The FDA's Overton era, and dispatches from Shanghai

0:07Margaret Manto: Welcome to The Read Out Loud, a weekly biotech podcast from STAT. I'm Allison DeAngelis.

0:12Jason Mast: I'm Adam Feuerstein.

0:13Margaret Manto: And I'm Elaine Chen.

0:18Margaret Manto: After a turbulent 18 months for the FDA, will a new nominee to leave the troubled agency bring more stability or controversy? If I have the privilege of being confirmed, I will work with the dedicated career professionals to make sure every aspect of clinical trials and drug development is optimized. This will not only bring development back to the United States, it will bring cures to patients faster. If confirmed, I will work to ensure every talented person at the agency shares the goal of making the FDA the agency of the possible rather than the impossible. We take a look at Heidi Overton and what her tenure may mean for the future of the FDA.

0:57Jason Mast: And our colleague Jason Mass spent the last week in Shanghai attending a biotech investing conference. We'll chat with him about the rise of Chinese biotech.

1:08Margaret Manto: All that and the latest biotech news after a word from our sponsor.

1:20Jason Mast: biotech moves fast blockbuster clinical trial wins brutal drug blow-ups shifting market tides if you're not paying attention you're already behind that's why i write biotech scorecard every thursday morning i cut through the noise and break down what matters right now data deals and the people and companies making real moves. It's unfiltered analysis from someone who's been covering biotech for more than 20 years. If you want to keep up and stay sharp, subscribe to Biotech Scorecard, only for StatPlus subscribers.

2:00Jason Mast: Alison, on a scale of 1 to 10, how excited are you that the Great British Baking Show starts this week?

2:07Margaret Manto: I'm about at a seven. It hasn't sunk in yet that it's starting, but I'm getting excited. How are you feeling?

2:14Jason Mast: I'm at like a nine, mostly because I hope in the first episode, Nigella Lawson, who is one of the new co-hosts of the show this season, like somehow they work in the micro-Wave reference.

2:25Margaret Manto: I have no idea what you're talking about. Oh, yes. You know who's at a 10 out of 10 for excitement? Elaine Chen. Never been more excited in my life.

2:33Jason Mast: Dear listeners, you'll be sick of us talking about the great British baking show. So buckle up.

2:39Margaret Manto: So let's turn to some biotech news. Allison, you had a really interesting story this week about investors, pharma companies getting interested again in osteoporosis treatments. Tell us more about that. Absolutely. It's something that 15 or 20 years ago would have been very familiar. Pretty much every big pharma at that point had a drug for osteoporosis, this condition that affects millions of Americans that causes their bones to become very brittle and weak and break. They all kind of walked away. That field went silent and now it's reemerging. And it's something that I think that listeners should really be paying attention to.

3:17Margaret Manto: Most venture capitalists that I've talked to on the subject have something in the works. There are going to be companies emerging with new treatment options for this disease. And it's something that the pharmaceutical companies, too, are also getting much more excited about. We just saw last week Eli Lilly has said they want to make a bigger push into bone health and osteoporosis. And I've heard of a couple of other pharmaceutical companies that feel much the same. So it's going to be something that we will chat about more on this podcast.

3:47Jason Mast: And biotech acquisitions have kind of taken a little bit of a breather late summer, early fall. But we did have a relatively small Radio Pharma merger this week. Allison, why don't you tell us about that?

3:58Margaret Manto: Yes. So this week we saw two companies, ITM and Telix Pharmaceuticals, merge. Telix is actually buying out ITM's equity. This deal is worth about$1.65 billion up front. It could potentially be worth more. This merger was very interesting because for the longest time, Novartis has been the leader in this space, This field of new cancer therapies that actually drop radioactive isotopes onto cancer cells to hopefully destroy them. And this merger creates a new entity that could be a big competitor for Novartis. They have the two drugs that are being most widely used. Everything else is still in human testing.

4:46Margaret Manto: and ITM and Telex pairing up creates this really powerful new entity in this field. We will see how this works out. Telex investors, a little wary of the deal, but will likely, I imagine, approve it. Thank you, Alison.

