Pioneering Viral Diagnostics with Dr. Nigel McCracken COO of Virax Biolabs

Join us as we discuss viral diagnostics and pharmacology with Dr. Nigel McCracken, Chief Operating Officer of Virax Biolabs. Dr. McCracken shares his expertise in drug development, focusing on oncology and infectious diseases, and discusses the company's pioneering work in detecting immune responses and diagnosing viral diseases. The conversation covers the impact of technology advancements in the past decade, the introduction of the Immune Select Profile in the Virax Immune T Cell Diagnostic Platform, and the evolving landscape of viral diagnostics post-COVID-19. Dr. McCracken also shares insights on maintaining high-quality standards in R&D and offers advice for aspiring professionals in the fields of drug development and diagnostics.

https://www.viraxbiolabs.com/

00:00 Introduction and Welcome
00:40 Meet Dr. Nigel McCracken
01:29 Nigel's Journey in Pharmacology
05:08 Innovations at Virax Biolabs
09:05 Impact of COVID-19 on Viral Diagnostics
12:53 Ensuring Quality in Diagnostics
16:37 Future Trends in Viral Diagnostics
20:20 Advice for Aspiring Researchers
23:13 Nigel's Personal Insights
24:20 Conclusion and Farewell

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Music by keldez

Transcript

0:01

Hi there! Welcome to the From Lab to Launch podcast by Qualio, where we share inspiring stories from the people on the front lines of life sciences. Tune in and leave inspired to bring your life saving products to the world.

Meg Sinclair: 0:17

Hi everyone. And thank you for tuning in to from lab to launch podcast brought to you by polio. I'm Meg, your host, and I'm delighted to be here with you today. Before we dive into today's episode, we'd love it if you could take a moment to rate and share the podcast with your circle of enthusiasts, science enthusiasts. And if you're interested in being a guest on the show, please check out the application in the show notes. Today, we're excited to be joined by Dr. Nigel McCracken, the Chief Operating Officer of Virax Biolabs. Nigel has over 25 years of R& D experience in drug development with expertise across oncology and infectious diseases. At Virax Biolabs, Nigel is at the helm of pioneering research focused on the detection of immune responses and the diagnosis of viral diseases. In today's discussion, we'll explore the innovative work being done at Virex, the impact of their latest projects on global health, and the future of viral diagnostics and therapeutics. Check out the show notes for his full bio and links to learn more. Let's bring him in. Welcome, Nigel.

Nigel McCracken: 1:22

Welcome. Thank you very much, Meg. It's lovely to be here and lovely to speak to your, your audience.

Meg Sinclair: 1:29

Well, Nigel, I'm very curious after reading your bio, what initially sparked your interest in biochemical toxicology and pharmacology, and how did it lead to your current role here at Virex?

Nigel McCracken: 1:40

Well, as you said, I'm a pharmacologist by training. I initially did biochemistry, pharmacology, and later on I did clinical pharmacology. So I've always been interested, you know, in studying how medicines affect the body and also how your body deals with those medicines that you take. And that's, I guess, that's As to, you know, what pharmacology is all about. So I've always been interested in understanding sort of disease processes and targets, and how you interact with them. And then also how the body normally gets rid of drugs, because they don't stay in it forever, sort of thing. You would have a bit of a problem. So I've always been interested over the years is, you know, why people respond to certain drugs and other people don't. And then as, as I guess, as the, you know, Things have moved on and whatever, you know, and we talk about translational medicine and translational development, you know, under being able to translate from animal work to human work. I've always been right in the midst of that sort of thing. And the nice thing over the years is the technology. The, the ability to, you know, to work with different data sets and, uh, you know, and, and, uh, it's, it's, it'd been incredibly, it's been a lot more fun in the last 10 years because of the technology and AI and stuff. And that wasn't the first sort of 10, 15 years of, of, of my drug development experience. So

Meg Sinclair: 3:03

great. Um, that's interesting that technology in the last 10 years is sped up. So has that sped up discovery in your experience too?

