Speakers: 

• Kymberli Shropshire: Global Head of FSP, TFS HealthScience
• Ian Kovacs: Executive Director of Safety and Pharmacovigiliance, TFS HealthScience
• Alison Sampson: Head of Pediatrics, Rare Diseases, and Orphan Products (Europe), TFS HealthScience
• Dorothy Blythe, Principal Clinical Data Manager, TFS HealthScience
• Sonya Hunt (Moderator)

 

 Speaker 1 – Sonya Hunt (00:07): 

Good day to everyone joining us and welcome to today’s X Talks webinar. Today’s talk is entitled Modernized Approach to Functional Service FSP, necessary Evolution on the Road to True Partnership. My name is Sonya Hunt and it’s my pleasure to be your X Talks moderator for today. Today’s webinar will run for approximately 45 minutes. This presentation includes a Q&A session with our panelists. 

This webinar is designed to be interactive and webinars work best when you’re involved. So, please feel free to submit your questions and comments for our speakers throughout this presentation by using the questions chat box. We’ll try to attend to your questions during the Q&A session. 

This chat box is located in the control panel and that’s found on the right hand side of your screen. If you require assistance, please contact me at any time by sending me a message using that chat panel. 

 

Speaker 1 – Sonya Hunt (01:00): 

At this time, all participants are in listen only mode. Please note that this event will be recorded and made available to you for future streaming on x talks.com. At this point, I’d like to thank TFS HealthScience who developed the content for this presentation. 

TFS HealthScience is a clinical development organization providing support for biotech and pharmaceutical companies with tailored drug development solutions. They combined the functional services capabilities and global reach of a CRO (Contract Research Organization), with the flexibility and personal approach only a midsize CRO can deliver. With over 700 staff in offices in North America and Europe, the organization provides multi-therapeutic, full-service and functional service solutions, including single service and outsourcing models. 

Now it’s my pleasure to introduce you to your speakers for today’s round table discussion. First, I’d like to introduce you to Kymberli Shropshire. She’s a Global Head of Functional Services Partnerships (FSP) with TFS HealthScience. 

 

Speaker 1 – Sonya Hunt (01:59): 

Kymberli is responsible for the operational delivery of global partnerships and relationship management. Kymberli has spent over 20 years working for two of the top five global clinical research organizations (CROs) and a top U.S. academic research organization where she has applied her leadership in a variety of functions including global alliance management, data operation contracts, and site management. 

Next, it is my pleasure to introduce you to Dr. Ian Kovacs. He’s the Executive Director of Safety and Pharmacovigilance with TFS HealthScience. Ian is a highly motivated business leader with a proven record of accomplishment in establishing and maintaining profitable and compliant pharmacovigilance systems and leading operational teams. He has over 20 years operational and leadership experience in all areas of pharmacovigilance, including EU, QPPV and medical information gain within both pharmaceutical companies and CROs. 

Next it is my pleasure to introduce you to Dr. Alison Sampson. She is the head of Pediatrics, Rare Diseases, and Orphan Products (Europe) with TFS HealthScience. 

 

Speaker 1 – Sonya Hunt (03:05): 

Alison has over 20 years of clinical research experience. She has a project management background leading both clinical cross-functional teams and Alison has experience of a wide variety of therapeutic areas with particular expertise in rare diseases in neonates and adolescents. 

Now it’s my pleasure to introduce you to Dorothy Blythe. She’s a Principal Clinical Data Manager with TFS HealthScience. And Dotti, as we call her, has 37 years of project and data management experience spanning of breadth of role across the pharmaceutical industry. Specifically, she has managed a variety of programs including real world evidence research. Dotti has managed countless clinical trials as well as lead strategic initiatives across data management. 

So today our panel of FSP experts are excited to address questions about their FSP experience at TFS HealthScience in an ever-changing leadership of clinical development. The functional service (FSP) model has had to evolve along the way to successfully work with biopharmaceutical and biotechnology. 

 

Speaker 1 – Sonya Hunt (04:09): 

This session, I will be your moderator and I’m going to ask the panel questions for the round table discussion. Then we’ll open questions to the audience. So please hold your questions to the end. 

Let’s start first with two poll questions for our audience to engage in. This is done in real-time. I will give you 40 seconds to complete this poll. You should see it in front of you. There it is. So, all you have to do is select one of the below and the question that we have for you is, 

“Has your organization ever used functional service model?” 

So your options are yes or no. So please go ahead and pick one of the below and then I will close the polls and share the results with you. Your participation is strongly encouraged and very much appreciated. 

Okay, it looks like we have the majority of our audience have cast their votes, so thank you very much for that. 

 

Speaker 1 – Sonya Hunt (04:53): 

Let’s take a look at the results. Okay, so here’s the result and the result. Oh, this is great. We have 100% of the audience are saying yes to has your organization ever used functional service model? 

So, thank you very much for that. 

Now let’s take a look at question number two, poll question number two, and I will launch that for you right now and you should see it appear in front of you. And there it is everyone. Okay, so just like before, this will be done in real time. So if you could just please go ahead and select from the below. 

The question that we have for you is, 

“What is your or your organization’s experience level working in an FSP model?” 

So, we have three options. You can choose from the below, no experience, some experience or experienced. Well, lets look at our group. We have the majority of our audience have cast or votes. I’m going to leave a few more seconds for those of you who have not. If you can go ahead and do so now, that’d be greatly appreciated. 

