Trials with Maya Z

 Hello, everyone. I'm super excited because I have one of my really dearest friends and a leader in the clinical research industry with me today, Oren Cohen, the Chief Medical Officer of Fortrea, a company with lots of years of experience, but also leading the way into lots of things like innovation.

We have an amazing topic, but before we dive into the topic, Oren. I'll give you the right to introduce yourself. Tell us a little bit more about your background.

Thank you so much, Maya. It's wonderful to be with you today. always wonderful to be with you, but it's an extra honor to be with you on your podcast, which I always listen to and is filled with great nuggets of what's going on in the industry and important trends. I'm Oren Cohen, a physician by training and scientist by training, but I've been in the industry for about 25 years, and I serve as chief medical officer for Fortrea, which is a new name, but it's an older company, and it used to be COVAN, so then it was part of LabCorp, now, for the last year, it's been an independent CRO totally focused on clinical development. I'm also president of the Clinical Pharmacology Business Unit, so the phase one clinical trial is part of the business, and then another hat that I wear is on the faculty. I'm a consulting professor of medicine at Duke University School of Medicine just down the road from me here in beautiful Durham, North Carolina.

Thanks, Oren, I have known you for quite some years already, and I've heard so many incredible stories, but the story that really sparked my curiosity and excitement is the story of how you led the development of a firm like a brand-new pharmacological unit and that you built from scratch to be also patient-first, patient-centric, patient-friendly, all the patient related like buzzwords, but here we don't speak about buzzwords, we speak about reality.

And when I decided to invite you to my podcast, I really wanted to tell this story, Oren. So I know you went through a lot, but can you tell us first, why did you decide to start working on this pharmacological unit and why it was so important that this is aligned with the patient experience?

Yeah, thanks. That's a great question and, one that I have a lot of passion around. So, yeah, in Fortrea we have four clinical research units, three in the US, one in the UK. And, I love all my children, Fortrea initially had that unit starting, more than 35 years ago, and it was located in a building next to the University of Leeds, a building called Springfield House, and let's just say that building had seen better days. So, the original part of that building was built in 1792. And then as you see in the UK, you know, other parts of the building were bolted onto it over time. But a few years ago, the clinic director would call me, and she would say.

You know, it's raining in Leeds, and I'm sort of, you know, well, you live in the UK, it rains a lot, and she said, no, no, no, it's raining inside the clinic.

Oh wow.

God. Yeah, so quite a dated infrastructure that we really needed to refresh. We looked at all kinds of options. We looked at what it would take to restore that building, and it didn't work.

It really wasn't feasible. There's a gentleman, wonderful, wonderful friend, in the UK, Sir Roger Marsh, who is a wonderful proponent of development in the north of England. You know, England really has two different economies and he is a great advocate for investment in the north. And in Leeds, in the city of Leeds, there's this incredible area south of the river that was one of the chief birthplaces of the Industrial Revolution, but over the years it was abandoned.

There are these wonderful old buildings, and nothing happening there. And so he has been a great advocate for developing that part of the city with life sciences with restaurants and hotels, hospitality, all kinds of things, and it's happening. And so we were one of the first anchor tenants, if you will, and we found a building that has great bones, it's next to an actual replica of an Egyptian temple, which was built in the 18th century as a mill, as a factory, there's a whole great story behind that, but anyway, we're in a large building next door.

And yes, everything in the building is brand new. We started from scratch. Our staff was intimately involved with the architects and builders to design this clinic in a way that is super friendly to modern clinical trials to patients, and to our healthy volunteers. The design follows our workflow, but it also has incredible accommodations, for the comfort, and safety, and security of our trial participants, both patients and normal healthy volunteers.

So some of the examples, it's a very green and sustainable building. There's lots of light coming in from outside, there are these huge, atria, open atria. There are actually a couple of giant trees growing inside in these atria.

