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Episode #11 - Clinical Trials Part 1

Steve Abbott:

Hello, everybody. Welcome back to episode 11 of Cincinnati Cancer Advisors' Medical Minute. I'm here with Tim Schroeder, chairman, founder, and CEO of CTI ... This is a mouthful ... CTI Clinical Trial and Consulting Services.


Tim Schroeder:

A lot of C's there.


Steve Abbott:

There's a lot going on there. Did I get it right?


Tim Schroeder:

You got it exactly right.


Steve Abbott:

Okay. All right. Gotcha. Tim has just been a great friend of our organization. Great supporter. Always available to give his advice. They've also been the supporter of several of our events too. I'm looking forward to your support of our Pete Rose event coming up in February, which will be great.


Steve Abbott:

We're going to kick off the first of three episodes here today about clinical trials. There's a lot of, I'll say, misconceptions. You correct me if I'm wrong, Tim, but a lot of those, I think, centers around the fact that most people think of that in a bad way like, "Oh. I'm at the end of my rope. There's nothing else they can do for me, and I'm just going to become a guinea pig." That's really not true anymore. I don't know if it ever was, but we'll talk about things like that during this series of three coming up. Why don't we start out with just some real general information? Why don't you tell people what a CRO is, what it stands for, and what a CRO does?


Tim Schroeder:

Absolutely. If you think about, I think, pharmaceutical research in general, Steve, going back decades and decades, in most people's minds, it was Pfizer, it was Merck, it was J&J. They developed the compounds in their laboratories. They did any testing associated with it. They generally manufactured it themselves. What most of us were probably the highest level of familiarity with were their reps who were in the physicians' offices.


Tim Schroeder:

If you fasted forward now in 2021, 2022, what's happened over the last two or three decades is they outsource most of that. Our industry, which is called the clinical research industry, also called pharma services, part of that is what we do, which is as a CRO, a clinical research organization. So just like General Motors years ago outsourced making a lot of the parts for the car, the pharma industry outsourced to the CRO industry overseeing and managing the research. So we will have large pharma companies. We'll also have very small emerging biotech companies that will come and hire a company like CTI to actually manage the research on their behalf.


Steve Abbott:

Oh, cool. Okay. You know what I think, and maybe more and more people are getting to know, but CTI's a little bit of a gem of a company here locally. And I think people drive by, maybe they see the logo and maybe don't fully understand, but you guys have grown like crazy. So, how many employees do you have locally? How many employees do you have around the world?


Tim Schroeder:

Yeah, it's a great question. We are a Cincinnati headquartered company. We started the company 23 years ago, and we started actually in a small, very small, old house on Auburn Avenue, outside of Christ Hospital down the road. It housed the first 10 employees till we outgrew it. But as you mentioned, now we're a global company with offices in 60 countries.


Steve Abbott:

Yes, that's crazy!


Tim Schroeder:

We have about 500 employees here. So a little bit less than a third of all of our employees are based here in the Greater Cincinnati-Northern Kentucky region. We actually have multiple locations here. Our headquarters are in Covington on RiverCenter, which is the two towers that are right next to the suspension bridge, looking into Downtown. I always tell everybody I have the single best view out of my office anybody in the region has because we get to look out at the river, the stadiums, and the Downtown skyline.


Steve Abbott:

No, that's cool.


Tim Schroeder:

And then, we also have a phase one unit where we actually do some of the early-stage drug testings ourselves right off of I-71 next to Xavier University. And then we have a new laboratory also off of 71 in the Baldwin Complex. And then most recently, just in the maybe last month or so, we announced a joint venture with Cincinnati Children's where we are actually going to be manufacturing some of the cell and gene therapy products that are being used actually to treat and cure cancers right here.


Steve Abbott:

Oh, that's awesome.


Tim Schroeder:

And that location hasn't been determined yet, but we've got three final locations, and they're all within 15 minutes or so of each other.


