Wendy Tate and Dylan Rosser Talk Metrics in Clinical Research
About the Advarra In Conversations With…
The future of healthcare innovation hinges on research and clinical trials. Advarra sits down with leading experts to dig into pressing issues and explore cornerstone solutions. Join us as we discuss topics and trends impacting the healthcare of tomorrow and advancing clinical research to be safer, smarter, faster.
About This Episode:
In this episode, Advarra’s Wendy Tate and Amgen’s Dylan Rosser delve into the importance of data collection in clinical research and share best practices to leverage metrics to effectively communicate and collaborate among sponsors and sites.
PhD, MS, GStat
Senior Clinical Research Strategist
Executive Director, Global Development Operations
Wendy Tate (00:04): Hello, this is Wendy Tate and I am the Senior Clinical research strategist at Advarra and I’m really excited to be joining the seventh episode of “Advarra In Conversations with.” Now I’ll hand it over to Dylan to introduce himself.
Dylan Rosser (00:16): Thank you, Wendy, equally as excited to be joining this episode, this is Dylan Rosser, I’m the Executive Director at Amgen’s Global Development Operations organization.
Wendy Tate (00:25): Today, Dylan and I are going to discuss the ins and outs of metrics for developing safer, smarter, and faster clinical trials.
Dylan Rosser (00:32): Thanks, Wendy, a really interesting topic and aligns with the first comment I always receive from anybody involved in clinical research, and that is: show me the data.
Wendy Tate (00:40): Absolutely I couldn’t agree more so let’s jump right in and really talk about why data collection is important for clinical research, so let’s level set with our Community, because we all know that there’s a lot of data collected in clinical research. So, Dylan, can you tell us from a sponsor perspective, why is so much data being generated and why is it important?
Dylan Rosser (00:59): Absolutely yeah metrics and performance data are critical across the entire clinical trial execution lifecycle from initial protocol development, ranging through to the generation of the final clinical study report. This in itself means that we’re generating huge volumes of data, the sponsor level which is likely myriad of the site level.
From a sponsor’s perspective, our internal processes are highly regulated. We have our standard operating procedures, and we capture cycle times across the spectrum of study planning, study startup, and conduct and close on.
All of these drive continuous improvement across that spectrum and they may be invisible to a lot of the sites that we’re involved in. So I’d be interested to see how does this mirror how sites look at their data and how they look at their processes?
Wendy Tate (01:43): Definitely, I think a lot of what you just mentioned there is definitely mirrored within the sites. Coming from academic research, my office and all of my colleagues were constantly measuring site cycle times how we were performing in the national perspective of a trial. And really not just taking a look at it from a single study perspective, which might be a little bit more about sponsors doing in the concept of agent development, but really looking at it as a portfolio and, basically, how are we as an entire research program performing across multiple studies and multiple agents and multiple indications?
And you know I think a lot of the data that we’re collecting for clinical research studies, which obviously helps with answering the scientific questions that are being asked when it comes to agent and therapeutic development, really, we’re taking a look at it, also from an operational perspective: Where are our strengths, where our weaknesses, how can we better drive drug development and how can we help the patient populations that are in our associated clinics? And so when it comes to metrics and data collection you know it’s really important for the site to be measuring their performance, not just for the sponsor collection of data, ensuring that your side of the house has that information to be able to continue phase to development, but also for our research portfolio, to make sure that we are obtaining the trials that best fit our patient populations that are seen in the clinics that we’re meeting the needs of our participants and subjects. But, also, that we’re operationally using our resources to the best possible outcome.
Dylan Rosser (03:18): That’s interesting I mean you mentioned there the kind of decision making of selecting the right site or selecting the right studies, for your sites and operational metrics play a significant part in that we, as we go through the site selection process and the site activation process, we use retrospective data and predictive analytics to try to understand what the historic performance may have been and what the future performance could be.
And so, when we look at our study startup metrics and we’re looking at IRB cycle times, we’re looking at the cycle times for the approval of contracts, for instance, a lot of that information will give us an insight into how that site would perform. But our initial kind of foray into site activation will really be about how do we develop our protocol, then, how do we get the first subject enrolled, and trying to understand how a site may fit into those parameters of rapid acceleration and rapid deployment and the study really interests us.
So I don’t know if there is a component of that that you measure and does that factor into your decision to get involved in a clinical trial if there’s an extended period of time between protocol approval and first enrolled in an overarching study or whether there are your other influences at play?
