Leading Through Adversity: A CEO Roundtable On Drug Development During A Pandemic
Source: Life Science Leader
Four biopharma CEOs discuss with Rob Wright, chief editor of Life Science Leader, how they are leading their organizations and conducting drug development during the COVID-19 pandemic. Appearing in this video are:
Jeremy Levin, DPhil, MB, BChir, CEO of Ovid Therapeutics
Gil Van Bokkelen, Ph.D., chairman and CEO of Athersys
Rachel King, CEO, GlycoMimetics
Ted Love, M.D., President & CEO, Global Blood Therapeutics
Editor’s Note – The following is an edited transcript from a Zoom call roundtable conducted on Wednesday, July 29, 2020, with four biopharmaceutical industry CEOs.
Hello, I’m Rob Wright, chief editor of Life Science Leader. During today’s CEO roundtable, we’d like to talk about drug development, especially, how you do it during a pandemic era. Because while there’s been a real significant focus on development of vaccines and treatments for COVID-19, the reality is that there’s so much unmet need in rare diseases, regenerative medicine, sickle cell anemia, cancer, and on the list goes. So, with me today are four CEOs from publicly traded companies, and we’re going to talk about, some of the best practices they’ve been seeing employed in biopharma drug development during this ongoing crisis. So, I’m going to have each introduce themselves alphabetically. We’re going to start with you, Rachel.
Rachel King, CEO, GlycoMimetics: I am Rachel King, I’m the CEO of GlycoMimetics.
Jeremy Levin, D.Phil., MB BChir, CEO, Ovid Therapeutics: My name is Jeremy Levin, and I’m the CEO of Ovid Therapeutics.
Ted Love, M.D., CEO, Global Blood Therapeutics (GBT): Hello, I’m Ted Love. I’m the CEO of Global Blood Therapeutics.
Gil Van Bokkelen, Ph.D., CEO, Athersys: Hi, everybody. I’m Gil Van Bokkelen, and I’m the chairman and CEO of Athersys.
Wright, Life Science Leader (LSL): Thanks for those concise intros, because I’m anxious to get each participant sharing their thoughts. And I want to start with a direct question to Rachel King. Let’s start with the overall environment. How is it, as far as drug development, innovative medicines, and biomedical technologies; what does the environment feel like right now?
King (GlycoMimetics): Well, I’d say there’s, there’s two aspects to it. One is, of course, it’s a very challenging environment, because of what we’re facing in these COVID times. All of us are adapting to that in many ways. I think we’ll be talking about that today. There’s a lot of challenges that situation poses to us individually and to our companies. At the same time, I think it’s a time where we do still have an important amount of opportunity, and I’m not just talking about opportunities to address COVID, but opportunities more broadly, because there are tremendous unmet needs. And I think the industry continues to have a remarkable capacity to address those needs, and surprisingly, actually a very good ability in the current times to finance those activities. In spite of it being challenging, as a result of everything we’re facing in COVID, I do think there’s a tremendous amount of opportunity for us to continue to do what we do. And in the context of COVID, also show how we can specifically address the critical need that the world really faces now with that disease.
Wright (LSL): Has anybody felt like, their therapeutic area is taking a way back seat to COVID development right now and making it more challenging?
Love (GBT): Well, I certainly have felt that, and think that’s somewhat appropriate. The reality is, we are focused on a disease [sickle cell disease] that’s very egregious, in a population that’s very disadvantaged, but they’re also at very high risk if they get COVID. We want to make sure that everything we’re doing is focused on protecting those patients. Insisting that those patients [involved in a clinical trial] get on buses, get on public transportation, go into environments where they’re interacting with people that may present a risk to them, is not something we want to do. I liked and agree with everything Rachel [King] said. I think the key word that I heard used was, adapt. We’ve been trying to adapt, to make sure that we do more things remotely, to try to keep people out of harm’s way, and we’re doing a lot of the groundwork to be prepared for the other side of the epidemic. It’s had a tremendous impact. We are not trying to stimulate patients to go out and interact where they may be at more risk to get COVID.
Wright (LSL): Is there any example of the shifting and adapting that was done to keep something moving forward that someone would like to share?