5:13Margaret Manto: President Trump's new choice to run the Food and Drug Administration made an appearance on Capitol Hill Thursday. If confirmed, Heidi Overton would be the youngest FDA commissioner ever. Overton, who is 37, is currently on the president's domestic policy staff. She works closely with Secretary of Health and Human Services Robert F. Kennedy Jr., including on his remake of the country's vaccine policies. Overton is known for her work in Trump's Maha movement, but at the same time, she is viewed by many Maha supporters as an obstacle to the sweeping changes they want to make. Her nomination comes at a critical moment for the agency.

5:50Margaret Manto: The FDA lost thousands of staffers as a result of federal doge cuts last year, And Overton could replace an embattled commissioner who was forced out and who many say politicized the FDA's regulatory process. To find out more about Heidi Overton and what may be next for the FDA, we're joined by Margaret Manto, STAT's new FDA reporter. Margaret, thanks for joining us. Hi, thanks for having me. So, Margaret, who is Heidi Overton? Heidi Overton is a preventive medicine physician who has served within both Trump administrations. administrations. She's been on the President's Domestic Policy Council.

6:27Margaret Manto: She's currently Deputy Director, and then she was formerly a White House Fellow. She has a degree in medicine from the University of New Mexico, and she started a surgical residency at Johns Hopkins University, but then left that residency to start doing research on opioid use under none other than Marty Makari, who was the previous FDA commissioner. And she's really made her name for herself as a Maha ally who is nevertheless somewhat of an arbiter of how the Maha movement should be translated into policy. So she's both gained allies who see her as someone who could really translate the Maha movement into action, but then also some critics who say that she can be a bit of an obstructionist.

7:15Margaret Manto: Margaret, you've said that she's a bit of a conservative's conservative. What does that mean? Yeah, so she really came up in the first Trump administration before the Maha movement was a thing. She joined the Domestic Policy Council under Brooke Rollins as a White House fellow, and then she went on to work at Rollins' think tank, the America First Policy Institute, after Trump left office in 2020. And she has really made a name for herself as someone who is entrenched in this old guard of conservatism. She is interested in things like price transparency and she's an ardent anti-abortion activist and she's not part of the populist alternative science movement that's come up through Maha.

8:10Margaret Manto: Now the one exception to that is her opinions on the COVID-19 response. And so she's talked about how she was really radicalized by working within the Trump administration during the COVID-19 first year and has talked about how she felt like science was under siege. Medical organizations were putting ideology over medicine. So she's really someone who straddles the worlds between the conservative movement and the Maha movement. And you mentioned that some people in the Maha movement see her as obstructing some parts of their agenda. What specifically do they take issue with? So she has really acted in her role on the Domestic Policy Council as someone who is taking the policies put forward by elements of the Maha movement and crafting them into something that can become an executive action that the president will actually act on.

9:11Margaret Manto: The Atlantic reported on how Joe Rogan, the noted podcaster, wanted President Trump to discuss Ibogaine, which is a psychedelic made from a root bark, and actually creating the language that would become a executive order around psychedelic therapies. And she, The Atlantic reported, cut down the language of the Maha movement that Trump would actually act on. And to be clear, Margaret, the Maha movement has been very pro-psychedelics, and they've seen Overton as someone who's watering down that effort. Yeah, I think that they are concerned that she is someone who is really slowing things down, trying to put them into the language of the federal government in a way that they don't always appreciate.

10:01Margaret Manto: So let's talk about what has preceded Overton's nomination. These last 18 months since Trump took office have been, to say the least, shaky for the FDA. There's been a lot of turnover and uncertainty among staff. Walk us through what led us to where we are now. Yeah, you're totally right. The FDA has had a rough go of the past 18 months. It was really cut back by the reductions in force led by Elon Musk's Doge in 2025. It lost around 20 % of its total workforce. It's down to about 16 ,000 from a high of 20 ,000. And it's lost a lot of people just through simply people not wanting to work there anymore.

10:44Margaret Manto: Long-time career staff have been really troubled by what they perceive as political meddling in the agency, a loss of deference to career scientists, and they've been leaving the agency in force. Now, the agency has tried to build back some of those staffing shortages, as I reported on recently. It's making an effort to come back from the lows of 2025. President Trump recently appointed several new officials to the FDA, leaders at two key centers, Center for Biologics Evaluation and Research and Center for Drugs Evaluation and Research, people who are really seen as more stable and scientifically minded than previous appointees.

