Leadership During COVID-19 — A Biopharma CEO Roundtable
Five biopharmaceutical industry CEOs discuss challenges their company's have faced, along with best practices implemented in managing through the COVID-19 chaos.
Participants include:
- Mike Clayman, M.D., CEO, Flexion Therapeutics
- Leen Kawas, Ph.D., CEO, PharmD, CEO, Athira Pharma
- Rachel Leheny, Ph.D., CEO, CalciMedica
- Caroline Loew, Ph.D., CEO, Glympse Bio
- Paul Wotton, Ph.D., CEO, Obsidian Therapeutics
- Rob Wright, Chief Editor, Life Science Leader, moderator
Edited Transcript
Editor’s Note – The following is an edited transcript from a Zoom call roundtable conducted on Thursday, April 30, 2020, with five biopharmaceutical industry CEOs.
Hello, I'm Rob Wright, chief editor of Life science Leader magazine, a monthly best-business practice publication that provides biopharmaceutical executives with actionable information that they can use. With me today are five biopharmaceutical industry CEOs. We've asked them to join us to discuss approaches to biopharma leadership during these unprecedented times. Because while COVID-19 seems to disrupted nearly everything, the reality is that life in biopharma goes on. The unmet medical needs that were a problem for patients prior to the coronavirus still exist. How do companies go about fundraising, executing clinical trials, leading, manufacturing, hiring, and so on, given our new environment? These are the types of questions we look forward to exploring with today's panel. Let's meet them.
Mike Clayman, M.D., Flexion Therapeutics:
I'm Mike Clayman, CEO of Flexion Therapeutics. Flexion develops, locally administered medicines for musculoskeletal conditions. We have a commercialized product ZILRETTA, a knee injection for osteoarthritis knee pain, that's been on the market now two and a half years. We've pivoted successfully to going to e-detailing for our salesforce. We have roughly 100 sales reps across the country. Because of the suspension of elective surgeries [during the COVID-19 outbreak], patients are not presently getting total-knee replacements. The reason you get a total-knee replacement is because you have pain-refractory-available therapy. So, ZILRETTA is a logical choice for those patients. We believe that there's an opportunity to make a difference for many patients who are waiting to have their surgeries. And, our sales reps actually have more time to talk with physicians who are not in the operating room now.
So, it's been a very interesting evolution. Top of mind for us is employee safety. We closed the company on March 16. Everyone has been interacting virtually. We have weekly virtual huddles with the entire company, almost 300 people that the vast majority (i.e., 95 - 98 percent attend), as a way of communicating with people. We think these virtual huddles are an important vehicle to ensure people are up to speed with what's going on in the company, how we're addressing concerns they may have, and what we're doing to ensure safety. We suspended clinical trials about a month or so ago, because our investigational sites were not continuing to see patients. But we're very excited about what's in the pipeline, and as soon as feasible, reinitiate clinical development.
Leen Kawas, Ph.D., Pharm.D., Athira Pharma:
Hi everyone. I'm Leen Kawas, CEO of Athira Pharma, a company in late-stage clinical development focusing on developing small molecules that impact neuronal health through regeneration. Our most advanced program is focused on Alzheimer's and Parkinson's diseases. But we also have additional assets that focus on regeneration, whether in the central nervous system or periphery. In addition to neurodegenerative indications, we have a focus on neuropsychiatry as well as peripheral neuropathy. One thing that I'll be focusing on is yes, we are in an unusual environment. But I think the intrinsic value of what we're doing, everyone on the panel and in the industry, hasn't been lost on the rest of the world.
