Speakers:

• Scott Schliebner, Sr. VP, Clinical Development Services and Head of Rare Diseases and Orphan Drugs, TFS HealthScience
• Alison Sampson, Head of Rare Diseases and Orphan Drugs (Europe), TFS HealthScience
• Samaya, Moderator

Speakers: 

• Harold Nadin, Director of Talent Acquisition, TFS HealthScience 
• Marta Santos Espada, Associate Director of SRS, TFS HealthScience 
• Ryan Muse, Moderator, Xtalks 
  

 

Speaker 1: Ryan Muse (00:00:05): 

Well, good day to everyone joining us and welcome to today’s X Talks webinar. Today’s talk is entitled Innovative Functional Service Provider Solutions for Biopharma Growth and Transition. My name is Ryan Muse and I’ll be your Xtalks host for today. 

Today’s webinar will run for approximately 60 minutes, and this presentation includes a Q&A session with our speakers. Now the 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 the presentation using the questions chat box, and we’ll try to attend to your questions during the Q&A session. 

This chat box is located in the control panel, which is on the right hand side of your screen, and if you require any assistance along the way, you can contact me at any time by sending a message using the same chat panel. At this time, know that all participants are in listen only mode, and please note that the event will be recorded and made available for streaming on Xtalks.com. 

 

Speaker 1: Ryan Muse (00:01:03): 

At this point, I’d like to thank TFS HealthScience who developed the content for this presentation. TFS HealthScience is a full service global CRO (contract research organization) that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey. In partnership with customers, they build solution-driven teams working towards a healthier future, bringing together nearly 800 plus professionals. TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas. 

I’d like to introduce our speakers for today’s event. With nearly 20+ years of experience in the recruitment and operations domain, Harold Nadin is deeply passionate about assembling and guiding high-performing teams to provide tailored clinical research services. He is currently the Global Head of Talent Acquisition and UK Country Head at TFS HealthScience and Marta Santos Espada, who recently joined TFS as Associate Director for Strategic Resourcing Solutions (SRS) based in Portugal. Marta has more than 20 years of experience in clinical research having worked across the pharmaceutical industry, small CRO and large global CRO sectors. Marta has an engineering degree in biotechnology and a master’s degree in clinical investigation.

Now without further ado, I’d like to go ahead and hand the presentation over to our first speaker for today, Harold Nadin, you may begin when you’re ready. 

 

Speaker 2: Harold Nadin (00:02:31): 

Fantastic! Ryan, thank you so much for the excellent introduction. Appreciate you inviting us on today. I want to thank the Xtalks team for inviting us to this presentation, and also to the team here at TFS for their support and Marta as well. I also want to thank the people for attending today. I know in Europe, tomorrow is a bank holiday for most of the people in Spain and Portugal. I think Poland as well. So, if you are having a bank holiday tomorrow, I sincerely hope you close your laptop immediately after this webinar and call it a day. Marta, would you like to say a few words, just introduce yourself? 

 

Speaker 3: Marta Santos Espada (00:03:10): 

Hi to everybody and thank you for joining us and I hope you get as much fun listening to us as we did preparing this for you. 

 

Speaker 2: Harold Nadin (00:03:24): 

Excellent. So, let’s talk about the webinar we’re going to be running today. We are going to be reviewing a few key subjects with relations to FSP solutions within the biopharma industry. Obviously there was a brief intro there to TFS HealthScience, but I wanted to develop on it a bit further to explain how we manage our processes and the way we work here at TFS. So obviously we’re rapidly expanding CRO (contract research organization), we’re headquartered out of Sweden, we have sizable presidents in the U.S., Europe, and various other areas. Our key values are trust, quality, passion, flexibility, and sustainability. I mentioned this because these are integral to our approach to FSP work and we’ll go through this a bit further later on, but I just really want to mention that at this stage to explain how we structure our processes here at TFS. With regards to FSP, the four key things we’re going to focus on today are going to be, first of all, introduction to the challenges faced by the biopharma industry. 

 

Speaker 2: Harold Nadin (00:04:28): 

That’s a very big subject. So, we could probably do an entire presentation on that alone. We’ll start with that and then we’re going to go into some deep details about how to manage teams effectively, team structures, team management. Marty will go through that with you. She’s an expert in this field, has got some great insights. They’re going to talk to you about projects management and importance of clear consistent communication to ensure project success that honestly, that transparency is really important, that trust referring back to our values. And then my slides where I’m then going to do a slide on best practices for talent acquisition, onboarding, and retention. Again, we could do an entire presentation on that and I would love to, but we’ve only got so long, so we’ll do a quick slide on that. In addition, we’re then going to talk you through a case study which explains how we pull all this information together and shows us how we can deliver or use these lessons in practice for one of our clients. So, we’ll go through that later on. However, before we do that, I believe we have a poll. I’m just going to go through. 

 

Speaker 1: Ryan Muse (00:05:36): 

Yes, thank you so much. So appearing on everyone’s screen right now is a polling question and you can participate by selecting on any of the answers you see in front of you and then clicking submit. 

 

The question that we’re asking is, “what is your primary challenge in scaling clinical operations?” 

 

Your answer options are: 

1. Resource constraints 
2. Regulatory complexities 
3. Adaptation to market changes 
4. Technology integration 

We’ll give everyone some time to consider their answer as it best applies to yourself. And again, to the question of what is your primary challenge in scaling clinical operations? Looks like most of you have your answers in, so thank you so much for participating. 

Let’s take a look at where your votes have come down. We have ourselves here, 33% of you selecting for resource constraints and then split 22% along the rest of our answers for regulatory complexities, adaptation to market changes and technology integration. Very interesting. 

Thank you for participating, and I’ll hand things back to Harold. 

 

Speaker 2: Harold Nadin (00:06:32): 

A thank you very much. I feel like that’s the kind of question which could have had option 5, 6, 7, 8, 200- something. There could be a million different ways to explain the challenges which are facing the industry right now. I think it’s also quite interesting that they were split so well, so evenly across each of them. It’s clearly dependent on the industry or the industry, your employer, your department, your area that you work in, country, even your role type. There’s all kinds of different things which can affect your delivery. We’re going to focus first of all, the first item to actually go into that in a bit more depth and look at some of the challenges facing the industry. So first of all, if we look at the industry in 2024, despite the industry’s resilience, we’ve been navigating a series of complexities, a lot of complexities that are requesting us or require us to adapt to change, to reflect them. 

 

Speaker 2: Harold Nadin (00:07:27): 

First of all, if we look at the market dynamics, the global pharmaceutical market is valued at around 1.3 trillion, which is a lot of money in 2020, and we’re seeing an average compound growth of around 5% in the years prior to that. So we have been seeing robust growth, and this has been driven largely by things such as aging populations, prevalence of chronic diseases, and also things like emerging markets, China, India, and Brazil, which represent massive growth opportunities, huge populations, lots of opportunities to run studies. Of course with these countries, these emerging markets, there are issues with regulatory and market access challenges that require careful planning, but there was a lot of opportunity there. The issue is that a lot of big organizations, big pharma companies, it’s difficult to navigate those changes. There’s also the impact of COVID-19. So the pandemic, which seems so long ago, it’s still having a massive impact on our industry and argue with the entire global economy. 

 

Speaker 2: Harold Nadin (00:08:30): 

It distributed affected around 80% of clinical trials worldwide during its time, which led to delay suspensions, cancellations, and patient enrollment also dropped significantly by around 60% during its peak, which affected the drug development pace even further. As we all know, it takes a long, long, long time to get drug to market, and this has only hampered that even further. There’s also been the rise in virtual and decentralized trials, and this has been an interesting, I feel like it’s been a buzzword for probably a decade now, but the pandemic certainly accelerated the adoption of virtual and decentralized trials. We saw more people willing to participate in these trials as a massive increase around 72%, and also people, the virtual visits replace a lot of in-person visits, which is really encouraging, but I would argue that it hasn’t changed so great, and it’s good to see the industry starting to change and become less bureaucratic and more innovative. 

 

Speaker 2: Harold Nadin (00:09:30): 

I’d argue that it hasn’t really been the blockbuster paradigm shift, which in clinical research methodologies that we kind of thought it would become. Yet I think in time it’ll become much more adaptive and much more effective, but at this point in time, it’s not made the massive impact. We expected cost and time implications following COVID-19 have been significant as well. So the related delays and disruptions are expected to result in a net loss of around 20 billion for the biopharma industry could be actually more, and in addition to that, the price of bringing new drugs to market following the pandemic has increased by around 10 to 20% depending on the indication and the therapeutic area. And this effect, this has made a massive impact in addition to all the other time restraints that we’ve had as far as costs are concerned. Then we’ve got regulatory challenges and adaptations. 

 

Speaker 2: Harold Nadin (00:10:27): 

So, submissions have during the pandemic were significantly made more difficult. We’ve seen a massive uptake in the regulatory process and the challenges occurring, which has made things even tougher. They are starting to see a change in that. So regulatory, regulatory issues are starting to ease, but there’s a lot of backlog, which we still have to go through. But despite these challenges, I think if the industry can start to adapt to ai, start to look at new innovative ways of thinking, start to embrace things like decentralized trials and machine learning and the analytics that these tools offer, it could really help us with drug development and help us to have a much more efficient and agile drug development process overall. So, it’s been a challenging year, but I think there’s certainly light on the horizon for the industry.  

 

Speaker 3: Marta Santos Espada (00:11:26): 

Speaking of challenges and opportunities, I would like to share with you the advantages and why FSP models are an option to face these challenges and to grab these opportunities. Harold was talking about, so aligning the client’s strategy with CROs allows for the use of flexible paths by using client’s own process or the CROs proven systems, whatever works best for the project, and promotes seamless navigation through the complex project to reins with expert guidance for smooth progression towards desired goals. So, there were recent surveys that showed that around 70% of biopharma companies utilize some form of outsourcing for clinical trial services with FSP models being increasingly popular for their flexibility and cost effectiveness by aligning their own strategy with the CRO expertise. Biopharma companies utilizing FSP models experience and average on average a 20% reduction in clinical trials cycle times up to 30% faster enrollment and cost savings up to 40% in clinical trials compared to traditional outsourcing approaches. And why is this? It’s because FSP models can mitigate operational and financial risks by transferring responsibilities for specific functions such as clinical trial management or data analysis to experienced outsourcing partners, primarily due to the flexible resource allocation and pay for performance structures inherent in FSP partnerships. Sorry. Then this allows biopharma companies to scale their operations up or down quickly in response to changing project needs, market dynamics or regulatory requirements. H 

 

Speaker 2: Harold Nadin (00:13:36): 

Don’t have a poll. 

 

Speaker 3: Marta Santos Espada (00:13:38): 

Oh, we have a poll. Surprise. Yes! 

 

Speaker 1: Ryan Muse (00:13:40): 

We do. Thank you so much with our previous poll. For our audience, please select an answer you see in front of you and then click submit to participate. 

This question we’re asking you for our next poll is, “what factors are most critical when choosing an outsourcing model for your projects?” 

 

Your answer options are: 

1. Our compatibility with existing systems 
2. Expertise and reliability of these service provider cost 
3. Speed and efficiency. 

Again, the question we’re asking is what factors are most critical when choosing an outsourcing model for your projects? We’re all much faster at voting now. Thank you so much. 

Let’s take a look at your results for this poll. We have ourselves 43% for speed and efficiency, 29% of you selecting expertise and reliability, 14% both for the compatibility with existing systems as well as cost.  

So, thank you again for participating and I’ll hand things back to our speakers. 

 

Speaker 3: Marta Santos Espada (00:14:36): 

Great. 

