June 18, 2024 • 26 mins
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
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
(00:01):
Hi there! Welcome to the FromLab to Launch podcast by Qualio,
where we share inspiring storiesfrom the people on the front
lines of life sciences.
Tune in and leave inspired tobring your life saving products
to the world.
Meg Sinclair (00:17):
Hi everyone.
And thank you for tuning in tofrom lab to launch podcast
brought to you by polio.
I'm Meg, your host, and I'mdelighted to be here with you
today.
Before we dive into today'sepisode, we'd love it if you
could take a moment to rate andshare the podcast with your
circle of enthusiasts, scienceenthusiasts.
And if you're interested inbeing a guest on the show,
(00:37):
please check out the applicationin the show notes.
Today, we're excited to bejoined by Dr.
Nigel McCracken, the ChiefOperating Officer of Virax
Biolabs.
Nigel has over 25 years of R& Dexperience in drug development
with expertise across oncologyand infectious diseases.
At Virax Biolabs, Nigel is atthe helm of pioneering research
(00:59):
focused on the detection ofimmune responses and the
diagnosis of viral diseases.
In today's discussion, we'llexplore the innovative work
being done at Virex, the impactof their latest projects on
global health, and the future ofviral diagnostics and
therapeutics.
Check out the show notes for hisfull bio and links to learn
more.
(01:19):
Let's bring him in.
Welcome, Nigel.
Nigel McCracken (01:22):
Welcome.
Thank you very much, Meg.
It's lovely to be here andlovely to speak to your, your
audience.
Meg Sinclair (01:29):
Well, Nigel, I'm very curious after reading your
bio, what initially sparked yourinterest in biochemical
toxicology and pharmacology, andhow did it lead to your current
role here at Virex?
Nigel McCracken (01:40):
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 andalso how your body deals with
those medicines that you take.
And that's, I guess, that's Asto, you know, what pharmacology
(02:01):
is all about.
So I've always been interestedin understanding sort of disease
processes and targets, and howyou interact with them.
And then also how the bodynormally gets rid of drugs,
because they don't stay in itforever, sort of thing.
You would have a bit of aproblem.
So I've always been interestedover the years is, you know, why
people respond to certain drugsand other people don't.
(02:24):
And then as, as I guess, as the,you know, Things have moved on
and whatever, you know, and wetalk about translational
medicine and translationaldevelopment, you know, under
being able to translate fromanimal work to human work.
I've always been right in themidst of that sort of thing.
And the nice thing over theyears is the technology.
The, the ability to, you know,to work with different data sets
(02:47):
and, uh, you know, and, and, uh,it's, it's, it'd been
incredibly, it's been a lot morefun in the last 10 years because
of the technology and AI andstuff.
And that wasn't the first sortof 10, 15 years of, of, of my
drug development experience.
So
Meg Sinclair (03:03):
great.
Um, that's interesting thattechnology in the last 10 years
is sped up.
So has that sped up discovery inyour experience too?
Nigel McCracken (03:12):
Yes.
I mean, I think from the pointof view, I mentioned I did
biochemistry, it's aboutpathways, it's understanding the
pathways of disease and, youknow, and normal, normal sort of
biology.
I think in the past it was, youread it in a book and whatever,
you know, and you tried tomemorize it.
And I think the ability now isyou've got the ability,
(03:34):
especially with sequencing andworking with DNA protein that
you.
You can actually, so you canactually plug all of that data
in and, and find out exactlywhat targets are lighting up
upstream and downstream andwhatever you, you know, and then
from that you can actually inferan awful lot about what, you
know, the, the drugs that you'redeveloping are doing now,
(03:54):
usually with small molecules,and we we're talking about non
therapeutics, non antibodies andwhatever.
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 thattarget on like a, an antibody
sort of thing.
So you need to understand themolecular target.
And when you think about thatresponse, it's not just the
(04:16):
efficacy that you want, but youneed to understand as you push
the dose.
you're going to potentially getsome safety issues.
And this is where the toxicologyand understanding that safety
side of it comes in, becausethey're both, when you talk
about response, it is theefficacy and the safety, and you
need to understand that sort ofthing.
And I think that's certainlysomething I've been doing for at
(04:36):
least trying to do for the last30 years, sort of thing or
whatever.
And, uh, you know, understandinghow, how your body gets rid of,
you know, of drugs, but also howyour bodies interact with
specific targets, you know, froman efficacious point of view.
And, and that's, that's beenfun.
It has been real fun.
And going back to what we talkedabout around the, the
(04:56):
technology, the ability to, youknow, to work with large
datasets as well as diversedatasets is just moved drug
development on leaps and boundsin the last number of years.
Meg Sinclair (05:08):
Well, speaking of leaps and bounds, there's lots
of innovative projects happeningat Verox Labs.
You've recently launched theImmune Select Profile within the
Verox Immune T Cell DiagnosticPlatform.
Can you elaborate a little bitmore on this platform and how it
works?
Nigel McCracken (05:25):
Yeah, I mean, the platform itself, we're
obviously very interested in,you know, let's say T cells, you
said the adaptive immuneresponse, 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, somesort of pathogen, you're going
to have an immune response.
(05:46):
And that usually involves, youknow, B cells and your T cells,
you usually get a fever about 48hours later and stuff like that,
but generally your T cells arethe ones that are, that are
dealing with the virus itselfand whatever.
And I think, you know, you getspecific signatures from that,
you know, if you remember backto SARS CoV 2 days, you can get
this.
You know, cytokine storm wherethere's a just an overreaction
(06:08):
to that.
And then it potentially causedproblems on on on normal
tissues.
