The Directors: Tom Lynch and Skip Burris on how NIH funding cuts imperil biopharma innovation—and cost patient lives

Thomas J. Lynch Jr. and Howard A. “Skip” Burris III lead two institutions that couldn’t be more different—an NCI-designated Comprehensive Cancer Center on one side of the country and a for-profit research enterprise on the other—but they stay up at nights worrying about the same thing:

“Changing the paradigm of how research is funded and how care is funded, I think makes us all a bit nervous,” said Lynch, president and director of Fred Hutch Cancer Center, an NCI-designated Comprehensive Cancer Center in Seattle.

“To stop that flow of ideas from universities and from hospitals to pharmaceutical companies, it is going to basically hand the future of biopharma to countries outside of the United States,” he said.

Burris, president of Sarah Cannon Research Institute, a for-profit community oncology research enterprise in Nashville, agrees. 

“We’ve got a lot of work to do. But so many patients, so many new therapies, so many drugs. In that sense, the opportunities have never been greater,” Burris said. 

“But on the other hand, we’ve got all the, as Tom uses the word, ‘uncertainty’—all this unrest, wondering how we’re going to be able to pay for this, how we’re going to be able to reimburse for various activities,” Burris said. “And really trying to have my team not get distracted and try to reassure them that financially we’re going to be okay, we’ve got to be diligent, we’ve got to think about how we handle those, but to really stay focused on the patients, the trials and the new drugs that are coming forward. 

“And that’s been a bit of a challenge and more so of a challenge of late.”

Lynch and Burris appeared together on The Directors, a monthly series which focuses on the problems that keep directors of cancer centers up at night. 

This episode is available exclusively on The Cancer Letter Podcast—on Spotify, Apple Podcasts, and YouTube.

Julie Gralow, chief medical officer of the American Society of Clinical Oncology, said uncertainty is what keeps her up at night, too. 

“The uncertainty about all of the realignment, the funding cuts that have been proposed in majorly drastic ways,” Gralow said, appearing on The Cancer Letter Podcast as a discussant on this episode. 

“It’s the uncertainty in many ways. And then the changes. Something is said one day and then the next day it’s taken back,” she said. “We’re just all holding our breath waiting to see what else happens.”

The only way to react to uncertainty is to plan, Lynch said. 

“If you’re not planning and you’re not thinking about how you’re going to respond to this, you’ll be caught unprepared,” he said. “One of the things I try to counsel my team on is to react to the knowns, not react to just the fears.”

Gralow agrees.

“I really, really liked the line that Tom said, ‘React to the knowns, not the fear.’ Because we don’t know how things are going to play out, level out in the end right now,” she said. 

There’s too much up in the air. 

“We don’t have an NCI director right now. We have a proposed budget; we don’t have a final budget. The 15% indirects that have been ruled to be illegal, Congress negotiates indirects rates, but we don’t know where that’s going to level out,” Gralow said. “So what’s keeping me up is all the uncertainties and not being able to react because I don’t have actual knowns that I trust will still be there tomorrow.”

The American Society of Clinical Oncology sponsored this episode. ASCO plays no part in the editorial direction of this podcast. 

Some highlights:

“It’s not that our system is perfect”

Lynch, Burris, and Gralow readily acknowledge there’s room for improvement in health care.

“It’s not that our current system is perfect and it’s not that our current system doesn’t need to be shaken up and changed,” Lynch said. “And I think there’s a tremendous number of inefficiencies in the way we do research and in the way we care for patients.” 

But how much disruption is too much? 

“I think that we all know that there has to be change,” Lynch said. “And the question is how do we get there? And how do we get there without disrupting and destroying the elements of what we have now that are so good?”

Sarah Cannon has been a “disruptor,” Lynch said. “And I say that in great admiration in a very positive way, because what they’ve been able to accomplish in terms of research excellence and clinical research excellence is envied by every cancer center in the country.”

Eliminating inefficiency is necessary, but it’s a process that should be led by experts in the field, Gralow said.

“We need experts. We know that there are inefficiencies in all that we do. That could be better, but we should have, I think, input from the experts that know the system instead of just coming in and making assumptions that it’s okay to cut indirects that pay for facilities, that pay for the administration required,” she said.

“We do need to think about innovation and shake it up and eliminate inefficiencies, but we need it to come from at least in large part, people who are doing the work, who know the system and know what can be cut.”

On research funding

While Sarah Cannon (unlike NCI-designated cancer centers) does not rely on NIH funding, fear over both NIH funding and tariffs has had an impact on clinical trials, Burris said:

NIH funding has a trickle-down effect, Lynch said, recalling Burris’ recent lecture at Fred Hutch.

“Skip must have covered about 250 drugs, looking at just what contribution Sarah Cannon has been able to make,” Lynch said. “As I sat there and thought about it, all of those agents started with fundamental scientific discoveries in basic laboratories throughout the country. And they were funded by NIH research, which led to biotechs being able to innovate, which led to pharma being able to create products, which led to places like Sarah Cannon and the Hutch and other centers around the country being able to do trials, to show that these drugs worked, and led to changes in how people do from cancer.”

Investing in this work is essential, Lynch said. 

“Clinical research has got to be something which is a central core mission,” he said. “You have to invest in it, you’ve got to staff it, you’ve got to have the expertise, and you can’t do it as a part-time unfunded mandate. And you’ve got to develop a core expertise in it.”