Steve Abbott:

That's awesome.


Tim Schroeder:

So we do have a big presence here locally.


Steve Abbott:

Yeah. I'm glad you threw out phase one because, in the next episode, we're going to talk about those different phases, too. And I think people need to understand the difference between those.


Steve Abbott:

It's interesting because if you think about a company the size of CTI and certainly there are huge companies out there that don't operate in 60 countries, I think Mediabase operates maybe in 40 to 45, why is it that a company let's just say, for example, it's a $200 million company in 60 different countries, why do you need that diversity around the world?


Tim Schroeder:

Well, and you rightly hit the nail on the proverbial head. Everybody has their own business model. And when we started CTI, both myself and Lynn Fallon, who's president and co-founder, both came with transplant backgrounds. So our background, I was a faculty member at the University of Cincinnati and Cincinnati Children's. I made a stop in the biotech world for about five years prior to starting XI. But we came with this background in solid organ transplant and bone marrow transplant. And by definition, a lot of our early research took place in those fields.


Tim Schroeder:

More recently, we've started to do a lot of rare disease work and a lot of cell and gene therapy work, what we call regenerative medicine. But I think the hallmark of all of our research tends to be hard to find patient populations. So one of the things that require is a big footprint geographically so that you're close, not only to the patients, but you also want to be close to what we call the key opinion leaders or the thought leaders who are driving the research.


Steve Abbott:

Yeah, that makes sense.


Tim Schroeder:

So you say, "Gosh, why do you have eight offices across the Middle East?" It's because there's really important work being done in that region and we need to be close there.


Steve Abbott:

Yeah. That makes total sense. So at any given time, about roughly, and obviously this can vary, but just a rough frame of reference, at any given time about how many different trials do you have going on concurrently across all the different disease types?


Tim Schroeder:

I would say typically between 200 and 250 different studies. And to your point, they can be a very early stage where we're treating the first patient in the world, or they can be even post-approval where the pharmaceutical or biotech company is trying to find out more information about the drug, even after FDA or other regular authorities have already approved it.


Steve Abbott:

You're setting this up really well for episode two, by the way. This is good.


Tim Schroeder:

I've been well-coached.


Steve Abbott:

Thank you. And then just, we're going to close out this first episode; we try to keep these a little short and punchy so that people don't fall asleep on us. But what would you say are the main therapeutic areas that CTI deals with? Is it literally across the spectrum of everything, or are there certain-



Tim Schroeder:

It is across the entire spectrum, but I have to say, especially over the last five years, the combination of regenerative medicine and our immunology background, which came from the transplant, has really focused us in immuno-oncology.


Tim Schroeder:

And I don't have to tell you, based on both your past career and your current leadership role, but if you look at immuno-oncology, it's basically using the patient's own immune system to try to treat or cure a particular malignancy. That's taken up probably as much as 40% of all of our activities of late. So very, very common, and great progress. We're seeing some just phenomenal breakthroughs with research in that area.


Steve Abbott:

That's actually really exciting because we just did ... we've done a series on immunotherapy. We just closed that out. What are you guys doing ... is it a lot of adjuvant-type stuff, or is it ...


Tim Schroeder:

It's a great question. Typically, when we start out, as you might expect, we have to go through a rigorous protocol and review from both national or international groups like FDA. And then at the same time we have an institutional review board or ethic committees to make sure that the risk-benefit is understood. But normally, we start out after everything else has failed. And then, as we start to get safety data and start to understand better what we call efficacy or how the drug works, we're able to then move it earlier in the treatment. So some of the things startup as an adjuvant and then ultimately, if it's successful, it might move into a primary treatment itself.


Steve Abbott:

Oh, cool. All right, sounds good. Okay, so we'll go ahead and wrap this episode up. Tim, you've been great as always, and I'll see you back here in a couple of minutes/next week. Anyway, thanks, and we'll be back for episode 12 here shortly.

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