Julia Jones:
My name is Julia Jones. I’m the VP of Business Development at Agilex Biolabs here in Australia. During my 30 year career, I’ve worked with both large global and regional CRS, whose focus is working with biotech companies across almost all therapeutic areas, and in over a thousand phase one to phase three studies. I’d like now to introduce you to Jason Valentine Agilex founder and CEO.
Jason Valentine:
Hi, my name is Jason Valentine. I’m the CEO of Agilex Biolabs here in Australia. Just by way of introduction, I started my career in the industry in 1994 as the first analytical scientist in the first phase one unit set up in Australia. I soon realized over the coming years, that Australia had a part to play in global drug development and the speed with which that can occur. So I’ve spent the rest of my career building CRS and our analytical facilities to that end. Getting drugs to market faster, and ultimately improving quality of life, and hence saving some lives along the way. What I’m here to talk about today, is the Australian clinical trial industry and the advantages that it can have from a global clinical trial perspective in terms of quality, speed, and cost. Which are the pillars of decision making that you would need to go through, to make a decision to come to Australia.
Jason Valentine:
I’ll talk a little bit about the COVID-19 situation, and how that’s affected trials globally and also within Australia. And then talk about how you might go about scoping out Australia as a destination for clinical trials. So by the end of this presentation, hopefully you’ve got the information you need to go to your board and state a case as to why Australia makes sense. I’ll start with quality. If we can’t tick the box on quality, there’s no point progressing. The reality is, Australia has fantastic key opinion leaders, some great principal investigators that have been running clinical trials for decades. The CROs, RFA with FDA and EMA requirements. And in fact, our whole Australian service provision industry sets itself to that standard because ultimately that is the client base that Australia is servicing. Most CROs in Australia and service providers will be able to talk about situations where their data has been presented to the FDA or EMA with success.
Jason Valentine:
So that’s the technical quality, the regulatory knowledge … Equivalent quality to anywhere else in the world. I did want to touch on the quality of service specifically. Australian CROs recognize that it can be perceived as a negative, that there is a time difference between the two countries. And Australian CROs, as a result, have built into their DNA, working out of hours and really focusing on delivery. So that, that perception can be blown away the first time you work in Australia. You’re actually taught … Here, clinical trial staff talk about the concept of a longer working day where actions can be taken in the afternoon in local time, where the client’s based, and then the Australian businesses can work through the night to deliver outcomes overnight. So in a way, extending the working day. So quality service is a real focus and equivalent expertise to anywhere else in the world.
Jason Valentine:
Just moving on to the timeliness of Australia. Australia has the Clinical Trials Notification Scheme, which is the process by which clinical trials are approved to be run. The burden of the review is on the ethics committee, and the TGA issue a letter of acknowledgement to allow the study to go ahead. Now that process is a five to 10 day process, end-to-end. You have to have your data in two weeks before the ethics committee process, but the total timeframe is approximately five weeks. Now for healthy volunteer early phase trials, that is the extent of the process, and it’s a very competitive timeline anywhere else in the world. I’ll talk about late phase later on, but the other advantage is from early phase clinical trial perspective, that you don’t require an IND to do your trials in Australia. Which means if you’re a small biotech or pharma company, thinking about going in an IND process, you can get critical human data, sometimes a little bit of efficacy information, to boost the value of your asset ahead of an IND, which is incredibly beneficial.
Jason Valentine:
GMP material is not required for first in human trials. That’s also another time saving advantage. So with regard to light FIH trials, there is a governance process that’s required on top of the regulatory process in Australia. And that takes up to three months. So the regulatory process in itself, coupled with that governance, isn’t quite as beneficial, but equivalent to what’s available anywhere else in the world. From a light pep phase perspective, some of the advantages around the access to the Asia Pacific region and the ability to access in a local timeframe, pose therapeutic lead naive markets to fast track patient recruitment, which is a real benefit. And Australia in itself, isn’t as saturated with clinical trial activity, and you’re able to get trials run there also. So that’s the speed advantage. Primarily around early phase clinical trials, but some key advantages for late phase as well.
