Webinar: Tech-Enabled Oncology Clinical Trials — Delivering Faster, Higher Quality Trials for Sponsors

Simon Burns: Hello. Thank you for attending our webinar today. Wendy and I are thrilled to have you all and speak to you today about Tech-Enabled clinical trials in Oncology. Let’s jump right in.

 So, as I said, the topic for today’s webinar is Technology-Enabled oncology clinical trials how to deliver faster, higher quality trials with technology.

Let’s introduce the crew we have here today. I’m the Co-Founder and CEO of Vial. I come from a technology background having been on the founding team of several successful technology companies that have reimagined other industries, and that are now excited to be building at a team with- with Wendy, and- and several other, to reimagine clinical trials using technology and a great team to do so.

Wendy, do you want to introduce yourself?

Wendy Pinson : Sure. Good afternoon. My name is Wendy Pinson. I currently serve as Director of Oncology for Vial.

I’ve been in the clinical research industry for 14 years, working across multiple therapeutic areas during that time. My experience began on the site side of both pharmaceutical and biotech companies.

Following my site experience, I transitioned to the CRO side of our industry, and I’ve worked for a multitude of sponsors over the years. I’m thrilled to join Vial and to help expand our oncology team.

Simon Burns: Awesome. And as you’ll see, the combination of Wendy’s skillset with a decade-plus of- of clinical operations experience, deep understanding of sponsor pain points, deep understanding of clinical operations, indication, finding indication nuances, and my background coming from technology and product serves us well as Vial. And it’s one of the core things that we’ve done purposefully to build out a team with two very distinct backgrounds, to mold each other.

To kick us off. What brought us together? Well, Vial was founded with a key mission in mind. And that mission is to reimagine clinical trials, rebuilding infrastructure to support faster, more efficient clinical trials. And our approach to do that is really twofold. The first is to build a network of clinics. I think we’ve been surprised when we speak to clinics in oncology, whether it’s private practice or academic settings, how much they’re looking for something new, um, whether it’s query management or site startup timelines, some of that , local IRB are a part of the story, but even just the core process of going back and forth, getting into a trial with CRAs at a CRO, getting into the trial support throughout the trial, they have pain points across the board. And they’re looking for something new, a breath of fresh air when it comes to the CRO space. And so we’ve been able to build a network of oncologists. We’re very excited about our model.

And the second is building and employing a technology platform. And we’ll talk about that today everything from site startup, to the roll in period, and everything in the background is all supported by technology platform that’s connected end to end.

I opened about talking about how our team really merges two worlds. It merges the existing CRO worlds and all of the benefits that come from a deep expertise of the sponsored pain points, a deep understanding of the nuances in each therapeutic area, as well as tech- leading technologists leading engineering teams, leading product management teams. Hence, the merger of these two, that’s helped us build what we’ve built so far; which is that interconnected technology platform. But not a platform that’s disconnected from reality, when it’s very- very much rooted in the pain points, and focused on driving efficiencies.

So, with that, let’s turn to the first question for Wendy. Wendy, we’d love your opinion here. We speak to a of early state oncology companies the ClinOps teams in particular, and they go, “It’s our first trial. It’s our first trial in this specific tumor type. First trial, with this modality. Give us advice. How should we run our trial? How should we design our protocol to ensure or drive up the chances for success?” and sure many of them are on the call today, asking and thinking exactly this. what would you tell them, in terms of how to design their protocols to optimize the clinical trial?

Wendy Pinson : So, my advise would simply be not to rush the process, do your homework ahead of time. We all wanna see new therapies advance. I know all of us have likely been touched by personal experience, which a loved one may have lost their life too soon to malignancy. And we think, “Wow. Why can we not get these drugs to market sooner?” We want to, but we need to kick these protocols off correctly and with efficiency, from the beginning. And that would be my best advice.

Perform as much pre-clinical work as you can. Don’t choose the first CRO that shows up to the bid defense that just has the best bottom line number. Really vet your CROs. Choose the CRO that has integral processes and technology put into place to serve the patients in the therapy best.

