First in Human: The Panel Series on “Building a World-Class Clinical Organization to Optimize Operational Excellence”
On Demand | Online
Embark on an enlightening journey with “First in Human: The Panel Series,” where industry titans converge to delve into the core of operational brilliance. Led by host Bruno Gagnon, SVP of Global Clinical Operations at Opthea, this powerhouse panel features Natalie Masterton, VP of Clinical Development Operations at Chinook Therapeutics; Kristi Clark, VP of Clinical Operations at Avidity Biosciences; Suliat Oyelami, Director of Clinical Operations at Eidos Therapeutics; and Rich McCormick, EVP of Clinical Strategy and Vice President of Oncology. Discover the roadmap to crafting a world-class clinical organization, gaining exclusive insights and actionable strategies from these esteemed leaders to optimize your clinical operations and chart a course to unprecedented success.
First in Human: The Panel Series is a live online panel discussion bringing together influential leaders in the clinical research industry. For this 60-minute panel, we feature a handpicked selection of ClinOps executives where panelists will engage in insightful discussions tailored to their specific area of expertise.
Rich McCormick: Hello everyone. Welcome to the First in Human: The Panel Series. My name is Rich McCormick with Vial. Thanks everybody for taking time to join and we look forward to the conversation today.
Bruno Gagnon: So welcome everybody. This is Bruno Gagnon. I’m gonna be the host for this event. We will start with introducing people and then I will kick it off in terms of the theme. So, my name’s Bruno, as I said. I am Senior Vice President of Global Clinical Operations at a company called Opthea. It’s a small company out of Australia and we are working in wet AMD. So age-related macular degeneration and we are running Phase 3 pivotal trials. But today, we’re gonna talk more about like in general, clinical operations but I have a really good panel of people that I basically hand-picked. So the first thing, I wanted to say thank you to Vial for allowing us to kind of do this together. I think it’s gonna be a very interesting to see this, group of clinical operations leaders. And we have three women today who have a very unique perspective and I’ve known all of them, and worked with all of them in my past career. So let’s go in the order of the slide. Maybe, Natalie, you wanna introduce yourself? And then we’ll go Kristi, Suliat, and then Rich.
Natalie Masterton: Sure. Thanks, Bruno. Good morning everyone. This is Natalie Masterton. I’m Vice President of Clinical Development Operations at Chinook Therapeutics. I’ve worked in the industry for over 20 years leading clinical project management program management, portfolio management and clin ops teams across biotech and pharma. For the last four years, I’ve been at a company called Chinook Therapeutics, as I said. It was a startup four years ago based out of Seattle, Washington, focused exclusively on developing precision medicine for kidney disease. In the last four years, we’ve built a tremendous amount of value and in the last month, we’ve been recently acquired by Novartis and we currently have three clinical stage programs two of which have Phase 3 trials. One with top line results that are about to come out and a second late stage program with a Phase 3 that just launched. And so, looking forward to sharing some insights with everybody today and, having some great discussions with the panel. So, thanks for the opportunity to be here.
Bruno Gagnon: Thank you, Natalie. Kristi?
Kristi Clark: Morning everybody. My name is Kristi Clark. I’m VP of Clinical Operations at Avidity Biosciences. I’ve been in the industry for 30 years and exclusively in the rare space since 2012. At that time, I started as CRO with four industry veterans and we did focus on that rare space. And we were acquired five years later and by Precision for Medicine. Since then, I moved on to Avidity Biosciences. I was so excited to get back to the biotech side of things. And we are a company with three programs in the clinic in rare neuromuscular disorders and I’m very much looking forward to t- chatting with you all today. Thank you.
Bruno Gagnon: All right. Thank you, Kristi. Suliat?
Suliat Oyelami: Hello everyone. Good morning. Good afternoon to some of you. My name is Suliat Oyelami. I’m Director of Clinical Operations at Eidos Therapeutics which is a Bridge Bio company. I’ve been at Eidos, for a little over two years, but I’ve been within the clinical operation realm. I started as a monitor, project management, vendor management inspection readiness, you name it, I pretty much have done that all over the last 14 years. It’s a really exciting time for us at Eidos, especially because we just shared some top line results from our Phase 3 study in Amsterdam during the European Society Cardiology Conference. We primarily focus on cardio renal diseases specifically cardiomyopathy. So I’m really excited to, to really dive into the discussion today and, learn from the great panelists, as well as share my experiences. So looking forward to it.
Bruno Gagnon: Thank you. And then to represent the perspective of the CRO, we have Rich.
Rich McCormick: Thanks, Bruno. I’m Rich McCormick, the Executive Vice President of our Clinical Strategy team and then the Oncology TA lead here at Vial. So I have over 20 years of CRO experience, predominantly supporting biotech clients delivering complex oncology trials. So I joined Vial in October of last year. I was really excited to be joining a CRO that’s tech-enabled, committed to being efficient and cost-effective for our biotech clients. Look forward to the conversation today, and back to you, Bruno.
