06 Oct Session D – Life Sciences Track

Life Sciences Track – Expanding Progress and Opportunities in Gene and Cell Therapy

Moderator:

• Jeff Galvin, CEO and Founder, American Gene Technologies

Speakers:

• Dawn Driscoll, MBA, Ph.D., GAICD, Chief Executive Officer, Cell Therapies Pty Ltd
• Bill Enright, CEO, Vaccitech
• Jon Rowley, Ph.D., Founder and Chief Product Officer, RoosterBio, Inc.

QUESTION: Tell us about RoosterBio

Our goal is to radically simplify the incorporation of living cells into tomorrow’s therapeutic products. We are not a therapeutics company, we are actually a tools company, and we supply cell banks and bioprocess media into the cell therapy and gene therapy field from which therapeutics are made. So they’re the cellular starting materials and the ancillary materials in manufacturing. So, we’ve taken the traditional media business model that was actually pioneered right here in Maryland and turned that business model on its head and focused it on the manufacturing and the product development. Our mission is to really fuel the rapid commercialization of scalable regenerative cures.

QUESTION: Tell us about Cell Therapies

We are a full service contract development and manufacturing organization. We’re fully licensed by the TGA, which is the Australian equivalent of the FDA, to produce cells for immunotherapy…various immunotherapy applications so we have a broad license for T-cell manufacturers in both clinical trial as well as commercial applications. And there’s really interesting quirk in Australia versus the US, where we’re required to have manufacturing inspections very early on in the development process, so we’ve already obtained those licenses so when clients come to us, they know that they’re coming to an organization that has basically de-risked the entire process and been through the process with a regulator.

American Gene Technologies is a clinical stage immunotherapy company, and we are really focused on using the T-cell side of the immune system to prevent disease or cure diseases, where we know T-cells are going to be important. We’re focused primarily right now in chronic infectious diseases like Hepatitis B, Human Papilloma Virus, as well as in oncology, so we’ve got multiple programs running in the clinic right now. The big news out of American Gene Technologies right now is obviously that we have been approved by the FDA to start a clinical trial for an HIV functional cure. And we’ve been working on this for a while. And we have a lot of preclinical data which is giving us significant confidence about our ability to actually cure HIV and a functional cure basically would be. And I’m pretty confident about it because we have really put together a dream team of HIV clinicians scientists and folks that are very experienced at it.

QUESTION: What can the Maryland stem cell research fund do to help accelerate cures in this field?

They’re already doing a lot. They’re funding a lot of basic translational research within the universities. Just a couple years ago, they put together funds specifically to help industry, which is to fund both product development as well as clinical trials that are being run in Maryland. And so there’s lots of opportunity there. We’re a small company here in Maryland and have grown over the last few years, and we’ve benefited from two of their two grants, specifically on the product development side and we successfully have launched two products based off of the funding that came out of there.

So they are actively helping the small companies here which is really great.

With workforce development, one thing that’s happening with lots of great companies that are moving to the area, the talent is getting slim. So the workforce development aspect, I think it would become an interesting area for them to expand into.

We’re finding it easier to get sort of entry level folks but a little bit harder to get experienced Ph.Ds.

QUESTION: When we were prepping for this session, I was surprised to hear about some of the projects Cell Therapies is working on with companies in the United States. Could you just tell us a little bit about those ones. You know the products that you’re working with.

There’s two fairly high profile projects and clients that we have which are very highly public knowledge, and I have my clients approval to talk about this publicly. The first being a company based in Boston that is developing various gene therapies for rare disorders. And we’re doing a lot of their product development and bringing those products into clinical trials in Australia for that company, and that’s been great because of their non-cancer applications. So, our team gets to become immersed in the biology of another disease state and really the biology of a different type of cell from what we work with most frequently. Another high profile client is Novartis. We are in the end stages of tech transfer and we’ll be launching manufacturing for Australia and quite a few other countries in this region. We’ve been pretty thoroughly road tested by some of the biggest companies in the world. We’re quite comfortable working remotely.

QUESTION: What are the major characteristics of MSCs that you think will be useful in the future in terms of treating different diseases, and you know sort of what’s the broadness of that platform.

