SBIR / STTR 101. April 27, Lisa Kurek Managing Partner

Transcription

1 SBIR / STTR 101 April 27, 2010 Lisa Kurek Managing Partner Biotechnology Business Consultants, t LLC / BBCetc t 803 N. Main St., Ann Arbor, MI Phone: [email protected] North Main Street Ann Arbor, Michigan [email protected] 2 1

2 BBC Team Marilyn (Mickey) Katz Pek Partner Emerita & Founder; Academic Administration; Grants Expert; Successful Entrepreneur Lisa M. Kurek, MS Partner; Medical Device and Biotechnology Sales, Marketing, Product Development and General Management Michael P. Kurek, PhD, MBA Partner; Biotechnology Senior Management; High Tech Incubator Management Andrea Johanson, PhD Program Director; Grant Assistance Andy Jakimcius, MS, MBA Principal Consultant: R&D management; software/hardware engineering; tech transfer Bhramara Tirupati, PhD Consultant, Grant Development Kristine Bergman Administrative Manager; Grants Management, Bookkeeping, Administrative Management 3 BBC Consulting Partners Sumer Pek, MD Basic and Clinical Research, Grant Review at the National Level, Bioethics David Jackson, PhD Biotechnology R&D & Management David Herzig, PhD Pharmaceutical R&D & Licensing Thomas Borton, PhD Environmental Sciences, Non NIH Federal Funding Gerald Roston, PhD Pharmaceutical R&D & Licensing 4 2

3 Now, about you.. 5 What is the SBIR/STTR Program? A $2 Billion+ Federal Funding Program SBIR: Small Business Innovation Research STTR: Small Business Technology Transfer 6 3

4 Our Outline for Today Program Overview Eligibility SBIR vs. STTR Participating Agencies/Agency Differences Dept. of Defense (DoD) Dept. of Energy (DOE) National Science Foundation (NSF) National Institutes of Health (NIH) Elements of a fundable proposal 7 8 4

5 What is the SBIR/STTR Program? A federal funding mechanism to support small business to: Stimulate technological innovation To develop products with commercial merit 9 Which Would You Choose? Venture Capital 6 12 months to funding <1% probability bilit Need to know someone Unlikely to fund early stage Take equity (sometimes lots) Take a board seat (and sometimes control) SBIR / STTR 9 months to funding 9% 37% probability at NIH SBIR Don t need to know anyone Will fund early stage Don t take equity Don t take board seat $2 billion per year available Peer review 10 5

6 Purpose of SBIR/STTR Programs Create jobs Promote small businesses: recognized more and more as a unique national resource of technology innovation This is NOT an alternative source of funding basic research! 11 Rule #1 Learn the Rules! 12 6

7 The Basics 2.5 Years, $1,000, The Basics 2.5 Years, $1,000,000 Phase I: 6 Months, $100K Phase II: 2 Years, ~$750K+ 14 7

8 Three Phases of SBIR/STTR: Details Agency Dependent Phase I Feasibility 6 months 1 year $60k 200k Phase II Expand results, pursue further development 2 years $500k $1 m Supplement to Phase II Institute Specific Not available at all Institutes Some Institutes fund only after SBIR Phase II Some Institutes fund only after STTR Phase II Phase III Commercialization Your own $$ ( ie no government $!) 15 Participating Agencies* SBIR STTR DOD - $1200 m HHS - $650 m NASA - $138 m NSF - $105 m DOE - $102 m SBIR Only USDA - $19.3 m DOT - $4.0 m EPA - $7.0 m DOC - $9.4 m DoED - $8.4 m DHS - $30 m TOTAL: >$2.3 B * 16 8

9 Eligibility for Funding (1 of 3) Small business < 500 employees For profit Located in the U.S. R&D must be performed in the U.S. 17 Company controlled research facilities Documentation Required! **Access to special facilities is permitted 18 9

10 Eligibility for Funding (2 of 3) Company controlled research facilities Documentation Required! Access to special facilities is permitted PI s primary employment with the small business during project (NIH SBIR only; NSF SBIR & STTR). 19 More on Eligibility (3 of 3) At least 51% U.S. owned and independently operated Firms more than 50% owned by corporations, VCs, institutions ARE NOT ELIGIBLE for SBIR/STTR awards. UNLESS the majority entity meets the definition of a small business (< 500 employees; ownership) SBA Considering allowing ALL VC owned companies to participate Visit for more information 20 10