Nigel McCracken: 3:12

Yes. I mean, I think from the point of view, I mentioned I did biochemistry, it's about pathways, it's understanding the pathways of disease and, you know, and normal, normal sort of biology. I think in the past it was, you read it in a book and whatever, you know, and you tried to memorize it. And I think the ability now is you've got the ability, especially with sequencing and working with DNA protein that you. You can actually, so you can actually plug all of that data in and, and find out exactly what targets are lighting up upstream and downstream and whatever you, you know, and then from that you can actually infer an awful lot about what, you know, the, the drugs that you're developing are doing now, usually with small molecules, and we we're talking about non therapeutics, non antibodies and whatever. You understand that, you know, small molecules. I would say inherently dirty, but, but it has a target, but it doesn't usually just act on that target on like a, an antibody sort of thing. So you need to understand the molecular target. And when you think about that response, it's not just the efficacy that you want, but you need to understand as you push the dose. you're going to potentially get some safety issues. And this is where the toxicology and understanding that safety side of it comes in, because they're both, when you talk about response, it is the efficacy and the safety, and you need to understand that sort of thing. And I think that's certainly something I've been doing for at least trying to do for the last 30 years, sort of thing or whatever. And, uh, you know, understanding how, how your body gets rid of, you know, of drugs, but also how your bodies interact with specific targets, you know, from an efficacious point of view. And, and that's, that's been fun. It has been real fun. And going back to what we talked about around the, the technology, the ability to, you know, to work with large datasets as well as diverse datasets is just moved drug development on leaps and bounds in the last number of years.

Meg Sinclair: 5:08

Well, speaking of leaps and bounds, there's lots of innovative projects happening at Verox Labs. You've recently launched the Immune Select Profile within the Verox Immune T Cell Diagnostic Platform. Can you elaborate a little bit more on this platform and how it works?

Nigel McCracken: 5:25

Yeah, I mean, the platform itself, we're obviously very interested in, you know, let's say T cells, you said the adaptive immune response, you know, whether it to be a virus, you know, or to, you know, some sort of pathogen and whatever, and we know that, you know, if you are, if you do get exposed to, you know, some sort of pathogen, you're going to have an immune response. And that usually involves, you know, B cells and your T cells, you usually get a fever about 48 hours later and stuff like that, but generally your T cells are the ones that are, that are dealing with the virus itself and whatever. And I think, you know, you get specific signatures from that, you know, if you remember back to SARS CoV 2 days, you can get this. You know, cytokine storm where there's a just an overreaction to that. And then it potentially caused problems on on on normal tissues. Um, but again, you know, what we're trying to do is harvest, you know, the, you know, the signals that come from from your adaptive immune system and then try and develop diagnostics to give some sort of guidance around T cell dysfunction, and we'll talk a little bit more around what T cell dysfunction means in respect to, um, something like a post viral syndrome. But the thought here is, is that, you know, we're exposed to many viruses, and I'm sure that the majority of us have got lots of dormant viruses like herpes or EBV or CMV. which are not usually causing us problems. Now, when we get exposed to something like SARS CoV, sometimes, you know, even just SARS CoV and the latent viruses then come up. And then you, you're basically, what happens is you maybe your, your body gets to that stage where it can't really remove that pathogen completely without causing a problem. Now, the question is, you know, can we? Look at the T cells and look to see if there is dysfunction there. And if that dysfunction and the signature that that actually comes out is, is it actually related to some of the symptoms that we actually see for something like long COVID or post viral syndromes? Now, It's very interesting. If you read the scientific literature, you know, people have been, we've, we've heard about ME and chronic fatigue syndrome for many, many years and whatever, you know, and, and there's an awful lot of commonality about these post viral syndromes like long COVID and whatever, you know, where the symptoms are very, very similar. We hear about chronic fatigue, we hear about brain fog and stuff and things like that. And our thought is that with the platform, it's fairly agnostic to the actual, um, uh, virus itself. Um, and what we are wanting to concentrate on is this T cell dysfunction because the T cell dysfunction will have an effect on say mitochondrial dysfunction. And we know the mitochondria itself is, it's getting 90 to 95 percent of the actual energy store in the body. So that's what we want to sort of target. Now, The way we were coming at it with the platform is we're utilizing specific peptide mixes to stimulate the T cells or activate the T cells specific to the virus. And then we're looking at that signature and that signature of cytokines as well as specific markers and then looking to see if we can actually Make some sort of association with that around this T cell dysfunction and linking up to some of the symptoms that are associated with these post viral syndromes. But some of the main symptoms, and we're certainly not going to catch all of them. I think the last count, I think with long COVID, there was up to 260 different symptoms for long COVID. And, but certainly where we are concentrating on is more around the T cell dysfunction and that knock on effect on the symptoms.

Meg Sinclair: 9:04

Yeah. Speaking of COVID 19, how has the pandemic reshaped the landscape of viral diagnostics? And how has the pandemic influenced your work at Virax Biolabs?