Jason Valentine:
Moving on to cost. The R&D tax incentive in Australia, 43.5% rebate, cash rebate, is an enormously beneficial program that’s been running in Australia for several years and is utilized exclusively. Certainly our client base, if they are eligible, utilizing the R&D tax incentive, what you’re required to do is set up an Australian subsidiary. There are some rules and requirements. You need to be less than $20 million in revenue, but our clients are utilizing this all the time. And it’s a well trodden path that US and European clients to be using this scheme, which is an enormous advantage. Some things that you just need to watch out for, you do need to use a good R&D tax providers, and most CRS and service providers in Australia will be able to help you out with a person that they can refer you to, to use. There were some early issues with repatriation of funds and repatriation of IP and those sorts of things in the early days, if you use a quality provider, it’s absolutely no problem, and we certainly don’t see any of those issues moving forward.
Jason Valentine:
So talk to your CRS in Australia and service providers about who to utilize for that process. And you’ll be very happy with the cost saving that it provides and CFOs love the cost advantages. So they’re the three pillars of advantage that I talked about. Quality, speed, and cost. I’m just going to talk about COVID-19 and the impact that’s had on the industry from a global perspective, this is a recent paper that came out from global data on the 14th of May, just a visual representation of the hotspots around the world globally in terms of COVID-19 clearly Europe and the US have been significantly impacted. Australia, as you can see, is in quite a good position. Has that affected the global clinical trials market? Some information recently put together by global data suggests that there are 826 trials that have been impacted globally. They’re trials that there has been some public notification that they’ve either been delayed, slowed, or have had enrollment suspended. 50% of those studies within the United States and approximately 30% of those were in Europe.
Jason Valentine:
So Europe and the US have significantly suffered from the lockdown over the last couple of months. And we are starting to see clients coming from Europe and the US looking to find options to run their trials, having been stalled in other jurisdictions. So Australia, this is the Department of Health States and Territories Report from about a week ago. And this is how Australia has faired through the pandemic. This is cases per day. Most countries are used to seeing these types of graphs. Australia has faired fairly well. A couple of things, were a fairly dispersed population. We don’t have high density, medium density housing, certainly not as much as in other jurisdictions. And the government have been really strong on clamping down on people that are not honoring the social distancing rules and people have been getting funds. And we got a great level of compliance very quickly. The government have also been very focused on the medical advice, and although it’s had economic impact in all sorts of areas, as it has around the world in travel and hospitality, they’ve not jumped to bending to those economic pressures.
Jason Valentine:
And we still only just on the 11th of May, have had some of the reinforced earlier rolled back to allow us to continue to have even 10 people in a social gathering. Even though we’ve got three weeks of very few cases, it’s a relatively conservative approach. So, how has it affected the Australian clinical trial industry? Well, the clinical trial industry in general was designated an essential service straightaway, which means all of the clinical trial facilities have been able to continue. Hospitals were impacted initially as they were preparing for an influx of COVID-19 cases, but they didn’t eventuate to the extent expected. And so many hospitals have only had limited impact and patients studies have been able to continue. There have been some slowed down, but with the rollback of restrictions, they’re looking to start up again. Phase one units for that period had to decrease their capacity to 50% only using every second bed in their facilities.
Jason Valentine:
That’s actually not a 50% production in capacity. They usually operate at 70, 75%. So it’s about a 30% production. But trials have still continued is the bottom line. And they’ve continued across the board, early phase and late phase. And we’ve remained relatively unaffected compared to groups in Europe and the US. So if you’re in Europe or the US and your pro program is halted and you are having trouble getting trials up and running, right now, Australia is a great alternative to allow your asset to continue its development. Okay. So hopefully I’ve convinced you that Australia is worth looking at, and you’ve got the ammunition you need to go to your board and provide some preliminary justification as to why Australia makes sense. I want to switch tack now and look at how you go about scoping Australia as a destination for clinical trials.
Jason Valentine:
Now, I’m going to put up a list of service providers in Australia. I just want to be clear that it’s not exhaustive list, if there are people missing, it’s my apologies. I’ve listed everyone alphabetically. We work with all of these groups and they’re all very good service providers. So the point I’m trying to get across here is there’s a whole group of service providers that you’re going to think about touching based with in Australia, depending on what you require. Now, in my view, the best way to go about that scoping process is firstly, to talk to your networks and find someone that has had success in Australia, or has some experience running multiple trials in Australia, they can be a great source of information as to who to go to, to get some good quality advice about the landscape. You certainly don’t want to be Googling and going down the process of talking to all of these facilities, there is an opportunity to tailor your process.