Love (GBT): One of the things we’ve done is changed some of our protocols. For example, for those that had much more frequent hospital or office visits, we changed those protocols to decrease those numbers, and in some cases, converted them over to something that can be done more locally, at home, or via telemedicine. So, we’ve been adapting to try to make sure, that despite COVID, we can still get the data and the information to develop our therapies.
Van Bokkelen (Athersys): I think the adaptation really runs across a spectrum of really important activities. On the clinical trial front, I think Ted [Love] captured it perfectly, in the sense that a lot of trials have had to be modified or adapted. Thankfully, the FDA has been a fantastic partner for many companies and organizations in this regard. For example, follow up visits or how they might be conducted in some cases, implementing the modifications so that you can do them remotely, so you didn’t force patients to come back into a clinical environment, particularly if they might be in a precarious position from a health perspective. But I think all of us would also agree that operationally there has been a lot of disruptions that we had to adapt to. Six months ago, if you go back to the beginning of the year, yeah, we probably used things like Microsoft teams, or some platform like that whether it be Zoom or something else, now it’s become a way of life. And, and so we communicate, not only across organizations, but basically within our organizations, and [these tools have] become an essential part of communication to keep people aligned and facing in the same direction so we can get important stuff done. But honestly, I think the challenge would more of finding an area that COVID-19 has not impacted, in terms of the operations of our companies, because it seems like it’s pretty much had an impact on everything we can think of from clinical development research activities, to just day to day operations of people coming into work or working from home. I mean, a whole series of different things. Rachel [King] mentioned [COVID-19] impacting the financial environment, albeit in a somewhat unexpected and maybe positive way, it’s reminded people how important our companies are in the work we’re doing is, which I think is a good thing.
Levin (Ovid Therapeutics): I think that in every crisis there’s opportunity. As an industry, we are comprised of some of the smartest people that I’ve ever met, and the executives have pivoted in a way which is remarkable. Sometimes it’s impossible to continue [working] in the exact way that you did previously. And I’ll get to that in a minute. But as an industry, I think the learnings that we’re going through now may transcend and transform our industry in the future, because some of the things that Gil [Van Bokkelen] just mentioned become natural and normal, while others we’ve had to adapt. You’ve heard about Ted [Love] trying to get people to clinical trial sites. These are all things that sometimes we have followed a pattern, which has been rather unchanged for the last 20 years. Not because they’re necessarily the best practice, but because they’re habit. And because we got used to doing that way. So, I think I would like to step back and say that to me, there have been disruptions, and I’ll tell you perhaps two minutes on that, but there also has been the opportunity to make a big difference in how I would project doing something in the future. So, in the rare disease area, there’s a really great need to appreciate the family and what role the family plays. Even more than any other time. They generally bring the child to the hospital or the clinical trial site. They monitor the childhood home. And in particularly in the rare epilepsies, this is a catastrophically difficult process to do, because you have to take somebody who’s intubated. You have to get them to the clinical trial site. You have to then monitor them at the clinical trial site. Now, if you start thinking about how one makes it easier, not having to do that, in actual fact, while you may delay a trial a little bit at the end of the day, you come up with a solution that actually works. And with the creativity of the FDA and the willingness to engage in a dialogue on something different than was done previously, you end up with new solutions. And we have, we have had wonderful interactions with the FDA, great ways of now assessing many of these patients at home in ways that weren’t previously available to us. We have new tools. I do know the disruption has caused significant delays in many trials, but I also know there is a teaching that we’re adopting, and I believe that that’ll carry forward for years to come.
King (GlycoMimetics): We’ve talked a lot about how our own communications have changed and interactions in this virtual world. And I have to say, sometimes I still feel shocked when I think about what we’re dealing with. When we first came home to work, I think it was in March, I didn’t bring quite enough things from the office in that first week. I just thought somehow, that I was going to be going back and maybe naively, I just never could have foreseen that we’d be in the situation that we’re in right now. I still feel, some days, I just kind of can’t believe that this is the way we’re where we’re working now, and a lot of what I’m doing for work, I’m doing from this room, which is just very strange. And so, there is just a personal feeling of strangeness in the new work world is still something that strikes me. One of the things we’ve been challenged by, in terms of the physical work, is what we do in our labs, because we have had a number of our employees who work in the labs, who can’t work from home. And so, for them, we’ve been trying to develop protocols consistent with the recommendations from the CDC and other public health officials, that will enable them to go back to work. We’ve looked at staggered schedules. We’ve reconfigured some of the workplaces and, and really tried to find a way to enable those people to physically get back on site. So, I did want to add that there is that aspect of the adjustment as well. Another thing I would add on the adjustment side, is that there’s the connectedness, which is great, but sometimes even an over connectedness that happens I think, in the current work environment, where you can be connected all day, all night, whenever you want to. I think we also need to find ways to enable our people to disconnect. So, there’s a whole host of new learnings, not only around productivity, but I think also around more personal aspects of how we actually work in this environment in ways that are not only productive, but good for people also.
