Need to Write a NIH SBIR Phase I Grant Abstract? Use this Great Model

by Tom Hollon

I’ve run across a SBIR Phase I grant abstract so superbly organized and cleverly persuasive I’d like to show it to you.

Below is the abstract of Jim Stice of Twin Star Medical in St. Paul, Minnesota. I found it in the NIH RePORTER, NIH’s public database of information about funded grants. Stice’s grant, “Hollow Fiber Catheter for Drug Delivery into the Prostate,” was funded for $397,000 — far more than the average NIH SBIR Phase I award. A grant this good is worth a close look for lessons on grantwriting. Here’s Stice’s 375-word abstract:

Significance: Benign Prostatic Hyperplasia (BPH) will become an increasing burden on economic resources with the aging population. Surgical treatment is well established and has provided satisfactory results in 60 — 80% of men. However, it has been associated with significant morbidity and risk of complications; therefore considerable efforts have been directed toward developing alternative minimally invasive treatments. Ablation of the prostate by direct injection has the potential to significantly reduce expense and morbidity; drugs are available to chemically ablate the tissue. However, though direct injection is a seemingly straightforward approach to the problem, backflow along the needle track and uneven distribution of drug after injection are significant drawbacks to chemoablation. In contrast to conventional injection needles, the hollow fiber delivery catheter is completely porous; therefore the surface area of tissue in contact with infusate is considerably increased. Hypothesis: We hypothesize that use of a hollow fiber catheter for direct infusion into the prostate will result in elimination of backflow and greater volume of distribution than the standard-of-care needle injection. Preliminary Data: We have demonstrated that the hollow fiber eliminates shear plane and reflux in a tissue phantom gel model, and increases the amount of adenoviral gene transfer by ten times in rodent models (relative to needle infusion). Specific Aims: This project entails preclinical testing of the hollow fiber catheter for eventual application to human patients with prostate disorders. In Specific Aim 1, we will construct and validate human-scale hollow fiber catheters that are suitable for use in dogs. A widely used clinical injection needle will be directly compared to hollow fiber for delivery of dye in a gel model and ex vivo dog prostates. Reflux of infusate and delivery distribution will be quantified along with catheter transmittance properties. In Specific Aim 2, we will use the validated catheters and compare to needles with in vivo injections into a dog prostate. An antibiotic, dye, and contrast solution will be infused and distribution will be determined by evaluation of reflux into bladder by assay (antibiotic), reflux along needle track by fluoroscopy (contrast) and prostate distribution by dye visualization (post procedure prostate removal and sections). Together, these studies will demonstrate the utility of hollow fiber catheters for prostate injections and accelerate the commercialization of hollow fiber for clinical use.

Four reasons why this is a great SBIR Phase I abstract

1. Bold and italicized text make it easier for reviewers to get an overview of what’s important

Use of bold face type and italics in abstracts is rare, in my experience; when it’s done at all, it’s mainly to help reviewers notice specific aims. Here, though, Stice uses bold letters to offer reviewers an easy road map to the abstract, with sections for Significance, Hypothesis, Preliminary Data, and Specific Aims. Italics help reviewers pick out Specific Aim 1 and Specific Aim 2. I might have used capitals (SPECIFIC AIM 1)  or caps and italics (SPECIFIC AIM 2). Part of winning grants is making the reviewer’s job as easy as possible. Stice does this from the beginning.

2. Bold text draws attention to especially attractive aspects of the proposal

Here I refer to Hypothesis and Preliminary Data. Many SBIR abstracts do not explicitly state a hypothesis, so making Hypothesis stand out on the page tells SBIR reviewers (who are mostly academics doing hypothesis-driven research) this is their kind of grant, even if the hypothesis involves a product rather than a biological mechanism. Furthermore, the way Stice states the hypothesis suggests this project may eventually produce publishable data; this too should appeal to reviewers from academia.

Run-of-the-mill SBIR Phase I grants often lack preliminary data; the rules of competition don’t require it. By making Preliminary Data stand out, Stice alerts reviewers that he’s following the higher standard of academic NIH R01 grants, where preliminary data is required. Academic reviewers who sweat blood trying to win R01s will respect this and probably believe, all things being equal, that his grant has a higher chance to succeed than Phase I grants without preliminary data. Although I haven’t data to prove it, I suspect few SBIR Phase I grants win $400,000 without strong preliminary data to suggest the research will succeed.

 3. Little summaries inside the big summary

Don’t assume reviewers will understand your abstract just because you do. Research plans are so complex that even their abstracts can be daunting to grasp, especially when, as often happens, reviewers read grant applications in the dead of night when they should be in bed. Your grant is dead if they misunderstand it, so the question is, how do you reduce the risk they’ll misunderstand.  One way, which Stice uses here, is to include sentences that summarize groups of other sentences. Including little summaries within a big summary can make the big summary easier to understand. Stice does this twice.

The first little summary is the one that begins the Specific Aims section: “This project entails preclinical testing of the hollow fiber catheter for eventual application to human patients with prostate disorders.” In 19 words he provides the big picture of what the two specific aims (described in the next five sentences; 124 words) are about.

The second is the abstract’s last sentence. In my opinion it’s the abstract’s (and entire research plan’s) single most important sentence, because it summarizes the success NIH can expect from funding this grant: “Together, these studies will demonstrate the utility of hollow fiber catheters for prostate injections and accelerate the commercialization of hollow fiber for clinical use.”

I would have made one small change here, adding two words in bold:

Overall Impact: Together, these studies will demonstrate the utility of hollow fiber catheters for prostate injections and accelerate the commercialization of hollow fiber for clinical use.

Overall Impact — the likelihood a SBIR research project will succeed and contribute importantly to improving health — is the most important thing reviewers score for technical merit. Winning depends mightily on this score. Stice’s final sentence nicely summarizes his overall impact; expressly identifying it as the overall impact statement would have helped his reviewers remember it.

4. Contagious confidence

Suppose the Overall Impact sentence had been written like this (where I’ve used maroon to insert my words among Stice’s):

“Together, these studies will attempt to demonstrate the utility of hollow fiber catheters for prostate injections. If successful, they will accelerate the commercialization of hollow fiber for clinical use.”

The words I added suggest less confidence about the project’s outcome. You could say that’s justified, since no one can guarantee how research will turn out.

But this is about writing for money, which is why I added my words to Stice’s above — I wanted to show you a deliberate bad example of what not to do. If your words suggest you’re not sure you should win, NIH will be sure you shouldn’t. So make your confidence in your research plan show up on the page. Because confidence is contagious.

Reread the abstract, particulary where you see the word “will”, and you’ll notice several places where a less skillful writer than Stice could have lowered confidence in this project. The confidence he projects in this abstract is really smart grantwriting.

A great abstract will smell like a winner

A good SBIR Phase I abstract conveys a research plan’s essentials. A great one excites reviewers that they’ve got their hands on a winner, a grant they’ll actually enjoy reading. That’s what this excellent abstract does, and why I recommend it to you as a model to consider when writing your own. Great job, Dr. Stice.

 

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