Jeff Elton:

Welcome to the ConcertAI Podcast season two. I have the great pleasure today of being with some very long-term colleagues and partners, Sibel Blau and Caroline Merillat. Dr. Blau has had the pleasure of working in the context of Quality Cancer Care Alliance. It’s one of the largest independent oncology networks that has been fiercely independent of assuring the vitality of community oncology, both from the care delivery side and from the clinical research side. Sibel and Caroline have been responsible for setting up a new research entity called Exigent.

When you bring these themes together, they’re at the front edge of work in the fields of real-world data, advancing clinical research into the community, assuring that all patients have access to clinical trials, assuring the trial populations themselves will ultimately look more like the standard-of-care population that will get newly approved drugs. With no further ado, let’s begin the conversation with Sibel and Caroline.

Sibel, how did you go into oncology first? What brought you into the research side of oncology? Because that was a distinct choice. And maybe a little bit about your practice setting as well.

Sibel Blau:

Sure. Well, thank you very much for this opportunity. And it’s great to talk about QCCA and Exigent Network. I’m a medical oncologist and hematologist, always been interested in oncology ever since I was actually 15 years of age. For me, oncology was a naive dream of curing cancer. Well, it is not that naive because in my career, I believe I cured a lot of cancer patients. Yet, we know we cannot cure everybody. This is why the research and scientific development is so important to me, to be able to help patients with cancer.

I got into QCCA, and I was one of the founding members of QCCA because we are an independent oncology practice world. My practice is an independent oncology practice in Pacific Northwest, and there are practices, just like me, that do a great job in the community. This is why most of the patients, about 85% of the patients, are seen in community oncology. We work with patients day in and day out and deal with all their issues, anything from socioeconomic levels to end-of-life, to really work on opportunity to work with the research, to work with their care.

We created QCCA because we felt that independent oncology is at risk. A lot of people think that doctors, clinical oncologists, make a lot of money and there is a lot of greed there. The concept of what we really do and what is perceived, or what is being represented, is very different.

Jeff Elton:

I’m going to ask you a lot more questions about that, and I want to ask you one more question. I have to ask about why 15 years old? How did you know you wanted to be going to college at 15? And then, I actually will do Carolyn, but I want to go right back to where you were about independent oncology.

Sibel Blau:

All right.

Jeff Elton:

But why 15?

Sibel Blau:

Well, I was even younger than that when I decided to become a doctor. But I read Madame Curie’s life. That’s what got me interested in oncology.

Jeff Elton:

Wow.

Sibel Blau:

I was 15.

Jeff Elton:

That’s great. Caroline, maybe a bit of an introduction of yourself and how’d you come into the world of oncology research?

Caroline Merillat:

I’ve been in research for just over 18 years total. I fell into research because I actually had the skillset to do it, and a friend of mine referred me into research. I started doing research in a nonclinical setting, and it was in the community, which was really amazing to engage. But at the time, I worked on some of the time grant-funded projects. So, when the project was done, so was my job. So then, I got into pediatric oncology and fell in love with the process of oncology and the way that we could touch people, patients, families, that kind of thing.

Then, I ended up moving to Florida, worked at another institution, and there I engaged in a lot more parts of research. I’ve done all the different phases of research, plus all the different process involved in research, from data entry all the way up to supervising. But while seeing patients, some of our patients would drive maybe seven hours to get the treatment on a trial. And then, just like every other family, cancer hit my family, too. I grew up in a very rural area, and I also then had to refer my family to a bigger institution to get the best care and felt that was sad. Because everyone can’t do that. They don’t all have the resources.

And then, I came into a contact who knew about QCCA. And when it came to QCCA, I didn’t just apply for a position, I asked to be a part of the organization and make change in the world. That is how I came to be at QCCA two years ago.

Jeff Elton:

There’s clearly layers of motivation and things that brought you guys together. Sibel, you have some phrases sometimes about what QCCA is and how you think about independent oncology, and you’re very protective also of independent oncology. Maybe you can describe a little bit more about why you’re so motivated and what brings that motivation forward, and a little bit about what really differentiates what QCCA is as an entity. Because it’s quite different than other organizations and corporate forms and other things that have emerged. I think it’s important for people to really understand that.