Wright (LSL): You mentioned the productivity around people still being able to go into the lab, and I’ve heard about different staggered schedules, and people being grouped in teams to prevent outbreaks and so forth. I’m just curious, has anyone experienced a situation where a member of a team did test positive for COVID and then how that was handled?
Van Bokkelen (Athersys): We’ve had people that were worried, maybe they developed symptoms like a runny nose or something, or weren’t feeling 100 percent, and weren’t sure if they had come in contact with someone [with COVID]. In fact, I went through that very early on in the process, and out of an abundance of caution, I made the decision that I was going to work from home for two weeks and self quarantine, which I did. So, I basically spent two weeks in my basement, which my wife wasn’t super happy about. But the reality of it was that I felt like I needed to do that. And it was, I think, in some ways, a good message to send to other people in the organization to say, look, if the CEO can do it because he just wants to be cautious about what may or may not have happened [perhaps we should be cautious too]. Now, subsequently I tested negative. We’ve had several other people that have gone through a similar experience, including a couple of people that had to travel. And they were worried that, Hey, I might’ve come in contact with somebody during the travel and I’m just not aware of it. So, I’m going to self quarantine for a two week timeframe following the guidelines that we put in place. But thankfully, you know, we, knock on wood, have been COVID free. But it’s because the people in our industry have in some ways, maybe a greater capacity or sensitivity to understand what it means to take precautions and be cautious in this type of environment. For those of us that have spent any time in a research lab, and understanding the importance of maintaining a clean and sterile environment, when you kind of put that into practice on a broader scale socially, I think some of us have a greater awareness for that. And I think that’s probably showing up in the operations of a lot of companies that have been implementing policies and procedures.
Wright (LSL): On another call Gil [Van Bokkelen], a CEO was talking about having these staggered schedules to minimize exposure and number of employees in the office. And, and this lab person saw the CEO in the office and said, you are not supposed to be here. You’re putting us at risk. And he appreciated being called on that and left. So, I thought that was a great example of, you know, really transparent communication between the team.
Van Bokkelen (Athersys): We’ve all gotten used to basically dealing with, these things, the face mask, basically, which we have to have an endless supply of them. It’s become the new normal.
Wright (LSL): The next direct question I wanted to direct to Dr. Levin. In what ways has the pandemic stalled developmental efforts?
Levin (Ovid Therapeutics): Well, we know BIO took a lot of effort to try and work on this, and we have a lot of data now. It’s actually had an effect across the industry. There are many really innovative programs and trials that have been stalled in large measure because of the desired and need to actually get people to a hospital to have an assessment of a very specific kind. We won’t see the results and impact on that for a little while, but there’s little doubt that other areas, not surprisingly, such as patients who are in clinical trials for cancer drugs are definitely affected. And these are patients at high risk, in any event, they’ve been unable to get to the trials sites or the trial’s been shut down, not because of anything other than the risk to the patient of coming there. So I think we’ll see that work through the system. Now, you might think that that is disproportionately cancer, but I’m using that as an example. But you know, companies like Lilly shut down its clinical trials, because they knew they couldn’t get to the patients in the numbers that were required. Another quality of impact is somewhat mitigated by the really stepping up to the plate by the FDA where as you know, there’s an entire process for dealing with missing data. And that has yet to play out. We don’t, I don’t, have information that I could provide you to say, how has that assisted those who might’ve partially finished a trial, and now have gone to have a discussion with the FDA. I believe we’ll learn a lot more over the next three to six months, because that’s what we saw. You know, we did the best we possibly could, but the reality was, we were delayed by three months. We will now deliver our pivotal Phase 3 [clinical trial], three months late at the end of the fourth quarter of this year. And we’re similar to a lot of other companies. I would say, the bulk of the delays are being seen in those who had to go to primary care facilities, who simply said, we simply can’t risk these patients coming in. That will have a roll down effect down the line. It’ll affect many of the PD-1 trials, a lot of the T-cell trials that are ongoing, and I think the CAR-T cells that are ongoing. But, the outcome of that is yet to be determined, as I say, I think we need to wait a little bit.
