Ep. 360 - FDA’s FIH plans. Plus: billion-dollar deals, funds

A pathway proposed by FDA to cut the time it takes biopharma companies to get to first-in-human trials is more ambitious than similar policies in Australia, China and the U.K. On the latest BioCentury This Week podcast, BioCentury’s analysts assess the proposal, as well as a concession for the biopharma industry on first-in-human studies in PDUFA reauthorization negotiations with FDA.
The analysts also discuss the latest pair of billion-dollar biotech deals: Gilead's $3.2 billion takeout of antibody-drug conjugate company Tubulis and the acquisition of Soleno by Neurocrine for $2.9 billion for its Prader-Willi asset. Finally, BioCentury’s analysts discuss the new $6.3 billion Blackstone Life Sciences fund and the €1 billion vehicle unveiled last week by European VC Jeito Capital. This episode of the BioCentury This Week podcast was brought to you by IQVIA Biotech.

View full story: https://www.biocentury.com/article/659127

#FDA #FirstInHuman #BiotechMergers #BiotechInvesting #LifeSciencesVC

00:01 - Sponsor Message: IQVIA Biotech
03:24 - FDA First-in-Human
11:44 - America First PDUFA Policy
17:43 - Gilead Buying Tubulis
23:41 - Blackstone's New Fund
28:37 - Jeito Capital
30:44 - Parker Institute

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

Transcript

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Voice Talent: 0:02

BioCentury This Week is brought to you by IQVIA Biotech. A full-service CRO right sized for biotech. Dedicated to helping biotech leaders close unproductive gaps in clinical development so they can protect timelines, preserve capital and stay ahead of risk.

Jeff Cranmer: 0:22

A pathway proposed by FDA to cut the time it takes biopharma companies to first in human trials is more ambitious than similar policies in Australia, China, and the U.K. But how long could it take to implement it? We'll discuss the proposed policy on the latest BioCentury This Week podcast. Plus biotech's Deal O Rama continues as Gilead adds depth in ADCs with a $3 billion takeout of European biotech Tubu And a similar size deal puts Neurocrine's strength behind Soleno's Prader-Willi drug. We'll also discuss new funds from Blackstone and Jeito and get an update on negotiations on the PDUFA agreement that is emerging between FDA and industry. I'm Jeff Cranmer, host of the BioCentury This Week podcast. Joining me to discuss all of this are Editor-in-Chief, Simone Fishburn. Washington Editor, Steve Usdin, and Paul Bonanos, Director of Biopharma Intelligence. But first, BioCentury Grand Rounds US is returning for its third year this June in the Pacific Northwest, specifically Seattle. This is not a large generic conference. It's a focused forum where VCs, biopharma executives, academic innovators, and biotech founders engage in the kind of cross-sector dialogue that rarely happens elsewhere. As a delegate, you'll debate translational sciences. Biggest hurdles here are world class presentations from researchers at the translational frontier and connect directly with the funders shaping what gets built next. Attendees have called it intimate, potent, on point in a masterclass in curating dialogue. Simone, you'll be there.

Simone Fishburn: 2:38

Yeah. Jeff, I am super excited. As you know, this one is close to my heart, this academia industry interface. We talked about it before and we will continue to talk about it again. But we have a whole bunch of Nobel laureates there. And some great farside chats in addition to some really in-depth scientific panels. So check out the website at wherever Jeff tells you.

Jeff Cranmer: 3:03

BioCenturyGrandRoundsUS.com, and you can register there. You can apply to present. My colleague Karen Tkach Tuzman and I will take a look. If you're one of the super early innovative companies that is interested in getting on stage at BioCentury's Grand Rounds. All right, Steve, A proposal by FDA could sharply reduce the costs and time required to launch first in human studies, how?

Steve Usdin: 3:35

This was a proposal that we only really have about a 250 word blurb about it. So everything that I'm gonna say now is extrapolated from that plus conversations that I've had uh with people around it. What FDA a is proposing is a new regulatory pathway that's designed to significantly shorten the time and cost required to initiate first inhuman Phase I clinical trials. What FDA's proposing is that companies be allowed to substitute new approach methods, non-animal models for some of the traditional animal testing requirements. The idea is that this would transform how early stage safety evidence is generated and conceptually it's a big step forward. But, and there's always buts, right? First, FDA frames it as both the scientific and an industrial policy initiative, which I think is a mistake. They should stick to the science for lots of reasons. One of them is that there's no reason to think that the scientific advances that would allow non-animal tests to support approvals, would somehow be limited to the United States. Other countries are gonna be able to do whatever it is that FDA allows companies to do here, I think. In any case, I think that the whole proposal there's a bit less there than it seems, right. Um, the pathway would require congressional authorization, and more importantly, it needs a lot more scientific validation and regulatory implementation. There may be specific areas where it could be partially implemented in a few years, say for monoclonal antibodies, but it would take years before it's fully operational.

