The 3 elements of the COVID vaccine challenge

Stephanie: Hello and welcome to TEC Live. Stephanie Christopher here, chief executive of The Executive Connection. TEC connects CEOs, executives, and business owners to the world’s largest business leader network.

Leah: Back in the studio once again, it is my wonderful pleasure to welcome Stephanie.

Stephanie: Thanks, Leah. It’s wonderful to be back in the studio once again my special guest today is in his own studio in Perth. Jayden Rogers, the CEO of Linear Clinical Research is joining us today. Jayden has worked across a diverse range of entrepreneurial experiences spanning biotech and is passionate about innovation within healthcare. The particularly interesting thing about you, Jayden, is that you assumed the CEO role of a research organisation in November 2019. Jayden Rogers, welcome to TEC Live, first of all.

Jayden: Thank you, Stephanie. It’s a pleasure to be part of TEC and it’s a real honour to able to speak.

Stephanie: Yeah, so I should mention and we’ll get to it later, that Jayden is a member of our community of The Executive Connection, so doubly good to have you here.

In 2019, when you took on this role, you had no idea what was coming down the line, did you, in clinical research?

Jayden: No, we … yeah, I entered the role and as I think aspiring CEOs do, we had our hundred-day plan and had a bold strategy and thought I had a grasp on what the year might look like. Interestingly for us too, this was our, 2020, our 10th year anniversary for Linear too, so we had a really exciting year planned out. Then COVID hit, so yeah, that changed things, but it also presented a range of challenges and opportunities as a new CEO.

Stephanie: Let’s just start with that, as a new CEO, and then let’s get on to the opportunities for Linear and the work you’re doing now. How was that as a new CEO, having to really switch strategies from what you were doing to what you’re doing now?

Jayden: Yeah, it was a really surreal time and I know it was such a challenging time for everyone. I think what helped me through that period was having a background in startup and small business where you had to make decisions and you had to make decisions without information. I think that was one of the challenges early on in the COVID period was there was so much happening, there was so much news, and you had to make decisions. We were fortunate in making a number of decisions that were at the time may be controversial but in reflection were the right decision. We’re fortunate in-

Stephanie: What were they?

Jayden: Essentially locking down. We’re fortunate, we had early insight into COVID, I think as well. We have a China lead, we’d invested in China as a market for three or four years now. Our China lead happened to get stuck in China very close to Wuhan early in the year.

I still recall a WeChat message warning me that they had discovered that there was asymptomatic spread of this new virus, which is really concerning, that this spread, it could spread without symptoms so it was very hard to then track. That message came through, I think in early Feb. At that point in time, we all thought it was maybe contained to China, but that was very worrying. We also had a client base, our biggest client base in the US, and there was a number of people that are followed there. So we made a decision that this was a real threat early, and we’re fortunate to having a number of people in our team, medical and nonmedical, who have background in public health. We’ve moved pretty quickly to limit access to our clinic, limit access when you want to travel from the high risk areas at that point in time, but then broadly having travel bans into our clinic. We moved very early to incorporate COVID testing and building our own capabilities around that, which at the time was quite early to do this, but in reflection, it put us in good stead.

I think having that entrepreneurial background of trying to solve problems really helped.

Stephanie: And a pivot. You could pivot.

Jayden: Pivot, yes. Pivot was a word that we used. Yeah, that helped navigate through that period, and a bias to action. They were the things that helped as a CEO, and then ultimately having a really good network. I’m very fortunate with a board, an outstanding board that we have at Linear who are very accessible. Having a network of both the group, the TEC group and others … and then yeah, just really what helped me within our business, I think, is being able to go back to some of those core values of what your purpose is, and as a medical research organisation, that really harnessed both myself and the team.

Stephanie: What a great insight into your induction into the CEO role. You were saying before to me, Jayden, that early on, you thought you were going to be doing clinical trials on patients who had COVID. Is that right? You would have been doing clinical trials on treatment methodologies for COVID?