 

Speaker 1 – Sonya Hunt (05:53): 

Okay, that looks like it’s everyone. Let’s take a look at the results. Okay, the results are here and let’s just take a look. 

So we have here 0% are saying no experience. We got 20% are saying some experience and 80% of our audience are saying experience. Thank you very much, everyone, for participating in our first two poll questions. 

Okay, now let’s get started. Let’s welcome first our TFS panels. We’ll welcome everyone. And I want to first start off with, let’s get right to the heart of the discussion today. And I’m going to start off first with Kymberli. So, Kymberli, can you tell the audience about what is TFS’S modernized approach to functional services? 

 

Speaker 2 – Kymberli Shropshire (06:36): 

Certainly. Thank you so much Sonya and thanks everyone for joining us today. At TFS, we really have taken a look at the market and our client needs. We really ensure that we focus on our client partners and in doing so as a mid-size CRO, we really have seen that the old model of an outsourcing arrangement really has dated itself. And the modernized approach is really talking about strategically growing and pivoting to our business and our client’s needs. And that business really also entails everything from our participants to the technology that we use. And in a specific function, it’s often that you want to ensure that you’ve thought through not only that functional area but also the therapeutic expertise. We focus on ensuring that our FSP team is aligned with our projects, that we bring the expertise in the forefront for our client partners. It also is the fact that it comes to supporting the overall clinical development program or device for that matter as we know that digital health is growing and that’s a big market for us to think about, especially with covid, that really has brought to the forefront that we can think outside the box and that’s where functional service partnerships in FSP really also thrives that we’re able to allow our client partners to focus on their core functionality, whether that be the device as a biotech, the science of their drug and drug development line, and even the midsize as we’re growing in their portfolio from making those right decisions and the service and the function that we provide. 

 

Speaker 2 – Kymberli Shropshire (08:17): 

We specialize in that. We bring the expertise to the table from clinical regulatory biometrics, keeping the data cohesive with data management, medical writing, and our biostats team and drug safety, which is not only our clinical safety but post-marketing and how crucial that is. So really the ability to scale a team, to meet organizational function and also really be that collaborative partner alongside our clients is where we have taken a approach to FSP services. 

 

Speaker 1 – Sonya Hunt (08:53): 

Thank you very much Kymberli for that detailed answer there. Alright, let’s move over to Alison. Alison as the Head of the Therapeutic Area, which includes rare diseases. What do you see as the client value of an FSP? 

 

Speaker 3 – Alison Sampson (09:05): 

Okay, well thank you Sonya. So yes, just picking up on some of the things that Kymberli said. So rare disease trials are usually a challenge. That’s because there is often little or no track record in clinical research in that therapeutic area. So it’s a challenging area to work in. Protocol amendments are common and you need a very flexible approach. So as I mentioned from what Kymberli was saying, FSP used to be a model that you would look for bigger trials, maybe phase three trials. But we are seeing that FSP works really well in rare disease trials. And the reason for that is that rare disease trials are very unpredictable. All trials are very unpredictable, but rare disease, particularly because there is no chat record, the trials are often experiencing protocol amendment. They are designed to actually for protocol moment to some extent often for adaptive design. 

Speaker 3 – Alison Sampson (10:13): 

So no go and go decisions and these can steer the path of the trial and change the scope of the trial literally overnight. So you can expand into a wider therapeutic area or not. And the FSP model really works well in this disease area. So in a traditional full service model, you might expect in these ever changing times and ever changing protocol that you would have to go through perhaps change order in a full service model, which would mean time, which would mean a delay in responding to regulatory agencies. But an FSP model it, it means that you can expand or contract to your team with ease to some extent you can adapt to changes in the scale of the study or not. And it’s a really, I think, efficient way of working in a rare disease trial or across rare disease studies, which are quite often biotechs often run a pipeline of rare disease studies and they have concurrent studies running at the same time. So I think the FSP model in a rare disease disease scenario is really efficient and really effective. 

 

Speaker 1 – Sonya Hunt (11:39): 

Okay, well thank you very much Alison for answering that. Let’s go back to Kymberli. Kymberli, there are different outsourcing models in the industry. Can you tell us what they are and what TFS offers to client partners?  

 

Speaker 2 – Kymberli Shropshire (12:08): 

Is it good now? 

 

Speaker 1 – Sonya Hunt (12:09): 

Yes, yes, now we can hear you. Perfect. Thank you. 

 

Speaker 2 – Kymberli Shropshire (12:11): 

My pleasure. It’s quite interesting, the poll, as we’ve seen earlier from our audience and their experience, functional services had different meanings depending on as it’s grown in the industry, different companies have taken on those different definitions, but really there’s core areas that stand out and one of those is really a tactical partnership and a service provider. So really it’s that providing a functional service designated for a one to project need and then you have your preferred provider really providing that service offering under a master agreement or across the book of work. And then the strategic partnership, kind of a non-compete partnership supporting each other in a variety of services. And I say each other because a partnership truly means that is that you really want both organizations values to come across and one of those key pieces for us at TFS, that is where we see the mutual benefit of a relationship and we really focus on not only the one-off job, but really the long-term relationship. 