 

Speaker 2: Harold Nadin (00:14:38): 

It’s interesting. The fact that cost was so low on there is quite surprising, and I think compatibility with existing systems will probably become more as we start to implement more AI and more automation, which we’ll go through in a bit. I think that requirement is going to increase over time. Again, there probably should have been a button which said all of the above as well. I’m sure people would’ve loved that, but it’s great insight. Sorry, Marta, over to you. 

 

Speaker 3: Marta Santos Espada (00:15:06): 

So, about strategies for peak performance. So, teams with some researchers made reveal that teams with high levels of engagement achieve on average 21% greater profitability and 17% higher productivity. So, a study by a project management institute found that poor communication leads to project failure one third of the time emphasizing the critical importance of effective communication in project success. So, these FSP model strategies of creating a strategic team setup and minimizing clinical effort by enhancing communication and positioning the FSP as a natural extension of the client allows us to ensure a bunch of important, important items. I just have a few here to share with you, but I’m sure we could be speaking about this for the entire hour, but let’s just, the ones that we found more appealing right now is first effective project management and communication. Then second well-coordinated teams that can improve operational efficiency and accelerate project timelines. 

 

Speaker 3: Marta Santos Espada (00:16:39): 

Ultimately, reducing cycle times for key deliverables such as protocol development, patient recruitment and data analysis. Another one, well-managed teams with robust quality management systems and adherence to regulatory standards that contribute to higher data quality and compliance rates in clinical trials. And this improves metrics such as protocol deviations, data accuracy, and regulatory inspection findings. 

Another item is efficient team management practices such as resource forecasting, capacity planning, performance monitoring that can lead to cost savings and reduce and resource optimization metrics such as resource utilization rates, budget adherence and cost per patient enrolled can quantify the financial impact of well-run teams on FSP delivery. 

And last but not least, well-run teams are better equipped to identify and mitigate project risks proactively and timely address issues and implement corrective actions to minimize the disruptions to FSP delivery. So, why does effective communication enhance client relationships? 92% of biopharma sponsors consider effective communication and collaboration as key factors in selecting and retaining CRO partners. 

Clear and honest communication fosters trust, transparency and stronger relationships between CROs and biopharma clients, ultimately leading to higher client satisfaction levels. Effective communication between CROs and biopharma sponsors is associated with shorter cycle times and faster study startup timelines in clinical trials, timely updates, progress reports and proactive issue resolution contribute to improved project efficiency and delivery. 

 

Speaker 3: Marta Santos Espada (00:18:44): 

78% of biopharma sponsors rate effective communication of project risks and issues as critical for successful project delivery. Transparent communication allows for early identification and mitigation of project risks, reducing the likelihood of delays, budget overruns, and quality issues. Clear and honest communication helps align the expectations and deliverables between CROs and biopharma sponsors, ensuring the projects objectives, timelines and resource requirements are clearly defined and understood by all stakeholders. 

Misalignment of expectations is a common cause for project delays and client dissatisfaction in outsourcing relationships. So effective communication enables CROs and biopharma sponsors to navigate changes, unexpected challenges and evolving project requirements with agility and resilience. Open communication channels and regular stakeholder meetings facilitate collaborative problem solving and decision making in response to changing project dynamics. So, for all this, I think that one of the biggest advantages of an FSP model is the building of bridges and communication channels between the CRO and the client leveraging from all parties knowledge and expertise. 

 

Speaker 2: Harold Nadin (00:20:13): 

Thank you, Marta. Next up, invitation, recruitment, retention and getting a bit of echo. I think it stops. So willing, war for talent, strategies for acquisition, talent acquisition and retention. So, despite all the doom and gloom we see as far as economic projections and the media, the biopharma industry is projected to create 4 million new jobs between now and 2030, which underscores the growing demand for talent within the sector. 

I was actually quite surprised when I learned that it’s a huge number of new positions that are going to be created. I think it’s more important now than ever for organizations to have a much more strategic approach to talent acquisition to attraction, and to really allocating what it is they need from the skill sets from their professionals. I think gone are the days when you could just say, okay, we’re going to replace the people that leave and we’re going to hire when we have new business requirements that’s gone. 

 

Speaker 2: Harold Nadin (00:21:18): 

Businesses need to have a much more structured approach to recruitment and a long-term plan, the strategy for how they deliver. Now, AI is a huge, huge discussion point within I think most industries, but recruitment in particular. I think new technologies can certainly help improve recruitment processes and increase the number of candidates we have coming through talent pools, but I think it’s going to have a massive impact in recruitment in particular, particularly when it comes to candidate engagement. 

Rather than seeing AI as a new workforce for recruitment, I don’t see myself or my team being replaced by bots anytime soon or avatars or anything like that. I see it much more as a way for us to improve or increase the amount of candidate engagement we can do and to improve the quality of the candidate engagement and the candidate journey. 

 

Speaker 2: Harold Nadin (00:22:09): 

So, within this, in particular, but if I speak to my recruiters within my team, or in fact generally within the industry, if I say to them, okay, what could I do to make your lives easier? How could we improve your productivity or improve the amount of outreach that you do or the amount of hires, the same response will always become, and that is, I do too much admin. I want you to take away the admin. I don’t have time to set up my interviews or do X, Y, Z or whatever else. 

Do reporting, and I think that’s where AI can really impact recruitment, particularly within this industry. If we can take away some of the more administrative tasks, it gives a lot more time for the team to focus on what we used to do within the old days of recruitment. Focus more on having a talent portal, having groups of people that you connect with very, very regularly, even if you don’t necessarily have a job for them right now. 

 

Speaker 2: Harold Nadin (00:23:02): 

I think that approach to recruitment’s really gone back in the day when I started in recruitment. They would add a little black book, put people’s names in, and I would write ’em all down in pen. I’d pick up the phone and I would phone them. That’s gone now thanks to there’s lots of automation and these kinds of things, great systems, but I think if we can enable our guys to have more time to have those kind of old school conversations and those old school communities, it’s going to have a really positive effect on recruitment and candidate experience. And of course the hiring manager experience as well. 

As I’m sure a few of you are, it’s fascinating when I think about it. My first recruitment job back in the day, believe it or not, we were faxing CVS to our clients and we’d received CVS by fax and by letter. 20 odd years later we now, there’s avatars speaking to candidates and all kinds of different things that we’re doing. So, it’s crazy to see the change that’s happened in time. 

 

Speaker 2: Harold Nadin (00:24:00): 

I’ve been particularly interested in this from my perspective as the head of recruitment for TFS back in Q1, beginning of Q1, we enabled AI into a lot of our processes within the organization. Not massive change, but small things here and there, specifically interview scheduling, generating job descriptions and job efforts. 

We used that AI for that. We also used AI to help us create new interview processes. We could target specific behaviors and specific competencies. These kind of things would’ve taken hours and hours of work prior to us implementing this, but now we can do the press of a button, which is fantastic, and arguably often you could say that they do a better job than some of the recruiters would’ve done before. 

Sometimes need some changing, some honing. But overall, it’s been really, really, really, really positive despite the fact that only a little bit of time has passed, we’ve seen a fairly dramatic reduction in time to hire, and we’ve seen more significantly higher number of applications coming through as a result of new systems and processes we’ve got coming in. 

 

Speaker 2: Harold Nadin (00:25:02): 

So, the early signs of the data and the information which is coming through is really, really, really positive. I’m fascinated to see what it looks like at the end of the year once we’ve got more data and we’ve got a bigger, bigger norm group for us to look at, but it’s been really good. Another good thing with AI, the analytics, which comes off the back a bit, is fantastic and we’ve got some great new tools which allow us to see when people drop off, why they’ve dropped off, how many clicks, all these kinds of things which can report back to us and make recommendations. 

These are the kinds of things which are very, very valuable to me as a talent acquisition manager, but also really, really valuable for the team and also our business leaders too. So, I think AI is going to have a really, really positive impact on recruitment. It’s going to save us a lot of time and a lot of admin, which recruiters notoriously hate. 

 

Speaker 2: Harold Nadin (00:25:53): 

We need to make sure, of course, that we retain the personal touch. I think it’d be very, very easy to just have a very, very high volume, reach out messages, emails, and really forget the personal approach, which is integral when you’re speaking to a candidate. Building those authentic relationships is really, really important. If you don’t build those relationships, then you will, well, you won’t get these people to come and work for you. If I think about when I speak to my recruiters, especially the guys that are earlier in their career about what are the most important things you should be thinking about when you speaking to a candidate, they’re obvious ones are experience, maybe salary, expectations, notice period, that makes sense of course. But the number one and most important question is the candidate’s motivations. Why do they want this job and what are they looking for you as an employer? 

 

Speaker 2: Harold Nadin (00:26:47): 

These two questions are so important, A, because you can be frank and say, okay, yeah, of course we can offer you what you’re looking for, great news, but you can really help to build their motivations into the negotiation at the end. So when you make the offer, you say to them, not only we going to offer you your dream job and a fantastic salary, we’re also going to offer you all those softer things that you mentioned right at the beginning of the process, which helps to really help to seal the deal when you’re closing the offer. 

So again, I think AI will help to enable these conversations, but I think we’re always going to require the personal touch. It’s going to be particularly important, especially for these FSP projects where you need people who really bought into the client, really bought into the organization. It’s going to be super important. 

 

Speaker 2: Harold Nadin (00:27:31): 

Good recruiters engage hearts and minds when you’re hiring candidates. If you think about if you may have been looking at new jobs yourself, or you may have moved jobs recently, you must really think about the fact that changing jobs is very stressful. You don’t know if you’re going to like your new job. You don’t know if you’re going to like your new boss. Maybe you miss your old job, maybe the systems aren’t as good. Maybe you’re overwhelmed, you’re overworked, you’re underworked. Underworked is a surprising issue, believe it or not, a lot of people feel like they don’t have enough to do or they feel like a bit of a spare part and that comes up more often than you might think. So, there was a lot of stress doing that and make change in those jobs. So, building that rapport and building that trust is again, very, very important. 

 

Speaker 2: Harold Nadin (00:28:16): 

Referring back to that personal touch, it’s extremely important you respect that candidates when they’re going through the process. I’m referring to recruiters here, but I’m also talking about hiring teams. You as a hiring manager, and I’m sure there are a few of you on the phone today who have hired people who are part of hiring teams, it’s extremely important you treat your candidates with respect. I’m sorry to turn this into a lecture, but make sure you are selling. 

Make sure you are assessing the motivations. Get to know them, build that rapport with them, even if they aren’t right for your job right now, they may be right for a job six months down the line, or they may be right for another job within another team within your organization. Always be selling, always be positive. You need to be thinking about the mindset of that individual as they’re sitting down to interview. 

 

Speaker 2: Harold Nadin (00:29:03): 

I personally hate interviews. I’m sure a lot of you guys too, so it’s important you make that process as simple and enjoyable and productive as possible. Onboarding processes, onboarding I think is more important than ever now, and it’s critical for setting new hires up for success. You need to integrate them into your culture. You need to integrate them into your system, your technology, some of the things I mentioned before, the workload, the demand, the management style, all these kinds of things. 

So, it’s really, really important. You’ve got a great onboarding process set up. It’s also important that you have people that own those processes, not the delivery of those processes. It may be that HR does this part of the process or it does this part of the process, but you need someone to own the overall process to make sure that gaps aren’t missed or things fall through cracks. 

 

Speaker 2: Harold Nadin (00:29:52): 

Onboarding what happens if this goes wrong? The negatives of onboarding got a quick snap for you. Society for Human Resource Management said that the turnover rate for the life sciences industry is 17% higher than other industries. So we have a high turnover rate within life sciences across all other industries. That includes banking, retail, FMCG Tech, we are significantly higher, which is quite surprising to hear. But in addition, they also noted that our new employees are 69% more likely to leave in the first six months. Now, that is a very, very concerning stat for me as a recruitment manager. I don’t want to have to be recruiting for people every six months for people that have left organizations, but it also goes to show that there is a gap there within our industry where people are not being onboarded in the right way or to be honest with you, not being hired in the right way. 