Jayden: To a degree, yeah. Early on, when it really took off, we worked … we were based in part of a major hospital complex, the Charles Gairdner Hospital. When we were meeting with the other stakeholders and the emergency response groups, we were all looking at what we would need to do in the event of the same situation that we saw in Italy. So we were lending at digital expertise to the management of COVID patients that would be coming into the hospital, we’re looking at how we could redeploy our clinic to ultimately support either other patient groups or potentially COVID patient groups, and we were gearing up with a range of scenarios to contribute to the fight. We early on put our hand up to say we need to support the healthcare system and we need to be part of the solution here.

But fortunately, by the time we were in position with the system, the COVID cases stopped coming through. It was quite remarkable in Western Australia, anyway. There was a very rapid response in how hospitals and wards were set up as they were across Australia and preparations were in place, and then the patients stopped coming through.

We had a number coming through from cruise ships that came to Western Australia. However, yeah, fortunately we didn’t have to support the COVID patients with research. However, at the same time as a medical research organisation, we were looking very closely at how we can contribute more broadly, and the idea of supporting vaccine development was high on our radar. I wouldn’t say we pivoted, but we really focused our energies on that.

Stephanie: You’re working with a Chinese pharmaceutical company, or it’s a Chinese pharmaceutical vaccine that you’re trialing. Is that right?

Jayden: That’s right. Yeah. So we, very quickly, when we realised that COVID was going to be an issue, we thought we need to lend our weight to vaccine development. Australia has got the best medical research system for early phase in the world, I think. That’s well acknowledged in our case. We’ve been doing this for 10 years and we’ve worked on some of the biggest breakthroughs, particularly in cancer but across a whole range of areas. We’ve got an organisation like Linear in each state in Australia so we’ve got the infrastructure and the system to do research really well. So we put our efforts into identifying a potential vaccine candidate that we could work with and contribute to.

Fortunately, because of that investment in China over the last three years, we have very deep relationships and networks in that country and we identified a particular vaccine candidate that was very interesting. It was based on an established technology platform, so it has been used in humans before in clinical trials. It was a safe approach for a vaccine, but also, they had partnered with some of the biggest players in the world. They were the first group that GSK partnered with. GSK, the biggest vaccine manufacturer in the world. They were funded by CEPI who’s leading the fight to get vaccines accessible to all countries. They also partnered with the world’s biggest contract research organisation. So we saw it as exciting technologies, global partnership, and leveraging connections, we’re able to have really good discussion. Then we’re able to work together on the phase one study, which is currently running here in Perth, which has been very exciting and touch wood, to date, it’s gone very well and in discussions to the later phases of this particular vaccine as well.

Stephanie: It’s really good and very exciting about Perth. Question, though. So Perth has done well or been lucky or whatever. Things are going well in Perth. If you’re doing a vaccine … bear with me while I give my kind of, my version of it, that you’re injecting something into your humans who are trialing this that will prevent them from contracting COVID-19. How are you going to test whether it’s successful when there’s not a lot happening in Perth? If you were in Collins Street in Melbourne or in other places or certain hotspots in Sydney, it’d be fine to say, ‘Okay, go and sit in that restaurant and see if you end up with COVID.’ How’s that make any sense at all in a state where there’s very limited cases?

Jayden: Very good question.

Stephanie: Thank you.

Jayden: Drug development is inherently complex. It’s probably one of the most complex processes that you can undertake. It typically takes 10-plus years, $2 billion to get a drug to market. In order to establish how a drug works, there’s a number of critical steps that you need to go through. The first step before you actually test if a drug works is to test that it’s safe and understand how that drug works. Typically, you do that in healthy people. You don’t go into that disease state. That’s where Australia became really important for COVID research, not just in Perth, but there’s studies running in every state now which shows how important Australia is. We’re recruiting what you’d call healthy volunteers.

