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

NCATS Director of Clinical Innovation

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FY23 Ends with a Bang, but Some of Us Are Whimpering

By: Michael Kurilla, M.D., Ph.D., NCATS Director of the Division of Clinical Innovation and Erica Rosemond, Ph.D., NCATS Acting Deputy (Division) Director and Branch Chief

October 5, 2023

This month’s Ansible provides an update to the August Ansible regarding the CTSA Program awards in FY23, the first year under new mechanisms. 

 

As expected from our modelling, we can report that the public data available from NIH RePORTER reveals that the 16 new UM1 CTSAs that were awarded during FY23 experienced a total cost increase of 14% in aggregate over the UL1 Grant Year 5 / FY22 UL1 budgets.  The UM1s have a 17% average increase of the UM1 budgets over that of the Grant Year 5 / FY22 UL1 budgets. Only 2 out of the 16 new UM1s had minimal decreases in their total budget compared to Grant Year 5 / FY22, however, all UM1s received more than 95% of the resources that were provided prior to FY23, as directed by our FY23 Congressional Report language.

 

As a reminder, all 16 UM1 CTSAs were required to submit a K12 with their original UM1 application. 12 new K12s were funded during FY23 with a total average scholar slot increase of 14%. Of the other 4 K12s that were not funded in FY23, some took advantage of discussions with Grants Management to negotiate a start date (in FY24) that would be more beneficial to their programs. Some K12s were not meritorious and will be expected to resubmit as allowable under the notice NOT-TR-22-022.  Notably, under the new suite of CTSAs mechanisms the risk associated with a poorly scoring K12 (or other optional applications) has been eliminated and will not impact the consideration of funding the CTSA UM1, allowing NCATS to preserve its strong support for the CTSA hubs. NCATS expects that all UM1s will receive a K12 during the tenure of the 7-year UM1, that will, in turn, ensure that the clinical and translational research workforce is robust and that the CTSA Program is supporting as many future investigators as possible. 

 

The number of applications for Ts was not equivalent to that of the UM1/K12 as would be expected and allowable per NOT-TR-22-008 (optional companion applications may be submitted at any time the submitted UM1 new or resubmission application or award remains active). In this first year, we have 4 new T32 postdoctoral programs and 6 new T32 predoctoral programs, with 3 programs not having been funded before. The overall / combined slot increase for these 10 programs increases the portfolio by 24 trainees over that of Grant Year 5 / FY22 levels for these programs.  In this first funded cohort, we are seeing programs expand, either with a focus on a different cohort from previous awards or a completely new program as they never applied or were previously insufficiently meritorious. It is encouraging that even with this small first cohort, this is exactly what we were hoping would happen to bolster and build the clinical and translational science workforce at both the graduate and postdoctoral levels. 

 

An update to the August Ansible reporting the award of 3 R25 programs, we now have one additional R25 bringing our total portfolio in this new program to 4!  This doubles the number of short-term programs to a total of 8 programs! We are gratified to see interest towards early pipeline activities and suspect that resource allocation decisions limited prior utilization.

 

The high impact specialized innovation programs (RC2s), designed to address critical gap areas or emerging technology innovations in clinical and translational science was undersubscribed. However, we can report 4 awards in FY23 (link here).  We suspect that many applicants are interested to see flavor of projects funded prior to throwing their hat into this ring.  You will be able to hear about 2 of the RC2 projects (PI: Khairat, Center for Virtual Care Value and Equity – ViVE and PIs: Tristani-Firouzi and Estabrooks, A Translational Platform for Rapid Genomic Medicine) at the 2023 Fall CTSA Program Annual Meeting, November 6-8 (registration now open here).

 

To assist with identification of potential partners and determination of Budget Tier requests, a new partner list has been released that includes updates of partners from the new cohort of 16 UM1 CTSAs (emailed to CTSA PIs and Administrators on 9.25.2023 and to be posted here: https://ncats.nih.gov/ctsa/funding/CPUBRT by the end of November).  To ensure that applicants calculate their budget request and ensure they have unique partners, applicants are strongly encouraged to verify their funding tier (with partners) in advance of application submission through the CTSA FOA Questions mailbox (send to: CTSAFOAQuestions@mail.nih.gov) (NOT-TR-22-036).

 

In summary, in FY23 the new CTSA Suite funded 16 UM1s, 12 K12s, 10 T32s, 4 R25s and 4 RC2s.  We continue to listen to the community and think about how to enhance the administrative aspects of the mechanisms.

 

A brief outlook for the budget in FY24 is currently expecting flat budgets for NCATS and the CTSA Program. While the situation is quite fluid (and much may have transpired since penning this missive, under the direction of budget office, we are confident that we can navigate FY24 obligations.

 

We look forward to seeing many of you in person at the 2023 Fall CTSA Program Annual Meeting, November 6-8 (registration now open here) and will likely have some interesting stories to relate.

 

None of the things one frets about ever happen. Something one's never thought of does.
- Connie Willis, Doomsday Book

Michael G Kurilla
Erica Rosemond
 

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