Tina Soulis, Founder and Director at Alithia Life Sciences

Jesus Moreno (00:01.676)
Welcome back to Global Trials Accelerators, the podcast where we dismantle the barriers to clinical innovation and explore the strategies driving the next generation of life-saving therapies. In one of our last episodes, we spoke with Kristin Middle, with whom we explored the Valley of Death and how a flat regulatory strategy can sink a startup before it even reaches the patient. Today we will be looking at

Today we will be looking at the execution engine that pulls companies through that valley. For most biotech leaders, the biggest threat isn't the science, it's the burn rate. In a tight market, finding a way to get clinical grade data without draining the bank is the ultimate competitive advantage. Australia has emerged as the fast lane destination for clinical trials, but navigating that

Road requires more than just a map. It requires a practitioner who has traveled the path both through the boardroom as well as the clinic. Our guest is Tina Solis, founder and director of Aletheia Life Science. Tina has spent 30 years in the game bringing a unique perspective that spans from the boardroom of ASX200 companies

the Australia equivalent of SMP 500 to top executive roles in big pharma. The background gives

That background gives her a rare top-down view on exactly how to move a drug from the lab to the clinic. Tina, welcome to the show. It is a pleasure to have you with us.

Tina Soulis (02:04.489)
Hi, Jesus, I'm really thrilled to be here and talk about Australia. And obviously the value proposition of coming to Australia.

Jesus Moreno (02:10.648)
Thank you.

Jesus Moreno (02:14.602)
Of course, and that's one of the main questions I want to ask. But Tina, I would like to take a step back and start with a previous question or a previous step in that journey. You've led teams at the ASX200 company and Global CROs. Why and when did you decide that it was time to double down on the CRO you

boutique model with Alithia instead of scaling into another industry giant.

Tina Soulis (02:50.975)
Yeah, thank you, Jesus, and great question. I mean, I love what I do. I've been doing this for nearly 30 years or over 30 years, I should say. Now we're in 2026 and about five years ago, I noticed that there was a bit of a gap in the market in Australia, particularly for clients whom we mostly work with, which are the small to medium biotechnology companies and device companies. And they're coming to Australia for various reasons, not only

their great value linked to the exchange rate, but also the R &D tax incentive, which can see folks getting 43.5 % back of whatever they spend that is classed R &D in Australia. In order to do that, they need to set up a local subsidiary. And that vehicle requires a local director, local Australian director. The Australian directors I was coming into contact with were all lawyers, finance, business people.

and blessed them. They were great at what they did, but they had never run a clinical project. in my mind, they weren't really adding any value to what that client was trying to do in Australia. So I saw that as a bit of a gap in what was around. At a time when our borders were closed, so clients could not come into our country. We could not travel out of the country, but the clients still wanted their projects to keep going. So I started off.

as an Australian resident director with a lot of connections, whether it was to key opinion leaders, to sites, to helping them select big CROs, global CROs for their projects, and then it took off from there. So offering a boutique service, more personalized service, not transactional. So that's the starting point of the business five years ago.

Jesus Moreno (04:40.354)
And fortunately, that gives you a holistic view of the entire market and the entire process. And being a sponsor and a vendor now, how does that change the way that you manage your clinical budget today? Has that experience of paying the bills per se previously and now

offering the services. Has that had any impact in the way you strategize the clinical budget?

Tina Soulis (05:17.391)
Absolutely. Because having been a clinical director of an ASX company, I know the importance of no surprises in your budget. You have a particular budget. And back when I was clinical director of a top ASX 200 company, it was through the GFC, the Global Financial Crisis. So was even more important back then.

just as it is now. guess it's our own little GFC right now in the world, right? So the same pain points apply. So then one of the things again that we are doing and we've tried to do and make better in Alithia is that we have full transparency of the financial process. So once we provide a client with the grid bid of an itemized

Jesus Moreno (05:48.942)
Yes.