U.S. research funding cuts will have international reverberations, Lynch said.

“To stop that flow of ideas from universities and from hospitals to pharmaceutical companies, it is going to basically hand the future of biopharma to countries outside of the United States,” Lynch said.

Yet, for those afraid of funding cuts, Lynch advises caution: 

On clinical trials, drug development, and tariffs

“Fundamentally we’re oncologists, and oncologists are the ultimate optimists in terms of thinking that the cup is half full,” Lynch said. “Skip would never have become a phase I doctor if he didn’t believe that those drugs were going to work. I know that technically the objective of every phase I study is safety, but there is not a phase I study Skip has done in his career that he hasn’t hoped that somebody responded to the drug, and that’s the reason he talked to the patient about it. So we’re optimists at heart.”

Optimism underpins drug development, too, Burris said.

“Being an optimist, the success rate of drugs is up 50%, it’s up from 8% to 12%, but you still only have 12% of drugs starting phase one trials getting FDA approved,” Burris said. “So we all remember the winners, forget the losers. But those are the challenges. And I think when pharma biotechs think about planning for drugs, and manufacturing for drugs, and getting ready—having to do that all within the U.S. or to build new factories to handle that, that could be a real stress on the system.”

Tariffs will likely have a significant impact on biopharma and generic drugs, Burris said. 

“It’s likely more expensive to make those drugs in the U.S. than elsewhere,” he said. “So I don’t know that that helps us in the long run, but that is what they’re having to do to go down that path. And so, it’s going to put pressure on smaller biotechs in that regard to be able to hang in there.”

The power vacuum complicates matters, Gralow said.

“We’re not even sure who to negotiate with and what is going to impact the price of these drugs, the availability and accessibility of these drugs,” she said. “What incentives will there be to bring some of this manufacturing, especially of the generics and the biosimilars back in the U.S.? We don’t know.”

“There’s not been enough done,” Burris said. “We’ve been talking about this for years, and I know a number of folks are very interested in it, but I don’t think we’ve made the improvement in generics we need to.”

Drug pricing is not the only concern, Lynch said.

“I don’t think that hospitals or research organizations are immune from the impacts of the general business climate. And I think that’s probably how I’m most worried about tariffs and seeing how that plays out,” Lynch said. 

On optimism and resilience

“I think one of the advantages that we have as a profession is that it’s a profession that is built upon a certain amount of resilience,” Lynch said. “And that resilience comes from the patients we see and interact with. And we watch how patients can overcome challenges that we could never imagine facing. And I think that’s allowed us as medical leaders, and as physicians, and as nurses, to be able to develop the same kind of resilience.”

We will keep enduring, we will keep succeeding, we will find ways to survive.”

Burris agrees.

“I think the resilience and the optimism will win out for cancer, maybe more so than in other disease settings,” he said.

Listen to the full episode on Spotify, Apple Podcasts, or YouTube.

A transcript of the podcast is available below:

Jacquelyn Cobb: Welcome back to the Directors, a special segment of The Cancer Letter podcast, sponsored by ASCO, the American Society of Clinical Oncology.

This time, Thomas J. Lynch Jr., President and director of Fred Hutchinson Cancer Center, and and Howard A. “Skip” Burris III, President of the Sarah Cannon Research Institute, discuss how the recent NIH funding cuts imperil biopharma innovation—and cost patient lives.

Lynch is also the Raisbeck Endowed Chair for the President and Director at Fred hutch.

This episode, Julie R. Gralow, chief medical officer and executive vice president of ASCO, appeared on the podcast as this week’s discussant.

Let’s get started

Paul Goldberg: Well, gentlemen, thank you so much for finding the time to talk with me on The Directors. This is our fourth episode. And what we decided to do is to talk more about how community and for-profit enterprises are doing in addition to the cancer centers, because really when you think about it, over the past 25 years or so, one of the biggest stories was the interaction of community and academia in all spheres. And here we are talking about this today at this time of great uncertainty. And my first question is always the same, which is what’s keeping you up at night?

We’ll start with you, Tom.

Tom Lynch: Paul, there’s so much that’s keeping us up at night right now. When you think about cancer centers through the country, we really share the mission of doing remarkable science, taking incredible care of our patients, and serving our communities. And I think pretty much every cancer center, whether it’s community-based, whether it’s freestanding, whether it’s university-based, is facing the same concern, the same uncertainty about how we fund our missions. How do we find the funding to be able to take care of patients in a way that allows us to also proceed with great cutting-edge clinical research? How do we fund basic science discoveries?

And the funding from NIH has been so critical to building the American biotech and biopharma infrastructure. And that is coming under attack right now. And I guess not to say attack, it’s really just the uncertainty of not knowing what we’re dealing with. And the kind of changes that changing the paradigm of how research is funded and how care is funded, I think makes us all a bit nervous.

Skip Burris: I would echo those sentiments. There’s so much opportunity. We’re at a place where obviously the incidence of cancer continues to go up modestly, but the number of survivors is up by a substantial amount. But yet at the same time, while we’re talking here today, every 50 seconds somebody’s passing away from cancer, still 600 deaths a year. So we’ve got a lot of work to do. But so many patients, so many new therapies, so many drugs, in that sense, the opportunities have never been greater.

