\u201cI don\u2019t know of a single grant that left my desk that was not approved and funded,\u201d NCI Director Anthony G. Letai said on this episode of The Cancer Letter Podcast.<\/p>\n<\/p>\n
This episode is available on Spotify<\/a>, Apple Podcasts<\/a>, and Youtube<\/a>.<\/p>\n Letai recapped his first year as NCI director in conversation with Paul Goldberg, editor and publisher of The Cancer Letter, and laid out his priorities for the year ahead.\u00a0<\/p>\n In the conversation, Letai discusses his goal of calming uncertainty at the institute, and why he hopes the metrics from his first year as director\u2014which he lays out in detail\u2014will change the way NCI is portrayed by the media.\u00a0<\/p>\n \u201cI hope I don\u2019t see any more reports of NCI cutting funding, because it just is not consistent with the facts,\u201d Letai said.\u00a0<\/p>\n NCI has given away all the money it intended to, Letai told Paul.\u00a0<\/p>\n \u201cHe\u2019s saying that NCI has not been cut back,\u201d Paul said. \u201cIn fact, it\u2019s giving out more money and more grants than ever before. So, that\u2019s reality.\u201d<\/p>\n While NCI is reporting thriving extramural research spending, that is not to say that the Trump administration hasn\u2019t attempted\u2014and succeeded in making\u2014a litany of policy actions that imperil the cancer research enterprise, Paul said.\u00a0<\/p>\n \u201c[Letai] calmed the thing down,\u201d Paul said. \u201cHe calmed the place down. But also, I don\u2019t want to sound like everything is great or that I think everything is great. I mean, the administration really did try to cut NCI and NIH by about 40%, and the Republicans in Congress and Democrats in Congress stopped that. So, there\u2019s that. And we\u2019ve been covering efforts by OMB to put in political review of grants essentially, and all funding. That\u2019s not happened. There was just a few weeks ago actually a discussion of an executive order which has not been issued. Well, we\u2019ll see what happens after the midterms.<\/p>\n \u201cSo, I mean, we\u2019re just covering politics, but we have to be realistic about what\u2019s actually happening and what\u2019s not happening. And what\u2019s not happening is the cutbacks in cancer research.\u201d<\/p>\n Letai credited NCI staff with the institute\u2019s success in getting extramural funding out the door during a tumultuous time.\u00a0<\/p>\n \u201cThese are all record-high numbers. And it\u2019s a real tribute, I think, in a challenging year, that the NCI staff, despite a lot of public doubt, just kept their nose to the grindstone and week after week, month after month, did their job, as I said they were doing.\u201d<\/p>\n Stories mentioned in this podcast include:\u00a0<\/p>\n This episode was transcribed using transcription services. It has been reviewed by our editorial staff, but the transcript may be imperfect.\u00a0<\/p>\n The following is a transcript of this week\u2019s In the Headlines, a weekly series on The Cancer Letter Podcast:<\/p>\n Jacquelyn Cobb: This week on The Cancer Letter Podcast\u2026<\/p>\n Paul Goldberg: Well, it\u2019s really interesting because a year ago, your first order of business was to get people to calm down because everybody was bracing for some really catastrophic events.<\/p>\n Anthony Letai:I think that\u2019s true. That was a top priority of mine was just to calm things down. Partly I affected that by, in the words of a famous journalist, being boring and repetitive. But it was just because I really think I had a simple message and I didn\u2019t see a reason to change it. The simple message was the NCI is in business. It remains in business. Its priorities haven\u2019t changed. Its mission hasn\u2019t changed. And our goal is to reduce cancer suffering in the United States.<\/p>\n Paul Goldberg: You\u2019re listening to The Cancer Letter Podcast. The Cancer Letter is a weekly independent magazine covering oncology since 1973. I\u2019m your host, Paul Goldberg, editor and publisher of The Cancer Letter.<\/p>\n Jacquelyn Cobb: And I\u2019m your host, Jacquelyn Cobb, managing editor of The Cancer Letter. We\u2019ll be bringing you the latest stories, groundbreaking research, and critical conversations shaping oncology.<\/p>\n Paul Goldberg: So, let\u2019s get going.<\/p>\n Jacquelyn Cobb: Hello, Paul. How\u2019s it going?<\/p>\n Paul Goldberg: Hi Jacquelyn. How are you? Where are you? Are you in Canada? Are you in Maine? Where in the world?<\/p>\n Jacquelyn Cobb: I am back in Maine. This is my space. But yeah, we went to Nova Scotia. This weekend was insane. I cannot put it into words. I had no idea it was up there. I feel so ignorant, but it literally is like a little Big Sur, Cape Breton Island National Park. We did a 10-mile hike and it was ridiculous.<\/p>\n Paul Goldberg: Sounds great.<\/p>\n Jacquelyn Cobb: Yeah, I\u2019m on a high from it for sure. But anyways, I can take us through last week\u2019s headlines. Story one was of course our conversation with the cancer letter that was with NCI director Anthony Letai. Paul had a conversation with him at the year anniversary of his directorship. And that\u2019s really what this podcast is going to be. It\u2019s what it\u2019s going to be, the conversation with Paul, between Paul and Dr. Letai. But before we go there, we\u2019ll kind of just go through the rest of the issue so that you all can hear about everything else that went on, which was a lot last week. It was a really cool, really full issue.<\/p>\n And just the last plug for the Directors, I would suggest even if you just listen to this via audio, I would definitely suggest reading Paul\u2019s story because I think he had some fun with the language and it was a really fun read. So, I would definitely suggest that and that compliment-<\/p>\n Paul Goldberg: So, it\u2019s a consumer warning, right?<\/p>\n Jacquelyn Cobb: If that\u2019s what you want to say. I would never say such a thing, but-<\/p>\n Paul Goldberg: Well, if I was having fun with the language-<\/p>\n Jacquelyn Cobb: Yeah, yeah, which is I feel like-<\/p>\n Paul Goldberg: \u2026 it\u2019s a consumer warning.<\/p>\n Jacquelyn Cobb: Yes, yes. We\u2019ll leave it mysterious.<\/p>\n Paul Goldberg: Be aware.<\/p>\n Jacquelyn Cobb: But our story too has a very similar reaction for me to be honest. It was also a really fun writing story from Paul and also news that we broke. Michael Caputo was appointed to the President\u2019s Cancer Panel. Do you want to talk a little bit about that, Paul, a little bit more about the story?<\/p>\n Paul Goldberg: Yeah, it\u2019s sort of an interesting story because in a larger part of the story, the bigger picture, there you go, is that NCI has these special mandates, special privileges, special authorities under the National Cancer Act of 1971. And one of them is the President\u2019s Cancer Panel. And the President\u2019s Cancer Panel is as effective as the relationship between its members and the president. And here\u2019s a guy who is a longtime political operative, Republican political operative, who ended up getting a head and neck cancer and being treated while running the PR part of COVID response some time ago.<\/p>\n And it seems to have, I hate to use the word politicized him, but that is kind of the word because that\u2019s kind of how this guy operates. It\u2019s politics, politics, politics all the time. And it\u2019s actually kind of interesting that he did get named to the President\u2019s Cancer Panel. And it\u2019s also interesting that the idea of that special authority of NCI, of the cancer panel to just walk with something into the Oval Office is something he takes very seriously. So, we ended up having an interesting chat. His big interest is the microbiome and survivorship issues, which certainly deserve attention. And it\u2019s also of interest to the White House chief of staff, Susie Wiles, who is a breast cancer survivor.<\/p>\n So, it was kind of an interesting question. And by the way, if you are interested in lowering toxicities and that sort of thing, then there\u2019s really no place better position, no place that can really do this, but NCI and the publicly funded research because think of it this way, if you have a branded drug that\u2019s on the market, would you be deescalating, running deescalation studies? Probably not because you already have an approval and who wants to sell less drug, even though of course prices can be adjusted and all that, whatever. So, really the incentives aren\u2019t there.<\/p>\n Or if you\u2019re dealing with something like a platinum drug, which is what gave this guy a lot of toxicity, Mike Caputo, then it\u2019s an off-patent drug. So, it\u2019s not a branded drug. Who\u2019s going to investigate deescalation there if that\u2019s even necessary? I don\u2019t know. Nobody. NCI could ask that kind of questions. And then the microbiome, it\u2019s a diet. So, who would run that kind of study but NCI? So, publicly funded research is really important and it\u2019s interesting to see this, to hear this from someone who is on the right side of the political spectrum. So, Republicans get cancer.<\/p>\n And by the way, going back to what our most important story for this week was, which is my chat with Dr. Letai, he\u2019s saying that they haven\u2019t really, NCI has not been cut back. In fact, it\u2019s giving out more money and more grants than ever before. So, that\u2019s reality.<\/p>\n Jacquelyn Cobb: Yeah. I feel like it really kind of hearkens back. That\u2019s a little bit of a dramatic way to say that, but to just a lot of the coverage we did when we were covering the potential NCI cuts, just the idea that they\u2019re really the only ones who are able to fund basic science in the same way where it\u2019s riskier, not so obviously profitable or not so confidently profitable or introduce revenue, however you want to say it. But yeah, this is a really, really cool issue to have so many examples of it right in a row and the hope and the positive news that Letai is saying that things are really not only fine, but good.<\/p>\n Paul Goldberg: Yeah, he\u2019s calmed the thing down. He calmed the place down. But also, I don\u2019t want to sound like everything is great or that I think everything is great. I mean, the administration really did try to cut NCI and NIH by about 40% and the Republicans in Congress and Democrats in Congress stopped that. So, there\u2019s that. And we\u2019ve been covering efforts by LOMB to put in political review of grants essentially and all funding. So, that\u2019s not happened. There was just a few weeks ago actually a discussion of an executive order which has not been issued. Well, we\u2019ll see what happens after the midterms.<\/p>\n So, I mean, we\u2019re just covering politics, but we have to be realistic about what\u2019s actually happening and what\u2019s not happening. And what\u2019s not happening is the cutbacks in cancer research.<\/p>\n Jacquelyn Cobb: Yeah, absolutely. Well, kind of a tenuous transition here, but speaking of survivorship and the potential side effects of chemotherapy, is that too loose? I\u2019m going to skip to Sara\u2019s story about an MD Anderson study suggesting that psilocybin may prevent chemo-induced neuropathy. And I\u2019m not going to get into a whole big thing here because you have Dr. Letai to listen to, but I just wanted to sort of speak to the importance of survivorship research is really, it can be a matter of survival as well when side effects affect adherence to chemotherapy and maybe lead to suboptimal doses and things like that. So, that was just one little point I wanted to say to connect because it\u2019s very important.