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403: Biotech exec Jeremy Levin on the industry's strategic turning point

47m 22s

403: Biotech exec Jeremy Levin on the industry's strategic turning point

This episode of The Readout Loud covers key biotech news and features an interview with Jeremy Levin about his book "Biotech in the Balance." The hosts first discuss Verve Therapeutics' gene editing treatment, which reduced cholesterol by 62% in a Phase 1 trial. They caution against overhyping the early-stage data, noting that existing statins and PCSK9 shots achieve similar reductions, and highlight ongoing questions about safety, durability, and market access. They also report that Retro Biosciences, a longevity startup, became a unicorn with a $1.8 billion valuation after closing a financing round. Looking ahead to the ASCO conference, the hosts note that Revolution Medicines' pancreatic cancer drug and a PD1-VEGF inhibitor from a Chinese drugmaker are expected to be highlights, though questions remain about global data replication. In the interview, Jeremy Levin argues that biotech is at a turning point: while scientific discoveries are extraordinary, the system that turns them into medicines is fracturing due to capital pressures, regulatory instability, and public distrust. He defines "bold" as disciplined courage—choosing important science, being honest about data, and defending institutions like the FDA. Levin warns against the "politics of unreality," where facts are treated as positions, and expresses concern about the FDA's independence, citing leadership upheaval, political pressure, and arbitrary cuts that threaten predictability and innovation. He emphasizes that molecules don't respond to ideology, and patients are not helped by slogans.

