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BioCentury

Product Development

Back to School, behind the scenes: a BioCentury podcast

BioCentury editors discuss takeaways from interviews with biopharma industry KOLs

Sep 9, 2020 | 1:50 AM GMT

BioCentury’s Back to School has returned for the twenty-eighth consecutive year, prescribing biopharma’s once-in-a-generation opportunity to reboot how drug development is done in the wake of the COVID-19 pandemic. On the latest edition of the BioCentury This Week podcast, Editor in Chief Simone Fishburn and Washington Editor Steve Usdin join Executive Editor Jeff Cranmer to discuss the key takeaways from their interviews with executives, investors and other industry leaders on how the biopharma industry can entrench fundamental changes that can lead to a step-change in both the pace and reach of drug development.

Citing BioCentury’s interviews with Novartis CEO Vasant Narasimhan and Roche’s Bill Anderson, Usdin discusses how empowered employees have helped pharmas respond nimbly to the challenges posed by COVID-19. Narasimhan is CEO of Novartis AG (NYSE:NVS; SIX:NOVN), and Anderson is the CEO of the Roche Pharmaceuticals unit of Roche (SIX:ROG; OTCQX:RHHBY) (see Cover Story:  “The Imperative of COVID-19: Biopharma’s Once-in-a-Generation Chance for Change”).

Usdin and Fishburn highlight common themes that run through many of their conversations with the industry leaders. For example, Usdin says Narasimhan, former FDA Commissioner Scott Gottlieb and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) President and CSO George Yancopoulos each cited the importance of investing in surge capacity to prepare for the next pandemic.

Fishburn points to the common refrain of collaboration across industry, a theme mentioned by nearly every one of the KOLs who spoke to BioCentury. She also discusses what she learned from U.K. Vaccine Taskforce Chair Kate Bingham and Oxford Univesity’s Martin Landray about how the U.K.’s RECOVERY master protocol trial, which identified dexamethasone as an effective treatment, is a model that other countries are trying to emulate.

A transcript of the episode follows.

[00:00:00] Jeff Cranmer: Welcome to BioCentury this week. I'm Jeff Cranmer, Executive Editor of BioCentury and I'm joined by...

[00:00:11] Simone Fishburn: Simone Fishburn, Editor in Chief,

[00:00:13] Steve Usdin: Steve Usdin, Washington Editor.

[00:00:16] Jeff Cranmer: I am digging the snazzy new intro music from our new friends in Boston, The Kendall Square Orchestra. Steve and Simone, as you know, last night we kicked off BioCentury's 28th Annual Back to School edition. Which this year we are delivering as a week long multimedia event, with essays and data charts, produced daily and complemented with 19 exclusive audio interviews with select industry leaders, such as Scott Gottlieb, Kate Bingham, and more.

[00:00:46] Simone, what will Back to School address this year?

[00:00:49] Simone Fishburn: There's really only one topic that you can address, and that is, how can the industry take all of this energy and commitment that it's taken to expediting countermeasures for COVID-19 and convert that into some kind of standard practice. Basically some way, what are the key take homes for reducing the amount of time and the amount of money it takes to bring a therapy to market. But at the same time, there are other lessons from this year.

[00:01:28] There are two really big messages that industry, and in fact, the whole ecosystem must learn. One is that we really have laid bare the racial disparities in healthcare, and that cannot go on. And the other is, that everybody was completely asleep at the wheel when it came to pandemic preparedness. That can never ever happen again.

[00:01:54] Steve Usdin: I would actually add a corollary to the one that you mentioned about racial disparities, which is about global inequities in access to medicines. One of the things that's going to happen, several people that we spoke with on the podcast... including Vas the CEO of Novartis mentioned, is that it's inevitable that people living in large parts of the world; in Africa, in South America, Central America, much of Asia are not going to get access to vaccines and to therapies for COVID-19 probably for a year or more after people in more affluent countries get access and that's something that I think is unacceptable. It's unacceptable both from a human point of view, but also from a public health point of view. If people in other parts of the world aren't protected and they're at risk, then all of us are going to be at risk.