Rachel Leheny, Ph.D., CalciMedica:
HI, I'm Rachel Haney. I'm the CEO of CalciMedica. This has been a whirlwind time for us. CalciMedica is a virtual company. When the shutdown happened, we basically all just went home and have been working 24-hours a day from home. CalciMedica has been around for a long time, and is probably the leader in an area called CRAC channel channel inhibitors. We had been developing our lead compound, CM4620-IE, which is an IV-formulation for acute pancreatitis. When the COVID stuff started to happen, we were in the midst of raising money to go into a 2B study, and we are now in COVID-19 instead. The drug works in an acute fashion, down-regulating the immune system going to the lung and endothelium. We had seen some evidence of activity in lung injury. We moved into COVID-19, and right now, are in the midst of an interim look at our data from a Phase 2 being conducted in five sites. So, we're a company that did a strong pivot, and one of the first small companies into the clinic with a molecule that will address COVID-19 pneumonia.
Caroline Loew, Ph.D., Glympse Bio:
I'm Caroline Lowe, CEO of Glympse Bio, a series-A funded company based in Cambridge, MA. We have a platform of noninvasive biosensors that can measure and project predict the trajectory of disease, giving a real-time functional readout that's clinically actionable. So this has the potential to transform disease detection and response monitoring. Our first indication is in NASH, that's currently in the clinic, and our second indication is in oncology, and that's very close behind it.
Paul Wotton, Ph.D., Obsidian Therapeutics:
Yeah, I'm Paul Watton, I'm the CEO at Obsidian Therapeutics, a company also in Cambridge, MA. And, we're a company that's working on being able to control cell and gene therapy activities using a small molecule to do that. We're a company of about 60 people right now and, we're on track to grow to about 80 people this year. that we're off track a little bit. but nonetheless, we continue to work, in the labs and getting used to working from home. we've also had an interesting challenge because we work with Bristol Myers Squibb as a partner and I'm pleased to say that we've been able to keep those dialogues going with, with the guys at BMS, who were faced with very similar situations to ourselves. So it's affecting all size of company, whether they're a small biotech like us or a large pharma company. But we seem to be getting through this together, which is a good thing.
Wright (LSL):
Great. Well, I appreciate everyone taking the time to introduce themselves and appreciate you joining us on the zoom call. I know zoom fatigue is a real thing, because we are trying to focus on everyone at the same time, but we're going to get through it together. What I'd like to do is a round of direct questions with each guest. I'm going to do this alphabetically. Starting with Mike. How are you holding up? How is your family?
Clayman (Flexion):
Yeah, I appreciate the questions. and we're very lucky that the family's fine. My wife and I are sequestered, hunkered down in our house in Gloucester, MA, with three boys who are all well living in different parts of the country and doing things virtually just as we are. The hardest part of all this is missing the human contact of friends and colleagues at work, which is probably a statement of the obvious. But we are doing well and appreciate you asking.
Biopharmaceutical Manufacturing During COVID-19
Wright (LSL):
Mike, you're a CEO of a commercial stage company. Wondering if you could walk us through and shed some light around the types of decisions being made to minimize the impact of biopharmaceutical manufacturing during COVID19?
Clayman (Flexion):
We've been very fortunate as it relates to manufacturing. We had, approximately 10 months-worth of labeled product on hand in the U.S. ready for distribution, plus another 12 months-worth of active API ready to be manufactured at our site. We work with Pantheon as our contract manufacturing organization. We never want to trivialize anything, but we entered this pandemic in a very good place in terms of inventory. Our manufacturing people are in contact with their Patheon counterparts on an almost daily basis. In addition, we have people in the plant who are talking to their colleagues regularly. The first question we had moving into this pandemic is what is our inventory. Do we have to be concerned about it? Do we need to ramp up manufacturing? And the answer to those questions was no [as the government had stopped all elective surgeries, which is primarily where our product is used]. We have a tremendous working relationship with Pantheon. They've been excellent partners, and we've been blessed to not have to worry about supplying the needs of the market [at this particular time].
Wright (LSL):
Does anybody have anything they want to add?
