SPEAKERS

Dr Megan Robertson, Jane Gaunson, Ricky Johnstone

Welcome to Country  00:00

We acknowledge the traditional Aboriginal owners of country throughout Victoria, Australia, and their ongoing connection to this land. We pay our respects to their culture, and their Elders past, present, and future.

Dr Megan Robertson  00:22

Hello, everyone, and welcome to Global Victoria Healthtech Talks, a show that's about healthtech, business and opportunities in Melbourne and across Victoria in Australia. Victoria has a unique and globally competitive healthtech ecosystem. That thriving and open for business in this podcast series will provide insights into the strengths within our ecosystem that are attracting global attention. Want to explore the expertise, engage with experts, identify markets or learn about how you can team up with top Aussie healthtech companies? Then you're in the right place. I'm your host, Dr. Megan Robertson. And today on Global Victoria Healthtech Talks we're covering a subject matter that many of us unfortunately come into contact with either personally, or via friends and family. Today we're talking about the interesting, but potentially life altering, topic of oncology. I have two wonderful guests today that I'm thrilled to introduce to you. First up I'll be talking to Professor Ricky Johnstone. And my second guest today is Dr. Jane Gaunson. Today my guests will share their perspectives on the oncology sector and discuss the strengths and capabilities of Victoria in this area.

Dr Megan Robertson  01:47

I now have the pleasure of welcoming Professor Ricky Johnstone. Ricky has a range of roles, including Executive Director of Cancer Research at the Peter MacCallum Cancer Centre, where he oversees more than 700 staff and students. He's also Head of the Sir Peter McCallum Department of Oncology at the University of Melbourne. And he's an interim Board Director at Nexomics. Ricky's research has followed a translational pathway that fully integrates fundamental cancer and immunological research, preclinical development, right through to the testing of novel therapeutic regimes. Sounds to me like you're a busy person, Ricky, thanks for taking the time to join me.

Ricky Johnstone  02:29

Thanks, Megan. And it's great to be here. And I look forward to discussing all things oncology.

Dr Megan Robertson  02:34

So oncology is a broad topic that impacts nearly all of us in some way as cancer. While cancer is the disease, the term oncology is used regarding treatment, study and research. So we're all on the same page, what does oncology actually cover, Ricky?

Ricky Johnstone  02:51

Yeah, so Megan, it's a subspecialty, really, of medicine. And it's the subspecialty is of cancer, as you say. It's around how cancer is caused, how we diagnose it, how we treat it, and then how people live with it post-treatment. And I think that survivorship part is something that is probably a little less understood, a little less appreciated, but so very important. So especially as we're finding that our, our diagnostics, and our treatments are getting better and better. More people have good outcomes with their cancer diagnosis. But there are side effects, long lasting, that we need to be able to deal with. So I think that survivorship part is something that's becoming more prevalent, more interesting over time.

Dr Megan Robertson  03:38

Thank you. So Victoria has a long history in oncology research and therapeutic developments. What makes up the oncology sector in Victoria?

Ricky Johnstone  03:50

Yeah, so it's a diverse sector. We think about hospitals obviously, that's where our patients are all treated places like Peter McCallum, St Vincent's Hospital, The Austin, The Alfred, you know, the major tertiary hospitals in Victoria with Peter Mac, being the only cancer focused hospital actually in the country. There is the university sector and we've got a rich history of university involvement in oncology and cancer research. Medical Research institutes, you know, think about the Walter and Eliza Hall Institute (WEHI), The Oilvia Newton-John Institute at the base of The Austin Hospital. There's government Yeah, we've got a Victorian Cancer Agency, which is really important. And then there's industry. So you know, think about CSL and, and those sorts of, you know, heavy hitters, who all make up a very rich and diverse sector and very integrated, I must say.

Dr Megan Robertson  04:41

So this is a sector that has long been strong in Victoria. If we go back, we can talk about the WEHI as it's known locally, the Walter and Eliza Hall Institute was pivotal in the original discovery of G-CSF and the colony stimulating factors. That's really transformed healthcare across the globe.

Ricky Johnstone  05:01

It has and and, you know, it's Walter and Eliza Hall Institute or WEHI has been going for 100 years. And it's based around fundamental science. And it's important to note that, you know, those colony stimulating factors and the study thereof, and the translation into the clinic is all based around fundamental science and Don Metcalf in particular, you know, just a doyen of, of blood research in the world, actually. So, you know, Don was interested in in how blood cells developed, and how they went from stem cells into, you know, specific cells, and the factors and the signaling pathways that were involved in that. Then it was this beautiful arrangement between scientists like Don, and clinicians at the Royal Melbourne Hospital and other hospitals in Victoria, who translated that into a clinical study, into clinical studies, that a now mainstream, you know, standard of care. It's just a remarkable story and something we should, I think, is Victorians be proud of,

Dr Megan Robertson  06:01

And I suppose more recently, that process has been repeated with Venetoclax.