 

Speaker 2 – Kymberli Shropshire (13:17): 

And that’s where a fit for purpose model is essential. As Alison said, with rare disease for example, thinking about that therapeutic area, being able to hit the ground running, knowing that you have the challenges and patient recruitment or also in retention or the type of results that you’re going to have making. So those real time decisions and having a team wrapped around that particular design for a protocol or portfolio of work really ensures that the team is able to be successful and take away and de-risk, if you will. Some of the challenges that happens with A one-to-one project start, we’re able to really at TFS pull in what is important about a fit for purpose design, which is cultural fit and also functional expertise. We keep this top of mind, we ensure that we’re building upon that every single time and we’re learning those lessons all along the way across our client partners portfolios. 

 

Speaker 1 – Sonya Hunt (14:18): 

Thank you for those key points there. Thank you so much for that Kymberli. Alright, we’re going to shift over to Ian. Ian, can you tell the audience what functional outsourcing means in the context of safety? 

 

Speaker 4 – Ian Kovacs (14:29): 

Sure. So outsourcing in a functional capacity in the context of safety is really about outsourcing the entire safety function. So specifically for the small emerging companies, really it’s about outsourcing nearly all of the safety activities. So for clinical trials, typically you’d outsource all of the safety for the across all of the studies, irrespective of who is the clinical CRO. And in post-marketing safety, it’s typically about outsourcing the entire pharmac viant system. And then what we see is as the company size increases, this is when companies typically start to develop their own internal safety capabilities. And so the complexity of the partnership changes. So rather than outsourcing the entire safety department, you’re typically building that partnership around the company’s existing infrastructure. Now when you look at large pharma, the outsourcing of safety as a function is really about outsourcing part of the ance system. So for example, with large pharma, it may be about outsourcing the case processing rather than the outsourcing of the entire safety department. 

 

Speaker 1 – Sonya Hunt (15:39): 

Okay, good point. Thank you so much for that Ian. Alright, we’re going to shift over to Dotti. Dotti, relinquishing operational control can be uncomfortable. Can you speak to any advantages to working with FSPs that compensate for the control that is transferred? 

 

Speaker 5 – Dorothy Blythe (15:53): 

Sure. Thank you, Sonya. One major advantage is access to the wealth of the experiences that we get by working with so many different sponsors and so many different using so many different systems and processes. And at TFS we take an intentional approach to learning from all these experiences and really trying to distill them down and to best practices and also just as importantly into practices to be avoided. And this applies to both systems and processes. So the FSP relationship brings the value of all those experiences to your company without the investment by your company that would otherwise be required to get those learnings firsthand. 

So by allowing us to handle the technology and the operations, we are going to choose the right tool for the job. We’re going to relieve you of the stressors of investing in the resources that would take to evaluate those tools. We’re going to relieve you of the stressors associated with procuring the various resources across the different roles that are going to be required to bring you to what you’re looking to get out of the effort. And we’re going to take all of that and manage it for you, allowing you to stay focused on the science and not have to worry about the operations. So I think that is a nice trade when you’re relinquishing control, you’re giving it to someone that you know is experienced and can make those decisions for you. 

 

Speaker 1 – Sonya Hunt (17:35): 

Alright, thank you very much Dotti for that. Okay, we’re going to shift over to Kymberli now. Kymberli, can you speak to the advantages for companies to outsource in an FSP model? 

 

Speaker 2 – Kymberli Shropshire (17:45): 

Sure. Picking up where Dotti left off, it’s the operational expertise and also taking on the technology. The tool sets the overhead, if you will, within an FSP model as a CRO partner, and I’ll emphasize partner in this as well is in order to really see that those responsibilities add value to our client partner. What I will say and many examples that we’ve had in our experience in our 25 years of existence is that when we focus on establishing our partnership to services to our clients, we really manage the optional expertise but also understand the baseline values of our client partner. 

That synergy really comes together, and it creates a long-term relationship. We actually offer different models and a different approach because flexibility as previously mentioned is really key, one of the keys to a partnership. And we have preferred provider where again, we are the provider of choice for a function or for multiple functions. 

 

Speaker 2 – Kymberli Shropshire (19:03): 

We provide the oversight, we can bring in the tooling, we’re asked to provide that tooling expertise across different platforms, whether that be a customer’s platform or our own. We also work on a hybrid model. We work with our full-service teams where it may be a full-service project on a couple of projects and then we have the full portfolio for safety for example or for biometrics. 

So that also again lends to the ability for consistency, especially when it comes to safety and even can speak to this a bit further, but even in the biostat space and biometric space holistically for emerging companies, mid-size, pharma biotech, again the thought of FSP seems overwhelming because you are thinking, am I going to have a team? I don’t need a team of a hundred or this massive group to come in and take over this operation. But really the approach is the investment in creating a team that is working alongside you based on your need and your size. And so we take on that complexity that can be really time-consuming for our client partners and it really again decreases their overhead costs and then it adds to the collaboration and the expertise that we can bring to the table. 

 

Speaker 1 – Sonya Hunt (20:20): 

Okay, well thank you so much for that Kymberli. Alright, let’s go back to Dotti. Dotti. Can you tell us how your experience as an embedded resource brought value to the client? Were any benefits realized that we’re not anticipated? 

 

Speaker 5 – Dorothy Blythe (20:34): 

Sure. Being fully immersed in the client’s world allowed for really a seamless integration of my skill sets and experience into their already established. And that was really the benefit that was anticipated. The client’s immediate needs were met and that allowed for additional wins and trust to be established relationships to get forged. 