Bruno Gagnon: Thank you. All right. So, Catie, I think we can go with the first topic and then I will facilitate. I don’t know if there was any housekeeping. It’s a discussion, it’s a panel discussion so you will hear the perspective from each team member. Not everybody will talk on every single topic because then we would talk for hours and hours. But you’ll definitely hear and people can jump in and out. And obviously, Q&A, you can type your questions so, Catie, anything else I should say before we get…
Catie Neel: Yeah, that’s correct, Bruno. If the audience wants to type questions in as the discussion is going, feel free. And at the end, we’ll plug those through. Back to you, Bruno.
Bruno Gagnon: Perfect. Excellent. So the first thing is, like, why did we pick this topic? This is a topic that is kind of near and dear to my heart. It’s about developing an organization. Now some of us have started sometimes where you’re the first employee in clinical operations. That happened to me when I was at Eidos and that’s why I hired I mean not, [laughs] I hired Suliat and also I invited her to present today because this is a very positive experience as you may imagine which ends up in the Phase 3 clinical study with top line, result. And that’s why I, it’s fav- favorable meeting the end, primary endpoints. And so, that’s kinda the goal that we all have is develop drugs not only to meet on that medical needs, but for that, you need to get the job done and it’s usually clinical operations who will develop this infrastructure. So that’s the theme.
Then also the context of being efficient. And so when, you think about a kind of a world-class organization that is efficient. So we’re gonna talk a lot about that, like risk management and being efficient and, building the organization. So maybe we start with this kind of buzzword of operational excellence. What does it mean for you? So maybe I start with Kristi.
Kristi Clark: So operational excellence means a couple of different things to me. Of course, there’s the, technical side of hiring people that have the skills that you need to execute on trials. But I think it goes beyond that. I think it’s about training, it’s about culture. Also, I tend to hire people that are a little bit OCD or perfectionists and try to have a diversity in that and what they love to focus on. I think that’s worked really well. But we like to operate in a matrix. So at the end of every meeting, if there are decisions made or information that needs to be shared outside, we ask ourselves at the end of that meeting who else needs to know? Is it bio stats, is it data management, how can we support our team so we’re not working in silos. I feel that’s so important because your teams grows as they work with the different groups. So that’s really important to me. And also, I think having a common goal-
And that is really our goal is to get treatment to patients where they don’t have treatment. And so as long as that team that I’m hiring is also focused on that, the excellence shines through. So that’s just some top level comments.
Bruno Gagnon: Very good. Now, Natalie, I know you’ve been through a very important effort of restructuring your organization and developing. You wanna tell us a little b- bit about this in the context of what is, for you, operational excellence?
Natalie Masterton: Yeah, I mean, I really like what you said, Kristi, and I agree. I think you hit on maybe a, core tenet for me. I mean at, the bottom line, operational excellence in clinical operations is about delivering high quality data on time and on budget consistently which is the goal. But I think that’s the what in, what we have to do. But I think it’s more about the how. For me, clinical operations often sits at the hub for clinical trial delivery, right at this nexus point where we h- have nearly everything we do is cross-functional in nature. And I think, when I think of operational excellence, I think of our clin ops team working in close partnership creating a space, facilitating a space where we’ve got a lot of cross-functional coordination collaboration so that we can move fast together, right? Across that finish line. ‘Cause like, like you said, Kristi, I think there’s so much that we’re doing that’s, really in in coordination.
So having an effective clinical trial team structure, I think is a core principle for how we get work done and making sure those are working effectively. And then just the, other concept of operational excellence is that of continuous improvement, right? And just always learning from what we do. I think we, w- we’re fortunate in this business to rinse and repeat. We get to, to run clinical trials over and over again and so, I think carrying those findings forward is just a really important concept and taking time to do lessons learned. So.
Bruno Gagnon: Thank you. Now, Suliat, anything to add from your perspective?
Suliat Oyelami: Honestly, Kristi and Natalie nailed it on the head for me. I mean I, echo every comment and I do wanna stress the hub, I look at clinical operations as truly the hub of everything, collaboration is truly key. Without collaborations with both your internal and external parties, operational excellence is, it’s not feasible. It, just simply is not feasible. So I, agree with those comments and I really think that the bottom line to it is the how. I think that’s the part that we do struggle with on a day-to-day. We can define it as much as we want, but how do we get there? So those collaborations and partnerships is absolutely necessary.
And then tracking the lessons learned, sometimes we huff and puff and then we achieve what we need to, but do we take the time to go back and reassess what could we have done better and how do we implement better practices moving forward? So, absolutely agree with those comments.
Bruno Gagnon: Thank you for that. And before we go to the next topic, maybe, we can throw it to Rich a soft ball and say since CROs are there to a- to, to deliver, and maybe what is the perspective what’s the difference an excellent CRO would have? A well-oiled machine. What’s the perspective there, Rich?
Rich McCormick: Yeah. I think Natalie really hit on sort of the way the CROs think of it and it’s being able to deliver quality data on time and on budget. So what that means from a CRO perspective is really fully vetting the opportunity when it comes in. Is it the right fit for your organization? Is it something that you can operationalize a team and successfully deliver that project for a client? I think sometimes on the CRO side the, over promise, under deliver comes into play ’cause you wanna win the business. And, that’s something that myself and my team we, look at that really closely and we wanna make sure that we’re able to set a client up for success. So needing to have robust processes in place but be flexible strong quality background, good data and technology I think are all pieces that come in to being able to deliver operationally.
