SPEAKERS
Dr Megan Robertson, Silvio Tiziani, Rebecca Lim, Dominic Wall, Welcome to Country
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 00:13
Hello, everyone, and welcome to Global Victoria Healthtech Talks, a show that's about health tech business and opportunities in Melbourne and across Victoria in Australia. Victoria has a unique and globally competitive health tech 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 health tech 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 the hot topic of regenerative medicine.
Dr Megan Robertson 01:17
I have three wonderful guests that I'm excited to introduce to you today. First up is Silvio Tiziani, who is the Chief Executive Officer at the Centre for Commercialisation of Regenerative Medicine Australia, or CCRM Australia for short. My second guest is Associate Professor Dominic Wall, Chief Scientific Officer from Cell Therapies based in Melbourne. And finally, we'll hear from Associate Professor Rebecca Lim from Prescient Therapeutics, who is their Director of Scientific Affairs. My guest today will share their insights and perspectives on the sector and explain the strength and strong collaborative capacity of regenerative medicine in Victoria, Australia.
Dr Megan Robertson
So first up today is Silvio Tiziani. Silvio is the CEO of the Centre for Commercialisation of Regenerative Medicine, or CCRM Australia. He has extensive experience in private and public organisations, and as CEO of CCRM Australia he is placed at the centre of the local regenerative medicine ecosystem, including government, private funding organisations, academic research centres, biotech, and pharmaceutical companies. Through his work, Silvio has developed strong international links across North and South America, Japan, Korea, Israel, and Europe and beyond. Hi, Silvio. And thanks for joining me.
Silvio Tiziani 02:46
Hi, Megan. Great to be here. Thank you for the invitation.
Dr Megan Robertson 02:50
Thanks, Sylvio. Let's start with the basics so that we're all on the same page. Silvio, what actually is regenerative medicine.
Silvio Tiziani 02:59
Regenerative Medicine is such a broad term and there's lots of definitions depending on references that you seek. But I like to think of it as a branch of medicine that seeks to regrow, replace, or repair diseased or damaged tissues, organs and cells.
Dr Megan Robertson 03:21
Thanks, Silvio. And how does CCRM Australia fit into the regen med landscape in Australia?
Silvio Tiziani 03:28
CCRM, Australia was established to support the Australian regenerative medicine sector by the government, both the federal government here in Australia as well as the Victorian Government. It's modeled on a very successful Commercialisation of Regenerative Medicine Center in Canada, we've been working closely with the Canadians to establish a similar model in Australia. The the main focus for CCRM is the creation of companies in the regenerated sector. And those companies can be supported by a number of mechanisms. But more importantly, you need a whole ecosystem to develop these companies. And this was recognised by the Australian Government and the Victorian Government when they established CCRM as a support system for the Australian regenerative medicine sector.
Dr Megan Robertson 04:25
So Sylvio, you're based in Melbourne, at the Australian Regenerative Medicine Institute out at Monash University, one of our two major universities in Melbourne. Tell me about the strengths of the ecosystem in Victoria what particularly drew CCRM to establishing CCRM Australia in Victoria?
Silvio Tiziani 04:48
So the success of CCRM is founded on a comprehensive and complete ecosystem in the regen med sector. Whether you need basic research, as you mentioned earlier, government support, a vibrant industry ecosystem, investors. Regenerative medicine is done very well, all around Australia, but predominantly in Victoria. The majority of the research infrastructure is found in Victoria. So the number of practicing academics, clinician researchers, the health system, the investment by the Victorian Government in research infrastructure and facilities, the quantum of investors, and support services and supply companies, the majority are in Victoria. A lot of people therefore gravitate when wishing to establish in Australia to Victoria.
Dr Megan Robertson 05:52
Regen med is really a high tech and very specialised area. It requires a particularly highly educated and experienced workforce. How do we how do we build that in Victoria? How do you get that engaged workforce that is there to support companies when they want to come in and do things.
Silvio Tiziani 06:11
An engaged workforce is easier to find if you've got the right infrastructure, and we have an excellent health system, an excellent academic system, and an excellent level of support from government. What we've noticed is that there is a high degree of interest from overseas for people to come to Victoria, to actually work. And in fact, in establishing the Australian Regenerative Medicine Institute at Monash University, one of the easiest things to do was to point to our infrastructure. And that enabled us to recruit high quality researchers and support staff.
Dr Megan Robertson 06:52
So you've mentioned that we have a very high quality workforce, they're well engaged, because there is a community if you like, we've referred to it as an ecosystem, but it's more than almost a research community. And we've got the set up with academic education and healthcare in Victoria to support regenerative medicine, what else attract companies to come to Victoria in particular, as well as Australia.
Silvio Tiziani 07:20
So there is very good support from the Australian Government to establish a subsidiary or other company, or to base yourself in Australia. And as I said earlier, the benefit the benefits of establishing in Victoria as such that most people will come to Victoria. So very good government support tax incentives, very good support services, migration companies, R&D tax advice, the support services that you need to establish yourself in Victoria are very well established.
Dr Megan Robertson 08:02
Okay. So as well as the actual, academic and research, we actually have the service organisations as well, who can provide the background information for tax incentives, setting up your subsidiary, how to run your company in Australia. Those things are all based here in Victoria. It's a great portal of entry into Australia. You mentioned the R&D Tax Incentive. Can you tell me a little bit more about that?
Silvio Tiziani 08:26
Well, I could, but I'm not a qualified tax consultant, Megan, but that is a very generous system that's been established by the Federal Government. And it does qualify you to receive significant taxation benefits as a result of conducting research in Victoria or in Australia, for that matter. And in fact, that tax benefit is significant. And also, you're able to claim it in the financial year that you expended it.
Dr Megan Robertson 08:57
Yeah so, for companies that have a revenue and annual revenue of less than 20 million, I understand that you can get up to 43.5% cash rebate, and that comes each financial year, you don't have to complete your trial or complete your research. But you can get it so that it can assist with funding your subsequent years. If you're set up well and prospectively registered.