[00:02:43] Simone Fishburn: Not disagreeing with that at all, but I want to go, Jeff, to the four stories that we're going to be rolling out this week. And I'm going to come back to Steve's point in a minute... because the first one which publishes today, Tuesday, makes the point that biopharmas must address that reality of racial disparities in healthcare outcomes that have been exposed by COVID-19.

[00:03:04] Those realities absolutely extend to developing countries, and as Steve has pointed out, their access to vaccines. But they do not stop there. They are at every biopharma's door, even in the West and my message, therefore, is that it's not okay for small companies to say, "I'm not working on something that is for malaria and that's the third world, whatever", they really need to be looking at the racial disparities on their own doorstep, which have shown us that Blacks -- African Americans, have a much higher liability for COVID-19. But the truth is the data has been out there for a long while that there are several other diseases, where racial and ethnic minorities are overrepresented and they are not being fed proportionately into or represented proportionately in clinical trials or in drug development.

[00:03:57] That is not only true in the U.S., it is true also in the U.K. and in fact, it's true in other countries, but many countries don't actually collect the data.

[00:04:06] Jeff Cranmer: What are some of those diseases?

[00:04:08] Steve Usdin: They're diabetes. They're chronic heart disease. They're many kinds of cancer.

[00:04:13] Simone Fishburn: We actually have some charts, Jeff, coming out in the material today that actually show that graphically.

[00:04:21] Jeff Cranmer: Excellent.

[00:04:21] So each day we're going to be coming out with a story, as I said, Tuesday's will focus on racial disparities. On Wednesday, we are going to publish two stories, in fact, that talk more about the nuts and bolts of what's being done extraordinarily in the pandemic that needs to carry on afterwards. And one of those is what I'm going to call the "third rail" of data sharing, that companies have started to show during the pandemic and we will make the case for where and how they should continue to do that afterwards. Another one is coming out tomorrow, is a big focus on master protocols, adaptive platform trials. And the RECOVERY trial in the U.K. is the poster child in COVID-19. I think I would say Steve, would you say I-SPY is probably the poster child prior to the pandemic for a master protocol platform trial, but they've really not been used very much.

[00:05:17] Steve Usdin: I agree, I-SPY has really, it's been a model... not only for master protocols, but for adaptive trials and I think that's a key concept. The story you mentioned, is one really about what are the lessons from the COVID-19 experience that industry and even more governments and societies at large have to learn to become better prepared for the next pandemic, because everyone who I spoke with about this said it's inevitable that there will be more pandemics and it's quite possible that future pandemics would be far worse than COVID-19.

[00:05:50] There are things that have been known for years, for decades, that have to be done or could be done to better prepare us. They haven't been done and now they need to be done. There's no excuse not to do them. Basically, there's a need to have a continuing R&D enterprise, focused on counter measures for known and unknown emerging infectious diseases.

[00:06:12] There's a need to create manufacturing surge capacity. There's a need to incentivize the development of new kinds of diagnostics, so diagnostics can be, ubiquitous and also to have surge capacity for diagnostics. And finally for, surveillance capabilities so that these things don't sneak up on us.

[00:06:32] Jeff Cranmer: So you've spoken to collectively 19 key opinion leaders in industry. Everyone from Mark McClellan, Peggy Hamburg and Scott Gottlieb... three, obviously, former FDA commissioners. You've spoken to Bill Anderson from Roche, Michelle McMurry-Heath from BIO, what podcasts would you like to highlight for us?

[00:06:56] Steve Usdin: Obviously they're all worth listening to, they're all great. I think that one of the things that really surprised me, was the concordance on a lot of points that people had. And some of the concordance was surprising.