Love (GBT): I would add that we definitely have suffered delays. And what we’re trying to do, as I mentioned, is simplify and augment trials. And in some cases, add more sites ultimately, so that we can get back on the timelines. The area where I think we have really, really stumbled is our effort to begin to build the groundwork, to make our drug available in low-research countries (e.g., Sub-Saharan Africa). For us to do that, we really need to build some alliances with government leaders and government agencies, and that’s very hard to do remotely, because that does involve a lot of trust. So, we actually had a number of "pilgrimages" set up, but this year they were all canceled. We’re going to try to get that effort back on track. That is a multiyear effort that was essentially, completely derailed by COVID, and it probably can’t take place in the way that it needs to take place until we’re allowed to travel.
Wright (LSL): One of the concerns I had, and this isn’t a question I shared in advance, was around when we think about, diversity and inclusion within clinical trials. That has always been a challenge. Right now, we have seen how COVID has really devastated the minority communities in the United States. And I wonder, how that is going to affect the clinical trials for COVID-19, you know, and, and getting a diverse group of patient populations. Anybody else kind of get a sense on that, about the minorities and their willingness to participate in a COVID-19 vaccine trial?
King (GlycoMimetics): Well, I think the participation in vaccine trials is going to be challenging, not only for the minority population, but I think we have a, we have a significant group group of people in this country who are anti-vaccine and skeptical of vaccines. So, I think we’re going to have have broad challenges at participation. And I do agree, that we have a particular responsibility to include people from the African American community in particular, in the COVID vaccine trials, because of the disproportionate effect that they and other people of color have as a result of the disease,
Van Bokkelen (Athersys): I think that’s right. There’s also some concern among some segments of the population that we are going too fast on some of these things? Do we really know at the end of the day, if these vaccines are going to be safe and effective? And people are kind of waiting. Obviously, a huge chunk of the population isn’t really going to be in a position to critically assess the data at the end of the day, but I think they’re paying attention to it. I think Rachel’s [King] right. There’s a lot of people out there that are the, the anti-vaxxers if you will, that basically just, it doesn’t matter what the vaccine is or what it’s designed for. They don’t want any part of it, because they think it’s inherently bad or whatever, whatever it might be. But there’s other people out there that I think are just a little bit worried and skeptical, and they kind of want to wait and see, "Okay. We’ve never tried to develop something this quickly before, what is that going to lead to at the end of the day, in terms of actual protection, safety, ability to not only enroll patients in the clinical trials, but also to deliver this as an effective defense, if you will, on a widespread population basis.
King (GlycoMimetics): When you look at what challenges we’ve had in this country, simply getting people to wear masks. Then, when you think about actually getting people to go in and be inoculated, I think that we are going to have challenges in getting the level of vaccination that we want to see. Someone said, it’s not vaccines that help people, it’s vaccinations that help people. In other words, you’ve got to actually deliver the vaccines. You’ve got to get the people inoculated. And I think it’s incredible what the government has done, and what companies have done, to step up to try to develop vaccinations and other therapies. But I do think that rolling out the vaccine/s is going to be challenging.