Silvio Tiziani 09:20
That's a really important point that you can get that cash immediately to actually use it in subsequent years, rather than waiting years and years for the tax return.
Dr Megan Robertson 09:34
And I also understand that it includes everything to do or most things to do with your research, including clinical trials, which many international governments actually don't include in their R&D tax incentives.
Silvio Tiziani 09:47
Yes, that's right research of any time when you don't know what the outcome will be. And obviously that's a clinical trial qualifies for that R&D Tax Incentive.
Dr Megan Robertson 09:56
So Sylvio a lot of regen med companies come and set up in Victoria, what attracts them to Victoria?
Silvio Tiziani 10:04
There's an incredibly supportive environment in Victoria for companies who would like to establish themselves here. From the academic sector, clinician researchers are very willing to collaborate with new companies looking to develop their technology with the support of companies. We get a lot of inquiries from overseas regarding support for identifying collaborators, identifying places to base themselves, identifying research facilities. And it's very easy for us to approach the Victorian sector and identify very willing collaborators, very receptive facilities to provide services. And this Victorian Government has been exceptionally supportive in providing advice and guidance to these companies as well.
Dr Megan Robertson 11:01
So you talk about the Victorian ecosystem, it seems very interlinked and collaborative, I presume there's some healthy competition, but do you find it overall are we have friendly bunch to get involved with?
Silvio Tiziani 11:15
I don't think we're less friendly than most other people. We're very friendly in the sense that most people actually understand that we need to work together and collaboratively for mutual benefit. And the rising tide lifts all boats premise. So it's very easy to actually engage with a number of different parties who may be competing for mutual benefit. In fact, at CCRM, Australia, that's what we do on a daily basis.
Dr Megan Robertson 11:43
So Australia's awfully long way away, people see us literally, at the as the other end of the earth, how do we overcome that barrier? Yes, it's a long plane ride. But it doesn't feel that far for us. Why do people view us as being so distant?
Silvio Tiziani 11:59
Well, we are distant. If you're in North America, it's very unusual for people to travel to Australia. More often, I'll travel to Europe or to other parts of America. And the same applies for Europe. But my experience is that when they do come here, they're very impressed by what we have, both from a perspective of the infrastructure, as well as the quality of the people that we have in our talented workforce. In fact, in establishing the Australian Regenerative Medicine Institute, that was our major challenge, how do we recruit the talented people that we needed? In fact, getting them here meant that they really did understand what was possible, as a result of what we have here in Victoria. And we were very successful in recruiting a number of very well credentialed researchers who had choices of going anywhere in the world. But they chose to come to Melbourne.
Dr Megan Robertson 12:59
And I suppose over the last couple of years, that distance has actually worked in our favour. Because on the whole, we've been able to remain open for business with clinical trials, regenerative medicine, and our research going really, fairly strongly throughout the pandemic, due to the fact that we were relatively distant. And I suppose it's also included our confidence, with virtual communication.
Silvio Tiziani 13:28
Open for business is very much the word of the last couple of years for us. The other very important point is the quality of life here in Australia. And most people find it very attractive compared to some of the other places in the world.
Dr Megan Robertson 13:43
Excellent. Thanks, Silvio. That's been wonderful.
Silvio Tiziani 13:46
My pleasure.
Dr Megan Robertson 13:48
We'll be back in a moment with my next guest from Cell Therapies Associate Professor Dominic Wall.
Voiceover 13:56
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 14:09
I now have the pleasure of welcoming Associate Professor Dominic Wall who is the Chief Scientific Officer at Cell Therapies. Dominic has a very long history in Healthtech. In 1999, Dominic developed the cell therapy program at the famous Peter McCallum Cancer Centre in Melbourne, and was one of the founders of Cell Therapies in 2003, leading it to becoming the first TGA licensed service in this field in Australia. Not only is Dominic the Chief Scientific Officer at Cell Therapies, but he has a joint appointment as the Executive Director for Business Ventures at Peter Mac. He also provides executive oversight to the National Centre of Excellence in Cellular Immunotherapy, which was established in 2019 with an $80 million contribution from the Commonwealth Government of Australia.
Hi, Dominic, thanks for making time for us today.
Dominic Wall 15:10
I'm Megan, it's great to be here.
Dr Megan Robertson 15:12
So can you tell our listeners what is Cell Therapies? What do you do at Cell Therapies?
Dominic Wall 15:17
So Cell Therapies is a commercial enterprise housed within a cancer centre that specialises in making cell and gene therapy products available to patients, both locally and internationally. We support a range of activities, starting from pilot studies for human therapy, all the way through to commercial scale delivery of southern gene therapies to patients, both locally and internationally. We're also providing consulting expertise where people want to establish networks for cell harvesting, all the way through to cell treatment. And as such, we see ourselves as an end-to-end, vein-to-vein provider of services to those that want to sovereign gene modified cells for human therapy.
Dr Megan Robertson 16:05
Thank you. You mentioned that you do a lot of your work overseas. And I know that you've been on various trade missions overseas with both the Australian and Victorian government's How do you find supporting international clients are the larger ones as well as some of the smaller US and European startup companies?