Loew (Glympse Bio):
We were actually in the process of manufacturing clinical supply for late stage clinical development, as well as for early stage for our oncology product, and our bulk manufacturing is in China. In January, we were completing manufacturing for our late stage studies that we’re initiating later this year. Our manufacturing is actually 250 miles from Wuhan, China, so we got a very early look of what was going on with the pandemic. We were in regular contact with our manufacturing supplier in China, but I think from late-December, when we had some idea that there was a very serious situation evolving, we started talking to them more regularly, and that became almost daily contact across three key pieces of the organization. That outreach was essentially twofold. Firstly, to be empathetic (i.e., how are you dealing with this?). They were completely shut down, but got exemption from the government. Essentially, just 5 percent of the workforce was exempted in China to continue to work. So, we wanted to know if the workforce was safe? How were they supplied with regard to personal protective equipment (PPE), etc. But then the second piece was, how are we going to ensure that our supply chain will be able to allow us to continue to meet our timelines? That was a very interactive, ongoing dialogue. We were very fortunate, as we were able to meet our timelines. But even at the end of this bulk manufacturing situation, there was a question as to how we were going to be able to export. Our drug product is manufactured in the U.S., and the bulk supply had to be exported into southern CA, which was in a lockdown situation, so there we were going through the same cycle we had already experienced in China. That early look in China, prepared us for what we ended up doing for our own company in the U.S. as the pandemic situation evolved. But secondly, it sort of shooed us into a set of very proactive planning that prepared us well, and led to us not having any slowdown in our overall key programs.
Kawas (Athira):
We were also manufacturing for our late-stage clinical trial for Alzheimer's, and also using Patheon, as our product form is prefilled syringes. The first thing that people thought about was to make sure the supply chain was not interrupted, as the FDA and EMA guidelines didn't prohibit people from starting any clinical trial. But one of the things that these regulatory bodies emphasized was the assurance of a continuation off the supply chain. From a regulatory point of view, the guidance allows for some flexibility that previously was not allowed, like direct-to-patient shipment. The silver lining of all of this, is that the industry is being pushed to accelerate the timelines to get to a point where we have always wanted to get to (i.e., getting the safest treatments to patients as quickly as possible). The first thing we focused on was how we could make sure that our API gets to our drug product manufacturer, our drug product manufacturer to the depot, to the sites, and ultimately the patients. The industry reacted very quickly. Drug product, whether at the commercial or investigational stage, is considered critical and being prioritized. Yes. We had two weeks of panic and trying to figure things out, but things went back to normal very quickly.
Leheny (CalciMedica):
Manufacturing has been a big deal for us as well, particularly in terms of navigating this whole new world. We were in between clinical trials and had just done a batch of drug. For us, formulation is the biggest step in terms of preparing our drug, and one that takes several weeks to months to do. We were in the process of bringing together some clinical materials for our 2B study for pancreatitis, when we quickly entered into a COVID19 study, which we are now scrambling to get more drug available for. We use a group (Bioserv) here in Seattle for our clinical stuff, and they've been terrific at finding us time slots in order to get our drug ready for the next stage of what we're going to be doing in the clinic. In addition, we've also had to accelerate looking at moving into commercial manufacturing, because the formulation is a fairly complex issue. This has been just a whirlwind experience, with everybody seeming to have an opinion about how we should be doing this, because everyone thinks it should be simpler than it actually is. But the current situation has moved us into commercial probably a year earlier than we would have otherwise. I have to say, the groups that we are using have been incredibly helpful. I've never seen anything like it, withy teams from different companies getting on the phone to talk about how this is going to go, and the enthusiasm and commitment is just mind boggling.
Wright (LSL):
Leen [Kawas], you're in Seattle, the birthplace of the COVID-19 initial epicenter in the United States. How are you and your family doing?
