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Ep. 27 Burn the CRO Playbook: Ardian Latifi on Building a Sponsor-First Model
54 Plays1 month ago
Learn how flexibility, real-time control, and localized trial expertise are reshaping the future of CRO's from the man redefining it. Listen in as Ardian Latifi breaks down why Southern CDC’s sponsor-first model is more than an experiment; it’s the new path forward.
In this episode of Spark Time!, we sit down with Dr. Ardian Latifi, founder and CEO of Southern Clinical Development Consulting (Southern CDC). Ardian shares how his frustration with big, bureaucratic CROs inspired a bold, leaner model. One built for biotech sponsors, not shareholders.
Forget the one-size-fits-all, multi-billion-dollar corporate CROs. Ardian's approach puts sponsors back in the driver’s seat, with modular teams, consultants limited to just 2–3 projects at a time, and radically transparent pricing and timelines. No hidden handoffs or surprise delays. Just direct access, expert-driven trials built for speed and clarity.
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Transcript
Introduction to Sparktime Podcast
00:00:00
Speaker
Welcome to Sparktime, where biotech's thought leaders, investors, CEOs, and industry experts break down the evolving story of life sciences. Hosted by Danny Stoltzfus and Will Riedel, two scientists and strategic communicators, we dive deep into how biotech leaders can shape the narrative, win investor confidence, and communicate breakthrough science in ways that truly resonate.
00:00:21
Speaker
From emerging trends and cutting-edge technologies to what investors and partners really want to hear, we go beyond the usual echo chamber, bringing you fresh insights, unexpected perspectives, and the strategies that set biotech's top players apart.
00:00:34
Speaker
If you want to sharpen your corporate messaging, decode industry shifts, hear from voices shaping the future of biotech, and get inspired, then you're in the right place. Let's get into it.
Efficient Clinical Trials with Ardian Latifi
00:00:46
Speaker
Welcome back to Sparktime. Today, we had the chance to sit down with Ardian Latifi of Southern Clinical Development Consulting, or Southern CDC. And we know that conducting clinical trials can be ah really opaque process. Of course, part of that is by design, using ah randomized, blinded, controlled trials. But Ardian shared so many thoughts about how the trial process can be accelerated by just connecting teams with the right resources.
00:01:17
Speaker
And this is really kind of the rare story of empowered people, experts, scientists, clinical trialists, making clinical trials more efficient and getting treatments to patients faster. So stick around for an inspiring one.
00:01:32
Speaker
Today on Sparktime, we're thrilled to welcome Dr. Ardian Watifi, a true trailblazer in the clinical research arena. With over two decades of experience spanning preclinical and clinical research, Ardian has been at the forefront of advancing drug development.
00:01:46
Speaker
He holds a PhD from the University of Melbourne, where he specialized in drug resistance in ovarian cancer. Ardian's not just a scientist, though, he's also a visionary leader. As the CEO of Southern Clinical Development Consulting, or Southern CDC, Ardian is redefining the CRO landscape.
00:02:04
Speaker
His approach centers on empowering sponsors with complete control over their clinical trials and offering bespoke solutions that accelerate timelines and address unmet medical needs. Under his leadership, Southern CDC has become synonymous with innovation, agility, and excellence in clinical trial
Challenges with Large CROs
00:02:20
Speaker
services. So, Ardian, welcome to the podcast. how are you doing today?
00:02:23
Speaker
Very well. Thank you. I would, first of all, love to hear a little bit more about Southern CDC in your own words. So um Southern CDC has been established back in 2022 after decades of working in preclinical and clinical research that I and undertook.
00:02:40
Speaker
So little bit about myself, a bit of rationale to why Southern CDC was established. So um having worked in biotech sector for the last 10 years, I've worked from the project management up to director of clinical operations and during that time ah worked with ah many of the vendors cro's um understood the the landscape of how how the ah interaction is between the client and the cro's and most of the time although these biotech companies are very small
00:03:14
Speaker
compared to big CROs. The reason for for that is quite ah an obvious one, where biotech companies want to work with renowned and potentially CROs that could deliver on the trial. At least that's what the thinking is behind, but faces big challenges because of the scalability of of a CRO versus a biotech are not very compatible.
00:03:35
Speaker
And in In saying that, there's a cost associated with it. There are numerous other challenges that come with it. So to be specific, ah looking at how, for example, a biotech with several million dollars trying to develop a drug versus a CRO that is multi-billion dollar company, there is lack of compatibility in my opinion.
00:03:57
Speaker
And so some concrete examples around that are recruitment challenges that come with it. ah The budget is extensive. that The team they that's been assigned to a particular project ah becomes very challenging to work with because on one hand, you have ah s SOPs, stringent s SOPs from a CRO.