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[Music] Welcome to this week's episode of The Readout Loud, a weekly biotech podcast from Satt. I'm Allison D'Angeles. I'm Adam Forrestine and Elaine Chan is going to join us later in the episode. It's May 28th and on this week's show, we're chatting with longtime biotech executive Jeremy Levin about his new book. It's called "Biotech in the Balance", saving a strategic industry in an age of distrust. That sounds alarmist, and it is in some respects. But as Levin will explain, the book is also a roadmap to a brighter future for the biotech industry. The first recap of the week's news and a word from our sponsor. I'm Mika Kakathuda-Durink, SPP of Oncology at Gilead Sciences. McGilead and Kai are working on college starts with a simple question. How do we make progress truly meaningful for patients? Since 2020, our therapy has been used to treat more than 75,000 people worldwide with metastatic, triple negative, and HR positive, HER2-negative breast cancer. We bring that same patient-first mindset to other areas of high-end met need, including CAR-T-SELTHAREPY for people with difficult to treat blood cancers. Today, over 34,000 patients around the world have been treated with CAR-T-SELTHAREPY's from our portfolio. Across oncology, this perspective guides how we design clinical trials and pursue innovations so patients can access potential advances throughout their treatment journey. Learn more at gilead.com Okay, Adam, the stat team is getting on planes, trains, onmobiles. We're right in the middle of conference season, but first let's talk about social media. If you were anywhere near biotech social media this weekend, chances are you saw the chatter about the gene editing treatment knocking out bad cholesterol. Let's set the stage as a treatment that was originally developed by Verve Therapeutics and on Monday, Eli Lilly reported that a high dose of this therapy called Verve 102 reduced cholesterol levels by 62%. And executives are touting it as a potential treatment to broadly prevent heart disease. Yeah, this was interesting because, as you mentioned, Alison, this kind of went viral, depending on what social media platform you spend a lot of time on. Obviously, I spend a lot of time on X. And it kind of went on beyond the biotech, kind of BioX is what we call it. It's sort of tapped into a lot of the longevity folks who post a lot, the peptide lovers. And I think it has this kind of interesting appeal, right? It's because of the way it's being touted as, "Oh, we can edit your genes and you will no longer have the risk of high cholesterol, heart disease, you'll live longer." This is something that anybody can get. It's a one-time shot and boom, everyone's going to live a lot longer because they'll never have cardiovascular disease, which obviously is one of the, if not the number one killer of people in the world. So it's a great story. It's also very complicated. And it's not as simple as it's been portrayed, I think, over the last week. Yeah, it's been interesting to see clinical data like this go kind of mainstream as you put it. I mean, this was a phase one trial. This was very early. This was a fairly limited number of patients, wasn't it? I'm blanking on exactly how many patients it was in the moment. But I mean, this is where we come in with all of the caveats of, this is very early data. This is a trial that is largely at this point, phase ones are usually looked at for safety. And you have some outline questions about this type of mechanism when we're talking about genetic editing, then you get into all of the trickle-down questions of market access and how do you actually get this to patients and who can actually get this treatment if it is successful in clinical testing. It's not a treatment that is specifically being developed for any, you know, Tom Dick or Harry that's out there in the universe. But what you're seeing on social media is very much just like an end to heart disease and as you're right, Adam, the kind of longevity folks, you know, really health conscious folks touting this is like a huge game changer. Yeah, it's being studied in a patient population, people who have a genetic form of a high cholesterol. And, you know, which makes sense. You try to treat people with a little bit more advanced disease. At the same time, I think what's interesting here is that, you know, you mentioned Allison, the 62% reduction in cholesterol levels that was shown in the study for Vervo2 is great. But it's also a cholesterol reduction that is already achieved by statins and other medicines already available to physicians to treat patients. We have lots of, we have pills, you know, combinations of pills that you would take every day achieve that same type, same level of reduction of cholesterol. You have PCSK9 shots that you can take. The most convenient one in Clisorin is given twice a year, so every six months you get a shot, you get sort of the same benefit. Now, you know, what Verve and Lilly have touted here. And again, we've covered the story for years now. I look back the first story that we ever wrote about Verve. This is interesting. 