Trials with Maya Z

 
 In this episode, Maya meets Dr. Leen Kawas. Dr. Kawas is creating a biotech-focused fund to support life science innovations, utilizing her background as an inventor, scientist, and entrepreneur. She first led and co-founded Athira, a company for late-stage clinical programs. She took it public in 2020, raising over $400 million. Notably, she was the first woman in 20 years in Washington State, and one of only 22 female founders in the US, to take a company public.

Maya and Leen discuss the critical role of patient-centric clinical trial design and the importance of engaging with patients early in the clinical development process to ensure the success of clinical trials. Leen also talks about the challenges and solutions in making clinical trials more effective, including addressing patient diversity, optimizing the patient experience, and the importance of integrating clinical operation insights into clinical research for better outcomes. 

See a breakdown of all the ideas Maya and Leen share:
 
(01:09) How Leen Kawas got from a Pharmacist to a Biotech Entrepreneur
(02:39) Why a patient-centric approach is crucial for clinical trials
(05:36) Lessons from patient interactions
(19:23) Why site selection and staff retention are essential
(26:33) How to Empower Study Coordinators
(28:17) The way to build strong relationships with sites
(30:21) How to navigate the challenges with CROs
(37:19) How investors evaluate Biotech companies
(40:03) What is the future of clinical trials
 

Maya Zlatanova, CEO of Trialhub
Leen Kawas, Co-Founder of Propel Bio Partners
See all episodes starring Leen

 

Creators & Guests

Host
Maya Zlatanova
CEO of TrialHub
Guest
Leen Kawas
Dr. Leen Kawas is creating a biotech-focused fund to support life science innovations, utilizing her background as an inventor, scientist, and entrepreneur. She first led and co-founded Athira, a company for late-stage clinical programs. She took it public in 2020, raising over $400 million. Notably, she was the first woman in 20 years in Washington State, and one of only 22 female founders in the US, to take a company public.

What is Trials with Maya Z?

90% of clinical trials fail, 85% get delayed. Let’s deep dive into the world of planning and running of clinical trials with some of the most experienced and passionate people from the Industry and find out what makes trials more successful or more challenging. Welcome to Trials with Maya Z podcast!

Maya Zlatanova, CEO of TrialHub: https://www.linkedin.com/in/mayazlatanova/

  Hello and welcome to the next episode of Trials with Mya Z, brought to you by TrialHub, a data intelligence platform that helps clinical research organizations and sponsors plan clinical trials. This podcast is about how we can make clinical trials more successful and patient-friendly. Friendly, I am your host Maya Z and in every episode, I will be interviewing a leading expert from various industries in order to discuss some of the major challenges and brainstorm how we can solve them.

Let's get started.

 Hello everyone and welcome again to another episode of Trials with Maya Z. My name is Maya and I have a great guest today. I'm a little bit nervous to be honest because I admire her so much.

Leen Kawas. She's been an entrepreneur and an investor. she's very passionate about clinical development. She has an amazing experience. So before we dive into the conversation about clinical development, around how can we make clinical trials more successful, and how can we make biotech companies more successful, Leen, I'll give you the word to introduce yourself.

Yeah, thank you, Maya. So, career-wise, I had a very interesting, very rewarding career path. I started as a pharmacist. I worked both in retail and clinical setup, then moved into research and ultimately co-founded Ethereum, my previous company, which focused on developing of neurotherapies for neurological indications.

And I had an amazing experience both building the company financially, but at the same time, building a platform of drugs and a clinical pipeline, a late-stage clinical pipeline that I think, since then I became super passionate about clinical development and the importance of understanding clinical operation and how it impacts the data and the outcome of clinical trials. After that, when I took the company public and raised close to half a billion dollars. And when I left, basically the largest 1 of the largest investors in my previous company asked me to launch a healthcare investment firm. So currently I manage Propel Bio Partners, which is an over 200 million fund that focuses on investment and health care, biotech, medtech, and anything that impacts our industry.

Great, Leen. Thanks for this short introduction. I know we have many other experiences. Also, you're on the board of several companies. So you have a really broad understanding of what happens in the industry. However, I really want to focus our conversation today on something that we're both very passionate about.