00:04:16
Speaker
On the other hand, the sponsor would like to move fast and would like to ah go through those challenges a lot quicker than ah what you normally would be doing. ah inclined to to wait for. it And so what happens is ah that it becomes a big issue, both in terms of operations, but also deliverables.
00:04:36
Speaker
And from an operational point of view, I've been the forefront of of the biotech companies, whereby ah managed pretty much from start to end, from the first in human clinical trials to phase three trials,
00:04:49
Speaker
and it's difficult to try and manage a so CRO of hundreds of individuals on the other side whilst you're by yourself ah trying to project manage a whole clinical trial.
00:05:04
Speaker
So that's one of the why are the biggest problems from an operational point of view. There are individuals sort of within the the team that works on what the SIPs and plans dictate, which you you meant to adhere to but not at the expense of the, um and sometimes um unfortunately not used correctly. And what happens is at the end the result is you have a sponsor that is so not happy, has changed potentially, some of the expectations have been changed because it falls apart over a long period of time.
00:05:38
Speaker
o So you're speaking my language here in my pain. So I've experienced of those things. I'm thinking a lot. I'm hoping that it's making sense to you. but um Oh, yes, definitely.
00:05:51
Speaker
but So what Southern CDC stands for is we're very passionate, and this is driven by the fact that I've done a PhD in the past, ah to help patients understand receive the latest and the most innovative ah drugs out there.
00:06:07
Speaker
And we all have family members who suffer from one or another disease that would we would love to have access to the latest medicines. And to do that, of course, every drug goes through the clinical trial for obvious reason to be tested and make sure that it's safe to use.
00:06:24
Speaker
And I'm ah Our aim is to really facilitate this, be that from a site's point of view or from ah ah client's point of view, which obviously we value the contribution to the science and contribution to the overall yeah innovative drugs.
Complexity and Personalization of Trials
00:06:41
Speaker
but We believe that we facilitate that. And the focus is really to, for a couple of couple of main points really, increase efficiency um but think by streamlining clinical activities,
00:06:54
Speaker
We aim to really shorten the study timelines because otherwise it just never ends. These clinical trials gone forever. We tend to very much reduce the organizational structure, which then allows for that very quick interaction between our team and the clients, either clinical development team or individuals that are appointed to oversee this project.
00:07:19
Speaker
So that really sounds like a breath of fresh air having, and I mean, I haven't come from the clinical trial experience, but i I have had the experience of trying to project manage with large companies and feeling like their lowest priority because I'm like, we're a company of like 10 or 15 people. So that that feeling I really understand intimately.
00:07:41
Speaker
so said a different way, it sounds like you give your sponsors much more control over how their trials are executed and How does that kind of um manifest in day-to-day operations? And how is that?
00:07:55
Speaker
I mean, I think you've already touched a little bit upon how that's different from the traditional CRO model, but are there any other aspects that you haven't talked about? Yeah, there's there's a couple of other points that I wanted to address. And one is, what we do is utilize modular team approach.
00:08:10
Speaker
And what that means is we dedicate a ah team of experts, consultants that are ah very much like have expertise in that area to be part of that extension team that we discussed.
00:08:23
Speaker
the other but The other point I want to make is that we provide that bespoke solution. um And that bespoke solution is not... um it's more of a a soft skill than we have, understanding that ah what the client needs rather than have this cookie-cutter approach where all the CROs, unfortunately, utilizes that approach where um there's a tick box exercise almost, I feel like, where every project goes through the same thing.
00:08:53
Speaker
We know that no project, no clinical trial is the same. Yes, they do go through the same regulatory pathways. They need to manage it in certain ways, but solutions are not always ah the same.
00:09:06
Speaker
So, for example, there could be a ah patient population that doesn't quite fit with the immunological diseases or it doesn't fit with ophthalmology and it could be ah an overlap there.
00:09:18
Speaker
Most of those patients might fall through that. And I've been involved, in fact,
Trust and Communication in Trials
00:09:22
Speaker
in a neuro um the disease type of um ah trial where the patients were not exactly going through the same pathway.
00:09:34
Speaker
It's different with oncology patients because they they must be treated by oncologists. But certain other patient population falls through those through those specific, I suppose, pathways that aren't very clearly defined from the from the beginning.
00:09:52
Speaker
And so you've got to have not only just one plan ah to tackle, for example, recruitment, but you've got to think about outside the box. And that's one classical example that I can give you in terms of um how we we provide bespoke solution to a particular project.
00:10:11
Speaker
The other important point is we assign consultants that have the right experience. And we use consultants a lot because we believe that they are most experienced in the area of expertise.