Ricky Johnstone  06:07

Yeah, and again, WEHI was central to that, actually, in collaboration with pharma companies, AbbVie and Genentech. So that's, you know, another interaction that we often probably don't celebrate well enough, this interaction between the academic sector and the commercial sector. But then a series of hospitals, Peter McCallum, Royal Melbourne Hospital, other hospitals in in Melbourne, who put on the first patients with Venetoclax. And Andrew Robertson, John Seymour, and colleagues saw that with their own eyes when the patients were responding so well, and then, you know, that stimulated more clinical trials. And, of course, now to the approval of Venetoclax, in oncology. Just again, a fantastic story built around fundamental science, you know, David Vo, Suzanne Cory, Jerry Adams and Adreas Strasser. So that whole team at WEHI, who were just interested in how cells died, and why really fundamental scientific questions.

Dr Megan Robertson  07:07

That's great. And I think it highlights what we've talked about a lot in this podcast series, which is that health and medical research in Melbourne is a team sport. It involves people across the spectrum of science.

Ricky Johnstone  07:20

Yeah it is an an even more so now. I mean, we talked about big science, and you know, all the omics technologies, where we're not just looking at a single molecule or a single pathway, we're looking at an integrated network. And you can't just do that as a single entity, a single lab, or a single organisation, you need to be able to work with your partners, wherever they may be. Now, in Victoria, we are, you know, privileged to actually have different precincts where you know, that expertise is right at your doorstep, in Parkville, over in Clayton and Monash The Alfred precinct. So, there's not too many places in the world where you have these really high level precincts set up, where your colleagues are literally a stone's throw away. And, you know, I think that that drives the sort of innovation that we need to talk about the the infrastructure is available, the expertise is available. And the culture, and I think we shouldn't underestimate the culture of help, and collaboration and support that we have in Victoria. It's it's quite unique, actually.

Dr Megan Robertson  08:29

So you've mentioned the infrastructure, what are the highlights of the infrastructure, you know, the the modern infrastructure that are currently available for you and your colleagues to work with?

Ricky Johnstone  08:39

Yes, we mentioned omics. So, you know, there is genomics and different organisations have different aspects of that. We have an AGRF (Australian Genome Research Facility) node here in Melbourne that allows us to do sequencing at high level. University of Melbourne has set up a brilliant collaboration with Illumina, which is, you know, the most sophisticated genomics company in the world. So that's right here and there's an innovation hub that Peter Mac and University of Melbourne and others are involved in. We have a metabolomics capability here in Melbourne at Bio21 and proteomics and all the omics are there that are available. So that's for fundamental science. And then for the translation piece, we have clinical trials networks, that are really quite integrated and very rich from being able to put patients on trial and follow them to the biostatistics that are required, to the follow up analysis of of samples from those trials that have been done. And so I had Peter Mac with commercialised an aspect of that. Part of our molecular pathology service has now been set up as a business venture called Nexomics, where we integrate some of our molecular genomics from trials into an our business venture where we work with with the industry and that's another driver of research translational research pipeline.

Dr Megan Robertson  10:04

So Peter McCallum has been quite good at that previously, these developing really, business nodes that enable other people to be able to access your expertise and infrastructure in a commercial way. So you're also the home of Cell Therapies, I understand.

Ricky Johnstone  10:22

Yeah. So Cell Therapies is a sort of a 25 year overnight success story. When I first joined Peter Mac, which was about 22 years ago, Cell Therapies had just been initiated by Dominic Wall and Miles Prince. And I must say it was as if they'd gone into Bunnings and put together this, this infrastructure, these these clean rooms, that sort of hung on the side of the old St Andrews building, in East Melbourne where Peter Mac used to be. But it was was visionary. They knew that that that cell therapies was going to be it was going to have a place in oncology. We had a cancer immunology program that came across from The Austin Research Institute, headed by Joe Trapani. So all of a sudden, there were 25, lab based researchers who could now integrate with this new cell therapies unit. And now we have more than 120 or so cancer researchers at Peter Mac. And Cell Therapies is its own, you know, business venture is its own entity, that now manufactures are called CAR T cells now, not only for Peter Mac, but for other hospitals in Australia. And indeed, he's going to be a manufacturing site for for the region. So just a fantastic I think, example of again, bringing together fundamental science, and clinical activities, but with some vision, and some drive. And some people who really, I think, go out on a bit of a limb and follow their dreams. And we heard about that, from Don Metcalf through to, you know, Venetoclax, and the whole cell death group at WEHI. And an example here of cellular immunotherapy at Peter Mac.

Dr Megan Robertson  12:04

So Cell Therapies actually produces human grade cells for usage in clinical trials or therapeutics?

Ricky Johnstone  12:11

That's right, so there's 10 cleanrooms, at Peter Mac. And we can deliver clinical grade cells that can be engineered, genetically re-engineered. So in the case of car T cells, we reengineer the car T cells so that they have what's really a homing device on the on the T cells, that we re-infuse them back into patients, those cells now seek out and destroy the cancer cells. It's a, it's a fantastic therapy, certainly for some of the haematological malignancies. And we're hoping that we're going to be able to target solid cancers in a similar way, really good investment from the federal government, and for the state government in that and from the Peter MacCallum Cancer Foundation. So there's about $100 million in the last few years that's gone into expanding cell therapies in the manufacturing capability. So that we can produce the cells on home soil here in Australia. Previously, the manufacture is all done offsite, mainly in the US and in Europe. But now we can do it on you know, in Australia, which obviously speeds things up. But also, if you think about the supply chain, we don't have single points of failure. Now, we've heard a lot about the supply chain throughout COVID, and how that can affect clinical care. So that risk has been mitigated somewhat.