<\/p>\n And then the last story that we had last week was by Claire. She basically did a follow-up two years after FDA\u2019s decision to mandate a breast density notification as part of mammography screening for women in the US. So, that was really the conclusion there was we still don\u2019t really have an answer for these people. It\u2019s really just more information that we don\u2019t have anything, any idea of what to do with quite yet. Unless if I\u2019m understanding correctly, and Paul, correct me if I\u2019m wrong, unless you are already at high risk, then it sort of becomes a question of risk management and moving forward with your provider.<\/p>\n But that\u2019s definitely Claire\u2019s sort of domain, but it was a really interesting story and kind of just like a check-in of-<\/p>\n Paul Goldberg: A veil of confusion. That\u2019s kind of what we\u2019re talking about. And you receive a notification and what does it actually mean? Your doctor won\u2019t be able to tell you most likely. So, it\u2019s a cool story, very cool story. I really like that.<\/p>\n Jacquelyn Cobb: Yeah. And then we had a sponsored article about the ASCO GU Cancer Symposium. And then we had some really interesting cancer policies as well. One about the H-1B visa fee making a return, but then a federal judge blocking it and as well as Trump targeting HHS as well as other areas of the government in an $810 million pocket rescission or a clawback.<\/p>\n Paul Goldberg: Which had nothing to do. Let\u2019s just be sure before anybody starts to worry.<\/p>\n Jacquelyn Cobb: Yes, yes, yes. Thank you, Paul.<\/p>\n Paul Goldberg: NCI was not touched by that.<\/p>\n Jacquelyn Cobb: Yes, yes. And if you listen to the NCI or the Letai conversation, you will hear that directly from Letai himself. So, with that, Paul, is there anything else we can kind of hand it off to previous you?<\/p>\n Paul Goldberg: Hand it off.<\/p>\n Jacquelyn Cobb: All right.<\/p>\n Paul Goldberg: Thank you for listening. Hey, Dr. Letai, thank you for finding the time to talk with me and congratulations on your first year as NCI director.<\/p>\n Dr. Anthony Letai: Thank you very much.<\/p>\n Paul Goldberg: How is it going?<\/p>\n Anthony Letai: Well, it continues to be, I would say, an interesting and invigorating job. I\u2019m pretty excited about how things have been going. What I really wanted to do is make sure the NCI kept working, and I think it basically has.<\/p>\n Paul Goldberg: It\u2019s really interesting, because a year ago, your first order of business was to get people to calm down, because everybody was bracing for some really catastrophic events.<\/p>\n Anthony Letai: Yeah. I think that\u2019s true. That was a top priority of mine\u2014just to calm things down.<\/p>\n And partly I effected that by, in the words of a famous journalist, \u201cbeing boring and repetitive.\u201d<\/p>\n But it was just because I really think I had a simple message, and I didn\u2019t see a reason to change it. The simple message was, \u201cThe NCI is in business. It remains in business. Its priorities haven\u2019t changed. Its mission hasn\u2019t changed. And our goal is to reduce cancer suffering in the United States.\u201d<\/p>\n Paul Goldberg: Well, it seems people have been calm for a while now, mostly. Mostly.<\/p>\n Can we talk about something that has just happened?<\/p>\n Last week, an FDA advisory committee recommended the approval of GRAIL\u2019s Galleri test. And I realized while editing the story that NCI is the only place in the U.S. government that\u2019s willing to ask questions about efficacy, well, excuse me\u2014efficacy is really not the right word, but about the utility of screening modalities such as [Galleri].<\/p>\n Anthony Letai: I\u2019m not sure I would endorse it. We do ask questions. We ask no end of research questions about a lot of things, including screening and prevention devices.<\/p>\n But I don\u2019t think I\u2019d say we\u2019re the only people that do it, but I\u2019m happy to talk about how the NCI feels.<\/p>\n Paul Goldberg: Well, let me defend myself. I\u2019m not sure what USPSTF is going to be able to do. And it\u2019s been removed by an act of Congress from playing any role in payment for this. Of course, payment and the USPSTF\u2026 it\u2019s a recent development, relatively speaking, in USPSTF\u2019s history.<\/p>\n And we did [see] Phil Castle show up and speak at an open public hearing about the trials that you are conducting or trial you\u2019re talking about investigating\u2014<\/p>\n Anthony Letai: The Vanguard trial.<\/p>\n Paul Goldberg: So, that\u2019s when I said, \u201cWait, there is no one else who plays that role that I know of, for certain.\u201d It\u2019s possible USPSTF will be very functional. I doubt it, but it\u2019s possible.<\/p>\n Anthony Letai: Well, I think the NIH for health and the NCI for cancer, it is our role to be the research arm of HHS, the federal government, for matters regarding cancer. So, I think it\u2019s appropriate that we would look into these things. I also would say, \u201cDon\u2019t underestimate the importance of USPSTF on adoption and utilization, even if not directly on reimbursement and FDA-approval.\u201d<\/p>\n That\u2019s still, I think, a very important role that they have to play.<\/p>\n But let me just share a few thoughts about the Galleri test, which is\u2026 it goes a little beyond that.<\/p>\n I think I\u2019ll use the term MCED, M-C-E-D. I\u2019ll leave you to write that however you like, but MCED, just to say it easy, for multiple cancer early detection devices, like Galleri, as an example.<\/p>\n I think if you ask the question, \u201cAre MCEDs a good idea?\u201d<\/p>\n The answer is yes.<\/p>\n I hope that would be great and I would love to see them work. I think a real challenge in communicating about MCEDs is that when you mention MCED, people immediately picture a very idealized MCED.<\/p>\n And that is an MCED where every positive result is a cancer, every negative result is no cancer.<\/p>\n It\u2019s sensitive to detect very early cancers. And when they detect very early cancers, that essentially equates with a life saved.<\/p>\n And I think everyone would endorse an assay that performed like that. That is the ideal MCED assay. And I think very often in our conversations, people have in their mind that type of very ideal assay.<\/p>\n However, I think it\u2019s also important to understand the actual assays that we have on hand. So, with regard to Galleri, and this is just based on the company\u2019s own evidence, I think we just have to be realistic in how it performed. For instance, it\u2019s referring to the article in The New England Journal of Medicine and the trial run at the NHS [UK National Health Service].<\/p>\n I think it\u2019s a very well-designed trial, and I congratulate GRAIL for doing a very good trial.<\/p>\n But we can ask the question like, how good was it at detecting early cancers? And the answer is that it detected no more than 20% of them, depending whether it\u2019s stage 2 and a slightly lower number at stage 1.<\/p>\n So, it wasn\u2019t great at detecting early cancers.<\/p>\n That means that at least four out of five early cancers slipped under the detection of GRAIL.<\/p>\n The other question I think that\u2019s pertinent to ask is, \u201cWhen you see a positive result, what proportion of those really represented a patient with cancer?\u201d<\/p>\n About half. So, if you had a positive test, there was a 50% chance, roughly, or 48% chance, that you didn\u2019t actually have cancer.<\/p>\n That\u2019s more than a modest concern.<\/p>\n I think people who are getting a test like this are probably people who are very concerned or worried about getting cancer. And if they get a positive test like this, it\u2019s going to wreck their life for a while. In addition, it\u2019s going to subject them to sometimes costly, and even maybe a little risky, interventions like biopsies and CT scans and MRIs and the like.<\/p>\n So, it\u2019s not risk-free to have false negatives.<\/p>\n Now, I think they do a pretty good job. I mean, analytically, it\u2019s a very tough job in a population that has only a small proportion of cancer in it, which is what a general population looks like.<\/p>\n They still do a pretty good job, but I think what we have to ask is, \u201cWhat\u2019s the overall clinical benefit?\u201d Now, they had set for themselves the task as the primary objective to reduce the number of stage 3 and stage 4 cancers\u2014of late-stage cancers.<\/p>\n The idea is that if you diagnose a sufficient number at an early stage in the intervention arm, that you would have a reduction in late-stage cancers, which are the most troublesome ones, compared to the control arm that didn\u2019t get the assay.<\/p>\n They did not demonstrate that. So, it was a negative trial.<\/p>\n It was a clearly negative trial with regard to their primary objective, which is the reduction of stage 3 and 4 cancers. So, I think it\u2019s just important to understand the limitations of the real world assay that we have in hand.<\/p>\n And yes, they and other MCED companies aspire to the more idealized MCED I described, but that\u2019s not the MCED we have on hand right now. And we need to keep trying for that MCED.<\/p>\n Paul Goldberg: And FDA is not really looking at that aspect of it, which is clinical benefit. It\u2019s looking at the ability to, or at least based on the [advisory committee] meeting, it\u2019s looking exclusively at the ability to detect cancer, which is I guess there, sort of.<\/p>\n So, the question, I guess the rest is sort of outside your bailiwick, but you are going to be doing the [Vanguard] trial; right?<\/p>\n Anthony Letai: Yes. Our plan is to continue the Vanguard trial.<\/p>\n Paul Goldberg: Right. Right. And then as far as terminology, do you prefer MCD, or MCED, or do you care?<\/p>\n Anthony Letai: I think MCED.<\/p>\n Paul Goldberg: Really?<\/p>\n Anthony Letai: I don\u2019t really care, but I think that\u2019s more commonly used now. I think I saw MCD a little bit more last year and the year before.<\/p>\n Now, I think MCED is more commonly used. Yes.<\/p>\n Paul Goldberg: Interesting. Interesting. Because that was a question of whether FDA should allow the use of the word \u201cearly,\u201d but again, that\u2019s an FDA problem, not yours.<\/p>\n Can we go on to another question that\u2019s causing people to tear their hair out at the moment, which is AI?<\/p>\n As the NCI director, how do you think about the question of safety of AI? I know NCI is hoping to use AI, and is using it.<\/p>\n Anthony Letai: Right. I am not an AI expert, and no one should depend on me to gauge their level of concern about serious impacts of AI down the road. I think when people are talking about really worrisome effects of AI, it has nothing to do with cancer applications, so I\u2019ll leave that to others.<\/p>\n But with regard to applications in cancer, I think we\u2019re already seeing them. AI is very widely used in the in silico modeling of drug-protein interactions, modeling your small molecules to better fit or interact with your targets of interest, just as one of many examples.<\/p>\n There\u2019s a lot of efforts of using AI at various steps in the clinical trial progression\u2014that is, writing up protocols, consent forms, organizing data input, analyzing data afterward. These are all things that AI is either being used [for] or I think shortly will be used [for].<\/p>\n Of course, we also see it not in everyday clinical use yet, but in the analysis of pathologic and radiologic data, I think we\u2019re going to increasingly see use of AI for those purposes. I don\u2019t think any of those applications will be trained in a way that would possibly be any sort of danger to the population at large.<\/p>\n But I\u2019ll say what I said yesterday in a different forum, which is: It behooves us as the cancer researchers and cancer practitioners of the country that when we interact with people who are doing AI research, that we make sure they understand what we need.