00:10:25
Speaker
We make sure they are suitable for a particular project. It's understandable that youve when you have 20 different projects you're working with, you're not going to have the same team apply the same principles, the same consultants to a particular project.
00:10:40
Speaker
So our philosophy you've got to seek the right individuals and we employ all the um sort of recruitment networks as well as agencies to be out there and seek the right individual.
00:10:54
Speaker
but A medical monitor in oncology is is is one thing, but to be in the hematological malignancies is another, yeah for example. And so on.
00:11:05
Speaker
So it sounds like, I mean, it's not surprising, and you kind of told us this in the beginning, that your experience being on the other side of the fence in a smaller biotech situation really shaped the experience that you wanted to provide for your clients at Southern CDC. Yeah.
00:11:23
Speaker
but Absolutely. And in fact, ah it was never my intention to to develop a ah a full CRO or what we call clinical development firm.
00:11:33
Speaker
The reason for that has been because I really thought, I truly believe that there is there must be a different approach to how we do clinical trials and how we change that landscape in how we conduct clinical trials.
00:11:47
Speaker
um We need to be flexible. We need to be flexible. very much driven by what we do on a daily basis, and take pride on what we do as well.
00:11:57
Speaker
That was one of the but key sort of um ah areas or key philosophy for from one of my CEOs that I worked with in the past. If you truly believe in that, um I think you can you can make a difference.
00:12:13
Speaker
And in addition to what we what we also do is we use vendors um where if there is a specialty that others have developed, and for example, data management or biostats, there is efficiencies, in fact, in and seeking for vendors that could potentially reduce the overall cost of of of the of the project.
00:12:36
Speaker
Quite drastically. So what we do is we have competitive ah quotes from different vendors ah to make to make sure that we get
Traditional CRO Model Challenges
00:12:46
Speaker
the best outcome for the for the client.
00:12:49
Speaker
Generally, or typically speaking, a CRO will provide you with all the in-house, they call it in-house, but most of the time they're not. Yes. They unfortunately are outsourced and not even outsourced ah in the country, sometimes overseas.
00:13:06
Speaker
I have no problem with that, but I think it's unfair to have 60%, 80% profit on a vendor that potentially could have been very different in terms of the cost for that particular shop. Yeah, and just going back to one more kind of personal experience that I've had is that when you have the CRO hiring an external vendor, then you're like, you know, even more degrees of separation from what's going on and have even less control and less ability to find out what's happening and get updates and communicate effectively. So, yeah.
00:13:43
Speaker
Yeah. umm I'm glad i' glad you brought it up. You're removed from that. from that this is This is the key point about the you know taking control of the clinical trial fully because you want to see what's going on. You want to know exactly who who who's going to be in We hardly know it we hardly ever ever spoke to CRAs on the ground.
00:14:04
Speaker
CRAs have a key ah to a successful trial. Literally, they they can unlock the the recruitment potential for a particular site or really damage potentially the reputation of the of the sponsor on behalf of the CRA and vice versa.
00:14:22
Speaker
Really change things around. But if ah if the client is a aware, who they're working with and what they're dealing with, that's what I mean by taking full control of the clinical trial. And for us, it's ah it's ah it's a ah pleasure really to be working closely with the client because we can ah we can make much more progress everyone's trying to run their business the most in the most efficient manner. I think that's ultimately what causes that to happen. But it can be incredibly frustrating as the ah you as the client experiencing it. And, I mean, i'm not past, you know, calling people and being very angry and even flying out to visit them in person to be very angry. so
00:15:02
Speaker
um But, you know, situations like that can definitely be avoided. Yeah. Well, I think they can be avoided and they should be avoided in in in certain instances. I understand not every not every project is going to go by find the books.
00:15:15
Speaker
we We estimate things. We try and do the best that we can to run that clinical clinical trial. But I think what's important is I've noticed most of the time the clients would be very happy if they knew – well from the start, uh, how, ah you know, what's actually going to cost, what are some of the challenges, ah be very open and transparent with what, what's going on. And if it's a difficult study, you need to really address that from, from, from the beginning.
00:15:44
Speaker
Uh, but it's not, I don't think it's, uh, it's fair on the client if they are kept in the dark for two months and then present an issue with some, some solution that they've, you know, that they put together,
00:15:59
Speaker
ah and And then at that point in time, ask the client what they want to do. it's It's kind of not intuitive and in in my opinion. Yeah. And this is, I'm going to ask one more question, Will, and then I'm going to let you go for it because this is my, I've i've mentioned a few personal frustrations, but this one might be at the top of the queue, which is,
00:16:18
Speaker
If you're in a groove with your project team and then someone up and leaves and it's like the most frustrating thing ever, especially if it's the project manager, because you're like, I just built up a relationship with you. I just built up trust.