Dr Megan Robertson  13:29

And you mentioned in that the really deep commitment of the government, and I think that's another thing that has supported the health and medical research sector in Victoria. So it's both support from the state and the federal government. It's interesting that in our local grants, our National Health and Medical Research grants and others that Victoria consistently get between 45 and 50%, of all funding nationally, reflecting I think, the commitment for Victoria to maintain its strong, strong sector and environment in health and medical research.

Ricky Johnstone  14:07

Yeah, and I think it reflects, you know, I think the history where it's, you know, it has traditionally been very strong and Victoria, but also, as you say, the commitment and it goes beyond government, universities, you know, whether it's La Trobe or University of Melbourne or Monash or Swinburne, they're all committed to research in this state, and hospitals as well. So, you know, hospitals, they're really not funded to do research through the through the state government, healthcare budget, but in fact, we find ways to facilitate research, through philanthropy and through other ways that means that we have, you know, the whole end-to-end spectrum from fundamental science all the way to clinical care. And, you know, that doesn't happen just by chance. It's because it is integrated and involves government, university sector medical research institutes, hospitals and the commercial world. And you know, to be in lockstep, and, you know, we shouldn't underestimate how unique that is actually, and how lucky we are to have it in this state.

Dr Megan Robertson  15:10

So my next question for you is around the strengths and capabilities of the sector. We've just been talking about one, we have a very high quality healthcare system in Australia, with a wonderful range of internationally recognised experts. And that provides the capacity to embed our research in health care. What are the other strengths and capabilities of the sector? As you see it?

Ricky Johnstone  15:33

Yeah. So you mentioned capability, well, information is key here and digital information now. So we have now electronic medical records that have been rolled out across all that the entire hospital sector. In Parkville, we have a single electronic medical record EPIC which is now at Peter Mac, Royal Hospital, Royal Children's Hospital and the Women's Hospital. Just think about that being able to get access to that sort of information all in one place. Be able to use that information. Not only just for for standard of care for patients, but to then drive innovative clinical trials to be able to cherry pick the patients that will be needed for the right trial at the right time. So I think that a sort of an investment from government. That is probably, again, under appreciated. But the impact is huge. And of course, all the other major tertiary hospitals, in Victoria now, getting along with with, with electronic medical records, and integrating that. So we have registries, so we've got that rich information that is required.

Dr Megan Robertson  16:41

So you're talking about the linkages across all the hospitals and the universities. What's the VCCC Alliance?

Ricky Johnstone  16:49

Yeah, so the VCCC is an alliance of 10 partners, involving five hospitals, medical research institutes, and University of Melbourne. It's there to really drive collaboration. So the VCCC per se, doesn't deliver healthcare, doesn't perform research has probably a more prominent role in education. But the VCCC is there to help drive that collaborative network. And probably catalyse and stimulate some things that otherwise, you know, are really difficult to do. So you think about getting out into the, into the rural and regional areas. So that requires some telehealth and teletrials. So the VCCC has been able to stimulate a bit of that and with Peter Mac and others now we're getting out and delivery healthcare out into those areas, but at those areas, rather than everyone having to come into metropolitan Melbourne. So you know, they're the sorts of breakthroughs that I think can happen through a network and through an alliance such as the VCCC it's great.

Dr Megan Robertson  17:49

So Ricky, I suppose we should explain that the VCCC stands for the Victorian Comprehensive Cancer Centre. Now when was that initially established?

Ricky Johnstone  17:58

So it was established just after the, formally established, just after the GFC in 2008. And really, it was built into the plans to build a new hospital for Peter Mac. So a new site for Peter Mac. And it was thought that one way to achieve this was to not just build a new hospital and announce it as the new Peter Mac, but actually to to initiate a new entity that would bring together Peter Mac, and other members of the Victorian oncology sector within Parkville. So it's a little confusing because the top of the building says Victorian Comprehensive Cancer Centre and everyone associates the building with the with the Allaince, but it's truly an alliance. The building itself is about probably 90% occupied by Peter Mac, but also has laboratories at the University of Melbourne and Royal Melbourne Hospital. But it's essentially, you know, the Peter MacCallum Hospital. But the Alliance itself, I think, does provide real benefits actually, because it does formally bring together, as I said, 10 different Alliance members. And now that's been replicated at Monash in Melbourne, there's the Monash Comprehensive Cancer Consortium. And now the different consortium are working really well together. We've just got the Victorian Paediatric Cancer Consortium that has been established that has, you know, aspects of both sides of the Yarra, if we want to talk about it that way. And the benefits of having, you know, these sort of formal alliances in place that do drive innovation, and collaboration, and I think, you know, have a real place. But each organisation within the VCCC maintains its own independence and its own identity. I think that's important as well.