But on the other hand, we’ve got all the, as Tom uses the word, ‘uncertainty,’ all this unrest, wondering how we’re going to be able to pay for this, how we’re going to be able to reimburse for various activities, and really trying to have my team not get distracted and try to reassure them that financially we’re going to be okay, we’ve got to be diligent, we’ve got to think about how we handle those, but to really stay focused on the patients, the trials and the new drugs that are coming forward. And that’s been a bit of a challenge and more so of a challenge of late.

Tom Lynch: And Paul, I think one of the key things hearing Skip makes me think about: it’s not that our current system is perfect and it’s not that our current system doesn’t need to be shaken up and changed. And I think there’s a tremendous number of inefficiencies in the way we do research and in the way we care for patients. And I think that Skip’s organization has been a terrific disruptor. And I say that in great admiration in a very positive way, because what they’ve been able to accomplish in terms of research excellence and clinical research excellence is envied by every cancer center in the country.

And if Skip and Deanna and Tony had not thought of this years ago to think of a different way of how research can be organized, we wouldn’t really be in the place we are today. And so I think that we all know that there has to be change, and the question is how do we get there? And how do we get there without disrupting and destroying the elements of what we have now that are so good?

Paul Goldberg: What have you actually lost in terms of money, grants, contracts, deals with pharma—what’s lost?

Tom Lynch: For us, and Skip can obviously comment on what it’s like for Sarah Cannon, and for us it’s two things. One is what’s going to happen to our indirect rate which supports our basic science? And there are proposals to fix the indirect rate at 15%, that’s a current proposal from the White House. Now of course that will be negotiated and congress will have its impact, but that’s a significant funding hit to any center that does a lot of basic science. Second is grants that we have that focus on disparities are also in particularly the diversity, equity, and inclusion- related grants. Anything related to that has been stopped.

So we’ve seen cutbacks in grants—delays in grants, Paul, are sometimes just as difficult as denials and stopping of grants. Not knowing when your funding’s going to come through has been challenging for us.

Paul Goldberg: Do you have numbers or no not yet?

Tom Lynch: We have specific numbers on specific grants that we still remain hopeful that some of the grants that are currently being delayed will come through. Now for example, our Cancer Center Support grant was just renewed this year, and it looks like it’s actually flowing, which is terrific and we’re getting funding for that. So had we talked a week ago, I would’ve told you I was worried about that. I’m less worried today because we’re actually seeing that it’s coming through, so it’s a little difficult to put an actual number on what that would look like. Now if the administration’s proposal to reduce the NIH budget by 40% comes through, that will be an extremely challenging problem for everybody in biomedical research.

Paul Goldberg: Skip, how’s that looking on your side?

Skip Burris: So a little more indirect, not indirect costs as Tom refers to, but while we do some cooperative group work and some investigator-sponsored research, the vast majority of our relationships are conducting pharmaceutical and biotech trials. And all the pressures that then relate through to pharma biotech with their ability to fund these studies, uncertain about the future pricing of drugs, tariffs, patents, a lot of discussion still around the Inflation Reduction Act or the IRA. For the first time ever we’ve had and not yet out of a biotech crash, more and more biotechs than ever struggling to make ends meet, investors uncertain about how healthcare will be funded, and what the opportunities will be for new therapies, debates about orals versus IV. And we see that relate down into our clinical trial portfolio, having to be more conscious of where companies are with regard to their funding. And then they’re looking to make quicker decisions, and maybe not willing to gamble so much on later stage trials unless they’re really sure they have a winner. So that all plays together.

Longer term advocating, much like everybody else for academic medical centers in the NIH, because I know through my career these ideas, the identification of a target, an enzyme, a pathway has all come out of basic science. And the majority of that basic science has been at an academic center or the NIH. That obviously leads to pharma being able to actually pull together a drug, and actually do the chemistry and the engineering to deliver the therapy. But we can’t forget that these ideas that pharma biotech is putting into molecules that become commercially available, they came out of our basic scientists at these universities and at the NIH.

Tom Lynch: And Paul, I think just we were very fortunate about two weeks ago, Skip gave named lecture at The Hutch, and came up and talked about the state of drug development from the perspective of Sarah Cannon. And the breadth of agents that Skip talked about, both targeted drugs, immune modifiers, a great number of agents, Skip must have covered about 250 drugs, not in great, but looking at just what contribution Sarah Cannon has been able to make. As I sat there and thought about it, all of those agents started with fundamental scientific discoveries in basic laboratories throughout the country. And they were funded by NIH research, which led to biotechs being able to innovate, which led to pharma being able to create products, which led to places like Sarah Cannon and The Hutch and other centers around the country being able to do trials, to show that these drugs worked, and led to changes in how people do from cancer.

And if we change that paradigm or that ecosystem, I know the administration’s quite concerned, for example, about our international competitiveness. One of the areas we’ve been so successful in this country has been in biopharma. And to stop that flow of ideas from universities and from hospitals to pharmaceutical companies, it is going to basically hand the future of biopharma to countries outside of the United States. And the country best poised to take advantage of that is China. And so if we want to continue to be competitive globally, we’ve got to continue to invest in basic science.

Skip Burris: Well said.