Jason Valentine:
My suggestion is that if your network can let you know of consultants that have been really useful potentially by analytical labs, initially are a good source and central labs who work with the majority of the CRS and phase one units, and have relationships with the hospitals. They’re a good preliminary group to approach to get an initial scope completed. And what you’ll get out of that is some of the nuances of what people’s best attributes are. So I’ll do this by way of example. If you’re a company that wants to run a biosimilar trial in Australia, and it’s 300 patients, my suggestion would be to look at Nucleus Network/Q-Pharm. Nucleus Network, just appointed Q-Pharm as the phase one unit. That’s because they’re the biggest unit they’ve actually set up their capability in Queensland, specifically to recruit for biosimilar studies.
Jason Valentine:
And that would certainly be a group you should try. Now, that’s not saying C-Max, Linear and Scientia have any issues. They’re all very good units, but there’s that piece of information and that nuance that people in Australia know about that can narrow down your selection of service providers in Australia. The other one we commonly get is the longterm idea of the program. Are you planning to run a first-in-human trial? And we had one the other week that wanted to go straight into phase three, that could suggest that we choose someone like Novotech to run that because they have offices all over Asia. And if you’ve got the US arm covered for late phase studies, they could be a logical partner for your existing CRO. So there’s lots of nuances in all that. And I could go through a lot more, but I guess my message is get some information on trusted service providers.
Jason Valentine:
If you don’t have any of those, look at the labs and consultants as a first port of call to give you a broad understanding in the industry and talk about your program. And you’ll be able to get some good guidance as to where to start first and maybe restrict that list of 25 down to eight or nine that you know you’ve already pre-vetted through other sources. And then of course the CROs and phase one units are in a good position to give you advice about central labs and bioanalytical labs. So you do the reverse process as the second phase, and then you can restrict, but the volume of activity you need to go through with good quality information. You just need to be able to trust those sources. Okay. So that’s my advice on how to go about at phase one clinical trial, late phase clinical trials start up in Australia.
Jason Valentine:
Next. I just wanted to go through Agilex Biolabs, a part of our material and marketing material. And talk about some of the things you might look for when you’re down to talking to individual groups. So here’s one of our slides from our presentation, and I’d just suggest some of the things to look for. Firstly, and most service providers will have the variation of this. On the right hand side, under the Y Agilex you’ll see a lot of the similar … it’s essentially a shortened version of this presentation. Quality of service that is equivalent to anywhere else in the world, timeliness of the process from a regulatory perspective and other advantages with say and the R&D tax incentives underlying it all with a cost advantage. That’s pretty common. Just looking at the top, years experience. When you’re talking to a service provider in Australia, you’re looking as you would be anywhere in the world for 20, 25 years experience potentially, with the top tier people who you speak to, but always probe the second and third tiers.
Jason Valentine:
Who’s actually going to be managing the trial, looking for 10, 12 years experience. Project managers and study directors that are actually going to be running your studies. You’re looking for five to seven years experience in that cohort. Always worth checking that experience in a bit of detail. Also, you’re looking for volume. You’re looking for multiple trials in Agilex case, a hundred studies per year, 85 staff. We’ve got plenty of capacity, if there’s holidays and those sorts of things. So you’re looking for a robust business, that’s got some volume. We focus very much on repeat customer rate, just because it’s a real good percentage for us, obviously, but it’s worth asking that question. If it’s not offered, you’d also want to see that they’re working across countries that make sense to you, and that if you’re in Europe and you’re going to be going through EMA, or you’re in the US and you’re going to be going for FDA, that they cover off on the requirements there.
Jason Valentine:
And you can tell that from the client base. In Agilex’s case, about 40% of our client base is US. About 40% of our client base is Asian. And about 20% is European. So we cover all bases. With regard to service lines. Obviously the services will be different for each of the groups, but one thing to look for is growth and just general health of the business. So while most companies won’t give you detailed revenue information obviously. They will tell you about the compound annual growth in revenue. And it’s a good indication of fabrics are traveling, whether they’re growing, whether they’re growing too quickly, because which can also lead to problems. So you can get some really good information there. So that’s my advice on scoping out. First of all, the broader service provision industry, who’s who, and then some of the key questions to ask when you get down to speaking to individual providers.
Jason Valentine:
So hopefully that’s giving you a bit of an understanding of the Australian clinical trial in history. You’ve got the ammunition you need to potentially go to your board and talk about utilizing Australia for your clinical trial programs. And more than that, hopefully you got some decent, preliminary information to understand how to go about mapping out and scoping Australia and who’s who and how you get started with an appropriate scoping process that can get you to your goals a lot faster. So hopefully that’s been helpful. I’ll just put in some contact information there. If you want to contact us, please, please let us know, but happy to answer any questions from there. Thank you very much.