Dominic Wall 16:23
Well, I think I can echo Silvio's comments really that in the first instance, we sometimes encounter some resistance to the idea of leaving continental America or Europe to actually conduct work in another continent. But very quickly, we find our clients are very grateful to have access to an extraordinarily well-resourced ecosystem, ranging from key opinion leaders in the network of public hospitals, where we're based. And where we're situated, we have about 18,000 staff working in four public hospitals supporting all ranges of clinical care. But also, we're surrounded by a constellation of research institutes and universities. That mean within a few kilometers of where we live, we have just under 50,000 people working in a variety of knowledge economies to support solid gene therapy. So generally, when clients come to us, they are astonished by the depth of the resources. And that means that when they're considering opening a clinical study, we can find key opinion leaders for them, and investigators, we can actually find out two principal investigators who are only too eager to support their activities. But also we can call upon the full resources of our ecosystem, whether they be researchers or scientists or technical leads to support the tech transfer this technology into our environment. We also are supported by an extraordinary regulatory framework. And that regulatory framework recognises the approvals in other jurisdictions to the extent that if you have a US FDA IND, we can open the study locally without any further central agency of review. Similarly, if you're working of a gene modified cell, thanks to the sophistication of our framework, it recognises that most cell and gene products are actually an exempt dealing, which means that we can very swiftly open a GMO containing study without any further, again central agency review, and ultimately what many of our clients want is not just the technical capability, but also an assured path to a trial. And the best expression I can think of that is if I look at one of the very significant local trials and international trials that was run, which was the JULIET study, sponsored by Novartis, for aggressive lymphoma using a chimeric T cell product, a gene modified T cell from the from which are derived from the patient's own T cells, which were then modified and returned to that patient, were able to open that study from first touch to first accrual in just around 65 days. And I can assure you that with our large client, that was not something they had expected. They were pleasantly surprised that they could open a study not only very quickly, but we also ended up being the largest ex-US accrual site for that study. And that pivotal study, ultimately underpinned a regulatory approval and a BLA for human therapy. So I use that example just to highlight that not only is ecosystem developed, but we were able to deliver all of our clients expectations to open a study quickly, provide high quality data, which ultimately underpinned an international approval for that product.
Dr Megan Robertson 19:54
Thanks Dominic. You've touched on many areas there.
I'd like to take you back first of all to the TGA. Now, you don't have to have an IND open to open a study in Australia. How does the TGA regulatory system work for clinical trials in regenerative medicine?
Dominic Wall 20:14
Well, thank you, Megan. That's an excellent question.
So TGA is an exceptionally sophisticated agency that is already a member of the International Cooperative Scheme for Medicines Agency picks. And it recognises trial approvals in a number of jurisdictions to the point where, if it is confident in the integrity of that medicine, the agency, which is really extends to all the well known international regulatory agencies, they don't feel that there's a need for additional central agency review. But they will be prepared to work with a clinical site approval that is unusually through the ethics committee or the clinical site, and only require notification, not central agency review. They also have a very well developed inspection regime. And they do expect the manufacturing sites are involved with later phase trials from phase two onwards to also have a manufacturing license. So that just to be very clear. This medicine agency interacts with product trials in two forms. One is the regulatory approval for the trial, which they're prepared to recognise an approval internationally. And then for later phase trials, they will want to conduct their own manufacturing inspection. And they are again exceptionally sophisticated because they're able to approve a class for manufacturing. And currently, we have a T cell manufacturing license that covers all forms of T cells for human trial. They also are very open to support all other product classes. And over time, they've endorsed and supported many of our manufacturing license approvals for trials. So with those two arms of regulation, they're very consistent with the regulatory frameworks and other jurisdictions. However, again, I just want to celebrate that the extent of harmonisation is extraordinary, that you can have a gene modified cell therapy that's covered by an IND in North America, by Euro medicine European medicine agency trial approval, and that can be effectively converted into a local trial notification exceptionally quickly, without any further central agency review.
Dr Megan Robertson 22:37
What about on the times when you've got a company that is doing a trial solely in Australia? So you don't need an IND review or an EMA review? So what happens in that circumstance?
Dominic Wall 22:51
Well, again, I think that's a very intriguing question. Because there are some companies that even though actually not obliged to have an IND, they might see a strategic benefit in opening a US IND actually citing an Australian trial site. But there's always the option to return to the TGA with his own trial application, a CTA. And that CTA framework is very consistent with the trial applications you see in Europe or North America, with a very conventional expectations around the CMC component as well as the non-clinical and clinical sections of the application. And TGA, now is very familiar with the whole spectrum of cell and gene modified products, and they do have local experts available and evaluators to actually conduct their own trial approval.
Dr Megan Robertson 23:49
You've mentioned IND, European and CTA approvals. We know that the majority of clinical trials in Australia go through the CTN process through the TGA. What trials in regenerative medicine can go through the CTN and what needs to go through the CTA?
Dominic Wall 24:09
So the Australian regulatory framework went through a major period of reinvention during the mid 90s. And they moved from being a very heavily rules-based framework to a risk-based framework. And the logical conclusion of that was the biological framework, which clearly identified classes of product risk. And for many of the regenerative medicine products, which don't require genetic modification, TGA the medicines agency is very happy to actually transfer the responsibility for the trial approval to the local ethics committee. And as such, if you are working regenerative medicine product that does not have genetic modification, you'll generally find that provided the Ethics Committee endorses is the study in the protocol that there's no further central agency review required. And this is actually quite extraordinary. It means that for many fields of regenerative medicine that don't require genetic modification, for the initial human studies, you do not require a central agency review. And that does set it apart somewhat from other agencies around the world. But it is a very sophisticated application of risk principles to determine when TGA needs to intervene in a study to actually conduct a separate review. If you are working with a regenerative medicine product that does not have genetic modification, there is a very high likelihood that you will not require any further central agency review. And I can assure you, many Australian companies have actually used this opportunity to generate human data very effectively, to the point where they can actually quite readily use that data to open a later phase trial in another part of the world. And it is definitely one of the competitive advantages of coming to Australia, and to Victoria to conduct these studies.
Dr Megan Robertson 26:08
So just to clarify, the TGA Australia's Therapeutic Goods Administration, which is the FDA equivalent, has a process called the CTN, which is Clinical Trial Notification. And in developing that what they've effectively done is they've put the responsibility for the review and assessment of the clinical trial and the product, back to the human research ethics committees, which are our institution based IRBs.