So the first aspect of discovering a new drug, you test it in healthy people, you understand what the right dose level may be, you understand what the immune response is. You’re really trying to understand how that drug works so that you can then set up the next stage where you then go into those patient group, in that case, COVID. So, yes, you’re absolutely correct. We don’t have any COVID, touch wood, and hopefully we won’t have too much in Perth, albeit at things can change rapidly. We all have seen what’s happened in Victoria, but we are in a position to do the first part really quickly, really well, understand these drugs and then make sure that when they then go and test them in the patient groups, they know the right level of … they have enough knowledge to be able to set that study up to be pragmatic but also to try and get data as soon as possible. Because ultimately we’re trying to do something that we’ve never done before, and that’s get a vaccine on the market in 18 to 24 months. The quickest that ever been done before is about four to five years.

Stephanie: A couple of things there. With SARS with the SARS vaccine, that was one of the problems, wasn’t it? That the side effects weren’t good or the vaccine proved not to be safe. Is that right?

Jayden: Yeah, there’s a condition, I suppose, where you can actually cause enhancement of the disease with a vaccine. Dengue is another infectious disease where they saw that. So yeah, it’s not common, but it’s a very, very risky outcome in the event that it creates abnormal immune response from that vaccine which can then enhance the impact of that disease. That was seen in a number of development programs, I believe, and it’s one of the real key things that we look at with any vaccine development.

Fortunately, there’s a number of models that they can do in the preclinical work to really understand the risk of that. I think the majority of candidates in development have demonstrated that it’s low risk of that enhancement, but that’s exactly why you need to do the phase one studies, why you need to do them in healthy volunteers, and why it was important to do it in a place like Australia in the event that if you did see that, which fortunately we haven’t, it would be less of an impact than say, doing that in the US or Europe, where then those individuals would be exposed to COVID.

Stephanie: Thank you. So then my second part of my question is back to that issue. You’re testing that the vaccine is safe, inherently, on healthy individuals. How are you going to test though whether it will protect them from contracting COVID if there’s none kicking around?

Jayden: Yeah, then we’ll move into to the next stage. Typically you’ll do phase one, which is a safety study. You’ll do that on a small number of people, so that’d be in the order of a couple hundred people. Once you understand the safety profile, once you understand the immune response, and the dose that you wish to use, you’ll then move into what you would call a phase two or three study. Typically, they blend these two phases now, and that will go into tens of thousands of people, often across multiple geographies.

One of the biggest challenges that the drug companies face is choosing which countries to go and run those trials in, but you typically will choose countries where COVID is endemic or the cases are rising rapidly. So in the case of the US companies, they’re unfortunately doing that in the US now where there’s lots of cases. A lot of companies who would be looking towards Latin America, Africa, and these areas where COVID is on the rise. Then you would run these trials where a proportion of people get the vaccine, and then a proportion would get a placebo or a non-vaccine product. Then essentially, you’re waiting to see what the differences is between those that contract COVID and those that don’t and then severity of that disease, so that’s the bit of the unknown.

Actually, a real spanner in the works, I think with the vaccine from Oxford University in England, they were hoping to get some insight into the early phase, their phase one, on how it reduced the impact or reduced the incidence of COVID, but at that point in time, they actually got their numbers down, but I think they were able to get that level of information.

This is part of the variability and the challenges of drug development, but it also shows where we need to have a really coordinated response across geographies. I think in the vaccine development, and this is something I’m very, I think, passionate about, it’s really important for nations not to get focused solely on what they’re doing, because in order for us to fight this, we need to look across geographies, particularly in the research, but also in the manufacturing as well.

Stephanie: Of course. Okay, that’s really interesting. That also explains why it takes so long to develop a vaccine. Even when you’re talking about fast-tracked to 18 months, potentially, because you heard about Oxford and then it’s, ‘Okay, well if that’s good, how come we’re not all having an Oxford vaccine?’ Or you hear about this and say, ‘Oh, that’s great. Well, Perth’s doing it. They’re really smart. We’ll be ready to go by Christmas.’ But this is phase one, so you’ve got to do phase two and three and then review everything that’s happening along the way there, I guess.

Jayden: That’s right. Typically, you would do it sequentially. You’d do phase one, phase two, phase three, and then you wouldn’t start manufacturing until you’re at least in the phase three and confident on the outcome. So what they’ve done now is compress all those steps. The phase one studies … typically phase one in what their outcomes are, but you’re trying to get as much data as you can and then move very quickly into a phase two, three program. So we’re compressing the clinical development.

