Fiscal year 2025 is painfully but thankfully coming to a close in the next couple of months. As I’ve remarked to staff, when bad things happen and someone says, “I’ve seen worse,” hopefully this will be their last new ‘worse’ benchmark. Typically, around this time, we are in mop up mode with a few last-minute issues receiving attention as well as our excellent Center bean counters keeping us up to date on our budget status. Occasionally, a contract option may not be exercisable or an offset in an award due to unobligated balances leaves some funds on the table allowing for another grant to go out the door. This is also why we sometimes multiyear fund smaller grants as the administrative effort to push out two years of funding on a single R03 is far less than attempting to process two R03s (as an aside, this is partly the rationale for why many NIH ICs are lowering paylines and multiyear funding their RPGs). Given that we are living in atypical times with the funding pauses earlier this year followed by the evolution of HHS and NIH guidance regarding agency priorities, there is still a considerable workload of paperwork and administrivia to complete. At the same time, while we recognize that August is a month when a greater percentage of staff take vacation (both within and outside of NIH), crunch time does require rapid turnarounds. Please be as responsive as possible to contacts and requests from NCATS staff as they are working feverishly (Erica and I have supplied pizzas and grants management has a cookie supply to maintain blood sugar levels) to move the funding forward under the adjusted guidelines so that your funds can be obligated. Generally, a home stretch refers to a straight portion or final phase, and though there may be some twists with some whiplash along the way, together we can achieve our bean counters’ holy grail of $0.00 FY25 funds remaining on 9/30.&nbsp; Lastly, a very recent NIH notice, “<a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-138.html" target="_blank" rel="noopener noreferrer">Request for Information on Maximizing Research Funds by Limiting Allowable Publishing Costs</a>” has dropped. NIH is looking for input on a variety of approaches for limiting allowable publishing costs. Included in the notice are a couple of interesting analyses with some provocative results as well as a series of options that NIH is considering. Check it out. &nbsp;

By: Michael Kurilla, M.D., Ph.D., NCATS Director of the Division of Clinical Innovation