Dr Megan Robertson  19:49

I think you highlight as well there. One of the other real strengths of Melbourne is that we are home to two of the world's top 100 universities. I think there are only three cities in the world. And of course, that's the University of Melbourne and Monash University. And although there's a degree of healthy competition, there's actually a really strong collaboration across the two. And of course, they're supported by many other universities such as Swinburne and RMIT. And La Trobe that you've already mentioned. But it's really important that there are those high quality recognised high reputation institutions that sort of are the other base, if you like, of both the training and the science background that exists in the state. Now, where did the name Peter McCallum Cancer Centre come from?

Ricky Johnstone  20:40

The Peter McCallum Cancer Centre is named after Sir Peter McCallum. So he was a pathologist, actually born in New Zealand, but came and, and was raised and then studied at the University of Melbourne was Head of the Department of Pathology at University of Melbourne. And he had this visionary idea 70 years ago, that there will be a single place where cancer patients can be treated, where research would be undertaken, and they would have an education and public health aspect as well. So you think about that, having that vision 70 years ago to try and have, you know, essentially one place where our cancer patients could go to have all of their care delivered, but also have a very vibrant research and education component. You know, it was really remarkable, started off with humble beginnings, you know, very small place in La Trobe Street, moved to to East Melbourne, and now in 2016 to Parkville as part of the Victorian Comprehensive Cancer Centre Alliance.

Dr Megan Robertson  21:39

So the Peter MacCallum Cancer Centre is an integrated research and treatment hospital that provides healthcare services to the entirety of Victoria. And in fact, more broadly, when tertiary requirements come in. The Sir Peter McCallum Cancer Institute is actually part of the University of Melbourne and located separately, but interacts very closely with you.

Ricky Johnstone  22:03

Yeah, so there's a Peter MacCallum Department of Oncology is part of the Faculty of Medicine, Dentistry and Health Sciences at the University of Melbourne. And I'm privileged to be the Head of that Department. And it really is the academic link, I guess, for our staff at Peter Mac. So we have academic appointments through the University of Melbourne through that department. And of course, that gives us you know, brilliant access to the students at the University of Melbourne allows us to link with the University of Melbourne research capability, but also allows the university to have a direct link in to clinical services and clinical trials and clinical research and health services research. So it's a very symbiotic relationship. And if you think about it, it's steeped in history, it goes back 70 years to Sir Peter MacCallum himself. So I love that, you know, we've got this, this, you know, longevity to that relationship. And I think it's a very healthy relationship. We've been building on it now for a number of years, there are formal relationships and MOUs in place, and it's going from strength-to-strength, it's great.

Dr Megan Robertson  23:13

So that allows really that direct bench-to-bedside, and back to bench again, so that you've got the science informing the clinicians and the clinicians informing the science. And of course, the patients benefiting from all of that.

Ricky Johnstone  23:27

Yeah, and we spoke about infrastructure before, think about the computational infrastructure that's available through the University of Melbourne, the public health, you know, components, those sort of health economics, things that we we really don't have at scale at Peter Mac, but the university does have all those experts and the expertise, and allows us together to work on big programs, health services, research programs that we otherwise wouldn't to try and formally demonstrate the benefits of research driven clinical care.

Dr Megan Robertson  23:59

So it's a very synergistic relationship really, isn't it?

Ricky Johnstone  24:02

It is, it's wonderful. And, you know, it's, it's driven by leadership at the University of Melbourne leadership at Peter Mack, who realised we can't do this alone. And it goes back to that team science idea that that team research idea. And you know, it's wonderful. I have two terrific institutions within the state, University of Melbourne and Peter Mac, who work hand in glove with each other. And I'm in the middle of it, because I work for both organisations. So as I said, it's a privilege and a real honor.

Dr Megan Robertson  24:32

It's a great position to be in.

Ricky Johnstone  24:34

I've got the best job in the world.

Dr Megan Robertson  24:35

Yes. So building on that idea of collaboration. I understand there's also an alliance between Peter Mac and Boston's Dana Farber Institute.

Ricky Johnstone  24:44

Yeah, there is and again, there's some history there, Boston and Melbourne are sister cities. And we've, you know, through individual researchers and clinicians had, you know, this history of collaboration across the two institutions. In 2016, I was part of a delegation that went from Peter Mac to Dana Farber, we held a two-day symposium with them, we realised that we had so much in common so much we could learn from each other. So we formalised it through an MOU. And now we have through the Victorian State government support, an exchange program that's set up, where we have leaders in clinical research, in health services, research and in fundamental science, going backwards and forwards across the two institutions. We speak to our colleagues at Dana Farber all the time, we learn from them, they learn from us, we exchange talent, it's great.

Dr Megan Robertson  25:40

I suppose that's one of the other things that people often think about Melbourne, is that we are at the other end of the earth. But these days, that's not very far. So as you say, you talk to your colleagues in, in the US frequently, we travel there, and one of the comments when people come back here is often "it's not as far as they think". And it feels like home. You know, Boston feels like home really.