2019, when the company kind of came out of stealth mode. The story was written by the late great stat science reporter Sharon Begley, actually, wrote the first story about this way back in 2019. So it's been around for a while. And you know, one of the underlying premises of this is that for all the medicines that we have today to reduce cholesterol and improve cardiovascular outcomes, compliance with these medicines is very difficult. Like, lots of people just do not take, they don't take the pill on a daily basis. And so that's kind of one of the things that's being touted here is that, you know, this isn't what I'm done. So you would not have to worry about waking up every morning and remembering to take that stat. Yeah. It's great that you point out, Adam, that like stat has been interested in the Verve story for years. I mean, we've had them. We've been covering that when they first started dosing people, we've had them at our stat summits shout out to keep your eye on the calendar for the next stat summit in October. And like, this is clearly, this has been a startup, you know, Verve before it was acquired by Ely-ly-ly, was a startup of great potential that was doing something that very few companies were doing out there. And, you know, really was one of the most interesting startups out in the space. But the way that this drug is being talked about right now is I feel like it's at risk of getting overhyped where we're still at the very early stages of clinical testing and figuring out the market realities, the use case for a drug like this. And this is, I mean, this is the great debate in biotech of kind of building up excitement about something but not overhyping something. And I feel like Verve could be walking that fine line at the moment and Ely-ly-ly. Yeah. I don't want to sound like a total skeptic pessimist here because I think there is a lot of value to talking about gene editing as a technology or not just for cholesterol lowering, but for lots of different diseases. And stories like this bring gene, I think probably more than anything, bring gene editing into a more mainstream conversation, which I think is important because this is a technology that's getting smarter, better by the day. And while there's still lots of questions about gene editing, particularly around safety and durability, you know, it is the future, right? And I think we're going to see more and more efforts to use gene editing, you know, to either cure disease, prevent disease. And so, you know, the story, I think, as we mentioned at the top, this definitely sort of caught the attention, I think, of a kind of a much wider audience. Really quickly, jumping over to stories that have caught probably a similar audience, I wanted to give a little bit of an update on retro biosciences, which listeners heard from their CEO, Joe Betz-Liquat, and last week's episode, my interview with him shortly after our episode aired, they announced that they've done the first close of their new financing round value the company at $1.8 billion. So, retrobiosciences is officially a biotech unicorn. This company is the aging and longevity startup that's backed by open AI, CEO Sam Altman, and they are currently running their first clinical trial, testing a pill designed to enhance the body's ability to better clear up protein aggregates and patients with Alzheimer's disease. And we're expecting probably some initial data around the August timeframe. Joe had said. So you hectored him so much about financing and the fundraising when we were out in San Francisco at the stat summit. So they finally, they finally did something. They finally actually closed the deal. The results speak for themselves. It's all because of you. Well, okay, Adam, as I mentioned at the top, we are deep into conference season. You are shortly going to be flying out for the American Society of Clinical Oncology or ASCO conference, which kicks off on Friday. Several of our other colleagues will be on the ground in Chicago. What are you paying attention to this year? This is a big conference in the world of biotech. Yeah, this is the big cancer research meeting of the year. It's in Chicago. I fairly soon after finishing up this recording. I will be heading to the airport. Hopefully, there'll be no delays heading down Chicago. And yeah, you know, this is a pretty, it's a pretty newsy meeting, I think, for pre-cancer. You know, the headliner will be a revolution medicines and it's pancreatic cancer drug, directs and rassib, which we have talked a lot about. We've written a lot about since April when the company announced the, you know, pretty blockbuster phase three results in advanced pancreatic cancer in which the drug doubled, basically doubled survival in patients relatives of standard of care. This is what they call the rass, the pan-rass inhibitor. So it's an exciting new way of genetically targeting pancreatic cancer, which as most people know is, you know, a very, very difficult cancer to treat has sort of largely eluded previous efforts to find targeted drugs or immunotherapies that would be effective. We had a, we had a pancreatic cancer expert to talk about that on the podcast when that news came out back in April. So that's the, that's probably the headliner, I would say, for ASCO Sunday afternoon at their plenary session, which is kind of where the most impactful cancer studies are presented. They will be a headliner there. And then we'll be seeing some data on another class of medicine, these PD1 VEDGEF inhibitors. Ivan S. Mab is probably the one that's most closely talked about developed by a Chinese drug maker called the Kizzo and licensed globally to summit therapeutics. They will be presenting a lung cancer study also at the plenary. And this is a molecule, this is a class of drugs that's gotten a lot of hype, a lot of attention because the potential to, you know, potentially be better than Kichuta, which is kind of the dominant PD1 checkpoint inhibitor out there. So we'll see some really important data looking at survival benefit in a lung cancer patient population. Wait, Adam, I have to ask you because everybody always talks about so many pitches that I hear talk about the potential to best Kichuta, which has kind of been the lion in this, this whole ecosystem. Have you seen anything that you think could really best it? It is a difficult question to answer. I, I know what the results are from the study because but I'm not allowed to tell you. So we're going to keep that secret. You know, honestly, I don't think the study that's being presented is going to truly answer the question. One of the interesting tensions of all this is the whole China versus global data conundrum where, you know, a lot of these, well, this class in particular, a lot of the drugs have for kind of originated in China. A lot of the data that has looked really, really good and where this whole kind of like, oh, this