Nigel McCracken: 9:16

Yeah, I mean, I mean, Virax, uh, you know, Virax Biolabs is, it's, it's been about for quite a few years. And, and, and as you said, I think the initial focus was like a lot of, of companies was on develop, uh, you know, delivering sort of antigen tests and, uh, you know, to specifically identify the actual SARS CoV infection. But as you'll know, and I'm sure you hear in the news, certainly in the U. S. and wherever you know, that sort of, the, the symptoms associated with long COVID and whatever, you know, whether that's the do with the sort of chronic inflammation or, you know, it, it, it's having a big, big effect on society. And when I say a big burden as well, because lots of people who, you know, were very healthy before are really having problems with that. And then it's not necessarily going to go away. And when I say it's not going to go away, And that we will get exposed to, you know, SARS CoV in the future. It won't be maybe as severe, but it could be. And going back to what I was saying about these latent viruses and stuff like that, you know, with multiple potential, multiple infections, you have the possibility of getting that. Now, I think where we're coming at it is that if you can identify that T cell dysfunction early enough. Can you, with some sort of treatment management, that can be, it doesn't necessarily need to be a therapeutic, although there are therapeutics getting developed at this moment in time. Can you actually sort of, you know, have a better effect about catching it early than, than leaving it late when sometimes That T cell dysfunction can become irreversibly, uh, damaged, but certainly affected sort of thing, where it would be harder, uh, specifically to come back. Now our thought is, is that, just with many things, if you leave it long enough, Your immune system will hardwire into some sort of other other paradigm from where it was before. And I think that's where we want to sort of try and target to see, can we actually develop some T cell diagnostics to help with that early detection, you know, and you know, going back to what I mentioned. about people with ME and chronic fatigue syndrome. I think the biggest problem was it took so long, you know, for these, you know, uh, people who are suffering sort of from ME and to even, you know, get recognized about being a specific disease. And I think, um, I think that we can sort of, you know, um, you know, along with other researchers, um, you know, hopefully provide something that has value specifically as a person who, who's going along that journey. Sort of thing so that they're diagnosed early and whatever, you know, and, and then that there can be some sort of program put in place and it doesn't need to be necessarily drugs at this moment in time. It could be lifestyle. It could be diet. It could be some, some sort of exercise and whatever, you know, and again, our thought is to sort of be working and trying to get it. work with the health system systems very, very early on, uh, you know, to, to, because we know that it's not going away and we know that general chronic inflammation type, um, indications and problems, they're not going away. And, uh, and, um, that's, that's why I think we feel that we can, uh, we can actually make some sort of a difference here.

Meg Sinclair: 12:38

That's very exciting, uh, innovations you have going on. And as a mom of two school age boys, I can guarantee that we're not getting away from viruses anytime soon. They will keep going around. So this is great work you're doing. We'll have a huge impact. Um, ensuring high quality standards and R and D is crucial. How does viral X. biolabs maintain and monitor the quality of its diagnostic products and research processes.

Nigel McCracken: 13:09

Set the, you know, as I said, we've had a focus on the basically on the Virax Immune as we call it, the Virax Immune platform. So we sort of, you know, set up a Um, you know, and, uh, you know, in the last year, and as part of that, you know, we're actually sort of going for ISO accreditation at 13485 accreditation, you know, for which is for medical diagnostics, and that's obviously involves, you know, putting in place a quality management system, and then obviously then getting inspected specifically for that. So that's exactly what we're doing. You can also imagine, you know, when you're developing a diagnostic, uh, you know, and we're wanting to do that for, you know, a CE marked or IVD diagnostic, you know, there's, there's lots of things that you specifically need to do the whole product development. process, you know, um, is, is obviously got to be sort of managed. It's got to be put in place and as well as that, you know, as part of, you know, that regulatory sort of approval, you know, you need to, you need to do the analytical performance, uh, you know, as well as the clinical validation. So again, Obviously, our plan is, you know, of course, we want to make these, these kits available to researchers initially, because I think the exciting thing about, you know, sort of working in post viral syndromes, and we've talked about sort of SARS CoV and long COVID, the information is going to be coming out on that because there's been an awful lot of studies done, and the research that's been done on that are just coming out now. So we will, we will learn more and more. What is clear, you know, for most of the stuff that's come out, the adaptive immune system has got a quite a major role to play within some of these symptoms. So I think from that point of that encourages us, but certainly we want to be placed, you know, to be able to, you know, to help to work with that and to be in that and to be flexible enough to react to a lot of that data that comes out. So, so yeah, we're going to, we're working sort of with the regulatory people. The nice thing about, you know, working with the likes of the FDA, Uh, you know, and some of the, even some of the European ones is certainly with FDA, you can have sort of pre submission meetings. You can sit down with them and say, look, this is what we'd like to do. And, and it's a journey because what we would like to do, as long as everything sort of works out the way that we feel it's going to do, we would like to get that into the system early. And, you know, so as I said, when, in a patient's, patient's journey, that, that this would be offered potentially. To help with that sort of diagnosis, you know, for the general practitioner who's seen the seeing the patient or somebody who's admitted specifically to the hospital. And I think the nice thing, because you can actually partner with the FDA right from the beginning, they will tell you exactly what you need to do from a regulatory point of view for approval sort of thing. And because ultimately for the IVD and the diagnostic, what you want to be able to do is to be making some sort of clinical sort of, you know, Decision, uh, you know, following, following, uh, uh, the use of that diagnostic itself.