Simone Fishburn: 5:08

Yeah. Steve, I think you're underplaying your story. I thought it was really interesting. Sure. We don't know a huge amount about how FDA's strategy will play out out I think we probably do know that it's not gonna have an imminent impact based on some of the things you've just said. But I think one of the things that I thought your story did really well is to map it against what some of the other regions are doing. You showed about Australia, which has long been known to be a, a destination for clinical trials. China, you said silence means approval, is your subhead there And then, you know, the U.K. is also doing some interesting ways to accelerate it. You know, could you just walk us through like some of the similarities and differences between these?

Steve Usdin: 5:53

Yeah, so really. I've seen other people write about it and say, oh, this is similar to what's being done in Australia. or it's similar to China or the U.K. that's really not correct. The only thing that's similar really to Australia is that FDA has used a similar way of describing it, similar terminology, but they're talking about doing something really quite different. So Australia and China achieve faster trial starts primarily through streamlined regulatory processes. Australia leans on ethics committees to approve clinical trials, and they have very tight timelines for doing that. China has an implied approval model. Both China and Australia still rely on traditional evidence requirements. They're not scrapping the regular testing requirements and replacing them with non-animal models. They're doing what is already done, but they're doing it much quicker and they're doing it with strict timelines. The U.K. has taken a more incremental approach. so it's speeding reviews and it's integrating regulatory processes, but it's not fundamentally changing evidentiary standards. So what FDA's attempting is, is really a more transformative shift by redefining the evidence that's required for trial initiation. And this could be more impactful in the, in the long run, but it's riskier and it's, you know, as I said before, it's slower to implement. And it, it doesn't create any certainty about the US matching the speed or the advantages that global competitors have in the near term. Of course, there's nothing that could, there's nothing really preventing the US from doing both. Right. But we're not hearing now about FDA proposing these kind of timeline changes that would make the US competitive with regulators overseas. And, and one other thing I would say from talking to a, a lot of biotech companies is that. One thing that would be much quicker and would have a much more immediate impact would be revising the way that FDA thinks about pharm tox requirements and streamlining that and making it much more fit for purpose. There's a lot of, of angst about the extent of the data that FDA requires. And whether it's all really necessary and there's, there's, I think, a, a consensus that a lot of the data that FDA requires isn't necessary. And also maybe that it isn't necessary at the times when they ask for it. So one example that, someone gave me last week is that FDA often requires a great deal of stability testing for products before they go into Phase I trials. The point is that when things are at that stage, when they're just going into a Phase I trial, it's really meant to give you a go or no go decision. It's kind of putting that cart before the horse to start worrying about things like stability testing at that point when you don't even know if you've got a product that you're going to advance.

Simone Fishburn: 8:53

So that's really interesting. Something like stability testing. It's a very easy case to make. Why do you need this before going into humans, I mean, in a way that is really the sponsor's risk, right? You know, one of the things I wanted to ask is to what degree is this about changing the toxicity or the toxicology studies. So for example, the amount of, let's say, rat data that's required certainly for chronic studies, that's quite extensive. does that vary between regions? Is that subject to change? Sorry. One more thing, Steve, that I'm gonna roll into the same question is on efficacy. Does any of this sort of relate? So we know that a lot of animal studies are just, the animal translational models aren't really very predictive at all. So is that the sponsor's risk, again, are they asking FDA to be more sort of flexible about what kind of efficacy readouts are needed?

Steve Usdin: 9:49

I think so, and I think that there's really a sense that, What Australia and especially what China have done, is they've made it possible for companies to iterate to close the iteration cycle much more rapidly than what happens in the United States. The um Phase I trial launch. The first in human launch is really seen as something that's going to be a part of a feedback loop. And the more rapid, that feedback loop is the more progress that you can make. And that, I think is a, is a mindset that people want FDA to adopt.

