Ep. 6 - 18MAY2020
Simone Fishburn: Welcome to BioCentury This Week I'm Simone Fishburn, editor-in-chief at BioCentury, and I'm joined today by my colleagues...
[00:00:07] Steve Usdin: Steve Usdin, Washington editor, BioCentury...
[00:00:10]Karen Tkach Tuzman: Karen Tkach Tuzman, associate editor and head of preclinical content.
[00:00:14] Simone Fishburn: We're going to talk today about some of the developments going on in the world of COVID, and we will end by looking at something outside of COVID.
[00:00:22] We're going to look at some of the upcoming data in cancer that's going to be presented at ASCO and AACR. So we're entering a new phase, I feel on various fronts. We've got data starting to come out now for vaccines. We've got two new heads of vaccine initiatives, one in the U.S., and one in the UK.
[00:00:43] And I think one of the biggest changes, at least in the biotech universe, was the appointment of a new CEO of BIO. Steve, you sat down with a new CEO last week. Tell us about her and tell us why this is such a big departure.
[00:00:58] Steve Usdin: Well, I didn't actually sit down with her since, we can't really sit down with people these days, but I did speak with her, over Zoom, which is as close as you can get.
[00:01:06] Her name is Michelle McMurray-Heath. And to be honest, she's just a breath of fresh air, for the trade associations and, and more broadly for the policy community in Washington. She has both a kind of an effervescent personality, and a warmth to her. And also a tremendous depth of experience.
[00:01:26] She's been at FDA. She's got an MD, she's got a PhD. She's worked in the lab. She was, a senior leader at J&J. So she's got a huge CV, but also, a huge personality, which I think is going to be really important.
[00:01:43]Simone Fishburn: Let me ask you something, Steve. So obviously no secret. I'm delighted to see a woman and a different iconography, at the top of such an important organization. But she's got her work cut out for her. BIO has often been seen as the little brother, so to speak. Maybe a little sister of Phrma.
[00:02:00] What's she going to do to make the trade organization deaf. What's she got to do?
[00:02:08]Steve Usdin: The interesting thing is that in picking her, the leadership team at BIO weren't just looking for somebody who was different, they're also looking to take BIO in a different direction. I think that's something I wrote about and I think other people haven't really picked up on it. So what they said explicitly is they don't want BIO to be mini-Phrma anymore. And they want to narrow its focus really to two sets of issues. One set of issues is around patients and what the biotech industry can do to deliver solutions for patients. And the other is around innovation. So what they're not going to be doing, they told me, are some of the things that Phrma has done that BIO has traditionally tried to support Phrma on, which honestly, it hasn't been very effective on the one hand and, on the other hand, hasn't done anything to bolster BIO's reputation. So things like, I don't know, like BIO in the past has supported Phrma's efforts to prevent legislation that would cap increases of Medicare drug prices at the level of inflation, which is something that's very difficult to defend if what you're really talking about is patients and innovation. That pitch Paul Hastings gave me, is that, BIO's not going to be taking any steps in the future, he said, to try to help companies extend their patent monopolies. That basically their idea is that, once the patent is over, then companies should do everything that they can to encourage competition and that will lead to a kind of a cycle. There'll be continuous innovation.
[00:03:44] Simone Fishburn: So I think one of the themes that I'm picking up here and the timeliness of that and in some of my other conversations, is that this is really a time to show the world what the industry does best and some of that, if it's going to stick, is going to mean getting rid of some of the things that they used to do that are, you know, we're not defending them, should we say. BIO can only be as good as its members, or its members choices. One thing that came up when I spoke to Jay Bradner, who's the president of Novartis's NIBR, last week that I thought was really interesting. So what we've learned now from studies on the virus, on the SARS-COV2 virus, is how incredibly similar it is to the virus that caused SARS, the outbreak in 2003. He said that the active sites basically overlap and it's incredibly similar. And he said that was both exciting.
[00:04:42] And he used the word sad and he said the word sad because in 2003 if they'd followed through, if the industry had gotten together like it is now, and if they'd followed through, we'd probably have drugs in hand that would actually work against this virus, which I thought was interesting and chilling.
[00:05:01] I mean, on the other hand, it means that we've got a lot of good things that are going on. The biology is just racing ahead. People are uncovering new things all the time, and I think Bradner and other people feel that there's a lot of information coming out and they're pretty hopeful on the ability to create medicines that will block this virus. That said, it's not going to happen overnight. And I think that there's sort of a sense of public expectations. So I don't know if the BIO CEO role has a role in helping communicate to the public what is realistic and what isn't. I know you've certainly got thoughts on how people should approach that.