There’s a risk benefit ratio that we’ve got to consider there and make sure that we’re not increasing the risk. That’s very well governed in this industry and there’s a lot of engagement with regulators and physicians to make sure that we get that balance right, and safety protocols are in place.

Then the other thing is that the companies are starting manufacturing at risk. All the major companies in the vaccine space now, and you hear about this in the news with Pfizer and Moderna and Johnson & Johnson, they’re all manufacturing at risk. So they’re all investing in bonds, they’re investing in the raw materials. The challenge, interestingly enough, speaking with some of the manufacturers is not so much on the production of the raw product or the vaccine, but it’s other aspects of that supply chain. It’s the aspects of having enough vials and syringes and the little rubber stoppers that you put into those vials. Interestingly, that is one of the big logistical challenges with manufacturing. Then distribution, whereby vaccines are often kept at a temperature range. Then there’s a shelf life issue as well, but very complex process and they’re doing it at risk and they’re trying to do that whilst they do the clinical research. So you’re really having to learn on the fly, I suppose, as a vaccine developer at the moment. You’re having to become very multi-functional in your approach.

Stephanie: You don’t think of it, do you, all the little elements of supply chain to get something to market at scale? What have you had to learn on the fly?

Jayden: Wow. I think everyone’s learnt so much. I think it’s one of the great … well not one of the great things … I should say one of the opportunities out of COVID is we’ve learned a lot about how communities respond. We’ve learnt a lot about public health. We’ve learnt about the importance of public health and the relationship to the economy. But personally, what have I learned? I think I’ve learnt, a couple of early things that I learnt was the investments in culture and innovation really shine during the tough times. We were fortunate as an organisation to be able to pivot and respond because we invested in innovation and particularly digital, we were very digitally enabled. So as a healthcare organisation, we were able to send 60% of our workforce home within a week. We’d been cloud-based for three years and we’d been digital natives in some way for some time, so that process was remarkably efficient. Particularly in clinical research, we have so many protocols that you have to face. So innovation, investment in that over the preceding years gave us the ability to pivot, allowed us to operate as well. We would have been able to keep operating, even if COVID had really got hold because we could do so much remotely and we could work with our partners in the world in a digital space.

Clinical research is still a very paper heavy process, unfortunately. There’s a lot of writing on paper, entering into databases, so we’ve worked towards removing that step. So innovation helped and then culture. We’d invested heavily in building a culture that was autonomous, that was digitally enabled, and I think a very high trust organisational culture so that when we had to move quickly, we’re able to delegate a lot of tasks. We worked in a very distributed model of having various … we had a working group, we had various teams working on different aspects from building the work from home policies through to getting supplies and PPEs. We just worked in a very agile methodology that was really efficient.

On first glance, I think it could have looked a little bit disorganised, although I was blown away at how it all came together, and it was because of the cultural elements that we put in place prior to that, that we could just move. I was just blown away by what we achieved in a short period of time, as were our staff. When we did our culture surveys and we fed back from our staff, it was really interesting to hear that personally have been really tough for most people, COVID, but as an organisation, they were also thrilled on what we’ve been able to achieve and I think that was just a result of that effort and investment beforehand. It showed that the value of investing in the good times to make sure you can weather the bad times, I think that was a big thing that came through for me.

The final thing was just bias to action and making decisions and making decisions on not having the full information available, being bold to maybe make a decision but also knowing when you needed to consult. I heard our Premier talk about that, Mark McGowan, recently. I can’t imagine how hard it’s been for the national and federal leaders as well in making some of these decisions. Sometimes a bad decision is better than no decision is something that’s often said. I think this is a case where you have a bias to action is important, but they’re very tricky. A fine line that you’re trying to walk and particularly for any business owner in this environment, it’s really tricky.

Stephanie: It is tricky. I heard Pat Lencioni say the other day that in battle, the rule is do something. Don’t just stay put, you have to do something, and that’s that bias to action you’re talking about.