Wendy Tate (04:28): Yeah, absolutely. From a portfolio perspective, when you’re taking a look at multiple therapeutic areas when you’re taking a look at multiple investigators, especially when you have centralized offices of staff resources, whether those be financial resources, clinical research coordinators, regulatory offices.
You know we’re juggling at any time, dozens of studies that really need to best utilize those resources and so picking a trial is absolutely essential to ensuring that we’re best deploying those resources for several reasons, I mean we want to make sure that we’re doing meaningful research that is hitting a participant population. And we want to be successful, for the sponsors sites don’t want to be a zero or one accruing site, that’s not productive it’s not productive for the sites, it’s not productive for meeting patient needs, it’s not productive for progressing science from an academic perspective either. So a lot of the metrics you mentioned are definitely tracked very closely by sites. Even without sponsors asking for them how long does it take to get through IRB? How long does it take to enroll that first participant?
I had a Medical Director that I would work with that would constantly say that to his investigators, that you should always have your first participant identified before you even open the study to accrual. Not that you’ve collected data and you’ve done consenting and things outside of the protocol, but that you should know who your clinic base is made up of so that you know the patients that are coming in that could be really good potential subjects, so that you know that the study is going to actually affect the patient population that you’re seeing in your clinic. Even without sponsors asking for a lot of these turnaround times and a lot of these different data points, these are things that are already being collected, both by investigators and by study personnel. We need to make sure that we’re utilizing our resources appropriately. We need to make sure that we are hitting our patient populations and so with that being able to report back to our departments, to our funders, to other potential sponsors that we want to run research, we need to know how well we perform.
It might be slightly different definitions on what that means, you may consider the start of the activation process when you send the documents to the site. I may calculate that slightly differently, because I am reporting to the National Cancer Institute and they consider study activation when I submit a complete packet to the scientific review committee. So, we might have slightly different definitions that we need to have communication about. But we’re measuring very similar metrics to be able to talk about performance and talk about our ability to do good research. And that’s really important for us as sites to be able to communicate to sponsors, so that you also know expectations of us.
In certain centers, we need to have certain processes done. There might be different overhead items that need to be taken care of to ensure regulatory compliance, not just with federal research regulations, but with state laws, with institutional guidelines, making sure that our hospital partners are on board and knowledgeable so that they can execute the research properly. So when we talk about you know, making this research safer faster and better, a lot of that is really making sure that we understand our timelines to be able to communicate to sponsors how that time in the activation process and that time in the recruiting process is really maximizing those safety issues to ensure that research is done properly and data can be collected properly.
Dylan Rosser (07:50): You made a great point there actually around communication. I think the synergies are clearly there with the kinds of data that both sides of the house collect. We build resource algorithms based on again historic performance within our internal systems and internal processes to ensure we’ve got the right level of the resource being applied to clinical trials so we’re executing them in the most efficient ways we possibly can– you’re clearly doing exactly the same. Yet, it’s very rare that we actually share that piece of information to show how we support the various clinical trials.
So, I think it’s that there’s certainly an opportunity here for us to be more open on what we’re collecting and how that performance can play out in the clinical trial. One thing that I’ve been interested in in the last few years is how we can engage more in not imposing process and imposing kind of ways of working on clinical sites, but better involving with clinical sites and working with the process flows that you have where you’ve gained efficiency and how you can operate more effectively within the clinical trial.
So is there an opportunity here to look at, for instance, prescreened activity, screening activity of the inclusion-exclusion level of various protocols, and share that more openly? Because invariably sponsor companies only dive into that when there’s a recruitment issue, whereas if we have a clear line of site of that way up front, we can partner more closely and, hopefully, you understand where they may be issues, whether maybe problems in protocol design, maybe pivot a little bit more to get that trial executed more rapidly.
Wendy Tate (09:20): Dylan, definitely. I love a couple of the things you just said, you know, one of the phrases you just said is being open in metrics. And I feel like that is such a great opportunity for both sites and sponsors, that if we can just really be honest that this might not be the trial for us, we may not be a good fit for this trial. What I would hope would come out of a statement from a site to a sponsor is that the sponsor respects that site for it and approaches me again, not “Oh, my goodness, I can’t go back to this institution, because they’re too slow or they’re not going to be helpful, or they don’t want to do my research” but it’s if they say yes, they are dedicating themselves to the success of this trial they’re not just saying yes to everything. And I think having more openness in metrics can really play with that conversation if you come to a site and say, “we have this study and this syndication and we’re looking for this type of recruitment in this period of time here’s some inclusion-exclusion criteria like, what do you think?”