Go to the basics. Make sure that you’re designing your inclusion, exclusion to really align with those standard of care practices that’s being utilized for your tumor type now. Make sure that you’ve got a specialized medical monitor team that can truly give the investigators the support they need for the safety profile of that drug.

Last, but definitely not least, when you’re looking at your CROs, make sure you’re choosing a CRO that has a vast site network that can deliver. There’s going to be challenges with enrollment on oncology trials. There always is. And while we all wanna work quickly and efficiently, being thorough with those granular details will actually ensure that you finish [00:05:00] your enrollment ahead of time, but most importantly, with quality data that you can present to the FDA.

Simon Burns: A quick question has come in here. “Does Vial have the capabilties to contribute to protocol development? Can we actually get our hands dirty to help our protocols? Wendy?

Wendy Pinson : Yeah, absolutely. We have a great scientific advisory board on our oncology team that is specializes in multiple different tumor types. It is, in fact, our goal to have a specialist across every tumor type in oncology world. So, we absolutely can be a lending hand to help support writing those protocols.

Simon Burns: We have done quite a few. This is something we’re quite good at. Awesome. Let’s move along. Another key question from these folks you speak to on the clinical operations teams that biotech companies say. You know, tell me more.

You know, we’ve got the protocol. We’ve optimized the protocol for success. We’ve sat down with KOLs. We’ve sat down with several CROs. We think we’re gonna do a good job here. We think we’ve mapped out all the possible pitfalls. And yet, still, there’s- there’s often challenges.

Maybe give a little preview into what some of the challenges are that oncology companies tend to see in operations of a clinical trial, both in the site perspective and the CRO perspective.

Wendy Pinson : I mean, honestly, Simon, I think you hit it early when you said all sites that we talk to, they have various frustrations across the lifecycle of a of a project. We know there’s numerous challenges that come in oncology trials. And sometimes, that’ll cost us to lose sight of our end goal, which is just to help advance those therapies for patients that otherwise may not be able to fight this disease.

Unfortunately, I think the sites experience the brunt of those challenges and those inefficiencies. In a perfect world, we want our investigators and our study teams to be focused on patient safety and recruitment. But so many other areas consume their attention. Whether it’s the 10-plus vendors that a sponsor’s given ’em to work with, the lack of support they’re getting from one of their vendor platforms, continuously having to deal with on-site sponsor visits. I mean, there are so many things that we can name.

While none of those are just a huge time suck. When you combine them all, the study staff is wasting so much of their time, just on those simple inefficiencies. But think about a study coordinator running a a protocol, and being able to pick up that phone and have one person they can call, throughout the lifecycle of the project, for anything. Whether it’s an inclusion, exclusion clarification, a question about the EDC system. Something as simple as help with a query, or maybe they’ve got a subject in the office they need to randomize, and they’re locked out of their IWRS system. I mean, there’s just so many things and inefficiencies throughout the lifecycle of a project.

Vial is committed to streamlining that process. So, picking up that phone, having one human on the other end that’s not gonna tell ’em to submit a ticket and expect a response in 48 hours. But will help them, right then and there. I think that vision is what Vial brings to the table to help the site staff be able to focus on the true needs of their patient, and let us handle the inefficiencies of the protocol.

Simon Burns: Very well-said. We’ve got a couple of questions here to catch up on. We’ll get to Q&A at the end. But might as well get ahead of these.

First question’s from Sheila. ” Is it possible to run a complex oncology trial without large academic sites and who do you manage the allegation sites between prior practice and academic?” this is something we’ve talked a ton about.

 A key question to answer. Thanks for the question, Sheila. Wendy, what are your thoughts here?

Wendy Pinson : Yeah. Like, it’s the great debate in oncology, right? Do we take it to academic, or do we utilize private practice, oncology centers? And it is absolutely possible to run a study without going in to the academic world.