Um, but again, you know, whatwe're trying to do is harvest,
you know, the, you know, thesignals that come from from your
adaptive immune system and thentry and develop diagnostics to
give some sort of guidancearound T cell dysfunction, and
(06:29):
we'll talk a little bit morearound what T cell dysfunction
means in respect to, um,something like a post viral
syndrome.
But the thought here is, isthat, you know, we're exposed to
many viruses, and I'm sure thatthe majority of us have got lots
of dormant viruses like herpesor EBV or CMV.
(06:50):
which are not usually causing usproblems.
Now, when we get exposed tosomething like SARS CoV,
sometimes, you know, even justSARS 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 stagewhere it can't really remove
that pathogen completely withoutcausing a problem.
Now, the question is, you know,can we?
(07:12):
Look at the T cells and look tosee if there is dysfunction
there.
And if that dysfunction and thesignature that that actually
comes out is, is it actuallyrelated to some of the symptoms
that we actually see forsomething like long COVID or
post viral syndromes?
Now, It's very interesting.
If you read the scientificliterature, you know, people
(07:33):
have been, we've, we've heardabout ME and chronic fatigue
syndrome for many, many yearsand whatever, you know, and, and
there's an awful lot ofcommonality about these post
viral syndromes like long COVIDand whatever, you know, where
the symptoms are very, verysimilar.
We hear about chronic fatigue,we hear about brain fog and
stuff and things like that.
And our thought is that with theplatform, it's fairly agnostic
(07:56):
to the actual, um, uh, virusitself.
Um, and what we are wanting toconcentrate on is this T cell
dysfunction because the T celldysfunction will have an effect
on say mitochondrialdysfunction.
And we know the mitochondriaitself is, it's getting 90 to 95
percent of the actual energystore in the body.
So that's what we want to sortof target.
(08:17):
Now, The way we were coming atit with the platform is we're
utilizing specific peptide mixesto stimulate the T cells or
activate the T cells specific tothe virus.
And then we're looking at thatsignature and that signature of
cytokines as well as specificmarkers and then looking to see
if we can actually Make somesort of association with that
(08:37):
around this T cell dysfunctionand linking up to some of the
symptoms that are associatedwith 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 thinkwith long COVID, there was up to
260 different symptoms for longCOVID.
And, but certainly where we areconcentrating on is more around
(08:59):
the T cell dysfunction and thatknock on effect on the symptoms.
Meg Sinclair (09:04):
Yeah.
Speaking of COVID 19, how hasthe pandemic reshaped the
landscape of viral diagnostics?
And how has the pandemicinfluenced your work at Virax
Biolabs?
Nigel McCracken (09:16):
Yeah, I mean, I mean, Virax, uh, you know, Virax
Biolabs is, it's, it's beenabout for quite a few years.
And, and, and as you said, Ithink the initial focus was like
a lot of, of companies was ondevelop, uh, you know,
delivering sort of antigen testsand, uh, you know, to
specifically identify the actualSARS CoV infection.
But as you'll know, and I'm sureyou hear in the news, certainly
(09:39):
in the U.
S.
and wherever you know, that sortof, the, the symptoms associated
with long COVID and whatever,you know, whether that's the do
with the sort of chronicinflammation or, you know, it,
it, it's having a big, bigeffect on society.
And when I say a big burden aswell, because lots of people
(09:59):
who, you know, were very healthybefore are really having
problems with that.
And then it's not necessarilygoing to go away.
And when I say it's not going togo away, And that we will get
exposed to, you know, SARS CoVin the future.
It won't be maybe as severe, butit could be.
And going back to what I wassaying about these latent
viruses and stuff like that, youknow, with multiple potential,
(10:19):
multiple infections, you havethe possibility of getting that.
Now, I think where we're comingat it is that if you can
identify that T cell dysfunctionearly enough.
Can you, with some sort oftreatment management, that can
be, it doesn't necessarily needto be a therapeutic, although
there are therapeutics gettingdeveloped at this moment in
(10:40):
time.
Can you actually sort of, youknow, have a better effect about
catching it early than, thanleaving it late when sometimes
That T cell dysfunction canbecome irreversibly, uh,
damaged, but certainly affectedsort of thing, where it would be
harder, uh, specifically to comeback.
(11:01):
Now our thought is, is that,just with many things, if you
leave it long enough, Yourimmune system will hardwire into
some sort of other otherparadigm from where it was
before.
And I think that's where we wantto sort of try and target to
see, can we actually developsome T cell diagnostics to help
with that early detection, youknow, and you know, going back
(11:22):
to what I mentioned.
about people with ME and chronicfatigue syndrome.
I think the biggest problem wasit took so long, you know, for
these, you know, uh, people whoare suffering sort of from ME
and to even, you know, getrecognized about being a
specific disease.
And I think, um, I think that wecan sort of, you know, um, you
(11:43):
know, along with otherresearchers, um, you know,
hopefully provide something thathas value specifically as a
person who, who's going alongthat journey.
Sort of thing so that they'rediagnosed early and whatever,
you know, and, and then thatthere can be some sort of
program put in place and itdoesn't need to be necessarily
drugs at this moment in time.
It could be lifestyle.
(12:04):
It could be diet.
It could be some, some sort ofexercise and whatever, you know,
and again, our thought is tosort of be working and trying to
get it.
work with the health systemsystems very, very early on, uh,
you know, to, to, because weknow that it's not going away
and we know that general chronicinflammation type, um,
(12:25):
indications and problems,they're not going away.