Bruno Gagnon: All right. Let’s go to the next topic and I’m gonna start with Natalie on this. Natalie, you went recently through an acquisition by a large pharma so it means that you have you, did something very special as you were growing Chinook, right? And so, what would you say kind of sets you apart in terms of an organization, and it could be in general because other people will, be able to comment on this. But, what would set apart a very efficient clinical operations group? How do you distinguish yourself from others?
Natalie Masterton: Well I, think, in the last few years we’ve all learned that a key to being competitive and being effective in drug development is our ability to adapt, right? We need to adapt to be competitive. We need to be able to quickly respond to external events, external risks, threats, in a way that we’ve never had to before. And so, building a team, hiring and building a team that has kind of a flexible mindset is able to creatively solve problems in my mind is more important than ever. Kristi, you talked about hiring for kind of those people with, OCD-type of,
[laughs] I think those were your words, of a- approach. And I think nowadays we need that, but we also need to be able to hold in our hands kind of that ideal of what a strong compliance mindset and what that ideal is for all of us that we strive for and also have the flexibility to think about in the realities of real world trial conduct. What is an acceptable approach to things that mitigates risk adequately but still gets us to a place where we’re doing right by patients and, allowing our trials to move forward? And I think we’re being asked to do that in a way that we’ve never been asked to before, right? The, I mean, one small example shipping lab kits between sites, shipping drug product between sites, things that we hate doing that we just we’ve had to, we’ve had to face in the last several years during the pandemic, during wars in Ukraine and all those things. So I think that flexible mindset for me is an important one.
And then because there’s so many external threats, things we can’t control, I think another critical aspect to being a competitive high performing organization is all around planning, right? Proactive planning. And I think later on in this session we’re gonna talk about planning at the study level that, for me, as organizational leader, like Bruno, you speak about being a part of just that growth that we’ve had. I mean we’ve really needed to stay ahead of what the organizational needs have been and anticipate what that growth is gonna be and that’s in terms of head count and expertise, right? As an organization matures around you, you need to be able to anticipate just what finance is gonna need, quality what, those different maturing organizations are gonna, demand over time. So I think that’s been a, second piece of being proactively.
And maybe the last thing I’ll just throw in is focusing on our sites. I think that gives us a strong competitive advantage especially in the rare disease space. I think our sites are our first customer. Of course, patients are the ultimate customer, but we get to patients through our sites and we need to do everything to support them. We know they’re under-resourced, overworked they’re trying to do a lot with a l- very little. And so, even as we work through CROs, I think there’s a lotta ways for us as a sponsor to show up for our sites. First and foremost, I think making sure they’re well-compensated. I think there’s ways to do that. Making sure we’re accounting for all the extra administrative work we might be asking them to do, making sure they’re compensated for those things.
And then just showing up at SIVs, showing up, w- we do for our global trials, we do office hours. For our clinical trials, site just an off- sponsor offer, office hours where sites are able to call in. So those are just some ideas where I think that, kinda has set us apart, especially in this rare disease space.
Bruno Gagnon: Very good. Thank you for that. And, Suliat Eidos you’re at kind of at the other end of the spectrum- having a late-stage asset and so, I was I was wondering maybe from your perspective, what’s the aspect where you distinguish yourself or as an organization? Like, how, you are in a new phase of growth, for example at Eidos. So can you tell us a little bit how you’re working with with your leadership team?
Suliat Oyelami: Absolutely. So, Natalie touched on several [laughs], several different points and to be honest I, came from a CRO. I started my career from the CRO spectrum of things so I’ve had the pleasure of working with several different pharma companies as far as the build during. But then to, switch to the pharma side and working on the angle of not having as many resources and trying to do a balancing act with outsourcing many of the activities out to several different vendors, what can you do to truly separate yourself? What can you do to disging- distinguish yourself and ensure competitiveness? I always think, people. Whether that is your internal team, your sites, your patients, I always think people.
And I think it’s, really important when you’re working on, for a small biotech company and similar with Eidos as we are currently growing and we’re looking at additional resources, I’m looking for a variety of expertise. That is, that’s my bottom line. That is truly what I’m looking for because the more folks that we can bring in that have a general idea or a, variety of experience and expertise in different areas, the better we are. Because sometimes there’s things that you are going to tackle that you’re not gonna be able to predict and having people from the same expertise may not always be the best way to go about coming up with creative sits- situ- solutions outside of the box.
So I think of people, I think of team. As far as sites, is a big one. I mean, working on a huge global Phase 3 study and having to deal with different regulations and different site personalities and different wants from different investigators, we think of a, the center point of it all. How can we navigate through those challenges? But, to distinguish yourself by, I absolutely say, bring a variety of people to the table to help address any of the issues that you anticipate.
Bruno Gagnon: I’ll stay with you a little bit and maybe, Catie, we can go to question 3 and I’ll go with maybe I’ll stay with you for just a second, Suliat, and then we’ll follow-up with Kristi about hiring and retaining top talents. We’re in this era post pandemic, we know how many people don’t, decided to lose their j- no, not, well, leave their job. They didn’t lose their job, they basically quit voluntarily.