is better than Kichuta theme arose is because the data coming out of China from clinical trials done there. The study that's being presented asco is also a China only study. But today we haven't seen global studies. So studies of patients in the United States and, you know, North America, Europe, etc. that have replicated those results. Yes. Those studies are being conducted and there are reasons to believe that the results will be similar. In some cases, they may not. So I think, you know, that whole question about this new class of molecules, this VEGF PD1 inhibitor class, whether it's actually going to sort of live up to the expectations. That's a that's a chapter that has not yet been written. Our guest this week, Jeremy Levin, believes biotech is at a turning point. Extraordinary scientific discoveries are leading to new medicines and improvements in health outcomes for patients that were once thought to be impossible. But at the same time, the industry is facing acute disruptions from political movements, distrust in science, and the weakening of independent institutions that threaten its existence. Levin is a South African-born physician who has spent 30 years working in biotech. He's currently the founder and chairman of Ovid therapeutics, but before that, he was CEO of Teva Pharmaceuticals and a deal maker at Bristol Myersquib and Nevartis. Levin has also served as chairman of Bio the industry trade group. Most recently, Levin is an author. He's written a book titled "BioTech in the Balance, Saving a Strategic Industry in an Age of Distrust." Biotech, Levin argues in the book, must be recognized as a strategic asset, critical to patients, economic growth, and national security. Jeremy, congratulations on the book and welcome to the readout loud. Adam, thank you very much and thank you all for that great introduction. Well, we're going to get a little bit more into your viewpoint of the industry and your experience with the industry. But first, I wanted to understand, Jeremy, why did you write this book now? I wrote it because Biotech is entering a dangerous paradox. On the one hand, science is extraordinary and growing and more wonderful every month, frankly, but the system that turns that science into medicines is not only weakening, it's actually beginning to fracture. So we're seeing pressures on capital, pressures on regulators, pressures on public trust, pressure on manufacturing across the board on institutions that made American Biotech dominant. And I wanted to say plainly in my own industry, do not mistake scientific progress for the infrastructure solidity. The science is not the weak link. The system is. Jeremy, you're a Biotech industry insider and you say the book is written for other industry insiders arguing that they should be quote bold. Define that term for us in this context and why it's so important. Such a great question. I've often tussled with it and tussled internally about what it means to be bold. And bold doesn't mean to start with the negative, doesn't mean reckless. Bold, in my opinion, means disciplined courage. It means choosing important science, not fashionable science, not another glip one, not another PD one, not a repeat of what everybody else has done, do something different. It means telling the truth about data as well. It means building companies from my perspective that can really carry medicines to patients and not designed to sell after the next catalyst. That's tough. It's very hard. I know that. It means defending also, and this is the important thing. It really does mean defending them vocally, the institutions that make innovation possible. And that means doing so even when publicly that's uncomfortable. So, you know, for me, biotech being bold is not noise. It's the courage that you take under scientific discipline. If you don't do that, who else is going to support it? So Jeremy, this is not an overly political book, at least by today standards like like President Trump, for instance, isn't mentioned in the book. The current FDA up people that obviously we've all been reading about, writing about over last year and have is not specifically mentioned in the book, but you are concerned about what you describe as, quote, the politics of unreality. That's a phrase that you coined in the book. And you see that as a threat to the biotech industry. And I was wondering if you could explain what you meant by that. Adam, biotech depends on reality. I'm not talking about the imagination of, you know, her boy [BLANK_AUDIO] saying, "I've got a crazy idea and I want to try it out," and then being incredibly financed by somebody. No. I'm talking about a functioning industry requires and depends reality. So either drug works, doesn't work. Trial either shows benefit, it doesn't show benefit, and safety signals either exist or they don't exist. Where you really run into trouble, and I mean, really run into trouble, is the politics of unreality is dangerous because it teaches people that facts are just positions. They are literally just positions. Expertise, it becomes elitism and institutions are legitimate only when they agree with your tribe. Frankly, that's fatal to biomedical innovation. And we saw this in the Soviet Union when this happened back in the 1920s when suddenly science was blown up and they became subject to the Soviet Union's concept of what science had to be. And the result of that was millions died. Starvation went everywhere. Now that's an extreme, but I can assure you the politics of unreality that we enter into and it's a huge risk is fatal to biomedical innovation of any kind. Bottom line, you know, and molecules don't respond to ideology. And as far as I'm concerned, I've never met a patient who is helped by a slogan. Jeremy, one of the probably most direct ways in which politics can theoretically trickle down into the biotic industries through regulation. So let's talk about the FDA. You write that, quote, in an era of polarized politics and instant outrage, unquote, independent regulators are vulnerable