<\/p>\n I think very often discussions of AI with AI experts rapidly gets down to how they\u2019re doing what they\u2019re doing, and the techniques and the technology that they\u2019re deploying.<\/p>\n And there isn\u2019t as much time left for a very, very explicit discussion of, \u201cWhat problem are you solving for me?\u201d<\/p>\n Me, the cancer researcher or oncologist.<\/p>\n What problem are you solving for me?<\/p>\n What question are you asking?<\/p>\n Which specific function are you replacing?<\/p>\n We hear a lot about gathering data, organizing databases, sharing it, interoperability. These are all important things, but at the end of the day, you can have all the data in the world.<\/p>\n It requires us to let them know what problem we need solved.<\/p>\n Paul Goldberg: Do you need to put together a group, maybe, to have a look at it? A group of experts? Or is this not at that level yet?<\/p>\n Anthony Letai: There\u2019s no shortage of groups. I mean, our CBIIT [Center for Biomedical Informatics and Information Technology] here is actively involved in discussing, with a lot of people, applications of AI.<\/p>\n There\u2019s no shortage\u2026<\/p>\n This is from my perspective. There\u2019s no shortage of work going into this, or even applications and testing. However, I think it\u2019s very important that we pay attention to the opportunity to employ solutions that are interoperable.<\/p>\n And when I say this, I especially think across the NCI-designated cancer centers.<\/p>\n I think there\u2019s an opportunity to use an interoperable AI solution to really unify our NCI-designated cancer centers to work more as a unit, to share data as a unit.<\/p>\n I know there\u2019s going to be challenges in doing that, and data-sharing is never easy. But I think that opportunity exists, and I want to see if we can take advantage of it.<\/p>\n Paul Goldberg: Can we talk about the cancer centers\u2026 Last year, when the NOFO came out, it was too early for you to have an impact on it. How is it going now? Where is that issue of reviewing cancer centers?<\/p>\n Anthony Letai: So, now when we review cancer centers, the initial peer review is done at the [NIH] Center for Scientific Review.<\/p>\n Those comments, and the score, come to the NCI, as well as the individual cancer centers. And then we do an in-person visit with our leader of our cancer center program, which is Krzysztof Ptak, P-T-A-K. The difficult-to-spell Slavic name.<\/p>\n Paul Goldberg: It means \u201cbird,\u201d by the way.<\/p>\n Anthony Letai: Oh, it does? Okay.<\/p>\n Paul Goldberg: It does.<\/p>\n Anthony Letai: I didn\u2019t know that.<\/p>\n Anyway, we have a panel of experts, largely other cancer center directors, that actually make an in-person visit to the cancer center for further evaluation. [This] allows the cancer center being reviewed to expand on certain things, correct certain misapprehensions.<\/p>\n And so far, I would say that they\u2019ve been very satisfied with that and they welcome the opportunity. I think these reviews are going extremely well.<\/p>\n Since you bring up the subject of cancer center review, though, you probably may also know that there\u2019s a new NOFO that we\u2019ve submitted for the next series, the next round, of Cancer Center Support Grant reviews.<\/p>\n This NOFO is still under review, but I want to just mention an important part of that, because an important part of that next NOFO is that we will be including performance in clinical trial metrics as part of the cancer center evaluation by the NCI.<\/p>\n And by that, I mean that we are going to see if cancer centers are starting and executing clinical trials in a timely, efficient manner.<\/p>\n It\u2019s very well-understood in the government and pretty much anyone who pays attention to this sort of thing, that our clinical trials can be made more efficient.<\/p>\n And we know this is the case, because there are a lot of countries where they are more efficient and there\u2019s no reason why we can\u2019t do what they do. I think Australia is the most prominent example, but China is another example. I think China is a more difficult model for us to try to imitate, but even European countries. We have to figure out ways to do things faster\u2014we need to activate faster, and we need to enroll better.<\/p>\n Paul Goldberg: Well, I\u2019ve heard you were trying to streamline the review, simplify it. Is that happening? How are you going to do that?<\/p>\n Anthony Letai: The cancer center review is going to be greatly streamlined. We would estimate it\u2019s going to, roughly, cut the paperwork in half, and these site visits are going to be much shorter than they were before.<\/p>\n Paul Goldberg: So, in terms of this required paperwork, how much less?<\/p>\n Anthony Letai: I would say if you want an accurate answer on that, talk to Krzysztof. He\u2019ll give you a more detailed answer. He can tell you the specific items of data that have been\u2026 We\u2019ve consolidated certain sections, and we\u2019ve also reduced some of the data requirements. But he could give you a better estimate, like exactly what he thinks that\u2019ll shrink. I said something like half, but he could tell you.<\/p>\n Paul Goldberg: Something like half is good enough. Yes, I heard from center directors that your director\u2019s meeting went incredibly well.<\/p>\n Anthony Letai: Oh, good. I thought it went well.<\/p>\n Paul Goldberg: Because basically these were people who were very worried for when you came in, and now they\u2019re\u2014<\/p>\n Anthony Letai: Don\u2019t say it like that. They were worried before I came in.<\/p>\n Paul Goldberg: Correct. I stand corrected. So, what about\u2026 one of the first things you brought in was the therapeutic vaccine initiative. How is that going?<\/p>\n Anthony Letai: I think it\u2019s going very well. We\u2019re at this stage now\u2014there\u2019s a white paper that\u2019s out, and it, I think, does a good job laying out the skeleton of how we want to progress, which is two to three clinical trials investigating\u2014it prioritizes some of the different tumors we\u2019d want to investigate.\u00a0<\/p>\n But we specifically want to go after niches, or contexts, that are not being explored by commercial entities. Our job here is not to directly compete with commercial entities, but to investigate techniques, approaches, and also disease contexts that are not being fully studied in the commercial world. And I want to mention\u2014that includes some pediatric tumors.<\/p>\n So, our goal right now is, this is going to be a public-private partnership. This is being led by the FNIH, the Foundation for NIH.<\/p>\n And right now, FNIH is busy sort of raising money for the private part of that.<\/p>\n Paul Goldberg: So, the money is coming in; are you hearing anything?<\/p>\n Anthony Letai: Yes. Well, they\u2019re in the business right now of collecting the commitments.<\/p>\n Paul Goldberg: That\u2019s great to hear. Is there a very clear\u2014has it been published, rather, what the plan is?\u00a0<\/p>\n Anthony Letai: The white paper contains a pretty good look at the plan.<\/p>\n Then, I think the more specifics are going to await a more formal competition for individual sites and trials, and so forth.<\/p>\n Paul Goldberg: Well, getting back to NCI, everybody\u2019s really mostly looking at the grants getting out. Were you able to pay out everything? I should have really started with this, but\u2026<\/p>\n Anthony Letai: Were we able to pay out everything?<\/p>\n Absolutely we were.<\/p>\n And I\u2019m very well-prepared now with some numbers.<\/p>\n So, as you might know, or anyone might know who is sort of fine with it, there has been a lot of consternation. I think some of it wasn\u2019t all that well-informed.<\/p>\n People were accumulating data from sources, that weren\u2019t quite clear to me, and purported that the NCI, and the NIH, more generally, was not going to be able to complete payment of the extramural budget; that people were falling behind.<\/p>\n Now, I think we\u2019re all aware there were a lot of events at the beginning of the year that gave us a slow start, and some changes in how we were making grant decisions that needed to be accommodated into an existing program.<\/p>\n However, from way back when, I tried to make it very clear that we have a professional staff that was aware of the work that was set before it between then and the end of the fiscal year, that we were getting the grants out, that we were going to get the job done on time.<\/p>\n And all I can say is, again, sort of in a slow, boring way, we did our job and we got all the grants out.<\/p>\n And I\u2019m happy to report, this was an extremely successful year. I can give you some top-line numbers if you\u2019d like.<\/p>\n Paul Goldberg: I would love them. And if you have them in the table, we\u2019ll publish the table, as well.<\/p>\n Anthony Letai: I actually was going to give them to you in a bar graph form. Would that be acceptable?<\/p>\n Paul Goldberg: Fine. Yes, that\u2019s good.<\/p>\n Anthony Letai: So, for instance, in terms of total extramural dollars, I\u2019ve made the point before, that in 2025, despite what you might think by reading a lot of reports, we actually paid out more\u2014this is before I arrived\u2014more extramural dollars than ever before.<\/p>\n So, this is in millions of dollars.<\/p>\n This will make boring reading, just listing out numbers, but that\u2019s what I\u2019m about to do.<\/p>\n So, Fiscal Year 2024: $5,350. FY25: $5,460. FY26\u2014and this is just an estimate; it\u2019s not final until we formally report to the NIH, but it\u2019s $5,610.<\/p>\n So, as expected, higher than FY24, higher than FY25, and another record expenditure of extramural money by the NCI, which is what I\u2019ve been suggesting for a long time.<\/p>\n And I hope I don\u2019t see any more reports of NCI cutting funding, because it just is not consistent with the facts.<\/p>\n People are concerned about numbers of research project grants. This is just raw numbers, not thousands, obviously.\u00a0<\/p>\n FY24: 1,224. FY25\u2014there was a dip because of the multi-year funding\u2014964. FY26, our estimate, again, is 1,309.<\/p>\n So, a significant increase over FY24. People are concerned about early-stage investigators. Now, I\u2019m going to give you the numbers the way we count them. The NCI counts them a little bit differently.<\/p>\n We count the actual awards; they count the investigators, and it\u2019s a higher number. I can give you both, but FY24, 127; FY25, 90; FY26, 147.<\/p>\n Using the NIH accounting system, 199 early-stage investigators will receive RPG funding this year.<\/p>\n These are all record-high numbers. And it\u2019s a real tribute, I think, in a challenging year that the NCI staff, despite a lot of, sort, of public doubt, just kept their nose to the grindstone and week after week, month after month, did their job, as I said they were doing.<\/p>\n And they accomplished an excellent year of extramural funding.<\/p>\n Paul Goldberg: That\u2019s interesting. And everything that gets to your desk gets approved?<\/p>\n Anthony Letai: I don\u2019t know of a single grant that left my desk that was not approved and funded.<\/p>\n Paul Goldberg: Is there anything that you can say about the grants that might not have reached your desk, or is this where there could be a\u2014<\/p>\n Anthony Letai: I\u2019ll just say what I\u2019ve said before: the grants that reach my desk, reach my desk as a result of purely scientific review.<\/p>\n There\u2019s nothing but scientific review between the application and them reaching my desk. There is no hidden panel.<\/p>\n The only political appointee who is making a decision on these grants is the NCI director.