 There are a ton of, not just standalone research centers, but research centers that are affiliated with oncology private practices. So, just imagine a private practice oncology clinic that has clinical research embedded into their practice. Those are the sites you should go after if you’re not chasing academia.

They typically have a very short study startup timeline, in compared to some of the others. Some are under the jurisdiction of a local IRB, but the majority are not. Just the entire flow seems to run more smoothly and quickly when you target those, in my opinion.

And there are a lot of them out there. There are some great investigators that has been working in this arena for years, and are very passionate about helping their patients. So, those possibilities are absolutely out there. 

Simon Burns: Yeah. Just maybe quickly jump on there. I think when you speak to these private practices that we work with a lot, we do phase I, phase II work who like Wendy said, operate very smoothly, very, kind of streamlined operation.

They’ll tell you directly. It takes us one, two, three months for site startup, depending on the site. And they’ll say, you can go down the street, you can go work at the [inaudible 00:10:50], you can go to the [inaudible 00:10:53]. They’re gonna take six, nine months, right? Depending on exactly the structure. So that’s one trade off.

And the second is, you know, KOL, new modalities. Do you really need someone who’s at the cutting edge of the field that’s probably gonna lead you to an academic setting over a private practice. But I think, Wendy, nailed it on the head just to add a little context [00:10:00] there.

Okay. Second question here. “Have we approached the heavy hitters on oncology in attempt to have you join the network?” I’ll take that briefly head on. We built out the scientific advisory board, which both serves to help advise us in building the model, as well as helps create the context for that site network. Including there’s many heavy hitters on that. On the website, we have listed the full scientific advisory board.

I don’t wanna [laughs] play favorites in any way. But the leading academic institutions across the country are part of it, as well some of the larger private practice groups. So, really some of the, heavy hitters are part of that group. And, I think, in particular, I think that the heavy hitters almost are the strongest association and see the pain points most closely.

Someone joked to me one time that if you find a group of oncology KOLs hanging out around a barbecue, or somewhere typically, they’re talking about their distaste for CROs. That’s one of their favorite things to complain about. So, among those heavy hitters, we’ve had a really strong reception.

Let’s move on. I wanna talk briefly about how we built our technology platform, because this is critically important. A lot of technology has been built over the last couple of decades in in the space is built by CROs or built with CROs needs in mind, but not with site’s needs in mind.

And so, we started with a clear focus on the core end user. And so, PMs, CRAs, CRCs, Site Leads, over 150 interviews had deep focus on their core needs. We come from a software background building intuitive software comes out of the gate and how we think about. But this was the key focus of ours, we said, “Let’s build it intuitively. Let’s build it so that it reduces their burden.”

And then we worked very closely as we’ve been running trials between our two teams internally. And so, project management ClinOps works every day with our product design teams. Gives constant feedback, iterates, improves. And so you can see here, our E-source platform, critically intuitive.

There’s live chat unlike a lot of other platforms. You can directly access their team whenever you want. It’s intelligent. It catches potential errors in real-time, as you’re going through. And it’s a time-saver for sites. This is quite rare. Intuitive time-saver for sites, well-supported. We think we’re unique in building technology that fits site’s needs so deeply.

And then, from our perspective, this is what a CRA would view as data comes in. Again, intelligent, intuitive, modern software. This has been our focus, and it gives our- our team superpowers when running trials.

Lastly, one of the key focuses of our technology platform is patient recruitment. Both in driving patient’s to clinics from external sources. And so, we spend a lot of time. We now spent millions of dollars on our patient recruitment efforts. And so, we’re quite good at running. Whether it’s direct mail in radio, Facebook, Google other platforms online. We do NextDoor, we do Craigslist. All sorts of platforms to find patients.

After they indicate interest, our team will reach out to them. And so, we have a pre -screen team based in the United States, all with healthcare backgrounds who reaches out to patients, ensure that they have good experience, and schedules with us at the clinic. We also built EMR integrations into all the leading platforms. So we now have over 75 integrations in the core focus of our team. And so, the second the site is green-lit we’re pulling patient information out of their EMR, finding patients who are fit. And depending on the sites needs, I am calling them directly, or having the site call them.

