Section 1: Beginning the Grant Application Process

While true for any worthwhile task under consideration, having a solid plan of approach for writing an SBIR grant goes a long way towards managing the process and optimizing the likelihood for a successful outcome. Breaking the process down into distinct steps and having well defined starting and stopping points will help ensure process completion while reducing the chance of becoming overwhelmed. First and foremost, come up with a solid description of the idea for the research project. Development of this description is seldom easy, nor is it usually straightforward. A refined description of the idea becomes the foundation for further development into a focused and strong project. Mapping out the strategy for your writing should include:

• Making certain that the SBIR program is the appropriate funding mechanism for your idea.
• Leveraging your passion and scientific strengths for the project while making sure that the project addresses the mission and priorities of the agency
• Enlisting the help of colleagues who have depth and breadth of experience in competing for SBIR grants and who understand your project goals so they can provide critical feedback

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Section 2: Summarizing Your Project and Your Qualifications to be PI

As part of the SBIR application package, you will be required to summarize your research topic and your plan for execution. The place for this information is in the Project Summary/Abstract section. This section of your application is arguably one of the most important components because all of the reviewers on the study section will read it as it contains information relating to all five review criteria, which will be covered in detail later on. One of the best approaches to help wrap your head around this section is to picture yourself as a storyteller who will take the reviewers on a journey through your project. Success in getting the reviewers hooked on your story is how you will get them to champion your application.

Remember that all compelling stories have a resolution at the end; yours will be how your research and development will advance the field and make future investigations possible, particularly the Phase II portion of this project. Since the abstract will be made public once you receive an award, do not include any proprietary information belonging to the company.

More in-depth than a general biography, the principal investigator’s (PI) Biographical Sketch will also be covered in this chapter. This sketch must include a personal statement. With some imagination and creativity, there are ways you can use this statement to increase your chances of successfully being awarded funds.

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Section 3: Small Company Resources and Commitment

The facilities in which you will perform your research and development studies is one of the core criteria that reviewers will use to assess your SBIR grant application. As such, do not skimp on your discussion in your Facilities and Other Resources section. While important, providing merely a list of lab equipment and supplies that you will have access to is not sufficient. You also have to convince the reviewers that your small business supports you and your research and development endeavors. With regards to the agency requirement for you to disclose plans for data, model organisms and GWAS sharing, the plans you put forth will be part of the materials reviewers will examine and use to evaluate your application.

Describe these plans carefully, especially if you chose not to initially share your data, as is the case for many small businesses.

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Section 4: Describing Your Proposed Research

There is perhaps nothing more important to your SBIR application than describing your proposed research and development project. This information will be conveyed to the reviewers in both the Specific Aims and Research Strategy sections of the application. It is in these sections that you will address the Significance and Innovation of your project, as well as the Approach you will take towards successfully achieving the project’s objectives. These three criteria are included in the five that will be used to score your application.

To put a finer point on this, we are specifically referring to the Specific Aims and Research Strategy sections. They address your project’s Significance, Innovation and Approach, which are three of the five scored grant criteria that reviewers will use to grade your application (the other two being the Investigator(s) and environment, covered in the previous chapter). Your application’s Impact Score will depend heavily on how the reviewers perceive your specific aims and research strategy. While there is no specific section or template to detail the overall impact of your proposal, the agency wants you to clearly describe your project’s “impact” as you see fit. In this chapter, we will examine how you can use the Specific Aims and Research Strategy sections to satisfy the Significance, Innovation, and Approach criteria, as well as support the Overall Impact of your research and development.

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Section 5: Special Considerations for Research Involving Humans, Animals or Select Agents

The SBIR program does not generally support human clinical studies, especially in a Phase I application. Exceptions to this generality may be found in funding opportunity announcements, and even then funding for clinical studies is usually restricted to Phase II projects, nonetheless, your project may still involve samples or data from human subjects. If so, you must inform the agency by completing specific portions of the application regarding this use. Similarly, if your work involves the use of vertebrate animals, in this case as actual test subjects or as a source of tissue samples, there are a different set of forms that need to be filled out. Both you and your company must assure the NIH that human and animal test subjects will be protected. NIH cannot award any grant until such assurances are on file with the agency.

In reading over the guidelines, it seems apparent that they were developed with academic institutions in mind. This makes sense, as most of the extramural NIH funding awards are made to academic scientists. Unlike large universities, small companies eligible for the SBIR program seldom if ever have the resources to conduct human clinical studies on their own; they would subcontract that work to another vendor, perhaps even a university. The same holds true for animal studies; the expense and infrastructure involved to have an animal facility is almost always too steep for a small company to invest resources in, so this work would be contracted out. Nonetheless, any company engaged in non-exempt human subjects research conducted or supported by the NIH must submit a written assurance of compliance to the Office of Human Research Protections (OHRP). The Federalwide Assurance (FWA) is the only type of assurance of compliance accepted and approved by OHRP.