in two ways. First, the populist movements portray them as faceless, obstructive elites who get in the way of the people and the cures that they need. And then secondly, say that powerful industries really quietly seek to shape or capture regulators to serve narrow interests. And both of those paths you write are dangerous. Is the current FDA? Where are they positioned on that spectrum? Are they being affected by either of those two vulnerabilities that you lay out? Listen, this is a critical core question for what's happening in this system today. It's not the only one, but this is a core one. The FDA should always be fiercely, fiercely independent, not anti-industry, not captured by industry and not frightened by politicians or politics. As to where we are, right now, I'm really worried, very concerned that it's been pulled away from that critical center place that I described. The agency has had leadership upheaval. For having sex, we've just seen in one and a bit years, 90% of the top leadership has been either removed or has gone. When the doge entered, they cut 20% straight out without even knowing what they were cutting. They went in and closed rooms. So for me, it's not just a leadership issue. Yes, we've seen mighty Macarie resignation and Karl Diamanta stepping in as Acting Commissioner. But what we have to really focus on is something different. The turmoil, the political pressure and public conflict that they take with different drug makers, these are things that are really pulling it away from its center. That's not good for patients, not good for companies, and oh, by the way, it's terrible for investors. Predictability at the FDA is not bureaucracy. It's fundamental infrastructure. It's an infrastructure which has led America to being the greatest producer of medicines and the gold standard around the world. That is being shaken. So for me, the FDA should be completely pro evidence, pro patient and completely independent. And that's the center line. That's not an extreme and it's not there. I have a follow up Jeremy. It seems like more and more people in the industry are recognizing it and speaking out, actually, is the better phrase. Speaking out about what's happening, the upheaval in the FDA and how it's affecting the industry, what does the industry do about it? Because I would venture that like too much industry movement, too much industry lobbying could really easily fall into that or lend credence to the idea that industry is inappropriately influencing what should be an A political system. But as you're kind of laying out, the system as it is needs change. It is moving too far from center and it's not working as it should be. So what should the industry be doing? Well, institutions can't protect themselves. So when an institution such as this, which is critical, is shaken, the industry must stand firm. It must call out why this is a problem and it's incumbent on the industry. And I'm not talking about just the biotic industry. I'm talking about the giants. The Titans are dead silent right now. They are not standing up and saying what they're seeing. The Titans being the pharmaceutical companies. Yes, they can see it. They know that this is rattling. Their silence in part allows this to continue. In my opinion, this is not a moment for them to be silent. This is a moment for them to be clear. Now, at the same time, you bring a different point. Will they then be seen to be in co-hoots with the FDA? That is core to what this book is about. At the same time that they are calling out this change, they must address the issues that are fundamental to patients. They must point out what is going on and what our patients will suffer. It's not a question of innovation stopping. It's not a question of investment stopping. It's a question of where will it be? And we'll probably come back to that. But unless America has a functioning FDA, one that is completely independent, then we face a moment where no person in the street can be sure that when they go into CVS Wal-Mart or whatever pharmacy and take a pill out of a generic pill, that that pill is going to be one that is of high quality and is not contaminated because no FDA, no quality. Okay, so I want to switch topics to China. It's particularly relevant right now as we talk about the future of the biotech industry in the US. Do you see China as a threat, an opportunity or both? Elaine, it's so interesting. It's a word I probably wouldn't use, but in my mind, they're all of the above. China is, let's be clear, China is producing real science, real assets, real companies and real clinical execution. And deal flow will show you. Western companies are increasingly looking to China for partnerships and licensing deals, including fundamental drug development. So you can't pretend that China is irrelevant. In fact, that would be incredibly, incredibly foolish. China has expressed a very clear strategic intent. That strategic intent has been articulated five times over 25 years. They see biotech as infrastructure, strategic infrastructure for their country. As a consequence of this, they have a five step program. Step one was to teach many years ago, to teach folks to build APIs and molecules. Step two was to build testing capabilities, improve the FDA clinical trial structures and turn into kind of CROs. Step three was to attract the turtles, the great scientists that they had abroad, bring them back, put them into that system and say, okay, guys, go for it. Start producing, look likes and they did and everybody said, "Well, that's it. It's done." No. China had step four, which said, "Now we put the pedal to the metal and we're going to start developing novel new medicines." And they're doing it. They're doing it. Step five is exactly the same as every other situation that we have seen in China where they take that strategic approach with an area. It becomes part of the political parlance, the trade parlance, between countries. So China may be a threat, but only because we let it become a threat. Is it an