Simone Fishburn: 10:25

One more quick thing on this. Do you think, Steve, I know everything boils down to staffing, right? is this something where FDA is like differently staffed for, you know, review of later stage products? Is this something that, you know, it's a Whole mind shift change, but in addition to that, it's like a part of the talent base. is that different across the agencies?

Steve Usdin: 10:48

Well, I, I think it's partly a talent base and it's partly a way that things are organized. So the, preclinical requirements, the pharm talks requirements that FDA imposes on companies prior to getting clearance for an IND. There's a sense that I've heard from former CDER leaders that that they're too disconnected from the reviewers, there's too much kind of autonomy there and to, and too much of a sense that they are asking questions for the sake of kind of curiosity or um you know, too much risk aversion and that that is slowing things down. And that things should be taken into hand and streamlined so that you know that all of the kind of um precautions that are needed to protect patients are there. But that there aren't requirements that aren't gonna, actually lead to actionable information or necessary information.

Jeff Cranmer: 11:44

All right. And Steve uh first in human trials has come up in the negotiations between industry and FDA on PDUFA. What's happening there?

Steve Usdin: 11:56

So this is. So if you read the meeting minutes for PDUFA reauthorization, well, you don't have to 'cause I did. They tell a really interesting story, and it's a shift in the America first proposals from a stick to a carrot. Instead of penalizing companies that conduct first in human trials outside the United States, which is what FDA initially proposed; FDA wanted to impose essentially a $10 million penalty on applications for companies that do their first Phase I trials outside the United States. Now, FDA seems to be willing to offer a modest reward about a $2 million fee reduction for companies that initiate trials domestically, that do their first Phase I trials in the United States, that's a big change. When the proposal first came out for this um really massive penalty for companies that did their first trials outside the United States industry pushback hard, they argued that it would disproportionately harm small biotech companies and that it would disrupt the established PDUFA funding model. Still, there's significant details that remain unresolved. The PDUFA negotiations are supposed to wrap up by the end of this month, so we'll see how that plays out. One of the things that's unresolved is really how it's going to be defined. So FDA's offering this essentially$2 million fee reduction for Phase I trials that are anchored in the United States, exactly how that's going to be defined and how it's gonna be verified remains to be seen. What I also would add is that it's kind of gone from something that industry really wanted to avoid this big penalty to something that's kind of a meh, right? So the financial incentive under discussion now is too small, I think to meaningfully influence company behavior. It doesn't offset the cost and speed advantages of running early stage trials abroad. Or even the tax incentives in many cases that Australia provides. I think that if we get what it looks like we're going to get from the meeting minutes, again, industry kind of dodged a bullet. and FDA's gonna have a talking point that it's promoting America first clinical trial policies, but it's unlikely to actually change much.

Jeff Cranmer: 14:14

And what's the next step in the PDUFA negotiations?

Steve Usdin: 14:17

Well, like I said, there's still things that are unresolved we're not gonna hear about that uh how they get resolved probably until the final deal is released at the end of the month. One other America first proposal that's under negotiation. FDA wants to restrict PDUFA small business fee waivers to US based companies. This would, transform PDUFA into a more explicit industrial policy tool. And I think that it would discourage the really smallest biotechs that are based overseas from seeking US approval for products that have very small markets. Ultimately I think patients would suffer from that. Um, it could reduce patient access to new therapies, and it's not really going to promote US-based companies. It's not gonna help U.S. companies be more competitive. So we'll see how that ends up in the in the final package. So, FDA's gonna finish their negotiations with industry, I'm hearing by the end of the month they'll throw this over to Congress now. There's gonna be a lot of discussion. There's gonna be hearings, and there's gonna be a lot of proposals and discussions in Congress for legislation that would accompany the PDUFA reauthorization. I still think that at the end of the day, there's going to be um a lot more drama around this. Probably from the Trump administration side, there's going to be a strong urge to use some kind of brinksmanship to use the PDUFA process to get changes either at FDA or elsewhere that it wants. If there's a shift in control in Congress, it's likely that the Energy and Commerce Committee is going to be chaired by Frank Pallone, Democrat from New Jersey, who opposes a lot of the things that industry and frankly FDA want in terms of process reforms, that could be a sticking point. We'll just have to see what happens. And then there's a lot of groups, I'm gonna be writing about this in the coming weeks. There's a lot of groups that have come up with really interesting proposals for FDA reforms that could be appended to PDUFA for authorization legislation.