When you were telling me about Athira, your previous company, the one that you exited, of course, you did a lot of interesting and very innovative things there, but one of the things that, you mentioned is how much you emphasized bringing the patients and engaging the patients as early as possible in the whole clinical development process. can you tell me more about that? And yes, how did you do that years ago when that was probably not the status quo? It's probably the status quo. It's not even the status quo today, unfortunately. But why did you do it? And how did you achieve it?

So I think that with the experiences that I bring right as a pharmacist, I understand how drugs impact patients. And a lot of the times when products are in the market, if they're effective, they're not always optimal for patients. And when you go back and try to understand the reasons, it's the disconnect sometimes, not all the time, between clinical development and the reality of patients. And it was almost over 10 years ago when patient-centric clinical trial design was not trendy. If that makes sense. Actually, a lot of people thought that it's why are you doing this. It doesn't make sense. Patients don't understand the clinical research or the background behind it. But then I started, you know, before we start designing our phase two, phase three clinical trials, I started reading different protocols and we started a clinical trial for Alzheimer's, clinical protocols for previous companies, which we know that Alzheimer's basically, it's a graveyard of drugs.

And I was like, it's probably not because we don't have enough drugs that we want to test. There's another challenge, which is clinical trials that we need to focus on. And I realized that a lot of these clinical protocols are very busy, and one of the first things that I would ask any, any company that I invest with right now or previously at Athira is when someone proposes a clinical protocol,

I want to see the schedule minute by minute because patient experience is very important when we think about the clinical trial quality and the integrity of data, right? The other challenge that I've seen in clinical trials for Alzheimer's is the huge dropout rate. Right, which when we have large dropout rates, it impacts again quality of data.

So I remember working with my VP of clinical research at that point. Now she's a partner actually on the fund, Dr. . And I told her I wanted to understand, I wanna hear what the patients thought about any type of design protocol that we put forward. 'cause she was leading clinical trial design at that point.

I remember almost everyone I told about this idea, thought that is like. You know, you're naive. You don't know what you're doing. And I'm like, it's okay. Like, I don't care. I know that I need to hear the patient's voice. and, yeah, we've done a studio and the other important thing is We made it a safe place for patients.

We were not in the room when they were giving feedback, they were with physicians and nurses that they're very comfortable with. And they gave very genuine feedback about the protocol, the original protocol that we had. A lot of things I still carry. I think that session was amazing because a lot of the things that I took forward as a drug developer, I learned from patients. One thing is I remember a lady. She was an older lady. She was an Alzheimer's patient. She was a black woman and we care a lot about diversity. And one of the questions is like, why don't you participate in clinical trials?

I still remember saying here, 'Well, when I go into these companies that are running clinical trials and I go into their websites, I don't see anyone on the team that looks like me. So, she's talking about management teams. So how can I trust what they're doing? Like, that was a learning experience from a corporate point of view, right? At every stage, diversity is critical at every stage of the company, not just the clinical trial managers. Patients actually go to your website and try to learn about the company because it's a trust. When someone participates in the clinical trial, it's a trust relationship. The other aspect of the clinical trials, we used some measures, EEG that is impacted by food, okay?

For example, I remember one woman, whose husband was an Alzheimer's patient. She mentioned when I go into clinical trials, I get really overwhelmed because we go these long days, eight hours plus, and I don't know what we're doing. I don't know when we can eat. He gets really, anxious when we don't eat.

So I have, there's anxiety on the caregiver, right? You learn in that experience that Alzheimer's clinical trials really is a two-people trial. It's not just a single patient, you know? So, just creating a simple agenda for the caregivers so they know what's coming. Also, make sure that you don't have an eight-hour basically schedule. And if you have, you might make sure that you're entertaining. We got tablets and we had Netflix on it. So patients, caregivers, while they're waiting in the rooms and we made sure that they also wait in rooms because the other comment that we got was a lot of these sites, they do CNS, right?

Neurological. So, there in the waiting rooms, there are patients with different types of background. A lot of the time they're not on their drugs. So they have schizophrenic patients, you have personality disorders, which can be stressful for, you know, the caregiver of an Alzheimer's patients.