 

Speaker 2: Harold Nadin (00:30:47): 

Maybe the recruiters are overselling the position or the hiring managers aren’t selling it in the right way or they’re underestimating what is required for the role. It’s super, super important. You get the onboarding right. Cost of replacing staff can vary wildly depending on the role you’re in, but it can be anywhere from 20%. It’s usually around the average, but I have seen numbers go up as high as 200%. If you think about costs, training, time spent, recruited costs, everything else, lost client revenue, all these kind of things, especially with an FSP start to mount up, it’s very, very important. You get your onboarding right. There are a number of ways that you can ensure of a good onboarding. First of all, a good orientation program, a good standardized program, which is, as I said, managed by a process manager and has clear people who are responsible for different parts. 

 

Speaker 2: Harold Nadin (00:31:37): 

This may sound very obvious, but even things such as who sends the it? What are the timeframes for it? By it I mean laptop, all that kind of stuff. Who went to the, are the goals set up? How are the benefits communicated? All of these different things are, there’s so many different things you have to tick off, and it’s really important that that is owned and managed very, very well. 

Again, particularly with these FSP deals or these FSP projects because you need to make sure you’re bringing people in and onboarding quickly and make ’em successful as quickly as possible. Another good way of ensuring great onboarding is to have a mentor and or a buddy, again, not just having some piecemeal approach. You need to make sure that you define exactly what the responsibilities of the buddy are and exactly what the responsibilities of the mentor are. 

 

Speaker 2: Harold Nadin (00:32:20): 

Now, this will vary depending on who you are, your organization, whatever it may be. But generally the buddy tends to be your shoulders to cry on type individual, the person who asks the silly questions and I still have plenty. And then your mentor tends to be a person you need for that technical experience and the way that you interact with those two people can be completely different and each organization will manage it differently. 

But if you don’t have it defined, get it defined because it will just be a waste of everyone’s time. Structured training development, of course, you need to make sure that you structure your training and development, ensure these people train those gaps and fill in those areas where they need improvement. Have seen companies go as far as testing people before they join, whether it be for psychometric tests or verbal numerical reasoning or even skills testing so they can see where the gaps lie before the individual starts. 

 

Speaker 2: Harold Nadin (00:33:08): 

So when they join on day one, they’ve got a nice structured training program would be amazing. Those kinds of things are fantastic ways to work. Obviously it’s a lot of administration and cost, but you can really go to the extreme and be exceptional like that. But at the very end, ever end, you’ve got people who don’t have any training, no onboarding, nowhere to go for issues or queries. You need to make sure you’ve got good structured training and development really as well. When I think about development, you need to make sure there are career plans as well in place for individual. If you’re joining an organization, you’re not joining that organization to stay in the same role for the next 20 years. You’re joining that organization with the idea that you’re going to step up into the next level or the next level potentially into different teams, different departments, and it’s important you have those career pathways mapped out so that people can see those options and see that development. This as well will massively produce retention. One of the main reasons why people leave, particularly in the first two, six months to two years is because they don’t see any career development within the organization. And that’s a travesty when you talk about when we talked earlier on about the amount of money it costs to replace these people, we shouldn’t be losing anyone in the first year. Obviously some turnover, staff turnover is good, but not in the first 12 months. We don’t want that. 

 

Speaker 2: Harold Nadin (00:34:23): 

I wrote another good way of onboarding people is regular check-ins and feedback. That might seem really obvious, but you’ll be surprised how few people actually have regular check-ins and feedback with the hiring manager. And when I’ve looked at it, a previous employer of mine when I’ve looked at the research, tends to get worse as you become more senior. There was a senior person I met at a previous CRO and we were talking about his plans for his team, what are your plans for the year? What do you want your team to look like? Where do we need to focus the hiring headcount, planning, that kind of stuff. And I said, have you connected with your boss? And he said, no, I haven’t spoken to her for a year. I said, what do you mean you haven’t spoken for a year? And he hadn’t had a one-to-one with his boss for a year. And that for me was again, very alarming. And you think the more senior you get, the more experienced you get. This would be an obvious thing you’d do, but it’s surprising how little that happens. So it’s important that you do that if you’re a manager and certainly something which we pride ourselves on the TFS, it’s something that I pride myself on. Speaking to my team very regularly is critical because you will lose engagement and you’ll lose focus and they will lose sight of their goals and unfortunately they will fail. 

 

Speaker 2: Harold Nadin (00:35:37): 

Onboarding great way to onboard people effectively is to get ’em involved in social interactions and activities. Got a lot more challenging nowadays with a lot of people working remotely, particularly in our industry. I know for instance, myself, I work, I live in Leeds in the uk. I’ve got Rob who’s over in the US and I’ve got Nash, who’s down in Beck Cansfield near London. We’ve got three guys in Spain, a few in Sweden. It’s very difficult for us to all get together and have a drink or go bowling or whatever it is that you want to do for social activities. But if you can’t meet in person, it’s important. You meet virtually, team meetings, meetups, all these kinds of things, celebrate birthdays, successes, these things. Try and make it social. Try and engage people as much as you can. If you are lucky enough to have people in an office nearby to you, take the time to meet up. And I know especially for I think at the FSP team down in Spain and in Portugal, and we’re going to talk through the case study example in a second. They’re really good at that. They’re really good at pulling teams together and meeting up, and I think that’s another reason why the engagement is so strong down there. 

 

Speaker 2: Harold Nadin (00:36:45): 

I could go on about onboarding, but I’m going to move on to retention now. Retention in many respects is quite similar to onboarding. Retention just tends to be a development onboarding through to the next stages. I’m going to give you some more stats now. So organizations with high engagement levels, which goes hand in hand with retention, are 21% more profitable and experience 41% lower absentees to 41% of people not turning up for work. Again, those numbers speak for themselves, but I think it’s important that you do. Once you’ve got people on onboard and ready to go, it’s so important you keep them engaged. And again, I’ll go through these examples in a second. Some of them are quite similar to the onboarding, but it’s very, very important and do, it’s crucial to ensure that the standards don’t drop your KPIs, don’t drop your metrics, don’t drop your delivery doesn’t drop ways that you can manage retention, improve retention, career development opportunities. I talked about career mapping earlier on, knowing where you’re going to be going next, recognition and rewards programs, recognition comes in many ways. These things can be bonuses, these things can be salary increases, whatever it’s may want to do it, and often that’s what people think of when they think of recognition and reward. But often some people just want to be celebrated. They just want to a high five or a mention from the CE or mention from their boss or someone else. 

 

Speaker 2: Harold Nadin (00:38:10): 

These kind of things may have a massive impact on how someone feels. Money is great and I’d all love it. We’d all have a bit more money. I know that for sure. But often just having someone mention the fact you’ve done an excellent job and the time you put in has been recognized can have a real, real impact on you as a person, more so the mint money and really helps you to feel part of the community work-life balance initiatives are great. I, it’s different depending on project demands and client demands, and it also varies depending on your employer. You might have one or two projects, you might have 10 projects working on depending on which organization you’re with, but it’s important that you take time to do that. And these can be social activities, but it could also be, I know a lot of organizations nowadays have days out where they’ll do charity work or charity events. 

 

Speaker 2: Harold Nadin (00:38:57): 

These kinds of things are really good, but also also flexible work. I know some companies implement core hours, but outside of those times, people can start and finish when they need, and it varies depending on location and again, your project that you’re working on. But those flexible work life initiatives can be really good. These also include things like paternity pay, extended paternity pay, extended maternity pay, paid leave, unpaid leave, all these kind of things. It’d be really useful to keep people retained and keep them in the organization. Policies on these things are also very important. It’s, it’s good to have all clear so that everyone’s on the same page as to how these work. I mentioned compensation earlier on, but again, good compensation benefits is important. Salary ranges, obviously we’ve seen a lot of inflation over the past few years and we have seen a stock increase in salary ranges. 

 

Speaker 2: Harold Nadin (00:39:44): 

Again, we probably talk a lot about that, but it’s also the benefits as well. A good set of competitive benefits can be the difference between someone joining you and someone joining a competitor. I know this is more of a HR thing or recruitment thing, but it’s definitely set something to speak to your HR team about. If you are in a senior role because there’s slight improvement, the benefits can have a massive impact. Opening communication feedback is really important as well for attention. You want to be able to speak to your bosses, you want to be able to speak to your team without judgment. I think it’s super important that you foster that kind of environment. I know I definitely do within my team, I have to have a lot of difficult conversations with people, of course, and they’re very honest with me and I won’t say any names. 

 

Speaker 2: Harold Nadin (00:40:25): 

They know who they are, but to be honest, for me, I love it because it means I know exactly what the issues are and we can make those changes quickly. So I encourage you and any managers here to take that approach. And then finally got two final points. Employee engagement surveys, the surveys, we send them out I think now twice a year, and most companies are running them nowadays. I think a lot of organizations or people who run those surveys see them as tick box exercise more than anything else, but they should not be underestimated. The information you gather from them is frank, honest, anonymized feedback from your team as to exactly how you’re running the company and how you could improve. Don’t waste those opportunities, use that information to make changes. And then finally, promotion of diversity and inclusion. Obviously this takes many forms, but that diversity of thought, diversity of background can have such a great impact on your organization. Obviously the more the team, the more effective the team can be. So it’s very, very important you factor that into your retention plan. I think if you implement these improvements, you will see an increasing retention. Again, we could go into a lot more depth, but high level, that’s what you should be thinking about. 

 

Speaker 2: Harold Nadin (00:41:38): 

Now, we’re now going to talk, I mentioned before, we’re going to talk about case study that’s going to encapsulate all of these things that we’ve discussed, and I want to give you a real life example and specifically our recent Portugal project. Before I dive in, I must emphasize that whilst I’m presenting this project overview, I can take only the smallest amount of credit for the work that has been delivered narrat rating more than anything else. The real thanks and the real delivery itself really is owed to the S-R-S-F-S-P team. No sole, my recruitment team, Jayla, Lord Marta, of course, the finance team, Marta Halladay, everyone, all these people that work together to pull this project and together and make it a success. I can list, I’ll give a long list of names, but I word, but I think we couldn’t have done it unless we had pulled together as a team. I think it’s important to mention that not just because they deserve the thanks, but because we wouldn’t have succeeded if it wasn’t for the support of these individuals. So thank you all to your contributions. You know who you are. 

 

Speaker 2: Harold Nadin (00:42:46): 

So high level, back in 2022, a client of ours got in touch as they wanted to review their current FSP provider in Portugal. They’ve been in place for several years, but there were some key issues which had come about. The three top ones workers will structure. So the client themselves, they wanted to merge Spain and Portugal into one holistic Iberia region for a multitude of reasons, but they needed a provider that could adapt in both regions of both markets and grow and scale up. They’re also concerned about quality. Portugal is notoriously difficult from a quality and project management delivery perspective. I’m sure Marta can agree, but I think that the project delivery had started to deteriorate, slightly started to plateau, and again, you put it down to the Portuguese difficulty of regulatory concerns, everything else, but there was concerns that the provider would start to drop the ball slightly. 