Dominic Wall 26:36
Yes, that's exactly correct. And ultimately, it's a decision about who will accept the risk for the study. And it's recognised that in many settings, the clinical centres are sophisticated to the point where they can very readily and correctly assess the risks of that trial. And there will be circumstances from time to time when they may direct the investigator to actually go down the conventional full application route, which is the CTA, the Clinical Trial Application. But in most instances, my experience has been that they're satisfied with the controls and risks. And they're very happy to actually allow the clinical site to conduct the study. And as at the conclusion of that ethics review in the clinical site, they will issue a notification to the Medicines Agency, and within 14 days, without fail, they will be the provision of a CTN number. And that provides the formal approval for the clinical site to commence accruing patients.
Dr Megan Robertson 27:48
Thank you. Now, the CTN process works very efficiently in Australia. The other major efficiency and clinical trial startup is around ethics committee or IRB harmonisation. Australia has a unique national mutual acceptance program. Can you explain a bit about that to us?
Dominic Wall 28:09
Certainly. And even at the state-based level, we also see the common application process. And the reality is that the clinical infrastructure and the clinical networks in Australia sophisticated to the point that there's actually extensive collaboration between clinical sites, and has been recognised for a number of years that there's little value in having duplicative processes for trial approval. So what we have seen in increasing yours is the identification of a principal site in terms of the ethical review, but then following from that is a very swift adoption of other clinical sites, who are able to actually consider and approve that study without any further or duplicative processes or minimise duplicative processes. So our experience once there is a principal clinical site that's been identified, it's not too long before we see other clinical sites are joining in to the study with a minimum amount of bureaucracy and red tape.
Dr Megan Robertson 29:18
So Australia has a formalised national mutual acceptance program for its human research ethics committees, which I understand is credentialed by the National Health and Medical Research Council, similar to the NIH in the US, or the MRC in the UK. So once so you have to go to a specific ethics committee that is credentialed for NMA to get that broad approval. But once you do that, that approval can then be accepted by multiple sites.
Dominic Wall 29:52
That's exactly correct, Megan, and in my experience, most of the larger clinical centres actually They do have that recognition. But I'd also make a point that in addition to the NHMRC oversight of the ethics committees, we also know that TGA will be establishing a GCP audit program, just to absolutely secure the integrity of the ancillary information associated with clinical protocols. So I think you will find that there's never any question around the integrity of data that you encounter from Australian studies.
Dr Megan Robertson 30:35
Thank you. Now, that brings us on to data. Now, Australian data has a long history of being very well accepted by international regulatory agencies. How do people find their first in-human data being accepted into the FDA or the EMA.
Dominic Wall 30:56
So I can certainly speak for my clinical site where we have regularly contributed data to pivotal studies that have underpinned international approvals. And we've also experienced a number of FDA audits associated with the approvals of that pivotal data. But also it speaks to the broader ecosystem where we found research institutes in our ecosystem, have actually been involved in the approvals of incredible new lines of therapies. And one of the best examples I can think of is Venetoclax on the Walter and Eliza Hall (WEHI), that really was dependent upon the pivotal data that came from the Royal Melbourne Hospital, and the Peter MacCallum Cancer Centre. So time and time again, we see examples where Australian conducted studies have underpinned international approvals for these studies. And in my experience, there has never been a question around the integrity of that data. It is a common question because of course, sponsors will always be concerned that the investment they make in the study will actually pay dividends in terms of international approvals. I've never seen any justification for why that would be an issue, we have seen consistently, that that data is suitable for international approvals. Underpinning that is also the fact that the medical practice or clinical practice that we find here is entirely consistent with what we see in other jurisdictions. And there's often a concern that you may find that there's variances in resourcing, and medical practice, to the extent that what might be conducted in an Australian site might not be applicable in the primary jurisdiction. We've never seen that. What we have seen is that Australia is absolutely consistent in his medical principles and the general practice that you find in and certainly in my field in cancer medicine, and there's absolutely never been a question around a divergent clinical practice. We've been pretty consistent.
Dominic Wall 31:32
Thank you. So we've spoken about rapid startup. What about recruitment? The Peter MacCallum, where you're based is part of the Victorian Comprehensive Cancer Consortium (VCCC). Tell me how that works, how do you go with recruitment to your studies? How do you get broad engagement?
Dominic Wall 33:25
So again, Megan, you've touched on a really important point because the rate of patient accrual is usually a central preoccupation of the sponsor. And of course, Australia is a relatively small market compared to other regional or international markets. But one of the benefits of Australia is that it's actually an incredibly urbanised society. We are highly concentrated in medical care, where there is a lot of cross referral. So what we find is that if there's ever a local accrual challenge, we often establish referral pathways, where we very quickly identify patients nationally, and even sometimes internationally, participating in our studies. And within our own cluster of clinical sites, we run combined departments to foster that transfer of patients. We have a combined department of hematology between the Peter McCallum Cancer Centre and the Royal Melbourne Hospital. But if you also look at the Victorian Comprehensive Cancer Centre (VCCC), we have an alliance model where we work very closely we have a constellation of premier cancer centres and clinical centres across Victoria, who also refer patients through to us very effectively. And that is a guiding principle we we do often have to work with relatively rare indications and orphan diseases. And it's only through our consolidation of effort with other clinical sites that we can address our primary target which is to provide high quality accruals for these studies. It is absolutely essential that when we open a study we do start accruing quickly. And it is a key milestone, it is a point of measurement where we look very carefully or our accrual rates. And we were very careful to ensure that when we open a study, working closely with a sponsor, that we minimise the risk of conflicting or competing studies, which might impact the accrual rates. Because we are similarly motivated that we want to meet the sponsors and patients expectations that if there's a study open, that we can get patients onto those studies as quickly as possible. And a good example of that has been our Car T program, we have over 13 chimeric T cell studies running currently within our network of hospitals. And these range from allogeneic Car T cells which are produced for multiple recipients from another donor through to CRISPR edited Car T where there's been genetic editing of those T cells for human therapy, as well as the more conventional autologous Car T studies where the patients have their own T cells modified for human therapy. So what we've observed in recent years is that as we work with other clinical partners, we can offer quite a substantial menu of potential therapies for patients to get referred through our networks and through our partnerships to actually get access to the right trial as quickly as possible. In this modern era, many of these trials are potentially curative. And they offer often a potential therapeutic alternative, where the trial is probably going to result in a life changing outcome for that patient. So it is absolutely critical that across Australia, patients have that opportunity fairly and equitably, irrespective of where they are in Australia.
