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Michael G. Kurilla M.D., Ph.D.

NCATS Director of the Division of Clinical Innovation

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Heading into the Home Stretch

By Michael G. Kurilla M.D., Ph.D.

June 2, 2025

The process of awarding grants, both competing and non-competing, has been challenging in 2025 to say the least. We (NCATS, as well as the rest of the NIH) are way behind where we need to be at this point in the fiscal year. Partly, this has been due to new leadership from the NIH all the way to the White House with new policies that are typical for administration transitions. In general, things happen along traditional timelines with new policies or legislation that require some degree of interpretation for applicability, and this is typically summarized as ‘waiting for guidance,’ from NIH and beyond.  


Currently, our process has been refined, and we are trying to kick everything into high gear for the sprint to finish out FY25 (which ends September 30th). We began with the 3/1 start dates. Unfortunately, those awardees were part of our learning curve as well as experiencing evolving and changing ‘guidance’ which inadvertently included some whiplash, but as the changes have settled down and staff (both POs and grant specialists) have gained experience, and we anticipate accelerating the throughput dramatically. Summer is always problematic due to vacations as well as the generic ‘end of year’ chaos, but I implore you to remain engaged and as responsive as possible during this time. Lastly, even after NCATS has forwarded an award to HHS to be released, there is still another new level of review with an indeterminate timeframe.


As far as other goings on around CTSA-land, on June 2nd we held a N3C Community Forum, the first since last fall, and offered a glimpse of the next iteration of N3C as we transition to the National Clinical Cohort Collaborative version offering ‘dynamic’ tenants with institutions having greater control over how their data will be used. As previously discussed, we currently have an education tenant that is completing its 2nd cohort. Initial assessment shows tremendous satisfaction with the curriculum, interest in a 3rd cohort, and a significant demand for this type of training. Our two pilot tenants (Renal and Cancer) have provided solid information regarding infrastructure requirements, resource needs for utilization, and cost estimates. Ongoing discussions with NIH suggest that N3C will play a key role as NIH begins to appreciate the need for dedicated efforts in data science and the evolving digital landscape. We also have an ongoing project with NAIRR that may offer future access to high performance computing capability. 


Finally, as we’re dealing with the immediate need to get grants out the door, there continues to be much anxiety concerning the future of the CTSAs as well as NCATS. While there is a lot of speculation, at this point, Congress has not yet begun pondering FY26 appropriations. And given that HHS has only started with a full year budget once in the last two decades, it’s probably safe to assume that we will begin FY26 under another continuing resolution, thus leaving the current organizational structure in place. As such, the CTSAs should remain focused on what we do best: innovating and reimagining health and health care to create 21st century medicine.

 

Adults follow paths. Children explore. Adults are content to walk the same way, hundreds of times, or thousands; perhaps it never occurs to adults to step off the paths, to creep beneath rhododendrons, to find the spaces between fences.
- Neil Gaiman, The Ocean at the End of the Lane 

Planting Trees…

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Coordination, Communication, and Operations Support (CCOS) is funded by theNational Center for Advancing Translational Sciences, National Institutes of Health.

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