A lot of these sites have recruitment registries they have the ability to be able to take a quick look and say, do we have the patient population that could really recruit a subject into the study or not? And I think having those conversations up front and then taking a yes or no, and really utilizing that information to pick the best sites are going to maximize the sponsors ability to run a trial. But that’s also going to maximize the site’s ability to really dedicate those resources to you, to be able to say hey I’m going to give you my coordinator time, I’m going to give you this clinic space, I’m going to give you this cohort of patients and we’re going to really prioritize your study, and really make that successful and to do that, we need X, Y, and Z because this is how we are successful in being a recruiting partner with you. We talked about patient-centric research and there’s been a big movement for including patients and patient advocates and study design. You know, really, we need to do the same with sites if sites can be involved early on and say, I see that you have these inclusion-exclusion criteria do you realize that if you can move this laboratory range is this safe to do that because if you can bump that out a little bit, you’re going to open up a really big cohort of patients that can help with that. You’re really making it a lot more real-world evidence-based I think sites can provide a lot of information for that both scientifically but also with their recruiting metrics, these are the number of people, we see in this indication, we see this many screen fails, people don’t want to participate in trials because of X, Y and Z if we can provide those types of quantitative and qualitative metrics to sponsors early on in protocol development, we can help you recruit faster, and then we also feel like a partner.
There’s no longer this site versus sponsor. “I can’t tell the sponsor this because I’m competing with other sites”. It’s more of we’re partnering with our other participating sites we’re partnering with our sponsor for all of us to make this research successful.
Dylan Rosser (12:18): Wendy you said a few things there that were music to my ears, I think, patient-centricity certainly starts with physician and site centricity. I think having that relationship and open partnership to better understand what the challenges and opportunities are to treat our patients with the appropriate medications is absolutely critical for the physicians to be on board so that to me is a real value add.
A question around how consistent sites are kind of able to lay their hands on these metrics. Do they all adopt the clinical trial management system at their sites, or is this somewhat more haphazard in the way that it’s managed?
Wendy Tate (12:53): You know I think we’re seeing a lot more technology being implemented at sites, you know clinical trial management systems, CTMS’ are really much more widely used in research centers than we saw 10-15 years ago and you’re collecting a huge amount of data through those.
A lot of sites are now implementing secondary systems to be able to analyze that data. A lot of CTMS’ has their fantastic databases really capturing a lot of protocol level data, and I think where we’re seeing the movement in the last several years is the sites are now taking this data that is really meant for the analysis of a particular study and turning it around and saying let’s analyze our center. What are these protocol metrics telling us about us as a center where our strengths, where our weaknesses, what patterns, do we see in both protocol conduct, where do we see our portfolio landing, as far as therapeutic areas where are we seeing our partnerships with other sites and other consortiums.
And I think, especially now with this movement to decentralize trials we’re saying where can we optimize the ability to reach out to populations that aren’t coming to our brick and mortar where do we see our partners in the community, whether that be in the clinics, whether that be, the more rural regions, and those areas where we have populations that really need research access.
And so, technology is able to capture a lot of information that can then guide our sites to say, “how can I be a better site, how can we reach the population that we need to?”
I live in a rural area of the country and a lot of the research centers that are around my area are really looking at hundreds of miles of range. People can’t travel hundreds of miles every week to attend a clinical trial and so now we’re seeing how technology can play into that and, with that technology, we’re seeing data collection and we’re getting more information into these systems. It’ll be really interesting to see over the next year or two how the adoption of things like e-consent, how the adoption of patient-reported outcomes through electronic formats, the inclusion of wearables and other technology, and that type of data collection can drive even more data collection on the study, but also about performance. Again feeding back into, these are how sites can help participants beyond study these are how sites can help sponsors get a more diverse population into their studies and have those conversations about are you hitting rural areas, what about socio-economically depressed areas, what about various races and ethnicities that traditionally haven’t participated in research?
These are now metrics that sites are very closely tracking because funders, sponsors, and, quite frankly, it’s an ethical necessity for them to be looking at these to make sure that we have equity and justice in our studies.