 

Speaker 2: Harold Nadin (00:43:42): 

And then finally, long term, the client wanted to increase the volume, the number of studies taking place in Iberia overall. But in order to do this, they need to make sure I had an FSP partner with a scalable agile, could deliver, trusted, let’s going back to our values again and had the integrity to be honest and a trusted partner with them. So that was the reason why this came about. And then in step TFS, so we’ve been working with the sponsor in Spain for several years, and we’ve been able to establish a relationship for quality speed, adaptability, and we’ve done exceptional amount of FSP delivery in Spain. We’ve got a great team in Spain and they’ve been in place for several years. We’ve got good quality, good processes, so we had a great reputation. They made us aware of this situation and we went to tender. 

 

Speaker 2: Harold Nadin (00:44:37): 

But whilst we had that great reputation in Spain and great processes, an established team, we faced a big challenge. And that was that we had no presence in Portugal. We didn’t have an entity, a bank account, an office contracts, legal representation, staff, anything. Big, big, big hurdle. But instead of hesitating, we decided this was a good opportunity for us to grow our business, good opportunity to expand the relationship with this sponsor. We’d already done a fantastic relationship with them and just building more and more onto it. But we also knew that the integrity and honesty were going to be vital for the success, both for the projects itself, but also for the client relationship. If we dropped the ball, then we risked losing relationship overall. So this wasn’t just a tender to open up a new market. This was a tender that could potentially jeopardize the entire relationship with this client. 

 

Speaker 2: Harold Nadin (00:45:35): 

We wanted to throw our hat into the ring, but we had to make sure that we knew that we could make this happen. It was very, very important. We did that. So before we even submitted the tender, we then started to pull together the team. So we pulled the guys from the SRS, Spain team, PLAR sole, the rest of you, again, you know who you are. They pulled together a team of great people who knew the processes, they understood the regulatory issues, they understood what quality and what could look like specifically for that sponsor. 

So they were the core team. We then pulled together the hiring team. So I had two members of my team who had experienced hiring for that vendor and also both spoke Portuguese. So I reallocated them from one project to another. Obviously very valuable, but I make a point of hiring people that speak as many languages as possible for just this eventuality, and I knew that they understood the client demand. 

 

Speaker 2: Harold Nadin (00:46:34): 

I also assigned a project manager from my team, a guy called Sam, who is a much better project manager than I am. And I knew that he would be able to maintain good deadlines, good standards, and make sure the energy was going to remain high for this critical need. We also needed to identify the functional back-office partners so we can have a hiring team, we can have a team of people to manage them, but if we can’t build an entity or a bank account or anything like that, then there’s no point. 

So, there was some crucial support from our legal team, facilities team, HR, comp. These were the team that would help us understand how long it would take to set up these key things, how long it would take to open an office, contracts, these kind of things. This is why I mentioned at the start, the importance of bringing together the team. 

 

Speaker 2: Harold Nadin (00:47:21): 

We were all sat there. We all had one big problem we had to solve, and we had to be honest with each other. We didn’t have much time to solve it. We recognized be huge amount of work, but we’d identified the deliverables and the key challenges, which made the initial project implementation. From our perspective, our end very, very easy. Well, not easy, clear, we went to tender. We were very honest with the client. We flagged our advantages as a provider, and I think they were obvious, but we also, and also the track record over the board in Spain, but we were also very honest about our limitations, our challenges, and we explained how we would work around them, how long it would take to ramp up. And I think actually before I mentioned that, but also in the background, we were also begin to look at the quality and compliance and regulatory issues that we were going to face by adapting and growing into Spain. Obviously this is very, very important for us to do. Again, top of mind from a values perspective. 

 

Speaker 2: Harold Nadin (00:48:22): 

Yeah, it was very, very important that we did that. In addition, we also started to pipeline talent in Portugal as well. So even though we hadn’t actually signed anything at this stage, the team began to build pipelines of talent, began to have conversations, high level conversations with candidates, which was very, very useful. And that really helped us, again, with the honesty in mind, with the integrity, with the background, what we were doing. And the client was very, very appreciative. And we then went on to sign terms back in August. Our track record was a real big benefit, but I also think the honesty, which we were very honest with ’em upfront, this is going to be the challenges. This is how we’re going to fix them. I think that was really important for us winning the tender. We were up against very, very big name CROs that they could have gone with rather than us. 

 

Speaker 2: Harold Nadin (00:49:09): 

There were also other midsize and smaller CROs that were up for the Tinder, but they went with us because of the fact that we were offering something different. We were agile, we were scalable, we were proof of that. So, in September 2022, TFS embarked on this transformative FSP project in Portugal, and it was a big, big thing for us. It is a milestone for the organization. And over the following months, we’ve then started to work to bring it to fruition. Everyone, legal, finance, HR, TA (talent acquisition), and the business we’re able to set up the entity. We would then set up employment benefits and contracts in our bank account. We spent a lot of time particularly looking at comp and bend because it’s important that we ensured our compensation was attractive compared to our competitors in the market. We also found an office, which was great. It’s a really, really nice facility, and I think the guys really, really liked it, which is great. 

 

Speaker 2: Harold Nadin (00:50:07): 

We then began to go to markets. We started to look at, we would use all the recruitment channels, we could look at direct outreach, LinkedIn referrals. We went straight out to market and then took it up a notch as far as how we were attracting the client candidates. But in addition to that, we made sure that we had a clear strategy from an EVP perspective because we weren’t known in Portugal. We were an unknown quantity. Why would you go and work for this random company that’s turned up? So, it’s important that we had that message clear, and that was that we were growing, we had grand ambitions. We wanted to bring a new level of quality, a new level of process to Portugal, had a great big project. We have a great big client we want to work on, and the way we treat our employees and engagement with employees is fantastic, and we don’t overwork them. 

 

Speaker 2: Harold Nadin (00:50:56): 

We’re very honest with our approach. It’s a team mentality rather than individual KPI driven mentality. This really, really helped us to engage with candidates and got us out to the market very easily. So, at the beginning, things were looking very good. We knew that we’d have probably four or five months to get everything going. I think getting into Q1 was the initial go live date, but then unexpectedly, the current provider decided that they wanted to withdraw. And this happened in November. So, in November they said, we’re going to withdraw from this project, and you’ll need to take on ownership of the project at the end of December. So, we’ve now had the project cut down by three months. Now, this was a huge problem for us. Not only are we having to build a new market, open up everything that we need to do, all of the other things I mentioned about hire, all the staff, it was a large team that needed to be hired in a short time. We then had to do it in three months less time, which was a shock. 

 

Speaker 2: Harold Nadin (00:52:04): 

But I understand why the current provider did it. They were not satisfied with the fact that they lost their clients. So, partly it was kind of understanding and it was disappointing to hear. But the good thing is, is when we spoke with the sponsor, said to them, look, this is a problem. We’re going to adapt to it. And the sponsor was gracious, which was fantastic, but they also said, we’ve got patients and we’ve got studies that need to be managed, so we respect that this is going to be really hard work, but you’ve got to pull the cat off the bag to coin an English phrase. So this, we had to completely adapt everything and change all our plans. We had two months to take on the study. We were at a huge challenge on our hands. But with these kinds of things, it always happens with projects. 

 

Speaker 2: Harold Nadin (00:52:48): 

There’s always shortfalls, there’s always issues, deadlines change, and you have to adapt to the client needs. So team met remain resilient. We were already meeting with the client I think at this point once a week where we had meetings with the recruitment team, close collaboration meetings, data updates, make sure we’re staying on track. I think this then became biweekly. And then we were also meeting with the current provider as well to ensure that all the data was transferred effectively. And it was really important for us to help us adapt things. And the client was very much appreciative of this. 

 

Speaker 2: Harold Nadin (00:53:24): 

We started to contact the employees from the current provider as well to try and attract them over to come and reach with us. We wanted to make sure that the interview process was extremely thorough because we did have concerns around quality as well. So, we did contact some of them, but unfortunately, for the existing client, there were a lot of counteroffers, and there was also a promise of new projects. Unfortunately, a lot of them didn’t materialize for them, but this really slowed down the hiring even further. We knew that if we were going to be successful, we were going to need to broaden our search. We started to have some fairly honest conversations with them [the client]. One of the things we realized is that hospital study coordinators were a great place to hire potential junior CRAs (clinical research associates) for a client. And we’d seen success of this elsewhere o other projects, both on the full-service side and the FSP side. 

 

Speaker 2: Harold Nadin (00:54:13): 

So, we took this idea to them and said, look, we should be hiring, okay, there’ll be gaps in skillset and gaps in knowledge, but we’ve got some great people here. Great attitude. And really if you can hire for attitude and you can fill all those training gaps, you’ve got some great potential here. Some great staff had this conversation with the client. They’re appreciative, and while they didn’t make up a huge amount of the hiring, it helped us to plug a few of those little gaps. The little gaps in hiring. You have left one role here. Long roll over here was really good and really helped us be successful. Now, I’ve been talking a lot about recruitment. I’m conscious of time and I’m going to talk about the standards, the work the guys were doing. So the delivery itself, again, one of the reasons we won the relationship was the great success we’d had in Spain. 

 

Speaker 2: Harold Nadin (00:54:59): 

And when we went in, we spotted a lot of issues with the current service levels. I think some of the KPIs weren’t great. Trackers study documentation, there’s a lot of concerns. We had regulatory issues and we agreed the sponsor and the client that we would make significant changes. We met with the client very regularly to establish these, and the current provider was actually fairly supportive and helping us transfer everything over. As I mentioned before, I think the way we kept these standards high was, first of all was we set new KPIs and metrics of the client replicating what we were doing in Spain. We knew that was a good level, great service. Let’s move it over us and apply as much as we can. Great onboarding. It was really important. We wanted to make sure that they were onboarding in the right way. The EVP was good. 

 

Speaker 2: Harold Nadin (00:55:51): 

They had great client engagement. We had people from Spain who were able to teach them what quality looked like, what could look like, but also we made sure that it was communicated simply and effectively because we didn’t want to overwhelm them. We didn’t want to put the urgency onto these poor guys who just joined us as an organization. They don’t need to know there’s all this urgency happening. And again, that buddy and mentor relationship between the two regions was really important. We created action plans for the individuals, as I mentioned, but we also created action plans for the team, and I think that was what really helped to mentor foster the team environment for the guys there. The success is built based on the team’s results, the team’s KPIs, the team’s goals. And this team mentality has meant that they have fostered a really great relationship. 

 

Speaker 2: Harold Nadin (00:56:41): 

And I think I want to talk about this a bit later, but the employee engagement surveys in Portugal have been fantastic. Every single time we do one, they’ve been really, really positive, great management. Of course we’ve got Marta down there as well who definitely has an impact. But the fact that they focus on team mentality is great. And I think in addition to that, whilst there are some things that come from the more senior management improvements that need be made, a lot of the improvements and processes and honestly improvements to improve KPIs and metrics is actually done by the guys in Portugal. They come up, we say to them, how do you think we can improve that particular metric or that particular KPI that timeline, and they do it themselves and they come up with the ideas. And again, it really fosters that team mentality and it helps ’em to feel like they’re part of that client, part of the FSP client. 

 

Speaker 2: Harold Nadin (00:57:28): 

And I think that seamless integration between the two is so important with these kind of projects that empowerment, it’s really good for helping build communities conscious of time. I want to maybe go through it. So, the December ‘go live’ came, Spanish support during this period was critical. We could not have been able to deliver without them. There was a lot of guys in Spain that were supporting with a lot of work in Portugal during this period when in December ‘go live’ came. We had hired quite a few people, to be honest with you, despite the short timeframes, but there was a lot of support from them. We got compensated with overtime of course, but in addition, we tied a lot of the stuff into their goals and KPIs and development plans. So, it felt like rather than it feeling like us helping them, it was a regional goal. 