And there ended up being numerous examples of personal partnerships that were across the two companies. And I believe that really laid the foundation for the extension of that trust, which eventually led to a formal partnership and that’s the benefit that was not anticipated. The need for specific support translated into really a full support system and that system is flexible and fit for purpose and continues to evolve as the needs change. 

 

Speaker 1 – Sonya Hunt (21:39): 

Thank you so much Dotti. Ian, can you tell us about the TFSs experience for functional outsourcing in safety? 

 

Speaker 4 – Ian Kovacs (21:47): 

Sure. So TFS has got a very long history in providing safety services and a functional outsourcing model. And this is both in clinical development and in post-marketing. We’ve got several customers where we manage end-to-end safety in both clinical and post-marketing. Then we’ve got somewhere we started in clinical and it’s developed into post-marketing. 

And I think really when I look at the TFS experience, I think it stems from the size company it is because when you’re looking to outsource safety, you really need to have trust in the team that you’re going to be outsourcing to. You need to know that they can deliver the work, but you also need to make sure that the team’s going to be a good fit. And I think right from the outset it’s really important that you can meet the team that’s ultimately going to be assigned to the partnership. 

 

Speaker 4 – Ian Kovacs (22:31): 

Now I think this is where it gets much more challenging with the larger service providers because it’s much more difficult to bring that team that’s going to be assigned right to the discussion upfront. And so I think really for the majority of our partnerships we’ve got those with the mid-size companies where we are providing either the full outsource safety department or where we’ve developed a bespoke partnership model that’s deeply integrated into the client’s existing infrastructure. And we’ve built those partnerships by having those conversations upfront and understanding their needs and building our partnership around those needs. 

 

Speaker 1 – Sonya Hunt (23:06): 

Thank you so much Ian for that. Okay, so during the discussion today, we have learned that there are different types of SP models which can be applied to cross-functional areas. Kymberli, how does TFS bring a suitable FSP model? 

 

Speaker 2 – Kymberli Shropshire (23:22): 

Yes, so we really look at focusing on the ability to speak strategically and strategically from the onset that starts with the RFP, that starts with the proposal. We’re thinking about the long-term relationship from the beginning. You have our focus and that’s the differentiator. We focus as a mid-size CRO on our clients regardless of size and we ensure that we are there for them all along the way. 

And that is important because a partnership, as Dotti mentioned, is based on trust, but it also is the ability for us to be able to take what we know and learn, both the good and bad lessons learned are essential for us to be able to springboard and continue and to evolve. And that’s one of the pieces that differentiates us in our models is that we use the experiences that we have to expand upon and take a tactical approach for that next project or that next protocol and that next design as well as look at what’s happening in our marketplace. 

 

Speaker 2 – Kymberli Shropshire (24:31): 

As we know, technology is the center and bedrock of how we collect data. Now the pandemic really has pushed in the forefront the ability to think outside the box with telehealth type of projects and support where we may have not used certain tools in the past and they’re now becoming part of the ask that we receive in an RFP and how can we do that and be innovative across. 

So that really is what’s important. Again, it’s not just for large pharma anymore, the evolution is about looking at a tactical approach that fits a relationship that’s not just volume driven but it’s actually portfolio driven. Again, our size gives us the ability to support our client partners with a focus that others may not have. 

 

Speaker 1 – Sonya Hunt (25:22): 

Okay, thank you so much for that Kymberli. Alright, I’m going to go onto the next question. It looks like this is for Alison. Could you retain therapeutic expertise and knowledge between trials using an FSP model and what advantages would a hybrid FSP model have? 

 

Speaker 3 – Alison Sampson (25:45): 

I’m going to talk from a rare disease area point of view. So, in rare diseases therapeutic is niche and rare by definition. So, to retain that pretty specialized FSP model is actually really good. And in rare disease, it’s quite common now to run a natural history study to look at the progression of the disease by the, there’s no actual history of it. And then typically to run an advanced therapy. So, gene therapy or stem cell therapy study in conjunction with that. So these two studies could overlap. So, an FSP model works really beautifully in a scenario. 

You can have a team working on your natural history study that can easily move to your therapeutic study. They can expand, or they can contract, and it works really, really nicely. Typically, in rare disease, we tend to get biotech with venture capitalists funding to run these natural history and advance therapy studies, and they tend to start out with a full-service model because they don’t have that, usually virtual companies, they don’t have the actual staff or team to run a clinical study. 

Speaker 3 – Alison Sampson (27:14): 

But as they expand and as they get more funding, they might move to an FSP model. And in the middle, we can offer hybrid models. So, for example, we could offer safety or biometrics or medical writing, whatever these companies want or need. 

We as TFS are flexible. We offer both services, so we offer for service or niche f SP or anything in between. I think this is really key to our offering. It is that we can do this, we’re experiencing in both aspects, and we can offer something that’s really niche and fit purpose. I think Dotti actually touched on that, but you can really offer something that is bespoke for a client and it’ll allow these smaller biotechs, greater flexibility, offer them cost savings in HR and recruiting people but also save them time as well. 

An FSP model as opposed to full-service model, you can expand and contract your teams very rapidly. If you have a protocol amendment for example, that changes the scope of your project in FSP, that works very nicely. And so, it allows biotechs and medium-sized pharma companies to plan and to plan efficiently. And I think this is a really key advantage of the FSP model, particularly with a medium-sized CRO. 

 

Speaker 1 – Sonya Hunt (28:50): 

Thank you Alison for that. Okay, let’s just jump over to Dotti now. Dotti, from your experience, can you provide an example of how a partnership provided a potential competitive advantage? 