Jeff Cranmer: 16:20

All right, we'll keep our eye out on what you find, Steve. We're gonna take a quick break and then we're gonna come back and talk biotech deals.

Voice Talent: 16:31

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Jeff Cranmer: 17:38

We are back on the BioCentury This Week podcast. Last week Gilead announced its fourth significant deal of the year, we recently talked about its proposed acquisition of Ouro here on the podcast, uh, that's a deal. It is doing with its partner Galapagos. And back in February, the company proposed to buy Arcellx for nearly $8 billion and a cross border deal with Genhouse rounds out the group and now it is buying Tubulis. Uh, Paul tell us about the deal.

Paul Bonanos: 18:19

Sure. Um, Tubulis, so it's an antibody drug conjugate company privately held, very well funded based in Germany. they've been working on technologies to make uh ADCs that are more stable than some earlier generation ones with the, the linker and payload attachments, you know, they're designed to avoid releasing the payload prematurely cutting uh off target toxicity. Their lead program has some clinical data that came out at ESMO in October at target's uh NaPi2b, and there are some others behind it in the pipeline. also Gilead said that it's aiming to keep Tubulis mostly intact as an ADC research unit. They'll maintain a hub in Munich and keep the team, keep the platform alive. and as you may recall, Gilead paid a lot of money for Trodelvy uh in the Immunomedics deal. But as it has grown in cancer, it really didn't have much more going on in terms of ADCs. So this is a boost on that side. you know, they've really been trying to make their mark in cancer for quite some time. Uh, building on other areas obviously infectious disease. Our, our colleague Lauren, wrote a story about this recently. And this deal fortifies the pipeline further with ADCs brings in a research team that could make more. You mentioned the deal price, uh, about 3 billion. It's actually 3.15 billion upfront, but there are also milestones that could take the deal. The, the deals total up to 5 billion.

Simone Fishburn: 19:40

This is really another great deal for Europe. I'd also say it seems like Gilead likes Europe, actually. He's done a few good deals there this is something we take a particular, you know, look at obviously in our lead up to Bio€quity Europe, though we do it all year, all year long. I don't think normally that, Europe is thought of as a specific hot spot for ADCs, but clearly Tubulis has got some technology that is, compelling to Gilead and yeah, it makes sense,'cause as you said, Paul, they, they had Trodelvy but they didn't really have anything behind that. We've talked before about Gilead, making its mark in new areas and I think you really need to build a franchise, I guess, around a successful product if you really wanna mark that territory. Is that how you look at it, Paul?

Paul Bonanos: 20:25

Yeah, they, they had built some strength on the CAR T side. They acquired Kite and they have uh Yescarta, which I think is the bestselling CAR T out there. And the Arcellx deal was also building in the CAR T space. They have a multiple myeloma program, right? And that was 7.8 billion. So willingness to spend, willingness to grow in that area. And also Jeff, you're gonna be speaking soon about uh a VC fund in Europe uh as well, so continued strength on that side.

Jeff Cranmer: 20:50

We'll, we'll get to that in a, in a little bit. Yeah, Jeito billion dollar fund for the young VC firm out of Paris. So Paul, the other uh big deal last week that you wrote about Neurocrine tell us about that.

Paul Bonanos: 21:06

Soleno, yes. A company in a disease space we've been watching Prader-Willi Syndrome, a genetic disorder. It's characterized by a few things, but most notably a feeling of hunger that doesn't go away, an insatiable feeling, hyperphagia is the word for it. our colleague Danielle wrote a story a few months ago about how many different approaches there are to treating the disease. A lot of different targets implicated. And Soleno reached the market a little more than a year ago with a potassium channel agonist. And that's the first drug that really addresses the hyperphagia associated with the disease. There is something from Novo Nordisk addressing growth restriction, but it has a lot of contraindications and really the hyperphagia is a hallmark of this disease that kind of really, really was screaming out for a treatment. So Soleno's product uh VYKAT XR relieves the hunger aspect. It's been doing well since launch. It reached $190 million across roughly the last nine months of 2025. And now it goes to Neurocrine, which you may know markets Ingrezza for tardive dyskinesia and Huntington's disease. And then there's another drug chronicity for congenital adrenal hyperplasia. And one thing that we also thought was interesting, there have been some deals lately, billion dollar takeouts, where the buyer isn't a large pharma, neurocrine is not quite in that category. I mean, they're pretty big for a biotech, but they're not in the, the big biotechs tier, either kind of the lower part of the large cap tier. and, you know, Neurocrine deal is one, BioMarin made that deal for Amicus, late last year, Alkermes bought Avadel, Genmab bought Merus in the fall, that was $8 billion. So some action from that tier lately too. And, you know, we also talked about the frantic pace of deals. It, it really reached a fever pitch during the last half of March uh Merck buying Terns, Lilly Centessa, Biogen Apellis, all three of those were in the five to $7 billion range. And now these two more coming in around 3 billion upfront. If you taught it all up, if you go back all the way to March 20th, really not that long ago, less than a month there are $7 billion takeouts. Um, one, one of them is, is really kind of an asset sale, Novartis buying. Not a whole company, but a subsidiary of one to get an asset. all but one of the deals are more than $2 billion. And as I said, some of them are way bigger than that. If you, if you total up the seven, it's more than $28 billion upfront. And if you add in things like CVRs or milestones, the total layout easily cruises past 30 billion.