Kawas (Athira):
We’ve been doing well, though it’s been toughest on my daughter. She's two years old, and we’ve been trying to figure out how to keep her entertained. But my husband was a real champion during this period, because I've been on the phone from 7:00 AM to 8/9:00 PM. If you want to talk about Zoom fatigue, for sure, because with Zoom, there is no time between meetings, with about two seconds in-between to switch into the next link. So, it's been a very interesting period. I always try to look at the silver lining. While I'm spending more time interacting virtually, I’m also spending more time with my family, because when there is time between calls they are here. But health wise, everyone has been doing well. As for the business team, being in Seattle, we kind of got an idea about what potentially could happen, and reacted very quickly. The team has been doing very well, as a lot of the functions can be conducted virtually in our industry. As it is very hard to have the full team here in Seattle, there was already a virtual component to our operation that we transitioned over somewhat normally. The lab team has been fantastic in sticking to the rotational schedule and maintaining the lab and the work. We did have a period of shut down and had minimal function as an order from the state, but now things are back to normal. But it has also been a period where the team showed strong, collaboration and resilience to make sure the train is still moving, while we're all still healthy.
Biopharmaceutical Company Fundraising And Investor Meetings During COVID-19
Wright (LSL):
What has fundraising been like during this current pandemic? Because, though COVID-19 seems like the most important disease we need to tackle right now, Alzheimer's and Parkinson’s (two disease areas being worked on in your company) remain hugely important.
Kawas (Athira):
Athira had a very strong 2019, and going into J.P. Morgan (JPM) we were on a super high. We’ve had a lot of traction and interests in the work that we are doing, because we have a very innovative approach to targeting Alzheimer's. Plus, we had exciting data (in Alzheimer's subjects) that our chief medical officer presented at the 2019 Clinical Trials On Alzheimer’s Disease (CTAD) meeting. Having a very innovative approach, data, plus having achieved all of our milestones put Athira in a very unique position, which continued post JPM, that is until the market crashed due to COVID-19. Though I’m super impressed by the investors in this industry, as a private company, we have to give them time. Because we are competing with a public market that is currently on sale. But what I've noticed from investors, is that they recognize the intrinsic value of developing an innovative technology and the potential of providing true solutions for Alzheimer's and Parkinson's patients. We didn't lose that and the interest was still there. We just needed to be realistic, and give some time to investors to digest what was going on, to define the new norm. Going from a super high to silence was not a comfortable period for us. But, after two or three weeks, when at least the life science industry started to show some normalization and definition of the new norm, things picked up, and Zoom has been a savior. Moving from having face-to-face conversations with investors, to meeting in the Zoom platform, was initially awkward, as you're trying to figure things out. But now it's very natural. We are doing very well, and I’m excited for the next phase, which includes the initiation of our phase 3 clinical trial in the second half of this year.
Wright (LSL):
What about some of the differences between virtual pitching versus pitching in person?
Kawas (Athira):
The value of being in the room with investors is that you can read the room, and focus on the area/s where you see body language change in a positive way, because not everything is verbalized in these meetings. Both us and the investors are getting comfortable at the beginning of pitching with Zoom. For example, in many initial meetings, investors didn't want to have a video on. But that seems to be shifting, because we're always putting our video on, and the investors are begin to see that we are comfortable being there. So it’s a process, and it’s improving. And we've seen a lot of successful virtual roadshows and IPOS even in this nuclear winter of a current economy. The current situation is shifting the whole approach we have as an industry into a much more efficient path. But I miss the human interaction.