Dr Megan Robertson 37:00
So to clarify that Cell Therapies is based at the Peter MacCallum Cancer Centre, but you actually provide services to many other sites. So the clinical trials can run at other sites across Australia, in addition to or if desired alternative to the Peter Mac, you're not limited to the Peter MacCallum Cancer Centre.
Dominic Wall 37:27
No, absolutely. And there's quite a few examples of where we're supporting trials. Actually, they're not even conducted in Australia. So but I'd give a good example. And again, it's a really good illustration of how a virtuous ecosystem can work. And a good example of that is we work with a company called AVROBIO. That company actually arose out of CCRM, Canada initially, and they were looking for clinical sites, I had access to treatment, naive patients for endocrine metabolic disorders. And we're able to work with a treatment site of the Royal Perth Hospital in Western Australia, as well as a treatment site at the Royal Melbourne Hospital. And we're able to open that study in Australia, really using some very early first in world first inhuman data that had been derived in Canada to actually open studies across Australia, not at the Peter Mac, but at the Royal Perth and Royal Melbourne where they have very substantial national treatment programs for patients for these rare metabolic disorders. But as a company, we work with health centres all over Australia, and also all over the region. So we support trial partners across Southeast Asia, across Australia, but also internationally. We've also been involved in multinational phase threes, where we've actually worked on combined batch records where we simultaneously released products for multiple jurisdictions. So yes, we use every lever our disposal through our clinical networks, to facilitate accruals and to support studies. But we're also completely open to work with partners anywhere in the world to open their study.
Dr Megan Robertson 39:17
Thanks, Dominic. That's been a really rich source of information. Thank you so much.
Dominic Wall 39:22
It's my pleasure. Thank you so much, Megan.
Dr Megan Robertson 39:25
We'll be back in a moment with our final guests for today. Rebecca Lim.
Voiceover 39:31
Catch us on Twitter at global underscore Vic.
Dr Megan Robertson 39:46
My final guests joining me today is Associate Professor Rebecca Lim, who is Director of Scientific Affairs at Prescient Therapeutics with over 10 years experience in allogeneic cell therapies for regen med Rebecca initiated several first in human clinical trials for urgent unmet medical needs, including stroke and Crohn's Disease. Previously, Rebecca served as the Scientific Director for the cell therapies platform at the Hudson Institute. And she still holds an academic position at the Hudson Institute, and is an Adjunct Associate Professor at Monash University. Welcome, Rebecca.
Rebecca Lim 40:25
Thank you. Thanks, Megan.
Dr Megan Robertson 40:27
Now, can you give us give our listeners some background on Prescient Therapeutics?
Rebecca Lim 40:31
Sure. We are an Australian based biotech company. As of this morning, I did have a quick look before coming to the studio, our market cap sits at little bit shy of 200 million. So we are a small caps biotech company. Unusually, while based in Australia, based in Victoria, we have licensed a number of assets from the US. In fact, all of the assets that we have are US based. We have two targeted therapies. We're an oncology company. So the two targeted therapies target specific cancers. And we have two open INDs. One in acute myeloid leukemia, that's a trial running at the Moffitt Cancer Center in Florida. And we also have one on peripheral T cell lymphoma. And that's open here in Victoria, at the Epworth Health, we have at the end of last year licensed cell therapies asset from the University of Pennsylvania, and Oxford University. And we're looking to move that preclinical asset into first in human trials in Australia and in Victoria, with the help of colleagues who are sitting in this room. So we're very excited about that.
Dr Megan Robertson 41:34
Thank you. Tell us about your experience, working with international IP and KOLs (key opinion leaders) and bringing it to Australia. How has that been handled? How have your international collaborators seen the process?
Rebecca Lim 41:49
Sure. So that's let me unpack that question a little bit. There is a lot of capability within Victoria, around the IP international IP position and how the US Patent Office works. And I think that's quite relevant and worth mentioning. Because the some of the requirements around handling of those assets from the US are quite bespoke. And having those sorts of legal advice becomes really important, especially when you can pick up a phone to someone who's on the same time zone as you to provide information that needs to be turned around by the open of business, our time tonight, opening of business in the US. And while some people might consider that the differences in time zone can be quite challenging to manage, there are a number of different advantages, such as getting back to the patent office, getting back to patent examiners in time. In terms of working with international collaborators, that, again, is not really much of a problem for as long as you don't mind too much, occasionally working on a Saturday morning to address that timeframe. For six months of the year, our time zones a little bit closer. So you know, you're really waking up at a normal workday, and starting work maybe 7, 8am, which really isn't a challenge these days, I don't think particularly now that a lot of us are getting used to working off Zoom and on Teams and WebEx. I think that's a lot easier a pill to swallow. And in terms of working with international CROs, which I guess is the other component of running trials that are not based in the same city as you are, that becomes quite simple these days, because I think there's a growing understanding that the Asia Pacific region does need their own representatives. So you get international CROs who have people in business unit that might be based in Sydney, for instance, or in Melbourne itself. So it's not too difficult.
Dr Megan Robertson 43:54
What about working with local CROs if you had much engagement with local CROs in the region mid space?
Rebecca Lim 44:00
Yeah, and I think one of the local CROs that we have here was also recently acquired by a US company. 360 biolabs, was recently acquired. And that was quite a big deal for for Victorian biotech that makes the globalisation really work in our favour. So working with them, they are completely on top of what the FDA requires in terms of clinical reporting, the clear accredited assays that need to be run for those trials, developing biomarker assays that feed into US IND filings, they're on top of that, so it takes a lot of the pressure off us to do that due diligence.