00:16:32
Speaker
And then you're back to square one. And, you know, when I was doing this, I would be like, you know, that trust and that ability to communicate effectively was so key to hitting goals and milestones from the biotech perspective and So um biggest frustration in working with CROs was that. So how do you tackle ah making sure your clients don't have that sort of disruption? Because it can be a major reason clients don't come back for repeat business.
00:16:58
Speaker
Yeah, and I was in that situation too. And ah it resonates very well with me when you say how frustrating it can be. In one project, there were four yeah for turnovers, literally, of the whole team ah in the space of three years. So how do you tackle that? Well, I think we need to understand what the issues are ah to to begin with. And one of the biggest issues that i' I've spoken to all the other CROs, the major CROs at least, and that they see CRAs, which are key and project managers, what they all all say and have in common is involved in with too many projects.
00:17:39
Speaker
they They are hammered with probably four or five, up to eight projects at a given time. Now, you might be brilliant and ah ah very, very smart, very intelligent, but when you have eight projects, eight just protocols, ah i can I can see where the where the challenge is right away.
00:18:02
Speaker
That's a given. What we do is, at Salmon CDC, we assign consultants to two maximum of three projects at a time, and three projects depending on what they actually do.
00:18:16
Speaker
So we wouldn't even consider the fourth one. It's just way too many projects to be able to um really ah understand what's happening with that particular ah clinical trial.
00:18:31
Speaker
The other thing that we ah yeah it's quite and quite obvious is that the individuals in the CROs, they've got very stringent conditions and they don't really have much flexibility around that.
Consultant Empowerment and Retention
00:18:47
Speaker
and what i mean what i mean by that is really um when they want to move from one potential ah department or functional department to another or be able to want to grow ah that is you the structure is stringent and there has to be a reason for it which um which we agree with but it doesn't necessarily have to encompass very yeah these particular structures in place where it doesn't allow an individual to um to make the kind of decision on what they want to do.
00:19:21
Speaker
And so, for example, a CRA or ah a startup specialist is purely predominantly working in a very specific area. we We allow that as long as the the agreement we have with them um is clearly scoped out, we allow, for example, a CTM to clinical trial manager in this case to be ah doing some CRA work because that' that's what they love to do. And they have very common...
00:19:48
Speaker
um They want to be out there from time to time, but they want to have that flexibility. And so we we we tend to empower our consultants and empower our individuals who are working with us rather than degrade them.
00:20:02
Speaker
And that um lastly, but really important point is ah you want to nurture a person. ah a natural environment that will get the best out of individuals who are who are part of the organization ah rather than the worst.
00:20:20
Speaker
and one thing And when individuals are happy with the culture, Happy with the environment with the flexibility. um Happy to have those development growth and development ah pathways open for them.
00:20:33
Speaker
um We've not seen a single individual leave in the last two years. So that that's probably the way I draw the comparison. think sending you my resume.
00:20:47
Speaker
Well, we would be happy to. i said you I think it's just yeah the bottom line. I think it's you people leave for a reason and you need to understand that unless there is a ah personal family circumstances or or any of that nature that you can't really help with, then the rest should be we should be able to tackle and address.
00:21:09
Speaker
Well, Ardyn, I was going to ask, how do you how do you keep so many different consultants motivated and and overcoming the the challenge that comes with having so many people together? But it's it's pretty clear from what you're saying that the motivation lies in their empowerment. And so I love that.
00:21:26
Speaker
But I'm curious, you know where do you find all of these consultants? And is this approach really scalable? Yeah. That's a good question. i think we, first and foremost, we but we treat our consultants as business partners and we we we provide that avenue for collaboration.
00:21:43
Speaker
And so but we we understand that some of them have their private, literally private entities that they work through. But they're very happy to be part of our organization because they feel security is an important one for them.
00:21:57
Speaker
ah Flexibility, as I mentioned, is another. um And they also want to have this work-life balance. And so when we when we bring them on board, ah one of the first things that I will always say to them is, this is an umbrella that you're going to be working under.
00:22:13
Speaker
And um they... really appreciate the fact that they're going to be working with the client directly. And that's, that's again, and an important aspect because now we have the client who's happy, but also consultant that is happy.
00:22:26
Speaker
um They want to be able to have that interaction and understand the drug development far more than just the thick box as exercise at the site level. And that helps us really tremendously to develop that ah relationship with the client, between the client and the and the staff that we have.
00:22:46
Speaker
So it's a very interactive environment. And what we've done is we've been able to establish our network of consultants, as well as um those consultants now speak of on on on our behalf and they speak to others in they within the network, which leads them to joining us.