Paul Goldberg: Yeah. I’m remembering something just going back to history. When Tom was at Yale, the two of you tried to put together a collaboration which actually was visionary and probably a little bit ahead of its time. Can we talk about that since we’re all historians here? Or at least old?

Skip Burris: Yeah, of course. It was a great idea, maybe a little bit ahead of its time. Tom was the right partner or fabulous leader, recruited in great talent at Yale. Certainly some things, and I’ll let Tom address the Yale side, but certain things that are part of a university’s bureaucracy are part of the things that we just don’t have at a Sarah Cannon. I think when people talk about our secret sauce, a lot of it is really around speed. I use the analogy of “Why did we need FedEx when we had the Post Office?” Well, because people want things faster, they want it immediately. They want it delivered straight to them.

And so much of our effort has been both in getting drugs closer to patients, getting their local doctor to be able to participate in research, and then have our sites start at the same time, one contract to be handled at one time. All those sorts of pieces that can make a clinical trial process go faster. We don’t have the concerns of the Sarah Cannon around intellectual property and indemnification and the like, that one might have at a university. There aren’t the things to protect from that side. So I think that was one of the barriers. And actually our CEO and Yale’s lawyers actually did some postmortems on the fact that it didn’t become a successful relationship long-term.

Tom Lynch: On the other hand, I think I probably learned more about how to do clinical research from those few months we spent together talking about it, or a few years we spent together talking about it. And what I learned from learning more about Sarah Cannon, which I really have tried to do at the academic sites I’ve been at, is that clinical research is not something you do at 10:30 at night, or you do at five in the afternoon on a lazy Tuesday in February. Clinical research has got to be something which is a central core mission. You have to invest in it, you’ve got to staff it, you’ve got to have the expertise, and you can’t do it as a part-time unfunded mandate. And you’ve got to develop a core expertise in it.

It’s incredibly expensive. It’s high risk because you don’t know whether the trials are going to be successful. But what makes Sarah Cannon, what I think the special sauce of Sarah Cannon is they’ve decided to become a professional clinical research shop that puts in the resources to be able to make it work. And I think you’re seeing a lot of us are learning from Sarah Cannon that we’ve got to create structures like this.

For example, when people would come to academic centers from pharma to do monitoring of trials, they would be in a corner, in a chair, not even a cubicle, and we would fight over whether they could have internet access because they couldn’t get access to the internet because they weren’t certified to do so. You go to Sarah Cannon, there’s whole rooms and Skip, there’s probably buildings now. Last time I was there, there are whole rooms for monitors. Monitors walk in, they get a terminal, they get everything they need. And that kind of teaching I think has led us to get a lot better, because I think we’re all trying to incorporate many of the principles that Sarah Cannon has brought to clinical research.

Skip Burris: Well, thank you.

Paul Goldberg: Yeah, this was a time when there was this metric used about how much longer it takes industry trials to get started at cancer centers versus community at the academic cancer centers worth versus community. I don’t know, where is that model going of community versus academia? I’ve been seeing it merge and what impact does it have on this uncertainty or what impact does this uncertainty have on this merger—if it does?

Skip Burris: Well, I do think it’s something we’re seeing academic centers taking some strides forward. I know after Tom’s leadership there and the clinical programs that got built, they’re certainly doing things to be operationally more efficient and shorten their timelines. We certainly are doing the same things. We’re trying to measure start times in the six to eight week timeframe. I think one thing that is also important in that regard is to merge and blend the best of both sides in terms of steering committees and trial leadership. It’s great to have KOLs from academic centers together with KOLs from our Sarah Cannon sites participating.

And there’s a lot of young faculty that come out that are interested in the clinical research position, maybe where they grew up, maybe where their spouse grew up. So it’s been nice to recruit some of those folks to locations. Keep them involved in research, maybe limit their clinical productivity and keep them out of that system. But then that builds the relationships with the universities. We’ve got great relationships that persist from the physicians we’ve recruited from places in Boston, New York, Houston, and the like.

Paul Goldberg: Well, speaking of young faculty, how do you keep them from being demoralized and just saying, “Enough”?

Tom Lynch: So Paul, that’s a big part of what I work on now, which is we’re leading through times of uncertainty. And I think you’ve got, the way I tend to look at it, it’s two things. One is fundamentally we’re oncologists, and oncologists are the ultimate optimists in terms of thinking that the cup is half full. Skip would never have become a phase one doctor if he didn’t believe that those drugs were going to work. I know that technically the objective of every phase one study is safety, but there is not a phase one study Skip has done in his career that he hasn’t hoped that somebody responded to the drug, and that’s the reason he talked to the patient about it. So we’re optimists at heart. So I think that’s one thing.

I think you’ve got to make young faculty feel that you are aware and cognizant of what the risks are and what the challenges are. And that you’re not just a cheerleader, but you’re somebody who is really carefully looking at the upcoming headwinds, and planning for potential changes. Now the key thing is not to overreact before we have to react, meaning people are talking, the administration led with a 40% reduction in the NIH budget, which would be catastrophic for biomedical science. Yet in 2016, the administration led with a 20% decrease in the NIH budget and the budget was actually increased by 3% or 4%. So the point being is that we don’t yet know exactly what we’re going to be working on. And so being able to be careful, be prepared, being prepared for the worst, but planning for things in a number of different eventualities.