11:32Margaret Manto: There's a sense that the agency is rebuilding, but it remains to be seen whether Overton is going to be the kind of person who can continue that trend. Now, Margaret, as you mentioned, Overton has a professional relationship with the previous commissioner, Marty Macari. Under his leadership, the FDA, many people have said, became more politicized and decisions were no longer being made by staff scientists. What can we glean about Overton and how she might handle the politicization of this agency and also how she might handle rebuilding this agency? Overton is very different from Macari in a lot of ways.

12:21Margaret Manto: She is a pretty under-the-radar kind of person. She has made not a ton of public appearances in the last couple of years, even through her leadership role at the think tank with Brooke Rollins. She's stood alongside President Trump at executive orders, but she's still not super widely known. She's not a very outwardly opinionated person. She doesn't really disagree with the president. So I think she could have more of a role in terms of translating the president's desires to the FDA than Macari had. Dr. Macari really came into conflict with both career scientists and the president because of his decisions at the agencies.

13:14Margaret Manto: And Macari clashed with President Trump over flavored vapes, which President Trump was pushing for further approvals, and Macari was concerned about the health risks. So I don't know if we would see that kind of pushback from Overton were she to be confirmed. Let's get a little bit more into the controversies at the FDA that led to the ouster of the previous leadership. So Marni Makkari and Vinay Prasad, who led the Center for Biologics Evaluation and Research, were both seen as politicizing agency decisions. Vinay Prasad really got involved in decisions around one of Moderna's vaccine candidates.

13:57Margaret Manto: Those decisions were later overturned and Prasad left the agency twice. He left and then came back and then left again. So there was a lot of turmoil by leaders who were not advocating for the same stability and predictability that the FDA is known for and that industry leaders have really come to expect from the agency. Prasad certainly grabbed a lot of attention during his tenure there, but Makari was really at the helm, at the top spot of the FDA. What were some of the things that led to him parting ways with the agency? So Macari was known for being somewhat mercurial while he was at the FDA.

14:40He initiated a new

14:43Margaret Manto: priority review voucher program that could inject more political thinking into drug decisions, depending on who received the vouchers. He was the commissioner when thousands of FDA employees were laid off through the reductions in force and when others left because of concerns about how the agency was being run. And he also was advocating for a policy shift that would cut back the number of clinical trials that companies are required to submit from two to one, a clear policy shift without a ton of specifics about how it would actually be implemented, kind of spooked industry leaders who were concerned that Macari was introducing policies without really thinking them through beforehand.

15:35Margaret Manto: So getting back to Heidi Overton, why do you think Trump chose her? And what do you think is the hope from her supporters? Stability, I think, is the main thing that people are looking for, both within the FDA and in industry and from the White House as well. I think there was a desire after the turbulence at the FDA to level things off and bring it back to its former glory. I think Heidi Overton has a reputation for being someone who can get things done, who is a team player, and isn't someone who is trying to like go on podcasts all the time and really be someone in the media. And I think those are all things that are seen as positives right now for a future FDA commissioner.

16:26Margaret Manto: And what about her policy initiatives? What do you see there? I think the issue that will be most likely to see real action on from her is mifepristone and telehealth abortion access. She has spoken out against access to medical abortions via telehealth, and the FDA is undergoing a safety review of mifepristone right now. And I think that could really pave the way if Overton were to choose for the agency to take action on Mifepristone. It's something I've heard that industry leaders are concerned about happening. Other than that, I think her history of being a player in the president's domestic policy council and having the ear of the president in that way is something that she could bring to the FDA.

17:22Margaret Manto: And I think she will probably continue to serve as an intermediary between the desires of the Maha movement to deregulate and change the priorities of federal health agencies, along with the White House's goals, whatever those may be. Margaret, thank you so much for joining us. Thanks for having me.

17:52Margaret Manto: China was once known as a producer of generic medicines and Me Too drugs. Today, it's a global drug discovery powerhouse, turning out innovative drugs at a scale that rivals the U.S., only faster and for less money. Approximately one-third of the world's drug development pipeline is now coming from China.