Rooftop, terraces, separate areas actually for staff and for our research, participants to enjoy the five minutes a year when it's sunny in the UK. I'm kidding. Sometimes it's lovely there, but that rooftop area is absolutely gorgeous and there are solar panels that help us reduce our carbon.

There's a tremendous recreation area for the study volunteers and there are separate areas within this giant area. So you got big screen TVs and you got video game areas. There's actually an old-fashioned Pac-Man standalone. arcade game I find really cool. And then, you know, we also designed in the post-pandemic world, a lot of our study volunteers are working from home while they're participating that we built kind of office space for them to, to work.

So they really have a whole life within the clinic. And, at the same time, we built A clinic that is really fit for the purpose of modern, complex, clinical pharmacology trials. So special procedure rooms, high visibility wards, reconfigurable space, really, really tremendous. I love visiting there.

Yeah. The way you described it it was like a museum that I need to go and visit. So it's definitely already on my to-do list once I go back to the UK. But Oren, let me go back to the design of this building and You actually mentioned that there are two main let's say, spaces like one that's for the workers there for the staff, to actually follow their workflow, which is absolutely important.

I've been reading a lot of Harvard value-based healthcare publications that speak about how critical a hospital structure is to the efficiency of the hospital overall and the overall stuff. So that makes total sense. But here I want to actually dive deeper into the spaces that you've built for the patients because you said that you built this like a space where they can chill, like TV games, but also like an office space as well.

Why does this matter? Like, why did you decide to spend this extra effort, I know, we've been chatting during this process, and I know how much effort it cost you and the whole team to actually go through this whole exercise to perfect this unit. Why does it actually matter, now having it already up and running?

why did you spend these extra efforts on that?

So many reasons. And I think really the root of this is that it's like thinking deeply about who are our customers, and of course, we contract with biotech and pharmaceutical companies for the most part to conduct their clinical trials. But our research volunteers are truly, truly, they are heroes.

I mean, these people are volunteering for things, you know, that have risk associated with them.

Hmmm.

To advance science, to advance our understanding of the behavior of drugs, in humans mean a lot of. We do a lot of first in human trials. It means really, really important stuff. And our research participants, our normal healthy volunteers, and our patients are really important customers to us.

We talk all the time about how difficult it is to recruit into clinical trials. And, I mean, one of the things that makes a tremendous difference and, you know, we do our satisfaction surveys with our research participants all the time. How's the food? How are the accommodations? Is the bed comfortable?

Is the clinic visually appealing? I mean, because our study volunteers spend, sometimes they spend weeks confined in our clinic. And we better give them a nice experience. You know, I wouldn't say it's the Ritz Carlton. But our staff are extremely mindful of treating our research subjects extremely well.

Of course, the protocol is the primary concern, but the creature comforts make a huge amount of difference and a positive experience means that people are likely to spread the word, and maybe volunteer again for a study, and that makes everything easier. It makes it easier to recruit for studies and do it efficiently and well.

And have people have a positive experience. I mean, it doesn't really get better than that.

Yeah. So, to summarize what you said, experiencing your words is it's risky and uncomfortable enough to be a part of research. Sometimes you're a patient, sometimes you're a healthy volunteer. So, the perspective is different. But in both cases, it's uncomfortable enough to even think about becoming part of a research that comes with risks. And like every extra level and detail that contributes to another level of discomfort just contributes to people saying no to. So what you're trying to achieve is more or less overcome these details by making it a little bit more appealing, comfortable, and desirable to stay there even.

So that's. You reduce the likelihood and the reasoning why people should say, like, 'No more.' Or, you know, 'That's my last study.' So yeah, but it makes a lot of sense. How open are biotech companies and sponsor companies to that? Because I can imagine, I mean, not knowing the business behind that, I can imagine that for all of these things, this is something that costs money.

So how much biotech and pharma company sponsors, in general, do understand the need and importance of this comfort to provide it to the patients and appreciate it?