So we made sure that they were in separate rooms. They have game boards if they're able to do it for the caregivers and we have tablets that they can watch something on it while they're waiting. So it's less stressful. We provided meals. So those are the things that are just related to the clinical trial experience, which a lot of people don't think impacts data. It does impact data because if the patients feel that they're seen, they're going to commit to the clinical trial. They're going to go through the whole, even after I left the company, one of the things that the company is, and I'm still proud of is the dropout rate was much lower.

It was half of what you would expect from industry standards. And it's all from these small things. That you would deploy, and that this one doesn't start after the clinical trial starts. And that's to continue on. And we can talk more about other things that we've done as

That was actually my next question, Leen. When did you decide to actually have this meeting with the patients? At what stage of the whole clinical trial planning

Maybe a year, a year and a half before you started with the first draft. That we had for the clinical trial, we went, we had surveys with the patients, which we learned so much from the patients. The second part was we did also surveys and interviews.

In a way, we did with the operational team, right? A lot of people. That's another thing that is interesting in our industry. The clinical scientists are completely separated from the operational team who are running the clinical trial and the day-to-day operation. And, you have these. It's like designing, state of the art car without talking to the engineer, if that makes sense.

It's just like all of these designers that are putting things together because this is going to enhance the experience, but then you cannot really put it together. Right? So we just brought a protocol from previous other companies that aren't running. And we heard a lot of feedback around and even a draft protocol for us.

Because we use whatever industry standard if that makes sense. And the feedback from the operational team and the details in hospitals. When you are asking the patients to do an MRI, then to do a cognitive test, and then to go back and do a blood test. And, they said, you know, how much like just small things, how much walking is entailed.

So you start thinking about the clinical sites. If you either compromise on the sites that you're going to bring in, because you want to make sure that their map is reasonable for the patients to do that or if you really think that a lot of the good quality sites, which is the case, are academic and have these more complex maps for their sites, then you start thinking about innovative way.

How can I keep the protocol or the trial? Still deliver what I want. But it's in consideration, the environment, the sites that you're working and the patient, the patient population, and the caregiver population that we're working with.

Actually, if you ask me, you can't achieve what you want without considering that. I mean, you may think you can, but we all know these stats, 85 percent of clinical trials get delayed due to recruitment issues, 90%, and so on and so forth. So it turns out that we all, have a plan in our heads, but when we start executing, it turns out that plan cannot be executed for various reasons.

And I know firsthand that most of these reasons are exactly not considering what will be the actual experience of both the sites and the patients. So, let's say that it all makes a lot of sense. The good news is that I see the industry, not only speaking about, engaging with the patients, speaking with the patients as early as possible.

There are more and more people like you saying this is actually impacting my speed, dropout rates, all these types of things which actually have financial expression as well. But my question is what actually stops the industry from doing that on a scale? Like why are these companies still speaking about we know why, but how do we achieve that?

Why can't we do what you've done for every single clinical trial?

I think it's 2 parts and I want to highlight them. It's not only financial. It impacts the quality of the data.

Yeah.

And, so that's the other important part because it's like. If you give, you have to decide when you're designing a clinical trial, it's what's the most important goal of a clinical trial.

You cannot overcrowd it. If you're trying to find something in a haystack, then the drug is not working. You need to define your hypothesis. You need to understand what the drug would do and be honest with yourself and put forward the most important Outcomes of the trial that are meaningful for the patients, right?

Sometimes you overload the clinical trials with different endpoints that have no relation to clinical, uh, importance or patient outcome. Why we don't do it in the industry? I'll tell you from my personal experience. I think a lot of people use it as part of it, it's like AI for the tech industry.

It's like now trendy patient centricity. But really, I think there is a lot of rigidity sometimes in this industry. It's very hard to change things, right? Like I'm telling you from first-hand experience, a lot of people were saying why are you doing this? It doesn't make sense. It's not going to have an impact.

Another thing that I learned from the patients and it was very interesting is - if you ask Alzheimer's patients, there's a big focus in the industry around disease modification and the importance of disease modification for Alzheimer's patients. But a lot of these disease modification drugs, they don't lead to significant changes and symptoms in the disease.