00:23:05
Speaker
And so we we're not short of that. We're not short of that. It's a point in time that we have many, but then he's going to send us the CD as well. Yeah. Add one more to the ranks. That's awesome.
00:23:19
Speaker
So I want to switch topics a little bit to, let's just talk in general about drug development. So tell me about what is important to you, Southern CDC, in the context of drug development and and accelerating drug development.
Educational Gaps in Clinical Trials
00:23:35
Speaker
Our utmost importance for drug development is to reach those patients in need. And as I mentioned before, there are many many individuals, patients out there that are desperate for drug new treatments and we know that there is also ah a number of drugs out there who ah we're very excited to to to be part of and see the results in clinical trials.
00:24:03
Speaker
yeah And so the faster that a particular drug asset is in the development and faster approved by the regulatory, the faster they will have access to those drugs. So we're very much motivated by drug discovery and that will lead to patient outcomes.
00:24:21
Speaker
So, do most patients participate in these clinical trials that involve really innovative drugs? and No, unfortunately not, and for many reasons. But if you look at the stats, latest statistics,
00:24:39
Speaker
you will find that very, very low number of patients participate in clinical trials. um Most of them are probably due to the biggest ah impact factor factories in fact, around ah not having that educational background, I would say.
00:24:58
Speaker
the The clinical trials have always had this perception of the drugs are still, ah that there could be some side of effects, it could be major side effects that could potentially kill you.
00:25:11
Speaker
What we ought to be doing, I believe, is um provide and additional educations, both at ah site level, as well as the general public,
00:25:22
Speaker
because and and change that perception in how we look at clinical trials. Yes, they they do come with potential risk, but the way we we design trials these days, the way we have the preclin we've we've set up the preclinical ah ah assessments and and what we know about drug-drug interactions and drug development in general ah allows us to be quite certain about ah what we could but we could achieve and de-risk that clinical program.
00:25:55
Speaker
That's really interesting because one of the things we think about a lot is educating patients on how a particular drug may work, right? And how they would benefit. But I'm hearing that maybe we should also be educat educating them more just about the process that the drug has gone through to get to where it is when they may be up able to receive it. Because maybe just a little more education at the, obviously the right level would really build that trust that we know is so critical with patients.
00:26:29
Speaker
Absolutely. And I think it's it's really important to get the right individuals on board for for that educational piece, because I think at times we have corporate or corporate organizations that get involved and then becomes a little bit untrustworthy in that sense. But when we have individuals who have a experience and have public potential to to make those changes in in in someone's life, it would be a of great asset, I think, moving forward. Yeah, that's really, really special.
00:27:06
Speaker
um Thinking about the road for patients in the clinic and the road in order to get to the clinic is is a long one and it's an expensive one. And, you know, it's important that certain things get done, right? I mean, I i don't think shortcuts should be shouldn't be taken on the the route to approving a new drug, but um there's always room for improvement, right? And we talked recently with Jeff Baker, a former FDA deputy director, about this topic. And I'm really curious, you know, from your perspective in the space you're in, what are your thoughts on expediting drug development? And other than the the strategies you've already mentioned, what else do you do?
00:27:50
Speaker
I think one of the main strategies that we're trying to employ is ah the use of AI is and use of technology, really, to to drive um ah ah more efficiently.
00:28:02
Speaker
And um but for for instance, we we we know that um from the time you have studded design to the time you... ah embark on on recruitment, it takes months, if not potentially even years.
00:28:17
Speaker
And so all of that can be compressed and can be very much, I think, run in a more efficient way.
Operational Efficiency Enhancements
00:28:24
Speaker
And to give an example, ah when the the reason Again, going back to the modular team approach is that when you have a very dedicated team working in that particular ah for for that particular trial, ah you're able to see the difference between that and someone who's taken several months to get to to the clinic because um it's just...
00:28:45
Speaker
a very ah hierarchy type of approach but with other CROs. We take of an approach that you' you've got two, maybe three um highest level of of bureaucracy.
00:29:00
Speaker
And that allows us to very quickly um turn things around. So what might take for ah big CRO two weeks to respond to something, we respond in 24 hours. and And that allows us to...
00:29:14
Speaker
Yeah, so I'll give you example going through a protocol development or protocol our submission. ah We can turn things around with a site in less than a week, um whereas we've noticed with other CROs, it could take about a month or two ah to be able to do the same thing.
