05 Oct Session A – Life Sciences Track
Life Sciences Track – Pandemic & Risk Mitigation: A focus on preparedness & resiliency
- Linda Segal, Principal, The McCormick Group
- William Hearl, Ph.D., Founder and CEO, Immunomic Therapeutics, Inc.
- Anne Lindblad, Ph.D., Former President & CEO, The Emmes Company, LLC
- John Trizzino, Executive Vice President, Chief Business Officer and Chief Financial Officer, Novavax
Preparedness is a big challenge for any organization. And for us, I think the way we kind of looked at it is almost along lines with how we prepare for bad weather in the winter. And we made it possible for all our employees to be able to work from home, because we anticipated there would be cases where we would have severe weather where we would just prefer our employees to be safe and be home and be able to work. So, we outfitted everybody with the appropriate types of laptop computers so they could always have them at home. Set up the VPN situation so that we could work, and we’d had a video conferencing system on a kind of a basic level, install that originally.
And so, I think the way to do it is we’ve always taken the point of view that the health of our employees is the most important thing, as is taking care of their families. So with that philosophy in mind, I think, knowing that we gave everybody the ability to work from home, we instituted that and then once it became clear that the pandemic was expanding. Of course we have laboratory experiments, and having a CME in wet lab activities. We worked out a circumstance to allow people to come in, do their work, and then go home on shift so the building was never, never crowded and there was never a case where people had to work in close proximity. So we were able to endure that period of time very well because of the commitment of the employees and the tools we had kind of given them in advance. That turned out to be very useful for this circumstance.
One of the things I think for any company that’s important is just to have a really strong foundation. And so I see that as building and maintaining a company in a culture that really values transparency and trust. And that really helps you change as you need to change as an organization when things happen that are unexpected. So, I think from the very beginning, Emmes has always encouraged leadership and self-discipline, at every level of the company and this allows people that freedom to make choices and decisions without waiting so that helps them move faster when things are changing. Preparing for change and making change is easier than managing that change.
Just being really clear that our employees and our clients come first, and making sure that people are staying safe and able to communicate is paramount. Security is crucial here because we have offices in India and Canada and the US and now I have to add in everybody’s homes and that changes the paradigm with security. We have to worry about GDPR and HIPAA, and we need to make sure that we can stay compliant with those important regulations. And so having the tools and having the security is one thing but making sure staff is trained to use them effectively is actually part of the challenge too and making sure they know where to get help so they can be as efficient as possible.
I think one of the most important things we did was to encourage our employees who are already doing this to really communicate with clients, because the face of our clinical trials were rapidly changing. Making sure our clients knew what we were doing to maintain this the safety of the patients, making changes to protocol helping through the regulatory processes, etc. And then, you know, in hindsight Another important thing we did is we started a weekly 30 minute touch base on COVID and on corporate happenings with our employees and we continue to have incredible participation. It’s totally voluntary. But people really want to stay connected as a community and so we learned from that people needed help on, you know, managing being home alone, and not having that that camaraderie. And others with families that were trying to manage children and so by having our HR department help with special seminars and support groups I think also helped just the mental status of our employees to adapt to that change.
QUESTION: How has COVID affected clinical trials, especially the recruitment for those trials.
It’s been interesting. It wasn’t a total shutdown which we were sort of expecting that maybe nobody could recruit, but we found that many of the sites pivoted as well, and were very innovative so the best way to think about is that it’s all about innovation. I think this is a good thing for our clinical trials community. I think it really challenged us. We found that the FDA, long ago had guidance on risk-based monitoring and use of remote monitoring or centralized statistical monitoring and this really forced many organizations to actually implement these things a lot faster. We tend to be a little late adaptors because we’re risk adverse, we want to make sure we have the best clinical trials, but having to accommodate places where you cannot do on-site monitoring, you have to think of different ways because the quality of that data is essential to getting the answers to the questions that you started out with for recruitment. We found that some sites totally shut down, and were on pause, while other sites kept going, and they had instituted safe practices for seeing their patients but also sort of hybrid approaches that required that we go to the ethics committees with revisions to protocols that allowed patient reported outcomes, telephone interviews, and replace them in-clinic visits. And so there was a very fast need to make those changes and get them approved in the protocol so they could be instituted so that we didn’t lose out on any safety information for ongoing clinical trials. And so as we think about the future, I think we’re going to see more hybrid models than maybe we have in the past. And I think this might be very good for speeding recruitment into clinical trials to the future so as bad as COVID is, I think it’s been an opportunity for all of us to rethink how we do our business and maybe do a better in the future.
QUESTION: So I would have thought that maybe you would have had a problem recruiting, but it doesn’t seem like that’s the case.
No, not at all, I think, in fact, just the opposite. I think there was a high degree of interest. I think in the US there were potentially some challenges regarding the multiple 30,000 subject trials but even there, there’s a high degree of interest in pursuing those clinical trials. Even with the clinical research organizations as well as the individual sites, a high priority was being placed upon these trials starting as quickly as possible and simply based upon the availability of material and regulatory approvals.
QUESTION: What changes do you see that the market is predicting based on this pandemic and, and how long we may be in this state, and what talent pools? Do you think it will help with whatever changes are happening?