And, uh, and, um, that's, that'swhy I think we feel that we can,
uh, we can actually make somesort 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 ageboys, I can guarantee that we're
not getting away from virusesanytime soon.
They will keep going around.
So this is great work you'redoing.
We'll have a huge impact.
Um, ensuring high qualitystandards and R and D is
crucial.
How does viral X.
(12:58):
biolabs maintain and monitor thequality 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 theVirax Immune as we call it, the
Virax Immune platform.
So we sort of, you know, set upa Um, you know, and, uh, you
know, in the last year, and aspart of that, you know, we're
actually sort of going for ISOaccreditation at 13485
(13:30):
accreditation, you know, forwhich is for medical
diagnostics, and that'sobviously involves, you know,
putting in place a qualitymanagement system, and then
obviously then getting inspectedspecifically for that.
So that's exactly what we'redoing.
You can also imagine, you know,when you're developing a
diagnostic, uh, you know, andwe're wanting to do that for,
(13:52):
you know, a CE marked or IVDdiagnostic, you know, there's,
there's lots of things that youspecifically need to do the
whole product development.
process, you know, um, is, isobviously got to be sort of
managed.
It's got to be put in place andas well as that, you know, as
part of, you know, thatregulatory sort of approval, you
(14:13):
know, you need to, you need todo the analytical performance,
uh, you know, as well as theclinical validation.
So again, Obviously, our planis, you know, of course, we want
to make these, these kitsavailable to researchers
initially, because I think theexciting thing about, you know,
sort of working in post viralsyndromes, and we've talked
(14:34):
about sort of SARS CoV and longCOVID, the information is going
to be coming out on that becausethere's been an awful lot of
studies done, and the researchthat's been done on that are
just coming out now.
So we will, we will learn moreand more.
What is clear, you know, formost of the stuff that's come
out, the adaptive immune systemhas got a quite a major role to
play within some of thesesymptoms.
(14:56):
So I think from that point ofthat encourages us, but
certainly we want to be placed,you know, to be able to, you
know, to help to work with thatand to be in that and to be
flexible enough to react to alot 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
(15:17):
FDA, Uh, you know, and some ofthe, even some of the European
ones is certainly with FDA, youcan have sort of pre submission
meetings.
You can sit down with them andsay, look, this is what we'd
like to do.
And, and it's a journey becausewhat we would like to do, as
long as everything sort of worksout the way that we feel it's
going to do, we would like toget that into the system early.
(15:37):
And, you know, so as I said,when, in a patient's, patient's
journey, that, that this wouldbe offered potentially.
To help with that sort ofdiagnosis, you know, for the
general practitioner who's seenthe seeing the patient or
somebody who's admittedspecifically to the hospital.
And I think the nice thing,because you can actually partner
with the FDA right from thebeginning, they will tell you
(15:58):
exactly what you need to do froma regulatory point of view for
approval sort of thing.
And because ultimately for theIVD and the diagnostic, what you
want to be able to do is to bemaking some sort of clinical
sort of, you know, Decision, uh,you know, following, following,
uh, uh, the use of thatdiagnostic itself.
Meg Sinclair (16:18):
Great.
Thanks for sharing your journeythrough the regulatory landscape
there.
I think those pre submissions ormeetings are a good thing to
call out for people on that samepathway.
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 availableto them.
Meg Sinclair (16:35):
Great.
Thanks for sharing that journey.
Looking ahead, what emergingtrends or technologies in viral
diagnostics and immunologyexcite you the most?
And how is Verox positioningitself 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 ofbeen 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 partof the, the health, you know,
uh, um, security in the, in theUS are, there's a huge push with
(17:10):
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 thinkit's, It's not that it wasn't
there before, but there's a realsort of focus around
preparedness, you know, becausethe reality is, you know, these
(17:32):
things will most probably not goaway.
We will get, hopefully, it won'tbe a similar type of pandemic.
But the nice thing is, is, isthere's, there's definitely a
willingness.
To, to both, you know, be ableto provide, uh, you know, uh,
vaccines and stuff like that,but also specifically around the
diagnosis of, and that, that'sexciting.
(17:53):
And, um, I think what people arerealizing now, I think
previously, um, when you, whenyou looked at specific cytokines
and you looked at the immunesystem or whatever, you know,
it, we, we work with plasma, wework with serum and stuff like
that.
Now, It maybe wasn't, it didn'tgive you the same sort of, um,
(18:15):
important information around theorigin, 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 technologyis sort of moving towards, maybe
not such big panels, you know,of like 300, 300 sort of markers
and stuff like that, but morearound, you know, you know,
(18:36):
about the origin.
Okay.
So specifically looking atactivated T cells or B cells and
stuff and things like that.
So I think what we're findingnow, it's not just numbers, it's
also origin, you know, and Ithink there's, there's rooms
for, you know, for differenttypes of technology that maybe
that we used, you know, youknow, a number of years ago, you
(18:56):
know, whatever, you know, whichmaybe it's not so high
throughput, like, you know, flowcytometry, Uh, you know, or
fluorescent or early spot,whatever, you know, but it most
probably a combination of all ofthese things.
We, ELISA and stuff and thingslike that.
And I think that's the nicething because researchers are
using lots of different thingsbecause ultimately we want to
try and understand, you know,the role of the immune system in
(19:20):
these, these, these sort ofPathogens of these, these viral
infections.
I mean, it's not the fact that,you know, T cell exhaustion or T
cell dysfunction is notsomething new.
This is a target that oncologyhas been good after for the
last, I don't know, 20 years.
And, and we've seen such leapsand bounds with a lot of the
neuro therapies.
(19:40):
One of, you know, in college,cause that's what they're
targeting.