And when you actually ask the patient, what's most important for you? It's changes in the symptoms, right? Like what if you have pain, okay, and you're changing the underlying pathology of pain, but you're still sensing pain? You haven't addressed what the patient is struggling with, right? And the caregiver is struggling with it.

So I remember a lot of people pushing back. I was like, I need to have a clinical trial that focuses on symptoms. Even if the mechanism of action is disease modification, because if the symptoms do not change, then it's not going to matter for the patient. Um, I remember a conversation at CTAD with a CEO that basically was like, Oh, that's not going to work.

You know? And then I met with him a few months ago and he told me, Leen, I actually ended up doing what you were doing in my company. And I think that mindset is like. Big Pharma comes out and they put together these like strategies and everyone just follows right without challenging the status quo.

We need a more beginners mindset. And when I say beginners mindset is experienced people who approach problems with a different mindset of what brought us to these problems. If that makes sense. Not everybody hears a beginner's mindset. They think all like lack of experience. No, absolutely not. And the second part is technological.

You know, these things take commitment, time, and sometimes resources. You can do it efficiently if you're nimble, but having technological solutions that can help us capture this information. In an efficient way would be helpful for the industry. But first, we need to start with the mindset and a lot of people in the industry to go outside of their comfort zone and acknowledge that for us why we're doing this even now in our investment in the fund.

I say, when we're looking at an opportunity, I want to understand the impact on the patient. Understanding the patients is, you know, I don't want to use marketing, but they are the market for our industry. So if we don't understand the need, if we don't address there, we cannot just approach it with a pure science, you know, rigid mindsets.

We're dealing with humans. And in any industry, you incorporate your customer's voice. Very early on, right? Every when you talk to any other industry, the first thing they tell you is, have you talked to your customer? Did you get any feedback from our industry? No, it's like the patient is an afterthought, right?

Everyone asked. Have you talked with payers? And sometimes the payers are not the customer. That's a lot of things that people don't understand. It's not the payers. If you're not addressing a real need in the patient population, payers are not going to pay. So understanding your patient population, and bringing them understanding that this will have an economical impact on the company's long-term return on investment for the investors.

I think there will be a shift in The industry's mindset and more technology like what you're working on Maya as well.

  I hope you're enjoying this episode. If you find this topic relevant, you'll find it helpful to book a demo with our team on trialhub. com. Since 2019, we've supported more than 3, 000 clinical trials with country, site, and patient feasibility. We'd love to show you how and help you get your trial right from the start.

And now, back to my guests.

  I was going to ask you, but wow, so many different thoughts here, especially thank you so much for the definition of this beginner mindset, because sometimes, I was telling you about my story, starting from working for many years in clinical research, but somehow being an outsider because never worked at a pharma CRO.

But then again, I think you're absolutely right. This beginner's mindset helps you to see things and problems in a different way. So I would just summarize. What stops us like the barrier that we have today preventing us from actually doing this patient feasibility at scale? I call patient feasibility.

This is a term that we use in our company, but we want to more and more, bring awareness around patient feasibility because we need to make sure that we assess if a trial is feasible from a patient's perspective. So the barrier is actually mindset. And Yeah, recently I had a webinar on diversity, and we were joking that today the mindset is let's find the key opinion leaders, the ones with the most publications, and they will recruit our patients, and not where are the doctors that have the biggest positive feedback from patients and are exposed to more diverse type of population.

So, yeah, maybe the mindset is still not there. But you mentioned something interesting about technology and I wonder if, let's say, Mindset is something that's changing today, which I think is the case. What's the role of technology today in scaling this patient feasibility and the whole engagement with patients?

Where do you see the role? Hmm.

I think that's another thing I learned from interacting with patients very, very early on and throughout the clinical trials is clinical sites are located in different areas, right? Sometimes patients get to a clinical site in 5 minutes because they're living in a small town and sometimes it takes them hours to go there.

I think having a platform that can remove distances and, between the patients and the sponsor and physicians is very important. And it's not like dry surveys, because I've done these surveys online. Sometimes, you know, I remember, doing a survey for cognitive testing online.