[00:05:43] Steve Usdin: I think that there's a potential that you could look to the public is there's this tremendous thirst for credible people who have expertise. To talk. I mean, who would have thought that Tony Fauci would become a national or global hero, and the same with Scott Gottlieb. I've known both of them for a long time.
[00:06:02] I admire both of them, but, you know, honestly, they're pretty nerdy people for you to think that they're going to be global heroes. I've actually seen signs in my neighborhood where I live in Washington that say Fauci for President 2020. You know, that's not something that you would have expected to see.
[00:06:16] And I think that, Michelle McMurray-Heath has the potential to be a voice like that. She has the experience and the background and the personality to have that kind of credibility. It's going to be difficult because she's representing drug companies and the public doesn't trust drug companies.
[00:06:35] And there's a lot of bad reasons for that and some good reasons, but I think that she has the potential to become the same kind of figure as Scott Gottlieb and Tony Fauci are.
[00:06:46] Simone Fishburn: Well, I hope so. I mean, I wrote about this previously. I really do wish that the CEOs and the heads of R&D of the big pharma companies would be out in front of the public.
[00:06:57]I spoke to my dad this weekend. He lives in the UK. I challenged him. I asked him if he knew the name of a single one of the heads of R&D, or CEOs of any of the pharma companies. And it's sort of quite absurd in a way that they're not public figures right now. That they're not out there telling the world what they're doing.
[00:07:17] And you know, the answer lies within this community. Having said that, we have also seen a couple of big names from the industry take some important positions, public positions. Moncef Slaoui, who used to be the head of vaccines and the head of R&D after that at GlaxoSmithkline, has joined the U S vaccine initiative, and Slaoui really does have a long record of knowing about vaccines. He headed GSK's activities there. And Kate Bingham has become chair of the UK's vaccine task force, which was only created a month ago and had a couple of head's already, was being led by them. Now Kate is the chair.
[00:08:04] So I think we still have to understand how those dynamics are going to work. She's reporting directly to Boris Johnson. I think in both cases, it's not exactly clear what the role is. I think that industry background will be really important. But again, communicating to the public is, is going to be important because we've got data coming out now from these vaccine trials.
[00:08:25] So what does it mean and what doesn't it mean?
[00:08:28] Steve Usdin: So I thin k looking at Moncef Slaoui in the United States, he's heading up this organization which has a regrettable name of Operation Warp Speed. I think that it's really unclear what his role is, what this organization's going to do, how it relates to the ACTIV public private partnership that NIH is running with industry and academics and FDA.
[00:08:55] And then in turn there are other collaborations. There's the COVID R&D group that we've written quite a bit about. It's really not clear what Moncef Slaoui's role is going to be, what his responsibilities are, what his budget is. It really looks in a way like the administration has layered on a whole nother level of, management of leadership on top of things that were already happening without having clear lines of delineation. One of the things that I think interesting and it is heartening, is that the people who were underneath Slaoui in this Operation Warp Speed are Janet Woodcock at FDA, is the director of the Center for Drugs who's going to be in charge of therapeutics.
[00:09:39] Peter Marks, who's the head of the Center for Biologics at FDA is going to be charge of vaccines. So these are heavyweight people and they're the right people. The question is what their roles are, how they're going to relate to everything else that's happening. Because there isn't a need to have, for example, a new scientific director for the vaccines effort.
[00:09:59]That's already well in hand. What's really needed now is somebody who can coordinate the whole supply chain, who can figure out how we're going to get the glass vials made and distributed in the right places. How we're going to get the syringes made, how the logistics of the clinical trials are going to be done so that they're not stepping on each other and how the pharmacovigilance data is collected after vaccines are being used in phase three trials and perhaps in emergency use.
[00:10:29] Those are the things that really need to be done and to do those, it doesn't really need so much expertise in the science as in the logistics and in how government works. And how to make government work better and quicker.
[00:10:44]Simone Fishburn: And in the UK, again, I don't know exactly the brief of Kate Bingham. I hope to talk to her soon.
[00:10:50]She is a long time Investor, a managing partner of SV Health Sciences. But she's actually done a lot. And so she created, she was the driving force behind the dementia discovery fund, which, aims actually to find treatments for dementia for Alzheimer's that are outside of the amyloid hypothesis.
[00:11:12] And in doing that, she'd ga I don't know, maybe five, six, seven of the top pharma companies, she got government money behind that. She's managed to corral some quite substantial, players into channeling them towards a single goal. And so I think that corralling things will be part of her brief.
[00:11:32] And maybe as you say, similarly in the UK, where of course, one of the top vaccines is a front runner vaccines is, is being investigated, the Oxford vaccine. And before we go to talk about ASCO and AACR, Steve, just give us a quick top line on the data that came out last week about the Oxford vaccine.