Cell therapy developers have been figuring out how to take them outside the body, ex vivo, to expand them. And then just overwhelm the site of injury so you can infuse them and they will then home to the site of injury. A bunch get stuck in the lungs. So unless you’re treating a lung disorder like RDS, that might be a bug in some indications, it’s a feature. Some are directly injected into the site of injury. And, from my from my understanding, no one has really found a dose that is too high so you can really use a ton of these cells and overwhelm that site and really get that tissue regeneration starting. And then within a couple of weeks, you don’t see anything there, but the function of transplanting can last for months.

06 Oct Session C – Life Sciences Track

Life Sciences Track – Biomanufacturing in Maryland: Building a global footprint and maximizing the local ecosystem

Moderator:

• Curran Simpson, Chief Operations and Technology Officer, REGENXBIO

Speakers:

• Sean Kirk, Executive Vice President, Manufacturing and Technical Operations, Emergent BioSolutions
• Tom Spitznagel, Ph.D., Senior Vice President, BioPharmaceutical Development & Manufacturing, MacroGenics
• Aaron M. Vernon, VP, Engineering & Supply Chain, Autolus, Inc.

QUESTION: Maryland is now sort of being referred to as a strategic location for manufacturing, in general, so could you describe what is it about the area that you feel fits the category strategic location, maybe we’ll start with you.

We have a desire to enhance our overall collaborative effectiveness with not only HHS, BARDA, and other agencies, but also the FDA and the Department of Defense. Biodefense preparedness was really the origin of Emergent, so we’ve had a lot of great success and it just so happens that we’ve acquired products that came along with facilities, two of which happened to be here in Maryland. So to your point, through acquisition and organic growth we’ve ended up firmly rooted in the Maryland area.

Maryland’s real estate prices are reasonable compared to other biotech hubs like Boston or San Francisco. Maryland still has a substantial advantage over there even if you build within the city of Rockville for example it’s still highly discounted compared to other areas. One of the things in why we built our manufacturing facility in our actual corporate headquarters is to showcase manufacturing. It’s a way of advertising. 

Compared to Boston, it was still a much better cost basis for us to come to Maryland but also it came down to the talent. It has a substantial kind of cluster of people in particular biologics. But even more so in the last several years, cell gene therapy in the area is a pretty good cluster.

QUESTION: How do you deal with the necessary operational speed in Maryland? What are the advantages of being here and what are some challenges that you see the local area as it relates to employment, providing opportunities which.

We’re hiring over 300 people to support our efforts across our three manufacturing plants, and our product development facility is in Gaithersburg. The competition can be a bit stiff here and the talent pool is a bit undersized to serve all the different needs that exist amongst these companies and many others. I believe that much could be done to improve the overall personal income tax structure and other things that are sometimes a challenge to get people to overcome when they’re relocating here from, say the North Carolina area or other areas. Of course, some aspects of living here are actually less expensive than some of the other competitive markets. We’ve worked with the Chamber of Commerce and others in the past and we’re continuing to look to explore mechanisms to enhance the attractiveness of the greater Maryland area to the overall talent pool and get the numbers of candidates up to serve all of our needs.

QUESTION: Could you share some success stories around recruitment and in onboarding of new employees? What areas or techniques have you used to attract and retain employees and what can Maryland do to help support the next generation of companies that are involved in manufacturing?

We’ve been very successful recruiting directly out of college. That’s one area that does have a lot to offer, a lot of local colleges with talented individuals. And a lot of companies won’t give these people the time of day, so we were actually quite successful in scooping those people right out of college and training them and getting them, a rewarding and fulfilling career within manufacturing, and that’s worked quite well for us.

After that second or third year people leave. And, on one hand, we’ve decided we can live with that. If we can get a good two or three years out of them, that’s sort of a minimum but what we really try to focus on is, can we get them to the next part of their career, either into a more supervisory role within manufacturing which, honestly, the options are limited if you’re not expanding your capacity. But more importantly, getting them into development and things like that and we’ve, actively tried to do that and it’s still a work in progress.

Rockville has a lot to offer. Within just amenities, the street from us has 20-30 restaurants. One of the things we find is that a lot of our younger manufacturer employees are living in the cities, so Rockville does have more of a centralized location for that worker base.

QUESTION: Did you consider Frederick or Hagerstown? Obviously, the lower cost of living and potentially the real estate pricing being more affordable.  