Suliat Oyelami: [laughs]
Bruno Gagnon: And it’s hard. We cannot find good people, retain good people, keep people motivated. So maybe let’s talk about that, I mean, Suliat, from your perspective of managing and hiring, motivating people and maybe you stay brief on this one and we’ll get Kristi to g- give her perspective as well.
Suliat Oyelami: There was a hard stint there. I think we all can say the pandemic was, [laughs], something that no one anticipated and prepared for. So being able to quickly adapt and come at different at ways to oversee your studies remotely considering travel was not an option for a large period of time. But I will say that, yes, people were afraid. People were fearful, people left their posts so to speak. So how do you re-engage, how do you empower people?
You go back to your why, you go back to your mission statement and you pull people together and ask them what can we do to change the course? What can we do to retain you? I always try to integrate my team into the decision-making because now they feel invested in what’s going and what the next steps will be. So, yes. Pandemic was a, big one for us. But I will say that we were able to successfully exceed that, especially with enrollment. We exceeded our enrollment in, ways, and no one was [laughs] expecting. But yeah. That’s what I would, say to that, Bruno.
Bruno Gagnon: Thank you. Well, Kristi, so when you started at Avidity, it was pre-pandemic and I think you were very small and you grew the, team through that and then you have more and more programs. Now tell us a little bit about your strategy to hire, retain, motivate people.
Kristi Clark: Yeah. I joined smack in the middle of the pandemic so I didn’t meet anyone in person when I joined Avidity. It was all through Zoom. And what I was so impressed with was the people that I interviewed were talking about the culture of the company and I think that’s so important and there of course we do culture surveys like everybody else does. But I think it’s the fact that we put the patients first. They’re at the center, they’re in the DNA of our fabric of our company. And the people that respond to that, the candidates that you’re interviewing that respond to that or mention the patient, seem to be very vested in working at Avidity and being part of that culture.
The other thing that I think is so important is career development. That is something that, that we talk about during the interview process. But we’re also balancing this with, I don’t know if others have seen this, but I’m seeing candidates that ask for salaries that are not commensurate with their experience. So they want a lot of salary for very little experience and I f- I don’t tend to hire those people because they’re, not being realistic and so, those types of people will tend to wanna just climb the ladder versus being part of the culture of that patient treatment being the focus.
Some of the other things that we do are engage our team in pa- in patient experiences. So we send them to conferences. For us, that could be in muscular, I’m sorry, Myotonic Dystrophy Foundation conference things like that. Or, FSHD is one of ours, FSHD Society. And when the team gets to meet patients and talk to them about their experience, they really become vested in ensuring that they are finding solutions to get products to get treatments faster to our patients. How could we get there faster? So I think that’s really important.
Also, we ensure that our team is on other task force be it a diversity in clinical trials task force or pebbles in our shoes what are we the lessons learned. What could we do better, those types of things. And I, feel like their voice matters and I think that this was well-stated previously in that you have to involve your management team and your clinical operations team in the solutions to things. Like when you’re planning out head count, involving everybody, hearing what they need.
And then also, I think one of the biggest things that I really value is that, a work-life balance. Right now, we don’t have a lot of it, but I will say that we all support one another in taking true time off and that means covering for your colleagues, what can we do to help? And this camaraderie just comes through. So I just, I try to hire people, this was mentioned also, like diverse backgrounds and they all bring something to the table. And then finding that respect and trust and that’s what’s really important so that all the teams trust one another.
Bruno Gagnon: Very good. You came up with some deep, like elements of culture, like in the, kind of developing the culture of your organization whether it’s a corporate culture or even the department culture. And I loved when you talked about injecting a sense of ownership, like when you have your employees who know the disease but they know the patient population
… because they were able to maybe meet with patients or patient representatives, that is very important. So thank you for that. Let’s go to the next topic. We’re doing good on time. And it’s about focusing on what really matters. So, again, thinking about the context of smaller biotech companies, this is a bit, our target audience today, like the smaller biotech companies. We don’t have in this re- all the resources in the world and funding can come in waves. So, so how do we kind of really focus on essential to and, now you can optimize your work to really focus on the essentials. So maybe I, start with Natalie on this one and we’ll follow up with Rich from the CRO perspective. So, Natalie, you wanna get started on this one?
Natalie Masterton: Yeah. I, think it’s a great question. Like you said, Bruno, it applies to all of us but particularly small biotechs that might have some limited resources. For me, this is a mindset that has to start at the beginning, at the time of trial design and then really could get pulled through for planning and execution but it needs to be kinda the foundation of where you start from for clinical trial design. So at the time of design protocol development, we need to be thinking critically about our endpoints, our outcomes that we’re measuring, what assessments we’re using, what tools, what data we’re collecting. Understanding really clearly what data we’re collecting and for what purpose is critically important for us to be focusing on what the essentials are in defining those, right?
And I think it’s our job, I think, we’re in a unique position within clinical operations really to bring information to the table just to make sure we’re making informed decisions as an organization around what is essential. ‘Cause I think in the absence of understanding what the impact or cost is of some of these decisions, it’s just, it’s hard for people to understand, right? W- we’re under such pressure to get the most out of every trial we do, every single patient is so valuable. So there’s, there is a strong driver to do more with what we have but we know, and we need to be able to articulate, I think, the cost of complexity which is a hard thing to do sometimes but articulating the cost of complexity, articulating the cost could be one of feasibility, right? That we, don’t have a lot of feasibility around kinda what’s being proposed. Or even, I’d say just financial costs.