 

Speaker 2: Harold Nadin (00:58:12): 

It was supporting the whole team for this particular sponsor. So, it didn’t really feel like it was a labor, it was more of a we need to work together to get this done. By the end of February, almost all of the staff were onboarding. In fact, pretty much all of the onboarded. By the end of February, we allocated most of the resource from Spain to pick up the slack, but then we were able to offboard them later that month and had very, very, despite the fact change in the timeline, it had very, very, I think had any impact actually, in fact on the quality or in compliance issues or anything like that from a delivery perspective. So we were really happy one year on or just over one year on. Now things have got even better for us, which is fantastic. So again, Portugal is a tough market. 

 

Speaker 2: Harold Nadin (00:58:59): 

As I mentioned before, to manage from a regulatory perspective, startup perspective, and this can be quite discouraging for sponsors, but we’ve made such a good improvement to quality and delivery that the sponsor is now putting more projects and needs more resource in al, which is fantastic. And for them from their perspective, they really want to raise the credibility of the Iberia region and the significance of the Iberia region within their organization as well. So that quality is so, so important. So we’ve been able to replicate that and help them as well to raise their internal brand within their organization, which is a really good to hear onboarding and engagement remains consistent. We’re not being complacent though, so for instance, we constantly need to change things and make sure things getting better. So from an HR perspective, I know we reviewed benefits recently to make sure that they were still competitive. 

 

Speaker 2: Harold Nadin (00:59:52): 

We also looked at, we’ve also very, very recently decided to take another look at our career pathways for the clinical operations teams, CRA, CTAs, et cetera, to make sure that they are competitive and are engaging and we’re going to help people to see a path for themselves, so not being complacent, making sure we continue to improve the experience for these guys. Our leaders of course, remain humble. They listen to the guys in Portugal, they to TA as well, which I’m very, very happy about. Listen to HR and legal, and then they listen to the team. They’re a great team that we work with down in South Europe and they help us to learn and grow and fix things. And then we’ve built such a strong relationship now they’re built on trust, built on honesty, scalable as well. So important for FSP work, scalable agile approach. We’ve shown that we can do it and it’s only going to hold us in good stead in the future for this client. I could go on, but I’m conscious of time. Marta, have I missed anything? 

 

Speaker 3: Marta Santos Espada (01:00:54): 

I can’t get tired of this story. Really. Really, every time I think of this story, it makes me believe this so much. Because today we are a team of 27 people in this FSP model and it’s so great to see how everything works or how everything fit together so perfectly with IT was not just now Portugal start working. No, everybody contributed. Everybody helped. Different countries working together to pull this off. It’s really, really, really an inspiring story. I could stay here two hours listening to you talking about this. Really. That’s true. 

 

Speaker 2: Harold Nadin (01:01:49): 

I mean, everyone wants to be part of something, right? Everyone wants to grow something professionally or personally, but I think this was, like I said, my involvement with this project was small, very small compared to some of the other people. But even my small part, it was great and I’m really pleased with it. And it’s kind of set benchmark for what we want these kind of projects like in the future for our FSP clients. So yeah, there you go. I think that’s the final point on that. 

 

Speaker 1: Ryan Muse (01:02:20): 

All right, well thank you very much for this very insightful presentation. I’d like to invite our audience to continue to send some questions and comments right now using the questions window as we move into our Q&A portion for our webinar today. I’ve got a few questions from the audience, so let’s get started with what we’ve already received so far. 

The first question that I have here would like to know is, “if you can give an example of how FSP models have specifically addressed and overcome regulatory complexities in a recent project.” 

 

Speaker 3: Marta Santos Espada (01:02:52): 

Yeah, I can take this one for sure. I can share the example following in the same sequence of this Portugal case study that Harold was presenting, it’s a team, a new team, a recent team, and we started working with this client and for regulatory actions, we started working. At first we started working with our colleagues in Spain that were our mentors in pretty much everything about TFS procedures and how things worked and everything. And they already knew the sponsor, so they helped us a lot and mentored us. 

For this specific FSP model, we work together with the client, with the sponsor. So for regulatory submissions and procedures, for example, our clients handles the regulatory authority part of submissions and TFS handles the ethics and country specific part of the submissions. And this is particularly, it’s very, very, very helpful for the new EU CTR process, for example, because it works very smoothly and very stress-free. And we haven’t had anything going bad so far in this year end. Something we’ve been working and everything’s been working really, really well. Again, due to constant communication, constant work team using subject matter experts, every time somebody anybody needs, nobody’s alone ever. So, I think it’s the big tip here is nobody needs to work alone. Nobody needs to invent the wheel. 

 

Speaker 1: Ryan Muse (01:04:58): 

Very good. Alright, thank you so much for that answer. Another question I have here for you would like to know, “what are some of the most common pitfalls that you think companies face when transitioning from a traditional FSO model to an FSP model? And do you have any tips on how they can be avoided?” 

 

Speaker 2: Harold Nadin (01:05:15): 

I think that’s a question for you, Marta. 

 

Speaker 3: Marta Santos Espada (01:05:16): 

Oh yeah, I can manage it. I just need to think of it. It’s not the easiest question of all, but let me see. Some pitfalls that come to my mind for this type of transition would be the selection process of the CRO itself or the FSP model because the sponsor might have trust issues in the new hires. We don’t know who people are. Who are they, how do we trust that they’re going to be the ones that we want to, okay, so in our case, for example, in TFS, we gave our clients the opportunity to perform a less round of interviews to know the people we were choosing to work with them so that they would see if these people would have their profiles that they like, that they consider relevant for their values for their company. 

 

Speaker 3: Marta Santos Espada (01:06:28): 

Another pitfall would be invoicing, for example, how do we invoice the services? How does the CRO invoice the services to the client? For example, you could have invoices by hour, which is a nightmare. And we could avoid this by doing as we are currently doing with our client, that every single one of us is working for these clients. So, the invoicing is done on a monthly basis, not an hourly basis. We have, okay, we work this time every month, this amount of hours and this is what we’re going to invoice for example. It’s just something that came across my mind. 

 

Speaker 3: Marta Santos Espada (01:07:22): 

Other pitfalls that we could have oversight. How does our clients trusts that we are going to have an accurate and proper supervision of the activities that our people are going to develop. And here to avoid this, we could have plans agreed with the client, for example, on what are the oversight plans we could have? How can our line managers ensure that our people are delivering what they’re supposed to. We can have, for example, I am the line manager of the CRA group, so I am to schedule visits with them, remote activities with some kind of oversight to ensure to the client that we are keeping things on track, like metrics we can show to the client what type of metrics, what metrics are we accomplishing every month, monthly reports, regular meetings. We could have, I don’t know, weekly meetings by weekly meetings, clinic meetings. Everything is about trust, transparency. So, I think that yes, there are a bunch of pitfalls. Obstacles mostly, is we don’t know you, how can we make sure we trust you? And it’s about transparency, I think. 

 

Speaker 1: Ryan Muse (01:09:20): 

All right. That’s great. Thank you so much. 

 

Speaker 1: Ryan Muse (01:09:24): 

That’s a wonderful answer. I’m sure they really appreciated that insight. We have reached the end though of the Q&A portion for our webinar today. If we couldn’t attend to your questions, know that the team at TFS HealthScience will follow up with you or if you have some further questions, you can direct them to the contact information that’s up on your screen. 

I want to thank everyone for participating. In today’s webinar, you will be receiving a follow-up email from Xtalks with access to the recorded archive for this event. A survey window will be popping up on your screen as you exit, and your participation is appreciated as it helps us to improve our webinars. 

Additionally, I’ve shared a link to view the recording of today’s event in the chat box, which you can also share with your colleagues so that they may register for the recording here as well. Now, please join me once more in thanking our speakers for their wonderful time here today. We hope that you found the webinar informative. 

Have a great day everyone and thank you for coming. 

 

Speaker 2: Harold Nadin: Thanks, Ryan. Thanks, team. 

 

Speaker 3: Marta Santos Espada (01:10:19): 

Thank you, everybody. 

Speakers:

• Scott Schliebner, Sr. VP, Clinical Development Services and Head of Rare Diseases and Orphan Drugs, TFS HealthScience
• Alison Sampson, Head of Rare Diseases and Orphan Drugs (Europe), TFS HealthScience
• Samaya, Moderator

Speaker 1 – Samaya (00:10): 

Well, good day to everyone joining us and welcome to today’s Xtalks webinar. Today’s talk is titled Pediatric Rare Disease Studies: Patient-Centric Approaches. My name is Samaya and it’s my pleasure to be your Xtalks host for today. 

Today’s webinar will run for approximately 60 minutes. This presentation includes a Q&A session with our speakers. This webinar is designed to be interactive, and webinars work best when you’re involved. 

So, please feel free to submit questions and comments for speakers throughout the presentation using the questions chat box, and we’ll attend to your questions during the Q&A session. Now, this chat box is located in the control panel on the right-hand side of your screen. If you require any assistance, you can contact me at any time by sending me a message using this chat panel. 

We also have a handout available about type one diabetes in adolescents. Audience members, you can download that through the handouts tab in your control panel. At this time, all participants are in listen only mode. Please also note that this event will be recorded and made available for streaming on Xtalks.com. 

 

Speaker 1 – Samaya (01:28): 

At this point, I’d like to thank TFS HealthScience (TFS), who developed the content for this presentation. TFS HealthScience is a global contract research organization (CRO) that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey. In partnership with customers, they build solution-driven teams working for a healthier future, bringing together nearly 700 professionals. TFS delivers tailored clinical research services in more than 40 countries and supports customers with comprehensive solutions through three strong business models, clinical development services, strategic resourcing solutions, and functional services. 

Now, it’s my pleasure to introduce our speakers for today’s event, and our first speaker is Scott Schliebner. Scott recently joined TFS as Senior Vice President Clinical Development Services and Head of the Pediatric, Rare, and Orphan Disease business unit based in the U.S. Scott has more than 25 years [of experience] in clinical drug development having worked across the biotech nonprofit, small CROs and large global CRO sectors. 

 

Speaker 1 – Samaya (02:45): 

Scott also serves on the board of directors for two rare disease focused nonprofit organizations, uplifting athletes and angel aid, and he serves as a strategic advisor for GVA, bioinformatics, Halo Health Systems and Adamic Medical Innovations. 

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

Currently, Alison oversees clinical trials involving rare disease pediatric patients or orphan drugs. Her department works with centers of excellence, patient groups and registries to promote study awareness. Now without further ado, I’d like to pass control to our speakers. 

Scott, Alison, whenever you’re ready, you can go ahead and get started. 

 

Speaker 2 – Scott Schliebner (03:51): 

Excellent, thanks Samaya. First, let me just thank everyone. Good morning, good afternoon, depending on where you are. Thank you for joining our presentation today. We’re excited to share some learnings from the field in the rare and pediatric space, of course focused on patients through and through. I hope there’s some valuable lessons learned here for you. And of course we do have a chat function as well. 

So, if there’s a question you have as we go along, please don’t be shy, ask your question and we will do our best to get to all of them at the end of our presentation. And with that, I think we can advance a couple slides. And Alison, I think you can get us started when you’re ready. 

 

Speaker 3 – Alison Sampson (04:46): 

Thank you very much, Scott. Yes, indeed. Thank you everyone for joining as well from my side. So, patient centricity has become quite a buzzword in clinical research and in the new ICH version six, there’s a whole new section in patient centricity. So what is patient centricity? What is it? 

Patient centricity at heart? It’s really putting the ultimate stakeholder in a clinical trial at the center. They are the ultimate stakeholders and it’s designing a clinical trial process, supporting the patients and making the whole clinical trial experience the best we can. And that takes not only into account the patient but their immediate family and what they need and want from a trial, which is not necessarily what we’ve done in the past. 

