S02 E03

Patient Care and Clinical Trials During Covid-19


Marie Lamont



In the third episode of our second season, Peter Brenders, Founder & President of Kontollo Health, talks with Marie Lamont, President of Inteliquet, about matching patients to clinical trials during the pandemic.


Thank you for downloading the NPC Podcast from the National Pharmaceutical Congress for September 30th, 2020. This program is all about discussing and considering the purpose, process and people of the pharma industry during the Age of Covid. Each week, we continue the healthcare conversation by answering questions from listeners like you. 


This program is proudly presented in cooperation with Impres, Impres best in class commercial solutions offer top line and bottom line growth with maximum sales force flexibility, speed and efficiency. Learn more about their next generation commercial model www.impres.com


On today's podcast, our guest is Marie Lamont, President of Inteliquet of Dover, Delaware. Coming to you from historic Fredericton as your host, Peter Brenders of Kontollo Health. 


But first, here's that man with a bulletproof clipboard. Mitch Shannon of Chronicle Companies.




Thanks, Liona. 


I'm not even going to ask what that means. Anyone who's curious can just leave a message directly for Liona on our comment line at 647-875-9011. 




As everyone in the life sciences knows a flock of crows is not a formation of birds and it isn't your dad's favorite band. CRO is a contract research organization. 


Our guest this week, Marie Lamont, runs Inteliquet, which offers an interesting twist on the CRO formula. Her company provides technology, insights and services for optimizing clinical trials and pharma research. Sounds like that's exactly where data collides with traditional methods. Covid has put unprecedented pressure on researchers to create drugs at "warp speed", to use the Washington terminology. Can tech speed up R&D? 


Here's Marie in conversation with Peter.




Welcome to the NPC Podcast. I'm Peter Brenders, your host. 


In our continuing look at the impact of the Covid-19 on the purpose, process and people of pharma. This episode dives deeper into the pharma process for clinical research. 


Joining me today from the US is seasoned pharma executive Marie Lamont, President of Inteliquet. 


Welcome, Marie.




Thank you for having me, Peter. It's a pleasure to be here.




Marie, before we get started, I've known you for years and your work in pharma, especially in helping get treatments to patients. But now you're at Inteliquet. Maybe you could take a moment and give us some insights on your new company.




Sure, well, I'll try and make it super simple. At our core, what we do is match patients to clinical trials. In my mind, we bring choices to patients and physicians. 


So, if you're a cancer patient, your doc is probably bringing you one of three choices, they're giving you an approved therapeutic. But if it's not working, they may go off label, give you an off label therapeutic or you have a choice of participating in a clinical trial. And so our goal is to actually give more choices to treating oncologists and patients for cancer clinical trials. If I were to give you a stat, only three to five per cent of cancer patients participate in clinical trial. Yet today, targeted therapeutics are the wave of the future. And that's targeted based on diagnostic results. 


So, if you know that, that's the future: targeted therapies. But today, only three to five per cent of patients, they have that option. Most are devolving to old school chemo and radiation. And to me, that's a little bit of an abysmal number. So, the more options we can provide to doctors and patients, the better off everybody is. 


So at our core, that's what we do.




That's very cool. So, if I'm hearing you, right, it really strikes me is that Inteliquet is on the cutting edge of trying to help pharma and clinicians execute on research and care. But I would guess, then, that your business is akin to what I would say is the canary in the clinical research coal mine. 


You guys are seeing the direct impact of Covid-19. And what its having has had on clinical research. So, let's start with that obvious question, then, what impact has Covid-19 had on studies?




So, maybe I should talk about the affect and effect of Covid. 


So, the affect is that patients aren't going into cancer centers, unless they are acute patients. Most cancer centers have been trying to avoid having what I would call the most immune compromised patients come in. You don't want to bring patients in unless you have to, but what that also means is that for clinical trials, patients aren't coming in, they're not coming in for diagnosis. They're not coming in for visits. 


For biopharma, that means there aren't patients to potentially be cleared for trials. So early on biopharma started stopping, delaying or holding the start of new trials. And what that meant is their options started to go away. But I don't know how familiar you are, but there was also a clinical supply challenge due to Covid. And so what we saw globally is frequently clinical supply was not deemed as critical. And so some of those workers were unable to get to work and just the clinical supply at the time, wasn't able to get to centers when you multiply that by the fact that patients weren't coming into centers, and they weren't getting the clinical drug. 


So, it's a really interesting dynamic that happened. I want to say about 65 to 80 biopharmas paused trials or stopped new trials. And we saw the effect of that in patients. So, let's go to the biopharma space. But when you think about cancer centers, there's an impact there, they have less patients who are coming in, in general. They're routing their staff to acute patients. There's a couple of broad based cancer associations that applied algorithms to prioritize the patients that they were going to see and those that they should hold off. So and that's fairly public knowledge. 


