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New Possibilities in Oncology Research
Episode

Chris Learn, Vice President of Cell and Gene Therapy at Parexel

New Possibilities in Oncology Research

Brought to you by   | hosted by Joseph Kim

Cancer is not one disease, which means it cannot be addressed by one type of treatment or research.

 

In this episode, Chris Learn, Vice President of Cell and Gene Therapy at Parexel, talks about oncology research, cell and gene therapies, and the patients’ journey navigating this space. Chris breaks down the difference between traditional cancer treatments and next-generation therapies that target the disease’s root cause to control it and decrease cancer worldwide with this alternate option to drug development. The therapies tend to be more present at flagship academic centers and later stages of the disease. Still, Chris believes that performing them at earlier stages will help different sites become more familiar and encourage them to do more research about them. He discusses the challenges some sites may face to adopt these as desired procedures and shares how Parexel’s approach starts by focusing on the patient’s journeys.

 

Tune in to learn more about cancer research and treatment developments from Chris!

New Possibilities in Oncology Research

About Chris Learn:

Chris A Learn, Ph.D., Vice President, Head of Cell and Gene Therapy Center of Excellence at Parexel is a caregiver to his parents with incurable genetic illnesses and knows the importance of championing the patient. It is these personal experiences that drive his leadership and strategic direction for the operational delivery of Parexel’s cell and gene franchise.

Bringing 20 years of clinical trial execution and team management experience, Dr. Learn is personally committed, enthusiastic, and passionate about translational science. With an interest in the strategic development of novel therapeutics, Dr. Learn is a published author and has been a team leader in the registrational buildout, agency submission, and regulatory approval of five separate and unique marketed products (YONDELIS®, IMBRUVICA®, KEYTRUDA®, BREYANZI®, and ABECMA®).

A former project leader at Duke University, Merck & Co, and Istari Oncology, Dr. Learn has authored numerous clinical trial protocols, including the design, implementation, and execution of a variety of cellular and genetic therapies.

Over the past five years, Dr. Learn has served as a subject matter expert overseeing the clinical Development programs of >20 cell and gene therapy programs in rare diseases, CNS, pediatrics, and oncology for emerging biotech portfolios as well as large-cap pharma. His current interests and commitments lie in the phasing of dose, route, and administration of cell and gene therapies in the clinic well as how to use innovations in immunotherapy to drive these unique therapies further in terms of improving patient outcomes.

 

Research Confidential_Chris Learn: Audio automatically transcribed by Sonix

Research Confidential_Chris Learn: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.

Joseph Kim:
Welcome to Clinical Research Confidential. On this show, we highlight and demystify the inner workings of this greatly misunderstood activity called clinical research. Now, why is clinical research important? Well, it’s the basis for nearly every modern remedy for sickness and a growing method to build trust and solutions meant to optimize health, but it’s not for the faint of heart. And so on this show, you’ll hear what it really takes to succeed in the clinical research game. I’m your host, Joseph Kim, and I’ve spent over 23 years in the clinical research industry, now serving as the chief strategy officer for ProofPilot. Get ready for some adventures as we look into the underbelly of clinical research.

Joseph Kim:
Hi everyone. I am here today with Chris Learn, who is the VP of Cell and Gene Therapy at Parexel, which is a clinical research organization in the clinical research industry. Chris, welcome to the show.

Chris Learn:
Thank you so much for having me.

Joseph Kim:
So what I’d love to talk about today is really how different oncology research can be compared to like literally every other therapeutic area. It’s something that I’ve been told all my life. While I’ve never had direct responsibility for execution of oncology trials, I’ve always been affiliated with them when working with sponsors and whatnot. But the one thing that everyone always kept saying to me is like, oncology is different, oncology is different. How different is oncology? Just like at the very 30,000-foot level, how different is that kind of research compared to, say, asthma, or neurodegen, or diabetes?

