2020’s silver linings, New Year’s hopes: a BioCentury podcast
Unprecedented industry collaboration topped the “Best of 2020” list for BioCentury’s editorial team for a year in which there was no question what topped the “Worst” list. On the latest edition of the BioCentury This Week podcast, BioCentury editors discuss the industry’s bright spots of the past 12 months — data-sharing, diagnostics and more, and the lowlights — politicization of science, trial disruptions and the urgent need for diversity in clinical trials and biopharma companies.
The editors also take a shot at predicting the year ahead, seeing the industry’s women leaders attain new heights, innovation breaking new ground — and could it be the year of protein degradation?
Top of mind for many members of BioCentury’s editorial team is the way in which industry came together in a way it had never done before, said BioCentury Editor in Chief C. Simone Fishburn.
For Fishburn, diagnostics stepping into the limelight was an important step forward during the past year. “And now whole world is hanging on diagnostics. Everybody needs to get tested,” she said.
Associate Editor Karen Tkach Tuzman discusses the winding road for COVID-19 testing this year, and the bright spot of biopharmas pledging to take concrete actions to tackle systemic racism.
Senior Editor Lauren Martz zeroed in on the bounty of master protocol trials as one of the year’s highlights.
“We got to see on a really big scale the benefits that those types of trials have for the greater population,” Martz said. “I think we’re starting to see that these can actually help companies, too. The hope is that going forward this can be applied to other indications, and we can achieve some of those efficiencies beyond what we’ve just seen here for COVID.”
Executive Editor Jeff Cranmer noted that companies beginning to recognize the urgent need to increase diversity in clinical trials, as well as share data on a much broader scale were two other mileposts of the year. BioCentury addressed both themes in its annual Back to School issue, “The Imperative of COVID-19 — Biopharma’s Once-in-a-generation Chance for Change.”
“The COVID crisis itself really magnified what was going on in terms of racial disparities in terms of access to healthcare. I think it’s something that our industry will never be able to ignore again and that’s important.” said Tkach Tuzman.
Martz was among several BioCentury team members to call out the impact of clinical trial disruptions on small companies and patients as one of the worst parts of 2020.
For Fishburn, the lowlights included the politicization of science, and the lasting damage to public health organizations as well as the untold mental health burden across the population. She also flagged the undiagnosed cancers from postponed routine screens.
“There’s a reason that we have those screens. And the reason is that we detect cancers, and we detect them early. When we detect them early, we can catch them and save people,” she said.
Looking ahead, 2021 could be a turning point for several new modalities with mounting clinical validation highlighting benefits over standard antibodies and small molecules, ranging from approvals of CAR Ts against new targets to mRNA therapies and vaccines, according to Martz. Tkach Tuzman’s pick is for 2021 to be “a big proving year for targeted protein degradation.”
For Fishburn, the New Year will see biopharma’s women achieve new heights of representation in executive positions and company boards, and innovation continue to break boundaries, sparked by immigration and global cooperation.
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,
[00:00:14] Karen Tkach Tuzman: Karen Tkach Tuzman, Senior Editor,
[00:00:17] Lauren Martz: Lauren Martz, Senior Editor,
[00:00:19] Jeff Cranmer: Well it's our final pod of 2020. 2020 the year we learned how to teach 5th grade math while interviewing biopharmas brightest minds about COVID countermeasures while they're teaching 5th grade math. Perhaps the thing I least expected going into the year was the immense gratitude I would feel when I learned that Anthony Fauci, a kid from Brooklyn, can't throw a baseball.
So, we say goodbye to a grueling year. BioCentury's editors have furrowed among the disasters to pick out some of the positives from 2020, and call out some of the worst of the pandemic's collateral damage. And then we are getting out our crystal ball to see where the sun might shine in 2021. So, Simone, Lauren, Karen, I'd like to hear from you. What were the best moments for biopharma in 2020, what were the biggest disappointments, and what are you hoping to see next year? Simone what's top of mind for you?