Tina Soulis (06:11.401)
costing for their project, that costing then becomes a running budget throughout the process. And every month that client will see an itemized account of which items we have charged, which items we have charged to date, and what percentage or what amount is left to date. There are no surprises. The other thing that the other model that we work on is that unlike many other...

particularly larger providers that will ask for a certain percentage of that project upfront. We like to share the risk with our clients. So we pay, you pay as you go. So that is sharing the risk with the client, but that is the environment that we are living in. And it really does help small to medium enterprises with their forecasting, with their cashflow as well. And as I said, we share the risk. So that is another, I guess,

disruptor in the model of the CR in the CRO space, but one that we are proud to support our clients with.

Jesus Moreno (07:14.606)
And I think that that speaks to your the breadth of the the culture, the company cultures you've been exposed to. And I would like to explore that a little bit further by asking you what do you experience as the biggest cultural shock moving from a massive pharma company to a startup and that it

and how that affected the clinical operation strategy.

Tina Soulis (07:46.365)
Yes, thank you. It is, so my time in massive big global CROs was a time when you were, you had teams at your disposal. If you needed to write a protocol, you could reach out to the medical department. If you needed a question about how the FDA worked and what would the expectations be about a particular module for a client, could reach out to the regulatory department.

Moving into a small biotechnology space and working for a global, creating a boutique CRO means that we need to have that knowledge, we need to be agile, we need to use the resources at hand and do it time and cost effectively. And again, that is the model that I've created in my current company, Alithia, because every single person on our team has at least 15 to 20 years industry experience collectively.

We have hundreds of years of experience, but the buck stops with us, as we say, with that, because we don't have the luxury of having thousands of people at our disposal all across the world. We have to have the knowledge and we have to find that information quickly for our client. And because we do have the knowledge, equaling years of experience, we can do that. Or we know where to find that information or who to go to to find that information quickly.

And that is the other value that I added as local director. When I started up Alithia, I did support the clients initially as the Australian resident director because of my connections in the industry, because of the knowledge in the industry. even if the clients were working with an alternative big global CRO, that support in helping them troubleshoot and run questions past that the other providers are asking them.

is really powerful because it saves time and money. And ultimately that's the end game, right? To get to where they need to go quickly and cost effectively. Yeah.

Jesus Moreno (09:52.671)
Absolutely. And that's definitely a topic of conversation we covered with Kristen. And in that discussion, we explored how founders often focus on the science at the expense of the regulatory strategy. From your experience, when a US founder brings a drug or a medical device to Australia,

Tina Soulis (10:09.897)
Yeah. Yes.

Jesus Moreno (10:19.522)
What is the most common mistake or blind spot in the way they gather the data or they run their clinical trial so that eventually it can be submitted to the FDA or that data can be leveraged in their FDA process?

Tina Soulis (10:43.433)
Yeah. So many folks think that coming to Australia, you need to have an open IND or the equivalent to undertake a clinical study and that you you absolutely do not. So whether you are doing a phase one, a phase two, a phase three study in Australia, you never have to have an open IND. In Australia, the system relies heavily and is approved or every single protocol is approved by the ethics committee.

otherwise known as an IRB. And very rarely do the regulators get involved unless it's a very new novel class four biologic or something like that. Then we have like a mini-IND process. But 99 % of the projects in Australia are reviewed and approved by an ethics committee or IRB. And then we submit a form online to our regulators, which is called a clinical trial notification form. And that is acknowledged within 10 business days. And then you are ready to go.

You can start your project. So it's very straightforward and simple. So clients do not, if they're used to going to the FDA and opening up an IND, they definitely do not need to go to the time and particularly expense of that exercise. What we find is a lot of clients come to Australia. It's fair to say that the majority of preclinical work you will need to gather in terms of evidence to go to clinic. You will need in Australia, with the exception

of long-term toxicology. And together with that information, a lot of clients will raise enough funds to go to clinic. They'll do a clinical trial in Australia. And then they will use that information, which is perfectly acceptable to regulatory authorities such as the FDA and other parts of the world, such as EMA. And they'll use that information to support opening up an IND, raising more money.

licensing out their product or publishing or all of the above. So that is something that we really try and make clear to clients so that they do not have to wait and open up an IND and then come to Australia. It's really a game changer in terms of cost and time. Yeah.

Jesus Moreno (12:59.918)
And I'm curious to know if you would agree that those are probably the strongest arguments to consider Australia as a potential geography to run a trial of the speed and the validity of the data. In that context, do you have in mind or could we say that there's a specific

technology and would it be pharma or medical device or a specific specific excuse me I'm losing my my my thought

Tina Soulis (13:42.397)
It's okay.

