $ Banks $ SBA Loans 33 8 Training & Consulting, LLC 169

Equity: Angel Investment Typically high net-worth individuals Looking for a product, service, company or entrepreneur with whom they can identify Mentoring relationship Street Smarts Can move quickly 339 Entrepreneurial Opportunities The Venture Capital Route Large market opportunity Proprietary position Experienced management Exit strategy 340 Training & Consulting, LLC 170

Equity: Venture Capital Often specialize in a business sector Many have life-stage preferences Often require significant equity positions to invest Typically are able to invest more than angels Company needs a clearly defined exit strategy 341 Corporate Investment Team up with customers, suppliers, even competitors Lots of possibilities Joint ventures Strategic alliances Other business combinations Technology licensing May allow you to concentrate on what you know best your technology! 342 Training & Consulting, LLC 171

What you ll need for equity financing Extensive knowledge of your market How do you plan to make money? Elevator Pitch Clear, concise executive summary - only one chance to make a first impression! Business Plan 343 Investor Presentation* 1. Title 2. Problem 3. Solution 4. Business Model 5. Underlying Magic 6. Marketing and Sales 7. Competition 8. Team 9. Projections 10. Status and Timeline * Guy Kawasaki, April 2005 presentation, Wayne State University 34 Training & Consulting, LLC 172

Debt: Banks Difficult for start-ups to secure debt financing Risk averse Collateral Required May require personal guarantees Do not require board seats Do not share in profits 345 What you ll need for debt financing Summary of the loan request Historical balance sheet and income statements Projected balance sheet, income statement, and cash flow Accounts receivable/payable reports Breakdown of inventory Summary of collateral values Personal financial statements (incl. tax returns) Summary of the business and industry 346 Training & Consulting, LLC 173

Other Sources $ Personal assets $ FFF (Friends, family and fools) $ Vegas, baby, Vegas! 34 Follow-on Funding Commitments Internal resources (i.e. revenue) Friends, family, fools Debt Angel investors Venture capital Corporate investment HOW DO YOU DECIDE?? BE THE CUSTOMER! 34 Training & Consulting, LLC 174

Finance Plan - Recap How much $ is necessary to develop the product? When will the $ be required? Where will the money come from? How much $ is necessary to commercialize? When will the $ be required? Where will the money come from? 349 Commercialization Plan Elements 6. Production and Marketing Plan (or. Operations and anything else that is relevant that you haven t included already) 35 Training & Consulting, LLC 175

Production and Marketing Plan Manufacturing Plans 35 Regulatory Issues Animal use Toxicology studies Human use FDA GMP ISO 9001 CE mark EPA/OSHA Quality control Internal Expertise or Outside Consultant? 352 Training & Consulting, LLC 176

Commercialization Plan Elements 7. Revenue Stream 35 Revenue Stream How will you bring in $$ to the company upon successful completion of project? How will you grow your team to meet revenue expectations? 354 Training & Consulting, LLC 177

Generation of Revenue Stream How will you bring in $$ to the company? Manufacture/direct sales Sales via distributors Joint venture Licensing Fee for service 355 Sales Financials Product sales and margin projections, to include: Income: Revenue from sale of product Related licensing revenue Expenses: Cost of Goods Other sales expenses Bottom line in gross margin dollars and percent 356 Training & Consulting, LLC 178

10/12/2015 Commercialization Plan Elements - Recap NIH Proposed Layout Value of SBIR/STTR project Company information Market, Customer, Competition Intellectual Property Protection Finance Plan Production and Marketing Plan Revenue Stream No more than 12 pages 357 What is Commercialization? Ability to provide a solution to a problem in exchange for money Targeted and Differentiated Solution Important Problem Viable Business Model 358 Training & Consulting, LLC 179

Why focus on commercialization? Entrepreneur as a risk-taker Rather than a risk-manager 35 Final Words. Remember why the SBIR/STTR program is funding your company! Facilitate commercialization of technology Create jobs Encourage collaboration Justify your assumptions Be persuasive Why is this product important? Be realistic Develop your Commercialization Plan with the same scrutiny you give your Research Plan 360 Training & Consulting, LLC 180

But more importantly. Remember that you are running a company! 36 The Philosophy of Commercialization Life is sales! Know thy customer 36 Training & Consulting, LLC 181

COMMERCIALIZATION! ARE YOU PREPARED? YES! 363 For more assistance: SBIR/STTR Assessment Form at www.bbcetc.com Training & Consulting, LLC 182

BBC s Grant Assistance Assessment of competencies and capabilities Strategic planning Training on all aspects of the process including indepth proposal preparation Proposal development tools Pre-submission review and editing Assistance with revision and resubmission Post-award administrative assistance and grant management 365 BBC Team Lisa M. Kurek, MS Managing Partner Michael P. Kurek, PhD, MBA Partner Andrea Johanson, PhD Principal Consultant Becky Aistrup, Principal Consultant Kris Bergman Consultant, Grants & Contract Management Jayne Berkaw Director, Marketing and Outreach 366 Training & Consulting, LLC 183