[00:01:28] Simone Fishburn: Let me start by saying several of the editors — not everyone's on this call — but we've all weighed in and there's going to be a piece coming out this week with our picks. Several of us really saw the industry come together in a way it had never done before. Because biopharma was created — in what do you want to say the 80s? — and there's never been a disaster like this that has really given the industry an opportunity or needed the industry to step in and show the world the value of its day job. So, I think a lot of people called that out.
[00:02:02] Then some of us — I know Lauren, and Karen are going to weigh in — if you dig into the weeds there are also some other really important ways that we've moved forward, and we're hoping that some of these will actually stick. For me, one of the really big things is that diagnostics, which has really been the sort of poor relation of drug development for a long time, infectious disease diagnostics in particular. And now the whole world is hanging on diagnostics. Everybody needs to get tested. Another highlight for me is that Karen has become a huge expert in all the various methods, and we'll be covering these going forward. But these are finally got some respect; everybody the world over is talking about PCR testing, antigen testing, and these are household terms. That's a really big one for me. And I'm really hoping that investment in diagnostics can continue. They've shown how important they are even for getting economies back up again. So, I have a couple of others, but I'm going to hand over to the others to weigh in with us.
[00:03:06] Jeff Cranmer: Karen , diagnostics . Tell us a bit about what you learned over the course of the year now that you're our new Dx guru?
[00:03:14] Karen Tkach Tuzman: It was really interesting watching kind of the plane get built in real time. Both in terms of the tests themselves, but also in terms of people's understanding of what testing would be important and how. Really early on in the pandemic obviously there was the need to detect infections there was a ramping up of production for that. And, things like PCR reagents, and swabs became these crucial bottlenecks that everyone had to rally around.
It was also interesting watching the conversation evolve around what is the testing that you're going to need to reopen society. And at first everyone was talking about serology like, “Oh, if you can detect antibodies against the virus in people's blood then you can maybe give them a passport, they can go to work, et cetera.”
First of all, those tests came out in a way that was pretty variably regulated and FDA first said we're not regulating them than we are. There were some issues there. Also, people kind of quickly realized that we don't actually know if antibodies mean that you're protected or not. And actually the Infectious Disease Society [of America] has said there's really limited use cases for serology at least as of maybe a month or so ago.
Then the conversation evolved to actually repeated testing for the virus. The question is how frequently, what sensitivity, et cetera and that's still kind of the ongoing conversation.
And now we've moved into home testing and what are the implications of that? So, it's been a really interesting journey, and I've been grateful for a front row seat to that. And being able to talk to some of the experts in this as the pandemic's evolve.
[00:04:48] Jeff Cranmer: Excellent.
[00:04:49] Lauren, I know that you followed all of the master protocol trials for us across the year. And high on your list was pharma collaboration around COVID counter measures. Can you expand on that a bit?
[00:05:05] Lauren Martz: Yeah, Simone mentioned this, but I think it was really cool to see the industry come together to tackle this common problem. There was really an unprecedented collaboration around countermeasures for COVID. We saw companies decide to take their therapies into master protocol trials. And so, we got to see on a really big scale the benefits that those types of trials have for the greater population. I think we're starting to see that these can actually help companies too.
The hope is that going forward this can be applied to other indications, and we can achieve some of those efficiencies beyond what we've just seen here for COVID. I think that with these huge pharma and biotech collaborations that we've seen the infrastructure and the relationships are now in place and that's a huge positive from this year. The opportunity is just to carry that forward and I guess we'll see what happens.
[00:06:02] Simone Fishburn: Lauren, I think it's interesting because when we did this chart for our annual Back to School essay we looked at the number of master protocol trials across different diseases. What we saw was cancer had the largest number: It was more than 20. And in this one year COVID-related master protocol trials that were, I think, around 13 or something like that that had been stood up. So, that was just this year and that was even by July, August or something.
