Presentation is loading. Please wait.

Presentation is loading. Please wait.

Developing the Business of Technology Phase II Proposal Development Presented at: 15 th Annual NIH SBIR/STTR Conference October 22, 2014 Lisa M. Kurek.

Similar presentations


Presentation on theme: "Developing the Business of Technology Phase II Proposal Development Presented at: 15 th Annual NIH SBIR/STTR Conference October 22, 2014 Lisa M. Kurek."— Presentation transcript:

1 Developing the Business of Technology Phase II Proposal Development Presented at: 15 th Annual NIH SBIR/STTR Conference October 22, 2014 Lisa M. Kurek Managing Partner Copyright © 2014 BBC Entrepreneurial Training & Consulting, LLC

2 Phase II Proposal Development Assumptions (since we only have 90 minutes…) Phase II Planning Review of Key Proposal Components Elements of a Commercialization Plan To be covered:

3 Introduction to SBIR/STTR You meet the Phase II eligibility requirements Eligible small business The small business has company controlled research facilities The small business has research personnel You have received an NIH Phase I award You have or will have achieved your Phase I aims Funding Cycles match your commercialization goals Assumptions

4 4 The Project: What Does SBIR/STTR Fund? PRODUCT Development Based on “technological innovation” “high risk” Credible Commercialization Strategy

5 Phase II SBIR/STTR: Where Does it Fit? 5 3+ Years, ~$1,150,000+ Phase I: 6 Months, $150K+ Phase II: 2 Years, ~$1,000 K+ Phase III: Commercialization (no federal SBIR/STTR $$)

6 SBIR/STTR: Planning 3 Phases Phase I Goal = FEASIBILITY Feasibility of what? Whatever you hope to accomplish in Phase II! Phase II Goal = Further R&D How far? You decide based on… ULITMATE GOAL= COMMERCIALIZATION! Goals 6

7 Phase II Proposal Development Update scientific literature search and market research Write Commercialization Plan Acquire and Analyze Phase I data Demonstrate FEASIBILITY Plan experiments/R&D activities Convene the technical team For Phase II and beyond… Secure facilities and other resources Planning

8 NIH Review Criteria Significance Significant Science Significant Product Significant Commercial Opportunity Investigators Innovation Approach Environment 8 IMPACT

9 Writing the Proposal 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? Primary Questions to be Answered

10 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 (4 pg ea.) Facilities & Other Resources Equipment Project Budget Subaward Budget Cover Letter Commercialization Plan (12 pg) Forms Introduction to Application (1pg) Specific Aims (1 pg) Research Strategy (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 Components of an NIH SBIR/STTR

11 Which sections? What you are going to do? Why is it worth doing? Specific Aims Section Research Strategy Commercialization Plan

12 Specific Aims Single and most important page of application Sets out what you intend to do An Executive Summary of the Proposal 12

13 Specific Aims -- Outline The Company Significance Problem to be solved Gap in knowledge The Product Technological Innovation Impact Long Term Goal Rationale for the goal Phase I Results (“feasibility”) 13 PAGE LIMIT: One PAGE Phase II Project: Phase II Hypothesis Specific Aim 1… ̶ Criteria for acceptance Specific Aim 2… ̶ Criteria for acceptance Expected Outcomes ̶ Proof of Feasibility Commercial Application

14 Aims vs. Activities Specific Aims = Objectives Either achieved or not Do not yield results/data Have measurable, desired end points Tasks = Activities Steps to achieve your aims/objectives Make up your work plan They are performed or carried out Yield results &/or data

15 Research Strategy Significance Innovation Approach 15

16 Significance Significant product Significant science/technological innovation Significant need in the market Significant commercial opportunity Use references! Demonstrate: 16

17 Important Reminder A good idea is necessary but not sufficient 17

18 Research Strategy – BBC Outline 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 (summarize…. Detail in commercialization plan) Market analysis Competition (competing technologies and competitors) Commercialization strategy Other applications of the technology Significance – Make the Reviewer Care! 18

19 Research Strategy – BBC Outline 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? Innovation 19

20 Research Strategy – BBC Outline 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 ̶ Demonstration of Feasibility ̶ How the outcomes support the Phase II ̶ Technology developed, intended use, status of product development Approach 20

21 Research Strategy - outline Restate Specific 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? Approach 21

22 Summary Tell the reviewers: What (Specific Aims) Why (Significance, Innovation, Phase I feasibility) 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.) 22

23 Gantt Chart (who, when, where?)

24 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

25 Key Personnel: Build a Strong TEAM! 25 Your (the SBC’s) employees Includes the PI if SBIR If STTR should have at least 1 (may include PI) Subcontractor’s employees Consultants Other Significant Contributors e.g. “advisors”; 0% effort on project (think ahead to Phase II and commercialization )

26 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 (4 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 (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 Components of an NIH SBIR/STTR

27 27 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 CRITICAL!!