And it says here in this definition, and it’s very much true, it’s a mindset, it’s a, of thinking about developing a trial and then what the process would be for parents and or children or patients, how that would go and what things can we do to make it better. And the last bullet point here is why should we bother? 

 

Speaker 3 – Alison Sampson (06:21): 

In this slide we talk about what a rare disease is. A rare disease; the definition varies depending on where you are. It’s different for example, in the U.S. to Europe, but roughly it’s a disease that affects less than one in about 2000 people. Although rare diseases by themselves are rare, so obviously one in 2000, not very many. Collectively, they’re not rare. Lots of people suffer from a rare disease, and every year, we identify more and more rare diseases. As our technology with genotyping improves, we’re identifying large numbers, more of rare disease that we haven’t identified before. 

You see here, that 80% of rare diseases are genetic. With that, goes hand in hand the prevalence in children. So, about half of a rare disease occurs in children and the two often go together. And because we don’t understand about 80% of rare disease and what causes it, or how the disease progresses, still at about 30% of children are dying before the age of five from a rare disease. So, obviously we need to do more research and that research needs to be better. 

 

Speaker 3 – Alison Sampson (07:44): 

So, just really summarizing what I’ve just said, rare diseases, are not that rare, particularly about one in 10 people who live worldwide with a rare disease. Not all rare diseases are life-threatening. So that’s something to bear in mind, but many of them are serious and severe. And you can see here [on the slide] 95% of rare diseases have no FDA-approved treatment and as I mentioned earlier, about 80% are not well understood. So, it’s a growth segment in drug development as our technology advances, particularly in gene therapy and stem cell therapy and those sorts of advanced therapies. 

Going back to rare diseases in children, and as I mentioned, the two often go together, definition of a child can vary depending on where you are in the world, and this is just some tables here [on the slide] of how it might vary. So, particularly the adolescent age group can be different depending on where you are. If we’re working in different areas of the world and we often are in rare disease because we have to go where the children are, then we need to look carefully at what we do and the things we put in place and what the definition of an infant or a toddler or a child is in that particular country or area. 

 

Speaker 3 – Alison Sampson (09:17): 

This is quite astonishing statistics. Pediatric trials will only make up about 17% of all trials and that’s generally because they’re very hard to do. Childhood is fragmented, you get fragmented cohorts in terms of age. So, the response to a drug in a baby would be very different to the response to a drug in an adolescent. And this makes for complexity in pediatric trials. 

One of the many reasons why they make up less than 20% of all trials. And then of that 17% half, so around seven or 8% are unpublished or unfinished. One of the two and 20% of pediatric trials are discontinued early. So, there are many reasons for this and you can see the reasons below. A lot of it is to do with things that we can fix. Family inconvenience, expense, too many appointments travel quite often in around pediatric studies, parents have to bring other children with them, other young children and that does cause hassle. 

 

Speaker 3 – Alison Sampson (10:36): 

They [children] miss school, parents miss work, and all these things can be addressed, and this is the heart of patient centricity. It’s not the best process for the parent and the child. What we need for them is to take part in these trials. And the second statistic on here is that one in five parents and children come to their first visit and they never come again because of these reasons. 

That’s why we need to bother with patient centricity because we need to address all these issues so that we get children into these clinical trials and we reduce that draft statistic of 30% of children dying before the age of five. 

 

Speaker 2 – Scott Schliebner (11:21): 

Great, thank you, Alison. Well, with that background on what patient centricity is, little definitions on pediatric and rare disease, and again, keep asking that question, why bother? 

This is a little bit of a buzzword when we talk about patient-focused approaches, but again, why bother? Is this really worthwhile or is this just a buzzword? We’ll talk a little bit more about why we think this is so important and if you’re not fully on board, by the time near the end of our presentation, we hope you’ll ask some questions so we can further convince you about why this is key to clinical development. 

Before we talk a little bit about that, in front of us is the slide, the traditional clinical drug development paradigm. I want to briefly walk through this. I think this highlights again why there’s some areas for improvement, why we can do better when we think about patients. 

 

Speaker 2 – Scott Schliebner (12:16): 

So, by starting at the upper left and then kind of proceeding in a clockwise fashion, this is how we would typically sort of look at a new clinical study. There’s a clinical protocol that goes through a lot of development and eventually is approved by a multidisciplinary team of preclinical and clinical and medical, and operations. Then, we move this out, and we start to select investigators. 

We go through an ethics or IRB approval process for that particular study. Then, we start thinking about the participants that we’re going to recruit. As we circle through this and patients are enrolled, data is entered and analyzed, and eventually, we’re presenting, filing, and registering that data. 

This is this sort of traditional paradigm, right? We develop a protocol oftentimes as I like to say, it’s in a conference room in New Jersey, insulated in a bubble, and then we move to our clinical sites and then we start to think about participants or patients. 

 

Speaker 2 – Scott Schliebner (13:18): 

This is the way clinical development has largely operated for 30, 40, 50 years without a lot of really fundamental changes to the flow. What’s wrong with that picture of clinical development? Well, first starting here on the left was that protocol designed with any input from patients, from caregivers, from the site staff that’s going to execute the study or maybe from home healthcare nurses or other providers who will be involved. 

I can’t tell you many times we’ve seen a schedule of evaluations in a protocol come out for things that all need to happen in one day. And when you actually put that in the hands of a clinical site coordinator (study coordinator or CRC) and they look at that and they say, well, we can’t do radiology scans in the morning and then move down to a physical therapy suite and then move over to genetic testing. 

 

Speaker 2 – Scott Schliebner (14:12): 

We can’t do all these things in the same day. We should have thought about this. It would’ve been nice if you asked for our input. Moving along here is the schedule of assessments, which is really the nuts and bolts in the crux of a protocol when evaluations happen and what happens is that realistic and feasible for patients? 

I know in that proverbial conference room where this protocol was developed, we checked all the different boxes in the schedule of assessments of the blood draws we wanted at certain time points and the scans we wanted to happen here. And all of those data and exploratory endpoints were sort of put together on a protocol, but at the end of the day, we’re asking human beings to go through that process. 

Is it realistic what we’re asking and can people handle it further? When you get to the eligibility criteria in a protocol, we obviously have inclusion and exclusion criteria. Again, without sometimes some external input or pressure testing these criteria, we outline what we think the ideal narrow controlled patient population would look like. 

 

Speaker 2 – Scott Schliebner (15:19): 

And a lot of times there are very few, if any, patients who actually meet all of those criteria. What seemed good in theory for eligibility sometimes isn’t so good in practice when it comes to finding patients further. 

Does a study actually appeal to patients? A lot of time and effort is put into that clinical protocol. Again, sometimes that’s done within an insulated bubble without external input. Does the study appeal? Is it measuring endpoints that are meaningful for patients? Is the schedule of assessments just too much for families to handle? 

The burden of participation is extensive. It includes not only just as Alison said, hassles and time, but often travel. It also costs money to participate in a clinical trial and that money can be things like missed work, childcare, travel and logistics and things like that that are sort of hidden costs that we need to sort of think about those barriers that patients have and try to get those out of the way. 

 

Speaker 2 – Scott Schliebner (16:21): 

So these are a few things that I think is wrong with the traditional clinical development paradigm. So really the question kind of down here on the bottom, sort of like why bother with patient centricity? Well, why can’t we just continue to design studies the way we always have? Why can’t we just keep doing what we’ve done? 

I’d like to go to the next slide please and talk about why this isn’t working. So, in front of us is a little bit of data I will share, and this is the current clinical trial landscape from earlier in 2022. This is all sort of therapeutic areas, not necessarily rare in pediatrics, but it really highlights that we often design studies that don’t really work for our intended audience, the patients themselves. So, on the left are some metrics on the right is the impact of those metrics. I’ll just start off by starting with every year we have more clinical trials requiring more patients to enroll. 

 

Speaker 2 – Scott Schliebner (17:19): 

Earlier this year we had more than 300,000 clinical trials that were active or about to be opened requiring 40 million patients to enroll. For those of you in clinical development very well that clinical trials and drug development does not move forward and less patients participate and we rely on their data. The fact we need so many patients, you can see the impact of this. We now have more than half of all trials are delayed simply to recruitments. 

So, you can see we’ve got more studies requiring more patients and we’re putting out studies that don’t really work for people and the result is it’s delayed. Further, when we look at some other metrics, the far majority of patients live more than two hours from traditional academic medical research sites. What does that mean? That means even if patients do enroll, more than 30% of them tend to drop out before the study ends because traveling to and from that clinical site is too burdensome. 

 

Speaker 2 – Scott Schliebner (18:22): 

Travel is the most significant burden we’ve heard from rare disease patients When we ask them and we do surveys and I’ll share some more survey data in a moment. It’s that time back and forth to clinical sites that delays enrollment, it hurts retention and it impacts overall timelines. Of course, DCT paradigms now help part of this, but they’re only part of the solution. Lastly, when we think about studies that don’t really work for patients who aren’t designed for our intended audience, the majority of clinical trial participants still are male, they’re Caucasian and they’re not necessarily representative of the overall population. 

So, we have some issues around access and equity as well as not just good science by continuing to put studies out that aren’t really reaching the people we want to reach. Next slide please. So that’s the landscape, that’s what we’ve seen. But, if we’re going to be patient-centric and we’re going to be patient focused, then we need to talk to patients and we need to learn from patients and we need to listen to what they have to say. 

 

Speaker 2 – Scott Schliebner (19:27): 

So, there was a recent rare disease patient survey that included data from 458 rare disease patients and this group of patients that we asked questions of had either participated in a clinical trial or they had not participated in a clinical trial. And as you can see on the top of the slide, for those that did participate in a study, we asked them what were the biggest barriers that you faced in your personal experience? You can see travel again was number. 

I think that was number one, two, and three in terms of the top reasons travel and time again, there is a little bit of a financial strain if we’re asking people to leave work or get childcare or pay for some expenses for travel to maybe be later reimbursed. That’s just another burden for families that are already managing a rare disease. And, of course, there’s strain and there’s emotional aspects of this as well. 

 

Speaker 2 – Scott Schliebner (20:22): 

For the other group of patients who have not participated in a clinical trial, we wanted to know why. So we asked ’em the number one reason most of them didn’t participate was that they did not meet that eligibility criteria. It was too narrow, it was looking for a artificial patient that didn’t really exist. Number two reason was that the trial itself wasn’t enrolling any longer. Sometimes we go through all the process of opening up a clinical study at a clinical site and the window for enrollment might only be six or 12 months. 

And if that patient isn’t interacting with an investigator and hearing about that trial in a timely manner, that window of enrollment can close before that patient’s even aware trial site was too far away. Again, that gets to travel and time is another issue for why they didn’t participate. And then a lot of times you hear that trials are never even discussed with patients, whether it’s not top of mind of an investigator or there’s not enough opportunity in a patient physician interaction, sometimes we’re not even communicating the opportunity that’s out there. 

 

Speaker 2 – Scott Schliebner (21:26): 

So, this was some insight. Again, 450 plus patients, why did you participate or why didn’t you participate? It shed some light on some of the barriers in the rare pediatric population. I want to shift gears a little bit after talking. Why bother? 

The traditional clinical development landscape has included this process that’s a little outdated and occurs in a bubble and now we see the impact of that in the industry by studies being delayed and running behind schedule. So, as we shift into what are some solutions for this, how do we overcome some of these barriers? We immediately start with including the voice of the patient and the family early in the clinical trial design process. Not just once a protocol’s done and finalized and submitted to ethics, but early on let’s include patients in, let’s get their feedback on the design understanding if they can actually complete and enroll in a study and if it appeals to them. 