There was a number of articles that talked about some of those algorithms, but there's a downstream effect. And that is, it means patients aren't getting diagnostics. So if you have cancer, and you want targeted therapeutics, biopsies, blood draws, NGS or molecular results aren't being provided because the diagnostics aren't happening. And there's a number of studies and results that people have shown from data, I want to say Iqvia did a publication in May or June, that showed those numbers down. In our data Cancer Research Consortium results, we see diagnoses are down. But that also means treatments are down. 


So, it's this downstream whirl effect. If patients aren't coming in what's happening with their cancer journey? And cancer is one of those disease areas you can't really put on pause. It moves ahead without our intervention. So, I think there's a concern that there's a backlog of incredibly needy patients that need care. And cancer centers are trying to figure out how to triage, how to address that. Lastly, I think there's a revenue impact for cancer centers. And it's not even cancer centers, I think all hospitals see it too. Less patients are coming in for visits, there's less reimbursement to cover their operating costs, whether you're a traditional hospital, or a cancer center. It also means if patients are not enrolling in clinical trials, you've got revenue that's down. And so you've got a compounding impact of your normal treatment revenue and clinical revenue. 


Some peaks folks have had to reduce significant staff, firm willing staff, to centers we've talked to in the past month, has struggled to bring staff back. Staff have not wanted to come back in, they're worried about their elderly parents they were taken care of or their children and what would happen with Covid. And so there's a really interesting dynamic that's happening in healthcare broadly, not just in cancer.




So, as I listen to this, I'm starting to hear a sort of a spiral. And it's a downward spiral in terms of where care is going. But are you seeing as much as the pharmas and the companies have paused the trials or the centers have paused them as well. Are there any signals to saying that it's opening up or they're finding new ways?




I'll say there's a couple of things. We're seeing some trials opening back up, and we're seeing pharma take new ways. So, there's a couple of ways, pathways, those new alternatives come to the table. Oral therapeutics happen to be seeing an upsurge, especially in the cancer space, because patients aren't going into infusion centers to get infused therapeutics. 


And so all of a sudden, you're seeing orals go up from a treatment perspective, because those can be delivered to patients at home without them having to come into a cancer center. So, you're seeing an odd movement in the type of, if you will, method of administration for particular treatments, and so some of those companies who have the orals are seeing an uptick. I think, we're also seeing higher utilization of radiation chemotherapy. So those are sort of the traditional. I believe that one of the things we're seeing is a movement towards telehealth. And we are also seeing a movement towards evaluating comparators. 


Instead of doing a live arm to comparator there's this movement towards retrospective studies and synthetic cohorts, your numerical comparator arm instead of a head to head patient comparator arm. So, along with telehealth involved in trials as well as regular patient care, I think there's this movement towards the use of data to help support your filings versus an actual head to head.




Maybe we could dive in to the telehealth evolution that's there or virtual engagement. Often I can understand that clinicians and trial centers will need to take vitals and maybe draw blood and do other things that require in-person. 


So how is telehealth helping, is it in a hybrid model? And what pearls and pitfalls are we seeing in that approach?




Well, if you think that sites want to take care of their patients, right? The safety is more important than anything else. There is this increasing attention to the virtual world and the telehealth. Companies that couldn't get reimbursement previously for telehealth visits are finding that that has turned and now reimbursement and telehealth is being encouraged, or a hybrid, a visiting nurse coming in and doing the components a patient can't do for themselves as that hybrid model is happening. 


The challenge still comes down to the diagnosis. If you think that diagnostics still need to occur, no one has come up with how do we solve that in the telehealth world. But I think it's treating physicians want to see patients face to face and the framework to help that happen virtually as much as possible, you're protecting that patient against risk for as long as possible. 


The real question we all need to ask ourselves is will government and/or payers be continuing to allow for that virtual or hybrid telehealth model? Once the pandemic settles out? You know, I think from a cost perspective, telehealth saves a ton of money. But it hasn't been standard of care. Are we seeing this evolve that standard of care? Or are folks going to try and revert back? And what are the risks of reverting back? That's, I think maybe, what worries me a little.




So, what are you hearing from sort of trial sponsors and participants? Do they have a preference for the new model? I mean, certainly there's a pent up demand, as you suggested, but I'm just trying to think about in terms of approach, what preferences are emerging?




I think sponsors themselves have had to reprioritize their pipelines in general, both from a commercial and a trial perspective. They've had to figure out which trials they want to back off or restart. And some have been really on top of the modification to a virtual or hybrid model. Some have had significant conversations with FDA, about taking into account patient reported outcomes as a higher ratio than just your traditional trial data points. And so I think we have an interesting degree of flexibility happening in biopharma right now, the question is, who's going to take the lead, who will come out ahead, really supporting and pushing that hybrid virtual model forward?




You got to wonder that the trial sponsors would be pushing sort of the model forward, you got to figure also the patient care that the patients, the participants themselves would be asking. 