11 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 nonprofit research institution STTR requires the involvement of a non profit research institution However in either case: The Applicant Organization is always the Small Business! 21 SBIR vs. STTR Key distinctions: Across all agencies: Amount of allowable subcontracting Agency variations: Employment status of the principal investigator Dollar and duration limits 22 11

12 SBIR and STTR Differences SBIR Subcontracts: Phase I Subcontract 33% of total costs Phase II Subcontract amount 50% of total costs. STTR Subcontracts: Phase I and Phase II Small Business Concern (SBC) 40% Partnering U.S. non profit research institution 30% Remaining 30% discretionary SBC University Consultants Other subcontract 23 Principal Investigator Rules SBIR At least 51% employment with the small business company 10% effort on the project (suggested) 24 12

13 PI Rules STTR Official primary relationship between PI and the applicant company With or without salary Sufficient opportunity for overall scientific & technical direction of project PI may have a full time appointment with the partnering research or academic institution Institution would not consider at least 10% effort devoted to the project to violate full time employment status Check with your institution! 25 More STTR PI Rules PI with the Company part-time time and still at the University Each commitment a portion of 100% of total professional effort University commitment considered fulltime (use Consulting days per contract) 26 13

14 Advantages of SBIR over STTR No academic partner necessary Fewer agreements, fewer lawyers, less cost Control of funds Less or no academic/institutional indirect costs More funds available Set aside $$ higher Payments to academic consultant Earn $$ from grant in consulting fees 27 Advantages of STTR over SBIR Company lacks credible PI (>50% employed) No scientists employed by company Not ready to leave the University Access to superior academic facilities Institutional Review Board (IRB) Animal Welfare Committee Lab space/equipment p Higher percent subcontract possible 28 14

15 STTR Applications Extra Requirements Company & its University partner must sign intellectual property (IP) agreement Budget and Certification of Research Institution form required Virtual companies do not qualify Conflict of interest issues 29 How Can Academics Participate? Faculty member can own small company & identify someone else (well qualified) as PI Faculty member can be PI (i.e., 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 30 15

16 Rule #2 DO YOUR INTELLIGENCE WORK FIRST! 31 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 Gap funding provided d (competing continuation i grants) Payment types & schedules 32 16

17 SBIR/STTR Deadlines ( Solicitation Released Proposals Accepted Proposal Deadline NSF SBIR 4 Mar May Jun 2010 DoD STTR 2010.A 25 Jan Feb Mar 2010 DoED NIDRR SBIR 12 Jan Jan Mar 2010 HHS/NIH SBIR/STTR (Grants) Non-AIDS Related Topics PHS Omnibus 15 Jan Mar Apr Aug Dec Agency Differences Grants vs. Contracts Contracts Agreement to provide a product or service that is of direct benefit to the awarding agency. Grants Agreement to accomplish something for the public good in exchange for money, property or services

18 Agency Differences Grants vs. Contracts Granting SBIR Agencies DHHS (95% $$), NSF, USDA, DOE, ED Contracting SBIR Agencies DHHS (5% $$), DoD, DHS, EPA, DOT, NASA, DOC, ED Health & Human Services and Education participate in both 35 Agency Differences Grants vs. Contracts Grants Assistance Project/proposal is welldefined, but no formal agreement Progress/final reports Broad topics funded Agency contact unlimited i 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 36 18

19 Agency Differences Types of Grants Fixed Price Grants Awards will not exceed levels given in solicitation NSF= $150,000 Phase I / $500,000 Phase II DOE = $100,000 Phase I / $750,000 Phase II USDA = $80,000 Phase I / $350,000 Phase II Unrestricted Grants NIH Award guidelines laid out in solicitation Well justified deviations from guidelines allowed 37 Agency Differences Review Process Internal Review DoD, 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 38 19

20 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 Implement necessary tactics Follow the rules 39 For More Agency Information Plan to attend the National SBIR Conference April 21 23, Hartford, CT Held every Spring/Fall around the country