28 28 Don’t forget relevant items such as patents or other product development accomplishments

29 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 (4 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 (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 Components of an NIH SBIR/STTR

30 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 30 Critical for Phase II! (briefly summarize here; details in commercialization plan)

31 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 (4 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 (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 Components of an NIH SBIR/STTR

32 Letters of Support Consultants (required); must include: Role, Rate Time Subcontractors Other Significant Contributors Research Resources, e.g. Facilities, equipment not on budget or owned by company Commercialization Resources, e.g.: Strategic Partners Investors Key Customers Validate your resources and opportunity 32

33 Letters of Support Landlord to validate leasing arrangements and/or confirm facilities (e.g. incubator space) Resource providers (e.g., facilities not being paid for, equipment not owned or being purchased) Commercialization partners (e.g, investors, strategic partners, key customers) 33

34 Direct Costs E.g., Salaries, supplies, equipment, travel, consultants fees, subcontract costs Indirect Costs (F&A)  40% of TOTAL direct costs for Phase I (Includes fringe benefits) OR Request higher rate IF you can support it through a negotiation with DFAS Fee 7% of total costs (direct and indirect) Unallowable Costs Budgets Make sure to justify your direct costs extremely well.

35 Budget approach Work backwards to determine the direct dollars When a cap or restriction is enforced IF Budget Cap = $1,500,000 Direct costs =$1,000,000 Indirect costs =$1,000,000 x ~40%$400,000 Fee =($1,000,000 + $400,000) x 6.99%$97,860 TOTAL:Direct + Indirect + Fee$1,497,860 Therefore – design your project to fit  $1m directs

36 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 36

37 Commercialization There is no such thing as the “Build it and they will come” Business Model 37

38 Commercialization Technology This is NOT a feasible business model:

39 What is Commercialization? Ability to provide a solution to a problem in exchange for money Targeted and Differentiated Solution Important Problem Viable Business Model 39

40 Commercialization Plan Elements 1 - Value of this SBIR/STTR project 40

41 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? 41

42 Story 42 ReceptorPro: Part I

43 Commercialization Plan Elements 2. Company information 43

44 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 44

45 The Company Brief History Mission What will you look like in 5 years? 45

46 Entrepreneurial Opportunities Critical Success Factors Combination of technical & business expertise Customer focus with a well-defined target segment Proven business model 46

47 BUSINESS MODELS License Joint development Fully integrated manufacturing, marketing, distribution OEM Distribution Contract Manufacturing 47

48 Management Team Executive Officers Scientific Advisory Board Board of Directors Business Advisors Regulatory Experience Recruiting Plans 48

49 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 49

50 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! 50

51 Commercialization Plan Elements 3. Market, Customer, Competition 51

52 What it isn’t…. A Market Analysis is NOT a Commercialization Plan 52 Large Market ≠ Commercialization

53 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 53

54 Why a Marketing Plan? Foundation of Your Business Primary Communication Tool …inside & outside the company Source of company goals, milestones, and measures of progress 54

55 Do your homework a.k.a. – MARKET RESEARCH For the computer savvy For the socially adept 55

56 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 56

57 Story 57 XYZ Technologies: “Beseech Them…..”

58 Market Analysis 58

59 Market Analysis Potential 59 Addressable Accessable

60 Product Positioning Product Uniqueness Customer Needs : Big Need Many Products 3: No Need Many Products Big Need Unique Product 1: No need Unique Product 60

61 61 Put your product description through the “so what” test

62 62 Competitive Analysis

63 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? 63

64 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? 64

65 Commercialization Plan Elements Intellectual Property Protection

66 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?? 66

67 Story 67 ReceptorPro: Part 2

68 “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 68

69 Commercialization Plan Elements Finance Plan

70 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? 70

71 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 71

72 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 72

73 Commercialization Plan Elements Production and Marketing Plan (or…. “Operations” and anything else that is relevant that you haven’t included already)

74 Commercialization Plan Elements Revenue Stream

75 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? 75

76 Generation of Revenue Stream How will you bring in $$ to the company? Manufacture/direct sales Sales via distributors Joint venture Licensing Fee for service 76

77 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 77

78 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 78

79 79 What is Commercialization? Ability to provide a solution to a problem in exchange for money ̶ Targeted and Differentiated Solution ̶ Important Problem ̶ Viable Business Model

80 In summary…. 80 A good planning process is crucial for commercial success!

81 Final Words…. Remember why the SBIR/STTR program is funding your company! Develop your Commercialization Plan with the same scrutiny you give your Research Plan Go for the IMPACT! 81

82 Developing the Business of Technology Phase II Proposal Development Presented at: 15 th Annual NIH SBIR/STTR Conference October 22, 2014 Lisa M. Kurek Managing Partner Copyright © 2014 BBC Entrepreneurial Training & Consulting, LLC


Download ppt "Developing the Business of Technology Phase II Proposal Development Presented at: 15 th Annual NIH SBIR/STTR Conference October 22, 2014 Lisa M. Kurek."

Similar presentations


Ads by Google