They're targeting the samereceptors, whatever, you know,
that we are specifically lookingat it now.
And I think that's exciting.
And I think, you know, as Ifound, over the last 25, 30
years, you know, the technologyhas moved on and also we're
utilizing information fromdifferent indications and
(20:00):
whatever, you know, uh, youknow, and finding commonality
there that we can potentiallyuse and, and, uh, you know, to,
to hopefully come up with, withbetter solutions and, and
diagnostics, uh, acrossdifferent indications.
Meg Sinclair (20:15):
Well, I can't wait to see what comes on that front
and what comes out of Vyrax inthe near future.
For our listeners aspiring toenter the field of drug
development and diagnostics, doyou have any advice you'd offer
to them to help them navigatetheir careers and make
meaningful contributions tohealthcare?
Nigel McCracken (20:33):
What I would see is if I'm sort of looking
back at, you know, my, my sortof career as well, sort of
thing.
I mean, I, I, I love doing whatI do.
It's just very inspiring sort ofthing, you know, to be, to be
able to actually, you know, makesome sort of difference, you
know, in people's lives.
But I think what I would say isthat as a researcher and, you
know, you know, Keep wanting tolearn.
(20:54):
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, Iwas a pharmacologist and
whatever, you know, I studieddrug development in my, my early
days and stuff and things likethat, but keep learning because
what you want to do is you wantto become a drug developer.
So my approach was always.
(21:15):
To, you know, to, to, to go ands and, and work with somebody
who knows something and takethat information and what you
know, and, and, and then movealong.
You want to con, want tocontinue to learn and continue
to grow sort of thing.
Because I think when you've gotdifferent sort of knowledge from
different indications, that'swhen you start to become.
innovative and, and, and workingwith people, smart people and
(21:39):
whatever, you know, who've got,maybe got a different sort of
outlook from yourself andwhatever, you know, but that's
where you can really make a bigdifference.
So I would encourage people.
Yes, of course, it's great tohave a specialty, but continue
to learn and continue to, youknow, you know, you have to try
and take information.
And because ultimately, youknow, I didn't realize, maybe
(22:01):
some people.
Well, maybe not agree, but I wasvery, I was a typical scientist
that began very analytical,whatever, you know, and then as,
as I gained that information andthat experience, I started to
become a little bit moreinnovative and entrepreneurial
sort of thing.
And you start, you start, uh,you know, having things, you
(22:21):
start thinking things that Youmaybe didn't think about before
because you're starting to pullinformation from, from different
places.
Now, the funny thing that I'velearned over the years, the
knowledge is there.
The problem is, is, is trying toget the knowledge either whether
it's somebody in the next officedown to you and whatever, you
know, or that's what you want tospecifically.
(22:43):
Do so continue to to learn,continue to, you know, to, you
know, e evolve.
And, um, I would say just benice to people.
that's always, I've always foundthat 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
(23:04):
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 usout is more of a fun one.
I like to ask each of ourguests, if we ran into you at
the bookstore or at your locallibrary, in which section would
we find you?
Nigel McCracken (23:24):
Oh, definitely adventure.
All right.
I'd be in the adventure onebecause I, being a drug
developer for me is an adventurebecause there's no either,
there's no drugs that are thesame, even if they act on the
same target, and it's, it's, Ijust find it fascinating.
I find the whole body and thefact of, you know, usually your
(23:48):
body is in homeostasis andthat's what it does.
It tries to keep everything inhomeostasis.
Usually with some sort ofdisease, there's something
that's going to miss and then,and then it becomes, it goes out
of kilter a little bit sort ofthing.
So for me, it would always beadventure because my last 30
years of drug development hasbeen an adventure.
And now I've moved intodiagnostics because what I
realized was, you know, andcertainly some indications, uh,
(24:11):
the most important thing is todetect 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 ustoday, Nigel, and sharing your
drug development adventure withus.
Where can those who want tofollow along with your adventure
and find out more connect withyou?
Nigel McCracken (24:31):
Yeah, we've, we've certainly, with LinkedIn,
uh, you know, obviously we'vegot the sort of Virax, uh,
Biolabs corporate website aswell, sort of thing, where a lot
of the news of how things areprogressing.
And what we also try and do iswe, we, We, you know, as, as we
progress, you know, we would, wewould utilize certainly podcasts
and social media sort of thing,just to, to keep people informed
(24:53):
about how things are progressingin there.
But we're excited.
I think, you know, it's just asuper time to be, to be in the
drug, you know, developmentindustry and diagnostic
industry, because again, there'ssuch a willingness at both
within, within, you know, uh,pharma as well as, as
governments and whatever, toreally make a difference in the
(25:13):
future.
Meg Sinclair (25:16):
Great.
Thanks so much again for joiningus, Nigel, and sharing your
adventure.
I really enjoyed your passionand enthusiasm today.
Nigel McCracken (25:23):
An absolute pleasure.
Thank you.
Meg Sinclair (25:25):
Thank you.
Thank you for listening to thisweek's episode of From Lab to
Launch, brought to you byQualio.
If you like what you've heard,please subscribe and give the
(25:46):
show a positive review.
It really helps us out.
For more information aboutQualio, our guest today, or to
be a guest on a future episode,please refer to the show notes.
Until next time.
Hi there! Welcome to the FromLab to Launch podcast by Qualio,
where we share inspiring storiesfrom the people on the front
lines of life sciences.
Tune in and leave inspired tobring your life saving products
to the world.
Meg Sinclair (00:17):
Hi everyone.
And thank you for tuning in tofrom lab to launch podcast
brought to you by polio.