Ricky Johnstone  26:03

Well I've lived in both cities. I spent three years living in Boston and of course, was born and raised and continued to live here in Melbourne. And it's remarkable how similar they are. As two cities. We don't quite get as cold as it does in Boston,

Dr Megan Robertson  26:17

Thankfully

Ricky Johnstone  26:18

Thankfully, exactly. They don't have the beaches and some of the things that we like here in Melbourne. But I think culturally, it's very similar. And again, this history of research, and history of innovation in healthcare delivery, is strong in both cities. And that's, you know, a commonality that brings us together.

Dr Megan Robertson  26:40

Thanks, Ricky. We'll come back to you during the panel session a little later.

Ricky Johnstone  26:44

No worries. Thanks, Megan.

Dr Megan Robertson  26:50

Australia's Research and Development Tax Incentive provides up to a massive 43.5% cash refund, which is available to both local and international companies.

Dr Megan Robertson  27:08

Next up, we'll be talking to Dr. Jane Gaunson. Jane works in clinical research as the Head of Study Management at GSK, Australia. She's got extensive experience in all aspects of clinical trial operations from phase one through to phase four. With early phase oncology studies, a particular focus throughout her career. Jane is passionate about building the oncology ecosystem and facilitating an interface between industry and clinicians. Hi, Jane. Thanks for joining me.

Jane Gaunson  27:37

Thanks, Megan. Great to be here.

Dr Megan Robertson  27:39

So tell me a little bit about GSK, and what it's doing in Australia.

Jane Gaunson  27:43

Yep. So GSK is a science-led healthcare company. We have a number of different therapeutic areas that we focus on, but oncology is a big focus for GSK and has been throughout its history. GSK Australia is based in Melbourne, Victoria. So has a strong association with our local oncology networks and providers here.

Dr Megan Robertson  28:09

So how do you connect with the oncology scene in Victoria?

Jane Gaunson  28:14

We have a really strong history of collaboration with our local oncology experts in Victoria. Through clinical trials, but also in supporting translational research as well. And there's been many opportunities to connect the global GSK scientists, with our local clinicians and researchers to have a really collaborative approach to advancing oncology research.

Dr Megan Robertson  28:42

That also includes access to some of the molecules that you're working on and, and different resources that GSK has.

Jane Gaunson  28:49

Absolutely. So I think that's one of the really exciting things about working for an international healthcare company is the ability to bring together different people around the globe. And often there's compounds that are in very early development in GSK, at our with our overseas partner labs, and we're able to facilitate bringing those compounds out to Australia to help further the research that's being done here.

Dr Megan Robertson  29:17

Where is GSK based globally? And where is your home? And how do you find that global interaction with Australia?

Jane Gaunson  29:23

GSK head office is based in the UK, however, it really is a global company. We have research hubs in the US, but also throughout Europe, with Siena and in Italy being a focus as well. So it really is a global interaction that you know, we can bring to the table here in Victoria.

Dr Megan Robertson  29:46

One of the things we often hear about doing work with Victoria, is that Australia is a long way away. Do you find that a barrier for GSK?

Jane Gaunson  29:55

Not at all, I think we're very open to working with colleagues overseas in Victoria, and it's something we're really used to. And because we have that distance, it's nothing to pick up the phone or jump on a video call with a collaborator in another country. And teams in Victoria are really willing to do that. And happy to connect with people, whatever the time of day.

Dr Megan Robertson  30:24

So in your view, from an industry perspective, what are the strengths and capabilities of the health and medical research sector in Melbourne?

Jane Gaunson  30:32

So I think what we see from a global perspective about what people are interested in in Victoria is the highly skilled workforce. The researchers that are based in Melbourne, have years of experience, but are also supporting that next generation of scientists and clinicians that are coming through. So there's a wealth of knowledge here, which our global colleagues are really interested to tap into.

Dr Megan Robertson  30:59

It's interesting that you mentioned that mentoring and guiding of the junior members of the of the sector if you like, I think that's one of the real strengths, isn't it? And we've heard that from Ricky as well. It's those senior people who've been around for years, they mentor the next level down, and then they then in turn mentor on so that we end up with a really strong continuously learning workforce, if you like.

Jane Gaunson  31:27

Yeah, I think that's a really key point. And I think it's not just in the academic institutions that that's happening, but also across the industry. So when you come to Victoria, it's also the people working to support the research, whether that be an interest industry or other companies that work alongside our hospitals. It's a real strength. And everybody is, you know, looking to bring that next generation through.

Dr Megan Robertson  31:55

What sort of examples do you have of programs that perhaps highlight this collaboration that you've seen in your experience?

Jane Gaunson  32:03

Yeah, there's been many over the years, I think the early phase programs really are the highlight, and connecting global colleagues with the key expert globally, who happens to be located in Victoria. So we've seen a number of programs conducted here. So research programs, we have a very strong program ongoing at the moment in heamatology, where the Victorian investigators were involved from the very early phase research, we're now moving into phase three. And beyond that, as we head towards launch of the compound. But to see the collaboration and the value that the Victorian researchers bring, and how important their their inputs are to the global development of these molecules. And that we're really sought out as a place to conduct our clinical trials.

Dr Megan Robertson  33:00

That's great to hear. Those early phase trials are really pivotal and something of an area of expertise, in Melbourne. We have of course, Nucleus Network, which is a phase one clinical trials centre for healthy volunteers. But that's not generally where oncology lands, oncology studies, as we know, even the first inhuman are generally in hospitals. What's our startup time, like here? How does that rank globally?