Levin (Ovid Therapeutics): We’ve gone slightly away from your original question, which was about diversity and how we include them in the clinical trials, and I want to come back to that. In order to deal effectively with any kind of disorder, you need the population who’s going to be participating, to have confidence in the system that it is actually caring for them. In other words, that, whereas it’s in a rare disorder, the families really want to have their kids tested. Where you have a disorder that affects millions of people, then you need those people to feel that they should participate, because there is goodness that’s going to come out of that trial. I’m speaking simplistically, but I hope that your colleagues will forgive me, because at the end of the day, those who see this, they need to understand that there’s a terrible history of clinical trials behaving badly in the United States. As a consequence of that, the minority populations African-American particularly, have a natural reluctance in some senses, to participate in trials where they don’t necessarily see the value. So if we come to COVID, I think it puts a very special emphasis on the companies developing these vaccines, before we get to vaccination, to articulate utterly clearly and transparently, the science, the medicine, the objective of the trial, the clear metric that will say that it works, it doesn’t work. And that at the end of the day, that this is for a clear benefit to the population. In order to accomplish that, it’s my firm belief, that this is one of the most important things that needs to happen, now. In other words, if we hope that the minority populations will have confidence in these trials and therefore participate, if we’re hopeful that we will have a result that is understood, believed, and then can actually be brought into the community through vaccination programs, right now, before the results come out, we need to articulate transparently and clearly, a nonpolitical message, a medical and scientific message of exactly, exactly what we expect from these trials. If we don’t do that, we cannot expect the population at home, the anti-vaxxers, anybody, to accept a result which is suddenly proclaimed by a politician. I believe we’re in great danger at this moment in our industry’s history, and actually in this nation’s history, of doing exactly what occurred with the minority populations, the African American population, in times gone by, and by the way, that [Tuskegee Study of Untreated Syphilis in the Negro Male] was just beyond terrible, that these trials are used for reasons which are not medical (i.e., pseudoscience,) and there will effectively be a political statement as opposed to a medical statement. So, I deviated a little myself, but it does come from the teachings of what America has learned in this experience with the African American population in years gone by.
Love (GBT): I do have a little data on the question. Everybody may or may not be aware that the NIH actually has a website where they are trying to build a registry of people that are potentially interested in being contacted about the vaccine trials when they began. One of the things that I’ve been doing, with Rob Califf a few times a week is playing golf at around five or six o’clock. And so we talk about this stuff pretty much constantly. So Rob told me something that I didn’t know, and that is that this site now has a couple hundred thousand people who signed up for the site, and of those couple of hundred thousand, only 5 percent would be represented by African Americans, Latinos, or Asians. So, it’s really quite a miss. The good news is that Rob [Califf] is involved with Google and Verily [Life Sciences], and they’re going to be partnering with the NIH to try to get the word out. Honestly, I didn’t know about the website until Rob [Califf] told me about it. So, I went on the website. I signed up. I signed my wife up. So, hopefully we’ll be able to plug in and, and get more done here. Jeremy [Levin] touched on something. I also want to just mention a little bit. I got an email from a physician last week, and it was a remarkable email. It basically was describing a clinical interaction that he had just had with a father who had a son with sickle cell disease. And he was explaining to the father that the child needs to be vaccinated. And the father essentially said, "Well, I’m not going to have anything to do with this." The physician was initially planning on calling the father’s father (i.e., the grandfather) to try to influence, but he decided to take a different tack. He actually said, "I know why you don’t trust the healthcare system." And he actually had a genuine conversation about the Tuskegee experience, and about the experience he faces when he takes his kid into a hospital, how he’s mistreated, how they believe they’re drug seekers. He had a Frank conversation with the father. And he said, after the conversation, the father turned around and said, "Look, I trust you man. I trust you’re going to do the right thing for my son. Do whatever you think is right for my son." We need to do more of that in this country. And he actually had asked if GBT would be willing to try to put together some teaching materials to help patients, help healthcare providers to have these kinds of honest and authentic conversations. It’s very hard to build trust with someone, unless you admit, that you know, that there’s a basis for their mistrust.
Wright (LSL): When you talked about the NIH site, and that you not knowing of it, it revealed another bias, because the more well-educated are probably going to know about these things and say, yes, I want to be signed up. So we’re missing those people that are struggling, in the communities that are getting hit the hardest. I don’t know what all the answers are to trying to reach those communities. I did attend a diversity in clinical trial event that was put on by the Center for Healthcare Innovation in Chicago a couple of years ago, and they were doing active outreach, but I’m curious if anybody has heard of some new approaches [to reaching minority communities]?