I'm Meg, your host, and I'mdelighted to be here with you
today.
Before we dive into today'sepisode, we'd love it if you
could take a moment to rate andshare the podcast with your
circle of enthusiasts, scienceenthusiasts.
And if you're interested inbeing a guest on the show,
(00:37):
please check out the applicationin the show notes.
Today, we're excited to bejoined by Dr.
Nigel McCracken, the ChiefOperating Officer of Virax
Biolabs.
Nigel has over 25 years of R& Dexperience in drug development
with expertise across oncologyand infectious diseases.
At Virax Biolabs, Nigel is atthe helm of pioneering research
(00:59):
focused on the detection ofimmune responses and the
diagnosis of viral diseases.
In today's discussion, we'llexplore the innovative work
being done at Virex, the impactof their latest projects on
global health, and the future ofviral diagnostics and
therapeutics.
Check out the show notes for hisfull bio and links to learn
more.
(01:19):
Let's bring him in.
Welcome, Nigel.
Nigel McCracken (01:22):
Welcome.
Thank you very much, Meg.
It's lovely to be here andlovely to speak to your, your
audience.
Meg Sinclair (01:29):
Well, Nigel, I'm very curious after reading your
bio, what initially sparked yourinterest in biochemical
toxicology and pharmacology, andhow did it lead to your current
role here at Virex?
Nigel McCracken (01:40):
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 andalso how your body deals with
those medicines that you take.
And that's, I guess, that's Asto, you know, what pharmacology
(02:01):
is all about.
So I've always been interestedin understanding sort of disease
processes and targets, and howyou interact with them.
And then also how the bodynormally gets rid of drugs,
because they don't stay in itforever, sort of thing.
You would have a bit of aproblem.
So I've always been interestedover the years is, you know, why
people respond to certain drugsand other people don't.
(02:24):
And then as, as I guess, as the,you know, Things have moved on
and whatever, you know, and wetalk about translational
medicine and translationaldevelopment, you know, under
being able to translate fromanimal work to human work.
I've always been right in themidst of that sort of thing.
And the nice thing over theyears is the technology.
The, the ability to, you know,to work with different data sets
(02:47):
and, uh, you know, and, and, uh,it's, it's, it'd been
incredibly, it's been a lot morefun in the last 10 years because
of the technology and AI andstuff.
And that wasn't the first sortof 10, 15 years of, of, of my
drug development experience.
So
Meg Sinclair (03:03):
great.
Um, that's interesting thattechnology in the last 10 years
is sped up.
So has that sped up discovery inyour experience too?
Nigel McCracken (03:12):
Yes.
I mean, I think from the pointof view, I mentioned I did
biochemistry, it's aboutpathways, it's understanding the
pathways of disease and, youknow, and normal, normal sort of
biology.
I think in the past it was, youread it in a book and whatever,
you know, and you tried tomemorize it.
And I think the ability now isyou've got the ability,
(03:34):
especially with sequencing andworking with DNA protein that
you.
You can actually, so you canactually plug all of that data
in and, and find out exactlywhat targets are lighting up
upstream and downstream andwhatever you, you know, and then
from that you can actually inferan awful lot about what, you
know, the, the drugs that you'redeveloping are doing now,
(03:54):
usually with small molecules,and we we're talking about non
therapeutics, non antibodies andwhatever.
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 thattarget on like a, an antibody
sort of thing.
So you need to understand themolecular target.
And when you think about thatresponse, it's not just the
(04:16):
efficacy that you want, but youneed to understand as you push
the dose.
you're going to potentially getsome safety issues.
And this is where the toxicologyand understanding that safety
side of it comes in, becausethey're both, when you talk
about response, it is theefficacy and the safety, and you
need to understand that sort ofthing.
And I think that's certainlysomething I've been doing for at
(04:36):
least trying to do for the last30 years, sort of thing or
whatever.
And, uh, you know, understandinghow, how your body gets rid of,
you know, of drugs, but also howyour bodies interact with
specific targets, you know, froman efficacious point of view.
And, and that's, that's beenfun.
It has been real fun.
And going back to what we talkedabout around the, the
(04:56):
technology, the ability to, youknow, to work with large
datasets as well as diversedatasets is just moved drug
development on leaps and boundsin the last number of years.
Meg Sinclair (05:08):
Well, speaking of leaps and bounds, there's lots
of innovative projects happeningat Verox Labs.
You've recently launched theImmune Select Profile within the
Verox Immune T Cell DiagnosticPlatform.
Can you elaborate a little bitmore on this platform and how it
works?
Nigel McCracken (05:25):
Yeah, I mean, the platform itself, we're
obviously very interested in,you know, let's say T cells, you
said the adaptive immuneresponse, 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, somesort of pathogen, you're going
to have an immune response.
(05:46):
And that usually involves, youknow, B cells and your T cells,
you usually get a fever about 48hours later and stuff like that,
but generally your T cells arethe ones that are, that are
dealing with the virus itselfand whatever.
And I think, you know, you getspecific signatures from that,
you know, if you remember backto SARS CoV 2 days, you can get
this.
You know, cytokine storm wherethere's a just an overreaction
(06:08):
to that.
And then it potentially causedproblems on on on normal
tissues.
Um, but again, you know, whatwe're trying to do is harvest,
you know, the, you know, thesignals that come from from your
adaptive immune system and thentry and develop diagnostics to
give some sort of guidancearound T cell dysfunction, and
(06:29):
we'll talk a little bit morearound what T cell dysfunction
means in respect to, um,something like a post viral
syndrome.