If there is the pause, as you say, and that these trials have slowed down or stopped, and new care options are not happening. You have to figure there's going to be a pent up demand for that. Care doesn't like to be stagnant.




I believe there is a pent-up demand, and it will continue to kind of push up. The downside is the over reliance on pushing people into radiation and chemotherapy, which are fairly well known as toxic and so there's been a push back in that direction when you can't get the targeted therapeutic diagnostic results. 


And so there's this interesting balance of pent up demand, but also a push of certain patients over to what many of us would call older school treatment, even though it's standard of care. It's not targeted. And so there's some risks from a disease recurrence perspective. So, to pull that forward, my worry is there's going to be this massive pent up demand in diagnostics. What will that do to the industry? And is the industry prepared for that pent up demand? So, there will be pent up demand for determining therapeutic choices and treatment options. But to get there, you've got to go through the diagnosis first. How will we respond to that? How do folks triage that pent up demand? That's what's super interesting. 


This interesting backlog is potent, and it's potent around the globe. Because we don't know how that backlog is going to present itself and how. Will it be based on hotspots and geographies in different countries? Or by cancer center and their ability to get patients in safely? There's a number of things that haven't yet resolved themselves.




So you're seeing this from the perspective of many companies and in the support that's out there. So is there one thing, one important thing that a sponsor might not have thought of maybe it's a new company, but to come into the space, but they're going to be surprised by they need to think of? What counsel would you offer?




My counsel would be to the best of biopharma's ability, they should be considering companion diagnostics that run off blood testing. Don't rely on biopsies entirely, because a pandemic shown us that people can't get in to do biopsies. But going and getting a blood test may be much easier. And so I think there's an opportunity there for innovation in diagnostics and biomarker testing that would suit us very well into the future. As an industry, how do we give patients easier access to diagnostics around the globe? That's another one to try and solve. 


So, I think that would be my recommendation. Let's think about what choices are. In cancer, there's really a reliance on seeing tumor regression, doing biopsies, we've got to come up with some other really great alternatives as well. You know, biopharma can't go in and see sites, they cannot get in to see the cancer centers. Sites don't want to have a sponsor or CRA come in, there's a risk for patients. And it penalizes the sites with sponsors and sponsors aren't careful. 


So, I think our business challenge to the industry is to think differently. We're not traveling, if fewer trials are starting, how do we optimize the time to think about how to improve the process, not just to catch up but to change the overall trajectory? And I would argue, honestly, this goes beyond cancer, goes to any place where there is diagnostic testing, molecular or biomarker testing or even NGL. 


That's an opportunity I think the industry can seize to change the system. And both sides, healthcare as well as biopharmas, right? How do we do a better job of giving patients options choices, diagnostics and treatment? The virtual world of Teams, Zoom, FaceTime has been adopted more rapidly by healthcare institutions than ever before between their own staff. 


If virtual visits were something that was coming for patients. This particular pandemic has forced healthcare institutions to accept communicating with their own people virtually moreso than they ever used to. But I would also say sponsors and biopharma as well.




So the silver lining in Covid, we see in the research world: as much as there have been stops and declining in terms of trials, we've seen an improvement in connectivity across, internally and externally, among those involved in clinical research.




And much more reliance on the visual than just a phone call.




You've been listening to seasoned pharma executive Marie Lamont, President of Inteliquet. Thank you for listening.




Thanks to Marie and to Peter. 


Is it just me or is Peter starting to pick up a New Brunswick accent? Peter, it's time to come home. 


One of the comments you hear about the pharma business post-Covid is that we'll be split into two groups: those who are fluent in understanding data and knowing how it's applied and those who aren't. 


Marie's obviously part of the first group and if you're listening to the NPC Podcast most likely you are too. So, you won't need any instructions on how to catch up on any episodes you've missed, through Google Podcasts, Apple iTunes, Stitcher or anywhere else fine podcasts are distributed. 


You probably also know about the NPC Healthbiz Weekly e-newsletter. Every Tuesday, it offers industry news and comments from leaders whose opinions shape events in pharma. Subscriptions are free at chronicle.healthcare. 


This year's virtual National Pharma Congress will be a series of weekly 90 minute webinars featuring the best minds and the most vital subjects, starting Wednesday, October 21. 


Here's a hot tip: there's a flash sale on registration coming this weekend for 72 hours only. You can save some serious cash on the registration fee between this Friday and Sunday midnight. Check it out at pharmacongress.info. 


We want your questions and comments send them by email to health@chronicle.org or call our comment line. Liona is standing by to take your name, a callback number and the question you'd like to ask. Call 647-875-9011. 


The NPC Podcast was presented in cooperation with Impres, Canada's next generation commercial partner. Learn more at www.impres.com


I'm Mitch Shannon of Chronicle companies. The producer is Jeremy Visser. Your announcer is LIona Droidingham. 


Have a great weekend. Stay safe. See you next Wednesday.