Chris Learn:
Yes, sir, it’s a great question. Sometimes it’s a philosophical question, sometimes it’s just a clinical activity or task question. But the large-scale view of it is you are dealing with patients that are inherently going to suffer from what is known as disease progression. And so that means their status will elaborate and decline in real-time and rapidly such that there are no breaks or opportunities to engineer any soft landings. And in that time they will have multi-organ systemic involvement because of the disease, it will affect them psycho-socially, it will affect them emotionally, it will obviously affect them metabolically, and immunologically. And each of those will go into how the patient transits journey, as well as how they respond to these therapies. There have been some social science reports to show that individuals of a certain faith background or a more positive mentality tend to do better with certain types of chemotherapies and or cancer treatments. And we do know that certain types, endorphins, and hormones, are very responsible for helping leverage better responses in cancer therapies. So positive outlooks for those patients are quite good. So again, really, you’re up against a very brisk timeline of that patient declining and being able to engineer stops in tumor progression. And I think that’s categorically different from a lot of other diseases because those diseases, like you mentioned, asthma, or rare disease, focusing really on one particular organ class or system. Cancer is just really an all-out assault to the body and the mind, and so that is how this is different.

Joseph Kim:
Got it, so just at the disease level, you’re dealing with a whole different category of animal, right? A whole different category that’s fast and devastating.

Chris Learn:
And what we don’t know is what we don’t know. In regards to a lot of these diseases, we absolutely appreciate very nuanced mechanisms of why they’re occurring, but how that applies to the therapeutics we’re trying to leverage, we still have a very long way to go.

Joseph Kim:
Yeah, so there’s a ton I want to get into, but first, let’s talk about you a little bit. So your background is in life science or you have degrees in microbiology and chemistry and biology and immunology, and these were, I would argue, like, like myself as a life science undergrad, but you have a PhD, obviously, but these were not clinical sciences. Like in my, I have a degree in molecular biology. I never had an anatomy course, you know what I mean? So how did you find the change of studying like hardcore science and then trying to apply that in a more clinical setting? Like, was that an awkward transition for you to go through university to practice?

Chris Learn:
I was just very fortunate. I lost my dad when I was 18 to cancer, and so I knew at that moment, I was an only child, my parents were older, I grew up overnight, and so I knew that I needed a foundation of science to be able to do what I wanted to do, which was to look into and develop therapies for cancer. That was really the only interest I had in life. And I became very much a machine at the age of 18. I graduated first in my class at Virginia Tech. I took a full ride to Wake Forest. None of that mattered, I was just there to foundationally get to the point of immunology because I truly believe, in 1991, immunology was where all of this was going to go. I had this wonderful mentor, Dr. Klaus Elgar, who was at Virginia Tech, and we were all just waiting to sort of come out of the tunnel, if you will, because we knew immunology was going to be it and we had early signs of that. And by the time I got to Wake, I knew that my passion was not going to be in bench science. And so when I took my postdoc at Duke in the division of neurosurgery, working for an immunologist who is an MD PhD, we were treating patients in 2000 with cell therapies that would be novel for today. So that’s how far ahead of the curve we were. I was just simply, chance favors the prepared mind, Louis Pasteur, was just simply in the right place at the right time, but my appetite was such not for vengeance but to do something good. And I knew that foundationally was going to be translational medicine, but I would matter not to anyone, including John Sampson, to do, if I didn’t have that foundational core.

Joseph Kim:
Wow, so you, you started on this mission as a teenager and you had some really great education, drive, and mentorship along the way. Let’s break down the difference between immunology, immunological therapy, radiation, chemo, like help people understand like the big sort of categories of therapy for oncology.

Chris Learn:
Sure, so what we have done probably in the last, since, I guess World War One with nitrogen mustards and those types of really toxic things, we knew that could inhibit cell proliferation both healthy and tumor allergenic, so the advent of chemotherapy came from that. And then in the fifties, as we got more adept with lasers and laser technology, radiation therapy became another way to stall or kill tumor cells very specifically, it would do the same to healthy tissue if you missed your target. But so, really, for the past 80 years, oncology has been a franchise of chemotherapy and radiation. Only once you got into the late 1980s with Steve Rosenberg and IL-2 experiments at NCI, did we begin to really uncork immunology and these next-gen therapies, and part of that too was gene therapy and the associated cell therapies that went with that. So chemotherapies have evolved. I think what has really evolved is our measuring out of them and our regimens for them so that they’re not so toxic, too toxic, of course, that’s the point, but how the patient responds to that has gotten better, how we leverage the sequenced dose route and administration of chemos and radiation has become more pronounced. And so what you have seen is a tremendous decrease in overall death due to cancer in the Western world when these types of mechanisms are made available. So I think it’s been a real promising aspect, but for me, I believe in Hippocrates and the body is best placed to cure itself. The immune system, if leveraged correctly, will be able to do things that chemotherapy and radiation simply cannot.