I think the other thing is we’ve got to also rethink the way we practice medicine within academic medicine. We’ve got to rethink how do we diversify our revenue streams and look at other ways of bringing in commercialization revenue, philanthropy, all the other things that can help support our research enterprise? Because particularly from the basic science standpoint, and The Hutch has a prominent basic science position, that kind of research is always research that you need to find additional funding streams to support. You’re never going to support that just on NIH money.

Skip Burris: I’ll just add I think with the younger physicians coming in, having them pushed forward, featured prominently as early as I can with our team here, try to get them on stage, presenting, publishing, and keep them involved with KOLs from academic centers, all that to make them feel an important part of the academic development of clinical research while doing it in a community setting. Some of our community settings are in smaller towns, but the majority of the Sarah Cannon accruals coming from big cities like Nashville and Denver and Austin and such. And so great to have those physicians feel like they’re still part of the higher academic achievements that are ongoing. We’re going to have to have this sort of reach into the community in order to achieve our accrual targets. We can’t rely on patients traveling, all the things we’ve done to try to build the Sarah Cannon infrastructure.

Paul Goldberg: But how do you tell them to not be despondent? Or maybe how do you keep them from saying, “The heck with it,” then I’m just going to work for a community practice that’s just going to pay me for what I’m going to do, and forget this research nonsense?

Skip Burris: I think keeping them excited about, we’re transparent, we share the problems and the finances and the stories, but really keeping them the new therapies, the trial opportunities, as I was saying, they’re nothing like we’ve ever seen before. The science is moving so quickly, so keeping them feeling energized and keeping them with people that care about it, and keeping that excitement up, I think is one of the main things that I can do and that our leadership can do.

Tom Lynch: And I think Paul, to some degree, we select for physicians who want to participate in new things in medicine. One of the reasons people go into cancer medicine is because they want to see things get better. And so I think we do have the advantage of having a group of physicians who really care a lot about that.

I think the other thing, Paul, that this discussion makes me think about is how do we lead and manage and develop careers of the current young people, the Gen Zs, that are coming into practice now? And how do we make those, and the younger millennials, how do we accommodate some of the changes for a generation that’s been brought up very differently than many of the other generations and physicians? The impact of social media, the impact of prioritizing work-life balance, which many of the younger physicians are asking for more than their predecessors might have. These are challenges whether we’re talking about clinical productivity or research productivity.

Paul Goldberg: Are you thinking of austerity measures of some sort right now? Is that on the table or is that going to wait till we see what the president’s budget proposal and what Congress is doing?

Tom Lynch: I’d be curious how Skip approaches this from the Sarah Cannon perspective, but I would say that we plan. We plan for a number of different scenarios. We’re planning for how we handle a 40% reduction in the NIH budget. We’re also planning for how we handle a 2% increase in the NIH budget. If you’re not planning and you’re not thinking about how you’re going to respond to this, you’ll be caught unprepared. And so I think it’s prudent just like in any ongoing enterprise to be thinking ahead and planning. So we are planning for all the different scenarios that could occur.

Skip Burris: I think for us a little different with regard to not having the dependence on NIH dollars, but with the pressure on pharma biotech and the uncertainties on reimbursement, one of the places over the last few years that we’ve been investing is technologies to rely less on people doing things like data entry and some of the paperwork pushing. So we have launched our E2E initiative, EHR to EDC. So the ability to, which seems so simple, but to take the data straight from the health record to the case report form, those sorts of things improve everybody’s quality of life. But a number of systems investments we’ve made in order to try to not have to worry about replacing all of these with individuals, having folks practice at the level of their license. If we can leverage up one physician to do what we need them to do at that level and then have the appropriate support staff behind them, maybe folks with less of a degree and less salary demands, that’s a real win for us.

So we do, as Tom said, have a plan for how we can budget those dollars and try to move forward. Clinical research is very much a volume business. If you’re going to put the appropriate infrastructure in place, the only way to overcome that financial hurdle is to accrue. And so one of our other investments has been really along the lines of our personalized medicine team, teeing up for the physician with the data that’s available, including the genomic data, making sure they know when they come into clinic, what patients might be eligible for trials, and tee it up a little bit for them so that we can enhance accrual. So far that’s been very successful.

Paul Goldberg: I’m hearing about tariffs having an impact. So are you feeling that? Or also you would think that the price of drugs should be going up quite a bit? Is that happening or is that a few weeks away?

Skip Burris: Well, as Tom alluded to with the planning, we’re already hearing that from Pharma Biotech. They’re attempting to do what they can to manufacture in the U.S.. You saw some announcements recently about Big Pharma making some additional investments in that direction. It’s likely more expensive to make those drugs in the U.S. than elsewhere. So I don’t know that that helps us in the long run, but that is what they’re having to do to go down that path.

And so it’s going to put pressure on smaller biotechs in that regard to be able to hang in there. I think that revolves back to some of the investment dollars I talked about earlier. And the success of a drug, as Tom mentioned, I enjoyed giving the lecture, it was an opportunity to look back. Being an optimist, the success rate of drugs is up 50%, it’s up from 8% to 12%, but you still only have 12% of drugs starting phase one trials getting FDA approved. So we all remember the winners, forget the losers. But those are the challenges. And I think when Pharma biotechs think about planning for drugs and manufacturing for drugs and getting ready, having to do that all within the U.S. or to build new factories to handle that, that could be a real stress on the system.