Loew (Glympse Bio):
In general, the video helps a huge amount. You can actually see people, and there's some sentiment that you can feel by just seeing someone. But you don't get everything. You still don't quite get the same level of detail from the personal interaction. We're also doing fundraising, and overall, we haven't found a significant dip in the process. It's more about having patience, as empathetically, everyone is going through the same thing that you are personally at home. You're trying to figure out, if you've got kids, homeschooling. You're trying to figure out how or where do I get my groceries. Where do I find my flour? From the investor perspective, they're generally dealing with at least one, if not two things. The first is, they're dealing with their current portfolio companies, and many of those are experiencing a lot of very significant issues. That is sort of forcing these investors to spend a disproportionate amount of time with those companies when compared to the norm. So, you have to be patient, because they are dealing with a lot of complex issues, and these are not like the issues that we're all talking about now. So that's the first thing. The second thing is, if you're dealing with an investor who has public market exposure, that's going to be a major consumption of their time. Patience, empathy, and just standing in their show for a little bit is really important right now. While this is having a tendency to slow down the process, in general, we've found there's still good engagement. Investors still have an appetite to invest and be part of biopharma innovation. That hasn't really changed. As for the video, there still are those who do, along with those who don’t, switch on the video. I believe it does make a difference, and switch it on no matter what. It's always there and people can see me even if I can't see them. You have to have the courage to switch it on. Once you get over that, and make the decision to say, I'm going to switch it on no matter what. Even if your counterparts don't turn on the video in the meeting, at least they can see you, and they take something away from that. That’s important. That's our experience.
Clayman (Flexion):
At risk of being flip, we've had investors who did not have their video on. We were at a banking conference a few weeks ago, and so we had kind of back-to-back meetings, which, as a public company, that's what you do. But, where the default position was, “I'm not turning on my video.” And where we encouraged people to turn on their videos, which some did, there were occasions where we wish we hadn’t. I guess that the nature that comes with the current situation of working from home. Overall, Zoom is a very effective way to interact. It's not the same as being in person, but you can have excellent discussions, particularly with people who you've met with before, so you're building on a relationship. It's a little tougher to create a relationship over Zoom. It can be done, but I think it's just a different animal.
Wotton (Obsidian):
The other thing that this is teaching me is to have patience across the board. We’ve got some business development discussions ongoing right now. But given the situation we're in, these programs aren't moving along as rapidly as I want them to. I’m not the most patient person in the world, but I have been able to adjust to this new reality. And, I think, everyone recognizes, as was said earlier, that we've all got other stuff to worry about at the same time (e.g., getting our groceries). These might seem trivial, but we are all paying a little bit more attention to planning. At our company, we are learning what a huge difference planning can make, and using this as an opportunity to plan forward, which is bringing a bit more discipline into the company.
Leheny (CalciMedica):
One of our first calls with a potential investor, when this whole thing started, maybe the first couple of days where everyone was on lockdown. We got on our Zoom conference call, and this investor, in Boston, shared with us that they were doing the call from a bathroom in an effort to find a quiet spot away from a two-year old and a nanny. You get this vision of someone sitting in their bathroom trying to talk to us. Well, they did not turn on the video. People have gotten much more organized, but in the beginning, it was a real learning experience.
Wright (LSL):
Thanks Rachel. Since you were just talking, wanted to come to you next, but first want to know how you've been doing?
Leheny (CalciMedica):
My employees seem to be holding up very well. Everyone's at home. My family is all healthy. I've got a college student who, returned home, with a nasty cough from Boston, so, who knows. I have a high school senior who's not doing things you’d normally expect. but you know, everybody here in San Diego is doing well. I mean, we've got considerably low per capita incidence of the disease. So, I don't think we have quite the intense, sort of exposure feeling as other places.
When COVID-19 Presses Your Company To Make An R&D Pivot
Wright (LSL):
During the introduction you talked a little bit about doing an R&D pivot as a result of COVID-19, tell us a little bit more about that.