And so, you can see here, some of the EMRs highlighted. We work with large institution EMRs, like Epic, Cerner AllScripts, etc., as well as small system EMRs. 

 There’s a highlight of our prescreen call team. A couple of the team members

okay. Question for you, Wendy. The obvious question is, you know, we’re building all of this technology. What is the opportunity for technology? Where can technology be applied to actually drive efficiencies? You’ve seen this industry up close for over a decade. What, in your opinion, has the highest promise for driving efficiency?

Wendy Pinson : It’s hard to nail down just one with that, honestly. I mean, my favorite thing about everything you just presented, when I was early in my career as a study coordinator, I can only dream about someone being able to access the data in our EMR to truly extract, and tell me, “These are the patients that may quality, or may benefit from this drug.” Like, that was the dream of mine. So, that’s amazing.

Also, when you’re referenced that Vial has healthcare background enabled screeners, that’s amazing. I mean, coordinators spend hours upon hours with recruitment firms, and recruitment opportunities for patients that clearly don’t qualify. They’re mining data, they’re calling patients. And the basic inclusion, exclusion criteria is not met. So, that’s a huge time suck that we’re gonna be saving the sites from.

But also, just to take it back to the basics. I meant, I started in clinical research when we were still using carbon copy case report forms. The CRA would come out to your site, once all the quarries were resolved, we should- she or he would ship those original case report forms back to the sponsor. The queries, which were on colorful, little Post-It notes, by the way.

So, obviously, a lot in our industry has changed with technology, in a short period of time. And, while the majority of that change is designed to make clinical trials more efficient, of course, it presents challenges along the way. Therefore, I think we have to take it back to the site-level. And that’s truly what Vial has done.

You know, they have listened to key members that can tell them how an electronic platform should work and should [00:15:00] operate. And they have taken that to heart, and really implemented that. I think that’s gonna take numerous burdens off study staff, and just let them focus on patient care. I think that’s gonna result in, not only timely, but quality recruitment, data, and safety information for all of our sponsors. And, at the end of the day, I think that’s gonna be the key for successful enrollment in any clinical trial.

Simon Burns: Well, now let’s jump over to questions and answers. We have a series of questions here. First off from David. “Is Vial only oncology-focused?” Wendy?

Wendy Pinson : No, Vial is not only oncology-focused. Vial is multi-therapeutic. So far, we’ve got a very heavy background in dermatology, ophthalmology, GI, women’s health. Oncology is just the newest therapeutic area that we are looking to expand.

Simon Burns: From Sheila. “Are labs integrated?” I’ll take this briefly since it comes from a technology perspective.

Yes, we’ve worked with, not only lab companies, but also companion diagnostic companies, GS companies, in order to integrate the data right into our system. That means it’s visible from the sponsor perspective, also from my team’s perspective. It’s quite a bit more efficient to compile that data, structure it correctly in real-time rather than in, kind of, the after patient in, and to go in and structure that data. And so, it’s been quite efficient for us.

Another question from Sheila is, “Are site analytics available?” yes. We do structure dashboards for sponsors. All the information you saw there that we showed earlier, the workflows, all that data structure that’s shown in dashboards both in weekly client readings, but also accessible inside of those client meetings.

And last question for you, Wendy then we’ll open it back up, is private practices come with complexities some of them don’t have equipment needed and will need additional support. Maybe just give some of the challenges in doing private practice oncology trials?

Wendy Pinson : Sure. I mean, those are great points. Every site’s gonna come with challenges. To your point, some may not have the equipment that they need. Some may not have all the study staff that they need. And that’s just to the expected to a certain extent. But the great thing, in my opinion, is Vial can help to overcome those.

We’re not still at the mercy of scientific review committees; they’re gonna take nine months to get started up. Those are problems that we can fix along the way.

And with Vial’s infrastructure, we have amazing client success managers that work with our sites to help them overcome any challenges, so they can be successful at a protocol before they agree to work on it.

