NIH grant application tips | Insights from a grant reviewer

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One of the biggest challenges facing life sciences companies is finding sources of funding to keep their research and development moving forward. Within the life sciences industry, NIH grants provide a significant source of funding for researchers looking to get their idea off the ground. 

Brex recently sat down with Innoventyx CEO and frequent NIH grant application reviewer Dr. Guillermo Morales, PhD, MBA to share his insight into crafting a successful grant proposal in the life sciences industry. 

What’s your experience in the life sciences?

I’ve been in pharmaceutical drug development for 25 years. I have a PhD in organic chemistry and started as a bench chemist in the lab in pharma, making compounds and synthesizing molecules to test them against diseases.  

I’ve worked in each stage of drug development, going from the idea stage all the way through to commercialization. In 2000, I had the chance to co-found my first biotech company. I had to learn how to raise money, pitch to investors, and run a business from scratch. I went back to school and received my MBA in 2015, and then started my consulting company, Innoventyx, in 2016. 

Describe Innoventyx for me.

Innoventyx is a global pharmaceutical/biotech consulting practice. I think of it as securing the future of pharmaceutical and life science companies by helping the brains behind life science get their ideas and projects to market. I help them in every stage of development—by consulting with executives and PIs (Principal Investigators) on whether their initial candidates or products seem to have promise in the context of the market, for instance, or by helping them choose their grant targets and giving them feedback on the content of their grant applications.

Why did you become a grant reviewer for the NIH?

I was contacted by a scientific review officer from the NIH in 2018 to join them and become a grant reviewer. She was looking for an expert in life sciences and specifically wanted my help and expertise in a section that reviews grants associated with subjects that life sciences see a lot: small business, biological chemistry, chemistry, biophysics, and assays.

So what makes for a solid grant application?

Whether I’m advising clients or reviewing grants, I’m usually looking for solid execution in four key areas: significance, team, innovation, and approach.

Significance. You can think of significance as “Why are we doing this?” Not what are we doing, not here’s how we plan to do it, but why. What’s the status of the field we’re in? How is this R&D project going to be a game-changer for a given patient population or for a kind of diagnostic device? How will your field advance because of this? Maybe something wasn’t possible before—there was a technology gap in your field that has recently been filled—and you’re capitalizing on that to make advancements. For instance, if you’re in the field of cancer therapeutics, maybe you’re pointing out that this is the first time we’ve been able to attack a certain kind of cancer from a certain angle, because of X or Y recent innovation. 

Team. Who are you working with? What are their previous accomplishments, if any? And a key thing here is, do you have everyone you need on your team to accomplish what you want to accomplish? If you’re developing a new medical device but you lack an electrical engineer or a mechanical engineer, for instance, I’m going to notice. Or if you’re talking about your commercialization intentions and you have no plan to add marketing or business development expertise to your team, that’s going to be a problem. At the very least, I want to see awareness that you know what you’re lacking.

Innovation. It’s important to the NIH that you’re doing things from a new perspective. After all, if you’re going for SBIR or STTR grants, the overall goal is to eventually turn your research into patentable IP. If your research is too closely related to another already existing project, I’m going to make note of that. In the field of drug development, for instance, there are often attempts to add very similar chemical entities (drug compounds) to an already crowded therapeutic market. The NIH is less interested in funding overtly incremental research, which, again, is also why it’s important to focus on that Significance section.

Approach. What are your aims, and how are you going to prove that out? I’m looking for rigor here. What are the metrics you’ll use? Do they have statistical significance and are they truly relevant to reproducing what you’re doing? Here, you’ve got to take a stand on your methodology and make a strong case for how you’ll execute it. But I want to be careful to say that the goal here is not to just throw a bunch of graphs and charts at me. Make sure that when you’re proving out your approach, you’re being concise and clear with the data you share. Remember that reviewers like me are reading hundreds of pages per session. You’re always working against the fatigue of the reviewer. We can sense when folks are just throwing graphs at us because they hope we won’t notice that they’re not entirely sure what approach they’re going to take.

Commercialization is often a stumbling point for researchers. What advice do you have for scientists who don’t have experience in building a strong business plan?

I’m always looking for forethought and knowledge about the market. How big is the market for your drug or medical device, and how much can you make? Who will your clients be? How will you protect your technology? If you’re developing a drug, you’re unlikely to bring it to market before a decade is out. Can you make any predictions about pending regulations or larger industry trends that reassure me that you’re taking the long view? 

Another big thing I’m always looking for is a good, simple story. Don’t tell me that there are 50 different avenues you might take. Tell me why your specific aims will lead to a successful product. It’s similar to pitching to investors. Tell me in 1-2 sentences why this is the right research to invest in. Then tell me again, and then again, throughout the application. Make sure there’s a clear through-line for each bit of data. You can’t assume that your reviewer is going to “get it.” Don’t put it on the reviewer to connect the dots for you. If you’re pitching, don’t make the reviewer think! You run the risk that the reviewer might connect the dots the wrong way.

Even if you don’t have the entire picture of your market or industry, you want to convey that you’re aware of your potential pitfalls and that you’ve thought of ways to mitigate your risks. Which of those risks are most pressing and which risks do you think you can address most easily? Which stage of development are you going to have the most trouble with and why?

What’s the key to punchy storytelling or an engaging pitch? 

Yes, that’s easier said than done, right? It’s a common problem of grant applications—even business pitches— that they’re with a focus on data, in some cases becoming a data dump where data alone is expected to tell the story to sell itself. 

Reviewers have to read everything that comes across their desk. They’re human, too. Remember that you’re competing for their attention and their focus with everyone else they’re reviewing. If your grant becomes tedious or unclear or convoluted, they may take that as a sign that you’re not up to the task—especially the commercialization piece, which requires being fluent in the business side of the industry. 

In my consulting work, I often recommend that some applicants hire expert grant writers to help them craft a narratively engaging application. If that’s not something you have the budget for, at least have multiple people review your application. If any of them say, “I have a problem following this or that aspect of the proposal,” that’s a sign that you’re not being tight enough with your storytelling. 

What can you do if your grant application isn’t successful?

There’s always the option to resubmit it, though you only have one opportunity to do that for each application. Keep the title the same, and acknowledge in the grant that the work is a resubmission. Address and rectify all critiques in the feedback you received after the rejection of the first submission.

TAKEAWAY

The NIH grant approval process is highly competitive, and preparation is the key to a successful application. Before submitting yours, make sure you have considered and thoroughly vetted the significance of your research, the team involved in its execution, the innovation it will bring to the field, and the unique approach you will take to solve a specific problem. 

Brex thanks Dr. Morales for his invaluable expertise, insight, and contributions to the life sciences community. If you have further questions, you can email him or message him via LinkedIn. In the meantime, check out more information on initiating the NIH grant application process.

For more information on fundraising in the life sciences industry, see Brex’s How to Approach Life Sciences Fundraising eGuide. As always, Brex is here to help reimagine financial systems so every growing company can realize its full potential.

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