Coming into the Home Stretch

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Advice from the <a href="https://dailystoic.com/planting-trees-in-shade-well-never-know/" target="_blank" rel="noopener noreferrer">Daily Stoic</a>.&nbsp;In a past geological era (during my college days), I had the opportunity to drive across the country (multiple times). At the time, there were no ATMs, cell phones, or GPS. I made the trek with only a big wad of cash and a Rand McNally map. When my son was of a comparable age, I would comment to him that my generation didn’t have cell phones, computers, or video games growing up, so my generation was forced to invent all that stuff! What is most interesting about this is that we measure progress by our technology, specifically our technological gadgetry. And with all that gadgetry, we tend to view technological advance largely as some combination of faster, better, or cheaper. Also, we prefer technological improvements that offer the least operational or administrative change in our routines. This most easily results in a ‘bolt-on’ mentality where we simply add new technology into our mix without much thought to changing workflows or organizational structures, as well as health care delivery arrangements. But if we are to truly realize the full impact of advancing technology on medicine, we need to think beyond mere gadgetry and consider reimagining how we conceptualize health and how we organize and deliver health care overall including personnel as well as infrastructure. Instead of merely ‘faster, better, or cheaper,’ we need to add ‘different.’&nbsp;Advancing technology should not only change what we can do, but also ‘how’ we undertake addressing current issues. In addition, advancing technology allows us to ask questions never previously even contemplated. Over the past year, there have been numerous suggestions for NIH reorganization. While I have no enlightened opinions to offer on any of the specific proposals, I do feel that the current NIH structure may not be optimal for truly 21st century scientific and medical research.&nbsp;&nbsp;As an example, consider Parkinson’s disease; clearly a neurological disorder with a long history of support from NINDS. However, some of the more recent intriguing research findings have come from outside the CNS. The gut-brain axis with heavy involvement of our microbiome has been receiving <a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC4367209/" target="_blank" rel="noopener noreferrer">much attention in the last ten years</a>, including <a href="https://pubmed.ncbi.nlm.nih.gov/40244491/" target="_blank" rel="noopener noreferrer">Parkinson’s disease</a> with an emerging consensus that microbiome changes are not simply a consequence of disease progression or medication use. With regards to Parkinson’s diagnostics, a most fascinating <a href="https://pubs.acs.org/doi/10.1021/acs.analchem.5c00908" target="_blank" rel="noopener noreferrer">piece of work</a> appeared recently utilizing cerumen, AKA earwax and testing for specific volatile organic compounds (VOCs). This follows on the <a href="https://www.sciencedirect.com/science/article/pii/S1474442215003968" target="_blank" rel="noopener noreferrer">report</a> of a human being capable of ‘smelling’ Parkinson’s disease six years prior to diagnosis (this is also an great example of a clinical observation turned into useful science). Earwax turns out to be an excellent matrix for capturing VOCs which are also released from the skin but easily vaporized away (one more ‘omics to integrate – <a href="https://pubmed.ncbi.nlm.nih.gov/39129534/" target="_blank" rel="noopener noreferrer">volatilomics</a>!). In addition, Parkinson’s is not the first disease to sample earwax, as <a href="https://pubs.acs.org/doi/10.1021/acsomega.3c01943" target="_blank" rel="noopener noreferrer">Meniere’s disease</a> has also been diagnosed this way and most recently, even <a href="https://www.nature.com/articles/s41598-025-97440-2" target="_blank" rel="noopener noreferrer">cancer</a>. A recent <a href="https://www.nature.com/articles/s41598-023-47568-w" target="_blank" rel="noopener noreferrer">CTSA publication</a> reported a machine learning algorithm that can diagnose Parkinson’s disease by voice patterns from smartphone recordings. And this is not a unique one-off, as a company in Canada has published results of voice patterns predicting <a href="https://ieeexplore.ieee.org/document/10669945" target="_blank" rel="noopener noreferrer">hypertension</a> and <a href="https://www.mcpdigitalhealth.org/article/S2949-7612(23)00073-1/fulltext" target="_blank" rel="noopener noreferrer">Type 2 diabetes</a>. Finally, retinal scans which appear to be informative for diverse medical conditions such as <a href="https://www.nature.com/articles/s42256-021-00427-7" target="_blank" rel="noopener noreferrer">heart disease</a> or <a href="https://www.nature.com/articles/s41746-024-01292-5" target="_blank" rel="noopener noreferrer">dementia</a> has also tried its hand at <a href="https://www.neurology.org/doi/10.1212/WNL.0000000000207727" target="_blank" rel="noopener noreferrer">Parkinson’s disease</a> diagnosis.&nbsp;So, in addition to NINDS, we may need to add NIDDK, NIAID, NEI, and NIDCD (whose budget is smaller than the CTSA Program) to comprehensively address Parkinson’s disease, and that’s with just our currently available science. And more than likely, this type of scenario is not limited to Parkinson’s disease but represents an emerging appreciation that while our conceptualization of disease originates at the cellular and organ level, manifestations of disease are systemic in nature with impacts on physiologic processes unrelated to etiology. Medicine has always recognized this concept, but advancing technology has now afforded the opportunity for potential game changing exploitation that nearly borders on magic.&nbsp;Now try to imagine if the above were to apply not just to Parkinson’s disease, but to the vast majority of medical issues. Having an annual checkup could go something like this: Before the checkup, a <a href="https://www.exactsciences.com/cancer-testing/cologuard-stool-test" target="_blank" rel="noopener noreferrer">stool sample</a> is submitted. At the health care facility, a retinal scan and earwax specimen are obtained. Following that, a history and review of systems is obtained by a professional trained to ask specific questions and elicit information while an AI analyzes your voice pattern. During this time, the results of your stool sample analysis (both microbiome constituents as well as metabolites), retinal scan, and your earwax volatilomics analysis (AKA cerumenogram) have been integrated looking for confirmation from your voice pattern assessed against your genome sequence (which was obtained at birth and is part of your EHR) to render either a clean bill of health with some targeted lifestyle recommendations or a follow-up appointment with a physician for any identified or ongoing medical concerns. And you’ll likely have an AI avatar on your smartphone that will receive all the data generated and be able to discuss the visit with you long after the appointment.&nbsp;Sounds like science fiction? Sure. But then everything you’re doing right now would have sounded like science fiction (or magic) to this guy:<img src="https://uploads.ccos-cc.ctsa.io/753vz8_a85bedea2d.jpg" alt="Ah, Old Time Medicine | image tagged in comics | made w/ Imgflip meme maker">&nbsp;Of course, there’s lots of work to do, at least a generation’s worth (I’m looking at K scholars and T trainees). Critically, innovative translational pathways are needed for evaluating the suitability for integration of the analyses described above into routine clinical practice similar to blood chemistry. The CTSAs are uniquely situated within our vast, overwhelming, and balkanized academic medical research enterprise to not only develop and validate this emerging science, but to also translate these disparate elements into something truly revolutionary, rather than merely evolutionary and initiate what will someday be regarded as 21st century medicine!&nbsp;The future is not something we enter. The future is something we create.Leonard Sweet&nbsp;

Planting Trees…

NCATS Director of the Division of Clinical Innovation

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

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As FY25 comes to a close, most people at NIH are simply hoping to catch their breath before we learn what awaits us in FY26. The budget is (as typical) still pretty murky. The president has submitted a budget request which included an overall 40% reduction in total NIH funding as well as a reorganization plan. Bear in mind that Congress merely regards the President’s Budget as a suggestion. What we’ve seen with Congressional hearings on the budget have been uniformly uninformative. Little has emerged from the House. On the Senate side, <a href="https://www.appropriations.senate.gov/imo/media/doc/fy26_lhhs_senate_bill_summary.pdf" target="_blank" rel="noopener noreferrer">the Appropriations Committee did vote out their bill</a> giving NIH a $400M increase relative to FY25. There is also language specifically rejecting a 15% indirect cost rate as well as any NIH reorganization. This bill still requires full Senate approval and then will need to be reconciled with whatever comes from the House, so there is still a long way to go. And then there is still the possibility of a shutdown if the House and Senate cannot come to agreement.&nbsp;As far as grants go, the CTSA Program has been quite successful in achieving alignment with agency priorities for nearly 200 distinct grant actions. There may be a few more over the next couple of weeks as we await final decisions on certain contract actions. Overall, there were 61 hub awards with an average ‘haircut’ of only 2.27%. Over one third had no cuts at all and only 15% experienced cuts of over 5%.&nbsp;We have received all necessary approvals for the Fall Program meeting with the NIH Director as our keynote speaker. As a reminder, due to our inability to support CTSA activities at the spring ACTS meeting, the Enterprise Committees and other groups will be also meeting during this time. Hopefully, the arrangements with the hotel will be finalized by the time you read this.&nbsp;Enjoy what remains of summer.&nbsp;There’s always hope for something. Just not always… not always what we want.&nbsp;- James S.A. Corey, The Mercy of Gods&nbsp;&nbsp;

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Coming into the Home Stretch