Sibel Blau:

Years ago, when I was a new doctor, I had no idea of business of oncology. I became an oncologist because I wanted to take care of patients. But when you start working in a private practice, and I did come from the academic system, so I had no idea how it all worked, everything was magical. You just ordered things, it just happened. But here, you had to be very thoughtful because otherwise, you wouldn’t get reimbursed. If you didn’t get reimbursed, then you wouldn’t have a clinic to keep the doors open at. But we needed to own our own destiny and to be able to provide the best care and live our lives.

Well, years passed and, of course, the more you learn about the business of oncology, the more you realize, especially in this era where the reimbursement has cut down significantly, where other entities grew, the private equity firms that started buying oncology practices. PBMs came into the picture and started cutting down the piece that goes into what we pay our employees with. So many different pressures like this made independent oncology harder to survive.

Years ago, we were with another national organization and one of the best things about it, we had just developed a research network. That’s what I really wanted to do. At the end of it, in 2014, I went to a few people, a few practice members, and I said, “Let’s just do this, but let’s, this time, lead this ourselves. Because we are at risk. Our clinics are at risk. If we come together, we can do research, we can do all the other things that can bring revenues to our practices, and we can improve the quality of patient care. Because we’re going to share knowledge and best practices.” That’s what we exactly did.

QCCA was established on September 10th, 2015. Shortly after us, about maybe six months later, Barbara McAneny also started NCCA. We went in very similar paths with different focus in what we do, but our goal was the same. Learn from each other, bring more opportunities, bring more resources, so we can actually keep the independent oncology alive. Because that’s where I need to send my own family or my own patients to be taken care of. There is not enough space in the academia or hospital systems to deliver care.

Delivery of care, it’s an ecosystem. We need all of it, and I strongly, passionately believe we need independent oncology to be alive.

Jeff Elton:

I was struck, and we had the pleasure and I think one of the reasons you’re in Boston, and we can get you to the Cambridge studio here, is you’re holding one of your semi-annual meetings here during this period. I was struck by many of them are growing, many of them are even expanding some of their practice locations. Many of them are thinking about how they expand the research-accessible locations there. There was a vitality that was coming out of the group. How do you feel you’re keeping and actually almost encouraging that vitality? Because in a way, it was quite striking, just even in the conversation as you listen to them.

Sibel Blau:

Well, we know that the private practice is not a single sport anymore. You have to be in a team. And when you’re in a team, you actually can bring more resources and understanding what you can do to be better in many ways, both revenues and also quality. I think the QCCA gave that opportunity to practices to bring other ancillary services, to create things together that they wouldn’t otherwise do themselves.

My practice was Oncology Care Model practice, and we did extremely well at Northwest Medical Specialties because I learned from the people that actually knew how to do it. We got into data analytic tools, which we couldn’t afford ourselves, and those tools taught us how to behave to increase our value in the OCM. I’m not surprised the practices are able to afford and do more to provide better care to their patients despite the fact that there’s a lot of pressure going against us.

Jeff Elton:

For those that may be listening, don’t always talk about OCM, that’s the Oncology Care Model, which was a particular initiative. Just to make sure that that’s out there. But you mentioned Barbara McAneny, and I know the two of you and the two organizations got together to create Exigent, with the idea that Exigent could even become broader than your two organizations over time.

As you thought about really creating, probably the first in a long, long time, expanded capacity and capability research network, how did that come together? What was it that you thought you’d be creating, and what were you going to be providing that wasn’t available before?

Sibel Blau:

Well, it was actually QCCA years earlier. In QCCA, we figured out that we need to share our data to be able to learn from each other, and that led us to use the data to do clinical trials or other real-world data studies. Very small amount. In 2020, after working for a long time, we created QCCA Research Network. That’s really very unique because we use the same data warehouse. We have all our patients’ data in there, and we’re able to screen and do a lot of work to be able to help practices to provide information, so we can actually match patients to the clinical trials that are useful for them. We have great strategic partners. We use some digital tools and other stuff to really help that research.