Joseph Kim:
Yeah, right, right, right. So when we’re trying to develop drugs for oncology in cancer, which is dozens of diseases, really not just one, what does that look like from a phase one, two, three, perspective? Does it follow the same kind of thing of like healthy normals, PK, PD, or using patients much earlier?

Chris Learn:
I think what we are, what we have subscribed to, and what we need to evolve from is exactly what you described, Joe, is the paradigm, and it’s not a bad paradigm. It’s worked for many years, it just does not lend itself to acceleration. I think what you really want to do is have some statistical designs and some opportunities in your early phase studies, including phase one, not only determine safety and tolerability, which are your primaries for NIH or any regulatory agency, but what type of C signal are you seeing, right? These are incredibly expensive trials, access is becoming more difficult, not less in some regards, and so we really need to understand earlier the go, no-go decisions that need to go into this. So design of the protocols, how we’re leveraging those therapies very quickly is going to be important. It takes up to ten years, and now the most recent figure is a billion dollars to bring a drug. I think we can do better. I think we have to be smarter in how we leverage these designs, and I think there are agencies absolutely welcoming that now with their opportunities.

Joseph Kim:
Yeah, let’s get into more detail about these designs. So for starters, I think that there’s a myth out there that for all research you could get placebo, but in cancer that’s very different. Oftentimes it’s some drug or some drug plus something new, or there’s usually a combination of different therapies out there, right? Talk to us about how that, those treatments are assigned and you start to compare one thing against the other.

Chris Learn:
Yes, sir, great question. I think obviously in the near term, in the recent evolution of humanity, we have begun to see placebo as being largely maybe not the most ethical way to leverage clinical design and clinical research. And so when you move into oncology, what becomes the control arm, if you will, historically, the placebo, but what becomes the control arm is standard of care because it’s not ethical to give a placebo to a cancer patient. And I do think the control there is good in the sense that standard of care should tell you the benchmark, the baseline you need to work from to understand a benefit with the investigational therapy. So I think we will continue to see controls leveraged in terms of standard of care. We are beginning to see synthetic controls and external controls where it makes it cheaper for the study to simply go and find historical data on patients that are very well matched to the core protocol, matched to the standard of care that they would need. We’ve already got that data in so many different ways. Why do it again? But we’ve got to bring those costs down too, in that regard. So there are a lot of different opportunities to do that. I do think adaptive design crossovers, being able to understand segments, and in oncology, to your original point, oncology is a group where you don’t need to go out three or four years to understand the overall. You may only have to go out three or four weeks to understand if this therapy is really showing benefit or the opportunity to stop this person’s cancer.

Joseph Kim:
I mean, you just see the tumor shrink very quickly.

Chris Learn:
Yeah, I think so. And do you have what’s called stasis. It’s, does this tumor stay in that configuration? Does it not expand? I think what many of us in oncology go for is simply disease control. We are not to the point where disease cure is a reliable opportunity for the clinic. So I think those, to answer your question, those are sort of the different elements that are going into it currently. And I think as we create and we become more creative in how we apply data and investigational design, we’ll get better at this.

Joseph Kim:
Yeah, let’s take a random visit. Visit two, in a garden variety clinical oncology protocol, which probably doesn’t exist, but let’s pretend it sort of exists. Like, how different is a visit in an oncology protocol, how different is that from standard of care? Is it wildly different? Because in asthma it is very different, right? Because someone’s now coming in every week, which they probably would only come in twice a year. So talk to us about that difference.

Chris Learn:
I think it is very different now. I think 20 years ago it was not very different because 20 years ago you would have been using platinum doublets or a combination of chemotherapies or maybe a monoclonal antibody, which would have been very edgy at the time. Now it is super different because we are into the realm of cell and gene therapies and how visit two occurs is, really each patient, if they’re receiving a cell and gene therapy in oncology, get an initial dose, and then everything else is monitored, right? There are no subsequent doses, it’s all follow-up. So that is very differentiated from your 12 cycles of docetaxel over X number of months and we’ll see you back for imaging. And I think that’s good because it gets to be a better patient journey, and the cell gene therapy, in theory but often in application, is more specifically addressing root cause of disease. So think visit two is very different now, in good ways.