Tom Lynch: And Paul, I would argue that one of the concerns that we have about tariffs, yes, tariffs can increase the cost of doing business in a number of different elements of what we do, but there’s also the macroeconomic impact. So if our investment income is not able to support a research effort, if inflation and unemployment continue to be stubborn, inflation is stubborn, but if unemployment bumps up and makes the labor market more difficult, those are all areas that we would be concerned about in terms of affecting our general business climate. And I don’t think that hospitals or research organizations are immune from the impacts of the general business climate. And I think that’s probably how I’m most worried about tariffs and seeing how that plays out.

And again, it’s early and I think one of the things I try to counsel my team on is to react to the knowns, not react to just the fears. And tariffs could play out a lot of different ways. And let’s hope that as Scott Bessent, the Treasury Secretary mentioned, he’s hopeful that this is going to find a way to actually improve the economy long term. Whether it does or not, I don’t know. I’m not an economist, but I do worry about the macroeconomic effects of what we’re seeing right now.

Paul Goldberg: I’m actually going to needlepoint that line: “React to the knowns.”

Tom Lynch: Yeah.

Skip Burris: Yep. Well said.

Paul Goldberg: Yeah. Well, maybe I won’t. I’ll have to learn to needlepoint, but it’s worth it. It’s certainly worth it. But I guess the other bit that scares me is generics, because here’s one of the most idiotic problems in oncology is a shortage of generic drugs, and you can’t practice without them. So is that starting to happen because of the tariffs? Are you starting, are you seeing shortages? How are you planning? What are you doing with that? It affects both of you.

Skip Burris: Oh, it affects all of us. And I think that planning has started and discussions over the years, but no, we’re not there yet and shortages are anticipated, and that’s a shame. I think this goes to any other low-cost item that might be a commodity, if that’s what it is. When a drug becomes generic. Where maybe the United States is not going to be the cheapest alternative to manufacture such a product, we’ve got to figure out some way while we’re worried about the ever-increasing cost of branded drugs, we’ve got to figure out some way to support the generic system. The prices just got driven too low. It didn’t make sense for these individuals or these companies to manufacture.

So we got to think about some price support system there at some level that we’re willing to pay. But there’s not been enough done. We’ve been talking about this for years, and I know a number of folks are very interested in it, but I don’t think we’ve made the improvement in generics we need to. And generics are an important part. I worry about the regulation and the manufacturing and all aspects of the generics. And the biosimilars are coming fast and furious.

Tom Lynch: And along similar lines, I think we had problems with drug shortages of key cancer drugs even before tariffs. And so this has been something we’ve been dealing with. If you go back to when Skip was president of ASCO, it’s been an issue that ASCO has been advocating for. And I think also, Paul, it brings up the bigger point that the U.S. needs to have a critical manufacturing ability for critical elements, whether they’re defense elements or whether they’re pharmaceuticals. And we do need to have ways of manufacturing 5FU in the U.S.

The problem is right now it’s just economically, why would someone do that? You’ve got to create a mechanism whereby you can be competitive and be able to do it and see a business case for doing it in the U.S. But I would very much love to see the on-shoring of some of our pharmaceutical capabilities to secure the supply of these drugs. Because again, even before the current, this has been going back five to 10 years where cancer drugs have been in short supply because of some of the difficulties with the generic markets.

Skip Burris: I’ll just add too, I think, Paul, as I looked at, again, looked at the IRA list of the most expensive drugs, and I looked through some of the numbers there, a couple things came to my mind. One, quickly, is those are not the most expensive drugs. That list is the drugs we utilize the most. So the total spend on those drugs is what was the highest, but at the top of the list, some of those drugs were diabetes drugs and anti-stroke drugs and heart failure drugs that maybe that’s a place where we should be spending some money. So I don’t know that that list was created correctly.

Secondly, not on that list are antibiotics. And as Tom was alluding to with 5FU, my pharmaceutical friends talk about how do you motivate pharma to develop a drug that’s going to be fairly inexpensive that somebody takes for a week? Which is all you’re going to take the typical antibiotic, so we’ve really got to think about, as Tom alluded to, we’ve got to be able to manufacture a reasonable cost internally, and then we’ve got to be willing to pay to have that freedom, and that security around having that drug supply.

Paul Goldberg: So the solution is to put more money into the system, not pull money out of the system in some?

Skip Burris: Correct.

Tom Lynch: In some way.

Skip Burris: Yeah, it’s always cheaper if the end result’s a quick passing away, but improving life, living longer, we’ve got 10,000 people a day for a while longer still becoming Medicare aides. Those should all be good things. We just got to figure out how to pay for it.

Paul Goldberg: Yeah, how long do you think the system can last under this kind of pressure? How long can you, well, you’re now in the wait-and-see attitude. When do you go to the next level? Is there a trigger that you can see? At what point do you say, “Oh, shit”?

Tom Lynch: Paul, what you’re asking is almost a societal question as much as it’s a medical question right now. I think that we go through periods in our lives where society at large is there’s a certain amount of unrest in terms of where we are. I think one of the advantages that we have as a profession is that it’s a profession that is built upon a certain amount of resilience. And that resilience comes from the patients we see and interact with. And we watch how patients can overcome challenges that we could never imagine facing. And I think that’s allowed us as medical leaders and as physicians and as nurses, to be able to develop the same kind of resilience. So I don’t worry about that as much professionally as I do personally.