Leheny (CalciMedica):
Sometimes, a decision makes you, and you don't really make the decision, and I would say that this was one of those situations. I haven’t had quiet time for reflection in about eight weeks, so a lot of this is just 12-hours a day where you're just reacting. But here’s what happened. We were in the process of raising money to do a phase 2B study with our drug CM4620-IE in acute pancreatitis. People coming to the emergency room with acute pancreatitis are hypoxemic. They often have lung and kidney involvement. The team was in the process of doing that, and we were on a train (the Acela Express from New York to Boston) and our chief medical officer said, “You know, our drug could actually work in COVID-19 and the cytokine storm.” We all laughed it off. About a week or so went by, and we started to get calls from our clinical investigators who had used the drug in the past, asking if the they could use in COVID-19 patients? And, you know, we were like, maybe that wasn't such a crazy idea after all. Our original instinct was probably like a lot of people (i.e., go into patients in a sort of a one off at the discretion of clinical investigator, and if it worked inform the media, and wouldn’t that just be grand). We were a little bit lucky, in that the FDA was really starting to try to clamp down on that kind of stuff, so we realized very quickly that we were going to have to move into a clinical trial, and do it quickly. Fortunately, we had just done a drug run, so we had drug and we basically went to the FDA and said, “You know, we have an IND already in the pulmonary division. Do you think we can just start treating some COVID-19 patients? We'll send you a protocol.” They were like, “No. You'll have to refile the IND in infectious disease ….” That took a couple of weeks. But, from the day we filed the IND with a protocol, to the day we had our first patient receiving treatment, was less than 10 days. That was April 8, and now we are doing an interim look on this phase 2 study, cause we're at that point now. We're up in five sites, probably be seven by the end of next week. And it looks like we're going to finish our study at the end of May. Stay tuned. It's looking good. So very exciting. The drug basically works by going to the lung endothelium and down-regulating over activation, which then down-regulates the immune reaction to that. We see downregulation of IL-6, IL-17, TNF alpha, and we're seeing that in the COVID-19 patients just like we did in the acute pancreatitis patients. What we're trying to do with the drug, is treat the severe patients who are on oxygen and keep them off of a ventilator, and hopefully get them out of the hospital quickly.
Wright (LSL):
The next person I wanted to speak with is Caroline. How's the family?
Loew (Glympse Bio):
Thank you. They are all well, safe and healthy. All the employees on our team are also doing well, which is good. You can't take anything for granted nowadays.
Working Remotely In Biopharma During COVID-19
Wright (LSL):
Caroline, to my understanding, you live in Washington, D.C., and commute to Boston, so you were already familiar with remote work, but wondering if you could share a bit of your experiences as a CEO of enabling your team to be successful at remote work during the pandemic?
Loew (Glympse Bio):
Under normal circumstances, I spend a week in Boston with our team. But in late-February, we started to adjust our workplace operation. As we had that early look from what had been going on with our suppliers in China, we adjusted some protocols for working in the office. We have a very open-plan operating structure, reflecting our collaborative operating philosophy. The fact that we are a platform company, we collaborate extensively across the organization. So, we started putting in place a lot more hand washing and wiping and cleansing, but we also shut down for visitors relatively early in places where they were outbreaks. We moved much more to remote meetings from about mid-February, and started to prepare the team for the idea that we would switch to work from home at some point, it was kind of a question of when. So, we had about a three-week run into that idea, and started to meet with the team weekly to basically discuss, what we were seeing happening, and our expectation about what the evolution was. And then the first week in March when the first cluster of cases was emerging in the Boston area, we took the decision to move to work from home. We moved all of the non-lab-based employees to work from home, and deemed a group of lab-essential employees to continue working in the lab. Then we did two things. First, we asked that lab essential team if they wanted to continue working. We gave them a choice. Second, we provided additional support. For example, we gave them additional PPE. We allowed them to take a non-public transportation to work and we’d reimburse. If they wanted to park at the office and hadn't previously, we gave them access to parking. And, we put them on an operating structure (i.e., shift work) to help assure their safety as much as possible. We also prioritize our lab work ruthlessly, so only core programs that were essential to our priorities and progress were maintained. We did a couple of different things for the remainder of the organization working from home. First, we made sure that if people needed additional resources to work from home, they could discuss with their manager for support. Next, we put in place additional meetings to support this new operating infrastructure. We did other less formal things (i.e., virtual meet ups), so there was some sense of community similar to what we had when we were all present in the office. Actually, spending time working on that virtual operating model proved really important, as it took a couple of weeks to really iron out the kinks. As a social component, we have these virtual coffee times. We have a “quarantini,” a