But the thought here is, isthat, you know, we're exposed to
many viruses, and I'm sure thatthe majority of us have got lots
of dormant viruses like herpesor EBV or CMV.
(06:50):
which are not usually causing usproblems.
Now, when we get exposed tosomething like SARS CoV,
sometimes, you know, even justSARS 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 stagewhere it can't really remove
that pathogen completely withoutcausing a problem.
Now, the question is, you know,can we?
(07:12):
Look at the T cells and look tosee if there is dysfunction
there.
And if that dysfunction and thesignature that that actually
comes out is, is it actuallyrelated to some of the symptoms
that we actually see forsomething like long COVID or
post viral syndromes?
Now, It's very interesting.
If you read the scientificliterature, you know, people
(07:33):
have been, we've, we've heardabout ME and chronic fatigue
syndrome for many, many yearsand whatever, you know, and, and
there's an awful lot ofcommonality about these post
viral syndromes like long COVIDand whatever, you know, where
the symptoms are very, verysimilar.
We hear about chronic fatigue,we hear about brain fog and
stuff and things like that.
And our thought is that with theplatform, it's fairly agnostic
(07:56):
to the actual, um, uh, virusitself.
Um, and what we are wanting toconcentrate on is this T cell
dysfunction because the T celldysfunction will have an effect
on say mitochondrialdysfunction.
And we know the mitochondriaitself is, it's getting 90 to 95
percent of the actual energystore in the body.
So that's what we want to sortof target.
(08:17):
Now, The way we were coming atit with the platform is we're
utilizing specific peptide mixesto stimulate the T cells or
activate the T cells specific tothe virus.
And then we're looking at thatsignature and that signature of
cytokines as well as specificmarkers and then looking to see
if we can actually Make somesort of association with that
(08:37):
around this T cell dysfunctionand linking up to some of the
symptoms that are associatedwith 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 thinkwith long COVID, there was up to
260 different symptoms for longCOVID.
And, but certainly where we areconcentrating on is more around
(08:59):
the T cell dysfunction and thatknock on effect on the symptoms.
Meg Sinclair (09:04):
Yeah.
Speaking of COVID 19, how hasthe pandemic reshaped the
landscape of viral diagnostics?
And how has the pandemicinfluenced your work at Virax
Biolabs?
Nigel McCracken (09:16):
Yeah, I mean, I mean, Virax, uh, you know, Virax
Biolabs is, it's, it's beenabout for quite a few years.
And, and, and as you said, Ithink the initial focus was like
a lot of, of companies was ondevelop, uh, you know,
delivering sort of antigen testsand, uh, you know, to
specifically identify the actualSARS CoV infection.
But as you'll know, and I'm sureyou hear in the news, certainly
(09:39):
in the U.
S.
and wherever you know, that sortof, the, the symptoms associated
with long COVID and whatever,you know, whether that's the do
with the sort of chronicinflammation or, you know, it,
it, it's having a big, bigeffect on society.
And when I say a big burden aswell, because lots of people
(09:59):
who, you know, were very healthybefore are really having
problems with that.
And then it's not necessarilygoing to go away.
And when I say it's not going togo away, And that we will get
exposed to, you know, SARS CoVin the future.
It won't be maybe as severe, butit could be.
And going back to what I wassaying about these latent
viruses and stuff like that, youknow, with multiple potential,
(10:19):
multiple infections, you havethe possibility of getting that.
Now, I think where we're comingat it is that if you can
identify that T cell dysfunctionearly enough.
Can you, with some sort oftreatment management, that can
be, it doesn't necessarily needto be a therapeutic, although
there are therapeutics gettingdeveloped at this moment in
(10:40):
time.
Can you actually sort of, youknow, have a better effect about
catching it early than, thanleaving it late when sometimes
That T cell dysfunction canbecome irreversibly, uh,
damaged, but certainly affectedsort of thing, where it would be
harder, uh, specifically to comeback.
(11:01):
Now our thought is, is that,just with many things, if you
leave it long enough, Yourimmune system will hardwire into
some sort of other otherparadigm from where it was
before.
And I think that's where we wantto sort of try and target to
see, can we actually developsome T cell diagnostics to help
with that early detection, youknow, and you know, going back
(11:22):
to what I mentioned.
about people with ME and chronicfatigue syndrome.
I think the biggest problem wasit took so long, you know, for
these, you know, uh, people whoare suffering sort of from ME
and to even, you know, getrecognized about being a
specific disease.
And I think, um, I think that wecan sort of, you know, um, you
(11:43):
know, along with otherresearchers, um, you know,
hopefully provide something thathas value specifically as a
person who, who's going alongthat journey.
Sort of thing so that they'rediagnosed early and whatever,
you know, and, and then thatthere can be some sort of
program put in place and itdoesn't need to be necessarily
drugs at this moment in time.
It could be lifestyle.
(12:04):
It could be diet.
It could be some, some sort ofexercise and whatever, you know,
and again, our thought is tosort of be working and trying to
get it.
work with the health systemsystems very, very early on, uh,
you know, to, to, because weknow that it's not going away
and we know that general chronicinflammation type, um,
(12:25):
indications and problems,they're not going away.
And, uh, and, um, that's, that'swhy I think we feel that we can,
uh, we can actually make somesort 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 ageboys, I can guarantee that we're
not getting away from virusesanytime soon.
They will keep going around.
So this is great work you'redoing.
We'll have a huge impact.
Um, ensuring high qualitystandards and R and D is
crucial.
How does viral X.
(12:58):
biolabs maintain and monitor thequality 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 theVirax Immune as we call it, the
Virax Immune platform.