Jesus Moreno (13:46.403)
Is there a demographic that lends itself well to a particular type of study, whether it be a molecule or a device? Is there a patient population that can serve any type of technology or are there specific defined trends in the Australian market for US-based companies?

Tina Soulis (14:16.617)
Thank you, Jesus. That's a great question because first of all, I'd like to preface by saying that one of the reasons apart from the R &D tax incentive and the cost of the exchange rate that the speed because from the time that you have your final protocol to first patient first visit, it's usually two months in Australia before you get going, which is which is amazing. But one of the other really important reasons is that the data you're going to collect in Australia will be made up of

or participants, healthy volunteers, or patients that are diverse in their ethnicities. And that is super important when you're then using that data to put in front of a large regulatory authority such as the FDA, because they want to see that that data is representative of the US population, for example. And we can definitely say that in Australia. And the other part of...

got to remember what the other part of your question was as well between the two of us today. Yeah, it's, yeah, go on, go on, Jesus.

Jesus Moreno (15:18.03)
It was about any any particular

therapeutic areas that are of particular interest or that lend themselves well to this geography.

Tina Soulis (15:32.265)
Perf, yes. Yes.

Tina Soulis (15:41.277)
Yes, I would say that many, whether it's drug, know, small molecule or devices, that can be really lovely undertaken in Australia. There is, and the process, whether it's a drug or a device study is the same. The approval process I've just spoken about is the same. We are very well known for our first in human studies, our healthy volunteer studies, because of the nature of the work. And, and definitely Australia is very well represented. We have

a phase one unit in Perth. We have phase one units in Adelaide. We have now several phase one units in Melbourne, soon to be several in Sydney and one in Brisbane. And they, and on top of that, so they're mainly healthy volunteer clinical trial units. There are also small first in human units that lend themselves to work, for example, in infectious diseases or challenge, human challenge units.

or neurology. So as well as that human healthy volunteer first in human phase one studies, we are also very well known of course for oncology studies and have world-class facilities all across Australia. All of the major cities have world-class oncology hospitals, neurology studies, immunology, respiratory and of course

and chronology such as obesity and diabetes as well. Very well known in Australia and very well known for work in terms of devices and complex implantable devices. Also in Australia it's really important to note that everyone is entitled to what we have called Medicare. It's been around for almost 50 years now, which means that anyone can turn up to a public hospital and be treated and the philosophy of the public hospitals

And remember we have a population of 26 million people. So the specialists, for example, let's use neurology. A neurologist may have their own private medical rooms, but they're also most likely attached to a public hospital, which means they're going to be involved in research. They're going to be involved in private and public practice. And they're going to have students that do research as well, which means if they're enrolling in a particular trial, they've got a big catchment area.

Tina Soulis (18:01.577)
capture the patients from their private practice, refer them through the public system, capture them through the public system. So you can see that, you know, that catchment area for each of these groups becomes bigger and bigger with the therapeutic areas. Hopefully that answers your question, Jesus. Yeah.

Jesus Moreno (18:19.37)
Absolutely. Thank you so much for laying out that landscape. I think that's very valuable information for our audience that might be considering Australia as a potential destination for their trials. And I wanted to take a step back in something you mentioned previously, and it's this fast track or the timelines to be able to execute the clinical trial.

I understand that the Australian government recently launched the National One Stop Shop or NOSS to streamline ethical and governance of clinical trials. To your estimation, excuse me, in your estimation, how much of this is actually reducing the time to first patient for an overseas client or is it still a work in progress?

Tina Soulis (18:52.223)
Yes? Yes.