With all that, what we have is each other. We can talk to the doctors at the practices, we know the patients, and so we have this close-knit community where we have also technology helping to really accelerate research. We were about 15 practices in QCCA Research Network. We had a very small but very solid infrastructure. We started working with pharma. Also, some of these practices were already very good research practices. In 2022, Barbara and I started talking about it six months before. I’ve never created a company that took six months to create. When I talked to her about what we’re doing, she said, “Oh, we have about seven practices that are interested in this.”

We really whipped it up, and in June 2022, basically we expanded what we called QCCA Research Network into a bigger group of practices. And boy, what did it bring to us? We got expertise in phase one. We got expertise in bispecific CAR T-cell therapies. We have now a huge theranostics group growing up. And all of that happens with a very unified approach. We’re making now standardized protocols and SOPs. If I were a pharmaceutical company, I would go to Exigent and say, “Okay, we have a trial. Do whatever you want with this, because we have proven quality measures. We have practices that are very interested in doing research. We have patients and we have data tools to be able to help that.”

Jeff Elton:

Yeah. You were talking about you get to know the patient and the physicians, and the physicians know the patient. In one of the conversations I had at your meeting, it was interesting. Somebody, it seemed obvious, but it was not obvious, said, which is, “We’re not actually looking for patients for the trial, we’re looking for the right trials for that individual patient.” Even as just a very simple statement, it was a very big paradigm, different that was there. I heard it just in your language as well, which is, it’s actually what’s going to advance the best interest of that individual patient. Which, now, since you’ve got a common moral compass and North Star that’s within the organization, that seems to be there as well.

There’s an FDA imperative these days for having trials’ populations be closer to the ultimate population that will be receiving a new medicine under standard of care. From the description that you all gave about what you’ve built and the locations and where you are, and even this notion that you’re trying to be as close to the home and the community and the support network of the patient, it would strike me that you would be in a means by which actually sponsors could accomplish that. Could you say a bit more about that?

Sibel Blau:

Absolutely. We have this huge data warehouse we can access to data and understand where the patients are located and what their issues are, what their ethnic background is, and what is the barrier to deliver the care. One of our pillars at Exigent is actually health, equity, and diversity, and we have very active work going there. Anything from creating some prevention and high-risk clinics to really working in those communities. How do we provide care to three-hour away rural area where the patient cannot even eat food because their socioeconomic level is so low? How do we also communicate this? Because we have different communities.

There is Dr. McAneny’s site, for example, in New Mexico. They are adjacent to a Navajo reservation. So, how do you communicate with those patients? Because the idea is not just, “I am not an academician that’s sitting and this is my research protocol. I have to just accrue patients to just one particular protocol.” We’re trying to bring patients into the new drug development. It’s going to be helpful to them. But how do you translate that information to a group of patients out there that are really skeptical of clinical trials?

We have an active group that’s chaired by Dr. Sanchez, and also our clinical operations director, Caroline Merillat, that is growing, and including a foundation that can help some of these issues to be resolved. We’re also working with pharmaceutical companies to see if they have an interest. And everybody does, because there is an FDA mandate right now to see what they can do to help this, if we can partner at higher levels to bring the care to these patients. There is a misconcept, or at least it’s not a misconcept, but that’s how it’s been represented out there by academia, that they see all the socioeconomic level is more important to them.

We take care of these patients in our clinics. We have sites that have two urban sites and 23 satellites. Some of them are four hours away. Those doctors drive once a week to deliver care to them. We just need to reach to those patients in every way, including clinical trials.

Jeff Elton:

I guess I’m hearing the trials are more accessible. But I’m also hearing because you are in the community, part of the community, and they see you as part of that community, the trust level just from that is actually higher. Even this notion that they might consider a clinical trial is now higher because of that relationship.

Sibel Blau:

Yes. And we can do that better, though. There’s going to be need for more education, so that Exigent can provide the tools for that education.