opportunity? Absolutely. Because people will go and invest in it, because it's going to be very interesting. There are going to be many terrific medicines coming out of them. Is it a, and what does that mean? It means that in fact in the years to come, unless America gets its act together, China will increasingly, not now, not within three years, but certainly within five years, be the dominant provider of innovation in this world. And oh, by the way, the large pharmaceutical companies would have facilitated that by investing repeatedly in their capabilities. So I think it's for me the real question is how do we engage intelligently without becoming dependent? China is not just a market. China is a strategic system. We should learn from that. Jeremy, manufacturing is is probably one element of making biotech and pharmaceuticals, it's sort of a strategic focus of the United States. And on manufacturing in the book, you write, quote, I once believed that moving plants to lower cost jurisdictions was simply good business. And only later did I fully grasp the strategic price of that decision. End quote. Now obviously, President Trump has made domestic manufacturing of pharmaceuticals. One of his key strategic priorities for the administration. I assume that you agree with that. Yes, but with it's a qualified yes. What we did in the 60s, 70s, 80s and 90s was industrial colonialism. We sought out cheap labor. And we exported cheap labor to other countries. And our pricing on products was based on the labor costs example, a barrel full of Tylenol would cost roughly $12. Okay. If you manufacture it in Hungary, $4 if you manufacture it in India, all of that's labor. This is not the answer to bring back old-fashioned manufacturing. This is an opportunity for America to build immense capability in modern manufacturing, manufacturing which can set the pace for all types of medical and medicines being produced. So I agree with bringing back capabilities. But I qualify that by saying that I think you must have innovation built into the innovation of American manufacturing capability. That's one component of the second is you absolutely need to have the ability to manufacture and secure core pharmaceutical manufacturing on your territory. Because if you don't have that, you do not have biosecurity at all. And I think we now know that we underestimated the strategic cost of that occurrence. So you're referring to the manufacturing of API, the basic building blocks of pharmaceuticals? Yes. It factories matter. But for me factories not just without science, without strategy, they don't matter. You need to have factories that have got science, capital, talent and the trust. They're not just buildings. We're talking often when we talk about it today, we talk about manufacturing buildings. That's not the issue. It's what they're building, how they're building it and what kind of people are within it. That's what you really are trying to build a fundamental infrastructure and capability. The types of manufacturing projects that have been announced that have been brought back to the US over the last let's say 18 months. Does that fit this thesis that you've given a name in the book as as biobilt as kind of you know, future proofing the industry and our manufacturing capabilities? I think if you were to listen to those announcements, you would not be hearing about innovation manufacturing. You would be hearing about capacity. That is a portion of what should have been invested. What should be invested is how do we invest, how do we take the engineers in the great universities and training shops that we have in this country and build not just another replicant of a factory that was in Bangalore, but an entirely new concept of a factory in this country. The whole view of biobilt, it really says, "Biobilt wants to take you beyond just building buildings. You want to consider this as national infrastructure, the most modern that you can do." It's the idea that you can have discovery, FDA, NIH, universities, venture capital, the engineering departments, clinical trials. It's an entire wraparound that allows one to think about, manufacture is one core component, but it's not just the old-fashioned way of thinking about manufacturing. Manufacturing is a strategic capability and I would point out to you, just think about this for a minute. We are building self- therapies. We are building gene therapies. Each one of these in itself is a manufacturing miracle. Each one of these, the factory and the manufacturing, is the product. If we don't understand how to actually manufacture clearly and simply in a very fundamental strategic way in this country, we are going to run into severe trouble. That's what I'd like to see when they come back. I'd like to hear those who are talking about manufacturing, talking about building the greatest manufacturing capability for cells, the greatest manufacturing capability and facility for gene therapies, etc. For proteins, reducing the cost of manufacturing through automation and including AI, all the above. Essentially, what I'm really talking about is what the Chinese are doing. They're doing that right now. Bio-build is our opportunity to do it now and essentially build the system that builds the medicines. Jeremy, you end the book with a section called Ten Commitments for a Bold Biotech Industry. One that was interesting was number five, which is we will back long-term science with long-term capital. As we know, biotech is highly dependent on investors for its next round of capital, but so many investors today are most interested in near-term stock-moving catalysts or an M&A takeout rather than long-term sustainable profitable biotech companies. How do we incentivize that long-term investment and our long-term investors are dying breed? It's a vital moment that you've identified. Biotech was formed. I'm just going to go back to that same example 1973, her boy suddenly coming up with an idea and then being financed and Genentech being formed in 1977. This wasn't a