 

Speaker 2 – Scott Schliebner (22:34): 

So, there’s a lot of different ways we can do that. Of course, we can hold patient focus groups, we can do live protocol simulations, we can talk to parents, families, caregivers, advocacy organizations and run this concept by them and ask if their constituents can, this would appeal to them. Again, they are the ultimate customer, they are the ultimate stakeholder. They are who we rely on enrolling to move things forward. 

It is a little ironic that historically, we’ve not really asked for their input for what they’ve thought about the trial that we require of them. In addition, of course, many of you have been involved with natural history studies or registries. This real-world data (RWD) really provides some great metrics on disease progression, what characteristics make up a disease? It can help us choose eligibility criteria that are realistic. And then of course working with organizations out there. 

Patients know their disease the best. They know what they need, they know what they can handle. Taking that protocol development out of a bubble and actually interacting with patient organizations doesn’t have to delay protocol development timelines. These things can be done in parallel. It’s just a matter of, as Alison said, changing your mindset to be thinking about your ultimate customer maybe a little earlier in the process.  

We can move on to the next slide. I’m going to hand it back to Alison. 

 

Speaker 3 – Alison Sampson (24:05): 

Yes. Scott, as you said, it’s very important to explain what it is to take part in a clinical study picking up on the natural history studies. It’s quite common now to run a natural history or a real world evidence study followed by a therapeutic study. And the reason that we do that is because as I mentioned earlier, quite a lot of rare diseases are not well understood. 

So, to actually run a therapeutic study, it’s very useful to know how that disease progresses, what complications they might have. As you said, it could influence inclusion exclusion criteria. So that’s something that’s very useful and can actually change the whole landscape for a disease. Once there is good understanding of the disease progression for particular mutation for example, then this is really valuable information, not just for the ongoing study but for all ongoing studies that information about how the disease progresses is really, really important. 

 

Speaker 3 – Alison Sampson (25:11): 

However, to recruit parents and children into study that’s not therapeutic is very tough. And as we mentioned earlier, to overcome the barriers of travel, of finance, of hassle, all the rest of it, a natural history study is really not that attractive. So we need to make those studies and also the therapeutic studies, but particularly these foundation stones of understanding the disease attractive to parents and children. 

And with all studies actually irrespective with a rare pediatric or otherwise, the better a parent or a child or a patient is informed about the study, it’s well documented that they’re more likely to buy into the study and consent and be retained. As we mentioned both Scott and I earlier, huge dropout in pediatric studies, rare or otherwise. So what we’ve looked to do is to try and improve the informed consent process. And here I’m just going to talk about what are the tools we have, but there are many and anything that improves this process is worth having. 

 

Speaker 3 – Alison Sampson (26:23): 

So what we are doing in a current study is we’re using an informed consent flip chart and that has been carefully designed so that one side, the person taking the consents of the investigator or the sub investigate is looking at all the points he needs to go through with the parent or the child, depending if the child’s old enough. And then on the other side there’s that same information but nicely presented to the parent or the child in a much more simple way. And this process is in addition to the informed consent process or the asset process. 

As we know, informed consents now ever longer pages and pages now of quite difficult language, which is often required for legal reasons and then hard to simplify. So these tools that we are developing are in addition to that and to get the parents or the children to understand why we’re doing the study, what’s in it for them, if there is anything, if there’s any therapy or not, and really get them to have a good understanding of what it’s going to be to take part. 

 

Speaker 3 – Alison Sampson (27:36): 

How many times are you going to have to come to the clinic? Are they invasive procedures? Are they going to hurt? Are we going to get any reimbursement? Will we get help with travel? So all these things, all this information we aim to give to parents and/or children in this process. And this particular flip chart does make for a very nice standardized process across sites. Sites using this flip chart run through all the points on the flip chart, which hopefully covers all the points in the consent form. 

So, at a minimum, we’ve got that. And then anything more that the site tells the parent, or the child is a bonus. It is a very nice consistent consent process which is robust and one that you could rely on. And as we move obviously forward into more technological ages. I mean I’ve seen iPads used electronic tablets, all sorts of ways that this information can be given to parents or their children at time of consent. Next one please. 

So, this is just going back to as we talked about the study burden and I think Scott, you were going to go through some of some of the things that we can actually mitigate. 

 

Speaker 2 – Scott Schliebner (28:54): 

Yeah, happy to do that. I see that we also had some additional attendees join since we got started. I wanted to pause for just a second and remind you that we do have the chat function over within the tool that you can list some questions. We’ve talked a little bit obviously so far about what is a rare disease, what is a child definitions of things like that traditional drug development process and why it’s not really working. We need to evolve and we’re starting to talk about a little bit of some solutions. 

So, if you’ve got a question, feel free to populate it in the chat. We’re a little over the halfway mark, but we want to make time for that. Also, if you don’t have a question but maybe you have a comment or you have an experience that you’ve from your own experience with study something that you’ve done that was a nice patient-centric approach that you’d like us to share with the audience or anything needing clarification, we’d love to hear some of your input and we’ll get to those questions shortly. 

 

Speaker 2 – Scott Schliebner (29:52): 

So shifting a little bit here to thinking about, we talk about patient centricity, we talk about including patients in the process and the voice. Alison’s highlighted a nice little practical tool that can be used to better educate and inform and communicate. So what I’d like to talk about now is just the burden of study participation. So the clinical trial that we’ve designed, what we’re asking patients and families to participate in. Again, in the context of rare and pediatric studies, we know that we’re almost always dealing with, it’s either a child and a parent or maybe it’s a parent and a caregiver or maybe it’s an elderly family member and someone younger taking care of them. So we’re really talking about enrolling an entire family in a study for the most part in this space. And when we enroll a whole family in a study on top of the rare disease or the pediatric considerations they’re already managing, there’s a burden to the study. 

 

Speaker 2 – Scott Schliebner (30:54): 

So, we’ve talked a little bit about this already. So in front of us is a couple points regarding the trial design and things we can do to make it easier for patients. So again, involving patients and advocates and caregivers early and upfront in your design process. I can’t tell you how many times we’ve looked at final protocols and said, this is great. Here’s a couple comments. And usually a response we get is, well, the protocol’s final and it takes too long and it’s too expensive to amend it. So we’ll think about that the next study we do. 

So, that’s great, but let’s move this conversation further upstream so we can involve those patients and get that feedback before we finalize that study. What levers can we use? And by that, I mean within a study, within the different visits and assessments, we’re asking what levers can we do to push and pull to make things easier? 

 

Speaker 2 – Scott Schliebner (31:53): 

So in the world of post pandemic 2022, we can readily use telehealth. We can readily use home healthcare nursing, we can readily use wearables and other remote data collection devices. We can make studies more easy and friendly for patients that lowers the burden of participation. It might require us to think a little bit differently. 

It might require us to incorporate maybe another vendor or solution into the process might require us moving something away from a clinical site to a patient’s home. But there are things we can do to make a study easier for patients. And sometimes just opening up that schedule of evaluations and asking yourself, is this time point critical? Is this data point essential? And does a patient have to go to a clinical site for that or is that something that can be done remotely? 

On the lower left here, this idea of this field of dreams, of course if anyone’s seen the old kind of fantasy baseball, we used to open these studies up and say things like, well, patients will come, we’ll open the study up. 

 

Speaker 2 – Scott Schliebner (33:04): 

Our drug is so great, they really need something. They will come, they will join the study. We’ve learned pretty clearly and the data shows patients will not just come if it’s really burdensome, if it requires a lot of travel and time and if it just takes a lot from them emotionally, financially, otherwise they won’t come, which is why 50% of studies are now behind schedule. 

So we have to lose this idea of, oh, just deal with the inconveniences. We want to flip the conversation a little bit back to mindset, what do our ultimate stakeholders need and what can they handle because we do not move forward without the patients enrolling. So on the right side of the screen, there’s a couple other pieces here around solutions, decentralized trials. We can talk a little bit more about that. I’m hoping there’s a couple questions in the chat on that. 

 

Speaker 2 – Scott Schliebner (33:58): 

But thinking about meeting patients where they are geographically, but also maybe thinking about their age, their technology savvy, their ability to, some patients would love to have nurses come to their home for assessments. We’ve also spoken with patients who say, I live with this disease all the time. I really don’t want any healthcare professionals coming to my home. I want to have this be a safe bubble where I don’t deal with a clinical trial in my house. 

So, it’s about sort of learning where your patient’s at and customizing something for them. Patient concierge, patient navigator solutions are out there to help patients either in the upfront screening process or educating and informing them about the study, connecting them to clinical sites, but also being a support line for them if they have questions, if they need help coordinating travel, if they need help coordinating any other aspects of a study, we can create some type of support system the way other industries do for us as customers, the way we can reach out to a chat or a phone line to help us. 

 

Speaker 2 – Scott Schliebner (35:08): 

And lastly, back to this whole back on my soapbox, including the patients in the design. You can also include the patients throughout the process. So once your protocol is final, getting feedback on patients during how was your study experience? Would you enroll in this trial again, what are some things we can do to make this easier for your family? And then of course, involving patients after the fact and making sure that we communicate study results to them is really important. 

So, the burden of study participation is real. There are things we can do to minimize it. Here’s a couple ideas I hope that you’ll take down and consider when you’re moving forward with your next study. We can move to the next slide please. Thank you. So burden reduction. So if we make studies less burdensome and easier for patients, more patients enroll, dropout decreases, studies move along faster, clinical development costs actually go down and the entire cost of developing medicines decreases. 

 

Speaker 2 – Scott Schliebner (36:16): 

So, there is a trickle-down waterfall effect of the clinical protocol. If we can make it more patient friendly, the downstream effects on everything we’re doing become a little easier and a little more efficient. The impact can be dramatic. Less burden of course means that we’re also probably getting a more representative and non-traditional patient population, which is what we want. That can lead to more diversity. 

Of course, at the end of the day, we’re here because we want to conduct good science, we want to protect patients, but we also want to make sure that we’re conducting studies that are representative of the population that’s going to later use that new therapy. Okay, so let’s say you’re fully on board with this concept. Let’s say you love patient centricity. You want to include patients in the process. But let’s say you have colleagues who are skeptical and think this is just a fuzzy, soft, nice concept or a buzzword or a trend that’s going to go away. 

 

Speaker 2 – Scott Schliebner (37:21): 

Maybe you’re concerned about the impact or it delaying things for you or perhaps the cost. There’s a copy of a paper here by DIA and the clinical trial transformation initiative that also takes us a little further. So if you need some ammunition to bring to your colleagues, not only is this the right thing to do for patients, not only is it better science, it actually has a financial return on investment. 

There are dossiers and data out there that show making your study patient friendly saves you money. It saves you money in the short term and in the long run. So happy to share some details if you haven’t seen this paper before, but if you need to, if you’re on board, but you need to sort of show the financial component to others, there is a good rationale for why we want to do this. 

I’ll turn it back over to Alison on the next slide. I do see a couple of questions coming in. Thank you. We’re going to get to these shortly. 

 

Speaker 3 – Alison Sampson (38:20): 

Scott, yes, I love your analogy with the field of dreams and many times worked on studies where the patients haven’t come. One of the things that we are doing not only in the rare pediatric space, but in general for clinical research, it’s to develop a trial identity. We do this for a number of reasons. Probably the main reason is it’s just nicer. 

Most protocols are a mixture of numbers and letters and it’s quite personal and certainly they’re quite long, some of them not very memorable. In a clinical trial where you’re going to rely on things like referrals or feedback from other investigators or advocacy groups or parents themselves, it’s just useful and nicer to give a trial a name and that name can really reflect some of the aspirations of the trial. 