Tina Soulis (19:16.559)
question again, Jesus, it is still work in progress. It will not change the timeline. So, the system will not change itself. So, as I said right now, it's from the time a particular client has their package to go into to to get approval from an IRB or ethics committee and that package is really much the same as it is. So, you need an investigator brochure, a protocol, an informed consent, some local clinical trial insurance,

And the label of the investigational product needs to have an expirator. So we do have a few little nuances, but we can help with that. Two first patient first visit. It's going to be about two months for a healthy volunteer study, about three months for a multi-site study. That process will not change. We also have what's called a national mutual acceptance system. So if it's a project with, let's say, 10 sites across Australia, 10 different hospitals across Australia,

One of the hospitals we take on the lead site role, they're the ones that will use all those documents that I've just spoken about and submit to the ethics committee and get approval. most of the other sites will accept that ethics approval and we will just need to do governance or contracting. So that actually speeds up the process as well. And one other really, again, game changer in Australia that we've had now for over 20 years,

is everybody uses the same clinical trial research agreement template. It's called Medicines Australia. So if anyone in the audience wants to look that up, it's pretty revolutionized because it means, you know, years ago, 30 years ago when I worked in clinical trials, it would take months for one legal team to the other legal team to get all the wording right. Now there is no need for that because every single person, every single project uses Medicines Australia template.

and it really works whether you're from US or Europe or Australia. So that's the process. So that process will not change. The notion of a national one-stop shop is as a gateway for clients that are coming into Australia. The philosophy is that it will direct them to which ethics committee to go to or which IRB and direct them to particular, it's about the ethics and where to guide them.

Tina Soulis (21:39.763)
because under that system that we have at the moment, you don't even have to go to the ethics committee of the hospital where you are going to undertake your clinical trial. As long as that ethics committee in theory is under the national mutual acceptance, you can go to them because in Australia, the ethics committees meet once per month, generally in the hospitals. So depending on timing, you may choose to go to another committee and then refer it back to the hospital that you want to work with.

So that notion of the National One Stop Shop really is work in progress and it is about streamlining the entry of that project into Australia by a client and supporting that process and making sure that all the hospitals, everybody's working to the same system as well.

Jesus Moreno (22:27.936)
standardization, optimization, automatization, all buzzwords and for good reason nowadays. Yes, keeping in that line, correct me if I'm wrong, but I remember reading that Aletheia recently announced a partnership with OPYL to use AI driven analytics and with FDA and EMA,

Tina Soulis (22:31.635)
Yes. All passwords. Yeah.

Tina Soulis (22:48.189)
Yes, with trial care, yes.

Yes.

Jesus Moreno (22:56.428)
just releasing their joint guidelines for principles of AI in drug development. I believe that's the name of the guideline. How are you using this tool to predict trial success without falling into that risk or that trap of the black box, which regulatory agencies are so worried about?

Tina Soulis (23:05.021)
Yes, yes.

Tina Soulis (23:22.537)
Yeah, great question. Well, TrialKey is one of many, I guess, AI tools out there these days that we are embracing, cautiously embracing. I'm really excited about AI and how that is changing the landscape of clinical trials to streamline, to save time, because saving time saves money for clients and de-risks the projects. And tools like TrialKey enable us to run, it can be a

synopsis, but ideally it will be a protocol through this algorithm that then provides a very detailed report about the likelihood of success of the current design. And it takes into account previous literature and information on clinicaltrials.gov, for example, and it will then comment on the chances of success of the project in the current design.

It would also comment on improvements that will increase the chances of success. For example, it might be about geographical locations, it may be about the size of the study, it might be about inclusion exclusion criteria. So this is all work that would otherwise take a long time for a regulatory person or medical...

and clinical personnel, biotechs or within CROs. So it's really a wonderful tool to leverage and refine the protocol to give it every chance of success. In addition to the human factor, which of course is our experience, where we would use that information and refer back and say, well, yes, that's valid, but how practical and how logical is that to undertake and how realistic is that?

in terms of study budget. So we weigh all those things up. But definitely we are embracing AI cautiously, as I said, from note takers to tools like TrialKey to streamlining our work processes, our workflow internally. And we are developing our own AI tools. So I'm very excited about that over the next year.

Jesus Moreno (25:41.781)
Excellent. Thank you so much for that. And I wanted to ask if there's any other technologies that you've been engaging with as we look at 2026 and beyond, but I think you just laid it out. So thank you. Thank you for that. And I am sure that the audience is taking notes in regards to what are those promising tools that can

Tina Soulis (25:55.967)
Yeah.

Jesus Moreno (26:07.682)
reduce cost and streamline processes to increase the success rate of their trials. And Tina, you've covered so much in this conversation in such a short amount of time, and I'm very thankful for that. I would like to ask this final question and leave the door open to let you share with us whatever insights you think might be pertinent.