Jane Gaunson  33:28

Look really well, globally. Australia is often seen as the country that's going to be able to start the trial first. We've done that in recent times at St. Vincent's Hospital in Melbourne, where we started up in early phase, very novel, clinical trial with two novel compounds. And our local team was the first site to be activated globally. And the first site to put patients on as well. So it's seen as a place to come to get your research going and moving quickly, which is really exciting for us here.

Dr Megan Robertson  34:05

Yeah. So when you're doing your phase one trials, tell me about the regulatory process and how that varies from, say, Europe, or the US.

Jane Gaunson  34:14

Yep. So that's one of the reasons why it's so attractive to do research here is our startup timelines. So we have a very simplified process in comparison to some of our overseas colleagues. So there's no IND required in Australia. We have a national mutual acceptance program with our ethics committees, whereby one ethics committee will approve the study for conduct in Australia and that approval will be accepted by the other institutions also working on the study. So it's very streamlined in that way that we only need one approval. Each institution then will approve the research to be done locally, as well. And then we also have the regulatory piece. So it's a very simple notification scheme in Australia for our clinical trials, where we submit a notification to our regulator and they acknowledge that they were going to conduct the trial here in Australia. The great thing about having such a simple process, we submit the application and we're approved within about five to 10 days. And that means we can then import the investigational product into the country. So very simplified process, when you look at some of the processes in the European countries and the US as well.

Dr Megan Robertson  35:42

So in fact, the Therapeutic Goods Administration, Australia's TGA, or the equivalent of the FDA, or the EMA, has actually reversed the process, if you like, from if we look at the FDA. So instead of actually doing the review themselves, they actually delegate that to the human research ethics committees, which are our local IRB.

Jane Gaunson  36:04

Yes, that's correct. Yep.

Dr Megan Robertson  36:06

You notify them and they sign it off.

Jane Gaunson  36:08

Yep. That's right. So our local ethics committees, IRBs they're responsible for the scientific and ethical review of the protocol. So they're the people that are going to be looking at the detail, asking questions, understanding how the trial is going to operate and and how it's going to work in Australia. And the regulator is really just interested to know what's going on. But they don't want to review that detailed information.

Dr Megan Robertson  36:37

Excellent. So how do private companies and industry actually connect into and access the clinical trial sector in Melbourne?

Jane Gaunson  36:47

So there's a number of ways to do it, companies like GSK that have a presence in Australia connect directly with the institutions. And sometimes it really is a matter of cold calling, and finding out who's the best person in the local environment to work on a study. And think we find across the board is that people are always very willing to share that knowledge. And if they're not the right person to point us in in the right direction of where to conduct a trial. For other companies, they might use a contract research organisation to link in with the local research groups. But there's a number of companies that help facilitate research in Australia, some associated with VCCC when we think about cell therapies, and then other independent companies as well.

Dr Megan Robertson  37:39

And most of the major global CROs operate in Australia. So you've got your PPDs, IQVIAs, Syneos and various others who will work here, but there's also a range of more specific and more targeted or small boutique CROs as well. Do you work across the board?

Jane Gaunson  38:01

At GSK we work mainly with large CRO organisations who we have global contracts with. But I think the beauty of the landscape here in Australia is that there are those small companies as well, that can partner really effectively with smaller biotech companies. So it doesn't really matter how big you are. There's someone who can help facilitate that research locally.

Dr Megan Robertson  38:29

I'm interested as well in your comment about cold calling. I know it both Ricky's hospital and mine, we do have research offices that will help with that cold call process. Do you utilise those sorts of connections?

Jane Gaunson  38:42

We do. And there's, you know, there's also groups you can go to, to help facilitate feasibility work to understand who in, you know, the state or more broadly can conduct research. So Cancer Trials Australia is one such group that can help with that. And particularly facilitating sometimes those connections with more regional centers. But certainly we find that, you know, doing feasibility, and just having a connection with somebody locally will then open the door to a number of other groups. Recently, we've got an example of feasibility with Peter McCallum Centre, where that trial wasn't the best fit for them, but they gave us a number of other centers in Victoria, that may be better placed to conduct that research.

Dr Megan Robertson  39:36

Once you get your your trial up and started, you've identified where it is how do clinical trials actually work in Australia? What's available to make that process less challenging as you go through the actual recruitment, retention, and getting them through the whole process of the trial?

Jane Gaunson  39:55

So I think we've already touched on the startup and the ethics Again, there's CRO partners who can help with facilitating that ongoing research. But partnering with our institutions as well, is now becoming a lot simpler with the advent of electronic medical records, electronic record keeping for other clinical research documents, so that the trial master file, that all helps to make the process much more streamlined. Then we can connect him with groups for recruitment, if needed. With oncology research, in particular, we find the network's that the clinicians have a really the best way to connect with the right people for the trial. And it's that collaborative nature of the research that goes on in Victoria, I think that we really see that in our clinical trials, especially the early phase ones, where you'll see patients be referred in from other centres, because the clinicians are focused on finding the right trial for that particular patient. And it doesn't matter where that trial is being conducted. If they know it's not at their hospital, they won't hesitate to send that patient on.