18:10Jason Mast: Develop innovative drugs and the money will follow. In the last few years, pharma and biotech companies from around the world, you know the names, Pfizer, Merck, AstraZeneca, Eli Lilly, have spent approximately$50 billion to acquire and license medicines developed by Chinese scientists. The scale and speed of all this China biotech dealmaking is sparking a furious debate in the U.S. about the future of our own biopharma industry. Have we become too reliant on Chinese drugs? Are we losing our competitive edge? Do we need to copy what China is doing, or do we need to erect barriers to protect homegrown companies for national security?

18:50Margaret Manto: Stat reporter Jason Mast has been in Shanghai at a major biotech investment conference. He's been seeking answers to at least some of the questions that have come to dominate conversations amongst biotech executives, investors, and politicians. Jason, you are so far away from us, but yet also so close. Welcome back to the podcast.

19:09Jason Mast: Thank you so much for having me. All right, Jason, besides blowing Stats travel budget for the year, what are you doing in Shanghai exactly? There is a Jeffries conference here in Shanghai. Every year they host a Asia Pacific tour for people from GSK, Merck, AstraZeneca, and a lot of U.S. and global investors. And this year, for the first time, they have added Shanghai because there's all this interest in Chinese biotech, all this money flowing in. It's a lot of interest, a lot of anxiety and excitement around the burgeoning industry here. But unlike in Europe and the U.S., there is no flagship Chinese biotech conference yet.

19:52Jason Mast: So Jeffries is competing with J.P. Morgan, Morgan Stanley, some other investment banks for this ballooning industry here.

20:00Margaret Manto: So why specifically are they holding this conference in Shanghai and why now?

20:05Jason Mast: They're hosting it in Shanghai because it's the major biotech hub in China. It's the place where increasingly global investors are coming and global pharma companies are coming to see if they can scoop up some of these molecules that have been so valuable. And in the last few years, it's boomed with biotech companies. So, Jason, in the conversations that you're having, how much of that matches what we hear back in the U.S. about China biotech? Like, you know, we all hear how efficient they are, that they can develop new molecules, the flexible regulatory environment that lets them run clinical trials faster and cheaper.

20:45Jason Mast: Are you hearing that stuff there? And does it match what we perceive back here in the United States? I mean, it's hard to know whether the reality here matches what is perceived in the U.S. But at least as far as what folks are talking about, it's the same conversation down here. It's the same discussion of this is so much faster. This is so much more efficient. Can U.S. companies compete? When you talk about why things are faster, people throw a lot of answers at you. But there is at least the perception that Europeans are taking way too many vacations. Americans are not working hard enough, going for too many coffee breaks.

21:24Jason Mast: And Chinese companies are moving incredibly swiftly. And U.S. companies will have to adapt to that, that they're going to survive.

21:32Margaret Manto: We've talked a lot about why China has become this powerhouse. We know that the government has really supported the Chinese biotech industry. Regulations have been loosened. People can move through trials really quickly. From your conversations there, how much does that align with what you've heard that's contributed to China becoming a biotech powerhouse?

21:55Jason Mast: I think what people are talking about on the ground here when you ask, you know, what has led to this sudden boom? You have this years of stewardship by the government. You have these reforms to speed up how the NMPA, the Chinese FDA, regulates drugs. You have this rich group of young scientists and burgeoning number of STEM grads. You have these scientists who went overseas and came back. And you have companies that have now been through this cycle a couple of times, either because they were doing clinical research or manufacturing work for U.S. companies or because they tried to make some exciting new drug in 2015 and failed or had mediocre results and are now going back and trying to do it again and having much better results.

22:44Jason Mast: In the time that you spent there, is there anything that you've seen that really exemplifies this change, this shift that we have seen in Chinese biotech? Just the sheer sweep of it. You get to the hotel with a conference and across the street, there's BioShanghai. And in huge letters across this long, sweeping rectangular building, it says AI for biopharma, health for all, advertising this vision of BioShanghai. You go to some of these areas where there are buildings clustered and you'll see Heichmed and Abisko and another company back to back to back. these sizable Chinese biotechs that have popped up in the last 10, 15 years.