Let’s get to TEC and your group. How’s that been beneficial for you through this period?

Jayden: Yeah. TEC been, I think it’s been one of the things that’s actually been really important. I think … actually, what I found about TEC, one of the early learnings I had was that I wasn’t alone. As a new CEO going into the role at the best of times, I think every CEO and we talked about this yesterday, TEC group has that imposter syndrome moment. So certainly, I found early on as a new CEO going into what I felt was such an amazing company … We’re a high growth company. We’ve tripled in size in just over three years and we did quite tricky work, that feeling of being equipped to get through the good times or the bad times, and to hear other fellow TEC members talk about their journeys and their stories, their anxieties was just, it was almost like therapy, in a way. You realise that you’re not on your own. So just having that network has been really important. Having a great Chair, proud to be part of TEC 41. I’ll give a plug to Lyn Harding as our Chair, I think-

Stephanie: To Lyn, she’s a wonderful Chair.

Jayden: … has been wonderful as a TEC Chair and also as a mentor. Just having someone to listen to your, yeah, the challenges and the opportunities, to work through those, bring a different lens on it, has been really helpful. So I think it’s that network that’s what’s been really important for me. Then obviously, the ability to hear different frameworks and the guest speakers. I still just recall very vividly some of my favorite TEC speakers. Cameron Schwab really hit it with me

Stephanie: Incredibly moving. Yeah.

Jayden: There’s probably a bias here, but his approachable, authentic leadership, which struck a chord with me, that ties and disruption and looking at business that way was really fantastic. We had Dan Collins recently and just looking at high performance. So just getting to hear different methodologies has been helpful and I try and take that away.

The final thing I’d have to say is just using the TEC methods with my senior leadership team. I’ve started doing that, and the check-ins and some of the frameworks and trying to take those learnings that I get exposed to and deploy that into our executive team, that’s been really successful as well.

Stephanie: That’s good. Every executive team of a TEC member is nervous when they come back from a TEC day, aren’t they? You know, ‘What’s Jayden heard this week and what are we all going to be doing tomorrow?’

Jayden: Absolutely, yeah, and for someone like me that has maybe a short attention span and loves a new concept, that’s probably something you’d do after watch is that you don’t try and do everything at once, yeah.

Stephanie: ‘Here’s something shiny, let’s do that.’ Yeah, it’s having a plan around it.

Jayden: Yes, yeah.

Stephanie: Yeah. It’s interesting because what we’ve seen in our membership right now is some businesses are thriving, and some businesses that were doing one thing and have shifted to making something else, you know, producing some other product, are going gangbusters, and other businesses in TEC are really struggling. How’s that for you being in a group of business owners and CEOs who are having a diverse experience right now?

Jayden: Yeah, that’s such a good question, I think. I was fortunate enough … I’m just going to jump. I was asked to speak on a panel in the US for clinical research. It was really challenging because we had to talk about what we’re doing here in Australia and at that point, the US was in the heart of it, particularly in New York pandemic response.

Stephanie: Yeah.

Jayden: I was really so cognizant of talking about what we were doing, but have that empathy for those people, millions of people over there. I still remember how tricky that was of trying to be proud of what we’re doing, but be really respectful that they just had a battle on their hands.

I think within the TEC group, yeah, it’s been really hard actually in some ways to see the impact that other businesses have felt, and it creates … what it has done though for me, it’s crystallised that those of us that have an opportunity and those that potentially are a winner have an obligation. I think we have an obligation to do what we’re doing to the best of our ability. In our case, that was a go out, invest in the research to fight COVID, and that was in vaccines. We’ve got another three studies that are COVID therapeutics that we’re starting, and we actively threw everything at that because we knew that would help other businesses, the sooner we could get on top of the health impacts.

We also then realised, okay, we’ve got to support our suppliers, and we looked at our payment terms. We’ve got to support our community and get the message out there. So it just crystallised what we had to do and really the obligation we had, I really felt it was an obligation to be on the right side of that fence to do everything that we could.