So we’ve had instances where we wanted to do an exploratory endpoints, look at PDMCs, but once we’ve paused to look at it, we’ve understood that the cost impact would be close to a million dollars and it would be on an assay with we, we haven’t even validated certain [inaudible 00:27:10] types. So in those moments, we’re able to make more informed decisions. So I think it starts at the beginning and then we can carry it through.
So, but from a more practical perspective, I mean for me, the focus is always on a good protocol, good sites and then good oversight and controls around primary endpoints or the things-
… that matter most, which is patient safety primary endpoints, right? And I think we can get rid of a lot of noise if we have to. There’s so many really interesting solutions out there for us as clinical operations teams these days. But I think there has to be a strong use case for a lot of those technology solutions that we have. There’s a time and place for all of them, but I think we need to be thoughtful about how we use them.
Other ways to really just focus on the essentials, I think your country footprint is a really key way in which you gain efficiencies. Maximizing your sites in country. Every time you go to a new country, a new region-
The cost, the number of languages, all that goes up so much. So I think being critical about thinking about that’s another easy way. I think limiting your vendors another easy way to kind of bring down that complexity.
And then just a last plug I’ll make. I think there’s a, desire often to do large recruitment campaigns, digital outreach. Highly, costly which, what we know is like the return on investment in terms of patient yield out of those things can sometimes not be high value depending on the therapeutic space. I think there’s some therapeutic areas that it absolutely makes sense but there’s alternatives to that where you can be working through advocacy groups on more targeted campaigns or really doing your own material development for recruitment than working with sites directly. That’s just a much more cost-efficient way to approach it and doesn’t require all those resources and complexity of a large recruitment organization. So, those are just a couple ideas but would love to hear, Rich, what you think the-
Bruno Gagnon: Yeah. That’s a lot, that’s also, you covered a lot of ground. So from early critical design to like country and-
Natalie Masterton: … Yup.
Bruno Gagnon: … Coverage and then using platforms for [inaudible 00:29:15] enrollment. So, Rich, what’s the angle from a CRO perspective on, on hiring and focus?
Rich McCormick: Well, yeah, that was a fantastic answer. So I think for me, I’m just gonna go into maybe one aspect of that. And for us, we tend to see a lotta protocols and synopsis when they’re very early, very draft. So some- but something we always look at is the schedule of assessments and if it’s not there, then we make sure that we get it ’cause we wanna assess that patient burden. We wanna see what is essential for the primary endpoint and then how much does the, sponsor have a lot of nice to haves. They’re really gonna add complexity and layers t- to multiple aspects of the study. For, a study that’s really demanding to a patient with a lot of add-on type of samples or really strict time points are they just not gonna be interested? And at that point, if you’re losing patients for that reason, your timeline’s extending and we know what that means.
From there, it’s just flight aspect, too. I- if your coordinators are running all over the place with time sensitive samples trying to ship due to stability issues that’s, that can be problematic for sites that are already resource-constrained. And then there’s the query aspect of [laughs] it so if there’s a ton of collection happening in a study, then the site staff is gonna be dealing with things coming from multiple vendors. As you mentioned, Natalie coming from the CRO and it just may, it may put a negative presence on the study.
So I think, yeah, being aligned at the beginning on what is really needed for your primary endpoints and to really prove that the study’s working versus everything else that may be works within the company wanna collect ’cause they’re curious. So I think that’s a tough balance though. I don’t envy those in leadership positions at a biotech because you really are trying to find out as much as you can about your your compound and your [inaudible 00:31:11]. So I’m sure they are tough conversations to have.
Bruno Gagnon: Thank you. Very nice. Let’s go to question number five which is the theme is now more think of yourself as an architect and you need to build a house. So it’s the framework of the structure, or the infrastructure to be efficient. So maybe I start with Kristi here. Like, how do you do this? What’s, the vision on, creating the right infrastructure and be efficient?
Kristi Clark: Yeah, Bruno, you and I have had some conversations about this over the last couple years and what we’re doing, because we are a platform c- company and have three programs in the clinic as some of you do as well. I’m basing my structure by program. So there’s a clin ops lead that oversees each program and then there’s different folks hired for the different trials underneath those programs. And then we also intentionally have cross-functional supports. So I have a senior director that oversees consistency across all the programs. And this includes things like inspection readiness and are we collecting, why decisions are made, who made the decision, those types of things. They also oversee the eTMF to make sure everything’s being done correctly. And then we also have an unblinded team that goes across all the programs as well.
And then we are instituting some other potential employees, or FTEs rather, that will be global to help us support our programs abroad so we can have clinical support there. Something like a clinical trial liaison. So we’re looking at that.
But, I’m also looking to expand the group even further because as we grow there’s more and more things that I need to do in regard to some of the other task force that I’m part of and some of the other leadership things. So that’s what we’re doing. I’d love to hear from sub- from some other folks, too,
To see how you’re structuring your organizations.