<\/p>\n Paul Goldberg: That\u2019s fascinating.<\/p>\n There was a rescission last week. Is that affecting NCI in the least?<\/p>\n Anthony Letai: No.<\/p>\n Paul Goldberg: I didn\u2019t see that, either, so that\u2019s good to know. I guess now a really fun question: functional precision medicine\u2014how\u2019s that going?<\/p>\n Anthony Letai: There we go.<\/p>\n Paul Goldberg: That\u2019s your thing.<\/p>\n Anthony Letai: Yeah. So, just so people know what I mean by functional precision medicine.<\/p>\n First, I think we need to consider precision medicine broadly as a concept. It is the job of getting the right drug to the right patient. And I think, unfortunately, this became synonymous due to some very legitimate successes, but this became synonymous with genomic precision medicine.<\/p>\n Paul Goldberg: I see.<\/p>\n Anthony Letai: And I think we lost sight of the fact that there are other ways to assign the right drug to the right patient.<\/p>\n I sort of stumbled on this thinking myself in the work I did with venetoclax, where we were able to assign venetoclax to CLL and AML, and with many collaborators, get it FDA-approved for both of those in a very precision way.<\/p>\n But without genomics, there\u2019s no BCL-2 mutations to direct a BCL-2 inhibitor like venetoclax to CLL or AML. It got me thinking more broadly about this, and basically determined that there\u2019s a lot that we can get out of putting the drug you\u2019re interested in directly on the living, functioning cell that you\u2019re interested in and measuring something worthwhile.<\/p>\n That\u2019s the essence of functional precision medicine: Put the drug on the living cell and measure something useful.<\/p>\n I got interested in this 10 years ago or so.<\/p>\n I discovered there were other people around the world who were very interested in this, and we formed a society, and I think it\u2019s gained a lot of steam.<\/p>\n We had a very productive workshop a couple of months ago up at Shady Grove. Over a thousand people attended that.<\/p>\n We are now in the process, in the planning stages, of setting up a functional precision medicine laboratory at Frederick to do intramural work. And I await a white paper from that workshop that I mentioned to start planning for extramural support for functional precision medicine.<\/p>\n I\u2019m convinced that this is going to help get active drugs to patients.<\/p>\n I think you can think of three main ways that can be used.<\/p>\n It can be used as a companion diagnostic, when you already know the drug you want to use and you want to stratify a patient population to only give that drug or combination of drugs to the ones that it will work on. There\u2019s a role right there.<\/p>\n Another role is when you have a patient who doesn\u2019t have any standard-of-care options. You can screen that patient\u2019s tumor tissue, living tumor tissue, against a large number of drugs and identify ones that are active.<\/p>\n Finally, pure discovery.<\/p>\n There you don\u2019t have to rely purely on FDA-approved drugs or even things with drug-like properties\u2014they could be tool compounds\u2014and you can screen tumors. And I would suggest especially tumors for which we don\u2019t have great options, and test whether or not we can identify brand new pathways to be targeted, brand new sort of chemical entities that could be developed into drugs for tumors that lack an option.<\/p>\n So, there\u2019s discovery, companion diagnostic, and I\u2019d say personalized precision medicine tools are three important applications of functional precision medicine.<\/p>\n Paul Goldberg: When is the white paper coming out?<\/p>\n Anthony Letai: Good question. We don\u2019t have a deadline for that, but I would expect in the next couple of months.<\/p>\n Paul Goldberg: Yeah. We would cover it. Certainly we would make a note of it.<\/p>\n Anthony Letai: Great. We\u2019ll make you aware.<\/p>\n Paul Goldberg: Also, looking back, I think it was a few weeks ago, ASCO changed its view on this. And the position was formed way back, a generation ago, in response to chemosensitivity testing, which is a whole other universe.<\/p>\n Anthony Letai: Right. There\u2019s definitely a lot\u2026 There\u2019s sort of like primordial ex vivo, or in vitro, chemosensitivity tests. That\u2019s very old technology, and in a setting where there weren\u2019t very many drugs. And they just didn\u2019t have great utility.<\/p>\n Nowadays, we can do single-cell imaging, we can do AI-assisted analysis of tumor samples, and we\u2019re much better at ex vivo culturing.<\/p>\n We can do things much faster, which is hugely advantageous when you\u2019re trying to study a primary patient tissue. So, there\u2019s many, many technological advantages we have that they didn\u2019t have back then.<\/p>\n And we thought, in the field of functional precision medicine, that the previous ASCO cautions were a little bit outdated and excessively negative. And all I can say is, we\u2019re very grateful to ASCO for reconsidering the issue and putting out what I think will be a very useful statement that will end up helping patients.<\/p>\n Paul Goldberg: Well, it was, I mean\u2026\u00a0 to their defense, they formulated their rather nihilistic statement at the time when it wasn\u2019t nihilistic; it was just basically consumer protection from something that wasn\u2019t ready for\u2026<\/p>\n Anthony Letai: I agree. I want to make it clear: I don\u2019t think they ever did anything inaccurate or wrong.<\/p>\n I just think that we both realized that there was an opportunity here for an update, and I think they provided a very useful update.<\/p>\n Paul Goldberg: I mean, the science moved on. That\u2019s really a fascinating story. We should stay on top of that.<\/p>\n Getting back to something you\u2019ve mentioned, which is the clinical trials competitiveness. Is there more to say about this? You mentioned it in the context of cancer centers.<\/p>\n Anthony Letai: Well, I guess what I could say is, there are a lot of parts to this puzzle, and there\u2019s no one logjam and there\u2019s no one problem.<\/p>\n I think that we need to keep as our standard. Our goal is to be the best in the world. And I think we can achieve that. The U.S. has the resources, and we have the population.<\/p>\n Everyone already, I think, respects the quality of the data you get out of a clinical trial performed in the United States. That\u2019s not the problem. The problem is not the quality. It\u2019s getting to that quality.<\/p>\n If you consider late-phase clinical trials, it is too hard and takes too long to accrue American patients to clinical trials here in the United States.<\/p>\n If you consider early-phase clinical trials, where you\u2019re generally not enrolling as many people, the problem becomes the difficulty, the resources required, and the time required to activate those clinical trials.<\/p>\n So, we need to solve all of these, but there\u2019s many different solutions. There\u2019s things that cancer centers can do differently that I outlined. There\u2019s things that pharma can do differently.<\/p>\n I hope to make some progress on contracting and budgeting. This is something that\u2026 we at the NCI can act as honest brokers in bringing these different parties together.<\/p>\n And I think it\u2019s come up multiple times, that one of the big challenges, especially with respect to timing, is contracting and budget negotiations and indemnification, especially when you consider this has to be done sometimes in multi-center trials again and again and again and again, and everyone has a different solution to every different center.<\/p>\n I think this can be harmonized, and I think part of it will just require agreement, a will to make things work faster, and an acceptance that, maybe, we will not be able to mitigate every last bit of risk.<\/p>\n And a little more risk is going to have to be adopted by both sides in order to make things move faster. I think that pharma, they\u2019ve expressed a willingness to pay the money it requires to do clinical trials here. They\u2019re very concerned about just reliability and being able to do them fast.<\/p>\n I think we can help with that, and you can see the cancer centers who have made this a priority\u2014I think NYU Perlmutter [and] San Diego are two great examples of that\u2014have cut their activation times at least in half.<\/p>\n So, there\u2019s a lot that can be done and that\u2019s why I\u2019m optimistic that we can provide some solutions to this.<\/p>\n I think, also, cancer centers and the cancer ecosystem can act as a very important test laboratory for some of these ideas that can then be extended throughout the entire medical ecosystem.<\/p>\n Paul Goldberg: What about NCORP and cooperative groups? Is there a role for them? Can they be a part of the solution here?<\/p>\n Anthony Letai: I mean, I think so. I think NCORP is a great idea, a great organization. I think they could potentially\u2014[by] enrolling in the communities rather than in big cancer centers\u2014be part of the solution.<\/p>\n Paul Goldberg: NCI could really play a huge role in bringing it all together, all the players, and making it all happen.<\/p>\n Anthony Letai: I should say that we participate in a Project Trailblazer. We have regular meetings throughout HHS.<\/p>\n And there\u2019s many entities throughout HHS that are very interested in this, but also, Congress is very interested in this. It\u2019s a bipartisan issue. Everyone in government wants a healthy biotech and pharmaceutical industry in the United States, and they also want our patients to be getting the latest and most interesting drugs as soon as possible.<\/p>\n Paul Goldberg: At the most recent NCAB, you spoke about early-onset cancers. What\u2019s NCI doing on that?<\/p>\n Anthony Letai: Well, first, we continue to measure the magnitude of the issue. I think it\u2019s important to recognize that early-onset cancers are still on the rare side, so that even an increase in early-onset cancers doesn\u2019t mean a massive increase in cancer mortality more generally in America.<\/p>\n But it\u2019s a very important problem, because it tells us something is changing in our population or in our environment, and whatever that something is, we haven\u2019t identified what it is.<\/p>\n To me, it acts as a really, really important signal that we need to understand. So, part of what we continue to do is fund research to measure the size of the effect.<\/p>\n The other is to try to test, and we fund in our extramural program a lot of research looking at, \u201cWhat are the causes?\u201d<\/p>\n Can we identify, test some hypotheses as to what are the environmental cues or the population-wide cues that we can identify in people who are contracting these early-onset cancers, so that we can work at reversing what we see as an unfavorable trend?<\/p>\n Paul Goldberg: Is there a plan? Is there anything that\u2019s coming?<\/p>\n Anthony Letai: We don\u2019t have a centralized plan. What we\u2019ve chosen to do is [to] activate the hive mind of the extramural community to help us learn, \u201cWhat are the hypotheses we need to test to get to the bottom of this?\u201d<\/p>\n Paul Goldberg: Before you got to NCI\u2014so, you have nothing to do with this\u2014during the DOGE era, NCI lost its communications infrastructure, and that\u2019s actually one of the requirements, one of the provisions, of the National Cancer Act of 1971, so NCI had the same mandates as NASA.<\/p>\n Are you bringing it back? I mean, Your NCI Tuesdays with Tony, the Fred Hutch contract for public information, PDQ [Physician Data Query]. Well, how much of it is coming back? How are you going to bring it back?