2018 PRMRP Investigator Vignette

Title: Taking Ideas From Discovery to the Clinic

Investigator: Timothy Niewold, MD; New York University School of Medicine

So the mission of the PRMRP is to support the best research that can benefit active duty military, Veterans, and beneficiaries. Our mission is very much focused on military relevance. The programmatic review helps to ensure this when we see what is the best science that rises to the top.

There are multiple award mechanisms available through the PRMRP. And these start from the very early phase of the idea all the way to the clinical trial of something that would be applied in real-life medicine. So the earliest phase is the Discovery Award, and here, we have applicants come in with their great ideas that are usually out-of-the-box; preliminary data is not required. The reviewers are actually blinded at review from knowing who the investigators are because they really want to evaluate the idea. We don’t want so much emphasis being on the group; we want really the best ideas to rise to the top and those are small amount. It’s for a year and a half, but the idea is you give a boost to something to let someone check it out and see if their idea is really getting traction or not.

From there, you move to the Investigator-Initiated Research Award, which is a more substantial commitment, and you have to have some preliminary data and other good evidence, and that you’ve built a theoretical framework around what you’re proposing. Those are for 3 years and really allows enough financial support to take your research to the next stage.

After that, would be the TTDA award, or the Technology and Therapeutic Development Award, and that is a fairly unique mechanism to the Department of Defense. It fits in this in-between space, where there’s been basic work that develops the concept, and you got something you think might be able to take that leap from being just an idea to something in the real world and reduce to practice. It’s a big gap, I would say, in many research portfolios. There’s not as much support for this outside DoD. And I think that reflects the focus of PRMRP in trying to have the full pipeline for the ideas to become reality.

And then there’s support for a Clinical Trial mechanism. So when you have something that has passed the initial phase of the TTDA and you have usually an IND filed for this as a, as a new investigative drug, treatment, or device, then you can propose a clinical trial. And that’s fairly unique; there are not so many mechanisms where you can propose clinical trials available to investigators. And so the PRMRP fills a niche there. And I think one of the goals is that it really could function as a pipeline so that you could have something that was supported by PRMRP at each stage from Discovery to the IIRA and all the way through to the clinical trial.

So PRMRP addresses such a large number of topics, and as you can imagine, the challenge of balancing all of this is—is really formidable. I think we do our best so that scientific merit is always one of the primary considerations. So, if there is a topic that receives applications, but none of them are thought to be likely to yield results, then we just can't support them because we have to be good stewards of the dollars. You—you can't support an application that you think will not yield results.

The good news is that, for many topics, you’ll find at least a few meritorious applications. There’s an effort after all of the scores are in to try to pull ahead some of the topics that are under-represented. So we do portfolio balancing in that way so we can include as many topics as possible and be as responsive to these topics as we can.

Some of the grants do have a really kind of an exciting idea and potential for high impact, and many times this is accompanied by some level of risk. It’s almost part and parcel; it’s the same thing. So it can be tricky to evaluate those types of proposals. You try to find a tolerable level of risk and also to try to find the best ideas that have a chance to really make breakthroughs.

One of the things I’ve really enjoyed about PRMRP reviews is the focus on military-relevant grants that really could go forward and help people. And I think that that’s something that makes it a lot of fun. As a physician scientist myself, and with my own group, we have a large emphasis on things that are close to the clinic, and I think that’s one of the reasons why I’ve gravitated towards this type of peer review as well because, for all of the things that could be supported, it makes sense to support those things that are likely to make a difference, you know, and move toward the clinic. In the whole spectrum of research, I feel like my home is more on the translational side than on the very basic side. And I really feel like this has been a fun thing to do and a way that I can use my talents to help advance the health of military populations.