Bruno Gagnon: Yeah. Well, Natalie, I know you’ve made some important changes. You’ve implemented a lot of improvement recently. You wanna tell us a little bit about this?
Natalie Masterton: So we’ve, in our short amount of time, we’ve reorged a couple times already just because the growth has, and the organizational needs have changed. But, Kristi I love what you described. The concept of an unblinded team across teams, I haven’t thought of that. I think that’s a really creative solution. But similarly wh- what we’ve gone from is early days with an organization really having clinical trial leads doing everything, right? [laughs] Having, no specialization. Really having all that heavy burden and heavy expectations on single clinical trial leads, to developing out that, that specialization and those underlying support systems. So developing of the expertise and removing some of that workload from the tr- clinical trial teams and, the areas we’ve focused on have been similar to what Kristi mentioned. We’ve, got clinical systems expertise. We’ve got clinical finance expertise, clinical quality those are some of the main areas where we’ve focused and, had some good outcomes.
I’d say the other area is around patient, engagement and solutions. So we have a dedicated person and activities around all the recruitment initiatives and, patient engagement activities we’re looking to do, so.
Kristi Clark: Natalie, that’s a great point because. I was just gonna say for patient engagement I, would say that is to key and we have patient advocacy. They were actually hired before clin ops. And I think that’s a really great point and I loved your comment about the financial expert because right now, that’s falling on our clinical lead and with three or four different trials on each program, it’s not sustainable. And so that’s something that we’re putting in place as well. Clinical outsourcing plus that financial expertise and budgets and all of the POs and invoices. It’s just become too much. So I think that was a really great point as well.
Natalie Masterton: Yeah. And Kristi what’s your clin ops lead role look like in, in your organization? I’m, curious what that looks like.
Kristi Clark: It’s typically a director and they are overseeing the entire program and then they will hire associate directors or clinical trial managers to run different aspects of the trials. And then as we go global even more, a team will be built underneath. So that’s how we’re structuring it right now. And then those teams, they are really and truly experts in that indication. So we have a DM1 expert. And that’s, it’s working quite well but they, they also have support from development, data management, bio stats, medical writing. So they’re not just in charge of everything. They’re working within a matrix to make sure that the whole clinical trial execution team is working and functioning smoothly.
Natalie Masterton: Got it. Good. Thank you.
Bruno Gagnon: Good. And very inspiring. It makes it’s like a, it kind of creates a lot of, passion when, we all talk about this together because-
Rich McCormick: Okay cool. So then so Catie, maybe we’ll just push on while you try and get get Bruno back in. So we can move on maybe to our next question, I think it had to do with outsourcing and insourcing. Oh, looks like Bruno’s back. Bruno, can you hear us?
Bruno Gagnon: Yes. Can you hear me? I just… Some- something happened with my connection.
Rich McCormick: No problem. We were just segueing into the next question. [laughs]
Bruno Gagnon: Yes. Well that’s good we, that’s why we practiced. Eh, so you see there, the question there on the screen. So you start there, Rich, and give us your perspective.
Rich McCormick: Yeah, sure. So the question is really about in-house verse outsourcing. So from the CRO standpoint as I mentioned in the beginning, I joined Bio to be part of a company that’s looking to do things more efficiently. We’re also very new in terms of our, time in the space. So we’re a small company but what we find is the biotech clients that we’re targeting and that we meet with expect us to work with partners in certain areas. So, Sub-Zero in Latin America or Asia Pac are cl- the clients that we meet with aren’t concerned that we don’t have resources, bio resources in every country because what that means is, they know the companies that do and they don’t wanna be working with them anymore. Is they know the companies that don’t wanna be working with them anymore. I’m not sure if anyone caught that echo? I’m not sure if anyone caught that echo? Let’s mute Bruno. Let’s mute Bruno. All right. Sorry, Bruno. [laughs] but yeah, so we work with it’s, th- that’s just an example of where outsourcing is is the right fit for us at this point. And like I said, our clients seem to, be aligned with those kind of partnerships that we form.
It can also happen within the services. So sometimes they, a client may have a really heavy lift from a regulatory or bio stat standpoint, while we do have staff in-house, it may be the better fit for us to pull a partner in for the longterm success of that project. Where we really prefer to focus on in-house is our staff within the projects that are really site-facing. So our clinical operations team, we’d love to be in-house, project managers our data managers, medical monitors. Those are resources that we wanna have full control over and be able to sort of partner with y- with you and have them be extensions of your team rather than dealing with an outsourcing model in those critical areas. Do we have anyone else that would like to, weight in there? Maybe Suliat or Natalie.
Suliat Oyelami: Yeah. Rich, I I, have a very dear [laughs] spot in my heart for the CRO side of things I have to say. So your perspective is spot-on. I think being on the biotech side and working for a couple of the biotechs now and having to really dibble and dabble and create the perfect balance so to speak between what we’re outsourcing and what we’re keeping in-house with the limited resources that we have, a big piece that is a huge inspection finding right now is sponsor oversight of your vendors how do you, ensure that it’s taking place when you’re a team of 10 to oversee a team of hundreds of people? How do you do that accurately?