23:28Jason Mast: And in some cases, these are buildings that were previously owned by big pharma companies that had once, you know, eyed this Chinese market and then couldn't actually make it work, either because of the bureaucracy or because of, you know, the way that they went about it. And now Chinese biotechs have taken that over and this is the place where vcs are beginning to enter this super urban district downtown where there's a starbucks coffee roastery that's massive and a louis baton building that is literally in the shape of a ship and you go to the 38th floor and there is r.a capitals joshua Resnick talking about the firm's plans for China.

24:14Jason Mast: And he's sitting up there overlooking all of Shanghai. And you have other VCs that are also opening up shops. So there's all of these little signs of the level of activity that is going on here.

24:28Margaret Manto: So Jason, in the US, a lot of people are pitting the US and China against each other, saying it's this big competition. Is that the way that people in China view it?

24:40Jason Mast: I've been trying to get a sense of this. I think if you ask people, they will be like, look, disease is the enemy, but also only so many companies can survive. And you are always competing with whatever other biotechs are out there. You know, I spoke to one Chinese biotech CEO today who was like, look, U.S. companies cannot compete. We are too fast. We are too efficient. And they just aren't. So they have to either come and be part of this system in some way or they won't make the cut. Is there an awareness or a concern about some of the kind of protectionist rhetoric that has come from the U.S., from certain politicians and even some people in the industry about seeing China as a national security threat?

25:29Jason Mast: I think it's definitely a thing people are aware of and talk about. I think so far it hasn't dragged down what's been going on here. It hasn't dragged down the industry. One investor at the conference called it sort of the 100-pound gorilla in the room. But the geopolitical tensions, geopolitics comes up a fair bit. They do affect whether or not a Chinese biotech can sell itself to a U.S. company. But like the general geopolitical rivalry and tension does very much play into how this industry is shaped. There's a model that venture capitalists and Chinese companies are increasingly pursuing in which Chinese biotechs license their assets or their early stage molecules to a new company that is set up by U.S.

26:20Jason Mast: investors mostly. And in return, they get, you know, some level of equity and whatnot. But the reason that you want to set up this non-Chinese enterprise is it's easier to then sell to a U.S. pharma company because there isn't that same level of geopolitical tension. So all these things are in discussion and do matter. So Jason, you've reported on some patient deaths that have occurred in Chinese clinical trials, specifically some gene therapy trials that have been conducted over there. I wonder if that has come up in conversation, if you've heard anything about that while you've been there in China.

26:56Jason Mast: Yeah, it has definitely come up. In the case of these three deaths, I believe all three have been cases where companies or academics were using what is called an investigator-initiated trial, which basically has allowed Chinese companies and academics to start early-stage studies without the full standard central sign-off from the Chinese equivalent of the FDA. And that's been a big boon to the industry here because it's allowed companies to move a lot faster than you could in the U.S., but it's also raised these safety concerns about whether there's enough oversight and whether hospitals and academics are capable of deciding what is safe and what is right to go into humans for the first time.

27:44Jason Mast: And these three deaths have really underscored that. But the Chinese government slowed down and really started putting some new controls on these kinds of trials. But there's envy at this pathway in the U.S. And U.S. companies are constantly lobbying their government to allow them to have the same pathway in order to compete. All of which is to say that this has come up. It does not seem to be a major worry. When you talk to people, the competition for molecules here is as high as it's ever been. And people are actively bidding against each other and bidding against other investors, bidding against pharma companies.

28:27Jason Mast: It's basically a gold rush out here.

28:34Margaret Manto: Jason, have fun. Have a safe flight back. And thank you so much for joining us.

28:40Jason Mast: Thank you so much for having me.

28:45Jason Mast: That does it for another episode of The Read Out Loud.

28:48Margaret Manto: Our podcast is produced by Rachel Gottbaum. Our senior producer is Alyssa Ambrose. Our executive producer is Rick Burke. And our theme music is by Brian Joel.

28:57Jason Mast: And we'd love to hear from you. Tell us what you like about this week's episode, what you didn't like, and I don't know, your thoughts on Chinese biotech or the Great British Baking Show. You can do all that by sending us an email at readoutloud at statnews.com.

29:10Margaret Manto: And if you like what we do, leave a review or rating on Apple Podcasts or wherever you get your podcasts. See you next week.