Dr Megan Robertson  41:19

What about the patient advocacy groups? Do you interact with those at all?

Jane Gaunson  41:23

Yeah, so that's certainly something that GSK is starting to work more with patient advocacy groups. I know the VCCC have a strong patient advocacy focus. And it's, I think it's really exciting to see that the impact that starting to have on trials in general, and having input from patients or carers into trial design, and how we can make the trials work more simply for the patients while still getting the outcomes that we need.

Dr Megan Robertson  41:59

So Victoria is a small state, and we tend to think that we punch above our weight, is that real?

Jane Gaunson  42:05

Definitely, I think it's real. I think we see time and again, that the majority of oncology trials are conducted in Victoria compared to other states. And I think it's that the existence of those strong networks, collaborations like the VCCC that really bring the the research here, and we see patients traveling to be involved in trials in Victoria, that might be from other states, but also from regional areas. And over the last two years in particular, with, you know, COVID, people not being able to travel so much, we've really seen that the teletrial model, and being able to connect with regional patients has grown considerably during that time. So the VCCC certainly has a program where they've created a framework around teletrials to make it simpler, and to give some some guidance to regional hospitals that want to be involved in those trials. And really, what that means is that the trial will be run at a metropolitan centre, but will have smaller satellite sites in a regional area. So the clinician in the metropolitan centre will connect with their regional colleagues to consent patients and to enroll them on the trial. But they can then participate in the trial from their home base not need to travel into Melbourne quite as regularly as they were. And I think when we look at the importance of clinical trials in oncology care in general, that's a really exciting change for the whole sector.

Dr Megan Robertson  43:49

There had to be a silver lining to COVID Somewhere, didn't it? And I think that's one of the things that we've seen in Australia, the teletrials, the remote monitoring of patients in trials, even if they do have to come back to Peter Mac, from time-to-time, or the St. Vincent's or the other tertiary centres. There's much more that is now able to be done at home. Thanks, Jane. That's been a lovely chat. We'll come back to you in the panel session.

Jane Gaunson  44:15

Thanks, Megan.

Dr Megan Robertson  44:22

Catch us on Twitter, at Global underscore Vic.

Dr Megan Robertson  44:28

Welcome back. We've heard some fascinating information today. Let's finish this podcast with a short panel discussion with both of today's guests. Welcome back, Jane and Ricky.

Ricky Johnstone  44:39

Thanks, Megan.

Jane Gaunson  44:40

Thanks.

Dr Megan Robertson  44:41

So Ricky, first to you. We've been talking with Jane about the silver linings from COVID and one of the areas of real development in COVID was mRNA vaccines. This started off with work in oncology but got sidelined into infectious diseases with the pandemic. Is mRNA technology guy going to be important for oncology into the future?

Ricky Johnstone  45:02

Well, Megan, I think definitely and what COVID has taught us and, and really the vaccine programs that have come out of Pfizer and Moderna is that we can deliver mRNA as a therapeutic. There were technical hurdles to that previously about how it was formulated, whether we can get it into human systems and get the uptake right. And the success of those vaccination programs has demonstrated that, the world over. So now we can take those sorts of technologies and bring mRNA into vaccine development in oncology, perhaps bringing into neurosciences and other areas where previously without these technological advances may not have been possible. So I think it's a very exciting time. Of course, in Victoria, we have mRNA Victoria, and just full disclosure, I'm on the Scientific Advisory Board for mRNA Victoria. But you know, how wonderful is it that the Victorian government has invested $50 million into this in the first instance, to bring Moderna, to Victoria, to expand out research into mRNA technologies, and to build on those advances that have come through the COVID vaccine programs for Moderna and Pfizer. It's just wonderful. And I think we are seeing now, how we can you know, sort of drive those technological advances into other areas of health and medical research.

Dr Megan Robertson  46:30

One of the other things mRNA Victoria has done is they've really started to pull in some global startups with some exciting new approaches. Tell us about the startup environment in Melbourne. How do you find it?

Ricky Johnstone  46:43

Yeah, so I think I go back to when I was in Boston in the 1990s, I'm aging myself here. I was there 93 to 96 and there was a was a pharma presence, so a big you know, big pharmaceutical presence in Boston, there was obviously the the medical research institutes and the wonderful universities. But really, the startups had only just started to bubble along. And now if you think about Boston, it is a real hub. It is the Silicon Valley for health and medical research in the world. And that's where startups go, they build off, you know, the larger pharmaceutical companies, and of course, have the expertise and the talent that is in that city. I think Melbourne is at the precipice for a same sort of explosion. We've got CSL we've got some other big companies, as Jane said, we've got GSK and the other pharma companies who are firmly embedded within the research and clinical care network in Victoria. We really then just need the final piece of the puzzle will be those startups, the innovative groups, innovative companies that are really going to push the envelope. And I think that the state government is very keen on this. And now we've got these, you know, sort of areas like the Arden Precinct that I think could be, you know, a hotbed for these sorts of new startup companies. Same over in Clayton with the Monash Precinct. So think across the whole, you know, the whole city, the broader city, we have these opportunities to build here, the next couple of Cambridges, and why not?