And it’s something I think will continue to be a challenge for clinical operations, I mean if, let’s be realistic. There’s a lot of things that are happening within the hub so to speak. So how do you identify what’s truly a priority and how do you create key performance metrics or key performance indicators to, to kind of guide you and let you know, hey, this is a time for you to [laughs] pull the red flag and start reassessing certain things?
I will say for Eidos right now, because we do have the opportunity to bring on additional resources, now we’re really thinking about accountability and homing on who will kind of oversee what, who will over- you know, drive what as far as in-house and then as far as activities that are outsourced. But I’m interested, Rich, just from your angle being on the CRO side, when your sponsors kind of inquire about the metrics or clinical analytics that you have in s- in supporting how they can demonstrate their sponsor oversight when they are inspected how do you kind of direct them or advise them on, inquiries like that?
Rich McCormick: Yeah, it’s a g- it’s a good question. So within we have our core KPIs that we keep across all of our projects. They’re available to everybody. So there shouldn’t be any surprises if a sponsor decides-
There being vetted or if, it’s done mid-stream on a study, th- there should be no reason for them to be surprised because it should be provided to them on an ongoing basis. With us being a newer company, it’s been more common for us to, be dealing with pre-qualification-type audit. So sponsors coming in and wanting to make sure we’re set up for success. So that’s been a great experience for for our company to be able to learn from from those audits and those reviews and apply that to projects, you know as we go forward.
Suliat Oyelami: That’s helpful. That’s good to know. And, Natalie I figured since we lost Bruno, but Natalie and Kristi, if you wanna chime in on how integrate sponsor oversight in the frameworks that you’re building ’cause you have some phenomenal frameworks. I, took some notes [laughs] as we’re building our resources in our department here. So I’m, curious of what your thoughts are.
Kristi Clark: Yeah, I can start. We actually have a situation where we kind of learned something that, that, that wasn’t wasn’t the best, it wasn’t an optimal situation. But we had some we, our CRO couldn’t provide CRAs for us and so, we contracted on our own. And when you train these CRAs as just the clinical endpoint training and the oversight and making sure that they understand, they represent Avidity, well at this site is so important. And so, when we move to a different CRO, we ask that CRO to take over the management and hold their
Contractors up. And it really didn’t work out because the CRAs had such a tight connection with us that they would come to us even though that we were sending them back to the CRO to answer the questions. It just, didn’t work out quite the way we expected. And I had seen this when I was on the CRO side as well, a sponsor would ask us to do that and it’s always so challenging. So I would try to avoid the situation like that. But I have found that the right balance is based on need because if you can’t find that right resource that you have a contract, a CRA who has years of experience, cares about the patient, understands that monitoring is not just checking off EDC-
To, well what time [laughs] is the worst. There’s so much more to it looking at signals that you might see or cross-functioning, checking in with the vendors. Are they doing the e-pro whatever it is it’s just so key. So for me, it’s about just striking the balance of what can I find, do I have the resources, have an FTE, or could I use a consultant? And I like to use consultants that are experts, too, to help me-
Suliat Oyelami: Yes.
Kristi Clark: … look at where I have holes in my department. So that’s how it’s worked in our organization and, just throughout my career.
Rich McCormick: Very good. Let’s give a Bruno a second to see if he wants to come off mute. Bruno?
Bruno Gagnon: Perfect. Well, yeah, we’re almost at the end. Maybe we go to the last question and I’ll keep it open to see maybe if Natalie, you wanna start. But anybody can jump in. But maybe another little two to five minutes and then we’ll do Q&A. But, so it’s about managing risk, but also like for an accelerated clinical trial time wise. We, know we want to go fast very often but at the, it’s not at the, did no, we don’t wanna compromise quality. So how can we do early risk identification and mitigate having multiple mitigating strategies to help us expedite the process overall? So, Natalie?
Natalie Masterton: Yeah, for me, going fast is, for me going fast is, you have to define what the goal is. Sometimes FSA and FPI is an important milestone for certain organizations that they need to but most of the times what’s most important is LPI and top line results are getting your readout. And so, anchoring the organization around going slow to go fast is critical, right? I think amendments cost us time, amendments cost us time, risk quality and are, costly. And so I think doing everything around that protocol design, doing quality by design and exercise up front during protocol development to really make sure you’re identifying your critical to quality factors, building all your risk planning around those, I think is, just is, for me, that, kinda the core approach to how, you ensure you go fast.
And then I also just think we need to get, n- good, continue ge- doing really good at, forecasting, right? I think we, we need to have accurate forecasts against which we’re measuring how quickly we’re going and so make sure, making sure we’re using data to inform what we think our projections are gonna be and then, looking for ways to accelerate. But that’s-
Kristi Clark: Yeah I might add to those great comments, Natalie. A couple of things that just like you said, when you’re going fast, y- you are really trying to find the best and quickest way to the patient without compromising quality. And so, some of the things that come to mind for me are our sponsor oversight plans. So if the agency, or any agency walks through the door, you know you can show them exactly how you’re providing oversight across the program.
And then also if you’re in an accelerated situation approval and that’s what you’re looking for, I really think it helps to start, I know it sounds really early, but right from the beginning with inspection readiness meetings and you just schedule them quarterly and they might just be 20 minutes, but if you schedule them quarterly and get that team together and put folders together if there’s critical things that have happened on your program, you’ve got a folder for them, you make sure you’re not doubling up on where those items are located. It might just be, hey, check the eTMF here for this. It might provide a link.