Jeff Cranmer: 23:38

Healthy start to the year, Paul.

Paul Bonanos: 23:39

Mm-hmm.

Jeff Cranmer: 23:40

Alright. Speaking of billions Paul, you recently spoke with Blackstone about its new $6.3 billion fund. What did you learn?

Paul Bonanos: 23:52

Sure. Well um so if I can take the story back a little bit just for context. You may know the Blackstone name, it's a large PE firm, but the story here is, starts in 2018 really when Blackstone acquired a venture firm called Clarus and turned it into Blackstone life sciences. So I said a venture firm. It's not really just a venture firm historically. It, done what we called risk sharing deals. They're kind of partnerships. With Biopharma is where it provided as Clarus and Blackstone, life Sciences continues to do this provided cash and clinical trial support for a late stage program, and then upon the success of the trial, it would generate return. And now that Clarus has become Blackstone Life Sciences with the strength of its parent it was able to do much bigger deals. So. The first fund was $4.6 billion closed in 2020. It backed some products in the late stages, most notably had a broad deal with Alnylam. Um, it invested in two blockbusters, Leqvio, LEK-vee-oh, I think they might say, and Amvuttra. Leqvio is now a, a Novartis product, but it did originate with Alnylam, and it helped Alnylam reach profitability and, and sustainability. Anyway, that brings us to today. They have their new fund. It's even bigger. You said $6.3 billion. This fund six. Clarus had four, it's now two within Blackstone. And I got to speak with Nick Galakatos, uh, you can read the story that came from our interview. The theme of the last fund was how does the firm scale from Clarus size to doing bigger deals and develop products with blockbuster potential, and now it can go even bigger.

Simone Fishburn: 25:27

Yeah, I really recommend this story. I thought it was extremely interesting to hear in his words. You know, we cover a lot funds that really operate at the earlier stage of a company formation. And this one really operates much later on. And it was very interesting to hear about their deals with Alnylam and you know, how they're doing company building or company growth, let's say at the later stages of a drug development and even company growth. I mean, Alnylam was a very big company when it actually made that deal with them. Um, so I forget how, what its market cap was then. but that seems to have been a success, right Paul? For both sides,

Paul Bonanos: 26:11

Yes.

Simone Fishburn: 26:11

and I think, right. I think that there are a few, it is just a very interesting model that in a way, Paul, am I right in thinking this was like the first really big entry of private equity in the recent era, in the sort of spate. And so seeing how that's played out, I, I'm not sure that all of the other deals we are really yet able to see how they've worked. I'm talking about, you know, Sofinnova's deal and you're gonna list them all for me, right, Paul?

Paul Bonanos: 26:38

Abingworth, going to Carlyle.

Simone Fishburn: 26:39

Basically, right. Abingworth and Carlyle, and that, that sort of thing. But um but this is one where it's really interesting to be able to talk to him and see how that model is changing, changing the range of things available for companies at that point of, of their existence.