<\/p>\n Anthony Letai: I think you\u2019ve given a list. We do have a greatly-reduced, but very active and productive, communications staff that continues to support the NCI directly, here at the NCI.<\/p>\n We\u2019re grateful to have that. There\u2019s also central communications, a lot of communications. There were some reductions in force, but also communications were centralized to the NIH.<\/p>\n So, we do get support from the NIH on communications as well. But I\u2019d say most of the things that you mentioned are performed by our reduced staff here at the NCI, led by Nancy [Murphy] who is sitting immediately to my left.<\/p>\n Paul Goldberg: Some of what you are describing is really kind of free, like Tuesdays with Tony, probably doesn\u2019t cost the taxpayers very much.<\/p>\n Anthony Letai: Right. I think that\u2019s one of the beauties of the modern world is that, for better or for worse, it\u2019s easy to share one\u2019s ideas for free on a lot of different platforms.<\/p>\n And we continue to do that.<\/p>\n I think you\u2019ll see another NCI video coming out very soon. We\u2019re very excited about that. We hope to let people know how excited we are about recent advances in targeting RAS, and just remind people that that all started with NCI grants.<\/p>\n Paul Goldberg: So that\u2019s really\u2026 your NCI is all about that.<\/p>\n Anthony Letai: I think the American taxpayers deserve to know what\u2019s being done with their tax dollars here at the NCI.<\/p>\n And I think you need some of these long-form stories to describe the decades-long efforts that the NCI funds, up until something actually becomes a drug, or a therapeutic, or a test, or a preventative aid.<\/p>\n I think these things started with NCI funding, sometimes decades ago. By the time they reach the consumer, the fingerprint of the NCI is maybe less obvious, but people should know that it was their dollars that allowed grandfather to have this new RAS drug.<\/p>\n Paul Goldberg: Well, we should actually figure out a way to highlight each of these more, or maybe even to make a longer version of the same thing, which we\u2019ve been doing. We just haven\u2019t been doing it in a very systematic way.<\/p>\n We just cover RAS, but the fact that it began with the NCI grant, we should be doing more on.<\/p>\n Can PDQ come back? I know it\u2019s not been eliminated, but can it come back? Can the groups that run it, all of that, the review groups, expert panels?<\/p>\n That\u2019s not Tuesdays with Tony.<\/p>\n That\u2019s not free.<\/p>\n Anthony Letai: Just to remind everyone, the important job of PDQ was to organize boards of experts to advise us, essentially, what content should be provided on cancer.gov.<\/p>\n Many of those people have expressed a willingness to work even for free, which is very nice of them, but there still are some logistical struggles to making that happen.<\/p>\n But the long and the short of it is, it\u2019s a work in progress, and we\u2019re investigating whether there are ways to bring those people back.<\/p>\n Paul Goldberg: So, there\u2019s money attached to that potentially, so you might actually make it work.<\/p>\n Anthony Letai: I don\u2019t think that we\u2019ll need to expend the same resources we did in the past if we stand this back up again.<\/p>\n Paul Goldberg: I think you\u2019re probably right. Yes. So, what should we expect next year in terms of your priorities?<\/p>\n Anthony Letai: So, last year was a year, in my view, of calming things down and starting some things up.<\/p>\n So, you talked about the therapeutic cancer vaccine initiative; functional precision medicine; stabilizing grants funding; getting our communications, I think in a more proactive role; and then improving clinical trial competitiveness.<\/p>\n Now, things like the therapeutic cancer vaccine and functional precision medicine and clinical trials competitiveness, these are things that arose during the year.<\/p>\n And I can\u2019t rule out that new things are going to rise in this coming year that I want to pursue.<\/p>\n But my focus right now is, I feel that we\u2019ve identified a lot of important initiatives that I just mentioned.<\/p>\n And what I want to do is execute on them.<\/p>\n So, I really think, I hope for my Year Two, that we can really focus on executing on a lot of these initiatives that we\u2019ve started. It does no good to start an initiative if you can\u2019t bring it home.<\/p>\n So, I view Year Two being a big year of execution.<\/p>\n Paul Goldberg: You know what I actually forgot to ask, now that I think about it? I forgot to ask about microbiome.<\/p>\n Anthony Letai: We have, for several years, funded microbiome research. I think we did an estimate that we may spend something up to $100 million a year studying the influence of the microbiome on cancer, and maybe it\u2019s a reciprocal influence on cancer on the microbiome.<\/p>\n How the microbiome might influence initiation of cancer, and how it might influence response to therapy. So, it continues to be an important topic of study at the NCI.<\/p>\n This is something you might be interested in.. It\u2019s the beginning of January, we\u2019re going to host a workshop on the microbiome in cancer here at the NCI. It\u2019s available online. So, if you want to do us a favor, Paul, you could put down the exact dates in this article.<\/p>\n Paul Goldberg: We will. Absolutely. I\u2019m glad I asked, which actually brings me to the final question, which is, is there anything besides microbiome that I forgot to ask?<\/p>\n Anthony Letai: You\u2019ve been pretty thorough. I think most of the topics that I wanted to talk about overlap pretty well with the ones you seem to want to talk about.<\/p>\n Paul Goldberg: Well, that\u2019s great. I\u2019ve been awake all year! It\u2019s good. Congratulations on your first year. Let\u2019s hope there\u2019s not going to be another shutdown.<\/p>\n Anthony Letai: Well, it\u2019s looking good through December; right?<\/p>\n Paul Goldberg: Right. Anyway, congratulations again. Thank you so much.<\/p>\n Anthony Letai: All right. Thank you, Paul. It\u2019s my pleasure.<\/p>\n Paul Goldberg: Hey, Dr. Letai, thank you for finding the time to talk with me, and congratulations on your first year as NCI director.<\/p>\n Anthony Letai: Thank you very much.<\/p>\n Paul Goldberg: How is it going?<\/p>\n Anthony Letai: Well, it continues to be, I would say, an interesting and invigorating job. I\u2019m pretty excited about how things have been going. What I really wanted to do is make sure the NCI kept working, and I think it basically has.<\/p>\n Paul Goldberg: It\u2019s really interesting, because a year ago, your first order of business was to get people to calm down, because everybody was bracing for some really catastrophic events.<\/p>\n Anthony Letai: Yeah. I think that\u2019s true. That was a top priority of mine\u2014just to calm things down.<\/p>\n And partly I effected that by, in the words of a famous journalist, \u201cbeing boring and repetitive.\u201d<\/p>\n But it was just because I really think I had a simple message, and I didn\u2019t see a reason to change it. The simple message was, \u201cThe NCI is in business. It remains in business. Its priorities haven\u2019t changed. Its mission hasn\u2019t changed. And our goal is to reduce cancer suffering in the United States.\u201d<\/p>\n Paul Goldberg: Well, it seems people have been calm for a while now, mostly. Mostly.<\/p>\n Can we talk about something that has just happened?<\/p>\n Last week, an FDA advisory committee recommended the approval of GRAIL\u2019s Galleri test. And I realized while editing the story that NCI is the only place in the U.S. government that\u2019s willing to ask questions about efficacy, well, excuse me\u2014efficacy is really not the right word, but about the utility of screening modalities such as [Galleri].<\/p>\n Anthony Letai: I\u2019m not sure I would endorse it. We do ask questions. We ask no end of research questions about a lot of things, including screening and prevention devices.<\/p>\n But I don\u2019t think I\u2019d say we\u2019re the only people that do it, but I\u2019m happy to talk about how the NCI feels.<\/p>\n Paul Goldberg: Well, let me defend myself. I\u2019m not sure what USPSTF is going to be able to do. And it\u2019s been removed by an act of Congress from playing any role in payment for this. Of course, payment and the USPSTF\u2026 it\u2019s a recent development, relatively speaking, in USPSTF\u2019s history.<\/p>\n And we did [see] Phil Castle show up and speak at an open public hearing about the trials that you are conducting or trial you\u2019re talking about investigating\u2014<\/p>\n Anthony Letai: The Vanguard trial.<\/p>\n Paul Goldberg: So, that\u2019s when I said, \u201cWait, there is no one else who plays that role that I know of, for certain.\u201d It\u2019s possible USPSTF will be very functional. I doubt it, but it\u2019s possible.<\/p>\n Anthony Letai: Well, I think the NIH for health and the NCI for cancer, it is our role to be the research arm of HHS, the federal government, for matters regarding cancer. So, I think it\u2019s appropriate that we would look into these things. I also would say, \u201cDon\u2019t underestimate the importance of USPSTF on adoption and utilization, even if not directly on reimbursement and FDA-approval.\u201d<\/p>\n That\u2019s still, I think, a very important role that they have to play.<\/p>\n But let me just share a few thoughts about the Galleri test, which is\u2026 it goes a little beyond that.<\/p>\n I think I\u2019ll use the term MCED, M-C-E-D. I\u2019ll leave you to write that however you like, but MCED, just to say it easy, for multiple cancer early detection devices, like Galleri, as an example.<\/p>\n I think if you ask the question, \u201cAre MCEDs a good idea?\u201d<\/p>\n The answer is yes.<\/p>\n I hope that would be great and I would love to see them work. I think a real challenge in communicating about MCEDs is that when you mention MCED, people immediately picture a very idealized MCED.<\/p>\n And that is an MCED where every positive result is a cancer, every negative result is no cancer.<\/p>\n It\u2019s sensitive to detect very early cancers. And when they detect very early cancers, that essentially equates with a life saved.<\/p>\n And I think everyone would endorse an assay that performed like that. That is the ideal MCED assay. And I think very often in our conversations, people have in their mind that type of very ideal assay.<\/p>\n However, I think it\u2019s also important to understand the actual assays that we have on hand. So, with regard to Galleri, and this is just based on the company\u2019s own evidence, I think we just have to be realistic in how it performed. For instance, it\u2019s referring to the article in The New England Journal of Medicine and the trial run at the NHS [UK National Health Service].<\/p>\n I think it\u2019s a very well-designed trial, and I congratulate GRAIL for doing a very good trial.<\/p>\n But we can ask the question like, how good was it at detecting early cancers? And the answer is that it detected no more than 20% of them, depending whether it\u2019s stage 2 and a slightly lower number at stage 1.<\/p>\n So, it wasn\u2019t great at detecting early cancers.<\/p>\n That means that at least four out of five early cancers slipped under the detection of GRAIL.<\/p>\n The other question I think that\u2019s pertinent to ask is, \u201cWhen you see a positive result, what proportion of those really represented a patient with cancer?\u201d<\/p>\n About half. So, if you had a positive test, there was a 50% chance, roughly, or 48% chance, that you didn\u2019t actually have cancer.<\/p>\n That\u2019s more than a modest concern.