 

Speaker 5 – Dorothy Blythe (29:03): 

Okay. I think that adaptive designs probably provide a great example of how an FSP partnership can offer an advantage over a one-off outsourcing situation. And I think Alison mentioned it in the context of rare diseases, but it’s also really key in oncology because a lot of Phase I trials that are adaptive designs as they try to focus in on the right approach and those types of things. 

So, by nature, these designs require agile support and teams will often struggle to deliver even on one amendment. That’s challenging enough by the time you do the database updates and deal with all the downstream impacts from those database updates such as impacts on exports, integrations, reports, there’s a lot of work that cascades from it. So, when teams are getting these amendments and fast succession, they feel like they’re in startup mood for the life of the trial, but it’s complicated by the twist they have to manage through a change order process each time. 

 

Speaker 5 – Dorothy Blythe (30:20): 

It’s very time consuming. It can really get you off track. What would really be ideal in these time sensitive situations? Because really all of them are time sensitive. Usually, it would be a great advantage if the teams could kind of just get started when agency approval comes through for the amendment. So, with a partnership you can do that because what you can do is, and you have to balance your risk comfort, you can make as broad or as narrow an offering as people are comfortable with, but you can develop pre-approved units of work. So that’s because you know you’re going to have X, Y, and Z certain activities that are going to have to happen. 

So, if you talk about that upfront, get pre-approved units of work, then the teams aren’t able to move more swiftly. And the really great thing about that is oftentimes they’re able to deliver in alignment with the sites getting IRB approvals. 

 

Speaker 5 – Dorothy Blythe (31:21): 

You’re not having a month or so go by where data are being gathered and can’t be entered into the system. Safety surveillance and reporting may not even be impacted as they would if you were continuing to have to fill out paper and send it in manually until an update came through. So that is a real tangible competitive advantage. 

I think when you compare that to the traditional approach, when you have weeks of teasing out the changes from the protocol, making sure that you’re translating those updates into the database, getting cross-functional agreement, that you’re capturing all the right things in the right formats and that that’ll translate into the right components to be analyzed, then you have to get estimates from all the people across all the groups that are going to be required in order to make these changes happen. 

Put that in a change order, get that over to the client, get that reviewed, approved back over, and then you can start your work By eliminating a number of those steps, you can really save a lot of time and as I said, oftentimes you’ll be able to deliver in time for sites getting their approval. 

 

Speaker 5 – Dorothy Blythe (32:35): 

So I think that is a nice example how a partnership can give you a competitive advantage. 

 

Speaker 1 – Sonya Hunt (32:43): 

Thank you, Dotti, for that. Alright, let’s move over to Ian. This is a very interesting question right here. How has COVID-19 impacted functional outsourcing and safety? 

 

Speaker 4 – Ian Kovacs (32:54): 

So that’s a great question and I’ll answer that in the context of our experience at TFS. So I’d say that whereas across the board at the start of the pandemic, I mean clearly the conduct of clinical trials was severely impacted. We have a large proportion of our work that’s safety and so the volume really remained relatively constant at the start of the pandemic simply because the need to manage patient safety doesn’t disappear just because of a pandemic. 

And if anything, depending upon how the products are being used and perhaps in different ways during a pandemic, the need to monitor patient safety and potential signals increases. And what we’ve seen over at TFS over the course of the pandemic is that more and more customers are really actually looking to consider their safety outsourcing and looking to outsource that in a functional model. And that’s both in post-marketing and clinical trials. 

 

Speaker 4 – Ian Kovacs (33:48): 

And actually during this period we’ve started our largest ever functional partnership in safety. And I think when I look back, I think there’s two factors at play. I think firstly we’ve seen customers who are looking to accelerate their plans for marketing approval during the pandemic. And that’s not only just for products related to covid but also for other products. And secondly, we’ve seen customers who are looking to restructure their safety operations perhaps in order to reduce cost. So for example, in clinical trials where companies are looking for a partner across all of their studies because it’s much more cost effective than outsourcing on a study by study basis. And then larger companies looking to improve efficiency perhaps by centralizing local affiliate activities. Now clearly for large pharma with covid vaccines, well their outsourcing needs and challenges suddenly became very different once the vaccination started. And I think the challenges there have been more about the availability of resource associated with the massive increases in adverse event reporting. 

 

Speaker 1 – Sonya Hunt (34:49): 

Okay, thank you so much for that Ian. Alright, let’s go to our final question now. This is going to be for all of our panelists here. The question is what makes an functional service partnership successful? So I’d like to hear from each of you. So let’s start off first with Alison. 

 

 

Speaker 3 – Alison Sampson (35:21): 

So, flexibility to me is with my rare disease and rare disease and pediatric hat on is really the advantage of the FSP model because the trials in which we work in very unpredictable, they’re designed to go with the information that the trial provides. So, we may start with a natural history study and in parallel we work on a therapeutic trial. 

These studies are always changing; they’re almost evolving, and they can literally change overnight. The FSP model is really, I think, exceptional in these difficult to do trials. Originally, they were designed for big clients and big phase three studies actually were beautiful in these small and difficult to do trials because of the unpredictability of the trials. 

We have critical amendments regularly, like if we’re talking every month or every country that we go to, we are talking of these as Dotti very correctly said, these adaptive trials with the go and no-go decision, which can completely change the face of the study overnight. 