fluke. This was a venture capital taking a chance doing something bold, crazy idea and he is financing, he was financing a crazy idea because it was a crazy idea. And then from there you walk up to where we are today with several thousand companies, incredible science, evil evolved. What didn't evolve was the finance system around it. What didn't evolve was the attitudes of some of the people who were financing it. They saw this increasingly as a short-term trade. So just imagine what's going to happen. Let's take this fast forward unless there's a correction in thinking about investing. In a A few years time AI is going to tell you. take over investing. When that occurs, the specialists is going to vanish. When that occurs, you're going to find that the folk who were thought they were good at this and were trading, they were trading, but they're going to be like old-fashioned. Viatech is not a trade. Viatech takes 10 years to come to fruition. So our long-term investors are dying breed. There are a few of them. Actually, there's not that many of them. That's for sure. But are they dying breed? Almost certainly unless and when the system evolves, and this is where the legislators can most certainly plan incredibly important role. Our tax incentives, for example, if you hold your tax capital gains for one year, yeah, it's reduced. You get 20% something like that. If you hold it for 20 years, you get 20%. That doesn't make sense. You have to tear for an industry where it takes years for maturity of the product. You have to incent people to stay in the stock. You have to disincentivize them from trading it because if you're going to make your money on a daily trade, you're going to try and create as much volatility as you can in the sector so that that volatility will drive your profits, but there's nothing to do. Nothing to do with the successful failure long-term of the industry as a whole, although it will have an effect on one drug or another that fails, it doesn't fail. How's this for a nightmare scenario, Jeremy? You have an AI-created drug financed by an AI-powered investment vehicle, and then that drug is reviewed and regulated by an AI-powered FDA. Who needs humans? I thought you were going to go a different direction, which is all the, there's talk about all the biotech trials being on prediction markets now. Are we talking about short-term trades? Yeah, what is how harmful is that to the industry? Where are you building value? The one place that you're building value is in the short-term trade investors. Nowhere else. This doesn't help the companies. It doesn't free up capital to invest elsewhere. So for me, if I had my brothers, I would be absolutely at the door here and as a specialist investor discussing deeply with regulators on tax policies to treat this like, I guess, the closest analogy is actually long-term real estate. There's all sorts of things and our president does understand real estate. So Jeremy, as it stands right now, as the industry is operating right now, what does biotechnology look like in the United States and even beyond in 10 years, in 20 years? I love that question. It's so difficult. And anything I say is likely to be utterly, totally wrong. But what I'd like for it to be, what I'd love for it to be, tell us. In 10 years, the science will be more powerful than ever. AI will weave itself into genetic self-therapy, protein engineering, precision medicines. And there's one thing for sure though. That's the science is going to be remarkable because AI will be a huge piece of that and our understanding of how a gene translates into a protein and translates into a cell, translates into a system is going to, that's where they really, AI really will work at the at the system level, is going to be remarkable. But I'm going to be, make a prediction that unless America steps up to the plate, leadership in biotech is going to be very much more distributed globally. And I say that because I'm already hearing from the Australians, the EU, the Brits, although they're less than the game, and other countries around the world, that they are now shifting gears and focusing on this area as a strategic asset. Indeed, Germany's offering huge sums for scientists to come from us. In 20 years, I absolutely have the following belief. We're facing environmental crisis. We're facing the potential for huge pandemics in a crowded world. We're facing enormous changes in temperature and sweeping changes in the types of viruses carried by mosquitoes, etc. So, I'm 100% certain of this. Biotech will be one of the defining industries in human life. Because without it, we're going to run into trouble. The question, the question, and I know some people may think I'm being jingoistic, I'm not. I'm simply identifying what is real. The question is whether America will still lead it? Or we allow short-term thinking, political pinata playing, political interference, and institutional decay to move leadership elsewhere. Because science won't change. It will simply go faster and faster. And so, the future of biotech in my mind is secure. The future of American biotech leadership is not. Okay, well readers, if you want to read more, the book is titled "Biotech in the Balance Saving a Strategic Industry in an Age of Distress". Jeremy, thank you so much for joining us. Thank you so much, and Allison, thanks a lot. Adam, thank you very much. That does it for another episode of The Readout Loud. Thank you to Hyacinth and Bonato for producing this week's episode. Our senior producer is Alyssa Ambrose. Our executive producer is Rick Burke, and our theme music is by Brian Joel. We'd love to hear from you. Tell us what you like about this week's episode, what you didn't like, and what movie or TV show Adam should watch on his plane ride. You can do all that by sending us an email at [email protected]. I think I have work to do. Don't do that. And if you like what we do, leave a review or a rating. I know a podcast or whichever platform you use to get your podcasts. We'll see you next week.