Dr Megan Robertson 44:40
So 360 Biolabs specifically does all the high tech assays if you like and they're one of our great collaborators here in Melbourne. What about CROs who actually run your clinical trials for you? How have you found that in the regen med space?
Rebecca Lim 44:55
Yeah, I mean, our CRO is an international company. They do have, some of the operators are in Victoria itself, and the clinical sites do a lot of the monitoring anyways. And being able to pick up the phone to someone, or even drive down to the clinical site to have those conversations is has not really post any problems for us.
Dr Megan Robertson 45:20
Great. I think you've just highlighted one of the really important things there, which is that our, our clinical sites, our KOLs are great. And they're very easy to engage as both Silvio and Dominic have mentioned. But in addition to that, the actual staff working at the sites, our clinical research staff is a very high quality, and they're very helpful in doing things like monitoring, so I expect you liaise with them quite closely.
Rebecca Lim 45:46
Pretty much you wake up to emails from the US counterparts a US based KOLs, or I certainly do. And that gets fed through during the course of a work day to the Australian sites, our advisors, our reg advisors for the IND open trials, they provide feedback to us and we're able to get back to them with any updates on the clinical monitoring. If there any holdups in terms of drug product arriving into Australia, even the drug supply logistics that's kind of well encompassed within our ecosystem.
Dr Megan Robertson 46:25
So you run trials that are both multisite, so obviously international and in Australia, have you run trials solely in Australia, solely in Victoria or using your Victorian base?
Rebecca Lim 46:40
Yes, in my academic life, those clinical trials have run with allogeneic, cell based therapies, those were all run in Victoria. And that was simple enough to do particularly because there were, you know, first in human trials, smaller sites, you get face-to-face time with the clinical scientists who run the trials, I think one of the real benefits to running a small, single site, first-in-human trial in Australia is the ease of access to the clinicians who you work with, to write those human ethics applications. When you go through a CRO that can present some challenges, because they then you know, not lots of cooks in the kitchen. But when you have smaller sites, and as you've already discussed with Dominic, with those CTN route of approval within Australia, I think that also gives you an insight as to what the regulator's think is the greatest risk. And if you can make a good argument for it being a low risk, even within the regenerative medicine space, there is no need for that central regulatory approval.
Dr Megan Robertson 47:47
Certainly, from my experience, also, with clinical trials, the ethics committees or the IRBs, are very interested in the level of risk, but their main interest is that you explain that level of risk, so that the participant has the capacity to make the decision. So it's not necessarily whether it's low risk, or high risk. It's how well you explain that. And of course, we have dedicated services in Victoria that can assist you with your ethics applications. So that is another area where we can provide assistance. They mentioned you've come from an academic background and and Silvio mentioned the high level of education and experience that we have from coming from our academic centre. Tell me a bit about your own journey from researcher to the dark side in industry.
Rebecca Lim 48:35
I would never call industry the dark side, well, not ever again. As an academic researcher, I saw that translational research, particularly in the regenerative medicine space, it could not happen and we could not make significant impact to patient's lives without interacting with industry. I then became part of some trade missions and that's where I shared many hotel breakfast with Silvio, and had the opportunity to get mentored by people like Dominic. I think one of the important things as academics is that discovery phase, but also recognition and there's probably a little bit of ego in it, acknowledging that we can't do it alone. No single party can do it on its own. And probably about three or four years ago, I got kind of tired of sitting by the sidelines and looking wistfully at my mates going, oh, I want to do what you do. And that's how essentially I found myself in this position here. You know, I'm 10 months into the job and loving every second of it. And Victoria is a really vibrant community. When I reached out to colleagues like Dominic and told him, this is the first day of my new job, what do I do you have so many people who have walked that well trodden path and are more than happy to walk you through the similar process.
Dr Megan Robertson 49:59
So it's interesting, you talk about that symbiotic relationship between academia and industry. And I think that that understanding of that is very strong in Melbourne, particularly with our very strong university sector. And that university sector sparks a lot of different startups and businesses. So there's a real recognition around that. But the other thing is that if you go from research to industry, you can still go back again, there is not it's not seen as a harsh divide. Have you found Dominic moving between industry and research, where you sit, does that pose challenges at all?
Dominic Wall 50:36
It can sometimes be perceived as a challenge, but the reality is that it isn't. And it's very clear to Rebecca's point that it is an ecosystem where we are dependent upon each other. So there's very little resistance to the movement of people from an academic role to a commercial role and back again, and again, I can speak to my own circumstances where I maintain a clinical appointment within a public hospital while serving as a Chief Scientific Officer of a commercial enterprise. And yes, it does impact my disclosures and have to spend a lot of time addressing my conflicts of interest. But it is recognised as actually contributing to the whole, to have people have commercial skills contributing to decision making around clinical programs locally, and we we're very, very happy wearing my hospital had to actually have a constellation of commercial partners that we work with, we actually see the sponsors who are bringing these new therapies to the market as absolute critical partners, to actually improving patient outcomes. Everything we do, and discovery and translation depends upon a commercial event at the end. And that old binary thinking of a reference to the dark side, if I may say so, is is actually well and truly behind us because we recognise we're actually all generally pulling towards a common goal, which is to improve patient experiences.
Rebecca Lim 52:16
I just wanted to add one more thing. So in 2019, I was awarded career development fellowship by the NHMRC. So our vision of the NIH, and I was awarded that fellowship under the "Industry Category", which allows me to take up to two years off from my fellowship, to go into an industry role. And that's a very unique opportunity that I don't think most jurisdictions actually have. To have federally funded research applications and allow the fellow to actually step away from academic pursuits and step back into it. We also have at the moment through the medical technology, pharmaceutical sector, MTP Connect the series of Ready Fellowships, which allows anyone from a technical position to a clinical to a reg position to spend up to 12 months with an Australian-based company to develop those skills, because there's recognition that people need to be able to move between the two. And the talent may not necessarily lie right in front of you with within your own sector.