So we sort of, you know, set upa Um, you know, and, uh, you
know, in the last year, and aspart of that, you know, we're
actually sort of going for ISOaccreditation at 13485
(13:30):
accreditation, you know, forwhich is for medical
diagnostics, and that'sobviously involves, you know,
putting in place a qualitymanagement system, and then
obviously then getting inspectedspecifically for that.
So that's exactly what we'redoing.
You can also imagine, you know,when you're developing a
diagnostic, uh, you know, andwe're wanting to do that for,
(13:52):
you know, a CE marked or IVDdiagnostic, you know, there's,
there's lots of things that youspecifically need to do the
whole product development.
process, you know, um, is, isobviously got to be sort of
managed.
It's got to be put in place andas well as that, you know, as
part of, you know, thatregulatory sort of approval, you
(14:13):
know, you need to, you need todo the analytical performance,
uh, you know, as well as theclinical validation.
So again, Obviously, our planis, you know, of course, we want
to make these, these kitsavailable to researchers
initially, because I think theexciting thing about, you know,
sort of working in post viralsyndromes, and we've talked
(14:34):
about sort of SARS CoV and longCOVID, the information is going
to be coming out on that becausethere's been an awful lot of
studies done, and the researchthat's been done on that are
just coming out now.
So we will, we will learn moreand more.
What is clear, you know, formost of the stuff that's come
out, the adaptive immune systemhas got a quite a major role to
play within some of thesesymptoms.
(14:56):
So I think from that point ofthat encourages us, but
certainly we want to be placed,you know, to be able to, you
know, to help to work with thatand to be in that and to be
flexible enough to react to alot 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
(15:17):
FDA, Uh, you know, and some ofthe, even some of the European
ones is certainly with FDA, youcan have sort of pre submission
meetings.
You can sit down with them andsay, look, this is what we'd
like to do.
And, and it's a journey becausewhat we would like to do, as
long as everything sort of worksout the way that we feel it's
going to do, we would like toget that into the system early.
(15:37):
And, you know, so as I said,when, in a patient's, patient's
journey, that, that this wouldbe offered potentially.
To help with that sort ofdiagnosis, you know, for the
general practitioner who's seenthe seeing the patient or
somebody who's admittedspecifically to the hospital.
And I think the nice thing,because you can actually partner
with the FDA right from thebeginning, they will tell you
(15:58):
exactly what you need to do froma regulatory point of view for
approval sort of thing.
And because ultimately for theIVD and the diagnostic, what you
want to be able to do is to bemaking some sort of clinical
sort of, you know, Decision, uh,you know, following, following,
uh, uh, the use of thatdiagnostic itself.
Meg Sinclair (16:18):
Great.
Thanks for sharing your journeythrough the regulatory landscape
there.
I think those pre submissions ormeetings are a good thing to
call out for people on that samepathway.
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 availableto them.
Meg Sinclair (16:35):
Great.
Thanks for sharing that journey.
Looking ahead, what emergingtrends or technologies in viral
diagnostics and immunologyexcite you the most?
And how is Verox positioningitself 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 ofbeen 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 partof the, the health, you know,
uh, um, security in the, in theUS are, there's a huge push with
(17:10):
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 thinkit's, It's not that it wasn't
there before, but there's a realsort of focus around
preparedness, you know, becausethe reality is, you know, these
(17:32):
things will most probably not goaway.
We will get, hopefully, it won'tbe a similar type of pandemic.
But the nice thing is, is, isthere's, there's definitely a
willingness.
To, to both, you know, be ableto provide, uh, you know, uh,
vaccines and stuff like that,but also specifically around the
diagnosis of, and that, that'sexciting.
(17:53):
And, um, I think what people arerealizing now, I think
previously, um, when you, whenyou looked at specific cytokines
and you looked at the immunesystem or whatever, you know,
it, we, we work with plasma, wework with serum and stuff like
that.
Now, It maybe wasn't, it didn'tgive you the same sort of, um,
(18:15):
important information around theorigin, 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 technologyis sort of moving towards, maybe
not such big panels, you know,of like 300, 300 sort of markers
and stuff like that, but morearound, you know, you know,
(18:36):
about the origin.
Okay.
So specifically looking atactivated T cells or B cells and
stuff and things like that.
So I think what we're findingnow, it's not just numbers, it's
also origin, you know, and Ithink there's, there's rooms
for, you know, for differenttypes of technology that maybe
that we used, you know, youknow, a number of years ago, you
(18:56):
know, whatever, you know, whichmaybe it's not so high
throughput, like, you know, flowcytometry, Uh, you know, or
fluorescent or early spot,whatever, you know, but it most
probably a combination of all ofthese things.
We, ELISA and stuff and thingslike that.
And I think that's the nicething because researchers are
using lots of different thingsbecause ultimately we want to
try and understand, you know,the role of the immune system in
(19:20):
these, these, these sort ofPathogens of these, these viral
infections.
I mean, it's not the fact that,you know, T cell exhaustion or T
cell dysfunction is notsomething new.
This is a target that oncologyhas been good after for the
last, I don't know, 20 years.
And, and we've seen such leapsand bounds with a lot of the
neuro therapies.
(19:40):
One of, you know, in college,cause that's what they're
targeting.
They're targeting the samereceptors, whatever, you know,
that we are specifically lookingat it now.
And I think that's exciting.
And I think, you know, as Ifound, over the last 25, 30
years, you know, the technologyhas moved on and also we're
utilizing information fromdifferent indications and
(20:00):
whatever, you know, uh, youknow, and finding commonality
there that we can potentiallyuse and, and, uh, you know, to,
to hopefully come up with, withbetter solutions and, and
diagnostics, uh, acrossdifferent indications.