21 DoD: SBIR/STTR Contracts 41 DoD Critical Technology Areas 42 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 21

22 DoD Three Phase Program 1/2 Phase I awards (+ Phase I option) Typically y $60,000 to $100,000 6 to 9 months Phase II awards (by invitation only) Awarded on the basis of results of Phase I scientific, technical, and commercial merit of Phase II proposal Typically $500,000 to $750,000 Generally < 24 months (subject to negotiation) Expected to produce well defined deliverable prototype 43 DoD Three Phase Program 2/2 Phase III Obtain funding from the private sector and/or non SBIR Government Develop prototype into viable product/service for sale in military and/or private sector markets DoD helps with commercialization Each hawarding Component Has Unique Guidelines & Rules!! 44 22

23 DoD Programs are Component Specific! for example ARMY Phase I: $70,000 Phase I Option: $50,000 NAVY NAVAIR: Phase I: $80,000 Phase I Option: $70,000 Others: Phase I: $70,000 Phase I Option: $30,000 AIR FORCE Phase I: $100,000 READ THE SOLICITATION!!! 45 The DoD SBIR Program Funded ~$1.14B in FY participating components Figure from:

24 DoD STTR program Funded at ~ $132 million in FY 2008 Army, Navy, Air Force, Missile Defense Agency (MDA), DARPA, OSD Figure from: 47 DoD SBIR/STTR Awards 25% of Phase I awardees are first time ti DoD D winners. ~40% of Phase I projects are awarded a Phase II contract. In recent solicitations, a much higher % of STTR Phase I proposals were awarded. Figure from:

25 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 49 DoD Awarding Components 1/2 Army Navy Air Force DARPA (Defense Advanced Research Projects Agency) DTRA (Defense Threat Reduction Agency) MDA (Missile Defense Agency) 50 25

26 DoD Awarding Components 2/2 NGA (National Geospatial Intelligence Agency) CBD (Chemical and Biological Defense) SOCOM (Special Operations Command) DLA (Defense Logistics Agency) OSD (Office Of The Secretary Of Defense) 51 DoD SBIR/STTR Schedule Solicitation Solicitation Internet Release Proposals Accepted Starting Proposal Deadline DoD SBIR Nov Dec Jan 2010 DoD STTR 2010.A 25 Jan Feb Mar 2010 DoD SBIR Apr May Jun 2010 DoD SBIR Jul Aug Sep 2010 DoD STTR 20 Jul Aug Sep B 52 26

27 DoD FY2010.A STTR Solicitation Closes: March 24, AM EDT Army 30 topics Navy 45 topics TOTAL: 75 Topics 53 DoD FY SBIR Solicitation Closed: January 13, AM EDT Army 32 topics Navy 104 topics Air Force 1 topic DARPA 14 topics DTRA 1 topic CBD 10 topics SOCOM 8 topics TOTAL: 170 Topics 54 27

28 DoD Influencing Topics Search past solicitation topics Locate topics in your space Call the topic author Discuss your idea Gauge DoD interest Ask if accepting topic suggestions Some awarding components have web links to submit ideas online

29 DoD Electronic Submission Check the current solicitation for submission deadline! 57 DoD Registration Register your firm online: 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: 58 29

30 DoD Proposal Submission Each proposal submission must include: Proposal cover sheets Technical Proposal Cost Proposal Company Commercialization Report Tutorial: text.htm 59 For Updates Subscribe to the DOD SBIR/STTR Listserv Send an to: Put SUBSCRIBE in the subject line 60 30

31 DOE SBIR/STTR Program FY 2010 Funding Opportunity Notice 61 SBIR/STTR at DOE Phase I: Feasibility of Idea 9 month duration, up to $100,000 each On average, DOE funds 1 out of 6 SBIR and 1 out of 9 STTR (est. 360 total Phase I awards in FY 2010) Phase II: Principal R&D Effort 2 years, up to $750,000 Odds of winning: 1 out of every 2 to 3 Only DOE Phase I awardees may apply 62 31

32 SBIR/STTR at DOE SBIR and STTR: PI must devote at least 117 hours or minimum 3 hours per week Only one PI per project! (i.e. no co PIs PIs ) SBIR: STTR: PI spends >= 20 hours at small business; <= 19 hours at other organization(s) PI primary employment may be at either the small business or the research institution Source of PI s compensation for work on the project must be the small business Small business must provide technical control and oversight of the project even if PI s primary employment is at research institution 63 SBIR/STTR at DOE SBIR vs. STTR at DOE: If application has at least 30% collaboration with one research institution you may request consideration for both SBIR and STTR, thereby increasing chances of winning an award PI must meet SBIR employment rules for this option 64 32