Every other disease had a trickle, had one, or two. There were a couple of infectious diseases, there was ALS, a couple of neuro diseases. And I think what we've been looking for is people to recognize, the industry to recognize, the power of these trials. And the ways that they can really expedite drug development, even reduce costs and drug development, be patient-sparing. We're really hoping that people will have, I don't know, got their feet wet on this and be willing to try them more in other diseases even after COVID.
[00:07:05] Jeff Cranmer: Back in September, our annual Back to School issue focused on some of these themes. A couple of others that it focused on was the need to increase diversity in clinical trials, as well as data-sharing. And I think I've heard from a lot of my colleagues that these were two areas where we did see some really positive movement this year.
[00:07:34] Karen Tkach Tuzman: I think this was the year — and it was a confluence of things — but this was a year that I think biopharma as an industry and a lot of the world got really serious about reckoning with systemic racism. Calling it what it is, and acknowledging it in its ranks, and identifying concrete ways to do better. And this was, of course, in the aftermath of the George Floyd protests.
It was really it was heartening to see our industry do something more than platitudes, and pledge to take concrete actions. And there are a couple of things that stood out to me like MassBio, the trade org in the Boston area — they did this pledge which struck me because it had some really concrete metrics. It said biopharma that sign onto this pledge have to do at least a number of these actions to make their workplaces more diverse, representative, and you know, anti-racist, frankly.
Clinical trial recruitment is a big part of the focus of the industry really acknowledging the glaring gaps there. Particularly in Back to School, we did analysis of diseases where the Black community is disproportionately affected but then underrepresented in trials. And so, in the COVID crisis itself really magnified what was going on in terms of racial disparities in terms of access to healthcare. I think it's something that our industry will never be able to ignore again and that's important.
[00:09:07] Simone Fishburn: I agree, I think one of the really important things was that the conversation moved beyond just saying we need to think about staffing, and promotions, and the internal machinations within companies and in terms of enabling diversity to thinking about concrete things like clinical trials. And I've actually been in conversation with various people, one is an epidemiologist and I think it's really important that we start to have a conversation.
Not everybody agrees about the best way to end up with a better representation but outcomes is what we really need to be looking for. So, everybody agrees on the goal and the importance of it. But some people say you should create every trial with a view to ensuring diversity.
There's actually another school of thought that says, "No, that would make trials completely impossible to run; they'd be huge." And actually, there's an argument to do it this way. And I really that's something we're going to be continuing to watch at BioCentury. Now it's on people's radar. So, it's not a question of getting it on people's radar or needing to justify it anymore. Now it's a question of what are the best ways to design trials and strategies in order to achieve equity in health outcomes.
[00:10:28] Jeff Cranmer: All right, and thoughts on data-sharing?
[00:10:32] Simone Fishburn: I think data-sharing is one of the areas where I've heard different things. On the one hand, people are really glad that it's on the radar, and it has really moved forwards. And the other hand I really think it's inched forwards rather than taking big strides. The same might be true in retrospect about health outcomes and equity across different races. But I know that there was some people in the industry who are frustrated that they haven't managed to go further with this. There are others who are pointing to organizations like TransCelerate, and these very big consortia that came together that started to share data for COVID-19. The question really is: Are they going to share data on anything else?
[00:11:15] Karen Tkach Tuzman: Yeah, one of the things that was sort of disappointing was seeing how little there seems to be in terms of harmonizing. It sort of on the continuum of data-sharing. Harmonizing protocols so that everyone is speaking the same language and comparing apples to apples. One of the places you really see this as around neutralization assays of viral neutralization assays for the vaccines. Companies were publishing data at a pretty steady clip about their vaccines’ ability to induce antibodies, and trial participants and that's great. But the titers are all calculated using different methods. Different assays with different cell types, or different versions of the virus. It's natural that there might be some heterogeneity there. But this was really the moment I think [industry could have] pulled together on some of those basics. And it was a little disappointing that was not the case.