Tina Soulis (26:15.892)
Yeah.

Jesus Moreno (26:36.674)
For the VCs and the C-suite executives planning their 2027 clinical pipeline right now, what is the one question they're asking of their current CROs that they definitely should be asking? Is there something that they're missing out from the big picture?

Tina Soulis (27:00.873)
There are several questions. My answer with several questions I should be asking. The first that comes to mind, particularly, and I'm prefacing this with saying, companies are supporting their own portfolio companies to come to somewhere like Australia because there's time and cost efficiencies. So in that case, if you're choosing a CRO partner, please ask them what costs are not included.

in the proposal that they are giving you. What you don't want, as I said, I've been clinical director, I've been on your side and I've been on this side for a very long time as well. I understand the pain points. You do not want any surprises. So first of all, ask them what costs are not currently included and when will they be included and ask them to provide optional costs then for you. Ask them about the turnover of staff. And that is a big one for me.

I'm really proud to say that in five years of operation in Aletheia, we have zero staff turnover, which I think is unheard of in the CRO space. But one of the pain points I often hear clients say is, know, this is, it's just, you know, it's just paralyzed our project because every, you know, three, four months we have turnover of staff and then that knowledge is lost. So again, one of the philosophies of our

You know the way we work in a lithium is we give you the same team from the start to the end We don't have a concept of a startup team There is based outside of Australia and then handing it over to a project manager that doesn't know what's been going on So turnover of staff continuity of the team hidden costs and Big one the big one if they're coming to Australia also to take advantage of the R &D tax incentive You want to know that everything that CRO is doing for you?

or as much as they can is going to be undertaken in Australia. Because if it's not, and you find out that, for example, data management is not actually done in Australia, it's done in Ireland, it's done in India, it's done in Canada, you cannot claim those costs under your R &D tax incentive. And some providers will not tell you that until you're in the thick of it, and it's too late then. And then you've just lost a whole chunk of monies that you cannot claim, and you factor it in.

Tina Soulis (29:23.657)
So I think they're the main continuity of staff, what work is done, hidden costs. Yeah, I think they're the main factors that everyone should be asking. The other thing that we do that I do want to mention, and it's a very powerful tool, is that it is never too early to reach out to us or any other providers to talk about your clinical trial plans in Australia. Two years out is still not.

early it's fine. If you have an understanding of the type of project you would like to do, for example you want to do a first in human healthy volunteers study, you want to do a phase 1B study in 40 Alzheimer's patients, for example, you can reach out to us and we can provide really quickly for you a ballpark estimate that will vary with a lot of detail and a breakdown of costs and timelines.

And all of the things, all of the good things I've been talking about in terms of the system in Australia, all of that information will be included in this proposal ballpark in this document. And that is such a powerful document for folks to take to their stakeholders like their board, their VC companies, their collaborators, because it demonstrates what a time and costing scenario will look like in Australia.

We are more than happy to do that. There isn't any cost. There's no obligation. So that is a powerful tool. The second powerful tool is that once you have your investigative brochure and at least a synopsis of what you would like to do, we work with two particular ethics committees or IRBs in Australia and we can de-risk the project by submitting those documents and that will do a pre-review for you. So again, you will get a very cost-effective formal review.

in it's about 20,000 Australian dollars and again if you have a local entity you can claim those costs but in return for that you're going to get a written report that will potentially de-risk your project because it will tell you if there are any gaps in your pre-clinical data and whether that project is going to be approvable. So again a very powerful tool that could be used as a strategy way before you you come to Australia. So I'll leave you on those thoughts.

Jesus Moreno (31:42.894)
Tina Solis, thank you so much for this masterclass in clinical trial success and how it isn't just about the science, but it requires choosing the right geography, the right partners, and the right understanding of how the infrastructure in a particular geography works. Thank you for sharing your insights, for being in our show, and to our audience. Please do check the show notes to

learn more about Alicii Life Science and other resources on the Australia Research and Development opportunities. Until next time, keep accelerating.

Tina Soulis (32:22.729)
Thank you, Thank you, everybody. Thanks, Jesus.