Jeff Elton:

I look forward to actually discussing that at a future time. Caroline, in one session, one point in time, you espoused really finding technology to beneficially really augment the research teams, to allow them to do what they do best; interacting with patients and spend time. ConcertAI had a privilege of starting to do work almost a couple years ago in that particular area. But maybe you can just talk about how do you see the world? What supports clinical trials changing, and how would you like to actually even begin to see what a trial feels like, and the experience to the research teams, how you’d like to see that change and evolve as well?

Caroline Merillat:

To your point about using that technology on the day-to-day for the clinical research staff, everyone who’s been in research suffers probably from the same shortages in resources. Clinical research trials take a lot of effort to execute on a practice level, and data entry being one of those big time-sucks for the coordinators. Knowing how important it is and how critical to the end points that data is, that does take a long time.

And then, also finding those patients to go on the clinical trials. When we’re spending a lot of time in the clinic screening and spending a lot of time entering the data, that’s less trials we can open, so that’s less access for patients. The more technology we can incorporate to offload some of the effort from the coordinators, the better off the patients will be at the end.

We are in a unique position with our practices because we are close with them, like Doc Blau was mentioning a little bit ago. We can reach out to them. We have relationships with them, so we have access to their feedback to find out what does make it better. In utilizing some of these tools, we can improve the tools, we can make them great, and we can relieve some of the burden on all the practices.

Jeff Elton:

Together, I think we’ve talked about even saying, is it possible to get to a zero data entry kind of model for the teams, so that, in fact, they’re really just focusing on that particular patient? I guess some of what we’re seeing, we’re halfway there. But are you optimistic that that can get most of the way there, including some supporting capabilities?

Caroline Merillat:

Yeah. There’ll always be a human component to it.

Jeff Elton:

Oh, of course.

Caroline Merillat:

The more we can get to a place where even our source documentation is automated, that will help us with the AI piece of it. I think there are still barriers to break through in just the ideas on source documentation. Because right now, that’s probably the biggest barrier, I think, is some of the paper source that we have. And then, being able to integrate that into automation. But knowing that that’s what the barrier is, makes it easier to come to that solution. I think that I definitely can see most of everything being automated with more of a review process happening.

Jeff Elton:

What are you seeing? Because you exist in a world where you have your research workflows, but you’re interacting with sponsors. Sponsors bring their own technologies, et cetera. What sort of changes are you seeing in the sponsor view and how they’re beginning to think about how they want to interact with a network like Exigent?

Caroline Merillat:

Well, they are in definitely various different points of thinking throughout the different sponsors. We have sponsors that are really excited about the innovative approach that we can have. We’re privileged to work in this type of environment where our practices are independent, but that, on a sponsor side, provides a lot of challenges in their execution because they pretty much like standardization. We have some really great partners in Pharma that are willing to overcome some of those barriers, create new processes with us. And then, we have some that aren’t quite there yet, but have been really excited about starting those conversations.

Jeff Elton:

An important thing you just said here, which is, you’ve tried to change how you operate and how you work, and actually even have a single IRB review that goes across multiple separate legal entities. But also, you’re now seeing an appreciation where the sponsors say, maybe if we change a bit about how we work, that enables us to take advantage of some of the changes and efficiencies that you’ve put into place.

Caroline Merillat:

Yep, absolutely.

Jeff Elton:

You have a novel approach to just-in-time trials that you’ve really focused a lot and put a lot of emphasis on. Can you tell me a little bit about it? Because just what you’ve done and how you’ve done it with a consistency across multiple locations, that’s a pretty unique model, actually.

Caroline Merillat:

It is. Again, we’ve got some really great partners that have wanted to pilot these types of programs with us. We take a lot of care in the planning and setting up of the model with each and every sponsor, because there are multiple layers; sponsors, CRO, practices, Exigent. We build tools where we can screen and find the patients. We identify a patient. And once we identify that patient, our goal is 10 days to activate the site and get that patient enrolled, which is a extremely precise and collaborative effort on everyone’s part.

When we do find that patient, we prioritize our work to make sure that that patient gets enrolled on this study. And then, once the site’s activated, we continue screening and finding patients for them to add to that trial, and then keep looking for more patients at other sites.

Jeff Elton:

Doing that at a network level has clearly took a lot of work and infrastructure and capability, which I know is still being built out. So, congratulations to get as far as you have on that.