I think we need to, the problems that you’re alluding to, I think we need to have a country where we can disagree and not hate each other because of it. We need to have a country where people can politically be an issue and have different options and not have the vitriol that we have on both the right and the left at this point. And I think a lot of that is what’s leading people to be discouraged about where we are in the country.

Paul Goldberg: But institutionally, you feel like you can stick around for another couple of years?

Tom Lynch: Institutionally, we will keep going. We will keep enduring, we will keep succeeding, we will find ways to survive. It won’t necessarily be the same as it is right now, but when we keep our missions clearly in mind and central to our work, we will find a way to keep going.

Paul Goldberg: What about community outreach and engagement? Is that pretty safe? It’s still in the CCSG.

Tom Lynch: Yes, community outreach engagement is something that’s very much as I mentioned. It’s one of the three important missions of what we do is engaging with our community. That is still in the CCSG. The NIH is still asking us to make this a priority. And we’ve made this a priority here at The Fred Hutch. As have all 72 comprehensive cancer centers, and our community partners also are doing this as well.

Paul Goldberg: Skip, how does that look for you?

Skip Burris: Yes, I think there’s concerns. I think we want to be able to support and treat all the patients that require care. And as Tom said, we will figure out a way. I think that we’ve been through the roller coaster before, but the thing that still, it’s a shame the vast majority of patients don’t go into a clinical trial. So from our core business of Sarah Cannon, there’s still tremendous upside to go with that part of the business, which will always alleviate some of the financial issues. But also I think the folks choosing to go into oncology now, I’m optimistic about the future by just continuing to see some of the best and brightest wanting to go into the specialty. And coming into it and the challenges are there, but exciting for them to take on. But so I think the resilience and the optimism will win out for cancer, maybe more so than other disease settings.

Paul Goldberg: Is there anything we forgot to discuss? Anything you would like to bring up?

Tom Lynch: We’re just heading in, this podcast is being recorded right before ASCO and AACR get going. And this year we have the unique opportunity that both meetings are in Chicago. They follow each other only by four weeks because of the quirk of scheduling. So there’ll be a lot of time for oncologists to come together. To come together with patient advocates, to come together with pharma, to come together with biotech. And I am hopeful that some of the progress that we’ve seen in cancer will be something that we can celebrate, focus on, and maybe take a breath from some of the other concerns that we have over the next month or so.

Skip Burris: I would agree. I think the early hints and some of the press releases and the peaks at titles and the program coming together, there’ll be a lot of positive stories coming out of both of those meetings. And I think that’ll energize the folks a great deal as well. So great time of the year to, as Tom said, the hallway conversations are important, folks getting to speak to each other. That’ll be a real uplifting experience as well.

Paul Goldberg: Well, thank you gentlemen, and also thanks to ASCO for sponsoring this podcast. And see you in Chicago.

Skip Burris: See you there.

Tom Lynch: Thank you.

Paul Goldberg: Dr. Gralow, thank you for finding the time to talk with us. The format of The Directors was to have two directors of academic nonprofit cancer centers talk, but this time we changed it around to get more of a sense of what’s going on in high-level quality, community clinical trials-oriented practices. And we’ve got a bit more of a perspective, but your perspective is even broader. As chief medical officer of ASCO, you see more than, arguably, anyone. So what do you see?

Julie Gralow: Well, thanks for having me, Paul. And it’s true, my job as the chief medical officer is to represent community and academic clinicians and actually wherever they are, intercity, rural, global, et cetera.

I thought the discussion was very interesting because I saw a lot more similarities than differences in terms of what the issues are, what’s keeping them up at night, and their approaches.

Paul Goldberg: What do you see every day? What keeps you up at nights?

Julie Gralow: I think the uncertainty about all of the realignment, the funding cuts that have been proposed in majorly drastic ways. It’s the uncertainty in many ways. And then the changes. Something said one day and then the next day it’s taken back.

I really, really liked the line that Tom said, “React to the knowns, not the fear.” Because we don’t know how things are going to play out, level out in the end right now. We don’t have an NCI director right now. We have a proposed budget, we don’t have a final budget.

The 15% indirects that’s been ruled to be illegal, Congress negotiates indirects rates, but we don’t know where that’s going to level out. So what’s keeping me up is all the uncertainties and not being able to react because I don’t have actual knowns that I trust will still be there tomorrow.

Paul Goldberg: What about something that is very clear, which is drug prices or price of medical care, are we going to see that or is this an unknown?

Julie Gralow: Well, I don’t think it’s very clear and I think it’s a big unknown. I mean, on the one hand we have these really inexpensive, sterile injectables mostly made outside of the U.S, that have been going in and out of shortage. And because they’re mostly made outside of the U.S., tariffs could impact them, we don’t know. Another unknown is, do the tariffs impact drugs like these or not? We’ve heard both sides of it. For the newer drugs that are still on patent, generally more expensive drugs, some of them are also made outside of the U.S., will they be even more expensive? We just don’t know.