They love it. They absolutely love it and, and I would say you're right, the cost, the cost comes, can come into play. You can't do this anywhere. In a previous life, I did have a phase one clinic in central London, and there it was impossible just because of all the overhead costs of being in London, it was really impossible to be cost competitive.

But, as I said, there are really two economies in the UK, and the economy in the North is very, very different. And so, actually, even with this incredible infrastructure and facility, which did require substantial investment, but you know, we pay for that over a long period of time. It's not our cost for budgeting.

Studies out of Leeds are very competitive because overall the costs when you factor everything in are very, very reasonable. And, so you can't do it anywhere, but you can do it. The places that we're in are conducive to an investment like that and not hitting our customers in the pocketbook to have that extra measure of creature comfort for our patients and

That's a great business model finding these unique locations where you can actually create something really valuable to the local society. And at the end of the day, keeping the costs reasonable so that sponsors can actually benefit from this service.

I just wonder, Any idea how replicable is this? And especially now speaking about diversity in clinical trials, like looking at the US map, we all know that there are huge places, and regions in the United States, but not only in the United States, where there aren't actually research centers.

Can this be replicated in places like that in the States, for example, or like the model won't work the same way?

I think there are micro economies in the US where similar things are possible. I would also just say before leaving Leeds as a topic that Sir Roger Marsh I mentioned was a great advocate for us coming to this area and it's amazing to see the progress, the number of building cranes, the number of cool places that are popping up and it's kind of pushing the boundary further and further south of the river, lots of new businesses popping up.

It's really, really neat to see. It's great. For the local economy, it's providing opportunities for the workforce. And it's really a win-win all around. So I live in Durham, North Carolina, where a very similar thing happened. When I went to school here about 150 years ago, the whole of downtown Durham was abandoned and dangerous, and now it's like a destination.

And, you know, it may have swung too far. Now there are studio apartments that are selling for a million dollars right next to the freeway, but utter transformation within a city. And it's neat to be part of that in Leeds. In the U S, I would say, we're in several locations in the U S where it would probably be very difficult to do this in Dallas, for example, where one of our clinics is.

But you know, our clinic in Dallas is modern and nice and it's okay. We don't probably need to do that. We have invested in, we've expanded our clinics in Daytona and Madison. And again, I love all my children. They might not be quite at the same level of extraordinary as Leeds, but it's quite, it's quite nice.

Yeah. So yes, they are not in New York City Chicago, or San Francisco

Yeah. Yeah. Makes

perfect sense.

And I wonder, because I understand why you're saying I love all of my kids, but then again, like, the least has a special place in my heart. But I wonder that like This whole experience was definitely, taking a lot of your time, your efforts, like contributing to an extra level of stress and so on and so forth.

What are the lessons learned for building a patient-friendly pharmacological unit? What would you do differently? What would you repeat next time you're building a unit? Any lessons learned?

Oh, wow. Great question.

Where do you start?

what, what is key? And, I mean, I was in the incredibly fortunate position of having Some extremely competent and passionate local people involved. So, one of my leaders, Dave Simpson, and our clinic director, Heather Saywell, are based in Leeds. And they really did an enormous, enormous amount of work

to ensure the success of the clinic. I don't think it would have been nearly the same animal that it is without their personal involvement over a couple of years, intense involvement from beginning to end. And it's still not quite done because Part of the clinic is a new good manufacturing practices pharmacy.

Absolute state of the art that, it's finished, but now we're waiting for the regulatory inspection and accreditation, which should happen by the end of this quarter.

I would say, local people on the ground that it's just like when you if you build a new house and you're living in a different city if you're not able to be there a lot or have someone there a lot, it doesn't turn out the same.

You gotta be on site, and you have to push very hard because there are about 10, 000 little decisions that are made. And because of supply chain issues or just stuff that's found during construction, it's like, we think that this is going to be a much more feasible way. And there are some things where you can't compromise.