virtual happy hour at the end of the week. We had already been rolling out a learning and development initiative, which we made entirely virtual. And then, we focused the initial learning and development programs on things that were really relevant (e.g., supporting and adapting to change) in helping people go through this change. We used Slack as a communication channel, as the organization is very Slack centric, but put in additional channels that were very supportive (e.g., additional resources that people needed). Then, we made sure to be very attentive so that no one was left behind. It's very easy to think that I'm doing okay. I'm adapting. I see my colleagues are adapting, that you might miss someone who's struggling a little bit. They've got lots of kids and the homeschooling isn't working, or they're dealing with elderly family members. We were very attentive to that and made sure to reach out to individuals. For example, I personally now have a lot more one-on-ones with more people in the organization just to stay connected, and more importantly, just to make sure that everyone's okay. I know that the rest of my team is doing that as well. It took us two weeks to find our rhythm, and today, there’s very much a sense that we're operating at essentially the same pace that we were previously. We haven't missed any program timelines, and in general, working well. But, there had to be a concerted effort to establish that virtual operating model. It, it's not just a straight transfer from walking out of the office and keeping all the meetings that you have in your calendar and turning them into Zoom meetings. That's definitely not how it works.
Wright (LSL):
Thanks for that Caroline. I'm just looking at the clock and want to be cognizant of everyone's time and not miss out on inviting Paul to share something as well. so, so Paul, how are you doing?
Wotton (Obsidian):
I'm doing fine. Thanks. We're doing fine. We actually moved out of Boston to, Bucks County, PA, where we had a home prior to moving up to Boston about five or six years ago. Came down here primarily because it's easier to access shopping. So, it's actually working quite well for us. The company is doing well too. I'm really pleased with the way everybody's responded. One thing I've learned from this, which was, turns out to be a lucky break, is the importance of having a good strategic IT person in the company. We brought that on board in October, which most small companies don't tend to think about. But, in hindsight, it was a brilliant move, because prior, the company wasn't operating on anything like Microsoft Teams, which we put in place in around December. We also put in what we call the cyto hub, which is an intranet for people to communicate. What we've been able to do there allows employees to set up like drinks hours, or other social groups. We also use for town hall meetings every Wednesday for two hours. Plus, a lot of people are using for internal messaging. They're working hard, but they're also trying to be encouraging. So far so good, and we are all COVID-19 free in the company.
Best Practices For Working In The Lab Through COVID-19
Wright (LSL):
One of the things I wanted to ask you about Paul was regarding, proximity concerns in the lab. For example, I was talking to Lawrence Blatt, CEO of Aligos Therapeutics, an upcoming feature in Life Science Leader, and he was talking to me recently about some of the things they'd been implementing around COVID-19. He talked about employees bringing proximity concerns around being able to work safely in the lab. I think you've put together a plan around that as well, and wonder if you could share with the group what that involved?
Wotton (Obsidian):
Yes. We were a little bit earlier than most in anticipating how we might have to work under the, the COVID-19 situation. I was comfortable we’d manage through. But I have an M.D. in the company who is also an epidemiologist, and in the middle of February I remember him saying that we’d better get prepared for this because it is going to be a big deal. At that point in time, we started to triage our programs down to the ones that are most important. When we all started moving to working from home on March 9, we had our development plans laid out for at least three months going forward. We asked everybody in the lab to continue working as normal as possible, taking into account the most important thing being their safety. As such, if you weren't an essential worker for lab work, you had to work from home, which was enforced. For example, I actually went into the office one day on March 15, and was asked to leave by the lab techs, which I did. You got to walk the talk. In the lab, we put in place an early system where we were able to keep people separated. But we soon realized we were doing a lot of planning by hand and over the phone. So, the IT person got the team together and designed software to enable everyone to go in, plan their own lab work, make sure that no one else was going in at the same time in case they needed to use the same piece of equipment. This change to being more like shift work, along with this new productivity tool, has worked really well for us. We have absolute visibility on who's in the facility at any single time, and team members can see when they need to pair up on experiments. Because of that, we were able to deliver a critical experiment on one of our programs to Bristol-Myers Squibb (BMS) slightly ahead of schedule. That was all because of the level of coordination we were able to bring. Other companies are asking us for access to this software. I attend a call every Monday with about 180 other CEOs, and through Atlas, our venture capital partner, we’ve been helping others to implement the same kind of idea in their own company. We call the technology SWiFT (safe working functional tool), which we developed internally and are willing to let others use as well.