And so, I think these are the types of data that technology is really going to help us collect to better inform sponsors on how you can create trials that really do Speak to the ability for the intervention to affect the population as a whole.
All these trials in the past, one of my advisors in graduate school would say, they’re always done on old white men and then you get it out into the population, and you have a young woman who has a co morbidity that was never tested and you’re going to really tell them that this drug is going to help them do you really know that?
That’s the type of information, I think that sites can help provide back into sponsors that will feed into inclusion-exclusion criteria that will feed into recruitment metrics that can feed into the ability for a site to succeed, that could really progress, science and research into a realm of truly helping people and moving medicine forward.
Dylan Rosser (16:29): I couldn’t agree more, Wendy, and the decentralization, digitization, and democratization of clinical trials have to be at the forefront of our minds today. It should have been five years ago, should have been 10-years ago, but I think the technology now is advanced sufficiently enough to allow us to do that in a much more efficient and coherent manner.
A question, though is, how do we get that information back into the sponsors, because we can’t quote and speak to every single site about you know every single capability and try to understand the flow of data at the, a granular level, to ensure that we’re getting the most designed, the most effective trial. We have to select certain sites to have a candid discussion and correspondence – what mechanism would you suggest that we can do to try to get the best out of both sides?
Wendy Tate (17:15): I think that’s a great question, and I’ll answer it and then I’ll turn it back on to you for almost the exact same question because I think a lot of what sites are also looking for are: How do I compare, how do I look according to other sites, what are sponsors looking for, like what are your metrics as well?
And I think if we can open both paths of communication, where we’re giving information to sponsors and sponsors are giving information back about sites and performance on what they’re truly looking for, to have a conversation, then you’re going to see more flow of information. I think so much of the perception is still very much us versus them, it’s sites versus the sponsor, rather than both of us coming together as stakeholders in the same clinical research.
In previous experience, and I’ve heard my colleagues say the same thing. So many times we’ve heard during the negotiation process that you’re the slowest, or you’re the most expensive, or you’re this or you’re that, and that just demoralizes sites and makes it feel like we’re trying to be competing with other sites that were competing for sponsor resources, rather than saying, “What do you need to be successful, and, by the way, we still have to be able to run this in a solid manner.” One of the things that I would tell my investigators from the centralized clinical trial office perspective is, I’m not trying to play favorites with your trials what I’m trying to do is maximize the resources I have so that we can do as much research as possible. I know that’s exactly what sponsors are doing and I think we need to open that flow of communication.
And that will also hopefully give the opportunity for sites to say you know what I’m not a great fit for this trial, but have you talked to my colleague over here? They might really be able to help you with that trial because sites know their partners and they know who they work with and they know where successes are, but if they feel like they’re competing for a lot of resources they’re not going to necessarily lose a trial that could even if it’s not the most successful trial they have, lose a relationship that’s ongoing, so I think more open communication about what metrics the sponsors are tracking and then how we play up “where are you at with national enrollment? am I a rescue site?” Like those types of questions that sponsors don’t always necessarily want to divulge because they don’t want to give out certain pieces of information, I think are critical for sites to be able to say, “I’m a good fit, I’m not a good fit, or guess what I’ve got a friend over here and they enroll those types of trials like hotcakes, and you should totally go talk to them.”
Dylan Rosser (19:44): So great comment Wendy, around opening up the metrics. I mean only today I was looking at multiple reports that we’ve been generating across the board for site performance and the ability to actually understand what individual sites are doing against the wider site profile that’s involved in any given study.
We never share that information, or we don’t share in the detail that allows you to do something about it, to try to understand where problems may exist in performance and maybe quality, performance issues there may be, data integrity issues and then maybe good reason for that the protocol may not be designed in a way that allows you to capture the data appropriately because of the patient population, the complexity of the treatment regimens that we’re actually trying to treat.
So, I think sharing that information in a way that is simple and easy to digest is the right thing to do. How to do that, though, is going to be a challenge, I mean we’re looking at various digital platforms now that cloud-based that will open up, I think the visualizations that we’re looking at to the various sites, so they can better understand in a self-serving manner what we’re looking at and how you can best adhere to protocols and performing the optimal way that you guys can.