And it was so hard, even for me, but it was like, how can you, and I don't have anyone to talk to, or ask, or no resources to basically ask for. So having technologies that can capture the data from perspective incomer clinical trials, but also retrospectively, right?

And capturing all of the previous data from previous clinical trials and understanding the pain point across what were the things that impacted the quality of the clinical trial, the quality of the data, right? That's something that we somewhat did. We looked at when we were recruiting sites and I think the biggest focus in the industry again is picking sites that have the highest recruitment rates

Yeah. Yeah.

And not looking at the overall comprehensive quality of data that is coming out of the site. Other things that were like, people were recommending sites highly to me because they recruited. Significantly, right? They were the sites that accrued 20 percent of their patient population in a 400, 500 patient clinical trial. That's a large number, right? Then it accelerates your timeline and saves you upfront capital.

But then we did this, all of this manually, but if I had technology software, basically we went to select before we recruit any sites, I wanted the sponsor to directly interact with the sites and have the ability also to run surveys for the sites, talk with the team, look at turn off over how good is the retention of the sites, of their tech, you know, people that work in that site. You cannot get any of that just from talking that with the sites, right? You need other and you need people because all of when you're doing, for example, the patient reported outcome, basically the person who's doing the test, they have to sign or put their name down.

And if there are significant chages. And who runs these tests in one site? Then it's a problem, right? And the second part is, where does the data that is coming out of this site fall in the normal distribution of data typically, and especially at baseline. And if this site, the baseline data, or first visit data is an outlier to the overall, then even if it recruits 60 percent of your patients, I would take it out, right? All of these things, nobody, and still nobody thinks about it. And I see some companies when they get like in trouble, they go and add 10 sites right overnight. And you need to have a longterm vision. And, I could understand because I used to go under that pressure from my investors or my board, that recruitment timeline. And I always remind that I don't care about the short term and I don't want to have short-sightedness and just like focus on recruitment and forget the long-term goal, right? Which is a successful clinical trial. So all of these things and having softwares that can quickly get this information for you and not only focus on recruitment, it's recruitment and the quality of recruitment.

And the quality of the data that is coming out of a

You're raising such a big question here, and you're absolutely right. Actually, for the first time, someone speaks about focusing not just on the recruitment rate. And actually, I have even articles on the topic. A recruitment rate can be so, so misleading. I mean, We are one of the platforms that we provide such information, such insights, but we always are cautious on how you should look at recruitment rate.

We know that's necessary because how you do your budgeting, basically, you need this type of data. But then, whether this site has recruited 60 patients, Three years ago, or let's say one year ago, and today it's not the same. Maybe the patients are different, maybe the staff is different. Actually, you raised a very big point here.

How good is the site at retaining its staff? Maybe the principal investigator is the same. But what about the nurses? What about the study coordinators and all the people that are supporting the patients? That's a huge problem out there because there is a lack of education for study coordinators.

Only the state coordinators are the ones to spend the time with patients. Usually. They're the ones to actually understand them even better. Sometimes I'm actually challenging, should we do questionnaires with the sites? Actually, a lot of the time, study coordinators answer that, but more study-coordinator-focused questions.

Ask their opinion, not just the key opinion leaders. Anyway, I'm becoming very passionate.

And understanding the sites, right? You know, sometimes I say the study coordinator and the nurses are more important, important than the PI.

Yeah, all of them are important. All of them is that that's probably the complexity that all of them are important.

The industry only focuses on the PIs and only highlights the PIs. But I know you need to talk to the full team. That's another thing that I tell the sponsor. It's like we use CROs and we think that CROs, they work with hundreds of companies. Your project or your pipeline of clinical products are your babies, right?

You understand that. So, you're an entrepreneur, you understand that. Nobody's going to care about it as much as you care about it, and you should be able to talk to the sites, interview the sites. It's very important for people to understand that the outcome of your trials is dictated by the quality of the sites that you pick. And then the relationship that you have with these sites. And also, I used to ask to meet with the PI. With the team as well. Personally, like, I would put it because clinical trials is what makes and breaks biotech companies. And also seeing how the PI interacts with the team is very important because the way that the leader interacts with their team is going to be indicative of how motivated they are to go over and beyond for the projects that they're working on. And honestly, like every time you could feel like there's a collaborative energy within the team across every stage, they're typically the most passionate, and most committed and recruitment is just like Reasonable. You could see that they are very reasonable, very careful who they recruit very careful because also sometimes when you have a lot of recruitment and you have delays and data entry.