 

Speaker 3 – Alison Sampson (36:39): 

And with an FSP model you can expand on contract your teams very easily without, as I mentioned, the recourse. Going back to the change order process, you can retain across different trials. So, from just say, a natural history to a therapeutic trial, the expertise of setting up therapeutic CRFs and collecting data, your database, which will collect essentially similar information, that expertise can be crossed between trials through a pipeline. And it really is from my perspective, a fantastic model and retaining the very niche information that you get in rare disease studies. And often, when you work in rare diseases, it’s like I have on more than one occasion been the first to work on a therapeutic trial for a particular indication. That therapeutic information and that therapeutic expertise is absolutely valuable. You do not want to lose that between different phases of a trial or cross-trials. So yes, to me, an FSP model offers great flexibility without loss of quality and, in my opinion, with increased quality because we are learning as a team altogether. 

 

Speaker 1 – Sonya Hunt (38:04): 

Okay, thank you so much Alison for that. Let’s jump over to Dotti. Dotti. 

 

Speaker 5 – Dorothy Blythe (38:08): 

Thank you. I would say for my area it would be expertise. I will go back to my earlier comment about the breadth of exposure that we get to systems and processes by having so many different partners and clients, it really is an invaluable resource because if you pick an ill fitted system or an ill fitted process, it just will be inefficient processing of the data. So I mean an example would be if you did not have a robust enough system, you would not easily be able to predict possible down the line cost, such as needing to add an additional component or additional system to process some of the data that maybe were not anticipated. 

Conversely, if you have a very simple trial, if you are using a state-of-the-art system, it could be wasteful. These systems are complex, they’re complicated, they require a lot of resources, they’re very powerful and they can do a lot. 

But if you don’t have those needs, then perhaps that’s not the best system. I think the point here is fit for purpose. We’re able to evaluate what the needs are and then recommend an appropriate solution to that. We have the experience to make those decisions. So, that’s really, I think, where our expertise is and what helps make the partnership successful. 

 

Speaker 1 – Sonya Hunt (39:42): 

Okay, thank you Dotti. Let’s go over to Ian. 

 

Speaker 4 – Ian Kovacs (39:47): 

So I think for me, trust is one of the most important aspects and certainly in my experience, those partnerships that have been the most successful are those where we’ve had the conversation regarding the design and the implementation of the partnership Right up front we’ve had the opportunity to get to know each other, we’ve had the opportunity to build trust with each other in our capabilities, but in also engaging in terms of looking at what the strategy of the customer is and where the partnership’s going. 

So, really, it’s about building that trust so that you can as a team present what in your experience is the right strategy for the customer. And you can get into that partnership discussion right early on even before the company’s chosen an outsourcing partner. 

I think that’s really where it’s so important to build that trust because down the line, as Alison was saying, it’s about building a partnership. Things may work, things may not work, and you need to have trust in both sides of the partnership in order to have a successful partnership. 

 

Speaker 1 – Sonya Hunt (40:53): 

Okay, thank you, Ian. Okay, let’s go over to Kymberli. Kymberli, what would you like to add to this? 

 

Speaker 2 – Kymberli Shropshire (40:59): 

My colleagues on the panel have said it all well. I think I’ll add partnership to round it out and really partnership, the reason I say that is it’s based on our client partners success. It’s based on finding real solutions and getting real results in challenging therapeutic areas. That’s essential. 

We understand the investment that’s made and also the investment in the outcomes, that’s key. So, as part of FSP model, really the success is saying that you’re fully invested, that you’re giving your undivided attention to your client partner, which they deserve in order to do that and fully harness what a relationship would be or the power of an FSP, it’s developing long-term relationships. That’s key. 

Through the transparency and trust, we can develop a comprehensive strategy and create economic scale. Those are all the benefits of it, but it’s really about engaging in a united portfolio and that engagement is partnership. 

 

Speaker 1 – Sonya Hunt (42:06): 

Okay, well thank you very much for answering all those questions. We have come to the end of this round table discussion, so thank you for your insights. 

Now before we get into the Q&A portion of the webinar, let’s do one more poll question. 

Okay, I’m going to launch it right now. Just like before it’s done in real time. So, your participation is strongly encouraged and very much appreciated. 

Just click on any of the below and the question we have for you is, 

“What is your interest in an FSP partner?” 

Some participants would like to know more or are very interested. Please go ahead and cast your vote and then I will close the polls in a few seconds so we can share the results with everyone here. 

 

Speaker 1 – Sonya Hunt (42:47): 

Okay, I’ll give you a few more seconds for those of you who have not. If you can please go ahead and do so now. I greatly appreciate that. 

Okay, perfect. Thank you so much everyone for participating. I’m now going to close the polls and share the results. 

Okay, so the results are here, and we have 100% of our audience are saying they have some interests. So, we have 0% who would not like to know more and 0% very interested, but we do have a 100% saying that they are interested. 

Thank you very much everyone for participating in our last poll question! 

Now we are going to begin the Q&A portion of the webinar where we are going to address your questions. 

Remember, please send in your questions by using that questions window that’s located on the right-hand side of your screen and we’ll try to attend to your questions during the time that we have together, with Kymberli, Ian, Alison, and Dotti. 

I did receive some questions while you were engaged in those conversations. I’m going to start with this first question and it looks like it’s for you Kymberli, this audience member is asking, 

“What is the current market demand for FSPs?” 