00:29:32
Speaker
And so I think there are operational changes that we can improve on. improve on ah From a regular point of view, I think ah there are private sites, for example, are far more efficient than, sorry, private ah ethics are far more efficient than, at least here in Australia, as you know, probably Danny, than public sites. And there is the RGO additional step that could take up to six weeks, maybe even longer, um to review and approve the study. So all of that can be
00:30:07
Speaker
I believe, can be yeah far more ah centralized, streamlined, and ah all of that well will generate better outcome for for the trial. That's the regulatory piece, and that's the brought up sort of timelines. um But having, i think we are we're very happy to, ah with the CTRA, at least the clinical trial research agreement that we have a standardized one, and that allows us for a quick sort of turnaround, at least at the site level.
00:30:38
Speaker
But there could be improvement there as well. it's It's such an important topic because, you know, we're intimately familiar with the needs for biotech companies to get clinical validation as fast as possible. So everything you just described, it seems, is teed up to ensure that that that is possible for these, you know, smaller biotechs that are bringing through, you know,
00:31:00
Speaker
um previously untested modalities and you know getting them that initial ah clinical validation, which really leapfrogged them to the next level in terms of um you know the growth of the company.
00:31:13
Speaker
Yeah, ah I believe you've got to speak the same language as they say. Yes. but Otherwise, yeah you know someone who speaks at at a different level, it's not going to understand, I believe, the biotech sector.
00:31:27
Speaker
And specifically, we we tend to do very well with those conversations. I had one this morning and it went quite well. I can tell you. That's great. So one of the most common transitions that biotech companies undergo is the transition from preclinical studies to phase one studies. So I'm curious about how Southern CDC helps expedite that transition as well. That's a very yeah very good question.
00:31:54
Speaker
At Southern CDC, what we tend to do and very, um very proud of our work ah that we do in terms of ah partnership model.
00:32:04
Speaker
And the partnership model allows us to start very early on those discussions with the potential ah clients ah at ad hoc consultancy-based agreements, which could potentially be very specific to CMC or regulatory or any other specific areas.
00:32:27
Speaker
We look at that package, data package, and go back and advise on, based on our expertise, advise whether that ah data package is sufficient and would be approvable.
00:32:41
Speaker
um We also have several individuals that we can access it's through the individuals that have been in the committees in the past, the review committees.
00:32:53
Speaker
and um All of that really contributes to ah data package that allows them to um unfold itself very quickly from the point of submission to approval.
00:33:06
Speaker
um We make sure that there is safety coverage um ah designed and what would be what what are some of the risk points, and and we mitigate those risks early on.
00:33:19
Speaker
One thing that most companies tend to lack, perhaps, of notice is that they do very little preparation ah ahead of the the clinical program.
00:33:31
Speaker
And really sets those companies apart from the ones that probably ah don't succeed because um we do a lot of preparation work very much at at the beginning, and that drives the clinical program lot faster and more efficient ah than the ones that we try to rescue, for example.
00:33:53
Speaker
We've done several of those rescue studies, um and they all have one common issue. there was no much not much thinking behind what they were but they were the planning i need to do.
Balancing Scientific Rigor with Feasibility
00:34:05
Speaker
Yeah. So on the topic of clinical trials, and of course, as you just said, you know you've been involved in a lot of rescue trials even, but we we know that just in general, clinical trials are becoming more complex as as we understand systems better and and the types of endpoints that we want to see and the type of data that we need to see. so I'm curious from your perspective, Ardian, what are biggest challenges in balancing the scientific rigor that we need as well as the real world feasibility in in completing clinical trials?
00:34:42
Speaker
Yeah, I think we we might have touched on a few points, but my my take on the... um ah but My take on that is ah to really have a ah stringent um review of the of the data um that I mentioned ah that needs to be, a produced and B, understood by the team.
00:35:08
Speaker
And that could really lead to great outcomes in the future. I think i think the yeah the the complex studies are mainly around ah even more complex diseases. But having said that, what we are trying to ah position ourselves ah ah in certain diseases, again, is to to have these individual treatment, um potentially individualized therapies.
00:35:33
Speaker
And that that makes it very complex because we are complex creatures, obviously. And and you need to have a ah you need to reflect on on on how you how you would want to do that.
00:35:46
Speaker
um And so from that point of view, i think a lot of the um individual assessments and essays that are designed to ah to capture that information is is is um super important.
00:36:02
Speaker
And in in doing so, though, um one could go quite quite deep into that analysis and really ah be very specific about how you treat ah individuals.
00:36:14
Speaker
So there are pros pros pros and cons on that. On one hand, you do you do want to treat specific diseases. On the other hand, you don't want to potentially put someone at risk. But by having that privacy...
00:36:27
Speaker
um actual privacy information that is at most important to to the patient. So obscuring that versus treatment would then become quite an important as aspect.
00:36:41
Speaker
So you had mentioned AI um and incorporating i AI into some of Southern CDC's efforts before. I'm curious, is is that one of the main tools that are is helping the company stay ahead?