<\/p>\n I think people who are getting a test like this are probably people who are very concerned or worried about getting cancer. And if they get a positive test like this, it\u2019s going to wreck their life for a while. In addition, it\u2019s going to subject them to sometimes costly, and even maybe a little risky, interventions like biopsies and CT scans and MRIs and the like.<\/p>\n So, it\u2019s not risk-free to have false negatives.<\/p>\n Now, I think they do a pretty good job. I mean, analytically, it\u2019s a very tough job in a population that has only a small proportion of cancer in it, which is what a general population looks like.<\/p>\n They still do a pretty good job, but I think what we have to ask is, \u201cWhat\u2019s the overall clinical benefit?\u201d Now, they had set for themselves the task as the primary objective to reduce the number of stage 3 and stage 4 cancers\u2014of late-stage cancers.<\/p>\n The idea is that if you diagnose a sufficient number at an early stage in the intervention arm, that you would have a reduction in late-stage cancers, which are the most troublesome ones, compared to the control arm that didn\u2019t get the assay.<\/p>\n They did not demonstrate that. So, it was a negative trial.<\/p>\n It was a clearly negative trial with regard to their primary objective, which is the reduction of stage 3 and 4 cancers. So, I think it\u2019s just important to understand the limitations of the real world assay that we have in hand.<\/p>\n And yes, they and other MCED companies aspire to the more idealized MCED I described, but that\u2019s not the MCED we have on hand right now. And we need to keep trying for that MCED.<\/p>\n Paul Goldberg: And FDA is not really looking at that aspect of it, which is clinical benefit. It\u2019s looking at the ability to, or at least based on the [advisory committee] meeting, it\u2019s looking exclusively at the ability to detect cancer, which is I guess there, sort of.<\/p>\n So, the question, I guess the rest is sort of outside your bailiwick, but you are going to be doing the [Vanguard] trial; right?<\/p>\n Anthony Letai: Yes. Our plan is to continue the Vanguard trial.<\/p>\n Paul Goldberg: Right. Right. And then as far as terminology, do you prefer MCD, or MCED, or do you care?<\/p>\n Anthony Letai: I think MCED.<\/p>\n Paul Goldberg: Really?<\/p>\n Anthony Letai: I don\u2019t really care, but I think that\u2019s more commonly used now. I think I saw MCD a little bit more last year and the year before.<\/p>\n Now, I think MCED is more commonly used. Yes.<\/p>\n Paul Goldberg: Interesting. Interesting. Because that was a question of whether FDA should allow the use of the word \u201cearly,\u201d but again, that\u2019s an FDA problem, not yours.<\/p>\n Can we go on to another question that\u2019s causing people to tear their hair out at the moment, which is AI?<\/p>\n As the NCI director, how do you think about the question of safety of AI? I know NCI is hoping to use AI, and is using it.<\/p>\n Anthony Letai: Right. I am not an AI expert, and no one should depend on me to gauge their level of concern about serious impacts of AI down the road. I think when people are talking about really worrisome effects of AI, it has nothing to do with cancer applications, so I\u2019ll leave that to others.<\/p>\n But with regard to applications in cancer, I think we\u2019re already seeing them. AI is very widely used in the in silico modeling of drug-protein interactions, modeling your small molecules to better fit or interact with your targets of interest, just as one of many examples.<\/p>\n There\u2019s a lot of efforts of using AI at various steps in the clinical trial progression\u2014that is, writing up protocols, consent forms, organizing data input, analyzing data afterward. These are all things that AI is either being used [for] or I think shortly will be used [for].<\/p>\n Of course, we also see it not in everyday clinical use yet, but in the analysis of pathologic and radiologic data, I think we\u2019re going to increasingly see use of AI for those purposes. I don\u2019t think any of those applications will be trained in a way that would possibly be any sort of danger to the population at large.<\/p>\n But I\u2019ll say what I said yesterday in a different forum, which is: It behooves us as the cancer researchers and cancer practitioners of the country that when we interact with people who are doing AI research, that we make sure they understand what we need.<\/p>\n I think very often discussions of AI with AI experts rapidly gets down to how they\u2019re doing what they\u2019re doing, and the techniques and the technology that they\u2019re deploying.<\/p>\n And there isn\u2019t as much time left for a very, very explicit discussion of, \u201cWhat problem are you solving for me?\u201d<\/p>\n Me, the cancer researcher or oncologist.<\/p>\n What problem are you solving for me?<\/p>\n What question are you asking?<\/p>\n Which specific function are you replacing?<\/p>\n We hear a lot about gathering data, organizing databases, sharing it, interoperability. These are all important things, but at the end of the day, you can have all the data in the world.<\/p>\n It requires us to let them know what problem we need solved.<\/p>\n Paul Goldberg: Do you need to put together a group, maybe, to have a look at it? A group of experts? Or is this not at that level yet?<\/p>\n Anthony Letai: There\u2019s no shortage of groups. I mean, our CBIIT [Center for Biomedical Informatics and Information Technology] here is actively involved in discussing, with a lot of people, applications of AI.<\/p>\n There\u2019s no shortage\u2026<\/p>\n This is from my perspective. There\u2019s no shortage of work going into this, or even applications and testing. However, I think it\u2019s very important that we pay attention to the opportunity to employ solutions that are interoperable.<\/p>\n And when I say this, I especially think across the NCI-designated cancer centers.<\/p>\n I think there\u2019s an opportunity to use an interoperable AI solution to really unify our NCI-designated cancer centers to work more as a unit, to share data as a unit.<\/p>\n I know there\u2019s going to be challenges in doing that, and data-sharing is never easy. But I think that opportunity exists, and I want to see if we can take advantage of it.<\/p>\n Paul Goldberg: Can we talk about the cancer centers\u2026 Last year, when the NOFO came out, it was too early for you to have an impact on it. How is it going now? Where is that issue of reviewing cancer centers?<\/p>\n Anthony Letai: So, now when we review cancer centers, the initial peer review is done at the [NIH] Center for Scientific Review.<\/p>\n Those comments, and the score, come to the NCI, as well as the individual cancer centers. And then we do an in-person visit with our leader of our cancer center program, which is Krzysztof Ptak, P-T-A-K. The difficult-to-spell Slavic name.<\/p>\n Paul Goldberg: It means \u201cbird,\u201d by the way.<\/p>\n Anthony Letai: Oh, it does? Okay.<\/p>\n Paul Goldberg: It does.<\/p>\n Anthony Letai: I didn\u2019t know that.<\/p>\n Anyway, we have a panel of experts, largely other cancer center directors, that actually make an in-person visit to the cancer center for further evaluation. [This] allows the cancer center being reviewed to expand on certain things, correct certain misapprehensions.<\/p>\n And so far, I would say that they\u2019ve been very satisfied with that and they welcome the opportunity. I think these reviews are going extremely well.<\/p>\n Since you bring up the subject of cancer center review, though, you probably may also know that there\u2019s a new NOFO that we\u2019ve submitted for the next series, the next round, of Cancer Center Support Grant reviews.<\/p>\n This NOFO is still under review, but I want to just mention an important part of that, because an important part of that next NOFO is that we will be including performance in clinical trial metrics as part of the cancer center evaluation by the NCI.<\/p>\n And by that, I mean that we are going to see if cancer centers are starting and executing clinical trials in a timely, efficient manner.<\/p>\n It\u2019s very well-understood in the government and pretty much anyone who pays attention to this sort of thing, that our clinical trials can be made more efficient.<\/p>\n And we know this is the case, because there are a lot of countries where they are more efficient and there\u2019s no reason why we can\u2019t do what they do. I think Australia is the most prominent example, but China is another example. I think China is a more difficult model for us to try to imitate, but even European countries. We have to figure out ways to do things faster\u2014we need to activate faster, and we need to enroll better.<\/p>\n Paul Goldberg: Well, I\u2019ve heard you were trying to streamline the review, simplify it. Is that happening? How are you going to do that?<\/p>\n Anthony Letai: The cancer center review is going to be greatly streamlined. We would estimate it\u2019s going to, roughly, cut the paperwork in half, and these site visits are going to be much shorter than they were before.<\/p>\n Paul Goldberg: So, in terms of this required paperwork, how much less?<\/p>\n Anthony Letai: I would say if you want an accurate answer on that, talk to Krzysztof. He\u2019ll give you a more detailed answer. He can tell you the specific items of data that have been\u2026 We\u2019ve consolidated certain sections, and we\u2019ve also reduced some of the data requirements. But he could give you a better estimate, like exactly what he thinks that\u2019ll shrink. I said something like half, but he could tell you.<\/p>\n Paul Goldberg: Something like half is good enough. Yes, I heard from center directors that your director\u2019s meeting went incredibly well.<\/p>\n Anthony Letai: Oh, good. I thought it went well.<\/p>\n Paul Goldberg: Because basically these were people who were very worried for when you came in, and now they\u2019re\u2014<\/p>\n Anthony Letai: Don\u2019t say it like that. They were worried before I came in.<\/p>\n Paul Goldberg: Correct. I stand corrected. So, what about\u2026 one of the first things you brought in was the therapeutic vaccine initiative. How is that going?<\/p>\n Anthony Letai: I think it\u2019s going very well. We\u2019re at this stage now\u2014there\u2019s a white paper that\u2019s out, and it, I think, does a good job laying out the skeleton of how we want to progress, which is two to three clinical trials investigating\u2014it prioritizes some of the different tumors we\u2019d want to investigate.\u00a0<\/p>\n But we specifically want to go after niches, or contexts, that are not being explored by commercial entities. Our job here is not to directly compete with commercial entities, but to investigate techniques, approaches, and also disease contexts that are not being fully studied in the commercial world. And I want to mention\u2014that includes some pediatric tumors.<\/p>\n So, our goal right now is, this is going to be a public-private partnership. This is being led by the FNIH, the Foundation for NIH.<\/p>\n And right now, FNIH is busy sort of raising money for the private part of that.<\/p>\n Paul Goldberg: So, the money is coming in; are you hearing anything?<\/p>\n Anthony Letai: Yes. Well, they\u2019re in the business right now of collecting the commitments.<\/p>\n Paul Goldberg: That\u2019s great to hear. Is there a very clear\u2014has it been published, rather, what the plan is?\u00a0<\/p>\n Anthony Letai: The white paper contains a pretty good look at the plan.<\/p>\n Then, I think the more specifics are going to await a more formal competition for individual sites and trials, and so forth.<\/p>\n Paul Goldberg: Well, getting back to NCI, everybody\u2019s really mostly looking at the grants getting out. Were you able to pay out everything? I should have really started with this, but\u2026<\/p>\n Anthony Letai: Were we able to pay out everything?