So being in closer to the DC area you have access to BWI, Reagan, Dulles, whereas going out to Hagerstown, for example, it’s severely limited in terms of the logistics and the cost and complexity would go up so that’s one of the reasons we wouldn’t go much further west in in Maryland. We did absolutely consider Frederick. Part of the reasoning also was to be located in the middle of the Rockville cluster as our US headquarters.

QUESTION: Cell therapy is an interesting area. Have you thought about the sort of ideal profile of employees in terms of academic training. Are you looking for people with advanced degrees, associate’s degrees or all of the above?

With very early stage clinical, you’ve got many more people with advanced degrees who are touching the product but that’s not sustainable especially not in a large scale. Certain roles that are associate’s degree and more of our manufacturing is probably in the four-year degree. When we’re talking shop floor, that wouldn’t require an advanced degree.

QUESTION: How do you manage that growth in terms of people in onboarding and training and also considerations for the academic level that you’re recruiting for.

We are hiring at virtually every level in the organization. It’s challenging. The pace of hiring is challenging, we have stood up some focused training and education methodology to get people on board and onto the floor or into the labs, and we’re moving at warp speed. I’m wondering how much stress this is going to put on the state of Maryland. So, the state of Maryland has long been dependent upon folks who are government employees but reside in the state of Maryland for income tax base. And as the government reassesses how it operates in a paradigm going forward, I’m curious as to if it may actually lead more individuals using the government as an example to relocate to the state of Virginia, where the overall tax structure is lower, creating downstream tax deficiencies in the tax base for the state of Maryland.   

QUESTION: Have you considered as part of the substantial growth you’re going through things like apprenticeships or on-the-job training programs to bring people in who might not have science degrees but also could be cross trained in the manufacturing?

Yes, we have a variety of different programs that are kind of sprinkled in throughout the organization and have apprenticeships and internships in a variety of different areas ranging from engineering to manufacturing. We’re looking at ways to continue to build them out and to improve the effectiveness of them if you will.

QUESTION: Historically, there have been initiatives in Maryland where labs have been set up to demonstrate for students how manufacturing works, how to put together valves, how to run bio reactors, etc. Is that something that Maryland should continue to invest in? I know that historically that has been developed and then kind of fallen away and then come back. Is that something that you feel that for example Montgomery College could do more to sustain?

It’s great that we have a cluster now in particular manufacturing, But there’s more jobs that we need to hire for than there are people available right now. So I do think that this is an area where companies can work together and work with the state to be able to do a little bit better job of helping to pipeline.

QUESTION: I imagine the facility you’re putting together will have a fairly high level of automation associated with it. Where do you find automation engineers in the Maryland area? What are the creative ways to find this rare skill and retain that that skill?

I wish I had a good answer to that, I think that the best I could say is that, not just in Maryland, I would say all around the country there’s probably not as good automation engineers and we’re all going through this. I think one of the things that is really exciting for automation engineers is the intention to be paperless on the shop floor and to run an almost fully digital supply chain.

QUESTION How important is the commute? When everything goes back to normal, do you feel like that is an impediment for further growth for you, or is it something that just people deal with and you tend to recruit, maybe less from remote more remote areas.

 We haven’t seen commute time be the final deciding factor. Surprisingly, we haven’t seen that be a big driver in either inability to attract people, or the ability to retain people.

QUESTION: One question I would ask around recruitment since that’s going to be front and center for you as the facility comes together. Do you think we are now in a position where people look at us as a hub, and that there are multiple opportunities so the resistance to relocate has gone down or am I just imagining that?

Today, we’re kind of on the precipice thing. People will feel like the DC area is another place like San Francisco like Boston where they could just be here for a long time. And if they have to, they can find opportunities, big companies, small companies and take different roles.

05 Oct Session B – Life Sciences Track

Life Science Track – Vaccine Development: Driving Partnerships in Maryland 

Moderator:

• Marian Ewell, Sc.D., Chief Scientific Innovations Officer, The Emmes Company

Speakers:

• Subhendu Basu, Ph.D., Chief Operating Officer, Adaptive Phage Therapeutics
• Syed Husain, Senior Vice President, CDMO Business Unit Head, Emergent BioSolutions
• Helen Montag, Senior Director, Corporate Partnerships, Johns Hopkins Technology Ventures
• Sally Mossman, Ph.D., VP, Head of R&D Center, US, GSK Vaccines

So, today’s discussion we’re going to be focused primarily on COVID-19 vaccine development, but I think a lot of this discussion and the comments can be broadly applied to other vaccines, as well. 