There’s a uniqueness to what we’re what we’re doing here at Novavax that I think from a talent pool standpoint, we’ve grown dramatically from the beginning of the year, bringing some over 150 people into the organization in that period of time. Everyone across the organization wants to contribute to the cause.
Montgomery County and this region has a tremendously valuable talent pool to tap into and so that’s been a success for us. Even on the infrastructure side, so whether it’s HR or finance, we have attracted some significant folks and the additional work that’s had to be done in those areas to build up that infrastructure has allowed us to tap in to those human resource needs and the regional talent pool. So, again, our experience may be slightly different than some others. But the region has allowed us to accelerate on all of those fronts because of the resources available here.
QUESTION: Have any of the talent that you’ve been needing been very different from what you would normally recruit for?
There’s going to be a huge backlog of trials that are likely to be launched in 2021. So once a vaccine is widely available, there’s going to even be larger growth just because there’s this pent-up demand. So I think that’s going to put a lot of pressure on our labor market to find attract and maintain talented staff to support these studies within biotechnology. And I think about our talent needs so I think about our experience we were really privileged to be working with the National Institute of Allergy Infectious Diseases and our staff were able to receive that protocol back, way back in the March timeframe and get the first patient in within four days. So we got the system up and ready and randomized, and that’s a new record for us. And I think what that speaks to is just staff being able to work collaboratively and innovatively so that we can maintain quality and rise to these occasions
I agree with the other panelists I mean the enthusiasm of our staff, wanting to make a difference, you know to human health in this pandemic is huge. And so finding talent that has that passion that’s willing to work remotely, collaboratively, and innovatively it means you need the people that are confident and self-starters. We can provide a lot of support, but it’s also going to come from a sort of the fire in the belly of our staff, because that’s really what makes a difference for us. What has been good about remote staff is, even though there’s a wealth of talent here, it opens the door globally.
QUESTION: What are some lessons learned?
I think we have to keep doubled down on managing remote workforces and managing by productivity, not by time in a chair, you know with being able to share screens, you can be virtually next to each other.
A long time ago I heard it takes seven touches you know in advertising to really bring a message home and that’s seven different ways to figure out how to connect with people. So that’s something that’s a work in progress. And where we’re concentrating is what we think is happening to our clinical trials community of hybrid trials, more direct-to-patient, maybe more virtual trials which have a lot of using electronic health records maybe sightless trials, etc. and making sure we’re prepared with all the technology we need and privacy and security as well, so that we can launch those kinds of trials as well. We do some of that now, but I think it’s going to become more predominant in our field. We need the best and the brightest to continue to work on technology because I think this will make trials less expensive and it could aid recruitment so we can recruit faster, which means we can get answers faster and hopefully better treatments to patients faster.
Now, I think the, my, my thoughts about heading into next year are that we just really need to kind of stay the course and as we had the ability to integrate more in person, activities, we’ll do that but I think the biggest issue is we have to be cognizant of the potential for a COVID spike. We need to keep our eyes open to the things that are going on in the public health arena at the moment with respect to the virus and not drop our guard until we’re sure that we are completely out of the woods. And so that’s why leaders such as Dr. Fauci have been so important to the dialogue. All people forget that Dr. Fauci is 80 years old, and he’s been around for every major pandemic that this country has seen since HIV. And the man has dedicated his life to making sure that we have a safe environment for our country. And so I look forward to hearing more from Dr. Fauci and implementing his recommendations for my company, and hopefully for our region to keep us safe.
QUESTION: Do you have a target for when you would like everyone back in the office when there’s a vaccine and when there is community immunity?
If I find that I’m in front of my computer a whole lot longer during the day these days than I ever was in the office in Atlanta. That’s an interesting statement because that’s one of the things we worry about with our employees is burnout. And so it’s part of trying to bring that awareness because people are putting many more hours in, and you know I’m interested in getting their fresh bright perspectives and if you’re burned out you don’t get that from them. As a company leader, you want your folks very refreshed, so we’re pushing ours to take time away from the office and unplug and finding we have to do that a lot more now in this remote workforce than we did when it was in brick and mortar.
QUESTION: What is your approach to becoming involved in nonprofit causes in your community?
Drew Parnell, who is on our scientific advisory board, is an advocate for Moveable Feast. We’ve given strong financial support to Moveable Feast as requested by an employee, and they are providing meals. For me personally, I’m a very big advocate of one of the local charities that provide support to cancer families of connections for cancer support.
We joined Montgomery County’s Corporate Volunteer Council because what it brought to us was the ability to offer a wide array of opportunities for employees to participate in giving back to the community. We’ve been doing some book drives, there’s opportunities using Amazon to make it really easy for employees who choose to donate to the local area or a specific cause a homeless shelter.
We really appreciate the help of Montgomery County for pointing us in different areas to give our employees choices, as well as people know that’s as a nonprofit revenue generating company and I think the effort that we’re putting forth right now with coronavirus vaccine is focused on a global response. We work with CEPI, the Coalition for Epidemic Preparedness and Innovations, and the funding support that we’re getting from them requires some global equitable allocation of product, as we’ve heard in the past about influenza pandemics and you know where is the product being made available what our coordination with CEPI puts us in a position of being able to make sure that we’re part of that global allocation process.