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Section 6: Your Proposal’s Budget

In addition to a description of your research and development project, your SBIR application also needs to have a projection of the amount of money needed to successfully perform the work. The budget and associated justifications that you provide are very important in conveying to the reviewer what your plan is for the funds they are investing. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

The NIH has two types of budget formats they will accept:

1. Modular Budget
2. Detailed Budgets

For SBIR (and STTR, for that matter) applications, the modular format was excluded beginning with the 2005 Omnibus Solicitation . So, you have no choice but to submit the Detailed Budgets — also called Research and Related (R&R) Budgets. This involves filling out three separate data entry screens, comprised of 11 different sections as part of the application process. Also, a separate detailed budget is required. Be forewarned — this will take you some time to complete. The justification documents will detail where you propose to spend your award money and why you are spending it in this manner.

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Section 7: Application Submission Tactics

Now that you have come this far along in the process, take some time just prior to submission to review your finished product. Your proposal must read like a single, cohesive, flowing document as opposed to individual parts that were cobbled together. Make sure your message comes through loud and clear - that this research and development project deserves to be funded, you are the best person to do the work, and your company is the only place where this work can be successfully accomplished. Ensure all of the sections communicate this message. Here again, if you can have some of your colleagues also give it the once-over and provide their feedback, you will be ahead of the game. Don’t discount the possibility of enlisting the services of a professional editor; they may be a nonexpert, but they can make sure the proposal reads as one integrated unit and that your message comes through.

You also need to compose a cover letter to introduce your proposal. This is part of the NIH’s application upload process, and the agency encourages you to do so. If you are submitting a changed or corrected application, a cover letter is mandatory. Make sure to include all attachments and that the attachments comply with agency requirements. If you upload all of your materials at least two days prior to the deadline, the agency will allow you two days to make any changes. After the deadline, this ‘grace period’ is not available. The best advice is to have everything checked and get it uploaded right the first time.

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Section 8: Your Application’s Review Process

Once submitted, your SBIR undergoes a superficial review by the Center for Scientific Review to make sure there are no errors which will automatically disqualify your submission. Assuming there are no red-flags here, the proposal is then reviewed by the Integrated Review Groups (IRG). Each IRG represents a cluster of study sections around a general scientific area. From here, your submission goes to a Scientific Review Group (SRG), usually referred to as the study section. SRGs for SBIR and STTR applications have more representation from industry on them than standard study sections; however academicians still occupy the largest part of the panel positions. The SRG is composed of mostly a dozen or more non-federal scientists, who have expertise in relevant disciplines and current research areas. The scientific review officer (SRO) however is an NIH staff member. Their job is to lead the group and designate a few key reviewers to analyze your proposal in detail. The other members of the study section will skim over your application, reading only certain sections in any detail. The study section votes and scores your application on the five review criteria discussed previously:

• Significance
• Innovation
• Approach
• Investigator(s)
• Environment.

The group also evaluates your proposal’s Overall Impact. Once completed, the SRO will compile a summary statement, including your application’s scores as well as a more detailed critique. After assessment by the SRG, the application will go to the institute/center national advisory councils for review. Council recommendations are based on considerations of scientific merit (assessed by the SRGs) and relevance of the proposed study to an Institute/Center’s mission, programs and priorities. Your application is only eligible for funding if both the study section and the institute/ center advisory council recommend it.

Reviewers also have another option they can use to streamline their review process and reduce the panel workload. If an application is unanimously judged by the peer review committee to be less competitive, it will not be discussed at the peer review meeting. These applications do not receive a numerical impact score, nor do they receive individual criterion scores. In short, these applications are not considered any further for funding.

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About the Author —
John W. Ludlow, Ph.D

Dr. Ludlow began his academic faculty career at the University of Rochester (NY) in 1991, with appointments in the department of biochemistry at the medical school and the university’s cancer research center. During this time he maintained an independently funded research laboratory training graduate students and post doctoral fellows in the area of tumor suppressor gene expression, protein structure, and function. Funding for his laboratory came from a variety of sources, including the NIH, the American Cancer Society, and private foundations. Dr. Ludlow began working in the commercial biotechnology sector in 2000, developing and managing research and pre-clinical programs for cell therapy and tissue engineered products, where he has continued to compete in, and advise on, multiple NIH award programs.

• Principal Investigators
• Research Analysts
• Small Business Research Personnel
• Research Professors and Research Managers
• Other Key Proposal Team Members

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