It’s that time of year again, we are back from summer vacation and thinking about submissions for the next NIH grant cycle. First up is the SBIR deadline on September 5th. Here at Zenobia, since we are getting ready to submit our own SBIR grant and have products and services to generate preliminary data, we want to share our experience and learnings with the NIH SBIR system. Our last grant was accepted on the first try which is very uncommon for NIH. We attribute that, in part, to learning from past mistakes and developing a grant submission process.
Over the years we have submitted several SBIR's and had very high success-rates with three NIH institutes and no success with a forth. This very different success-rate gives rise to our first suggestion. If you are having difficulties with one institute, you might consider repackaging your project and submitting to a different one! As we discuss below, learn about the institute, talk to program managers, understand your review panel and the types of grants they have funded in the past. It is a lot of homework but can save valuable time in the long-run and bring you the valuable funding you need to get your new idea off the ground!
Below you will find our step-by-step guide to submit a new grant.
Check your registrations! At a minimum check at least one month in advance of submission. If you have never submitted an SBIR, there are several registrations that you must submit. We are not covering that here because it is readily available on the NIH website. Check that your SAM registration has not expired (https://www.sam.gov/). This happened to us once. We submitted a grant and learned that our registration had expired so we could not submit until the next deadline! This was painful. The notification of expiration was in our junk mail.
Determine if your idea is appropriate, how to present it to the NIH and identify the best institute. There is a very nice document that summarizes all the institutes and their areas of emphasis. https://sbir.nih.gov/sites/default/files/2018-2_SBIR-STTR-TOPICS%20FINAL.pdf
Information varies by institute from very detailed to very general. Some institutes also summarize their funding cut-offs. Some adhere to the hard cut-off set by NIH and others will consider funding at a higher level if your grant fits one of their areas of emphasis. We always look at a few institutes to determine which ones might be the best fit for our ideas. Since we vary between technology development and drug discovery, we usually have some flexibility.
Once you have picked the institute (or institutes) go to NIH Reporter to see what grants they have funded: https://projectreporter.nih.gov/reporter.cfm. You can search by institute, grant type, program manager or key words to name a few. You can see how much money is typically awarded by that agency and get an idea of the focus of the agency. This can help you know how to present your ideas and refine your choice of agency.
Plan your grant. What will you include? How will you format it? The omnibus solicitation https://grants.nih.gov/grants/guide/pa-files/PA-18-574.html details review criteria and formatting guidelines. However, we have found a collection of sample grants and summary statements on the NIAID website to be very helpful in assembling our most successful grants. These are found at: https://www.niaid.nih.gov/grants-contracts/sample-applications.
Look closely at the grant format and strategy in these sample grants. Headers are clearly defined and directly correspond to the review criteria and sections of the summary statement. Remember that reviewers have many grants to review in addition to their day jobs. They are very busy people and the easier you make it for them to give you a favorable review, the better for you. Give them the answers to their review questions and back it up with data. In the past, I’ve discussed unexpected reviewer comments with program managers. The PM inevitably ask if I spelled it out what I just told them in the grant. Of course, I had not, and the advice was to spell it out. Don’t make them work to draw the conclusion you want. If this new technology has never been done before, say it (and back it up). Don’t make the reviewers conduct a research project and come to that conclusion on their own. Remember, the reviewers may not be an expert in your field and have very little time.
As you look at NIH Reporter, notice the name of the study section that reviewed the grant. Click on a project that resembles yours and go to the Detail tab where you find the study section name. The study section name takes you to the Center for Scientific Review website where you can click on the study section and obtain the meeting roster. Although the meeting roster rotates, you can get a general idea of who will be reviewing your grant. For example, you may see that most of the reviewers are from academic labs with a few from small businesses. They may all be biologists. Look at their background and expertise and write your grant in a language that they can understand. You can also request institute and study section in the new PHS assignment request form. It used to go in the cover letter.
Write your specific aims and send them to the program manager. The program manager is usually found on the NIH agency web-site and/or in the document referenced above. Send Specific Aims to program manager ~1 month in advance and ask to schedule a phone call. You can wait until the last minute but understand that everyone else is doing the same thing and you may not be able to schedule a call or have their full attention. The specific aims should serve as an executive summary for the grant. For examples, view the example grants above.
There are a few of the key steps we go through before submitting an NIH SBIR grant. We wish you the best of luck with your applications and if you need that last bit of preliminary data – is my target druggable, does my compound bind directly to the target, will my target crystallize? – let us know. We have experience running quick simple experiments for ourselves and others to generate that last piece of critical data to strengthen proposals. Our advice is free of charge!