So, I think that to me, that is something that we can look to the future towards. It’ll be interesting to see if again comes down to what resources at site allows you to be in that kind of self-service environment, or do you need to partner more closely with site liaison, as you have a strong relationship with the sites, have a fundamental understanding of the metrics that were collected and why and is able to actually tell that story to the sites into the physicians involved and the research staff involved, so there is that kind of equal partnership in the treatment of patients.
Wendy Tate (21:28): I want to jump on what you just said about relationships with the liaisons and sites, because I think that is so critical. In so many cases the relationships that our sites have with sponsors are really agent-specific investigator-specific and, quite frankly, we’re talking very broad we’re talking about entire research programs, entire development programs, entire metrics.
But in all actuality when we have the sponsor and site relationship it’s very protocol-based or maybe agent-based so you know, three or four protocols. And I love this idea about having the liaison with more relationships with the sites. If I had as an administrator, more discussions with sponsor liaison to understand the sponsor as a whole with what you were just talking about with these broad-spectrum reports, I could share more of our broad-spectrum reports as well, and we could have that conversation about where are the best therapeutic areas that we should be working with you on? Where are our investigators that can help with agent development? Whereas you as a sponsor where should you be guiding maybe some of your development or maybe I have an investigator interested in taking one of your agents and doing an investigator-initiated trial on it in an area that you’re discussing.
I think so many times, our relationships are so protocol-specific that we’re not really getting to the level. I can’t expect my coordinators to have this entire research program wide view: they’re too busy. Your CRAs are too busy, our monitors are too busy, they’ve got to get that trial done. We really do need to expand that relationship and that communication with these program wide metrics to the administration, who can speak more broadly, on behalf of the institution.
I remember a specific sponsor we had done an analysis at my previous institution about what trials we accrued really well on, and one of the things that we found is, we found that if we started a trial more than nine months after it started nationally, which means we were probably a rescue site, we didn’t accrue as well as if we did it earlier.
I had a conversation with our Medical Science Liaison first particular sponsor who came and said, “Hey we want you to start trial,” and that was one of my first questions and she’s like, “why do you need to know that,” like that’s not important, and I’m like, “let me show you why.” Let’s have that discussion and, quite frankly, you don’t want us at this stage of the game. You know, you may not need that because you’re looking for X number of participants and we don’t necessarily perform well in this indication with these particular study design issues. I think that’s something to really think about too. Is while we have these relationships with CRA and CRCs and investigators on a protocol, how do we build those relationships as organizations, institutions, and research programs to have those broader metrics conversations, what do you think from a sponsor perspective can be done about that particular issue?
Dylan Rosser (24:20): It’s a great point, metrics, well are all around us, I mean we have so much data and we come to the investigational site and ask for the ability to recruit patients and we get a number, and we have a number and a timeline associated to that. We don’t know the story behind it, we have no understanding of the fundamentals, the goal to make up those numbers. Yet, we take those metrics at face value, in many cases and make a decision whether that’s is appropriate or not. Whereas I think if we have that kind of liaison-kind-of-partnership upfront, kind of have a conversation around what those metrics truly mean, I think that will alleviate, one, the kind of us and their situation and, two, it will give us insight into what is causing of the kind of the key factors that are driving those metrics and because you’re taking them on face value on the excel spreadsheet is meaningless, we need to have a fundamental understanding what makes those up, so I think we need to absolutely move forward as an industry to kind of have those relationships and you know the sponsor companies, Amgen, should be investing in those areas.
Wendy Tate (25:26): You know those conversations would be really valuable to the sites, because sites are happy to explain why they have certain things in place. There could be a lot of reasons why that timeline is extended for perfectly good reasons if you’re part of a National Cancer Institute, NCI-designated cancer center, you have specific things that you must do to meet the requirements of that infrastructure grant. Even for industry sponsored studies, especially for industry sponsored studies, because you have federal tax dollars, which means you have taxpayer money going to help support your programs.
You have certain reporting requirements, you have obligations to our taxpayers for making sure that that that money is being used for solid research. That adds reporting requirements, that adds review requirements and centers can definitely tell sponsors that, and encourage that openness and that transparency to say yes, our most recent survey of our site showed that a lot of our larger centers take 120-to-180 days to activate a study.
I can tell you from talking to numerous centers that belong into that cohort they can tell you exactly how those 120-to-180 days are spent. They know it’s not just slacking, it’s not just laying on somebody’s desk for signature – there are numerous processes that are ongoing conversations about what’s sequential versus what’s concurrent, multiple things that need to happen because of legal reasons, because of regulatory reasons because of reporting reasons.