You can say, no, I, yeah, sorry. Recognize that it's hard, but this is what we read and this is what we're going to do. So it's all about, knowing when and how hard to push on the things that are really important. And having that local engagement that is so critical.

it reminds me of what we discussed just before starting our conversation today, yes, it did take you a lot of effort, but then, a lot of leadership, local, international, all sorts of like leadership, teamwork, but then nobody said that leadership is easy. At the end of the day, so, one thing that actually this story stands out is also like, it stands out with multiple things, but one thing that I definitely take away for me is this local visionary.

Suddenly this is like rebuilding and creating this unit is not just creating this unit. It's creating a community, like a new community place, like with all of the other businesses, all of the other places. And it actually reminds me because we started with patient friendliness, like what it's like to build a pharmacological unit that's patient-friendly around the patient-first concept.

So it reminded me of a project that I was involved in last year. Where we surveyed different, patients, with a type of brain tumor. One of the things that they said that they would like to see in a clinical trial is actually for the sites to be located near a theater or a restaurant or someplace they can spend outside of the clinical trial-like sites.

And when I asked but why do you need that? because all you think sometimes is that they feel sick and they will be at the site and you feel about like, like the site is their universe. But then again, these people were like, well, We are risking our lives. We don't know what will happen.

And let's say our close family friends may come in, maybe with us, we'd love for them to be with us because we don't know how much time left we have. So I hope that I can spend a little bit of time outside of the hospital at the end of the day. So having these places around such a unit or any hospital is more critical than we ever imagined.

So that opened my eyes and now that you kind of mapped. This whole community makes the unit even more patient-friendly. So congratulations on what you've achieved. It's definitely something that I would love to visit. And I'd love to see more and more of these like places where we can combine doing different activities, but still like being a part of a clinical trial.

And. I have one last question to ask you. It's a question that I'm asking every single of my guests and you've spent a lot of years in the clinical trials area, so you've seen a lot of things. So I know it will be a complicated question to answer, but still, is there one thing that can make clinical trials more patient-friendly and successful?

What would that be?

Yeah. I mean, it's such an important topic and I think everyone's paying more and more attention to it appropriately. I think regulators are putting demands on sponsors to have specific considerations around patient input. To me, so I've been interested in this for a long time and there are threads of research that came out of my original area was infectious diseases and immunology.

And this actually grew up within the infectious disease clinical trials community. And it's about the fact that in so many infectious diseases. You know, regulatory guidance on endpoints, if you look back in, over history, for community-acquired pneumonia, I mean, their microbiological endpoints, clearance of chest, improvement of chest x ray imaging.

And when you think about it, a lot of these endpoints are relatively meaningless to patients.

Hmm. Interesting.

that's a pretty good one, that's a pretty important one to most people. But the quality of life, and so there's this whole, literature on, I think it was originally called DOOR, Desirability of Outcomes Research, and, whether you ask patients directly or you ask caretakers to elaborate on what are the potential clinical trial endpoints that would be meaningful to patients with the condition, and then you start getting away from the x ray improved. I mean, x rays in pneumonia can take a really long time to clear. It's not from the patient's perspective, is that really important? Or is an outcome like, you know, for serious pneumonia that you recovered with full functional capability?

Or are there laboring deficits that have a meaningful impact on someone's quality of life? I mean, those things are much more important to patients and, there's lots of interesting literature on this, from different areas and, so there's some really interesting research out of Duke.

My, home and institution, Dr. Shelby Reed is really at the forefront of looking at how patients, make decisions about clinical trials, about participating in clinical trials, and about processing information about risk and potential outcomes. So these things are converging now and I think we're at a unique place in the industry where we have that opportunity to really push this forward in, in meaningful ways.

And I think it's, very positive. I mean, I think it's really meaningful. Maybe that's because I'm getting older and, you know. I'm a patient more often than I'm a doctor now. Yeah,

We all are. But like one, not like other question or because I lied to you. I said, it's going to be the last one, but then your answer triggered. Another question, and you said, because you said that you're rather positive about moving in the right direction of the right direction is working towards meaningful endpoints for the patients as well. One thing that I've learned from business is unless this becomes a must-have. Like everything will be recommended and it like will be by choice and by choice if it contributes to the budget, for example, like additional burden, extra processes, extra money, and so on and so forth, then it will be avoided.