Sibel, I’d like to go back and ask you a few more questions, and maybe it’s going to be a couple quicker ones, which is, if you were to talk to a potential new research site joining you, and at least my understanding is, Exigent itself is also prepared to integrate research sites that may not have been originally part of QCCA and NCCA in that particular model. But if you were to describe and say, “Here’s why you should be enthusiastic and begin to do most of your clinical research through Exigent,” what would be your key message to those other research-centric practices?

Sibel Blau:

I feel my practice does extremely good research, and we have early-phase development program with phase one in it, first-in-human studies. We do extremely well with traditional studies and deliver high-quality research. But even my site, among other very advanced research sites, don’t know everything and don’t have access to everything. By working through Exigent, one, there is a lot of lessened burden on the administrative site. Having this centralized approach, practices were worried about losing their employees because we would take over.

No, we reduced the administrative burden in the areas that are really not necessary for them to focus on, so that they can really focus on groundwork with the patients and coordination and do a higher-quality work. Not only they had to hire more employees in that regard, but that also comes with a budget. It’s actually budget-neutral for them. Whereas, if they had to put money in that administrative side, it wouldn’t have been possible. They couldn’t have advanced the research.

If you’re working with a centralized network like this, that is helping bring in access to greater trials and all the opportunities, you have a portfolio that’s so big that you can choose from, depending on your need and your ability. And then, over time, we are also developing this very close network of education. We just kicked off Exigent Academy, where we’re going to be training PIs, Sub-Is, CRCs. They’re already trained, but that further education, further training, so they are higher quality and they really have accreditation in certain areas. And constantly review what we do and what we don’t do right and develop SOPs together.

So yes, my site is an excellent site, but it can be only perfect by doing it with Exigent.

Jeff Elton:

I love the description that in the federation of more research entities, you both may get more capability. I also love the description that even as big as one site may be, you actually can provide capabilities at a more centralized level that actually normal economics could support. I’ve never heard, at least not over the last two years, and since the pandemic, have I heard anybody saying, “I have all the staff I need and my retention is perfect.” That’s not a statement I’ve heard coming out of anybody’s mouth. And so, I can only imagine that that augmentation is greatly and deeply welcomed and appreciated at that point.

But the notion of actually providing a broader range of studies that may even be some of the most innovative, important mechanistically in terms of what’s there, to allow people to tailor studies to their population, to their area, and to their capabilities, that’s something that would probably be very difficult to do on a standalone, single-entity basis. That makes a lot of sense, and that’s also got to just be tremendously valuable for them and the patients, obviously.

Sibel Blau:

Absolutely. How do you even get into your own data and make any sense of it? You don’t have time or capacity. But then, we have the data warehouse and the engine that the team can work with, other partners as well, to just sort out that data and help us with finding those patients, finding valuable research.

Jeff Elton:

If you were almost to give that same message that, “Here’s a sponsor with a healthy, early, mid, late stage pipeline and clinical trials that really may have worked occasionally with individual practice entities, but does not have a relationship with Exigent,” what would be your message to them about why they should begin to cultivate a broader longer-term relationship and maybe even change other relationships that they have?

Sibel Blau:

We’re serious about accelerating access to clinical research, and because we want to bring more opportunities to the patients and we want to help the science. What is a better mechanism than very nimble, very fast-working clinical practices with the highest quality, enhanced by an engine and a system that’s centralized, and that can work very closely with the sponsors? And also, as needed, with the physicians that have the patients, and even helping the physicians to really do the right things with education and training?

If I were a sponsor, I would think that time that Caroline mentioned, the 10 days and the just-in-time, by the way, just to give you a concept, it’s probably four months for an academic center. We actually did a study. It was a time model and I presented at ASCO last year. The independent practices, by using this just-in-time trial, identified all the patients four months before any academic site, including MD Anderson, found their first patient. We not only do it in a faster way, but in a much more economical and higher-quality way.

Jeff Elton:

I can actually attest that even in a site-based model with Exigent, you also are at some of the best-in-class timeframes from point of contract into site SIV as well.

Sibel Blau:

Exactly.