And while there are inefficiencies and the cost of care across the board, the cost of healthcare, but the cost of cancer care is really unsustainable in this country. We do need to work on that, figure out how to get all of these treatments to everyone everywhere. It’s also up in the air. It’s big uncertainties. We’re not even sure who to negotiate with and what is going to impact the price of these drugs, the availability and accessibility of these drugs. What incentives will there be to bring some of this manufacturing, especially of the generics and the biosimilars back in the U.S.? We don’t know.

Paul Goldberg: What about, I guess communication? The most recent thing and peer review at NCI, we just did a piece about the BSA being ended and oh, and of course registries, cancer registries. That, speaking of uncertainty, if you don’t have registries, you don’t know what in the world you’re doing. How is that keeping up at night?

Julie Gralow: Well, eliminating the scientific advisory board for the NCI is a problem. How are we going to get that kind of input? We don’t have a director as of this recording of our NCI, so we don’t know where that will go. Is it just they wanted a new board and will that come in?

We need experts. We know that there are inefficiencies in all that we do. That could be better, but we should have, I think, input from the experts that know the system instead of just coming in and making assumptions that it’s okay to cut indirects that pay for facilities, that pay for the administration required.

Instead of calling them indirects, I think we should go back to calling them F&A—the buildings and the administration and the facilities that are required to do the research that you can’t put into a grant. It costs more than 15%, especially for the basic research where you need the lab structure, et cetera. So we need leadership, we need input from those doing the work.

We do need to think about innovation and shake it up and eliminate inefficiencies, but we need it to come from at least in large part, people who are doing the work, who know the system and know what can be cut.

Paul Goldberg: In this case, there’s also something I’m hearing and I have no idea what to make of it yet other than I know it’s true, which is that NCI has just ended its entire cancer information work. So essentially who is speaking for the cancer program? That’s in the National Cancer Act of 1971, that NCI has to have the same kind of communications as, say, NASA. So what happens with that? How do you even decide when to take a stand and when to not?

Julie Gralow: This has been the problem because taking a stand against something that will reverse tomorrow, it gets you out with a statement that’s no longer relevant, but might put you in the forefront and now you’ll be scrutinized more. So again, not reacting to the unknowns or the uncertainties as much as reacting to the knowns. We feel strongly at ASCO and we’ve participated in providing an affidavit for the lawsuit that actually resulted in a permanent injunction against the 15% indirect rate. We will speak out when there is some action that our voice could result in. This was a case, it was in front of a judge, therefore us putting our reaction to it was critical, because it absolutely resulted in an action which was a permanent injunction against the 15% indirects, but we can’t overreact either when something might be overturned tomorrow.

The cut, which was about 50 people in communications at the NCI, that was the first real big cut we saw at the NCI itself, I think. And we’re just all holding our breath waiting to see what else happens. We need a director of the NCI, so we need to know who to talk to, who to negotiate with, who to build relationships with. And we don’t have that right now.

I think one of the themes that came out of that great discussion between Skip and Tom was related to: how are we going to support and grow and nurture the next generation?

I already know colleagues who have gone into industry specifically because in the last two months they have a great fear of being able to get R01s and do their research and buy out their protected time. We wrote and just published a paper called Promoting Reasonable Career Expectations and Maximizing Professional Fulfillment for Academic Oncologists, academic medical center recommendations coming from ASCO that Eric Winer is the first author on. And it really spells out how we’re going to support the next generation of both clinicians and clinical researchers and basic science researchers.

We need to have reasonable clinical workloads so that other activities can be done such as research, and we need to have the resources to back doing clinical research so we can participate in and conduct research. I think that paper really highlights that we need to protect the next generation and we need to reassure them that in these uncertain times about where funding will come through, that they will be supported by the institution.

Paul Goldberg: You mentioned also that ASCO is doing something about it.

Julie Gralow: Well, that paper comes out and reports on what we think are reasonable expectations back to the institutions, and we’re going to be monitoring it and see what changes are made. I mean, Eric Winer during his presidency year brought this as a high priority because he had really just during his presidency year, taken on being cancer center director at Yale and he felt he could have influence at his own institution if he had backing from such recommendations. So he wants to be a leader partnering with other cancer center directors in how we’re going to achieve this and ASCO will help support as well.

One other thing that I liked that came out of that discussion is Skip’s comment that clinical research is a volume business that you need to accrue in order to make it economically feasible. You can’t have this whole infrastructure if you don’t have high accruals. And this is something that ASCO, our clinical research committee, we’re really focused on making it easy for clinicians wherever they are, in community practice or at academic centers to accrue, make it easy for patients to participate in studies. This gets to decentralized trials and pragmatic designs and eligibility criteria that better reflects the real world, using telemedicine, for example, for clinical trials. And we have a partnership with ESMO that they’re leading in streamlining clinical trials.

We’ll have a discussion at the annual meeting on data not needed, stop collecting what we’re not going to use and analyzing our primary and secondary endpoints, and also around all of these extra forms and things that have been thrown at us that are not really necessary. The delegation logs and the USR form 1572, that’s been really over interpreted as to who you need to include on these things. Let’s make it easy and cut out what’s not needed in clinical trials so that we can have it be a volume business. We can accrue, we can get more of our patients on clinical trials and we can get answers to clinical questions sooner.

Paul Goldberg: Thank you very much for finding the time.