 

Speaker 2 – Kymberli Shropshire (43:50): 

The current demand is really growing tremendously in the biotech space and it’s really the fact of biotechs’ needing to have a partner to operationalize and provide some lower costs for overhead to look at scalable solutions for teams. 

The example of bringing in a safety system from beginning to end where they can keep the data collectively for making decisions. Honestly, the scale for a biotech company where you may have a small team and helping to operationalize functions or multiple functions is really valuable and has really taken a leap, if you will, into what we commonly see in a large size pharma company. 

 

Speaker 1 – Sonya Hunt (44:39): 

Okay, thank you Kymberli. 

Alright, let’s go on to our next question. This audience member is asking, 

“How does TFS determine cost for these models? Do you cost per FTE for a contract or a deliverable based costing?” 

Who would like to answer that question? 

 

Speaker 2 – Kymberli Shropshire (44:54): 

Yeah, I can take that as well. Actually, it kind of goes to what Alison said about flexibility. We look at the type of study or portfolio or design to make sure that it’s actually the right cost model. We have an FTE fee for service base. 

We also have a deliverable milestone and a preferred providership, if you will. Of course, we’re looking at how we can keep costs reasonable because we should be and have been able to provide expertise to reduce redundancies and risks over time, which then benefits both organizations when it comes to a costing model. 

So, those designs of milestone, or a preferred partnership cost structure is what we have put in place for our clients. We talk through that at the start of a partnership and the MSA level as well as throughout the portfolio and making sure we make adjustments as we see fit. 

 

Speaker 1 – Sonya Hunt (45:51): 

Okay, perfect. Thank you so much for that. Okay, here’s our next question. This audience member is asking, 

“What are the challenges for an FSP model on biometric?” 

Either Dotti or Kymberli, this might be for you. 

 

Speaker 5 – Dorothy Blythe (46:04): 

I can take this one Kymberli. Well, I think there’s potential for a lot of challenges, but I think knowing what they are and planning for them is really the key. So, I would say one of the bigger ones is understanding the split of services and function across the partnership.  

Depending on how the split of those activities rolls out, you really need to do not a high level, but once you’ve made decisions, what system and whose processes, if there is any crossover between the companies, we need to have a very technical discussion at a very granular level to make sure that we do understand what systems need to talk to each other, how they’re going to interact and the type and volume of that data and the frequency understanding that and all the foundational components under those systems. 

Really understanding how each piece is connected is essential to avoiding issues down the road. If you take the time to do that, and we do, you’ll avoid the majority of problems when it comes to technology. 

You really need to do the upfront work and the upfront validation. Make sure your systems are connected, talking and not vulnerable to various influences that are out of your control. If you can do that, you set yourself up for a much smoother rollout of the study. 

Kymberli, I don’t know if you would like to add anything to that. 

 

Speaker 2 – Kymberli Shropshire (47:48): 

I think you said it. I would say probably one other thing about technology and that’s just the understanding and being able to have some fluidity with the changes that technology brings, especially with decentralized trial models and design. And being able to pick from that toolbox, if you will, is where we have been able to work with our client partners and one of which Dotti is embedded with, to be able to pull out from the toolset. And for each project design, that’s another value is to be able to establish that right fit for purpose technology and not just kind of a cookie-cutter approach. So, I would say to Dotti’s answer or key piece for biometrics and data management specifically. 

 

Speaker 1 – Sonya Hunt (48:39): 

Okay, thank you both for that. This looks like it’s a question for Ian because we’re talking about safety here. This audience member is asking, 

“What is the advantage for companies to outsource safety in an FSP model?” 

 

Speaker 4 – Ian Kovacs (48:52): 

Okay, so in clinical trials I’d say that we still see companies outsourcing safety in a full service model where they’re outsourcing on a study by study basis. Now what tends to happen is as companies near the end of clinical development and begin to consider marketing approval, they then realize that they’ve got their safety data in multiple different safety databases and then potentially need to pay again to have that data migrated into a global safety database. 

So, outsourcing in a clinical trial safety is much more cost effective to manage the safety, it’s easier to have consistency. You can have a single set of processes, you can have obviously your SAE management within your safety management plans, you can have consistency across and it’s much easier to have the oversight of the performance if you’re outsourcing to a single safety provider as opposed to outsourcing to multiple different companies that are perhaps going to have different processes, different set of metrics. And it’s much more resource intensive to oversee that partnership. 

Now for post-marketing, we see that the smaller companies typically outsource because they don’t have the expertise, they don’t have the resources in-house to manage the broad set of pharmacovigilance obligations, particularly where you’ve got local activities as well that need to be done. And for the larger companies, as I said earlier, it’s about cost efficiency as you are looking at how your system has evolved and how it’s set up to then look at perhaps outsourcing that in order to consolidate some of the PV activities. 

 

Speaker 1 – Sonya Hunt (50:41): 

Thank you so much Ian, but don’t go anywhere. Here’s the next question. 

“Can each of you briefly provide an overview or an example of the companies you worked with in an FSP model today?” 

And Ian, let’s start with you again. 

 

Speaker 4 – Ian Kovacs (50:53): 

Sure. So, I would say at TFS, the majority of our safety business is actually managed as a functional outsourcing model. And I think simply that’s because it makes the most sense to outsource safety in that way. And the partners that we work with, they vary in terms of where they are in development. We’ve got some who only focus on clinical development, in which case we’re providing safety services across all of their studies. And then we’ve got partners who are in the post-marketing space who who’ve asked us to effectively be their pharmacovigilance system, in which case we are then working with them to make sure that they have the necessary oversight of that system. 