<\/p>\n Absolutely we were.<\/p>\n And I\u2019m very well-prepared now with some numbers.<\/p>\n So, as you might know, or anyone might know who is sort of fine with it, there has been a lot of consternation. I think some of it wasn\u2019t all that well-informed.<\/p>\n People were accumulating data from sources, that weren\u2019t quite clear to me, and purported that the NCI, and the NIH, more generally, was not going to be able to complete payment of the extramural budget; that people were falling behind.<\/p>\n Now, I think we\u2019re all aware there were a lot of events at the beginning of the year that gave us a slow start, and some changes in how we were making grant decisions that needed to be accommodated into an existing program.<\/p>\n However, from way back when, I tried to make it very clear that we have a professional staff that was aware of the work that was set before it between then and the end of the fiscal year, that we were getting the grants out, that we were going to get the job done on time.<\/p>\n And all I can say is, again, sort of in a slow, boring way, we did our job and we got all the grants out.<\/p>\n And I\u2019m happy to report, this was an extremely successful year. I can give you some top-line numbers if you\u2019d like.<\/p>\n Paul Goldberg: I would love them. And if you have them in the table, we\u2019ll publish the table, as well.<\/p>\n Anthony Letai: I actually was going to give them to you in a bar graph form. Would that be acceptable?<\/p>\n Paul Goldberg: Fine. Yes, that\u2019s good.<\/p>\n Anthony Letai: So, for instance, in terms of total extramural dollars, I\u2019ve made the point before, that in 2025, despite what you might think by reading a lot of reports, we actually paid out more\u2014this is before I arrived\u2014more extramural dollars than ever before.<\/p>\n So, this is in millions of dollars.<\/p>\n This will make boring reading, just listing out numbers, but that\u2019s what I\u2019m about to do.<\/p>\n So, Fiscal Year 2024: $5,350. FY25: $5,460. FY26\u2014and this is just an estimate; it\u2019s not final until we formally report to the NIH, but it\u2019s $5,610.<\/p>\n So, as expected, higher than FY24, higher than FY25, and another record expenditure of extramural money by the NCI, which is what I\u2019ve been suggesting for a long time.<\/p>\n And I hope I don\u2019t see any more reports of NCI cutting funding, because it just is not consistent with the facts.<\/p>\n People are concerned about numbers of research project grants. This is just raw numbers, not thousands, obviously.\u00a0<\/p>\n FY24: 1,224. FY25\u2014there was a dip because of the multi-year funding\u2014964. FY26, our estimate, again, is 1,309.<\/p>\n So, a significant increase over FY24. People are concerned about early-stage investigators. Now, I\u2019m going to give you the numbers the way we count them. The NCI counts them a little bit differently.<\/p>\n We count the actual awards; they count the investigators, and it\u2019s a higher number. I can give you both, but FY24, 127; FY25, 90; FY26, 147.<\/p>\n Using the NIH accounting system, 199 early-stage investigators will receive RPG funding this year.<\/p>\n These are all record-high numbers. And it\u2019s a real tribute, I think, in a challenging year that the NCI staff, despite a lot of, sort, of public doubt, just kept their nose to the grindstone and week after week, month after month, did their job, as I said they were doing.<\/p>\n And they accomplished an excellent year of extramural funding.<\/p>\n Paul Goldberg: That\u2019s interesting. And everything that gets to your desk gets approved?<\/p>\n Anthony Letai: I don\u2019t know of a single grant that left my desk that was not approved and funded.<\/p>\n Paul Goldberg: Is there anything that you can say about the grants that might not have reached your desk, or is this where there could be a\u2014<\/p>\n Anthony Letai: I\u2019ll just say what I\u2019ve said before: the grants that reach my desk, reach my desk as a result of purely scientific review.<\/p>\n There\u2019s nothing but scientific review between the application and them reaching my desk. There is no hidden panel.<\/p>\n The only political appointee who is making a decision on these grants is the NCI director.<\/p>\n Paul Goldberg: That\u2019s fascinating.<\/p>\n There was a rescission last week. Is that affecting NCI in the least?<\/p>\n Anthony Letai: No.<\/p>\n Paul Goldberg: I didn\u2019t see that, either, so that\u2019s good to know. I guess now a really fun question: functional precision medicine\u2014how\u2019s that going?<\/p>\n Anthony Letai: There we go.<\/p>\n Paul Goldberg: That\u2019s your thing.<\/p>\n Anthony Letai: Yeah. So, just so people know what I mean by functional precision medicine.<\/p>\n First, I think we need to consider precision medicine broadly as a concept. It is the job of getting the right drug to the right patient. And I think, unfortunately, this became synonymous due to some very legitimate successes, but this became synonymous with genomic precision medicine.<\/p>\n Paul Goldberg: I see.<\/p>\n Anthony Letai: And I think we lost sight of the fact that there are other ways to assign the right drug to the right patient.<\/p>\n I sort of stumbled on this thinking myself in the work I did with venetoclax, where we were able to assign venetoclax to CLL and AML, and with many collaborators, get it FDA-approved for both of those in a very precision way.<\/p>\n But without genomics, there\u2019s no BCL-2 mutations to direct a BCL-2 inhibitor like venetoclax to CLL or AML. It got me thinking more broadly about this, and basically determined that there\u2019s a lot that we can get out of putting the drug you\u2019re interested in directly on the living, functioning cell that you\u2019re interested in and measuring something worthwhile.<\/p>\n That\u2019s the essence of functional precision medicine: Put the drug on the living cell and measure something useful.<\/p>\n I got interested in this 10 years ago or so.<\/p>\n I discovered there were other people around the world who were very interested in this, and we formed a society, and I think it\u2019s gained a lot of steam.<\/p>\n We had a very productive workshop a couple of months ago up at Shady Grove. Over a thousand people attended that.<\/p>\n We are now in the process, in the planning stages, of setting up a functional precision medicine laboratory at Frederick to do intramural work. And I await a white paper from that workshop that I mentioned to start planning for extramural support for functional precision medicine.<\/p>\n I\u2019m convinced that this is going to help get active drugs to patients.<\/p>\n I think you can think of three main ways that can be used.<\/p>\n It can be used as a companion diagnostic, when you already know the drug you want to use and you want to stratify a patient population to only give that drug or combination of drugs to the ones that it will work on. There\u2019s a role right there.<\/p>\n Another role is when you have a patient who doesn\u2019t have any standard-of-care options. You can screen that patient\u2019s tumor tissue, living tumor tissue, against a large number of drugs and identify ones that are active.<\/p>\n Finally, pure discovery.<\/p>\n There you don\u2019t have to rely purely on FDA-approved drugs or even things with drug-like properties\u2014they could be tool compounds\u2014and you can screen tumors. And I would suggest especially tumors for which we don\u2019t have great options, and test whether or not we can identify brand new pathways to be targeted, brand new sort of chemical entities that could be developed into drugs for tumors that lack an option.<\/p>\n So, there\u2019s discovery, companion diagnostic, and I\u2019d say personalized precision medicine tools are three important applications of functional precision medicine.<\/p>\n Paul Goldberg: When is the white paper coming out?<\/p>\n Anthony Letai: Good question. We don\u2019t have a deadline for that, but I would expect in the next couple of months.<\/p>\n Paul Goldberg: Yeah. We would cover it. Certainly we would make a note of it.<\/p>\n Anthony Letai: Great. We\u2019ll make you aware.<\/p>\n Paul Goldberg: Also, looking back, I think it was a few weeks ago, ASCO changed its view on this. And the position was formed way back, a generation ago, in response to chemosensitivity testing, which is a whole other universe.<\/p>\n Anthony Letai: Right. There\u2019s definitely a lot\u2026 There\u2019s sort of like primordial ex vivo, or in vitro, chemosensitivity tests. That\u2019s very old technology, and in a setting where there weren\u2019t very many drugs. And they just didn\u2019t have great utility.<\/p>\n Nowadays, we can do single-cell imaging, we can do AI-assisted analysis of tumor samples, and we\u2019re much better at ex vivo culturing.<\/p>\n We can do things much faster, which is hugely advantageous when you\u2019re trying to study a primary patient tissue. So, there\u2019s many, many technological advantages we have that they didn\u2019t have back then.<\/p>\n And we thought, in the field of functional precision medicine, that the previous ASCO cautions were a little bit outdated and excessively negative. And all I can say is, we\u2019re very grateful to ASCO for reconsidering the issue and putting out what I think will be a very useful statement that will end up helping patients.<\/p>\n Paul Goldberg: Well, it was, I mean\u2026\u00a0 to their defense, they formulated their rather nihilistic statement at the time when it wasn\u2019t nihilistic; it was just basically consumer protection from something that wasn\u2019t ready for\u2026<\/p>\n Anthony Letai: I agree. I want to make it clear: I don\u2019t think they ever did anything inaccurate or wrong.<\/p>\n I just think that we both realized that there was an opportunity here for an update, and I think they provided a very useful update.<\/p>\n Paul Goldberg: I mean, the science moved on. That\u2019s really a fascinating story. We should stay on top of that.<\/p>\n Getting back to something you\u2019ve mentioned, which is the clinical trials competitiveness. Is there more to say about this? You mentioned it in the context of cancer centers.<\/p>\n Anthony Letai: Well, I guess what I could say is, there are a lot of parts to this puzzle, and there\u2019s no one logjam and there\u2019s no one problem.<\/p>\n I think that we need to keep as our standard. Our goal is to be the best in the world. And I think we can achieve that. The U.S. has the resources, and we have the population.<\/p>\n Everyone already, I think, respects the quality of the data you get out of a clinical trial performed in the United States. That\u2019s not the problem. The problem is not the quality. It\u2019s getting to that quality.<\/p>\n If you consider late-phase clinical trials, it is too hard and takes too long to accrue American patients to clinical trials here in the United States.<\/p>\n If you consider early-phase clinical trials, where you\u2019re generally not enrolling as many people, the problem becomes the difficulty, the resources required, and the time required to activate those clinical trials.<\/p>\n So, we need to solve all of these, but there\u2019s many different solutions. There\u2019s things that cancer centers can do differently that I outlined. There\u2019s things that pharma can do differently.<\/p>\n I hope to make some progress on contracting and budgeting. This is something that\u2026 we at the NCI can act as honest brokers in bringing these different parties together.<\/p>\n And I think it\u2019s come up multiple times, that one of the big challenges, especially with respect to timing, is contracting and budget negotiations and indemnification, especially when you consider this has to be done sometimes in multi-center trials again and again and again and again, and everyone has a different solution to every different center.