Simon Burns: Another question here. How does technology-driven aspect increase the rate of patient recruitment? Please elaborate. That’s a really great question. Thank you, David.

 I’ll pull back over here and jump right into it. Really, the main way to think about patient recruitment that we do, and how to drive it forward is that CRCs, Clinic Research Coordinators, are really strapped for time.

One of the main things that is a challenge, in terms of patient recruitment, is just coordinating with tens, if not hundreds of sites and making sure that they’re following best practices. And getting to everyone up to those best practices is a key challenge.

Now, best practices mean, not only doing the basics; finding patients in your electronic medical records, and contacting them, but also means running local advertising campaigns. It means connecting with nearby clinics to see if you can connect patients there. It means tracking your patient recruitment campaigns, and then testing and changing them.

Now, everything I just described is really outside the scope in expertise of what a clinical research team is quite good at. And so, when we support clinics, we say, we’re here to support. We’ve got best practices that’ll help you drive enrolling.” and so, when we say we’ll help you find patients your EMR, with technology, identify them, contacting them, if you want. I’m sure they show up almost all the time.

Of course, you have some folks that, with different preferences who wanna keep control. Almost all the time, they go, you know, “This was really quite challenging for me to go through eight different clinics. A lot of time invested just to find a patient, nevermind do everything that you do. Please, come come help us with EMR filtering.”

And same goes for the patient recruitment campaigns. Historically, a lot of patient recruitment vendors will run a campaign, you know, TV, direct mail, Facebook. And then they just send the emails to the research coordinator. Well, the research coordinator does not have time to contact that patient. They don’t have time to get in touch with them, identify if they need inclusion, exclusion criteria, and then have them come into the- the clinic.

With Vial, not only are we running high quality patient recruitment campaigns, we also have a prescreen call team, like Wendy said, US-based healthcare experience. They’re identifying high quality patients. And so, from a site perspective, I know that when Vial is involved I’m gonna get high quality patients who are gonna show up, and it’s not gonna be an extra burden on me. And that’s a real- really big game changer.

So, to summarize, in total I think the more traditional trial outside of this model is really held back because CRCs aren’t following best practices. They don’t have time to get around for recruitment as much as they should.

And Vial is taking on responsibility, and drives a lot of value, by being faster, following those playbooks, and really deploying best practices across all sites.[00:20:00] 

Sheila says, “How do you intend to remove the review committees? What’s the legality at the kind of institutions?” question on local IRBs, from from Sheila.

Wendy Pinson : Yeah. Sheila, to be transparent, we cannot review those. You’re right. It is a legality of many of the academic institutions. Which is why we kinda look back at, often, a two-pronged approach. You know, we talked a lot about oncology private practices that are locally-owned, and maybe just encompass clinical research. They can get started up much sooner.

While you’re starting those up, you can invest time in those academic centers that are looking at a six to a nine-month startup period, because of the legality measures they have in-place. So, we definitely can’t replace those. We just have to work creatively so that we can get the project started and executed on time. And encompass both sites.

Simon Burns: Sheila clarified. “Not the IRB. The scientific review before the IRB.” 

Wendy Pinson : Honestly, same approach. I meant, it’s the process and the legality that the site has in-place. A CRO doesn’t have a way to get around that. We can just work with our sponsors to ensure we have a great mixture of sites that we are bringing onboard, so that we can startup efficiently and timely.

Simon Burns: Awesome. Well, with that, thank so much for joining us today. Really appreciate our conversations about technologies and practical oncology trials. What Vial is doing, but also how we brought our conversation here. We’d love to pickup the threads and introduce you all to our team afterwards.

Don’t hesitate to reach out. I’m Simon@Vial.com. Wendy is Wendy@Vial.com. And we would absolutely love to have conversations about how we can support your upcoming trials. Don’t hesitate to reach out. So, thank you so much, and I appreciate your time.

Wendy Pinson : Okay. Have a great day.