That could lead to issues also in your clinical trials, so you need to also understand the pacing of recruitment and the quality of the sites for data entries. That's another thing, if you had safe software or a technology that can track how organized a site is with, and timely they are with the data entry because you have a deadline, you have the SMBs, you have all of that. If the timeline is crushed towards the 11th hour, the quality of the product that you're producing is also gonna be impacted, right?

You have deadlines with the FDA that you have to submit, so you need to make sure that the sites that you're recruiting are and understand that you don't work for you. They are partners with you on the journey. Because if they're successful, you're going to be successful. So you need to empower them to be successful.

Yeah. and again, going back to what you said before, it's important to remind ourselves our why the why for every single clinical trial at the end is quality data. The data is the proof if the hypothesis of the clinical trial is right or not without the data. No matter how many patients are recruited, no matter how much time it takes, no matter what budget, and so on and so forth, the data is actually the key.

That's the end result of every single clinical trial. So I agree with you. I have two other questions though. You mentioned how important it is to have this direct interaction with sites, but I know From my experience that very often most of the sponsors out there interact with the sites through a clinical research organization.

And, I can assume, correct me if I'm wrong, that your company was also relying on clinical research organization services and Support when managing these sites, maybe even when they were selecting the sites for you. So how can you have this direct communication with the sites while also partnering with the CRO?

Is that possible? What was your experience like?

Yeah, that's absolutely possible. And I actually wrote about this about like how to decide on service providers depending on your stage and the style of the company.

And, basically, we use a clinical research organization that was really good, but it was not a good fit for a small company that wanted to be involved because large CROs, they do everything, but also CROs, they have a lot of turnover, whenever there's a merger or increase in size things gets lost.

They have a lot of SLPs that don't make sense for your organization. Actually, a lot of people think full-service CRO is better for smaller companies and, um, you know, tailoring CROs is better, but I don't think so. I think it's the other way around because full-service, huge full-service CROs when, for example, Elli Lily engages with them, they acquired a whole department, which is always the A team for a period of time, right? So they become like a Lily throughout. So there's no distraction, but small companies, you have your project manager that is working on two, or three, or sometimes more clinical trials.

So they're not super dedicated to your work. They're not going to be waking up at 4 a.m. Answering questions for an overseas because they have others they need to manage. They need to have a cadence for their work. What we've developed is a more tailored type of Service provider network. Instead of using the large one, we shifted from the large one to the smaller ones.

And I was upfront from the beginning. We need to engage with the sites, and that increased recruitment. So engagement from the sponsor with it's exciting. Like a lot of the sites, the CROs will tell the sponsor don't burden the site. They don't want to hear from, you know, from the sponsor because they're very busy.

And I used to remember, like, if I talk to a site or I visit a site, they get so excited because they feel that they're seen, they feel that they are part of your team. And when you explain to them how the drug works, when you show them the data that has already been captured, they get very excited because they are part of something.

And again, bringing it back to the patient, they become very excited because they feel that the work they're doing, it's not just data entry, or capturing blood pressure, or patient recruitment. They feel the work that they're doing has an impact. Because they are part of your team.

You include them in your vision. You include them in the mission of the work that you're doing. CROs will push back, but I tell sponsors, I tell my companies that I work with, this is your clinical trial. Okay, you're bringing a sponsor to partner with you to enable you to do and achieve your goals. So make sure that you define the relationship early on. And when we did that, like there are some key things that each company needs, even if it's terrifying for smaller companies, there are some aspects, some of the site monitoring has to stay in house and it's terrifying. I know, but I'm happy to talk to any entrepreneur who's thinking about these things.

I remember Shwe telling me, like asks me a lot of things. I was like, I don't know. I've never done it. And she's like, what do you mean? Like she's terrified, right? She's like, what are we doing? I am also, you know, terrified, but I know we can figure it out.