And then also story boarding as you’re going along so that you’re not waiting till the very end. And that can happen during those inspection readiness meetings. It’s just been really effective for us to have those. And then also scenario planning. So if you have to pivot because you see a signal or something, how does it affect the accelerated approval plan, what can you do differently? And so those things have really helped.
Bruno Gagnon: Okay, I think we can probably go to the Q&A session. I do not see the questions so maybe Rich, if you are able to read them, maybe you read and then we can direct the questions.
So maybe you read some questions and if, and anybody right now on the, on… By the way, I thank you. Yeah. It was really a great dynamic discussion but I think we may have some questions, either live questions from the audience, they will type them and we will read them out loud and anybody can pick them up.
Rich McCormick: Perfect. We have two questions so far that came in on the chat. The first one is, can you ask the panel for controls for disruption caused by restructuring, so department- or company-wide? So do we have anyone on the panel that maybe wants to talk about restructuring a little bit and kinda what the, panel controls are or that you’ve experienced?
Kristi Clark: So I’ve been through this a few times at previous companies and I think one of the most important factors is planning. So, it’s communication, planning how things are going to work, how you map out what the changes are, how it affects them if it does at all. I try to run block as much as I can because we are always in execution mode. But I just find that communication is absolutely key. And I think sometimes executive management doesn’t want to share certain details and, just clinical endpoint [laughs] training is so important for a CRO to know what our milestones are, corporate milestones. And it’s the same thing, it’s that sharing of information so people don’t feel left in the dark.
Rich McCormick: Very good. Okay.
Suliat Oyelami: I do wanna add to that just briefly, Rich. Communication is absolutely key but I, also wanna add transparency in that communication. Because we [laughs] I’ve experienced a few restructurings on, both sides, both on the management side and then being part of it and having to deliver the message. But I think we always need to anticipate and be careful as far as how we’re delivering the message. But if we know that we don’t have a plan in sight to be comfortable to tell our team that, you know what? At this time, we don’t know what the future necessarily holds but at this time, this is what we are working through and this is where we currently stand. And then, really create an environment for folks to ask questions. So I would say restructuring is really tough especially when you have to let people go. But also for people to adapt to change. That’s challenging as well, so.
Rich McCormick: That’s great. Thanks, Suliat. So maybe Natalie, you can take the next question. I’ll give you a heads-up and then I’ll read it. So it mentions when choosing a CRO partner to work with, what are the most important aspects you are looking for in making the right choice for your organization?
Natalie Masterton: Well I think it first, defining what the rationale is. Kinda go b- going back to what Rich was talking about before. I think we need to be clear on what the drivers are for outsourcing. Are you looking for capacity? Are you looking for geographic footprint? Are you looking for expertise? What, wh- what are their, what are the drivers for outsourcing, right? Is one of the, one of the first questions I would ask.
And then what’s the most efficient way to achieve those, goals? I think as a, smaller company, I think the bottom line is w- we’re often trying to look for CRO providers that do have a large global footprint but that can also support a smaller client like us. And that, comes down to cultural fits, right? I think we need to find CROs that have shown an ability to be responsive, reactive adapt to to our needs and to, to, the unique needs of a biotech company.
And so, those are some of the things we look at. And then just past performance is certainly one of them and we do overly robust evaluation using really robust RFIs and RFPs that we we leverage for CRO evaluation.
Rich McCormick: Yeah. Great answer. Absolutely. Kristi, I saw some nodding. Did you wanna chime in on that on that question? [laughs]
Kristi Clark: Yeah. I thought it was great, Natalie, and those are all the same things. I think Suliat’s nodding as well. One thing I’ve learned over the last couple years is outsourcing by piecemeal is really challenging and that’s something that we had to learn the hard way. We had a lotta vendors on our programs and this go-round, I we’re really looking for a partner in our CRO and we plan to be transparent with them regarding corporate milestones and things.
But also, what I, really don’t wanna do is mess with their ecosystem. So if we could utilize them for as much as we can, it’s better because then we’re not forcing them to us our eTMF, for example. Really letting them work into the system that works the best for them. So that’s, I’m hoping, is a very successful plan [laughs].
Rich McCormick: [laughs]
Suliat Oyelami: I think it will go well. I have to [laughs], I have to say, Kristi, because those partnerships are, so ideal. I think when I first joined Eidos, it was a ton of vendors across the entire program. And right now we’re trying to streamline that. How can we bridge the gap and collaborate and set the tone so that you don’t have to keep resetting that expectation with every new vendor that you bring on? So I agree with that.
Kristi Clark: Great point.
Rich McCormick: Awesome. Great. Bruno? Would you like to come back on for for closing?
Bruno Gagnon: Yes. Well, I wanna first say thank you to the panel members and a big thank you to Vial for making this event possible. I think it was really motivating. As I said earlier, I really enjoyed it so I hope that it was the same for the d- the people who participated online and thank you for your questions. And maybe we do this some other time if, there’s so many of these questions, we could talk for, hours. So we wanna be respectful of everybody’s time. We’re at the top of the hour, so thank you everyone and it’s a wrap.
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