I was blown away by the resilience though, and what I saw from the members that were in the trickiest situation was the resilience, how they handled that. But also what I saw was people thinking how do they pivot, how do they overcome it? It was challenging but it was inspiring at the same time, hearing the varying impacts that COVID has had. Even to this point in time, just seeing the situation in Victoria as well, really, I think it’s important to consider that we’re all in it together. Victoria is really in the thick of things at the moment and I consider this is a national problem, not just for Victoria. This is for us all to fight.

I feel the same way when we see other businesses. So where there’s opportunities to invest in programs that will support your other businesses, we’ve got an expansion project. I was really thrilled when we looked at that. That was a local design construction firm and that would create local jobs. That means that you’ve got to bring forth these projects, I think, and we’ve got to invest, I think. That’s the other thing, we’ve got to invest. I think we’ve got to … the other aspect too, which I learned from my fellow TEC members, was we’ve got to think differently. I think the rules have changed in business now. As someone in the health space, I don’t think it’s going to go back to normal within the next couple of years, to be honest. We’ve got to think differently, and I’ve learned that from all these guys that were really in the thick of things and on the other side of the fence.

Stephanie: One more question about TEC, and thank you for indulging me. What would you say to someone who says, ‘Well, TEC’s great and I really want to be part of it, but I’ll wait a few months till this is all over.’ What would you say to that person?

Jayden: Great question. Such a good question as well.

Stephanie: It’s my job, Jayden.

Jayden: Yeah. I think … I love it. Look, I think it’s one of those things … I like that thinking as an entrepreneur in a sense, and that I’m big on the lean startup in a way and I’m big on build the product, heavy MVP, deploy, learn, and then iterate. In a sense, I think it’s the same. You could forever see it and say, ‘Is the timing right? Is everything going to be right?’ You won’t know, in some ways. I would suggest if you’ve got the ability, join, get involved, understand, learn, and then go. So start sooner now because the sooner you start, the more data you’ll get, the more insight you will get that you will know if it’s right or you’ll get the benefits from it.

I think in some cases, the timing may never be right if you have too high of bar but if you’ve got that ability to essentially invest in that or take part in it, I’d strongly suggest do it sooner than later.

I think the other element too, is that I always consider the COVID situation. The framing we had was it’s a health challenge, it’s a psychological challenge, and it’s an economic challenge all wrapped up into one. The psychological challenges as important as anything, so by joining and building your network, by learning new ways of attacking problems, I think it certainly helped the psychological side, which ultimately, I think, help the economics and the health side as well.

Stephanie: What a lovely way to wrap up, with the three elements of the COVID challenge. With the pivot you’ve led in your organisation as this has unfolded, and for helping us understand where phase one fits in, in a vaccine trial and where phase two and three may well be undertaken. That’s very helpful. For you as a person and a leader, Jayden, to understand the value of having peers, of having other people and diverse peers, so not people just doing exactly the same thing as you, just with similar roles and similar challenges, but a completely different context. So I will be watching with great interest you and your career, and also Linear and how this trial goes; naturally, we all have a vested interest in this. But what a great conversation and I’m so appreciative of the thought and time you’ve put into this.

Jayden: Thank you, Stephanie. Great pleasure. Look, as you can tell, I’m very fond of TEC and I really am passionate about medical research and I just … yeah, look, I really appreciate this opportunity. The one thing I would ask, I suppose, of fellow TEC members and listeners is that we’re in this together. We’ve got to support our folk in Victoria and New South Wales and wherever is next, but we’ve got an opportunity here. I think we’ve just shown as a nation, we are so blessed we can contribute to this and we can come out of these in an even stronger position, but we’ve got to think differently and we’ve got to work together to do that. Thanks for that opportunity and look forward to continuing the TEC journey and listening to more podcasts.

Stephanie: Thanks so much, especially this one. Thanks, Jayden. Thanks very much.

Jayden: Thanks, Stephanie.

Stephanie: So that’s TEC Live for today. CEOs are in the business of making decisions and leadership is the art of execution. I’m Stephanie Christopher, and look forward to talking to you next time.