Paul Bonanos: 26:54

Yeah, even really big companies are still resource constrained in their way. I mean, one of the deals from the new fund is with Merck uh obviously a, a company that has, you know, plenty of, plenty of cash. But um they're collaborating with them on an ADC from um Sichuan Kelun in China. The publicly disclosed information at the time of the deal was 15 late stage trials across six cancer indications. And um Blackstone is putting in 700 million in support. So they're sharing, yes, sharing the risk and uh collaborating late uh on a late stage product like this. And, and I should clarify also, they do some earlier deals beyond these kinds of collaborations that I've described. They sometimes take an asset from a biopharma that is, you know, somehow non-core or non-strategic, and they create a spin out, if you like, or a, a separate company, some sort of entity with the goal of developing it further up to some kind of readout, whether it's pivotal or proof of concept. And then make it, an attractive asset for a biopharma to buy. There is an example of having done this already with a hematological company called Anthos. The asset came out of Novartis, and Novartis itself wound up being the buyer eventually. But that's kind of another bucket beyond the late stage collaborations where they're kind of more in a mid stage mode and in many cases. And part of the way that that works is also the idea is that they prep it for a sale without ever needing to go public and having the deep pockets of a giant fund like this, allows them to fund up to some kind of, some kind of important readout without having to source the public markets, which has been difficult. So they give you an option to do it that way.

Jeff Cranmer: 28:36

Okay. And, and I wrote about Jeito's new fund not quite as late in how it plays as Blackstone, but definitely later than a lot of the other funds that we write about. Jeito invests primarily in European biotechs that it believes are about three years away from a milestone that could trigger an acquisition. The new fund is a billion euros, which brings what it has raised to about 1.6 billion euros. I got to speak with Founder and CEO Rafaèle who launched the fund the first fund about six years ago, and now they've got a portfolio of about 20, 21 biotechs uh almost all of which are European or have ties to Europe, with the exception of uh one NewCo that they invested in and that's Callio, ADC play. One thing that I thought was interesting, again, on the eve of Bio€quity Europe, Rafaèle sees new interest in Europe from LPs part of that's due to geopolitics. She has been fundraising for two decades, and she says now is the first time she has really seen LPs from the U.S., from Asia, from Brazil, really want to come to Europe. Uh, she said that in the past, Europe was almost a bad word. And let's see, uh, trio of exits really helped the firm to raise this new fund. So has its commitment to European biotechs. She sees European companies valued at about 30% less than their US counterparts at the time of entry to deals. But at exit, comparable values with U.S. biotechs. That story as well as the Blackstone story up on BioCentury.com. You can also read Steve's stuff. I'll drop links into the show notes. Steve also had another piece about the Parker Institute Steve, quick tease on that one.

Steve Usdin: 30:51

So the Parker Institute's coming up on its 10th anniversary, and so I thought it was a good time to take a, a look at it. It's, it's really fascinating. They're emphasizing the translational space. Their goal is basically to create a kind of a closed system where they can fund researchers who are doing cutting edge research in cancer immunology which is basically all of cancer research now. And then have data sharing agreements, information sharing, material sharing among researchers at multiple institutions. And then move move that research into the clinic rapidly, either by creating spin out companies or out-licensing or other forms of convening of, of these companies. They're also co-investing with some of the biggest VCs in the biotech space. they said they basically, in the last 10 years, they've, uh I don't have the numbers in front of me now. I think it's about $400 million that they've. invested in the space, and that's leveraged about $4 billion of venture money. You have to go back to my story. I may have my numbers a little bit wrong, but it's basically, it's in the right direction. To me, it's really fascinating because they're so laser focused on this idea of translation and Karen Newsome who I um interviewed the former CEO of the American Cancer Society. She said flat out, she said, we don't really have a problem in the United States or maybe even globally. on the discovery side, we're really doing really well there. The problem is in translation. Um, and they're trying to crack it. And some of the companies that they have created or that they've been involved with in early stages are having products that are in the clinic that are moving toward humans. So, you know, we'll get a readout, we'll see whether basically what they're doing is successful or not. And, and I think that the bigger question then also is whether it's more broadly applicable. Is it something that can be scaled in other therapeutic areas?

Jeff Cranmer: 32:46

Translation, bottlenecks in translation theme of Grand Rounds U.S. in Seattle, check that out. Check Steve's story on the Parker Institute out, good piece, glad that you've made time to write that one, Steve. A little different than what you usually cover. All right uh you've been listening to the BioCentury This Week podcast, subscribe. Check out our sister podcast The BioCentury's Show and we'll be back next week. thanks to Kendall Square Orchestra, which provides the music for BioCentury's Podcast.

Voice Talent: 33:24

BioCentury would like to thank IQVIA Biotech for supporting the BioCentury This Week podcast. To learn more about how IQVIA Biotech’s dedicated teams deliver support from innovation to impact, visit IQVIABiotech.com