Keys to Writing Successful SBIR Applications: The Industry Perspective Michael Andre, Ph.D. San Diego, CA

1. Keys to Writing Successful SBIR Applications:The Industry PerspectiveMichael Andre, Ph.D.San Diego, CA

2. Personal SBIR/STTR Experience • 1 successful STTR • 7 successful SBIR applications with 5 companies • Phases I, II and Fast Track (I + II) • All but 2 of these required re-submission • 16 unsuccessful applications • 25 years service as Scientific Reviewer on NIH/NCI and DOD Review Panels

3. My Purpose • Demythologize the process • Encourage new applicants • Recommend ways to write better applications • Offer examples from both successful and unsuccessful applications • Relate personal experience

4. Key #1Understand the NIH Process in Detail • Review available Solicitations • Currently open • Pending • Understand Review Criteria: • Significance • Approach • Innovation • Investigator • Environment • Commercialization

5. Know the NIH Review Criteria • Does the study address an important problem and have commercial potential? Significance • Are design and methods well-developed and appropriate? Are problem areas addressed? Approach • Are there novel concepts or approaches? Are the aims original and innovative? High risk vs. high payoff? Innovation • Is the investigator appropriately trained and capable of managing the project? Resources? Investigator • Does the scientific environment contribute to the probability of success? Is the environment unique? Environment • Is the company’s business strategy one that has a high potential for success? Commercialization

6. Key #2Start Application Process Early! • Do not wait to the last minute. • Do not expect anyone to help you with an application at the last minute (me included) • Seek help of experienced applicants early in process • Assemble a strong scientific team • If you have a weakness or gap in expertise, fill it early • Start no less than 3-5 months before due date • Did I mention: Do not wait to the last minute!

7. Key #3Identify Appropriate Scientifically-Based Problem • SBIR is a Research program, but a development orientation may be acceptable even desirable (non-hypothesis driven) • Consider your company’s strengths • Try to exploit those strengths to address a specific NIH Program initiative • Consider your weaknesses too • It is rare that a small company will have all the necessary expertise for a strong application • If you have no track record of commercialization, get a partner who does • Partner with other companies or academics to fill gaps • Consultant? Maybe, but be careful • Contact NIH Program Director in advance where possible • Review similar currently funded projects

8. Key #4aGrantsmanshipAlways Consider the Reviewers • Who is going to review your application? • 10 or more on the Review Panel who will score your application • However, primary review by 2-4 persons with appropriate expertise assembled by SRA • Business, science, medicine and sometimes consumers are represented • They have a big workload of applications • It is a tough and mostly thankless job • Not everyone on the panel will have detailed relevant expertise • [Is there someone you DO NOT WANT to review your application?]

9. Key #4bGrantsmanshipAlways Consider the Reviewers • What are they looking for? • Readable and understandable application • Do not assume they will know everything you know • You understand your application best so convey it to them • Clear and concise language, “lay summary” • Clear plan for Phase I, II and III • Feasible methods • Appropriate objective tests of success for each Specific Aim • Significance, Approach, Innovation are emphasized • Promising preliminary data are very influential • Solid letters of support for commercialization

10. Key #4cGrantsmanshipAlways Consider the Reviewers • Read your material critically as if you were the Reviewer • What are the weaknesses? • Boldly point out potential difficulties, do not hide them • Suggest ways to address them or provide rationale • Recruit an independent reader • Provide alternative methods if a particular approach is not successful Help the Reviewer write his critique

11. Key #4dGrantsmanshipAlways Consider the Reviewers • Be realistic about your goals • Provide a feasible timetable for key objectives • Be realistic about your budget • Keep to guidelines unless extraordinary, justifiable circumstances • Ask Program Director for early guidance • Do not depend solely on SBIR/STTR funding Help the Reviewer write his critique

12. Checklist • Have you honestly assessed the commercial viability of your technology? • Do you have a talented professional to be a PI? • Is the PI supported by the right team? Does he have the time? • Do you have the resources to write the grant application or contract proposal? • Do you have the resources and capabilities to execute? • Do you have the business resources needed for a successful launch? Plan each step before writing

13. Lifecycle of an SBIR Application Sample Summary StatementFirst Submission – Not Funded The reviewers acknowledged that the potential significance of this proposal is high, but the innovation is only moderate. They were also skeptical of the described method for evaluating success. Overall, there were many concerns that lowered enthusiasm for this proposal.

14. Sample Summary StatementSecond Submission – Better but Not Funded Overall Evaluation: This is a worthwhile project which this team is well qualified to conduct. The work is clearly presented and there are no a priori barriers to the implementation of their ideas. If successful, this would be a significant development as a clinical screening tool at a reduced cost. The only reservation we have about this Phase I/II proposal is the monumental amount of work they propose to do. One is led to wonder if this is realizable. There are two ways to think about this: one can reach the conclusion that they will not accomplish some of this, or one could think that the tax-payers will be getting a great deal for their money in terms of research productivity. We are leaning towards the latter.

15. Sample Summary StatementThird (and last) Submission – Funded! The expertise of the investigators was singled out as an important strength of the application. Both phases of the work were clearly presented and the milestones were judged to be well defined and quantifiable. The Phase II effort was considered to be a logical extension of the Phase I program. These strengths lifted the enthusiasm of the study section members, which elevated further during discussion. The one weakness is that innovation was considered moderate since the idea of using expert systems for diagnosis is not new. The feature that was found to be of particular interest in this plan… Another minor concern voiced by the reviewers was the apparently large amount of work proposed. Despite these concerns, however, the study section held very high enthusiasm for the project, as indicated by the final priority score.

16. Main Points • Key #1Understand the NIH Process in Detail • Key #2Start Application Process Early! • Key #3Identify Appropriate Scientifically-Based Problem • Key #4GrantsmanshipAlways Consider the Reviewers

17. Writing SBIR is a Painful Experience butWriting SBIR is a Valuable Experience • Structured, critical self-assessment • Highlight strengths and weaknesses • Identify talent gaps inside the company, outside sources • Refine pathway to commercialization • Review competition • Helps you focus company on core activities • Strengthens your business plan • Unencumbered funding • Opportunity to explore new avenues for business development • Validation of your company’s merit • Treat it like a “mini sabbatical,” recharge your creativity

18. Some Recent Successful Examples • Computer-Aided Diagnosis (Almen Labs) • Intrinsic Silicon x-ray/γ-ray detector for high resolution mammography (PrimeX) • Selenium x-ray detector for mammography (ThermoTrex) • Ultrasound Computed Tomography (Techniscan) • Non-contact ultrasound for skin and wound evaluation (SurgiSonix) • CdZnTe process for nuclear medicine camera (Digirad) • Volumetric rendering, registration and analysis for tumor response to therapy (Utopia Compression) • Acoustic Holography Breast Imaging (AIT)

19. Good Luck!