[00:12:04] Simone Fishburn: And this was not a new problem for the industry. The industry had this exact same problem with PD-1s, where you've got gazillions of companies going after it. Then when the first ones came out they were all using different analytical methods and so physicians couldn't compare across them. And that is something that as you say for COVID — it's just like everybody sees everything now so everything's amplified. But that is absolutely problem that's got to be fixed going forward in terms of drug development, and ability to compare across trials.
[00:12:34] Jeff Cranmer: The collaborations went well beyond data-sharing. For me that was one of the coolest things to watch this year. Very early on I think it was you Simone who talked to Novartis’ Jay Bradner, and he told you something to the effect of "it's quite uncommon for us to call our neighbor Takeda and ask for a stick of butter", but that's exactly what these companies were doing. Bradner mentioned to us that he or someone on his team got a call from Andy Plump, who's the president of R&D at Takeda. Andy just said "we've got some protease inhibitors you're welcome to test them". And they stood up a team in this area right away. Seeing a lot of that happen I think was really unprecedented.
[00:13:21] Simone Fishburn: That's one thing that we at BioCentury have had a front seat to witnessing this collaboration with the COVID R&D Alliance, and there've been a couple of others. Steve Usdin, who's not on this week, but he's also been talking with many of the big movers and shakers in the ACTIV trials, and so on. And so it's really been interesting to get some of the backstories on that.
[00:13:45] Jeff Cranmer: Yeah, and I guess speaking on behalf of Steve — we let him sleep in today; well deserved after he wrote some 300 articles this year — his pick was validation of mRNA vaccine platforms that rapidly develop new and highly effective vaccines. And he called this a new stage in preventing disease.
[00:14:08] Simone Fishburn: Actually I want to ask Lauren very quickly about that. Do you think Lauren that's now vaccines going forward. Everyone's going to start with an mRNA?
[00:14:16] Lauren Martz: I think it could be yeah. I think this year is a big moment for new modalities in general; these mRNA vaccines have been incredibly impressive the way they can be a manufactured, the way they can be adapted to new indications. I think we'll see what happens as more people are vaccinated. But I think a lot more companies are going to step into this space. A lot already have. There are a ton of mRNA companies.
[00:14:42] Jeff Cranmer: I'm very excited to watch that. Another of our editors who we let sleep in, take a little time off is my fellow co-host of this podcast Virginia Li. She has been watching developments in financing for biotechs this year. And it goes without saying IPOs had a banner year in the sector breaking all records. SPACs made a comeback with specialists at the helm. And each week we saw a flood of new, innovative companies. And one way we measured that was in how many emerging company profiles we wrote. And I think we wrote, what was it Simone, about 20% more than in past years?
[00:15:28] Simone Fishburn: Yes, we did.
[00:15:30] Jeff Cranmer: So let's get to the bad news here.
[00:15:34] Simone Fishburn: Other than the obvious, right?
[00:15:35] Jeff Cranmer: Other than the obvious. Well, I mean the death toll, it needs to be said. The death toll from COVID-19 clearly tops everyone's list everywhere. And especially here at BioCentury as of this morning, it stands at 1,767,187 according to Johns Hopkins...
[00:15:59] Simone Fishburn: That's worldwide?
[00:16:01] Jeff Cranmer: Yes, Center for Systems Science and Engineering (CSSE) COVID-19 Dashboard. And it's sobering to think that number is likely already out of date. But looking beyond that our editors have picked out some of the other collateral damage, and other lows from the year. And I think it's worth briefly touching on this. Simone, I know politics was on your mind a bit.
[00:16:29] Simone Fishburn: I have three very specific things that have just been in my mind all year long on this one as a scientist, somebody who's been doing science, I dunno, since I was 16. It’s really disheartening to see the politicization of science has been going on the last few years, but this year it just took a new trajectory. And the lasting damage that's happened to public health organizations through that. I don't know how we get back from here. I hope we do. But that has really been very troubling.