TOPIC: So the first broad topic that we have is what are the some of the unique challenges for developing a COVID vaccine. So I’d like to start with what type of vaccines are in development.

There are really two overarching challenges in developing a COVID-19 vaccine: One is urgency, and the other is scale. In terms of urgency, we really needed a vaccine yesterday or at least as soon as possible. And for scale, we’re looking at an enormous challenge of needing to vaccinate the entire world’s population. 

We are really lucky that there’s a very diverse range of vaccine candidates in development, and they have various strengths in terms of addressing those overarching challenges as some of the candidates in development are representing very cutting edge technologies things like mRNA vaccines, like the ones from Moderna or Pfizer. And those are very exciting because they’ve been able to those companies have been able to develop design a vaccine candidates very quickly and get them into clinical trials, breaking records for how quickly they could get these into first in human testing.

On the other hand, those new platforms have never gotten to the point of being a licensed vaccine and they face challenges on the scale dimension, trying to set up manufacturing capabilities in the moment and then getting ready to distribute vaccines for which the formulation still got to be optimized. On the other hand, do you have more well established platforms represented, including the one from GSK in partnership with Sanofi Pasteur. And for many of these well-established platforms, it takes a bit longer to be able to design and develop a vaccine candidate and get them into the clinic for technical reasons. On the other hand, when it comes to scale, we have the infrastructure set up and experience with manufacturing vaccines and these platforms. So I’d say overall it’s fantastic to have such a broad range of different vaccine candidates in the pipeline. We really need as many shots on goal as possible, and ultimately will likely need more than one successful vaccine, just given the sheer numbers of people that will need to be vaccinated across the world.

QUESTION: What do you think realistic timelines are for developing a vaccine, and how can we sort through kind of what’s realistic for media hype kind of surrounding this?

I think everyone’s pulled together; The bureaucracies have been cut down and supply chains are being pried open. But there is the biology, and biology has its own timeline and it can be compressed. So, we can recruit all the patients we need, people are lining up. You know, this is the duty the clinical trials will proceed. But at the end of the day, if you’re looking at a one dose or a two dose vaccine. And then ultimately determining if it certifications. You need to have the incidents happening and then it’s going to take some time to actually establish that and this is beyond safety. I can see a vaccine coming on which is emergency-use authorized earlier, based on early efficacy. And hopefully, middle to end of next year.

Sure I mean I think you can add you can accelerate the process to be able to get to the point of entering the clinic. And we have certainly seen cases of that. There’s certainly efforts to manufacture millions of doses at risk while those clinical trials are underway, but it’s very difficult to dramatically accelerate an effective clinical trial process. I know that a lot of the trials being pursued are using adaptive trial designs and then really novel aspects of that for you. Even if you have a successful candidate coming out, I wouldn’t want to minimize the challenges of manufacturing and distributing the vaccine at the end. I think that’s when you know we haven’t faced something on this scale.

QUESTION: What type of a bar do you think they will need to pass in terms of immunology? What level of protection, what type of duration, why type of protection?  

I don’t know if we know what is a protective response. We’ve fallen back to historical knowledge. So everyone’s assuming that you need an antibody neutralizing data, which is reasonable to actually protect. But there is literature coming out that indicates that a T-cell response, And then you overlay on top of the anecdotal evidence that individuals have been infected are getting reinfected that throws a wrench in a classic understanding of the biology and what is actually protected for this vaccine. So the question is, is it masking, is it just behaving more like a common cold virus where you get repeated infections, but you don’t have a long-lasting immunity. Are you going to be able to have a classic traditional vaccine immunity we get, you know, two doses, and then protected for three years. Honestly, I don’t think we know the answer to that until we advance some of these vaccines through the clinic and do a longer follow up. 

We have to make sure that we test in a way that that meets the public trust so that once the vaccine is developed people will be willing to take it.