33 DOE Strategic Goals Energy: Promoting a diverse supply and delivery of reliable, affordable, and environmentally sound energy. Science: Providing world class scientific research capacity and advancing scientific knowledge. Environment: Protecting the environment. Defense: Df Protecting ti our national security using advanced science and nuclear technology. 65 Technical Topics at DOE You must directly address a topic and subtopic and apply to that topic: Energy Efficiency and Renewable Energy Basic Energy Sciences Fossil Energy Biological and Environmental Research Advanced Scientific and Computing Research Nuclear Physics Environmental Management 66 33

34 Technical Topics at DOE (continued) Defense Nuclear Nonproliferation Nuclear Energy, Science and Technology Science R&D Knowledge Diffusion Electricity Delivery and Energy Reliability High Energy Physics Fusion Energy Sciences 67 Technical Topics at DOE drilling down a bit deeper You must directly address a topic and subtopic and apply to that topic: 7. Wind Energy Technology Development a. Manufacturing and Assembly b. Component Reliability c. Condition Monitoring 68 34

35 DOE Phase I Stats FY 2009: 319 SBIR Awards to 181 Small Businesses. Of these: 51 or 27% were First time DOE Winners 22 or 43% of the 51 First time Winners were First time DOE Applicants Awards Made in 32 States FY 2008: 281 SBIR Awards to 192 Small Businesses. Of these: 55 or 29% were Firsttime DOE Winners 35 or 64% of the 55 First time Winners were First timedoe time Applicants Awards Made in 33 States 69 Electronic Submission at DOE The DOE now uses grants.gov! g

36 Requirements for grants.gov Register with grants.gov Obtain a DUNS number Register with the Central Contract Registry (CCR) Designate an E Business Point of Contact (EBiz POC) Obtain password (MPIN) Complete the Grants.gov registration Authorize the AORs Allow at least 21 days to complete these requirements! After the process is complete, call the Grants.gov Helpdesk to verify: FY 2010 DOE Solicitation Schedule Release of Solicitation September 24, 2009 Submission deadline* November 20, 2009 Selection (Phase I) Spring 2010 Grant start date June 2010 *Acknowledgement, with assigned grant number, within four weeks of funding closing date 72 36

37 NSF SBIR Program 73 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

38 NSF SBIR Deadlines SBIR June 9, 2010 STTR To Be Announced 75 FY 2011 Solicitation (NSF ) Phase I Awards: $150,000 Estimated Number of Awards: 200 to 300 (pending availability of funds). Anticipated Funding Amount: $45,000,000 for SBIR Phase I Award notification: Four to six months from the proposal submission i Effective date: January 1,

39 NSF Solicitation Topics Biotech and Chemical Technologies (BC) Education Applications (EA) Information and Communication Technologies (IC) Nanotechnology, Advanced Materials, and Manufacturing (NM) 77 NSF /9/2010 PLEASE NOTE Focus on near term commercialization Letters of support from commercialization partners are required Communication with Program Officer is strongly encouraged 78 39

40 NSF Electronic Submission Required to prepare/submit all proposals through FastLane Instructions for FastLane Submission of Electronically Signed Cover Sheets No paper copy necessary Submission by 5 pm p.m. (your time) on deadline date 79 FastLane Registration Organization must be registered with NSF through FastLane PI must be registered with NSF through FastLane Point of contact (FastLane Contact/SPO) must be registered Instructions for FastLane tl f / t Once registration is complete, SPO is notified via e mail 80 40

41 NIH SBIR/STTR Program 81 National Institutes of Health The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the primary Fd Federal agency for conducting and supporting medical research. Helping to lead the way toward important medical discoveries that improve people s health and save lives, NIH scientists investigate ways to prevent disease as well as the causes, treatments, and even cures for common and rare diseases. Composed of 27 Institutes and Centers, the NIH provides leadership and financial support to researchers in every state and throughout the world