I think there are two others on the medical front that I keep thinking about. And one from my recent trip, just stepping away from drug development and just talking to family and friends about theirs and realizing that even among people who have escaped this terrible disease there is a massive untold mental health burden across the population. It's obviously extreme among emergency workers, and the health professionals, and people who've suffered the disease. But it's actually also among children, and elders, and everybody this incredible burden that this year has put in terms of stress and uncertainty. And I think we'll be living with this for a long while and trying to unravel that.
And one other thing that has just been sort of on my mind I think there's just going to be a large number of undiagnosed cancers. People didn't go to their routine screens they didn't do the things they should. And there's a reason that we have those screens. And the reason is that we detect cancers, and we detect them early. When we detect them early, we can catch them and save people. And so I think that I see these as a sort of ripple collateral effect. I'm going to stop there, 'cause I didn't want to be too depressing. But those are the three things that are on my mind.
[00:18:15] Jeff Cranmer: Karen?
[00:18:18] Karen Tkach Tuzman: Well, it's been disheartening to see how this administration has undermined the pandemic response in many ways. And it might be impossible to list them all. But the one that stuck out to me with my focus on COVID-19 testing this year is around the pursuit of a de-regulatory agenda in the midst of a pandemic. What I mean by that there's the belief you could reasonably debate about that it's counterproductive to have too much regulation. That you might slow down innovation. You might get in the way of progress.
[00:18:56] On the other hand, you might say regulation provides really important guardrails for getting things right particularly in biomedical innovation. And so there is a legitimate place for discussions around what regulations are necessary versus unnecessary. The Trump administration under HHS under Azar took some actions this year that were pretty perplexing to the testing community. Saying FDA had asserted early in the pandemic that while it normally doesn't regulate laboratory developed tests because of the emergency the pandemic goes emerging, the uncertainty around it. It was going to be reviewing COVID-19 tests that come from individual labs. And there's a long-standing debate about whether FDA should be regulating laboratory developed tests versus in vitro diagnostics. The difference there really comes down to is just one lab conducting this test in house versus is it being distributed as a kit more broadly.
[00:19:50] Congress is actually on its way to developing some regulation that unifies across the two. But that's a long-term thing that obviously got disrupted. Like COVID, like many other things. But basically at one point in the summer Secretary Azar put out a memo that said, "FDA actually doesn't have the authority to regulate laboratory developed tests for COVID". And it was just a record-scratch moment. This was a year that already saw a bit of zigzagging around. What is FDA's authority on tests, and on different types of tests. It caused FDA to then say okay, deprioritize. Like alright, we're not even going to look at those. Then the administration came back and said well wait actually you should look at those. It was kind of a mess. And it was just a thing where this is a time where it really should be all hands on deck to do things as safely as possible. And not really the time to tinker with how much regulation is good or bad. The administration made some of the response more challenging this year.
[00:20:46] Jeff Cranmer: Okay, I'm starting to feel a little gloomy. So I know Lauren, and a few other members of our team, their pick was the clinical trial disruptions that have hurt patients and companies this year. Any anything you want to say on that Lauren before we try to look for some rays of light?
[00:21:09] Lauren Martz: Sure, well to try to be positive. At the beginning of the pandemic it seemed like this was going to be a huge, widespread problem. I don't know that it was as bad as we expected it to be. But the ones who are hurt by this are the small companies, and a lot of patients. We saw clinical trials go on for cancer. But there are a lot of indications where people couldn't start their trials, or patients didn't want to go to the hospital if the indications weren't that severe. It's something that BioCentury has followed since the beginning we've been tracking the clinical trial delays. And fortunately we've seen a lot of them start back up. But it has been it has taken a toll on a bunch of companies in the industry.
[00:21:48] Jeff Cranmer: Indeed. Well, sunny side up, Simone?