One aspect here is an it takes into account the last two topics Overall from an acceleration standpoint. The exciting thing is, the industry has come together. So everything that would happen sequentially. People are very open to, and they’re working on, ways to bring it to do everything in parallel. Certainly there’s always a cost risk to that but you know these are the types of things that have been kind of put to the, to the side.

That’s one of the most important elements and it certainly puts people in a situation, out of their comfort zone. But I think the way everyone’s working together, including the government including the regulatory bodies, kind of putting all their knowledge and horsepower on the table to attack this together. I think that gives a lot of merit to the fact that it will be accelerated.

QUESTION: Once we get a candidate that makes it through the safety and efficacy testing, how do we get the scale-up and manufactured to really quickly deliver that vaccine candidate to the population?

It’s all about doing it in parallel, as much as possible and in advance. It’s essentially putting everything on an all-hands-on-deck fashion and really assessing the state of the process on the supply chain and getting the facilities ready at a rapid pace. To start, essentially immediately going into large scale manufacturing but I think it. It all comes under this at risk umbrella and there’s going to be decisions that are going to be made that are being made based on phase appropriate information. There may need to be still some modifications that are made down the road. But this is where the sooner you can bring in the regulator’s into it as well. Then it’s kind of an, it’s a very transparent at risk type of process which, you know, I think is kind of makes it sound easier said than done. But, um, you know the transparency is very important here.

QUESTION: What about this administration’s idea of involving the military to get the vaccine delivered and administered.

One of the significant efforts that have been that has been put in place is the formation of Operation Warp Speed. Emergent has had an opportunity to directly interact with Operation Warp Speed, and when you look at the construct of it, there’s a scientific element focused on innovation, the science behind the vaccine, the manufacturing aspect of it, and then there’s a very strong logistical aspect to it as, as well. It all goes into this all hands on deck, and it also starts to look at everything from a parallel standpoint, so they’re already thinking about the distribution in parallel to when the manufacturing is happening. Their support has helped us accelerate timelines from a supply chain standpoint, and given their expertise in this from a logistical standpoint, it’s a great add, and I think it can only help us. Now, before we have a vaccine, they also are bringing in expertise. That is very critical.

I don’t think we give them enough credit. It’s amazing what they can do, especially because they are unencumbered by return to shareholders and shareholder value. We wouldn’t have penicillin if it weren’t for the US military. And this was in the 1920s, so when we had the influenza pandemic and the military driving penicillin. It was the military, and you know they get stuff done. And then from a distribution perspective, it’s bar none. I think we’re lucky that the military is actually stepping into this, and I’m encouraged, because they will get it done. So, I think it’s a great idea to leverage the military.  

Well I think we’ve, we’ve heard, but probably amplifying the fact that there are a lot of government nonprofits foundations and private companies that are all partnering together on this work. We’ve partnered with several government agencies conducting vaccine research at NIH National Institute of Allergy and Infectious Diseases, the Walter Reed Army Institute of research, BARDA the biomedical Advanced Research and Development Authority. We’re also working with foundations and nonprofits like Bill and Melinda Gates Foundation, the Henry Jackson foundation, and others. Historically, the governments and NGOs have played a big role in vaccine development and in really preparing for emerging infectious diseases.

From a public private partnership standpoint so many merchants have a long track record and history with working with the government and its and its agencies I mean when you look at COVID-19 right now in our collaborations with them. I mean we have collaborations on the product side where they are supporting the development of our therapeutics that we have in development. And then on the cdmo side, the public private partnership to proactively reserved capacity to pave the way for a proven us supply chain for these vaccine candidates as well as expand capabilities as well. It kind of it comes to a spotlight right now during the pandemic. But there have been years and years of investment and collaboration and preparedness, as well as solving other public health threats as well.

QUESTION. What unique aspects of Maryland are furthering these partnerships?

We certainly have a broad array of universities that are actively involved in trying to work closely with all the industry partners in the state. It’s a small state, but we are close to the federal government so we have the advantage of knowing really knowing each other. It’s kind of a small network.

05 Oct Session A – Life Sciences Track

Life Sciences Track – Pandemic & Risk Mitigation: A focus on preparedness & resiliency

Moderator:

• Linda Segal, Principal, The McCormick Group

Speakers:

• 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.