And thinking outside of the box and changing the status quo is ultimately what's going to lead us to more successful drugs, especially in tough indications in the neurological space.

Yeah, thank you for sharing that like almost every single word I'm making a note here and I'm like, oh, I need to go back with my team and I tell them about that. I have another question though. I love this idea and I completely understand why this interaction with the site is so critical. Also interaction with the patients.

But then again, I'm thinking, okay, but maybe phase one, phase two, what about phase three when everything becomes global or at least in several countries? Like, how do you interact with sites and interact with patients on a global scale when things go to the next level and it becomes even more complicated with even more vendors and so on and so forth? Do you have any observations or any best practices?

We did it like we did it a face-to-face 3 global clinical trials. It's the same.

You know.

But did you use like local people? Do you have to hire local people or you just travel to

you travel and you hired local people. It's the same thing. Like, you have to make sure that you are not just another clinical trial.

Yeah.

Makes sense. Makes sense.

There's a face in front of it. And, you know, you can hire outside of the CRO or you can ask the CRO. I want this person to be full-time with me.

Hmm.

We got in Australia.

And also conferences, right? So as entrepreneurs, make sure that you network and conferences, you network with consultants, with CROs, and you never know when you're going to need it. A lot of people are like, Oh, why network go to conferences and network and talk to people, learn about other countries, learn about the differences.

Systems, health care systems, they are very different. Even Canada and the U. S. are very different than each other. So, understanding the impact of the health care system is very important when you are looking at the clinical sites, interacting with these PIs.

I have friends who are clinical science coordinators that I see them at conferences. We hug each other. I think a lot of people appreciate them, but I want to emphasize that it's very important for the people that are involved in the work that you're doing in clinical trials to be part of your mission.

I mean, if you send your children to school, don't you go and visit the school and make sure that the, who's teaching them, who's giving them the tests, who's grading them, look at the culture, you look at the whole environment, it's the same thing. Your clinical programs in a biotech company, they are your babies.

So think about it in the same way, and make sure that you are not just handling the drug. And saying, we'll see you in 6 months, right? When we open up the envelope, it's a relationship. It's you need to make sure it's continuum. It's not just at the beginning of the trial. It's not just at the big level of the trial, or the end of the trial, it's a relationship and it's a continuum of effort throughout the trial.

It's very interesting. I mentioned this webinar on diversity, but as we recently had, and you're repeating some of the same words and not just the webinar, like previous episodes, people repeating the same words. Trust. It's a continuum. It takes time to build a relationship. And, actually, the worst thing that you can do is be transactional.

Especially when we spoke about diversity because it's something that's still on top of my head. , the worst thing that you can do is show up in the community whenever you need them to recruit these patients and then disappear, for example. Or, let's say you may go to the clinic that you're expecting referrals, but you show up when you need the patients and not before that to build a relationship so that they can trust you. So when you go and say, now I have a clinical trial, now can we partner on that? And we've established this trust layer. So it's all, all these things are repeating and it's not just in clinical research.

It's in every single industry, every single business, every single union team, whatever you call it. So it's super, super interesting.

And 1 thing is, imagine if you do these surveys right ahead of your finalizing your protocol and you have a ClinOp team member that gave you feedback and then they feel that their voice is in your clinical trial. They're going to go to, work to make sure that the quality of the data is high to recruit the patients that you need for your clinical trials.

Same thing. I remember a lot of people, we got so many compliments on the clinical and the protocol for the clinical trial design from a lot of sites. It's like who designed this trial? Cause it's actually addresses a lot of the challenges that we. And understanding that it will pay off when you have a protocol that sites are excited about, and that patients feel at ease when they are included or they participate in a clinical trial, it will pay off.

Yeah, if you focus on the long-term thing and not the short-term thing, yeah, makes total sense. I need to ask you also, now that you're an investor in companies, which are these things that you're always looking at these companies so that you know that they're the right ones to invest in? I know this is too generic, but you've done this before.

So I guess that you're following your experience from the past. And that's how you more or less evaluate which are these companies that will succeed or not that the ones that are focused on the long-term thing, rather than the short-term thing, is there anything like that, that you're like using to assess these companies?