Meg Sinclair: 16:18

Great. Thanks for sharing your journey through the regulatory landscape there. I think those pre submissions or meetings are a good thing to call out for people on that same pathway. Yeah, that's been super

Nigel McCracken: 16:27

helpful. It's super helpful. Uh, you know, and, and we're, we're all very thankful that, uh, that, that that is available to them.

Meg Sinclair: 16:35

Great. Thanks for sharing that journey. Looking ahead, what emerging trends or technologies in viral diagnostics and immunology excite you the most? And how is Verox positioning itself to lead in those areas?

Nigel McCracken: 16:48

Well, as I said, I think what excites me is certainly, and I've just sort of been recently sort of, you know, um, had a, had a sort of, um, there was a sort of meeting barred up. BARDA, you know, which is part of the, the health, you know, uh, um, security in the, in the US are, there's a huge push with our new, iCreate sort of, um, where they want to go specifically around, you know, either being ready for the next potential pandemic if it comes, but also around diagnostics. And that's great because I think it's, It's not that it wasn't there before, but there's a real sort of focus around preparedness, you know, because the reality is, you know, these things will most probably not go away. We will get, hopefully, it won't be a similar type of pandemic. But the nice thing is, is, is there's, there's definitely a willingness. To, to both, you know, be able to provide, uh, you know, uh, vaccines and stuff like that, but also specifically around the diagnosis of, and that, that's exciting. And, um, I think what people are realizing now, I think previously, um, when you, when you looked at specific cytokines and you looked at the immune system or whatever, you know, it, we, we work with plasma, we work with serum and stuff like that. Now, It maybe wasn't, it didn't give you the same sort of, um, important information around the origin, you know, the origin of the actual cytokine, you know, whether it is, say, a CD4 or CD8 cell, whatever. I think a lot of the technology is sort of moving towards, maybe not such big panels, you know, of like 300, 300 sort of markers and stuff like that, but more around, you know, you know, about the origin. Okay. So specifically looking at activated T cells or B cells and stuff and things like that. So I think what we're finding now, it's not just numbers, it's also origin, you know, and I think there's, there's rooms for, you know, for different types of technology that maybe that we used, you know, you know, a number of years ago, you know, whatever, you know, which maybe it's not so high throughput, like, you know, flow cytometry, Uh, you know, or fluorescent or early spot, whatever, you know, but it most probably a combination of all of these things. We, ELISA and stuff and things like that. And I think that's the nice thing because researchers are using lots of different things because ultimately we want to try and understand, you know, the role of the immune system in these, these, these sort of Pathogens of these, these viral infections. I mean, it's not the fact that, you know, T cell exhaustion or T cell dysfunction is not something new. This is a target that oncology has been good after for the last, I don't know, 20 years. And, and we've seen such leaps and bounds with a lot of the neuro therapies. One of, you know, in college, cause that's what they're targeting. They're targeting the same receptors, whatever, you know, that we are specifically looking at it now. And I think that's exciting. And I think, you know, as I found, over the last 25, 30 years, you know, the technology has moved on and also we're utilizing information from different indications and whatever, you know, uh, you know, and finding commonality there that we can potentially use and, and, uh, you know, to, to hopefully come up with, with better solutions and, and diagnostics, uh, across different indications.

Meg Sinclair: 20:15

Well, I can't wait to see what comes on that front and what comes out of Vyrax in the near future. For our listeners aspiring to enter the field of drug development and diagnostics, do you have any advice you'd offer to them to help them navigate their careers and make meaningful contributions to healthcare?

