SBIR Program for the School of Medicine June 25, 2014

1. How to Write a Successful SBIR ProposalCasandra Rauser, PhDDirector of Research DevelopmentUniversity of California, Irvine SBIR Program for the School of Medicine June 25, 2014

2. 2012 – Director, Research Development, UC Irvine ($200M in past 5 years) 2009 – Research Development, UC Irvine (>100 proposals, $64M, 37% funded)2008 – 2009 Freelance Editor (technical science writer)2007 – 2008 Director, Tamarindo Preserve Conservancy, Costa Rica2006 – 2008 Tutorial Developer, Rapid Learning CenterPh.D. Ecology & Evolutionary Biology, University of California, IrvineB.S. Biology, Arizona State University Casandra Rauser,PhD

3. Funding is More Competitive than Ever

4. Grants are the Lifeblood of ScienceandSBIR Grants are Critical to Innovation June 8, 2009

5. SBIR: Small Business Innovation Research • 2.8% of Federal R&D Budget is dedicated to SBIR/STTR grants (increasing to 2.9% in FY15) • Must be led by US-based small business • SBIR – PI must be from small business • Universities may partner as subawardees • Phases: • Phase I – Proof of Concept ($75-225k) • Phase II – R&D ($750k-1.5M) • NEW: Direct-to-Phase II Pilot program http://bit.ly/NIHD2P2 (PAR-14-088) • NEW: SBIR Phase I awardees can apply for STTR Phase II and vice versa

6. SBIR: Where to Begin? • Identify grant: http://www.sbir.gov (SBIR at NIH: http://grants.nih.gov/grants/funding/sbir.htm) • Identify small business • Identify PI (from small business for SBIR) • Complete necessary registrations – especially the company • Start planning and writing!

7. Investigate What/Who has Won Before • Look up abstracts of past awards • Get copies of past winning proposals • Read successful proposals

8. Talk to Program Officers

9. Follow the Instructions!

10. How does the theme of a SBIR grant differ from other NIH grants? University Business Goal oriented Develop product Specific objectives, tasks, endpoints Short-term oriented Company controls Hierarchical (team) Confidentiality Proprietary responsibility • Open ended • Basic research • Unpredictable & no promises • Long-term oriented • Individual controls • Individualistic • Publish • Societal responsibility Adapted from G. Milman, NIAID

11. How do SBIRProposals Differ from NIH R01s? • SBIR: R43, R44 • STTR: R41, R42 • Others: U43, U44 • SF 424 (R&R) SBIR/STTR Application Guide http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_SBIR_STTR_Adobe_VerB.pdf • Commercialization Plan!

12. What are the Reviewers Looking For? • Significance • Innovation • Investigators • Approach • Environment • Overall impact • Clear, concise writing • Formatting and technical requirements

13. Budgeting • Proposal is about how you plan to spend this money • Total will determine scope of work • Make sure budget items are allowable under the guidelines • Failure to adequately justify expenditures will cause reviewers to question the validity of your project plan • Overhead (small business): can ask for up to 40% in Phase I w/o detailed justification • Overhead (subcontracts – e.g. University): 26%/54.5% for Phase I/II at UCI • Business charges overhead on 1st $25k of subaward • Profit: can ask up to 7% (patent/council/communication fees)

14. Now Comes the Hard Part

15. NIH Specific Aims: 1 page • Significance • Innovation • Approach • Investigator • Environment • Phase I Applications: same as Phase II, plus • Include technical questions you will try to answer to determine Phase I feasability • Phase II and Phase IIB Applications: • State specific objectives of R&D • Include impact on field(s) • What the proposed research is intended to accomplish in terms of technological innovation and commercial application • Define proposed product, process or service to be developed • Include milestones for each aim • Fast-Track Applications: • Cover Aims for Phase I and Phase II

16. Other Application Components • Research Strategy: Significance, Innovation, Approach • Phase I: 6 pages • Phase II/IIB & Fast Track: 12 pages • Commercialization Plan (Phase II/IIB &Fast Track): 12 pages • Biosketch: 4 pages • Resubmission Introduction: 1 page • For more information: • http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-149.html • http://grants.nih.gov/grants/forms_page_limits.htm for additional information

17. Research Strategy: Significance • Explain the importance of the problem or critical barrier to progress in the field that the proposed project addresses. • Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice in one or more broad fields. • Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field will be changed if the proposed aims are achieved. • Explain the project’s potential to lead to a marketable product, process or service. • For Phase II, Fast-Track, and Phase IIB Competing Renewals, explain how the commercialization plan demonstrates a high probability of commercialization.

18. Research Strategy: 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 interventions to be developed or used, and any advantage over existing methodologies, instrumentation, or interventions. • Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, instrumentation, or interventions.

19. Research Strategy: Approach • Describe overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project. Provide a tentative sequence or timetable for the project. Unless addressed separately in the Resource Sharing Plan, include how the data will be collected, analyzed, and interpreted as well as any resource sharing plans as appropriate. • Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims. • If project is in the early stages of development, describe strategy to establish feasibility, and address the management of any high risk aspects of proposed work. • Point out any procedures, situations, or materials that may be hazardous to personnel and precautions to be exercised. • If research on (hESCs) is proposed but an approved cell line cannot be identified, provide a strong justification.

20. Commercialization Plan • Phase II/IIB &Fast Track • Value of the SBIR/STTR Project, Expected Outcomes, and Impact • Company • Market, Customer, and Competition • Intellectual Property (IP) Protection • Finance Plan: include letters of commitment, intent, support, etc. • Production and Marketing Plan • Revenue Stream

21. Make the Proposal Readable and Easy to Navigate • Use short words in short sentences. Aim for 20 words per sentence – honest! • Use pictures, tables, and other graphic elements to break up the text • Use color

22. Write to Persuade, NOT to Inform • Why do this? • Why do it now? • Why do it with me?

23. Illustrate Project Concept and Work Plan • Visualize the overall project with a drawing • Specify major tasks and timeline using GANTT charts, calendars or flow charts

24. Putting it All Together • Write, edit, review, re-write, proofread • Get feedback from peers and/or mentors • Use all of the space you are given • Review again

25. Project Summary/Abstract • Do not include proprietary information • Write about the following: • Public health problem • Issues with current solutions • How your product addresses unmet needs • Summary of approach • Collaborators and unique resources and capabilities • Phase I specific aims • How anticipated results justify Phase II and further product development

26. Common Proposal Problems • Over budget, over page limit, incorrect format • Not innovative or significant • Inadequate test of feasibility in Phase I • Diffuse, superficial, or unfocused research plan • Lack of experience with research methodologies needed • Unconvincing case for commercial potential or societal impact • Unrealistically large amount of work proposed • Milestones not detailed • P.I. and/or team credentials weak

27. Summary: Grant Writing Strategy Before you begin to write • Identify an appropriate funding source/opportunity • Communicate with Program Officers early and often • Make a proposal development timeline • Follow the agency’s guidelines EXACTLY • Read successful proposals; attend workshops When you write • Pay close attention to review criteria • Write, edit, review, re-write, proofread • Get feedback from peers • Write a strong abstract that is CONCISE and COMPLETE • 2nd times a charm – Resubmission works!

29. Questions? THANK YOU! and Good Luck!