Podcast Summary

Key Points:

  1. The podcast discusses Verve Therapeutics' gene editing treatment (Verve-102) that reduced cholesterol by 62% in a Phase 1 trial, but the hosts caution against overhyping early-stage data, noting existing treatments like statins achieve similar reductions.
  2. Retro Biosciences, an aging and longevity startup backed by Sam Altman, closed a financing round valuing the company at $1.8 billion, becoming a biotech unicorn.
  3. Upcoming ASCO conference highlights include Revolution Medicines' pancreatic cancer drug (direct RAS inhibitor) and a PD1-VEGF inhibitor from Chinese drugmaker (licensed to Summit Therapeutics), with questions about global data replication.
  4. Jeremy Levin's book "Biotech in the Balance" argues the biotech industry faces a "dangerous paradox": scientific progress is strong, but the system (capital, regulation, public trust) is fracturing.
  5. Levin defines "bold" as "disciplined courage" – choosing important science over fashionable trends, being honest about data, and defending institutions that enable innovation.
  6. Levin warns of the "politics of unreality," where facts are treated as mere positions and expertise is dismissed as elitism, which he says is fatal to biomedical innovation.
  7. Levin expresses concern about the FDA's independence, citing leadership upheaval, political pressure, and cuts by DOGE, which he argues undermines predictability and infrastructure critical to the industry.

Summary:

" The hosts first discuss Verve Therapeutics' gene editing treatment, which reduced cholesterol by 62% in a Phase 1 trial. They caution against overhyping the early-stage data, noting that existing statins and PCSK9 shots achieve similar reductions, and highlight ongoing questions about safety, durability, and market access. 8 billion valuation after closing a financing round.

Looking ahead to the ASCO conference, the hosts note that Revolution Medicines' pancreatic cancer drug and a PD1-VEGF inhibitor from a Chinese drugmaker are expected to be highlights, though questions remain about global data replication. In the interview, Jeremy Levin argues that biotech is at a turning point: while scientific discoveries are extraordinary, the system that turns them into medicines is fracturing due to capital pressures, regulatory instability, and public distrust. He defines "bold" as disciplined courage—choosing important science, being honest about data, and defending institutions like the FDA.

Levin warns against the "politics of unreality," where facts are treated as positions, and expresses concern about the FDA's independence, citing leadership upheaval, political pressure, and arbitrary cuts that threaten predictability and innovation. He emphasizes that molecules don't respond to ideology, and patients are not helped by slogans.

FAQs

Levin argues that while biotech science is advancing rapidly, the system that turns science into medicines is weakening and fracturing due to pressures on capital, regulators, public trust, and manufacturing.

Being bold means disciplined courage: choosing important science over fashionable trends, telling the truth about data, building companies to carry medicines to patients, and defending institutions that make innovation possible.

The politics of unreality treats facts as mere positions, expertise as elitism, and institutions as legitimate only when they agree with one's tribe. This is fatal to biomedical innovation because molecules don't respond to ideology.

Levin is worried that the FDA has been pulled away from its independent center due to leadership upheaval, political pressure, and public conflicts with drug makers, which harms patients, companies, and investors.

Eli Lilly reported that a high dose of Verve-102 reduced cholesterol levels by 62% in a phase one trial, but it was an early study with limited patients and similar reductions are already achievable with existing statins or PCSK9 shots.

The treatment was touted as a one-time shot that could eliminate heart disease and extend lifespan, appealing to longevity enthusiasts, though experts caution it is early-stage data and not yet proven for broad use.

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