Joseph Kim:
Yeah, that’s good to know. Let’s talk a little bit about recruitment. So I think there’s these national figures of only 2%, 3% of patients with cancer participation. But then you go to like Sloan-Kettering and I’ve talked to them and they say actually 23% of our patients participate. Help us, what’s happening at Sloan-Kettering versus nationwide?

Chris Learn:
Yeah, so MSKCC is a flagship academic, maybe one of the best cancer centers on the planet. People really only go to MSKCC for one reason, and that is for potential access to advanced therapies. So that number being higher is a bias or a skew on the population basis onto it itself. If you go to, let’s say, Roanoke Carillon in Virginia, which is the area I grew up, then you probably have that number down there about 2 or 3%. And if you look across the greater expanse of the United States, that number is probably no more than 5 to 6%. But at academic research centers, it will be more. And I think that is something we’re actually going to have to address, because with the great resignation and the politicization of a virus, you have a lot of resignation and a lot of people moving out of the healthcare systems. And when people come in to be treated, it is now very hard to have enough staff on hand. Right now making national headlines, MD Anderson, probably in my mind, the best cancer center in the world, is 50% staffed. How do you run clinical? How do you run clinical trials like that, right? And I think the other thing which I didn’t mention is, because there is such enthusiasm, because there is such promise with these next-generation therapies, the amount of money that has flowed into the market has really increased competition, such that there are many more trials now available to patients. And if we just simply take those trials to MSKCC or MD Anderson, we’re going to miss a very large segment of the population.

Joseph Kim:
Yeah, so why is this research only happening at these world-class centers? Is it size? Is it equipment? Is it expertise? All the above. Combination?

Chris Learn:
It’s all the above. And people that you have walking up and down the wards at these primary and these tertiary academic flagships are the KOLs, and are very best opportunities to address cancer meaningfully. So that’s where people go.

Joseph Kim:
Oh, so what will it take to start activating the community oncology facility?

Chris Learn:
So that’s something that I’m very passionate about and we’re working on very actively because we believe there are very good researchers, very good clinical trial infrastructures at local community and regional settings. 80% of all cancer patients will be seen for their first few lines of therapy at those types of institutions. Very few of them make it to the tertiary flagship academic centers, and when they do, it’s usually too late. They’re so far along in their disease journey, there’s very little that the therapy can do. So by moving the therapies into earlier stages potentially and moving them into front-line or more accessible patient settings, we have a chance to better treat those patients if we catch them earlier in that disease journey. So there are a couple of propositions here. One, you may not have the resourcing issues and staffing issues at the local and community sites the way you do at the big flagship academic, and two is, you’re going to have a much more valuable set of patients if they qualify for your protocol based on where you’re at in your development journey. So I think there are some real reasons to do this. It’s not to take patients away from MSKCC or MD Anderson, we will never do that. But the point is we cannot drown MSKCC and MD Anderson. We cannot do that.

Joseph Kim:
Yeah, you bring up a really good point, which is, there’s always this fear of losing a patient because of research. But as you mentioned earlier, the stakes are so high. If you don’t do anything, you’re going to lose the patient one way or the other because they may die. Tell us more about the difference between, I don’t want to say physician referrals, but how open standard of care oncologists to letting their patients find or partake in clinical research. What’s been your experience?

Chris Learn:
This is a very tough subject, Joe. This is a super tough subject because you know, what has happened in the near term, and especially at non-academic centers is, hospitals throughout the United States are closing because they don’t have enough funding for one reason or another. Hospitals, right? So for these physicians to refer these patients out of their systems into other systems for treatment, there is an economic consequence to that, and we have seen that, and I think that will be a real challenge. From a patient-first perspective, I think what needs to happen is, those sites need to embrace the opportunity to conduct research and to support those patients either through a hub-and-spoke model where the tertiary serve as the knowledge base and the folks can fill in the treatment elements, as well as coming up to speed on how to become more familiar with these advanced therapies because if the market analysts and the clinicians are anywhere close to being right, these advanced therapies are not going anywhere. This will become the new aspirin. This will become the new Albuterol inhaler, if you will, right? The sooner they come online with that, the better they will be able to retain revenues in their institution. Also to dispense those therapies for those patients they’re seeing.