So what do you think and when shall we expect, this to be not only recommended as it is today, but actually required like the diversity plans, for example? Okay.

it's a good question. My crystal ball is not good enough. I think it's happening. I think it will happen. The thing that I worry about a little bit with regulatory mandates. And it's not a criticism of the regulators, it's just how things happen. And if you look at, if you look at diversity, equity, inclusion, as an example, it's certainly a good thing that, that this is top of mind and there's progress being made.

I worry a little bit about the means and the ends. , and I feel like a lot of people feel like there's just some magic about, oh, well, we're going to decree. A certain percentage of our clinical trials are going to include diverse and minority populations without getting at root causes to understand the historical context of why it is the way it is.

Why there's so much distrust in communities of color and the minority population? And to address that, you know, you need a long-term, so you need to actually foster the development of investigators in those communities. Who look like the patients in those communities, who serve directly the, you know, rather than saying that you're going to,

Yeah.

you know, you're going to create great transportation that takes care of them.

Take people from here and you're going to deliver them here where everything's different and it's just anyway you get the idea There's a there's a fit for purpose way of doing things and I think that'll be

Yeah.

also just wanted to go full circle because We started out talking about the new clinic in Leeds and I was there just last week visiting And, um, I had the really unique opportunity to see translational medicine in action.

You know, it was a phase, we had done the Normal Healthy Volunteer phase one trial for a small biotech in the U. S. That is targeted toward a rare disease, and the Normal Healthy Volunteer phase one trial went very well. When I was in Leeds last week, we dosed the first patient. With this rare disease in our phase one clinic, which was just absolutely brilliant, super nice lady from the UK, who's had this disease for years, and, the laboratory results, it's super exciting, I mean, to see this profound of a response.

And she's extremely excited and it just made me all kinds of excited because that's what it is all about at the end of

Absolutely. Absolutely. Thank you for sharing the story and thank you for all of the things that you shared today with me for the leadership example to you and the rest of your team for Treya. Keep doing and keep leading this way. And, yeah. Hopefully, we'll see like soon in the magic bow, even like more positive things in the space of making things more patient-friendly, making clinical

absolutely, absolutely. And if I could just ask you, because this is super important to you as well, I know, and you've built. I

mean, I have been just absolutely amazed at what you have built within a few years time and you've done it in such a way. There are different ways of doing things and your success has been just exemplary to me about someone who's passionate and interested in doing the right thing.

And when success happens in that context, I think we all need to celebrate it. And so it's. Is there a special sauce? I mean, your leadership is just so multi-dimensional. What, where does that come from? I mean, where does it come from? I know it comes from you, but

I don't know. No. Yeah. I think that there is only one word to describe that. And I think it's not something that it's only me having that. It's like people like you and all the entrepreneurs in our space and other spaces as well. It's resilience. It's resilience, believing in something that matters to you, whatever that is.

To me, healthcare, okay, let me stop here. Not healthcare, but health is the ultimate asset that we all have. So working towards better health, better healthcare, better clinical research, better treatment options is something that, Like really has that's something that matters to me. So even in the hard times, no matter what I do, or what I'm going through, this is the thing that gives me an extra level of energy to overcome whatever it is.

But as I said, it's not. Isolated just with me, I think with everyone, so I can just encourage everyone to think about your passion and find a way to work within your passion, because if that's the case, then you will be creating these pharmacological units, these websites, these software, these solutions, businesses, NGOs, whatever, but that's really important.

Thanks, Oren, for your recognition. Thanks for your time today. I hope my audience will really enjoy this conversation and hope to see more units like the Leach one and hopefully to see personally the Leach unit soon.

Come visit. I'd love to show it to you.

Great.

Thank you. Thank you so much.