[00:21:53] Simone Fishburn: I'm going to go out on a limb here, and I'm going to say that the situation for women in leadership is going to improve next year. That you're going to see greater representation of women in executive positions, in company boards. You're starting to see that a little bit, and I hope to see that accelerate next year.
I think that innovation is going to continue to break boundaries — that has been the trajectory. I think it's fantastic that the BioNTech founders. The parents, let's say, of the mRNA technology. One is a Turkish immigrant to Germany, a couple of Turkish immigrants [Ugur Sahin and Özlem Türeci], to Germany. Another Hungarian [Katalin Karikó] who really just kept going with that technology. And I think that we're all really understanding that immigration is really important for our business. And that is how you fuel things. I'm hopeful that we will either reopen our borders or continue to keep our borders open for science and global cooperation.
[00:22:56] Jeff Cranmer: That's, yeah, well said. I want to rep my fellow executive editor, Selena Koch. Her pick is for investments in "neuroscience continuing to rise with a broadening set of mechanisms including an emphasis on genetic drivers of disease that could finally make inroads into these historically intractable and devastating conditions such as Alzheimer's".
[00:23:26] Lauren, I know you are the queen of new modalities around here. Any that you're looking for a breakthrough in next year?
[00:23:37] Lauren Martz: Yeah, I mean they're already CAR Ts on the market but we're looking forward to the first BCMA CAR T. Which these have seen such incredible efficacy. This could be a turning point for that modality. And I think we're also looking for other breakthroughs in other major long standing challenges that the biotech industry has faced such as inhibiting KRAS. I guess we'll see what else comes up in terms of tough targets and new modalities next year.
[00:24:06] Karen Tkach Tuzman: I think it's also going to be a big proving year for targeted protein degradation. Like we've gotten Arvinas’ data, that's been coming out, and sending their stock with it. But I think we're going to see other companies enter the clinic with that modality as well, and hopefully see some more proof of concept.
[00:24:23] Jeff Cranmer: A couple of our editors, Virginia Li and Winnie Pong, they focused on what they're seeing as potential bright spots in clinical trials. Virginia is looking to see companies as we discussed earlier in the pod "taking more and more action to engage, recruit, and better represent racial and ethnic minorities in clinical trials", and she's hoping this translates into better outcomes across the board. Winnie says, "lessons and advances in trial design, manufacturing, regulatory approval" — that's a big one there — "and collaboration from the COVID-19 vaccine development to speed up other vaccines and therapeutics".
[00:25:09] Simone Fishburn: I just want to follow up quickly on Winnie's point about manufacturing. I don't know that I'm particularly optimistic for next year, but I'm optimistic that it will gain attention. We've seen this year how important manufacturing is to get product out. But there's also been a little bit of a battering for some other smaller companies in trying to get their compounds and biologics made. And so, that's something we're going to continue to follow at BioCentury. When we talk to members of small companies, leaders among small companies manufacturing is one of their biggest concerns. And so, that's something that we need to unravel.
[00:25:47] Jeff Cranmer: That's definitely something we'll be watching. One last ray of light to close out the program: Our friends at Kendall Square Orchestra recently presented a benefit concert, Symphony for Science, an online event with music and words. It benefited an organization called Next Step, which supports people with rare diseases, cancers and HIV. I've heard from them just this morning that the event was a huge success. They raised close to $80,000, with net proceeds benefiting Next Step. And the good news for you if you haven't seen it — you can still view the event and donate at symphonyforscience.org until the ball drops on what is it Thursday, Friday, when is this year gonna end? 2021 hurry, hurry, hurry, you can't come soon enough.
[00:26:47] All of our podcasts are available on Spotify, Stitcher, Apple, and Google.
[00:26:52] And 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.
[00:27:12] Lauren, Karen, Simone thank you very much, this was fun. And Happy New Year everyone. We will catch you with our JP Morgan preview next Monday.
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