Joseph Kim:
Yeah, let’s talk about some novel ways to actually enact a hub-and-spoke or activate the community. So a few years back, Novartis had something called the signature trial, where some version of a patient could bring the protocol to their doctor, and very quickly, through a lot of standardization and efficiency, you could stand up community oncologists and make them part of the trial in some way. I don’t know the real details of that was generally what’s going on. And then you have things like decentralized trials which can be overhyped for sure. How do you see it like operationalizing so you can activate the wider community of oncologists?

Chris Learn:
I’m not trying to be cheeky, but the operationalization of it is the easy part, right? We have these things, right? We have laptops, we have connectivity in ways that we’ve never had before, we have metadata that is able to meet up with and be tokenized in ways that are just ones and zeros of the ethos, and so I think for the mechanistic standpoint, it’s not a problem. I think contractually what you’ll have to get to is the revenue aspects and how these trials can play out and who gets what share of the pie, if you will. And then third to me, as an academic, third, the most challenging notion will be what can our colleagues in the local and community and regional settings learn and need to learn to be able to implement these trials. Now for signature and other types of trials that did this, the bar was a little bit lower because you were talking about interventions that were not unique or unknown to the local community or regional setting. When you get into things like cell and gene therapy, let me just surprise everyone, the applications of those by and large are not so different once you come to understand how to do them, meaning any hospital would be able to do these things. Now, there are certain cell-and-genes where you have to go intracranially or into organ and you need an interventional radiologist, and so therefore different level of skill is required. But for many cell and gene therapies, it’s simple infusion or injection, and we do that in our qualified hospitals, right? Our fact-certified hospitals, which say the fact says you’re capable of doing infusion, right? So I think if we can work out the logistics, that’s the easy part. If we can work out the contracts and the ownership, that’s the next harder part. And then getting people to sort of look past the or demystify, cell-and-gene’s too hard, I can’t do that, then I think we’re really going to make progress. Where cell-and-gene can bite you is, we do not have a universal understanding of how these therapies will necessarily respond in a patient. And so I have seen clinicians get very concerned and out of their comfort zone very quickly with patients who receive a cell and gene therapy because it’s not a signature response that they’ve been conditioned or experienced to before. Imagine doing that in a community site.

Joseph Kim:
You mean from both an efficacy and safety perspective, like that looks different.

Chris Learn:
Exactly, that’s exactly right. So, and because cell-and-gene will always be constantly evolving into new forms and next-generation assets, until we begin to embrace that learning curve and understand what we need to bring to bear in terms of … that, then we will only have cell-and-gene or advanced therapies that really … big flagship centers, it will just stay in the hub. For everybody, the most, and the sponsors most importantly, they don’t want to just sell these therapies post-approval in large markets. They want them to be able to be administered everywhere. So that becomes the next set of challenges and consequences.

Joseph Kim:
So it’s promising to hear that the intervention technique is very common. Just the intervention itself is different, so then everyone can sort of do it.

Chris Learn:
The outlay of what that therapy does in any particular individual is the great unknown.

Joseph Kim:
What makes, give me more detail, what makes the contracting piece a little bit trickier in something like this?

Chris Learn:
So we live in a very litigious society at this point and data is part of that legal process, where … this privacy, exposure, all of these elements are there. So when you have an informed consent for a particular trial where you will know exquisitely the genetic code of a particular patient, these are very sensitive matters, right? So that’s part of it. The other part of it, and I was referring to this a little bit earlier, the PNL bottom line, right? Who takes what home at the end of the day after caring for these patients? And so there’s a finite amount of money that goes into this and that could be spread around. And so like many of these sites are finding, it’s very expensive to pay and retain resources to do these, do these tasks and these activities. So it becomes contractually, and from a budgetary standpoint, a feasibility exercise on whether you can do this. And sometimes what you will find is sponsors will say, look, I know I enrolled my last trial at these three sites, I’m going back to these three sites because we have templated language, prior agreements, preconditioned wording, it’ll fly. I get it, but I’m not really sure if that helps the other 297 sites out, right?

Joseph Kim:
Yeah, this is where it’s like markedly different from asthma. You’re not dealing with the same level of sort of, no one’s getting their genome sequenced. Well, not really, not broadly. Patients with asthma aren’t getting their genome sequenced every day of research.