<\/p>\n I think this can be harmonized, and I think part of it will just require agreement, a will to make things work faster, and an acceptance that, maybe, we will not be able to mitigate every last bit of risk.<\/p>\n And a little more risk is going to have to be adopted by both sides in order to make things move faster. I think that pharma, they\u2019ve expressed a willingness to pay the money it requires to do clinical trials here. They\u2019re very concerned about just reliability and being able to do them fast.<\/p>\n I think we can help with that, and you can see the cancer centers who have made this a priority\u2014I think NYU Perlmutter [and] San Diego are two great examples of that\u2014have cut their activation times at least in half.<\/p>\n So, there\u2019s a lot that can be done and that\u2019s why I\u2019m optimistic that we can provide some solutions to this.<\/p>\n I think, also, cancer centers and the cancer ecosystem can act as a very important test laboratory for some of these ideas that can then be extended throughout the entire medical ecosystem.<\/p>\n Paul Goldberg: What about NCORP and cooperative groups? Is there a role for them? Can they be a part of the solution here?<\/p>\n Anthony Letai: I mean, I think so. I think NCORP is a great idea, a great organization. I think they could potentially\u2014[by] enrolling in the communities rather than in big cancer centers\u2014be part of the solution.<\/p>\n Paul Goldberg: NCI could really play a huge role in bringing it all together, all the players, and making it all happen.<\/p>\n Anthony Letai: I should say that we participate in a Project Trailblazer. We have regular meetings throughout HHS.<\/p>\n And there\u2019s many entities throughout HHS that are very interested in this, but also, Congress is very interested in this. It\u2019s a bipartisan issue. Everyone in government wants a healthy biotech and pharmaceutical industry in the United States, and they also want our patients to be getting the latest and most interesting drugs as soon as possible.<\/p>\n Paul Goldberg: At the most recent NCAB, you spoke about early-onset cancers. What\u2019s NCI doing on that?<\/p>\n Anthony Letai: Well, first, we continue to measure the magnitude of the issue. I think it\u2019s important to recognize that early-onset cancers are still on the rare side, so that even an increase in early-onset cancers doesn\u2019t mean a massive increase in cancer mortality more generally in America.<\/p>\n But it\u2019s a very important problem, because it tells us something is changing in our population or in our environment, and whatever that something is, we haven\u2019t identified what it is.<\/p>\n To me, it acts as a really, really important signal that we need to understand. So, part of what we continue to do is fund research to measure the size of the effect.<\/p>\n The other is to try to test, and we fund in our extramural program a lot of research looking at, \u201cWhat are the causes?\u201d<\/p>\n Can we identify, test some hypotheses as to what are the environmental cues or the population-wide cues that we can identify in people who are contracting these early-onset cancers, so that we can work at reversing what we see as an unfavorable trend?<\/p>\n Paul Goldberg: Is there a plan? Is there anything that\u2019s coming?<\/p>\n Anthony Letai: We don\u2019t have a centralized plan. What we\u2019ve chosen to do is [to] activate the hive mind of the extramural community to help us learn, \u201cWhat are the hypotheses we need to test to get to the bottom of this?\u201d<\/p>\n Paul Goldberg: Before you got to NCI\u2014so, you have nothing to do with this\u2014during the DOGE era, NCI lost its communications infrastructure, and that\u2019s actually one of the requirements, one of the provisions, of the National Cancer Act of 1971, so NCI had the same mandates as NASA.<\/p>\n Are you bringing it back? I mean, Your NCI Tuesdays with Tony, the Fred Hutch contract for public information, PDQ [Physician Data Query]. Well, how much of it is coming back? How are you going to bring it back?<\/p>\n Anthony Letai: I think you\u2019ve given a list. We do have a greatly-reduced, but very active and productive, communications staff that continues to support the NCI directly, here at the NCI.<\/p>\n We\u2019re grateful to have that. There\u2019s also central communications, a lot of communications. There were some reductions in force, but also communications were centralized to the NIH.<\/p>\n So, we do get support from the NIH on communications as well. But I\u2019d say most of the things that you mentioned are performed by our reduced staff here at the NCI, led by Nancy [Murphy] who is sitting immediately to my left.<\/p>\n Paul Goldberg: Some of what you are describing is really kind of free, like Tuesdays with Tony, probably doesn\u2019t cost the taxpayers very much.<\/p>\n Anthony Letai: Right. I think that\u2019s one of the beauties of the modern world is that, for better or for worse, it\u2019s easy to share one\u2019s ideas for free on a lot of different platforms.<\/p>\n And we continue to do that.<\/p>\n I think you\u2019ll see another NCI video coming out very soon. We\u2019re very excited about that. We hope to let people know how excited we are about recent advances in targeting RAS, and just remind people that that all started with NCI grants.<\/p>\n Paul Goldberg: So that\u2019s really\u2026 your NCI is all about that.<\/p>\n Anthony Letai: I think the American taxpayers deserve to know what\u2019s being done with their tax dollars here at the NCI.<\/p>\n And I think you need some of these long-form stories to describe the decades-long efforts that the NCI funds, up until something actually becomes a drug, or a therapeutic, or a test, or a preventative aid.<\/p>\n I think these things started with NCI funding, sometimes decades ago. By the time they reach the consumer, the fingerprint of the NCI is maybe less obvious, but people should know that it was their dollars that allowed grandfather to have this new RAS drug.<\/p>\n Paul Goldberg: Well, we should actually figure out a way to highlight each of these more, or maybe even to make a longer version of the same thing, which we\u2019ve been doing. We just haven\u2019t been doing it in a very systematic way.<\/p>\n We just cover RAS, but the fact that it began with the NCI grant, we should be doing more on.<\/p>\n Can PDQ come back? I know it\u2019s not been eliminated, but can it come back? Can the groups that run it, all of that, the review groups, expert panels?<\/p>\n That\u2019s not Tuesdays with Tony.<\/p>\n That\u2019s not free.<\/p>\n Anthony Letai: Just to remind everyone, the important job of PDQ was to organize boards of experts to advise us, essentially, what content should be provided on cancer.gov.<\/p>\n Many of those people have expressed a willingness to work even for free, which is very nice of them, but there still are some logistical struggles to making that happen.<\/p>\n But the long and the short of it is, it\u2019s a work in progress, and we\u2019re investigating whether there are ways to bring those people back.<\/p>\n Paul Goldberg: So, there\u2019s money attached to that potentially, so you might actually make it work.<\/p>\n Anthony Letai: I don\u2019t think that we\u2019ll need to expend the same resources we did in the past if we stand this back up again.<\/p>\n Paul Goldberg: I think you\u2019re probably right. Yes. So, what should we expect next year in terms of your priorities?<\/p>\n Anthony Letai: So, last year was a year, in my view, of calming things down and starting some things up.<\/p>\n So, you talked about the therapeutic cancer vaccine initiative; functional precision medicine; stabilizing grants funding; getting our communications, I think in a more proactive role; and then improving clinical trial competitiveness.<\/p>\n Now, things like the therapeutic cancer vaccine and functional precision medicine and clinical trials competitiveness, these are things that arose during the year.<\/p>\n And I can\u2019t rule out that new things are going to rise in this coming year that I want to pursue.<\/p>\n But my focus right now is, I feel that we\u2019ve identified a lot of important initiatives that I just mentioned.<\/p>\n And what I want to do is execute on them.<\/p>\n So, I really think, I hope for my Year Two, that we can really focus on executing on a lot of these initiatives that we\u2019ve started. It does no good to start an initiative if you can\u2019t bring it home.<\/p>\n So, I view Year Two being a big year of execution.<\/p>\n Paul Goldberg: You know what I actually forgot to ask, now that I think about it? I forgot to ask about microbiome.<\/p>\n Anthony Letai: We have, for several years, funded microbiome research. I think we did an estimate that we may spend something up to $100 million a year studying the influence of the microbiome on cancer, and maybe it\u2019s a reciprocal influence on cancer on the microbiome.<\/p>\n How the microbiome might influence initiation of cancer, and how it might influence response to therapy. So, it continues to be an important topic of study at the NCI.<\/p>\n This is something you might be interested in.. It\u2019s the beginning of January, we\u2019re going to host a workshop on the microbiome in cancer here at the NCI. It\u2019s available online. So, if you want to do us a favor, Paul, you could put down the exact dates in this article.<\/p>\n Paul Goldberg: We will. Absolutely. I\u2019m glad I asked, which actually brings me to the final question, which is, is there anything besides microbiome that I forgot to ask?<\/p>\n Anthony Letai: You\u2019ve been pretty thorough. I think most of the topics that I wanted to talk about overlap pretty well with the ones you seem to want to talk about.<\/p>\n Paul Goldberg: Well, that\u2019s great. I\u2019ve been awake all year! It\u2019s good. Congratulations on your first year. Let\u2019s hope there\u2019s not going to be another shutdown.<\/p>\n Anthony Letai: Well, it\u2019s looking good through December; right?<\/p>\n Paul Goldberg: Right. Anyway, congratulations again. Thank you so much.<\/p>\n Anthony Letai: All right. Thank you, Paul. It\u2019s my pleasure.<\/p>\n Jacquelyn Cobb: Thank you for joining us on The Cancer Letter Podcast, where we explore the stories shaping the future of oncology. For more in-depth reporting and analysis, visit us at cancerletter.com. With over 200 site license subscriptions, you may already have access through your workplace. If you found this episode valuable, don\u2019t forget to subscribe, rate, and share. Together, we\u2019ll keep the conversation going.<\/p>\n Paul Goldberg: Until next time, stay informed, stay engaged, and thank you for listening.<\/p>\n","protected":false},"excerpt":{"rendered":"\u201cI don\u2019t know of a single grant that left my desk that was not approved and funded,\u201d NCI…\n","protected":false},"author":2,"featured_media":924546,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[10],"tags":[49,48,84],"class_list":["post-924545","post","type-post","status-publish","format-standard","has-post-thumbnail","category-health","tag-ca","tag-canada","tag-health"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts\/924545","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/comments?post=924545"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts\/924545\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/media\/924546"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/media?parent=924545"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/categories?post=924545"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/tags?post=924545"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}