00:36:55
Speaker
are Are there other new tools and methodologies? and you know, what innovations innovations are are you excited about right now? Yeah, certainly. I think ah everyone is talking about the AI ai tools and certainly we ah we are looking at ah investing ah in in this space. I think it's going to be an important avenue to explore specifically around what could be more automated, what could be ah give us what what could be used in order for us to to be more efficient.
00:37:26
Speaker
Because um I'll give you an example. we wait every Every study will have some ah some factors and some ah important information that will be need to be captured and ah very much kept the same throughout the the study. and And one of them is schedule of events, for example.
00:37:46
Speaker
um But that can be utilized very quickly in if we if we could... apply the AI tools to then replicate that throughout the yeah ah other processes in business development, in operational, ah in and in so many different avenues and areas that um we work in.
00:38:06
Speaker
and It all comes back to that. It's almost like the the blueprint of the the clinical trial. And so apart from that, we um ah tend to use all the most sophisticated and tools around the CTMS, the clinical trial management system, ah the ETMF to make it, again, more ah simpler to use, ah easy and simpler to use, and and and allow people to um really focus on the important things rather than ah ah entry data or entry ah ah files into the specific folders that you need to.
00:38:44
Speaker
Well, I think everyone loves to hear that. ah so ah you know, how do you how do you envision the role of CROs involved in clinical research evolving?
00:38:59
Speaker
Yeah, I think ah the the the role is changing quadru quite dramatically. We've seen now ah quite a few CROs, unfortunately, um loss of profit in the billions of dollars in just the last year.
00:39:14
Speaker
um That's the latest reports that I've I've seen. And I think it's got to do with the... well well but They will need to change ah the way they operate in terms of ah engagement.
00:39:26
Speaker
So I think they're perfectly suitable for big CROs, big trials, a phase three trial, for example, with multiple sites in in various countries. However, when that is in... When you're dealing with a small biotech companies with a few million dollars,
00:39:44
Speaker
as capital, that mindset has to really change. Now, I understand that some of those CROs have also been able to, or at least have attempted to the the differentship differentiate themselves by having this biotech-specific component to that.
00:40:03
Speaker
but it's still within the big umbrella of the of the main ah entity. And so what happens is it just gets lost in translation. And so unfortunately, um that isn't working, I believe, hence the yeah the the loss of profit.
00:40:20
Speaker
um But I think there's still ah the the structure for multiple and global studies will need to remain and the same. But overall, internal organizational structure, I think, of having six, seven, eight layers of bureaucracy, that doesn't really seem to help.
Advantages of Australian Clinical Trials
00:40:42
Speaker
I couldn't agree more. I don't think layers of bureaucracy ever do any good for anyone, but that's ah different topic maybe for a different day. Yeah. I'm proud to be nice, I think.
00:40:56
Speaker
I want to talk a little bit more about Australia as it's, you know, it's my home, it's at your home, and it's, I'm sure, dear to both of us. And and one thing I know and i talk about a lot is that Australia has really unique advantages for running clinical trials and doing clinical development in general.
00:41:12
Speaker
so I'm curious how you think about leveraging those advantages and what would you tell – tell you know US or other international sponsors, what do they need to know about conducting trials in Australia?
00:41:25
Speaker
What ah Australia offers is great. One is um very quick timelines, startup timelines for a first in human. ah The US, for example, has the IND section, which could take six to 12 months.
00:41:41
Speaker
ah before you're even able to activate your first site. Whereas here in Australia, we don't have that. And what we typical typically have is the ethics approval for the trial.
00:41:52
Speaker
So as long as you have a good data um on the safety package, data safe package, then you should be able to get approval. The second parties the part of the regulatory is the TGA notification.
00:42:06
Speaker
Because of the um potential lack of funding, I believe, they don't get involved with the the the trial design or any other ah reviews that they do.
00:42:17
Speaker
It's simply and notification that um you will be commencing on the trial. They need to know basic information about the drug. They might ask you to provide additional information specifically to the excipients and ingredients of that particular asset.
00:42:33
Speaker
ah But that's where the responsibility stops. whereas um And if you go through private science, private ah ethics, you're looking at potentially two months to get approval. with That's inclusive of submission.
00:42:49
Speaker
inclusive of one review of the dossier and approval at the end. We typically do two to three months ah submission and approval and have the site up and running. yeah And the thing is, we do that all.
00:43:05
Speaker
but Absolutely. And I know a lot of ah a lot of companies out there claim to do the same. We've demonstrated it again and again that you could do that in three months. um If you really are lucky with ah approval, you can do it even less than time.