Chris Learn:
That’s right, and I do think, to that point, I do think one of the challenges for oncology is we have historically thought of it as hematologic malignancies and clones in the bloodstream, tumor genic clones in the bloodstream versus solid tumor masses that metastasized. I think what we are learning actively is there are probably ten subpopulations under each one of those and you will likely, unfortunately, to have any true outcome of merit, you will likely have to treat each one of those very specific.

Joseph Kim:
Yeah, so am I hearing this right, that using more of a physical manifestation as the category of oncology has kind of been like too simple model, and we’re really looking much deeper at that, and it’s not just.

Chris Learn:
Absolutely, I was working on the sponsor side in glioblastoma and we thought that there were probably one or two subtypes of brain tumors, grade four, very aggressive. And then a paper came out last year that said, yeah, we’re pretty sure it’s at least 11.

Joseph Kim:
Right, all based on sort of different biomarkers and things, not the physical look of a tumor.

Chris Learn:
So as you’re able to assess and access more data, your perspective expands. And will there be a contraction in how you can do your application? At some point, maybe, but then you have such a far journey to go to understand that new horizon before you get to a tool that can contract.

Joseph Kim:
Yeah, tell us what Paraxel is doing differently from other CROs to be excellent in this area.

Chris Learn:
…, so what we try, and let me just state this upfront, there are many good CROs out there. I’m not one to throw shade, I don’t believe that. I think what we are trying to do is we lead with the patient. We have spent a tremendous amount of time and energy and resource building outpatient modeling and patient innovations, and to be able to better understand that patient journey will likely and eventually unequivocally lead to the development of better therapies, and for many patients, it’s that journey that is so key. I was the, I was part of two CAR-Ts that were approved in the last few years, and what FDA wanted to really know was, tell me about, don’t tell me about the efficacy, I can see that, tell me about the patient journey. What do these patients go through to receive this form of therapy? So, and at Parexel, we spend a lot of time invested in that and developing and innovating in that regard. I think another aspect that we bring to bear is we have over 30 ex-officers from US FDA, EMA, PMDA, ministries of health across the world. We bring a perspective in at the early stage that’s very key for foundationally setting up the goalposts for getting a drug approved. And what we have found is that our regulatory support in oncology really is very key for us. We lead with that, we are seen as an industry leader with that, and we’re able to affect how these drugs are ultimately developed in the longer term. So when you couple that up with our clinical teams and our partnering with preferred partners that we know are excellent in this space, we believe we offer a very flexible and good opportunity to share knowledge in real-time with drug developers. I think for many CROs they try to consolidate and become a one-stop-shop. That is great and noble in many regards for a particular segment of your target population of sponsors, but not all sponsors want that. So whether it’s labs, whether it is clinical trials, supply and logistics, whether it’s access and commercialization, whether it’s CDMOs that manufacture very advanced therapies, we lend ourselves to these partnerships so that we can be flexible and nimble in this space, and I think that is the value proposition. I think the other thing is we have some exceptional owners in Goldman Sachs and AQT and they’re very passionate about the next generation of medicines to come on. So through the leadership of our organization, who have all tremendous pedigrees and experience, I think that’s our differentiator. I think that’s how it leads us forward, and for me, I really enjoy coming in to work each day. That’s not lip service because I know I have support, I know we have a plan, and I know there is an opportunity to see this turn up in clinic.

Joseph Kim:
Of course, it’s rare for anyone to rise to the executive level in an industry where they wanted to start out as an 18-year-old pursuing this sort of mission and dream. So I think congratulations to you, for sure, and it’s.

Chris Learn:
You’re kind, I appreciate it. I never tried to focus too much in the back. I just keep focused on, what, don’t ever lose that feeling you had at 18. You’ll never lose that hurt. Channel that, expand on that. But I thank you for the kind comments.

Joseph Kim:
Yeah, for sure. One final comment. Like, I mentioned DCTs but didn’t touch on that, but I’ll position it more broadly. Like with the proliferation of technologies and point solutions that, listen, they’re not going to go away and that’s fine. And then dovetailing with that, the DCT movement, which is one part hype, one part like, of course we should do it, how are you trying to make sense of all the different models and technologies out there to make sure that you’re bringing the best to bear for clinical development and not being a hammer, looking at everything like a nail?