Yeah, absolutely. I think that's actually one of our advantages of the fund is we bring that

scientific research and clinical operation experience. And just overall, I think, operations and biotech, which a lot of the investors do not have. It's also very transactional. So talking to management, talking to the CMO, talking to the CEO.

If you're in a biotech, I could understand if Eli Lilly CEO does not know the details of the clinical trials and the sites. But if you're the CEO of a biotech company, you better know what's going on in your clinical trials. Unfortunately, there is still that like, Oh, we're using this huge CRO.

They have a lot of experience and they're going to do everything. We're going to be outsourcing everything. And it's very obvious, like when you talk to management and companies that they understand the protocol, they understand the impact of all of these, they are involved in the recruitment strategy, they're involved with their sites.

So they know their sites, right? And even if you want to take the extra mile and interact with the site as an investor, you could see, it's the same thing. How I gauged basically. The quality of the site, the sites that will be working on our clinical trials right in my company. I do the same thing right now.

It's looking at the team, the management team. We talk with the VP of operations, clinical operation, and clinical research. If the clinical scientists are not working hand in hand with the clinical operation team, there is also a challenge there. So that's something that not a lot of people do. But if you talk with management companies and you kind of like.

Suggest that to them and you could see there is a change and they understand the impact of this change. Then it's a big part of our differentiated strategy is being able to quantify clinical development and clinical research risk. Because of all of these aspects. So, and we've been doing well, and I think, you know.

Yeah, And I can see why. It is something that I

like to remind myself. Go back to basic principles. Go back to basic principles. That's what you're trying to do. Let's understand the basic principles of this company. And then that will give us a better understanding. Okay. Is this company going to succeed or not?

There are all sorts of challenges, you know, better than anyone out there. But at the same time, if you're focused on the right things, and if you're passionate about it, you'll figure it out. Like you said, Leen, last question. What is this one thing that if we change today, will have the biggest impact on the success of making clinical trials more successful from your perspective?

hmm.

I think a lot of people and there's an underestimate of the impact of clinical operations on the success of clinical outcome and clinical child's outcome. So the 1 thing is we shouldn't have the clinical research scientists work independently from operation across whether their internal teams or external teams.

We need to mesh these things, these 2 together and have an operational oversight over clinical protocol development and clinical program development and have a clinical research scientific oversight on operations. I think that's been, it's very segregated right now in our industry. And if we have the clinical operation oversight on the clinical development side, we'll have much more feasible and efficient clinical trial and development and that will lead to higher success.

And if we have scientific and clinical research oversight or collaboration, I don't want to say oversight, collaboration between these two. We will eliminate it. I think one thing that you said, Maya, is sometimes someone makes a decision they don't have. They don't think that they have an impact on anyone.

They actually probably will have an impact on a chain.

Thanks. Exactly.

And ultimately, the clinical data outcome. So that's I think, for me, that's very, very important. And we should not forget that the patient's input is part of the clinical operation. Patient voice is part of clinical operation. They are the centerpiece of clinical operations.

Without the patients, we cannot do clinical research without the patient's commitment. We cannot do the clinical research. And I think starting with that mindset. Having the biggest focus on the patients. And the group of people that are impacted by diseases, regardless of the directly, the patients are not.

As the key drivers for what we do. And bringing them at the forefront in everything that we do, starting from investment, ultimately to product in the market and commercialization, I think will impact our industry significantly and will lead to more successful drugs commercially, that truly addresses patient's needs.

Thank you, Leen. I can't end this episode more inspirational than what you said. I have so many takeaways from this conversation. Your perspective is truly, inspiring and I hope that more people can listen to what you said, reach out and then get your advice, and just inspire and do things differently out of the box.

Think of this beginner's mindset, like you said, no matter big pharma, small pharma, biotech, whatever. Thank you once again, Leen, for your time, for your passion, and for your example. And yeah, I hope we meet again for another episode soon.

Yeah. Thank you so much, Maya. This is a lot of fun. I appreciate it.

  Hope you enjoyed listening to Trials with Maya Z. If you're interested to hear more about how clinical trials can serve patients globally, subscribe to the podcast on Spotify, Apple Podcasts, and Google Podcasts. Have a great day.