And yes, some of it can be improved, absolutely oh my goodness, it’s my entire research portfolio is researching research. I tell people I love the concept that we work in a field that’s always looking to improve upon itself.
We should be doing that, with our operations as well. So, our sites are really looking at that, how can we be more efficient, how can we bring a project management and business orientation into science to really make medicine be bigger, be better, be faster. And I think you know as many things that have been negative over the last 18 months, one thing that’s really been positive about the COVID pandemic is looking and seeing how fast we can actually develop something, test it, and bring it to market.
The fact that we did the COVID vaccines so quickly, as a global community, really shows that if we can have transparency about data if we can have transparency about metrics. If we can come together and figure out what needs to be done what’s nice to be done and what can be put aside, we can really progress research quickly, but that requires knowing our information, knowing our data, and sharing that across the board.
Dylan Rosser (28:10): Yes, that’s, all I can say is yes. I think the first thing that we hear whenever we’re trying to set up a trial is academic institutions, especially in the oncology arena, take an extraordinarily long time to set up. Yet to your point, you know within those 180 days, you know exactly down to the hour, down to the day, what is required and what information is be supplied to you know the various partners that you have internally but from a regulatory perspective and from an administration perspective.
We probably don’t have that insight, and because this should be a two-way partnership, I think if we have that insight, and we could look at our internal processes and try to understand if there’s anything that we’re doing is causing you guys to actually move those timelines out somewhat, or is this something that we can do to minimize your work and then bring those timelines in. Unless we can understand exactly what’s driving you know each of those days within your internal systems and internal processes, we can’t really do much on our side. So, I think you have that two-way communication is absolutely critical it’s, as you said, through the through the pandemic, I think the partnership that industry had with all the various sites, I think that that came through and obviously accelerate our ability to actually meet the demands of society.
Wendy Tate (29:27): So, Dylan from the sponsor perspective then, if you could ask sites what you really want to know about a site and how they operate to make you successful as a sponsor on your protocols. Like what can sites proactively give you or tell you or explain to you that make you understand or help you understand or open the black box of academia, or whatever type of site they are to really be successful? What do you need to know about a site to be successful in your trial?
Dylan Rosser (29:58): Study startup timelines are clearly critical and the more sites you can have set up in the most rapid manner, possibly gives you the greatest chance of success of actually recruiting and get into your last subject enrolled status.
Now study start-up is hugely complex, I mean it’s hugely complex on our side on the sponsor side with all the kind of business processes and the documentation the database bills, etc., that we have to put in play. To allow us to get that protocol out the site unable to then have data entered. But it’s equally as complex on the site side and there’s various components that we ask like how long does it take to contract with your site? We’ll get it takes six months or a year, how many patients will you be able to enroll in such and such a period and we’ll have a an enrollment rate upon six patients per month.
What goes into making those numbers up and trying to understand? Is this something that we can help with to accelerate? That, I think, is going to be important, so it’s more of a granular kind of insight into those metrics. Again to the point you made Wendy, do we have a CRA who is able to kind of dive into those metrics, or do we have to have more of a liaison at the kind of site level that allows us to better intervene internally here at the sponsor company was able to influence business process to enable you to actually move faster during your study’s startup process and during your enrollment process because those are the two areas that really cause the biggest kind of concerns and introduce the biggest hurdles into clinical research, study startup and enrollment and the faster we can move those two things together as a partnership, the better we’ll be able to service our patients alike.
Wendy Tate (31:39): So Dylan, thank you so much, it’s been really great to talk to you. I look forward to further conversation, and I hope our audience has really found this metrics conversation engaging. We’re really wanting to make sure from the site and the sponsor perspectives that we are able to foster conversations between all stakeholders and making research safer, smarter, and faster, and I hope that we can have another conversation down the line and continue the relationship on this topic, as well as many others.
Dylan Rosser (32:09): Thank you, Wendy, thank you for having me, it was a great conversation I hope we can continue this going forward.
Wendy Tate (32:14): Absolutely, and with that, we conclude the seventh episode of “Advarra in Conversations With.” If you’ve enjoyed today’s discussion, please keep a lookout on our social channels for our next episode – thanks for joining us!