Dr Megan Robertson 53:25
Very important, both of your comments, particularly around that juxtaposition and interlinking of research, academia and industry in Victoria, it really is a very dynamic area. You mentioned your grant, working for Prescient how have you found finding funding and grant opportunities within the Victorian Government in the Australian Government sector? Are they supportive overall? Are you Are there opportunities there that you can explore?
Rebecca Lim 53:56
There are an abundance of opportunities to the point that one could spend one's entire working year applying for grants, not that it is necessarily the best way to spend your time. But there are so many grant opportunities, there are federally funded ones that can be quite a lot bigger. They typically require, you know, dollar matching schemes, a lot of them. And what a lot of the federal government tries to do is actually link up multiple industry partners. So they want to demonstrate that you are actually leveraging the ecosystem. It builds awareness of the ecosystem. It builds into the manufacturing capabilities that the federal government has already developed. The state government, the Victorian Government, those tend to be smaller. There are a number of technology vouchers where it could be that the company applies for the technology voucher, but that money has to be spent in an academic institution. If nothing else, it builds awareness because quite often you don't even know what's in your own backyard until you're kind of forced to "have a look" and find the best ways that you can collaborate with the people that are within your own state.
Dr Megan Robertson 55:08
So, of course, Australia has the Medical Research Future Fund, which is a $20 billion corpus, which is being distributed over a period of time over on an ongoing basis to support clinical translation of research. It's really getting there to the people who are actually delivering. So our NH and MRC delivers more the basic science, the MRFF goes forward. But Victoria also has the Victorian Medical Research Acceleration Fund, enter the new Breakthrough Fund. Are you or any of our panelists aware of these funds or had any interaction with them?
Dominic Wall 55:44
And certainly, we've seen a number of industry grants coming forward, where there's a very strong emphasis on commercial outcomes from that investment, whether it's the modern manufacturing initiative from the federal government, or the program of Breakthrough Victoria, which is really administered by the Invest Victoria team. And it's clear to me that they're focused on ultimately, commercial outcomes for both federal industry, but also the state program through Breakthrough Victoria. And this is an initiative, an initiative that was announced relatively recently, so my understanding is that the assessment frameworks are still in development. But certainly our preliminary engagements with the state-based investment programs have been incredibly supportive. They're obviously concerned to build industry leadership, where there's not a duplication of existing resources, but they're keen to see unique opportunities to cement new manufacturing opportunities in Victoria, and we're tremendously grateful for this. And, yes, we're engaging, but it is quite early days still.
Dr Megan Robertson 57:10
Certainly from a hospital base, we've seen a very strong push from the state government, in particular, to encourage and support clinical trials. And that's the whole mechanism around clinical trials, including the industry input, and building their capacity as well. Which of course, is so important for regen med, because so many of the companies who are involved in regenerated are startups, relatively smaller companies. So Rebecca, you are originally based at the Hudson Institute, which is a medical research institute based at Monash Medical Centre. How do you find I think you've mentioned it already. But how do you find interacting with the health services in Victoria? How do you find getting access and getting in there to actually get your clinical trials or get ideas and assistance for how to do your clinical trials?
Rebecca Lim 58:03
I don't think my experience is very different to any scientist who is keen on moving the discovery research into the clinic. I found it very easy to get access to clinicians who were happy to lead the trials, getting access to research nurses who would help with patient accrual. Monash Medical Centre has its own translational research facility, which houses a clinical trial centre. It's a 24-chair, 8-bed, facility where most of the trials that are being conducted in that facility are generally oncology trials. So particularly clinical trials in that oncology space. It's a very, very busy centre, it has operated, they've been open for business throughout the pandemic. And so from my perspective, whether or not the trial was involving colorectal surgeons for the Crohn's Disease study, or involving neonates and their parents in the Neonatal Intensive Care Unit, that has not skipped a beat in the last couple of years. And that was with me stepping away from a full-time academic position. So I would say, open ready for business. It's not been a problem at all.
Dr Megan Robertson 59:22
Thank you. I think we've also been supported by the government's both state and federal, who declared the clinical trials were an essential service during the whole of the COVID pandemic. So that's been very helpful in assisting us to continue on with what I think as clinicians and as a sector, we see as an essential part of healthcare, giving our patients giving our community access to the latest available therapies, when other therapies are not, not available. So thanks very much, Rebecca. That's been wonderful.
Rebecca Lim 59:57
Pleasure.
Dr Megan Robertson 59:57
Listeners don't go anywhere just yet because we're about to launch into a discussion with all our panel members, so stick around.
Voiceover 1:00:06
More than 1/3 of Australian clinical trials activity takes place in Victoria. pharmaceutical and biotech companies across the globe recognise Australia's impressive capability. And many have chosen to undertake trials here in Melbourne, and across Victoria.
Dr Megan Robertson 1:00:37
We've heard a range of interesting things today about regenerative medicine, research and clinical trials. And I'd love to finish the podcast with a short panel segment today with all of our guests. So welcome back, everyone. Rebecca, Silvio, and Dominic.
Silvio Tiziani 1:00:52
Thank you.
Dominic Wall 1:00:52
Thank you.
Rebecca Lim 1:00:53
Hey
Dr Megan Robertson 1:00:53
So Dominic, I'm going to start with you. You talked a little bit about the Australian market being relatively small. And we do have to acknowledge we only have a population of 25 million. But Australia is important for where it's located as well. Tell me a bit about Australia as a base for the Asia pac and regional activity.