Van Bokkelen (Athersys): I completely agree with what Jeremy [Levin] and Ted [Love] have said. We need highly respected clinicians and clinician scientists, to be out there on the front lines using this as a teachable moment, and conveying this information regularly and consistently. I understand why the politicians are basically out there making the case for what they’re doing. They’re trying to be proactive and be helpful on multiple different levels. But the vast majority of the people in the country don’t really care as much about what the politicians have to say. What they care about is the highly respected clinical experts and voices. And this is a teachable moment. It’s probably the in teachable moments. I think back to Jonas Salk, to basically explain to people that, "Hey, something really important is happening right now. Let me explain it to you in human terms that you can understand and what you need to do," and basically convey that call to action to the general population. If you think about it, the call to action already went out to our industry and we responded like nothing that I think any of us has ever seen before in terms of the mobilization of companies and programs and scientists and research teams. That same thing needs to happen on a broader societal basis to explain to people, not only the clinical stuff, but also on, "Hey, maybe it’s prudent to keep the kids at home, not send them back to school right away, particularly in areas where there might be an intense outbreak." We need to be really cautious about some of this stuff and maybe measure twice and cut once before we make decisions that we might regret a little bit later. We all want it to be successful. We all want it to be over at the end of the day. But I fully agree, we need to make sure we’re communicating effectively. And in terms that all of society or most of society can understand and relate to.
King (GlycoMimetics): I think it’s going to take place at two levels. This is really important. I hope we’re going to have good, strong national spokespeople who can explain. People like Dr. [Anthony] Fauci has become a really trusted source to many, if not most, people. I hope we’ll continue to see trusted national spokespeople get out and explain things in ways that people can understand. Given what we’ve lived through in the past few months, people are maybe more likely to be willing to listen now. Because, we’ve heard many of the predictions that this was not going to be something to worry about, and the healthcare professionals have actually turned out to be right. So, I hope that that gives them more credibility. But I think coming back to what Ted [Love] was saying, I really want to emphasize that in the end, it’s going to be a very personal thing. So, communication has to happen at two levels; the national level, which I think we can hopefully all contribute to through BIO and other groups like that. But, at the personal level, it will be the personal nurse, physician, and healthcare worker, who builds that patient’s trust in the end. And I thought that story you told Ted was really beautiful, because I think it does convey what ultimately happens at each individual decision point (i.e., whether an individual patient will trust an individual healthcare provider or not).
Van Bokkelen (Athersys): And it doesn’t need to be people that are experts in virology, but I agree with you about Dr. Fauci, and in some of the other folks (i.e., the U.S. Surgeon General and others) that are really doing an effective job, and they need to do more of that. But if you look at guys like Dr. Ben Carson. He’s a spokesperson that many people trust. Now, he’s not necessarily on the front lines of this particular battle, but he’s somebody who’s got a very well established medical background, and a lot of people know, trust, and will listen to him. And if you have people like that out there that are basically saying, "Hey, here’s what we need to be thinking about. Here’s what we need to be doing." That’ll get more people paying attention and listening to what’s going on.
Wright (LSL): Here’s a wickedly naive question. Have any of the medical societies or organizations like BIO, ever put together some talking points for those clinicians on the front lines (i.e., here’s the five things that you can help a patient understand very quickly about how a clinical trial works)?
Love (GBT): I don’t think I’ve ever heard of a society doing that, and I do think doing some of that would be important. I did want to kind of step back and say, to the big picture of underrepresentation of people of color in clinical studies, I think the biggest issue, like for many of our social issues in this country, has been indifference. Right now, I sense a willingness to not be indifferent, or to fight indifference, to step forward. So, we have to acknowledge that this is something that we want to fix. Then the second step is, you have to invest in it. When you want to fix something, you have to invest in it. So, my sense is that the NIH is going to partner with Google and Verily, and they’re going to try something new. They’re not just going to be indifferent and accept the status quo for clinical studies. To your point about how to have this conversation. I think the reality is the data says the opposite. There’s a lot of data, that is published and well known, that a physician who offers a clinical study to a person who is white, is far less likely to offer that study to a person who is black, even if they see them. We don’t fully know why that’s true, but that needs to change. But we’ve been getting the data. We have data that shows that if I go to the hospital with a kidney stone, I’m going to get pain medication more slowly than Jeremy [Levin]. We have data that shows that if I have the same coronary anatomy, I’m less likely to be offered bypass surgery than Jeremy [Levin]. We know a lot of this stuff, but we haven’t really fixed it. And I think quite frankly, this is probably beyond the context of this conversation, but the fixes are going to have to be very comprehensive, because a lot of the things that we’re seeing with COVID are due to the fact that this is one of the most segregated countries in the world. And when you segregate people, it’s very easy that they’re not going to bump into me and have a spontaneous conversation. They’re not going to bump into Rob Califf. They’re not going to bump into anybody on this call. They’re going to bump into somebody more likely who is poor and uneducated. Most people don’t realize this, but that’s not true, if you’re poor and white in this country. If you’re poor and white in this country, you don’t live in poor white neighborhoods. You live spread among the population. So you are more likely to meet someone who could give you a job, because they run a business. So I would say that we are going to have to fix a lot of structural problems in our country, if we are very serious about correcting these things. We can do bandages to do clinical studies, but fundamentally, if we want to get rid of these problems, we’re really gonna have to unwind all the active stuff that we’ve built to basically segregate and disadvantage.