Dr Megan Robertson  48:18

I think you mentioned CSL. Another homegrown Melbourne phenomenon, of course, started out as the Commonwealth Serum Laboratories based in Melbourne, then went through an IPO and privatisation process. And now is a global force really, in blood technologies, vaccines and similar new areas. Now, Jane as one of the established international pharma, large pharma, well established in Melbourne, how do you find the interaction with the startup community over here?

Jane Gaunson  48:48

Look I think it's really exciting. I think, particularly the different precincts that you mentioned, and the fact that there's so much going on in Melbourne, and there's, you know, lots of opportunities to collaborate with local individuals. We have, you know, GSK has a program where we bring in students into industry, and it's fantastic, even just talking to them and, you know, hearing about the PhD research that's ongoing in Victoria, and seeing how they can then link that with industry. And you know, what's going to happen next.

Dr Megan Robertson  49:27

And both Melbourne and Monash University, now have well established entrepreneurship programs as well, which I think also do some placements in different industry around Victoria.

Jane Gaunson  49:37

Yeah. And I think, you know, isn't that an exciting place to be then in Victoria, where, traditionally, I think a lot of researchers saw they needed to go overseas to progress their career. Sometimes that was into industry or just, you know, furthering their lab-based research. But there's so much going on in Victoria now. That maybe there isn't that need so much to leave our shores. But to keep the knowledge and expertise here.

Dr Megan Robertson  50:07

From your perspective, how does international industry get involved in health and medical research in Victoria? How do they access the sector?

Jane Gaunson  50:15

Look, I think there's lots of ways international parties can connect with the local sector. So we spoke earlier about clinical research organisations and, you know, large global companies who are also connected into Victoria. But also there's a number of smaller groups as well, that can work directly, and help facilitate that research partnership with international companies.

Dr Megan Robertson  50:41

I think the other important thing we mentioned mRNA Victoria, but it is important that Victoria has global business offices, right across the world. In fact, there's a very strong one in Boston, and also down in San Fran working with the US startup sector. Similarly in Tokyo, Korea, China, and Europe. So there are offices as well, where they can link into. So there are plenty of access points. Now, the final thing I'm going to ask you about because you both come from very different perspectives on this is the R&D tax program. So often the R&D tax program is what gets people to first of all, look at Australia. And it's certainly important, although it's not the jewel in our crown, how does the R&D tax incentive work for GSK.

Jane Gaunson  51:29

So like a number of companies, GSK does research in Australia, so we're able to access the R&D Tax Incentive program. So it means that there's tax rebates for companies that do their research here in Australia, the amount of the rebate will differ depending on the size of the company. I think it's applied for annually. So it's, you know, a regular rebate that's coming in, that can be budgeted into, you know, a company's research framework I guess.

Ricky Johnstone  52:03

And I've seen that firsthand how important that is. So I was involved in the initiation of a company called Myricx. It was, I guess, funded through Brandon Capital. And the the R&D tax rebate was essential to get that startup off the ground and it's been going there for around five years, maybe even six years, have has had a couple of rounds of capital raisings and the R&D rebate, it was essential for that. And so we think we're going to have this sector, this startup sector, that, you know, scheme is, is pivotal. So we need to grow it and then to expand it. And we need to advertise, it was just how unique and how important it can be. For these, you know, new initiatives like Myricx and others.

Dr Megan Robertson  52:49

I think, particularly for the startup sector, it's vital. And it's it's 43.5% cashback, each financial year, on what is spent on R&D. And that R&D includes all clinical trial costs, which is quite unique. A lot of other countries have comparable R&D tax programs, but many of them don't involve clinical trials. So in Australia, you get the capacity to get your R&D tax rebate all the way through. And it's important not only for startups, where it's really it goes to the bottom line every year, but also in terms of tax rebates for the very large companies who do spend a lot of their investment in Australia on R&D.

Ricky Johnstone  53:30

And the scheme works. I mean, it's about investing locally. So you build your workforce, you build capacity, you build infrastructure. And you know, the rules are that the work needs to be done here in Australia. So I think it's, you know, it's all part of the growth of the sector more broadly. And again, nice interactions between government, academic sites, and industry. Fantastic.

Dr Megan Robertson  53:54

It really does reflect the broad base of support for health and medical research across Victoria. And thank you both today for really telling us a lot about the oncology research sector here and how strong it is. Strong, well established and open for business.

Ricky Johnstone  54:11

and vibrant, absolutely vibrant.

Dr Megan Robertson  54:12

and vibrant.

Dr Megan Robertson  54:13

Thanks.

Dr Megan Robertson  54:14

Thanks, Jane.

Jane Gaunson  54:15

Thanks, Megan.

Dr Megan Robertson  54:18

I hope you've enjoyed what you've heard today. And if you keen on more information, then check out the links and information in our show notes. And remember, Victoria is a great destination for all things healthtech, were open for business, and we're only an email or phone call away. I'm Dr. Megan Robertson. Join me for the next episode of Global Victoria Healthtech Talks.