Nigel McCracken: 20:33

What I would see is if I'm sort of looking back at, you know, my, my sort of career as well, sort of thing. I mean, I, I, I love doing what I do. It's just very inspiring sort of thing, you know, to be, to be able to actually, you know, make some sort of difference, you know, in people's lives. But I think what I would say is that as a researcher and, you know, you know, Keep wanting to learn. Uh, you know, usually when we, when we're at college or university or, you know, we, we, we've got a speciality that we, we most probably, you know, I was a pharmacologist and whatever, you know, I studied drug development in my, my early days and stuff and things like that, but keep learning because what you want to do is you want to become a drug developer. So my approach was always. To, you know, to, to, to go and s and, and work with somebody who knows something and take that information and what you know, and, and, and then move along. You want to con, want to continue to learn and continue to grow sort of thing. Because I think when you've got different sort of knowledge from different indications, that's when you start to become. innovative and, and, and working with people, smart people and whatever, you know, who've got, maybe got a different sort of outlook from yourself and whatever, you know, but that's where you can really make a big difference. So I would encourage people. Yes, of course, it's great to have a specialty, but continue to learn and continue to, you know, you know, you have to try and take information. And because ultimately, you know, I didn't realize, maybe some people. Well, maybe not agree, but I was very, I was a typical scientist that began very analytical, whatever, you know, and then as, as I gained that information and that experience, I started to become a little bit more innovative and entrepreneurial sort of thing. And you start, you start, uh, you know, having things, you start thinking things that You maybe didn't think about before because you're starting to pull information from, from different places. Now, the funny thing that I've learned over the years, the knowledge is there. The problem is, is, is trying to get the knowledge either whether it's somebody in the next office down to you and whatever, you know, or that's what you want to specifically. Do so continue to to learn, continue to, you know, to, you know, e evolve. And, um, I would say just be nice to people. that's always, I've always found that never hurts Nigel to people. It never hurts. What else? What you always tend to find, you either. You'll meet somebody, you know, four or five times, either on the way up or on the way down. So be, be, be nice to people.

Meg Sinclair: 23:09

That's great advice for anybody on their, on their career ladder there. Well, our last one to close us out is more of a fun one. I like to ask each of our guests, if we ran into you at the bookstore or at your local library, in which section would we find you?

Nigel McCracken: 23:24

Oh, definitely adventure. All right. I'd be in the adventure one because I, being a drug developer for me is an adventure because there's no either, there's no drugs that are the same, even if they act on the same target, and it's, it's, I just find it fascinating. I find the whole body and the fact of, you know, usually your body is in homeostasis and that's what it does. It tries to keep everything in homeostasis. Usually with some sort of disease, there's something that's going to miss and then, and then it becomes, it goes out of kilter a little bit sort of thing. So for me, it would always be adventure because my last 30 years of drug development has been an adventure. And now I've moved into diagnostics because what I realized was, you know, and certainly some indications, uh, the most important thing is to detect early. Because the earlier you tick, the more chance you've got of having an effect.

Meg Sinclair: 24:18

Yeah, that early intervention is so crucial. Thank you so much for joining us today, Nigel, and sharing your drug development adventure with us. Where can those who want to follow along with your adventure and find out more connect with you?

Nigel McCracken: 24:31

Yeah, we've, we've certainly, with LinkedIn, uh, you know, obviously we've got the sort of Virax, uh, Biolabs corporate website as well, sort of thing, where a lot of the news of how things are progressing. And what we also try and do is we, we, We, you know, as, as we progress, you know, we would, we would utilize certainly podcasts and social media sort of thing, just to, to keep people informed about how things are progressing in there. But we're excited. I think, you know, it's just a super time to be, to be in the drug, you know, development industry and diagnostic industry, because again, there's such a willingness at both within, within, you know, uh, pharma as well as, as governments and whatever, to really make a difference in the future.

Meg Sinclair: 25:16

Great. Thanks so much again for joining us, Nigel, and sharing your adventure. I really enjoyed your passion and enthusiasm today.

Nigel McCracken: 25:23

An absolute pleasure. Thank you.

Meg Sinclair: 25:25

Thank you.

25:27

Thank you for listening to this week's episode of From Lab to Launch, brought to you by Qualio. If you like what you've heard, please subscribe and give the show a positive review. It really helps us out. For more information about Qualio, our guest today, or to be a guest on a future episode, please refer to the show notes. Until next time.