42 NIH Institutes National Cancer Institute (NCI) National Eye Institute (NEI) National Heart, Lung, and Blood Institute (NHLBI) National Human Genome Research Institute (NHGRI) National Institute on Aging (NIA) National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Institute of Allergy and Infectious Diseases (NIAID) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) National Institute of Biomedical Imaging and Bioengineering (NIBIB) National Institute of Child Health and Human Development (NICHD) National Institute on Deafness and Other Communication Disorders (NIDCD) National Institute of Dental and Craniofacial Research (NIDCR) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institute on Drug Abuse (NIDA) National Institute of Environmental Health Sciences (NIEHS) - Est National Institute of General Medical Sciences (NIGMS) National Institute of Mental Health (NIMH) National Institute of Neurological Disorders and Stroke (NINDS) National Institute of Nursing Research (NINR) National Library of Medicine (NLM) 83 NIH Institutes Differ in Funding 20 institutes & 7 centers at NIH 23 of 27 make SBIR awards* Separate budgets (extramural funding) Do your intelligence work first! Target the $ * As of January,

43 SBIR Awards by NIH Institute NIH SBIR Phase I 2007 NINR NCCAM NIBIB NIEHS NIAMS NIAAA NCMHD NIDCR NHGRI NIDCD NIDA NEI NIMH NIDDK NIA NIGMS NICHD NINDS NIAID NCI NHLBI $ Millions 85 Success Rates 2007 NIH SBIRs (Phase I and II) NINDS NINR NIMH NCMHD NLM NHLBI NHGRI NICHD NIGMS NEI NIEHS NIBIB NIDDK NIDCR NIDCD NIDA NCI NCCAM NIAMS NIAID NIA NIAAA Phase II Phase % 10.00% 20.00% 30.00% 40.00% 50.00% 60.00% 70.00% 80.00% 86 43

44 NIH SBIR/STTR Omnibus Solicitation NIH Applications SBIR/STTR OMNIBUS Funding Opportunity Notice SBIR: files/pa html STTR: files/pa html Research Topics: 2_SBIR STTR topics.pdf SF424 (R&R) SBIR/STTR Application Guide 87 SF 424 (R&R) Forms Agency Specific Forms SBIR/STTR Special Solicitations Innovative Technologies for Molecular Analysis of Cancer (SBIR/STTR) Application of Emerging Technologies for Cancer Research (SBIR/STTR) Innovations in Cancer Sample Preparation (SBIR/STTR) Molecular Libraries Screening Instrumentation SBIR/STTR Integration of Heterogeneous Data Sources (SBIR/STTR) Manufacturing Processes of Medical, Dental, And Biological Technologies (SBIR/STTR) 88 44

45 NIH Proposal components Specific Aims (1 page) Research Strategy (6 pages) Significance Innovation Approach Supporting documents Human Subjects Vertebrate Animals Resource Sharing Etc. 89 NIH SBIR/STTR Budgets Unrestricted Grants NIH Award guidelines laid out in solicitation Phase I: $100k, 6 months Phase II: $750, 2 years Well justified deviations from guidelines allowed 90 45

46 The Peer Review Process 91 Who Are the NIH Reviewers? Review panels are assembled on an ad hoc basis for each meeting; therefore, their designations and scientific emphasis may change with each review cycle

47 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 93 NIH SBIR/STTR Application Guide NIH Applications Funding Opportunity Notice SBIR: files/pa html STTR: files/pa html SF424 (R&R) SBIR/STTR Application Guide SF 424 (R&R) Forms Agency Specific Forms PHS 398 Like Content Not Identical to PHS 398 Form Pages 94 47

48 95 For Updates Subscribe to the SBIR/STTR Listserv: Send an e mail to: [email protected] in the message body type subscribe SBIR STTR <your name> Subscribe to the NIH Guide to Grants and Contracts Listserv: Send an e mail to: [email protected] in the message body type subscribe NIHTOC L <your name> 96 48

49 Review Criteria Significance Technical merit Commercial value Approach Innovation Investigators EnvironmentE i Further criteria are always added by the reviewers! 97 DoD Technical Proposal Outline 20 or 25 Pages (Including 2 Cover Sheets) 1. Identification and Significance of the Problem or Opportunity 2. Phase I Technical Objectives 3. Phase I Work Plan 4. Related Work 5. Relationship with Future Research or Research and Development 6. Commercialization Strategy 7. Key Personnel 8. Facilities/Equipment 9. Subcontractors/Consultants 10. Prior, Current, or Pending Support of Similar Proposals or Awards 98 49