00:43:22
Speaker
so But that's from the time when we have the dossier ready. um if ah If the sponsor has everything ready for submission, That's what we're looking at. The second other advantage is we provide, of course, ah the R&D incentive, which is huge, 43% on every every dollar spent.
00:43:42
Speaker
um And we, every literally, we all ah but ah so at Southern CDC, we have all the consultants here in Australia, ah with the exception of one CRA and one Quality Assurance.
00:43:56
Speaker
we We do provide more than 50% of that r and d tax. um ah incentive. We also have vendors that in fact deal with R&D specifically, so we don't have everything and under the same roof for reasons that I mentioned before.
00:44:12
Speaker
um But also ah importantly, i mean, we have a fantastic healthcare infrastructure ah system in place that we can leverage on it. And I'm i'm just shocked to why we don't have more clinical trials and and why we don't have more companies here with all these
Advice for Startups on Clinical Trials
00:44:30
Speaker
incentives. Yeah, I mean, the thing that springs to mind as you're talking is that – um again, not wanting to be political at all, but you know we're hearing a lot about the FDA just slowing down on improving INDs at the moment. Yeah, we we would be very happy to have those conversations.
00:44:48
Speaker
um we We believe in our um you know approach and the way we've done clinical trials in the past ah has pretty much proven um our thinking behind our rationale, the hypothesis that we are scalable, we are able to tackle...
00:45:05
Speaker
ah Very complex studies. Most of our studies have been in oncology. So in oncology studies, they are they are quite complex, as we know. So we're able to tackle those, and I believe we can tackle the other ah trials as well. So, Ardian, as we come to the end of our discussion, I'm going to start asking for your advice. Yeah. And what I want to know first is, you know, for startups that who are entering the clinical trial space, you've seen you've seen it all, I'm sure.
00:45:39
Speaker
um So what what key advice would you offer to our listeners to ensure success in entering clinical trials and and avoiding the common pitfalls? We'd be ready to um ah discuss and have those discussions with individuals who are going to run your clinical trial ah for for pretty much from A to Z and have a very good plan of attack.
00:46:05
Speaker
um So preparation is fundamentally ah essential ah to ah successful clinical trial. ah Bringing on board ah the experts in in areas of ah ah specific areas of clinical trial ah will certainly help the the the the trial thereafter.
00:46:27
Speaker
um And I think importantly, working with the like-minded individuals will get you far. I would say that my next question is going to sound exactly like the last one, but we'll give it a go and see what you say. If you give us something different.
00:46:42
Speaker
So, Adian, if you had to give one piece of advice for someone who was entering the clinic for the first time and they're searching for the right seropartner, what would you what do you say to them?
00:46:53
Speaker
Search for the for a partnership that leads to a very close collaboration. Treat them as partner. your partners rather than ah CRO, a vendor that um is going to take the ah project on board.
00:47:08
Speaker
And once you sign the contract, everything changes.
Conclusion and Rapid-fire Questions
00:47:12
Speaker
So as long as yeah they have the philosophy of working with you, collaborating with you, and really being an extension um to your team, then it's probably a good fit.
00:47:26
Speaker
There are so many different matrices that you can use to assess the feasibility of a CRO. The soft skills or the soft part of it is more important. The soft factors are more important, I believe, than those that you can see. Yes. I think you should just take them on a date, see what they're like.
00:47:47
Speaker
That's how assess all my CRO partners. I mean, let's be honest. Yeah.
00:47:53
Speaker
I didn't think of that bit. I'm full of good ideas. yeah can be It could be like an expensive one if you've got a big CRM. That is true. Take the company card.
00:48:07
Speaker
Yes. If they're paying for it, then definitely.
00:48:12
Speaker
Okay. How about we end this with a quick rapid-fire question round? Are you ready, Ardian? Sure. Okay. Cricket or footy?
00:48:24
Speaker
40. Which team? S&M. Okay. That's a pass. Okay. Okay. Morning person or night owl?
00:48:37
Speaker
Used to be night morning now. Morning person. Wow. The switch. ah Favorite scientific breakthrough in the last decade?
00:48:49
Speaker
Gene editing. Yeah. Okay. Final one. One word to describe Southern CDC.
00:48:58
Speaker
Leaders. I love it. Good choice. I love it. Great answers, Ardian. pipe yeah It's been so fun to finally meet you, Ardian.
00:49:13
Speaker
Likewise. Thanks so much for joining us. I appreciate your time. I'm very appreciative of this opportunity. Thank you again. Well, thanks again to our listeners for joining Sparktime. We welcome you to join next time as we continue to explore the ideas, the thinkers, and the innovations that continue to drive biotech forward.
00:49:31
Speaker
We hope to see you there.