Jeff Elton:

And that’s actually been improving as well. Caroline, I know you have a lot of rich contact also with the sponsors. What would be your message to them?

Caroline Merillat:

I actually give this message on a weekly basis at least, but when I’m having a conversation with any of the sponsors, the advantage for them to work with Exigent, aside from the obvious, it’s in the community and the diverse population. But as far as operations go, we are fast. We usually have a contract done in eight weeks or less. We have sites ready to activate within that same eight weeks, so we’re working on contract and budget centrally. They don’t have to do that on a site-by-site basis.

And then, we’re working on the prep work to activation at the same time. So, we have even activated sites in the non-accelerated model in under six weeks. We can do it fast, we can get the sites that we need, we have higher-site engagement, and then we also have other centralized services to help those sites even recruit patients when we need to.

Jeff Elton:

I think the world of community oncology has gone through just enormous changes over the course of the last 15 years. If you were to articulate what would assure that ongoing vitality of independent oncology going forward, what is it that’s most important for that to remain and maybe even obviously to continue to grow and flourish?

Sibel Blau:

There is incredible talent among QCCA practices just during this summit. We also had NCCA sitting with us because we’re also Exigent members together. We have had different projects, both at QCCA and some similar projects. But what is very amazing is that we know we will not be able to survive if we are just doing fee-for-service drug pricing. And that’s if our medical oncology clinic is just dependent on that. But we want to remain independent. Believe me, I would be happy any day to take all this drug pricing away from me. That’s the only way we can survive right now, because that’s what our majority of margin comes from.

But we have other things we can provide and together, not only we find a solution to it, but the scale gives us the power of negotiation, power of access, sharing the knowledge with each other and learning from each other. All of that improves the quality of care that we deliver to the patients. So, I think our solution to all the changes, because we cannot compete with the vertical integration. We cannot compete with payers buying the PBMs and working with pharma and taking rebates, and therefore leaving us with nothing out there. We cannot compete with any of it. It is a reality.

But what we can do, we can get together even more and stick together. This is why QCCA and NCCA are planning to come together in a much more united way to approach things. So, bring our strengths. And with even larger community oncology coming together, we will have definitely a power to be able to provide those extra resources that’ll keep us not only alive, but thrive.

Jeff Elton:

What I hear from that is, it’s not about the vulnerability, it’s actually about the strength and then the resolve and the confidence in a direction that will act as the assurance of that particular vitality. That certainly echoes with the feeling and the sentiment that I got around the meeting and the forum. That was what was resonating at that particular meeting.

And so, this is a little bit about shaping that future destiny and taking that into your own sense of strategy. I heard you almost talk about reimbursement and emphasis here on value. I’m also hearing that you’re also thinking in a direction where you may shape even some of how that payments may be taking place in the future.

Sibel Blau:

Well, there is a huge deficit because of the inflation, and even more than what was predicted before COVID. In the next three to five years, there will be no money to pay for any services if we continue to go this way. In fact, for us really to catch up with the deficit, the doctors have to work more, they have to have less employees, and we have to probably charge more. And we won’t be able to. Therefore, how are you going to even be able to do this?

Now, during this meeting, we talked a lot about these things. It sounds depressing, but I really have this optimism, and that’s shared by Barbara McAneny. Together, we have a lot to do. I think we can be really a powerhouse and really remain independent, not needing to go into a PE-backed oncology practice, or be employed by a hospital system. I have all the respect for them, but they are a part of the ecosystem. They should not be the oncology caregivers.

Jeff Elton:

I’ve seen both of you take on a lot of issues head on, both of you persevere to a successful outcome. So, I have no doubt in my mind. I really want to thank both of you. I think for one, I think ConcertAI and me, personally, have had a pleasure of being engaged with QCCA formally since about 2018, when we started doing some collaborative work on retrospective RWDs.

We’re actually in the sixth year of actually doing that. We’ve had the pleasure of doing a range of other very novel areas, working now closely with Caroline in the whole area of digital and AI augmenting some of the efforts and activities of Exigent. In fact, many of that would not have advanced if we didn’t have the collaboration that we had so far. So, we’re quite grateful for that.