Loew (Glympse Bio):
We have a similar tool that we're using that we built in house. Just to add how important this was. We actually had a potential COVID-19 exposure from someone else in our facility (not from our company) who was diagnosed with COVID-19. When we were informed, having access to that tool, allowed us to specifically understand who had exposure risk. While it turned out that no one had actually been exposed, having precise clarity as to who had been in the facility, when, and who could have crossed paths with this person was invaluable, as it prevented us from having to shut down the lab, which is absolutely critical. It's not just about planning and having the ability to execute. There are real implications in terms of the health and safety for your employees, and in our case, it was able to help directly track an exposure issue.
Parting Pearls Of Wisdom
Wright (LSL):
Thanks for adding that Caroline. Knowing that you might have other Zoom calls, wanted to give everybody an opportunity to share a partying pearl of wisdom.
Clayman (Flexion):
The COVID-19 pandemic has translated into a very positive response from the biopharma sector broadly, and we hear it at the individual company level, in terms of collaboration and resilience. Rachel Leheny's CalciMedica example of repurposing a product to help with the pandemic is another example of the industry coming together to ask the question, what can we be doing to accelerate drug, vaccine, and diagnostic development? What other things can we supply (e.g., PPE) that we might have in our possession? The industry has done a marvelous job of coming together in the most collaborative way, and letting any barriers to that collaboration fall by the wayside to ensure that we are doing what we're all in this business to do — help patients.
Kawas (Athira):
I think that everyone would prefer that COVID-19 didn't happen, but we have to live with this new reality. I'm so impressed from the clinical operations side and the supply chain, and how proactive everyone in the industry has been, because COVID-19 touched everything we do. The transformation and from one place to another, for example, in our Alzheimer's trials, using telemedicine and digital platforms, all of that shift was accelerated by COVID-19. Everyone is shifting into a new paradigm, making clinical trials, clinical testing and the supply chain much more efficient. Of course, there's a lot of work that still needs to happen. But we also learned a lot about being patient during this difficult period.
Leheny (CalciMedica):
We are living by two adages: take each day at a time, and seize each day. You have to be kind of flexible, but intense, and it is hard to balance those two things in the same moment. But we seem to be doing it. But I would like to take just a moment and thank all of the people that are taking care of patients and doing the clinical work. It's been spectacular. In our trial we've had to ask nurses to go in and do extra blood draws and all of this stuff that's currently very frightening. But they're doing it to help patients and make things better. I just can't speak highly enough of the medical professionals in this country, and everything that they're doing to address this pandemic on the front lines.
Loew (Glympse Bio):
Three things have come to the core for us. The first is, people are everything. So, focusing on our people, keeping them safe, having clear communication, that has been first and foremost. Second, regarding our programs, creating those priorities early, keeping those priority programs on track, and maintaining focus. And then there’s planning. Creating contingencies, optionality, and flexibility. Very consistently we are finding that what we know today is not what we find tomorrow. That action of planning is just so invaluable, and it's what's allowing us to keep everything on track. And I can't emphasize how important that is.
Wotton (Obsidian):
One thing I've learned is how important effective communication is these days. When I was a kid, I used to like biology. But I'm appreciating Charles Darwin even more now, because we are adapting to survive. Across the industry we're developing novel products and innovating in biotech. But what I've seen in my own company is a level of innovation that goes above and beyond what employees are traditionally asked to do. We're all in this together, and we'll come through this together.