Chris Learn:
Right, I love that. I do something, not to be provocative, but I do not look at it. I do not try to fit it for purpose. I do not try to overanalyze it. What I try to do is, I try to sort of somewhat naively see what is working in this space and what is not. And if something isn’t working, is there an avenue to pursue there to make it more effective? And I think when you work with these types of push-and-pull with your patients and with your clinicians, you are going to see some flexibility and learning more and evolving this more quickly. What COVID did was it was a crucible that just simply accelerated the need to have alternative solutions. Were we tracking to DCT before COVID? Absolutely, absolutely. And I think how we apply these things going forward over time will be really important. Do we get there immediately or can different types of technologies that will be evolved or innovated help us do this better? Yes, and that’s what I’m watching out for, right? I think what has come so far has been excellent, and I think it’s not all fit for purpose, not all of it will graduate to that next level, but it’s a really good start. And I think if we talk about diversity and inclusion, I think if we talk about reaching underrepresented, I think if we talk about increasing access, there are ways to do that in the clinical trial segment by meeting, and this is a business school and marketing thing, but meeting the customer on their own terms, selling to them what they want to be sold. And I think by doing that in the investigational setting, that’s incredibly important. Now when we get to post-market approval and access to very expensive medicines, that will take a different set of algorithms and approaches, but in the investigational setting, I am very hopeful and I’m watching out to see what is working and what isn’t.

Joseph Kim:
Yeah, fantastic, final question. While we’re not old folks, me and you, we’re not spring chickens either. So what do you what would you like to accomplish before you’re done at Parexel?

Chris Learn:
Oh, that’s a really easy one. Just to spread the joy and the passion that goes into clinical work and investigational trialing. I think that is so important. I want things for the patients, obviously, I want things for my organization, but when you touch other people and you inspire a passion to do a certain line of research, it is life-changing, right? And I’m trying to do that with my teenage daughters, and it’s a process and it’s a cultivation, but what I most meaningfully can leave to anyone is hopefully some inspiration to take that next step, right? Because in a world that is so uncertain and so dark at times, I think knowledge in the light of what we’re trying to achieve and clinical truth is more important than ever, and we have now evolved tools and knowledge to do that. So if I can affect someone’s heart and mind to do this and like it, then I’ve done my job.

Joseph Kim:
Yeah, amazing answer, Chris. Listen, I’m sad I’ve never met you in person, really, this has been one.

Chris Learn:
We’ve got to change that, we’ve got to change that.

Joseph Kim:
We have to change that for sure. This has been one of the best conversations I’ve had in a long time. Thank you for coming on the show. This has been enlightening for me and certainly for our audience.

Chris Learn:
Thank you.

Joseph Kim:
Thank you for tuning into Research Confidential. We hope you enjoyed today’s episode. For more information about us, show notes, transcripts, and resources, please visit ProofPilot.com. If you’d like to debunk a clinical research myth, share some war stories, or maybe just show our audience what kind of heroics it takes to pull off gold-standard research, send us your thoughts, episode ideas, and more to help@ProofPilot.com. This show was presented by ProofPilot and is powered by Outcomes Rocket.

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Things You’ll Learn:

  • Next-generation cancer therapies take a long time to develop – gene and associated cell therapies were introduced back in the late 1980s.
  • Participants in cancer research are hardly ever given a placebo
  • Many clinicians in oncology work for disease control, not necessarily for a reliable “cure,” which is a misnomer anyway
  • While statistics regarding cancer research participation have always been reported as being between 2% and 3%, it is often above 20% in flagship academic centers. 
  • Hospitals can implement cell and gene therapies if they learn about them and bring what they need.
  • Cancer is not one disease – for every type of cancer tumor, there are many subcategories.
  • Oncology research is incredibly expensive and slow. 

Resources:

  • Connect with and follow Chris Learn on LinkedIn.
  • Follow Parexel on LinkedIn.
  • Discover the Parexel Website!
  • For more information about Research Confidential, please visit ProofPilot.com.
  • If you’d like to debunk a clinical research myth, share some more stories, or maybe just show our audience what kind of heroics it takes to pull off gold-standard research, send us your thoughts, episode ideas, and more to Help@ProofPilot.com.
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