Meg Sinclair (20:15):
Well, I can't wait to see what comes on that front
and what comes out of Vyrax inthe near future.
For our listeners aspiring toenter the field of drug
development and diagnostics, doyou have any advice you'd offer
to them to help them navigatetheir careers and make
meaningful contributions tohealthcare?
Nigel McCracken (20:33):
What I would see is if I'm sort of looking
back at, you know, my, my sortof career as well, sort of
thing.
I mean, I, I, I love doing whatI do.
It's just very inspiring sort ofthing, you know, to be, to be
able to actually, you know, makesome sort of difference, you
know, in people's lives.
But I think what I would say isthat as a researcher and, you
know, you know, Keep wanting tolearn.
(20:54):
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, Iwas a pharmacologist and
whatever, you know, I studieddrug development in my, my early
days and stuff and things likethat, but keep learning because
what you want to do is you wantto become a drug developer.
So my approach was always.
(21:15):
To, you know, to, to, to go ands and, and work with somebody
who knows something and takethat information and what you
know, and, and, and then movealong.
You want to con, want tocontinue to learn and continue
to grow sort of thing.
Because I think when you've gotdifferent sort of knowledge from
different indications, that'swhen you start to become.
innovative and, and, and workingwith people, smart people and
(21:39):
whatever, you know, who've got,maybe got a different sort of
outlook from yourself andwhatever, you know, but that's
where you can really make a bigdifference.
So I would encourage people.
Yes, of course, it's great tohave a specialty, but continue
to learn and continue to, youknow, you know, you have to try
and take information.
And because ultimately, youknow, I didn't realize, maybe
(22:01):
some people.
Well, maybe not agree, but I wasvery, I was a typical scientist
that began very analytical,whatever, you know, and then as,
as I gained that information andthat experience, I started to
become a little bit moreinnovative and entrepreneurial
sort of thing.
And you start, you start, uh,you know, having things, you
(22:21):
start thinking things that Youmaybe didn't think about before
because you're starting to pullinformation from, from different
places.
Now, the funny thing that I'velearned over the years, the
knowledge is there.
The problem is, is, is trying toget the knowledge either whether
it's somebody in the next officedown to you and whatever, you
know, or that's what you want tospecifically.
(22:43):
Do so continue to to learn,continue to, you know, to, you
know, e evolve.
And, um, I would say just benice to people.
that's always, I've always foundthat 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
(23:04):
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 usout is more of a fun one.
I like to ask each of ourguests, if we ran into you at
the bookstore or at your locallibrary, in which section would
we find you?
Nigel McCracken (23:24):
Oh, definitely adventure.
All right.
I'd be in the adventure onebecause I, being a drug
developer for me is an adventurebecause there's no either,
there's no drugs that are thesame, even if they act on the
same target, and it's, it's, Ijust find it fascinating.
I find the whole body and thefact of, you know, usually your
(23:48):
body is in homeostasis andthat's what it does.
It tries to keep everything inhomeostasis.
Usually with some sort ofdisease, there's something
that's going to miss and then,and then it becomes, it goes out
of kilter a little bit sort ofthing.
So for me, it would always beadventure because my last 30
years of drug development hasbeen an adventure.
And now I've moved intodiagnostics because what I
realized was, you know, andcertainly some indications, uh,
(24:11):
the most important thing is todetect 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 ustoday, Nigel, and sharing your
drug development adventure withus.
Where can those who want tofollow along with your adventure
and find out more connect withyou?
Nigel McCracken (24:31):
Yeah, we've, we've certainly, with LinkedIn,
uh, you know, obviously we'vegot the sort of Virax, uh,
Biolabs corporate website aswell, sort of thing, where a lot
of the news of how things areprogressing.
And what we also try and do iswe, we, We, you know, as, as we
progress, you know, we would, wewould utilize certainly podcasts
and social media sort of thing,just to, to keep people informed
(24:53):
about how things are progressingin there.
But we're excited.
I think, you know, it's just asuper time to be, to be in the
drug, you know, developmentindustry and diagnostic
industry, because again, there'ssuch a willingness at both
within, within, you know, uh,pharma as well as, as
governments and whatever, toreally make a difference in the
(25:13):
future.
Meg Sinclair (25:16):
Great.
Thanks so much again for joiningus, Nigel, and sharing your
adventure.
I really enjoyed your passionand enthusiasm today.
Nigel McCracken (25:23):
An absolute pleasure.
Thank you.
Meg Sinclair (25:25):
Thank you.
Thank you for listening to thisweek's episode of From Lab to
Launch, brought to you byQualio.
If you like what you've heard,please subscribe and give the
(25:46):
show a positive review.
It really helps us out.
For more information aboutQualio, our guest today, or to
be a guest on a future episode,please refer to the show notes.
Until next time.
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On Purpose with Jay Shetty
I’m Jay Shetty host of On Purpose the worlds #1 Mental Health podcast and I’m so grateful you found us. I started this podcast 5 years ago to invite you into conversations and workshops that are designed to help make you happier, healthier and more healed. I believe that when you (yes you) feel seen, heard and understood you’re able to deal with relationship struggles, work challenges and life’s ups and downs with more ease and grace. I interview experts, celebrities, thought leaders and athletes so that we can grow our mindset, build better habits and uncover a side of them we’ve never seen before. New episodes every Monday and Friday. Your support means the world to me and I don’t take it for granted — click the follow button and leave a review to help us spread the love with On Purpose. I can’t wait for you to listen to your first or 500th episode!