[00:11:51]Steve Usdin: The data on the Oxford vaccine, it actually highlights what I think, and I should have said what I think one of Moncef Slaoui's main jobs should be, which is to educate the public and to manage expectations around what is going to come out of vaccine and drug development. So the preclinical data that came out of Oxford suggests that their vaccine is likely to reduce symptoms. It's likely to reduce the incidents of pneumonia. And that pneumonia in turn goes into a downward spiral that causes people to go on to ventilators and all too often to die. So that if that's what it really does, in real life, it will be a tremendous positive accomplishment.
[00:12:37] On the other hand, it won't be what people are expecting. When politicians tell them and pundits say, "Oh well, everybody's going to be able to go back to life the way that it was before COVID. We're going to be able to have 50,000 people going into a football stadium was we're going to be able to have everybody jammed together, at schools like they were before."
[00:13:00]If the vaccine that comes out of all of this is like what the preclinical data on the Oxford vaccine suggests, that's not what it's going to be able to do because it doesn't prevent infection. It doesn't prevent people from spreading it. It doesn't prevent symptomatic or asymptomatic people from spreading the disease, and it isn't a hundred percent effective in preventing the most serious consequences from it. It's a step forward, but I think that it's going to be really important for people like Moncef Slaoui to set expectations. Because the danger, I think, is that people will see this and they'll say, "Oh well, it doesn't prevent me from getting the disease, and it's not a hundred percent so what's the point?"
[00:13:41] And they won't take it. There's going to have to be a lot of education to make people understand how a vaccine, even if it's partially effective, it can be a really important tool in preventing and lowering their personal risk and also in creating an environment that's going to make it possible to go back to normal, along with a whole bunch of other steps.
[00:14:04] It's not going to be a magic bullet.
[00:14:06]Simone Fishburn: Well that's a great point. Managing expectations is important. Hype is something that we've known a lot about in the world of cancer and Karen, I want to talk to you now, with relation to, cancer investigations that are coming out. Immuno-oncology PD1s have been all the rage for, I don't know how many years now.
[00:14:26] Everybody's been looking for the next PD1. What is important about TIGIT and what did we learn last week?
[00:14:37] Karen Tkach Tuzman: Great, last week as ASCO abstract started to come online, we started to see some victories for next generation approaches to establish paradigm. One of those being, as you mentioned, checkpoint inhibitors.
[00:14:51]We've been watching, I know at BioCentury for awhile, the rise and fall of different, what we call next generation check points. But in ASCO this week, it seems like we're seeing TIGIT kind of rise to the top as a promising Avenue with some data from Roche. We saw improved ORRS and, importantly, that there wasn't, didn't seem to be additional toxicity on top of the PDL1 inhibitor that they use, which was something that for the, the one kind of checkpoint combo that is really established, for PD1 and CTLA 4, that's been an issue as the extra toxicity. So, there was a lot of excitement around that. and there was also excitement around data from Macrogenix. they had a bi-specific a PD1 in lag three. and so lag three being another one of these next generation checkpoints that's been coming out.
[00:15:41]Simone Fishburn: I think another one is a completely new area, what we call a hot topic. And I think first serious clinical data coming out for protein degraders I'm going to call them. I think they've got various, various names, targeted protein, degraders and so on. just give us a top line on what those do and what is exciting that we heard.
[00:16:04]Karen Tkach Tuzman: So, Arvinas, which has been doing a lot of the firsts in this area, came out with the first clinical efficacy data for their projects, and this was in, really heavily pretreated patients, where they tested their androgen receptor degrader.
[00:16:21] And so these patients have gotten androgen receptor inhibitors before, along with a slew of other things. And, they showed in the -these were dose escalating studies, and so they're kind of focusing on, a certain dose and above. And then in, in those patients where the dose did hit, the sort of, serum levels that they've shown pre-clinically or are leading to, efficacy in those patients, they did see, some responses by, PSA decline. this, this is castrate resistant prostate cancer. and they also saw, restripe to see one. A response via a resist criteria. And so, this is the first time that we're seeing targeted degraders, provide some kind of benefit to patients, and indicating that it, it might really for patients where inhibiting the target, is no longer working, degrading it to taking those target to the cellular trashcan, might make a big difference.
[00:17:18]Simone Fishburn: Well, I think it's, you know, always gratifying to watch a new area. it takes a while for a new technology to get fleshed out. But it is certainly always interesting. One of the things that we watched at the innovation end in BioCentury, and we'll be covering more of the, ASCO and AACR data as they come out.
[00:17:38]So to our audience, thank you for listening. All of BioCentury's coverage is available at our website, biocentury.com. Our Coronavirus coverage is available in front of the paywall at BioCentury.com/coronavirus. Our podcasts, this and the others, are available on the website and via Spotify, Apple, Google, and Stitcher.
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