Dominic Wall 1:01:13
Thank you for making this really important point. Many of our larger clients when they consider the Australian market, initially, they might consider it to be potentially a relatively small market. But what's been clear is that when they've looked at it more strategically, they've identified that Australia and Victoria in particular can be effectively a platform, a sanctuary, for supporting a much larger regional market. And it's very clear to me that when, particularly at the commercial scale, when companies come to Victoria, they're actually thinking about the regional opportunity. And key to that is the fact that Australia has, again extraordinarily subtle and fast, important export arrangements. Every day of the week, we are sending and receiving gene modified cells all over the world. And we work with healthy normal material coming from North America coming into Australia, we work with vectors viral materials are designed to introduce new genes into sales that come from the UK from Germany and North America. And these come in regularly without any delay through our customs and excise they come in very quickly straight into our stores, our GMP control stores. So we can support and we do support trials and treatments all across Southeast Asia. And we have regulatory approvals that underpin that, whether it's with the Japanese Ministry of Health, Labour and Welfare, who have certified Cell Therapies as a supplier or foreign supplier to the Japanese markets, or whether it's the agencies in Singapore, or Hong Kong, or Taiwan or South Korea, we can support those markets. And instantly, as I mentioned that you can immediately perceive what that means in terms of the markets, we can also support effectively means that you have an English language manufacturing site that can work with tech transfer materials from North America. But we also have a very diverse workforce, Mandarin speaking, and other languages available within our workforce that can support regional markets instinctively without any delay or complication. So there's a distinct opportunity to consider Australia not only as the initial discovery site or a development partner, but also partner they can run a trial initially locally, but then later, regionally. But ultimately, we can also support a regional market and support trial sites and clinical sites all across the region.
Dr Megan Robertson 1:04:10
Thank you, I think you bring up a very important point there, which is the multicultural basis of both Victoria and Australia, that not only assists in doing business with our close partners, but it also assists in our clinical trials because we have that very marked clinical and genetic diversity. So we reap the benefits of being a new world and a multicultural world.
Dominic Wall 1:04:35
And that is indeed a really important point. Sometimes we deal with product development companies actually come out from Southeast Asia, who asked the obvious questions around the relevance of their preclinical data to the Australian community and we have to really reassure those clinical partners and in fact, Australia is an exceptionally diverse and inclusive society. Where we find very high numbers of people from of Southeast Asian descent in our communities, which means that the clinical data is not only pertinent inbound, but also we can support clinical data for communities across the world because of our history of being a point of migration from all across the world into Australia.
Dr Megan Robertson 1:05:24
Thank you. Now still, we oh, we haven't heard new for a couple of minutes. We do know that as we've said before, CCRM, Australia is based at the Australian Regenerative Medicine Institute at Monash University. And Monash University is one of the powerhouses of Australian research. And when we look at Australian academic funding, a lot of it comes to Victoria, what benefit does that give us in the longer term?
Silvio Tiziani 1:05:51
A lot of it is right! About 40% of all of the competitive grant funding in Australia comes to Melbourne. And what that does is obviously, there's more investment in Victoria, more research infrastructure, more capacity and capability of our scientists. And this is a great time to be working in the regen med sector overall. Last year, there was $20 billion of investment in regenerative medicine globally. $20 billion US dollars, which is eclipsed this year by $14 billion in the first six months of 2021. Level of investment is significant. The number of clinical trials, globally are significant. And Australia runs about 10% of those clinical trials in the regen med sector. So there is a lot of activity in Australia. And the majority of that activity is in Victoria.
Dr Megan Robertson 1:06:50
And do you see that activity growing in Australia?
Silvio Tiziani 1:06:54
it can only grow in Australia. The level of interest in some of our facilities, and Dominic outlined some of the capability and expertise that we have here at the VCCC, is indicative of what we have in Australia. Our experience at CCRM is that we do get a lot of enquiries from regen med powerhouse countries like the US but also Japan and Korea. And companies from those jurisdictions, see Australia as a very, very welcoming place to do clinical trials, to identify collaborative partners, and to invest in research infrastructure and base themselves here in Australia, but mostly in Melbourne.
Dr Megan Robertson 1:07:41
Thank you. Now, Rebecca Dominic mentioned that we have a very diverse population here. But we're pretty good at accepting diversity and particularly in our industry, in education, we have very strong representation from different ethnic backgrounds, but also a very strong representation of women. So how have you found being a female executive in biotech in Victoria?
Rebecca Lim 1:08:12
I think it came as a surprise to both myself and some academic colleagues, we were sitting at AusBiotech, I believe, in 2019 AusBiotech, looking at the panelists and realising hmm, there are actually more female CEOs on that panel than males. We had never seen that ever before on an academic panels, or the "manels" that are trending on Twitter. You don't really see that very often. And I think that's something to be really proud of, of what we have in Australia, there is a lot of championing of diversity, and inclusivity, whether it be ethnic, gender, or ableism. There's I think we take all comers, and in true Australian fashion, you prove yourself and you're in.
Dr Megan Robertson 1:08:59
Wonderful. And I think that brings us back to something Silvio said very early in our conversation, which is Australia is a great place to live and work. We really are very lucky. And one of the things I'm sure each of you is found when people do come to Australia, they do love being here, and they're keen to come back again. So do you get much return business Dominic?
Dominic Wall 1:09:22
Well, I have to echo that comment because we often have had the pleasure of hosting clients from around the world and I think whilst I wouldn't claim there's La Dolce Vita in Melbourne, there's elements of that, which they celebrate, particularly in the long summer evenings when they've come for quite grueling tech transfer sessions. Then they go kite surfing at St Kilda beach afterwards as a group. So we've seen lots of international visitors that are extremely keen to find any possible justification to come back to Victoria in particular and Melbourne specifically. So yes, absolutely. Whilst we have many commercial frequent fliers that come back up, to do more work with us, as an individual level, the friends that we make with our partner companies around the world that only too eager to come back to, to have the Melbourne experience.
Dr Megan Robertson 1:10:24
Thank you, Silvio, Dominic, and Rebecca for your time and your really valuable insights today. It's been a fabulous conversation. If you've liked what you've heard, please stay on and get some more information and check out the links and information in our show notes. Thank you, everyone. Thanks for being with us today.
Dominic Wall 1:10:43
Thank you.
Silvio Tiziani 1:10:44
Thank you.
Dr Megan Robertson 1:10:46
I hope you've enjoyed what you've heard today. And if you're 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.
Dr Megan Robertson 1:11:24
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