Wright (LSL): Wondering if we can talk a bit about how the pandemic has been a catalyst for drug development?
Love (GBT): There are always silver linings. As an industry, we are people who are hopeful, and we’re always trying to move ahead, even when running into obstacle. So I do think that we are figuring out ways to streamline and simplify our studies, to account for missing data. In the past, we’ve had draconian approaches to tackling such things, and now we come up with more sophisticated approaches. So I definitely think there will be some advances. I think Rachel [King] mentioned the money that’s been coming in our industry. It’s been a bit of a surprise, but we’ve been perceived as an area of the economy, unlike, for example, the service industry, the hotel industry, which is more COVID resistant. And in fact, we probably represent the industry that’s going to be the way you get out of this mess ultimately, and how to get out of these messes in the future. So, the investment has been good. The creativity that we brought to the table has been good, so there is going to be good coming out of this. There’s no doubt about it.
Levin (Ovid Therapeutics): In January of 2020, approximately 50 percent of all clinical trials and all dollars were focused on oncology. Right now, the dial has shifted. And one of the good things about the fact that we now have approximately 600 plus new trials or new programs focused on COVID is that that shift in industrial investment will have a profound, and as yet to play out, set of changes in different areas. For example, it won’t just be on clinical trials and how the FDA has looks at this. You can only imagine the findings that are going to come out of the discovery programs that are right now, embarked on trying to tease out new ways of clobbering a virus. You can only imagine what that means in terms of the role of vaccines in other areas. So for me, one of the most important fundamental industry-wide impacts is the shift away from oncology. A shift that has been absolutely instrumental in generating so many different technologies, but they have embedded themselves now in a different arena. From this we will see a flowering of work on immunology, understanding of T-cells, B-cells, how the body actually works in fighting viruses, and that, in and of itself, will lead to other things. For me, one of the silver linings of this horrible event, is that we’ve woken up to new areas. And whatever comes out of the COVID specific research, there will be a flowering of knowledge in areas that are tangentially related to it, but will lead to other discoveries perhaps, in autoimmune disorders, perhaps in other immune disorders. But I also know that it’s going to have a very profound effect on the industry and where we invest our money.
King (GlycoMimetics): We may look back at this time, similar to how we look back at the period when we were suffering from the AIDS epidemic. And, and there was a lot of innovation around clinical trials that came about because of the incredible human need at that time. I’m hopeful that a similar thing will happen here in ways that we don’t entirely foresee now, although many are along the lines of what you said, Jeremy [Levin]. One thing that I hope comes out of this, is that we really do recognize again, what everybody knows when you sit and think about it, which is the incredible value that vaccines bring to public health. I mean, one of the cheapest, most effective contributors to good health outcomes, and, you know, we’ve gotten through period of time where we kind of take them for granted, and to a point where we have a lot of, as we know anti-vaccine sentiment. I think we also may be looking at a different end points. We have a lot of debate right now around how are we going to know whether these vaccines are safe and effective? Do we have to do the traditional large trials and look at exposure over time? Or can we find some way of looking at some other endpoint that might be a surrogate, like neutralizing antibodies, and will that be a good enough surrogate? We don’t know yet, but that’ll be something that may come out this renewal of an exploration of end points. We may also come to some new approaches, which, are currently controversial, and I don’t know how they’re going to play out, but things like challenge trials. There’s a debate going on as to whether there should be vaccine challenge trials. That’s complex, and we’ll see how that plays out. But that’s just one example of a completely different way of thinking about drug development that we’re engaging with because of the crisis that we’re facing. So, I’m hopeful that humanity is going to come up with some really great innovations, not only in terms of technical innovations, but innovations in how we approach things, perhaps analogous to what we saw in the days of the HIV epidemic it’s epidemic.