[00:07:06] The CEOs of Novartis and Roche Pharma both attributed their company's resilience in the face of COVID-19 to the empowerment of their employees and I didn't really expect that. Novartis, has what they call an "un-bossed culture" and Roche, Bill Anderson said that they've gone as far as eliminating budgets and basically tell people to "do the right thing and justify it afterwards". And they both said that, this empowerment of their employees has accelerated in COVID-19 and they attributed it, to their success in keeping their operations running, and in being able to address COVID-19.

[00:07:43] Simone Fishburn: So a couple things, one is I think, probably every single podcast, people talked about the way people have come together, and the collaborations, and you know... that kind of energy. One thing that I thought was really interesting, one of my first podcast interviews that I did was with Kate Bingham, who is the Chair of the U.K. Vaccine Taskforce and she outlined to me why she thought the U.K.'s RECOVERY trial was so successful and what it did so well. And one of the last interviews that Steve and I did together was with Mark McClellan, who is the Director of Duke Margolis, and also a former FDA commissioner, and he outlined almost exactly the same points that Kate made. And I swear they didn't talk between them, I'm sure, the day before that.

[00:08:28] One interesting podcast to me was to talk to Martin Landray, one of the leaders of that master protocol trial. And what they talk about is the fact that they made the end points really simple and because basically, "do you live or do you die?", it was a 28 mortality endpoint. They reduced the burden on hospitals and the reason this is so important is that it meant that the trial could be conducted in about 175, what we would call in America "community hospitals", all through the U.K. -- Who normally can't do clinical trials because they make them so complicated, which is something we do in the U.S.

[00:09:03] So I think this is really important, not only for recovery, but also as a lesson for how to bring more hospitals and therefore more patients into the clinical trials enterprise, let's call it. And we talk about this idea of a network of clinical trials, so I think that hearing just the two of them articulate, basically the same points completely differently, and then talk to Martin Landray who reinforced all of that and had some nice sort of spicy English angles on it all, that was really quite interesting.

[00:09:38] Steve Usdin: It was interesting on the concordance theme; Scott Gottlieb, George Yancopoulos from Regeneron, Vas from Novartis... they all presented the same kind of ideas around the importance of investing in search capacity for manufacturing, and they all had the same solution for it. They basically said, instead of governments building standalone manufacturing facilities and having them ready for emergencies, that it's going to be a lot more effective to pay companies to create extra capacity and have the government be able to put a call on it, in case for emergencies.

[00:10:11] It's kind of a simple and elegant answer and I think it was interesting to me that everyone's thinking along the same lines.

[00:10:16] Simone Fishburn: Steve, can you think of any, I'm trying to think myself, do you think there are any places where there was real discordance? Where people disagreed with each other, if you would put one against the other? I'm hard pushed to think of one.

[00:10:27] Steve Usdin: I think that there was a difference in people's views about how much of what's happened during COVID-19 can and should continue.

[00:10:38] Simone Fishburn: Yeah, I agree with that.

[00:10:38] Steve Usdin: Josh Bilenker from the Loxo unit of Eli Lilly, basically said "After COVID-19 is over, things are gonna revert back pretty much the way they were". Other people said, "No, this is an inflection point things are never going to be the same again".

[00:10:51] Simone Fishburn: And I would also say that on infectious diseases... I had some people say, "Yeah, I think actually we're going to see a lot more investment in infectious disease and interest". And other people go, like you just said, "Nah, it's just going to go back to what it was. We'll forget this soon".

[00:11:05] Steve Usdin: And then the same thing about AMR. There were some people who said, "Oh yeah, this is going to be a wake up call and governments, and societies are going to make the necessary investments and policy changes so that we can avoid antibiotic resistance going forward". And other people said, "No, probably people are just gonna move on and screw it up, just like they have been screwing it up".

[00:11:24] Jeff Cranmer: You also spoke the two very prominent investors from opposite sides of the globe. From Europe, you spoke to Francesco De Rubertis of Medicxi and from China, you spoke to Nisa Leung from Qiming... what did they have to say?