And as I said earlier, we work with some companies who’ve got products both in clinical development and post approval. We’ve got some who also have expanded access and compassionate use programs. And for those we really look at the existing infrastructure of the organization and build a bespoke outsourcing model to fit in with their needs and their capability requirements. 

 

Speaker 1 – Sonya Hunt (51:57): 

Okay, thanks Ian. Sorry, let’s jump over to Alison. Alison, you want to comment on that? 

 

Speaker 3 – Alison Sampson (52:03): 

Yeah, so I’d like to talk about working in rare disease. We were working on natural history study where our sponsors retained in the natural history study, vertical writing, medical monitoring and safety in house, but they’re outsourcing an FSP model of the data management and the biostats. 

We anticipate that they will continue to do that in the sister study, which is a stem cell treatment, and they may even outsource some of these other factors that they’ve kept in house with these smaller studies. And the reason that they do that is to keep the expertise. This is an unmet need disease, there’s no therapeutic offering for this disease and that niche therapeutic area, it’s kind of a no-brainer to want to retain that amongst the teams that are working on your study because it’s very niche. No other company, other team will have that expertise. 

 

Speaker 3 – Alison Sampson (53:04): 

And so, at TFS, we can offer these at an FSP level, these non-therapeutic core parts of a study. So, like data management, et cetera. But if they want to outsource data management, we can do that. And I think, as Kymberli mentioned, we can offer a very flexible FSP model at TFS because we’re a medium sized CRO.  

We’re flexible in any case, but in between the offering of a full-service and a single-service like safety, we can offer everything in between and be very flexible with it. So, I think particularly in rare diseases, we offer something that’s really unique. And yeah, I think in terms of retaining therapeutic knowledge and quality, I think it’s quite unusual. 

 

Speaker 1 – Sonya Hunt (54:04): 

Okay. Alright, thank you. Let’s jump to Kymberli. Kymberli, your comments? 

 

Speaker 2 – Kymberli Shropshire (54:10): 

Yes. We actually have a couple of unique opportunities that we built in FSP model. One is with an academic center and our academic partner was really looking for support across data management, shifting from some older technologies and platforms to being able to move that into a partner’s remit who already had that structure in place who were able to build expertise across the platforms as well as look at what their book of work was and understanding that that variety is a mix between commercial and government. 

We were and have been able to really fully operationalize their services, meet their needs, not only from a cost perspective, but also a study design across different therapeutic areas, and introduce new tools and technologies to meet the needs of their portfolio and faculty. So, it’s a really good example that shows that the variety and being able to meet your client partner where they are and bringing expertise to the table to again, ensure that both missions are aligned, but also meeting the overall purpose of why we’re all in this industry. And that’s to help our participants where they need. 

 

Speaker 1 – Sonya Hunt (55:44): 

Okay. Thank you so much, Kymberli. I’m going to squeeze in one last question. We’re coming to the end of the time here. Dotti, this looks like it’s for you. 

“What does functional outsourcing mean in the context of biometrics and what types of FSP model are there?” 

 

Speaker 5 – Dorothy Blythe (55:59): 

Okay, functional outsourcing is exactly what it sounds like. It’s where the client outsources an entire function. So, for biometrics, it could be the, and we’ve discussed this already, it could be the full suite of services for biometrics. It could be just data management, it could be just statistics, or it could be just SaaS programming. 

Right now, I’m a partnership where all three of those services are outsourced to us. But really any combination, as Alison also mentioned earlier, any combination of those services are possible because again, it’s fit for purpose. We’re trying to meet your needs. So, whatever pieces you need support on, we can develop a model to support that. 

 

Speaker 1 – Sonya Hunt (56:46): 

Okay. Perfectly said. Thank you so much for that, Dotti. 

Thank you very much for those questions. We have reached the end of the Q&A portion of the webinar. 

If we couldn’t attend to your questions, the team at TFS HealthScience may follow up with you after this presentation. 

If you have any further questions, please direct them to the email addresses that you see on your screen there. 

Thank you everyone for participating in today’s webinar. You will be receiving a follow-up email from X- Talks with access to the recorded archive for this event. A survey window will be popping up on your screen. Your participation is appreciated as it will help us to improve on our further webinars. 

Now in a few seconds, I’m going to send you a link in your chat box. You’ll be able to view the recording of this event with that link and also share this link with your colleagues once they register for the recording as well. 

 

Speaker 1 – Sonya Hunt (57:29): 

Get even more out of today’s presentation by downloading the supporting materials that are available under the handouts tab. 

We have two of them there for you. 

One is a TFS company profile and then a TFS HealthScience Reference Sheet Functional Service Partnership. 

Please go and check them out. I encourage you to do that now. 

Please join us in thanking our speakers, Kymberli Shropshire, Alison Sampson, Ian Kovacs, and Dorothy Blythe, for that very insightful round table discussion and for answering all your questions. 

Thank you very much everyone! 

We hope you found this webinar informative. It has been my pleasure to be your webinar moderator (Sonya Hunt). On behalf of the team here at XTalks and TFS HealthScience, we thank you for joining us. I’m Sonya Hunt. Until next time, please take care and bye for now. Bye everyone. Thank you again everyone!