50 NSF Project Description Outline Limited to 15 pages 1. Identification and Significance of the Innovation 2. Background and Phase I Technical Objectives 3. Phase I Research Plan 4. Commercial Potential 5. Consultants and Subawards/Subcontracts 6. Equivalent or Overlapping Proposals to Other Federal Agencies DOE Proposal Project Narrative Limited to 20 pages including (12 pt font; 1 margins): a. Cover Page b. Proprietary Data Legend c. Identification and Significance of the Problem d. Anticipated Public Benefits e. Technical Objectives f. Phase I Work Plan g. Phase I Performance Schedule h. Related Research or R&D i. Principal Investigator and Other Key Personnel j. Facilities/Equipment k. Consultants and Subcontractors 50

51 NIH SBIR/STTR Development Timeline Establish corporate identity, define niche, refine business plan, recruit technical team Brainstorming meeting to describe problem, technical solution, resources and business case Explore broad market, customer(s), competition Planning meeting to develop application blueprint, make assignments Assemble draft for review by colleagues Get support letters Incorporate readers comments into final draft, include forms Check submission, verify image Time in months Negotiate with potential collaborators, subcontractors Specific Market anaylsis Responsible parties write sections of grant Register at Grant.gov and era Commons Submit to Grants.gov Obtain Organizational sign-offs 101 NIH Proposal components Specific Aims (1 page) Research Strategy (6 pages) Significance Innovation Approach Supporting documents Human Subjects Vertebrate Animals Resource Sharing Etc

52 Component 1: Develop Research Project 1/2 1. Make knowledgable observations 2. Search for background facts 3. Identify a problem caused by gp gap in knowledge or technology 4. Develop theories on causation & solution for the problem 103 Component 1: Develop Research Project 2/2 5. Seek clues on feasibility of a solution > Preliminary results 6. Formulate an hypothesis to test 7. Define specific research aims 8. Define the research process 9. Secure resources

53 Essential Features of a Hypothesis Must be testable: Availability of means and tools Competence of investigator Must be reasonable: Compatible with existing knowledge Must be significant: Promises to result in valuable new knowledge or technology 105 Specific Aims Introductory paragraph should Capture the vision with a broad goal justifying the research question Summarize relevance and feasibility of the approach(es) Engage the reader with strong, solid, testable hypotheses, or discrete, finite technology development goal Succinctly state each research aim in one sentence Experiments (as described in the research strategy section) support aims, aims test the hypothesis Be focused aims independent yet related to overall goal avoid dense text and acronym overload

54 Research Strategy New Structure Significance Innovation Approach 107 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

55 Research Strategy 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? 109 Research Strategy Outline Approach Prior work/preliminary Studies 110 Rationale Aims of the preliminary studies Results and conclusions Summary (how does the prior work apply to this SBIR/STTR) Specific Aim Rationale Experimental Design & Methods Data Analysis & Interpretation Potential Pitfalls / Alternative Approaches Expected Outcomes 55

56 Summary Tell the reviewers: What (Specific (p Aims) Why (Significance, Innovation, Prior Work) How (Research Strategy) Where (Environment) Summarize who, when and where: Gantt Chart Details timeline for project Details who will be responsible for completion of each aims Where the work will be done (company, subcontractor etc.) 111 BP #1 Never Forget: SBIR/STTR is federal funding mechanism to support small business to: Stimulate technological innovation To develop products with commercial merit

57 BP #2 Know Your Customer The Federal Government NIH, NSF, DoD CSR, TPOC Reviewers Institute TPOC, Program Manager The Target Market / End Users Other Investors

58 BP #3 Understand the problem as well as you understand your solution Market size and growth Customer profile Competitors Sales and market share projections Pricing and margin analysis Market trends 115 BP #4 Tell them what they want to hear, not what you want to tell them Significance Approach Innovation Investigators Environment Other RFP specific criteria

59 BP #5 Follow the Rules READ THE SOLICITATION!!! 117 BP #6 Get Help Get someone else to: Read for grammar Read for content Make sure you have answered the following two questions: 1. RE. Your Science: HOW? 2. RE. Your Commercialization: SO WHAT?

60 SBIR/STTR: WHY?? Non dilutive capital (i.e. it s free) Peer Review Validation of Technology Commercialization focus Funds technology risk Enables early transfer of technology and establishment of start up companies 119 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

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