[00:11:42] Simone Fishburn: Each of them actually gave a little bit of the perspective of where they are regionally. So, what was interesting about Nisa's, what I took away from that was this picture of a really much more developed biopharma ecosystem in China. She had talked about her career starting after the 2003 SARs outbreak, where there really wasn't this kind of ecosystem there. And it's evident from what went on in China after this broke out, the way companies got together. She's really looking at diagnostics and AI and the ability of AI through some of her companies, to advance technologies. And really, you just got this sense from this interview of this budding ecosystem in China, right? Budding is probably the wrong word... maturing is actually the correct, but I think it's been budding for a while... I think I'm going to go with maturing for a little bit now for that ecosystem.

[00:12:38] And with Francesco in Europe, we talked a little bit about preclinical assays and harmonization. He really actually emphasized what this means in terms of putting science on the front pages and how science is now the cool and interesting thing to do and to be. I asked him whether he thought that should continue and that we should continue to have scientists out there in the public really explaining their case and he said, "No, don't do that, scientists hate that... they just want to go back to their bench, bury their head in their work and do all that". He basically said, it's a good thing that we've got so much science out there, but no, don't ask scientists to do this as a day job.

[00:13:16] Jeff Cranmer: Steve, you had mentioned your conversation with Vas as yielding a surprising comment about the "un-bossed culture", were there any other unexpected things that you heard?

[00:13:28] Steve Usdin: Yeah, one of the things that he said that I thought was really interesting is that it's too early to declare success against COVID-19 and it's too early to say that the shortcuts that were taken are going to work. He cautioned, he said, "look, companies haven't done the dose ranging studies that they usually do. They've skip some of the preclinical testing that usually do. They've shortened a lot of the timelines".

[00:13:53] And he said, "look, we're going to have to wait till we get the Phase III results to know whether those were actually smart decisions". It may be that some of the things they're going to regret that they took some of the shortcuts. You know, there are good reasons why all of those things are done and maybe possible to speed them up, but he said, "Don't just assume that everything's going to be fantastic and that you can just skip all of these things with no consequences".

[00:14:20] Simone Fishburn: I think I wouldn't say regret, but rather not embed for the long term. Cause he said we have to do it now, but how much of these we adopt going on.

[00:14:28] But I do want to just end on one thing that I thought was very interesting that he said, which is that he said, "we've really learned that the precompetitive space is much larger than we ever realized". And so I think on the one hand on the clinical trials, we don't know in the future how many corners you can cut, but it does seem to be some convergence around the idea that there's more mining to be had in pre-competitive sharing than there has been until now.

[00:14:54] I don't know if he's optimistic, I'm optimistic .

[00:14:57] Steve Usdin: Just one last point, which is that I thought Rod McKenzie from Pfizer, he made a very good point along these lines. He said, "look, patients who have a whole variety of diseases and conditions are just as desperate as people who are faced with COVID-19 and companies and regulators, can't go back to business as usual".

[00:15:19] He said, "people are going to look at drug development timelines and they're going to see how fast things were done for COVID-19 and people have any one of a myriad of other diseases and conditions are not going to accept business as usual anymore". And he gave some specific things that have been done in COVID-19 that he thinks need to persist in order to get cures and therapies to patients with other diseases, just as quickly as is happening with COVID-19.

[00:15:51] Jeff Cranmer: I look forward to having that one hit my inbox, hopefully shortly. That's all we have time for this week .

[00:15:57] Music for all of our podcasts is provided by Kendall Square Orchestra, which connects science and technology professionals and other members of the greater Boston community to collaborate, innovate, and inspire through music, while supporting causes related to healthcare and education.

[00:16:14] All of our back to school content, including the audio interviews that you just heard about, can be found at biocentury.com. That's also where you'll find our COVID-19 Resource Center, where we're tracking nearly 800 therapeutics and vaccines.

Sponsorship opportunities: Sponsorship and Underwriting packages are available for webinars, podcasts and surveys. For more information, please contact Eric Pierce and Josh Berlin at conferences@biocentury.com.

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