Wright (LSL): I heard a story about how it has catalyzed someone to go back and look at developing a Spanish flu, vaccine, because nobody ever went back and solved it. If that came back, it would be a real problem. So very exciting. Maybe we could spend the next five minutes talking about what we need to do to help our elected officials come up with win-win policy making.
Van Bokkelen (Athersys): Everybody on this call is actively involved in BIO, either as a board member or as part of the leadership on the board, or various committees as part of the board. We’ve all been serving in that role for a long time, and we’re honored to do it, because I think BIO is the leading voice in terms of working with policy makers to help them understand some of the complex issues. Sometimes it’s regulatory. Sometimes it’s clinical, or developmental, or other things that shape the capital markets for example. All of those are critical to going into the mix to help companies that are committed to developing innovative, safer, more effective medicines that help patients that in many instances are either desperately sick or in some cases, trying to prevent something from becoming a life-threatening illness, or critical problem. One of the things that we’ve seen in this whole COVID-19 pandemic emergency, is it’s heightened everybody’s sensitivity, including policymakers in Washington, to the need to process a lot of information, make decisions about things, and then implement policies that are designed to expedite the collective effort to improve the situation and get to solutions faster and more efficiently. We’re very proud of the role in the activity that BIO has been engaged in and leading to actually help make decisions on that. But the list of things that they need to be thinking about is very long. For example, if you’re going to go get funding allocation to actually expedite the development of some of these things, how do you spend that? And what is the institution/s responsible for actually making decisions about how that money gets spent? Right now, we see a whole collection of different activities and institutions, from [the Biomedical Advanced Research and Development Authority] BARDA, to the NIH, to Operation Warp Speed, to Project ACTIVE, to other things that are going on. Everybody’s intentions are good and admirable, but there’s still a little bit of chaotic activity in terms of sorting out, how do we do certain things, and how do we ultimately get to the best result at the end of the day? I’ll tell you one thing that is an important lesson to be learned from all of this is, in times when there isn’t a pandemic, it seems like a relatively straightforward thing and maybe even rational to say, "Hey, do we really need a pandemic preparedness response team or office when we haven’t seen something like that for a long time?" Well, this situation, and I think in the past few years when we’ve seen H1N1 [swine flu], SARS [severe acute respiratory syndrome], MERS [Middle East respiratory syndrome] and other things that have been happening with a disturbing regularity, I think it illustrates the wisdom of that ounce of prevention strategy, or at least that once of preparedness strategy, and what it might ultimately mean at the end of the day. Because right now, we’re trying to basically spend trillions of dollars to mitigate the damage. Maybe we should be spending a little bit more money consistently on the front end piece of it so we can get ahead of some of these things, or do some things that might actually help get to a better place faster if we just maintain a commitment to invest in the types of infrastructure or other things that will put us in a better spot. And I think that’s really important.
Love (GBT): We need our political leaders to understand something that Bill Gates said in a TED Talk about five years ago, which was that the world was much more likely to lose a million lives through a global pandemic than we are through a war. The United States invests more in building war materials than anybody else in the world. In fact, I think we invest more as a country than the next 10 to 12 countries combined. We really need to investigate that and ask if that is how we want to spend our money, when we are less likely to save lives by investing there. We need to be investing in things that Gil [VanBokkelen] was talking about (e.g., science and innovation), to make sure that we’re prepared to be healthier. I think there’s some buzz on the state level too, by the way. For example, in California we spend our money on two things in a big way. One is a prison system, and the other is education. Prisons don’t reduce crime. There’s lots of data that shows what reduces [crime] is jobs and the eradication of poverty. We need our policy makers to start investing in our people, to create a better and safer life, rather than investing in things like defense and prisons, which are not putting us in a great place going forward.
Wright (LSL): Great. I know Jeremy needs to leave and we all agreed that we were going to wrap it up at four o’clock. And so with that, I’d like to thank everybody for participating today. I’m sorry. I feel like we’re kind of cutting it short, but thank you so much, and enjoy reading life science leader magazine, please subscribe at www.lifescienceleader.com.