It can obviously be a logo which could represent some of the colors of the sponsor company in general. It’s not a very expensive thing to do and it’s something that we really recommend, particularly for trials where recruitment is going to be hard and by definition, rare disease trials, recruitment is hard. So, this is something that’s one of the things, not a huge amount of money that would make a difference. And many of the things that we can do to mitigate some of the barriers to run pediatric studies don’t cost a lot of money. Some do, but yeah, this one doesn’t. 

 

Speaker 2 – Scott Schliebner (40:13): 

Great, great. So, there’s some good questions. One of the questions that’s come in from the chat, which kind of feeds right into this sort of slide, is a little bit about, what are some new advances in decentralized trials in regard to rare diseases? 

So, for those of you following along here, if you rewind back to pre-pandemic time, there was some buzz around decentralized models. We were calling them hybrid or virtual studies. There was a little slow adoption. This was a new paradigm. We got nervous about moving things away from clinical sites. There was concern about that. So once the pandemic hit and we realized that clinics were closed or patients couldn’t travel to a clinic and we needed some other kind of solution, we very rapidly pivoted as an industry into DCTs, which have really, honestly, kind of adopted some practices that we’ve used in the rare disease space for quite some time. 

 

Speaker 2 – Scott Schliebner (41:17): 

So when you talk about advances in this space, decentralized to me and maybe to some of you is really a spectrum from on the far left is something that is completely site-based to the far right would be something that has no brick and mortar site visits whatsoever. So historically, that whole traditional drug development paradigm, we’ve all been very site-based and we’ve seen that the burden on patients of travel and time and expense is real and it affects them and it affects our trials and that’s why we’re behind schedule on so many. 

As we move along that spectrum to taking some things away from a site and making them more virtual and bringing them to patients where they are, we move into more of these typical hybrid DCT models where we’re typically relying on, in the most case, telehealth where we can do video check-ins. We’re relying on nurses who can travel to a patient’s home not only to do blood draws and physical exams, maybe to support and train on drug administration and there could also be some other evaluations that occur there. 

 

Speaker 2 – Scott Schliebner (42:27): 

We’re also seeing mobile labs being developed in vehicles that can actually travel around and bring things like a CT or an MRI scan to a regional location. We’re also seeing groups like CVS and Walgreens and Walmart start to open up things like minute clinics in remote rural areas to allow for some clinic visits and sort of satellite visits to occur for a clinical trial. So, I think that’s another new development is that we’re seeing this DCT model move towards what makes it easy for patients. 

Some studies of course, are going to really need to rely on a lot of site-based evaluations and administering a gene therapy or conducting a PET scan is not probably going to happen in a patient’s home in the near future. But the reality is that there are many things that can move. And so it comes back to that. 

Take a look at your study, go right to that schedule of evaluations and really do a deep dive on what has to happen at a site and what can maybe move towards more of a hybrid or patient focused approach. So, the graphics in front of us speaks exactly to that. Moving on to the next slide. I’ll hand it back to Alison. I think we’re right near the last of our slides and glad we’ve seen a couple of questions come in. 

 

Speaker 3 – Alison Sampson (43:52): 

Yeah, indeed. Actually, I did see a question about the flip chart, and this takes us into the realm of vendors that we use. The flip charts that we’re using currently on our rare pediatric studies are being developed by medical communication agencies, and they are actually quite a lot of work. There is no one size fits all, but it’s worth the input into producing some quality parent facing materials because we want to keep those parents and those children engaged and in our studies. 

So yes, it’s not a cheap thing to do. Yes, it takes time. Is it worth it? Absolutely. And then there’s some other centricity vendors that we use at TFS and there’s a longer listlessness, but just to give you a flavor of the sorts of things that we use. So, travel reimbursement is something that is very common and as Scott said earlier, many of our patients live some significant distance from the trial centers. 

 

Speaker 3 – Alison Sampson (44:54): 

And just to pick out one concierge who’s actually a very nice vendor, they usually have someone who speaks local language dedicated to the trial and to the parents and child in a particular country. Not cheap, actually, none of these services are particularly cheap. 

But as Scott mentioned, yes, it costs more, but ultimately if you want your trial to succeed, ultimately there’s a cost saving because you’re much more likely to have a successful trial. And then there’s other things just quickly going through this. Prepaid credit cards so that parents can offset things like meals when they’re at the clinical site, vouchers, travel assistance, hotel assistance, even I knower definitely do babysitting type assistance for other children. 

So, as we said before, these things all cost, but ultimately it is worth doing because if you manage to keep your parents and your child in the trial and they don’t leave after the first visit because it’s too difficult, then ultimately there is a saving there and you’ll get a successful trial with successful data and it won’t finish in the 50% group that never finished and it go by the wayside. So there were many vendors that we can use and are using and you can use to mitigate some of these burdens to participation. 

 

Speaker 3 – Alison Sampson (46:34): 

And this is just a quick one. I know we’re coming up. So this is one of the things we developed particularly at TFS for parents and children. And this is a parent facing document which we customize for the particular trial. And this is to get the parents to think at the time of consent more critically about whether the trial is right for them. And it’s a questionnaire, we don’t collect it back, it’s just to get them to think critically about is it right and to prompt them to maybe to ask some questions. So can they take time off work? Can they bring other children with them? Would it be too burdensome? Are they against perhaps some invasive procedures that the trial protocol has in it? 

This is what we call it, the stepping stones, and it’s better for the parents to withdraw or not even start a trial then to come to that first visit and never come again. It’s better for them not to consent at all if they think the trial’s not right for them. So this is something that we’ve developed to try and stop that massive dropout right after the first visit. 

 

Speaker 3 – Alison Sampson (47:44): 

Hopefully we’ve shown you some things that you can do to make a more patient-centric clinical trial. Either for children are old enough to be patients themselves or for parents and children. There are many things we can do. We’ve only, as I say, shown you a flavor in the time that we’ve got of the things that you can do. But it’s really important that we think very carefully about the whole design process from even pre protocol right through to Scott mentioned providing results back to parents. How can that be a nicer process? Because if it’s nicer, if it’s better, we’ll all benefit from that. 

 

Speaker 2 – Scott Schliebner (48:27): 

Thank you, Alison. Excellent. So, we’ve got some questions. I know Samaya, I think, is going to jump in here, but again, we’ve covered a little bit on what is a rare disease, what is a definition of a pediatric patient, and additional drug development processes sort of not really working. We need to evolve. We’ve given you a couple of practical ideas and tools around thinking about changing a mindset and actually implementing some changes. It’s been some good questions here as well. 

Samaya, are there a question or two that you wanted to make sure we all hear and can address? 

 

Speaker 1 – Samaya (49:05): 

Thank you, Scott. Yes, so audience members, you can still continue sending questions for Scott and Alison. Yes, Scott, we did receive some interesting questions. So, I’ll start off with the first question. Scott and Alison, that question is, 

“What are your thoughts on the new version of I-C-H, I-C-H-E six R three and the patient centricity requirements?” 

 

Speaker 3 – Alison Sampson (49:28): 

It’s very nice to see that in the ICH guidelines, and I think I touched earlier on the fact that patient centricity is a mindset and that it’s something that we need to think about throughout the whole trial process. That new version of ICH, I think annex two, is due later this year. Also looks at diversity in patient recruitment, which Scott touched very nicely on. 

So, going forward, we want diversity. We don’t want half of our patients to be middle-aged men who are white because they’re not representative of all people with a rare disease. And there were many as I mentioned. So, it’s very good to see ICH go this way. And yeah, I think it’s validation that patient centricity is good for everybody and is even cost effective. 

 

Speaker 1 – Samaya (50:24): 

Thank you, Alison. And we have another interesting question from an audience member and that question is,  

“Patient and KOL involvement early on in study design is one aspect of optimizing the clinical trial planning and conduct. What about optimizing the country and site selection feasibility?” 

 

Speaker 2 – Scott Schliebner (50:47): 

Sure, that’s a great one. Yeah. Well, we’ve talked a little bit about patient input. Let’s not forget about our investigators and KOLs that actually need to implement these studies, right? It’s a great question! So, as we include that input in the rare pediatric space, you have some additional challenges as we’ve outlined above and beyond more typical indications. 

When you’re thinking about which countries you want to take your study to, it comes down to some of it is where are patients? So, we work in a lot of different areas like a beta thalassemia study where you may only see patients in certain geographic regions associated with some different ethnic backgrounds. 

So, you may have to go to certain regions, maybe some untraditional areas to enroll your study in to find those patients. Another consideration is thinking about a rare disease. Alison and I are working on one right now. 

 

Speaker 2 – Scott Schliebner (51:42): 

It’s a very rare dermatologic condition. There’s only a few highly specialized centers that can actually sort of manage patients with this complex condition. So that almost defines which countries we can go to. So we’re looking at a host of countries where there are these specialized centers, there’s other good countries that are just not even an option because we don’t have the centers. And then lastly, I think when you’re thinking about where to take your study to and optimize it, also, you can think too about are there country level disease specific patient organizations in those countries? 

For example, let’s say there’s a specialized center in Germany, is there also a patient advocacy organization in Germany that might have a registry of all of the patients in Germany that might make Germany really easy to open up a study and connect with patients? Some countries don’t have that kind of developed yet. So those are a couple considerations around specialized centers, thinking about disease background and where that occurs and advocacy organizations. And Alison, I welcome anything if you’d like to add to that. 

 

Speaker 3 – Alison Sampson (52:59): 

Yes, I think just to touch on the fact that for rare disease we often have to go where the patients are and they tend to be all over the place. I’ve worked on a study to recruit a hundred patients from a hundred sites. That was all over the world and I think we have to be prepared to do that to make our trial successful. So yeah, I think it was indeed a very good question. But yeah, we have to be prepared to do all sorts of things to make these trials work and it is important and it’s worth it. 

 

Speaker 1 – Samaya (53:32): 

Great. Thank you, Scott and Alison. Our next question is,  

“What new development trends in the next five years are in the rare disease space with the advancements of CRISPR and other gene therapies, what does the next five years look like in your opinion?” 

 

Speaker 2 – Scott Schliebner (53:53): 

Great question. Alright, break out your crystal ball here. Well, one thing I’ll jump in to start, but one thing I think we’re seeing of course is every year we’re seeing more and more rare diseases become identified, right? We’re learning more about the genome, we have more sophisticated genetic testing, something that we used to think of as a disease now as a condition with four subtypes. So we’re learning more. 

I think we’re going to see more and more disease types. Some that aren’t even rare, become further subdivided into, we see this in the oncology space where we’re looking at a tumor type with a certain kind of mutation or things like that, and you end up with just a little slice of those patients. So I think some of the rare disease learnings will get applied to some other therapeutic areas, I think, which will be great. 

 

Speaker 2 – Scott Schliebner (54:49): 

I think we’re also getting improving improvements on, for those of you who’ve been in the rare space for a while, you’re familiar with the term diagnostic journey where patients and families often have to go through multiple, multiple physicians and healthcare systems to even try to find the accurate diagnosis for what they have so then they can start to pursue a treatment. I think that part will start improving quite a bit. I think you’ll also see more and more pharmaceutical biotech companies as well as labs and other testing facilities slowly continue to move into the rare space because again, collectively rare is not rare. When you take all of these little rare diseases, they add up to 10% of the population. So there’s a lot happening out there. Those are a couple things I guess that I think of high level. Anything you’d like to add, Alison? 

 

Speaker 3 – Alison Sampson (55:44): 

That was a wonderful answer, Scott. The only thing I’m really thinking of is patient-centricity. I think now we’re seeing even in regulatory forms, I’m thinking of the MHRA where they’re asking, have you asked any patient groups? Has there been any patient centricity input into this protocol? People start to look for it now. It used to be a nice to have, but it’s become so much more important. So, I think going forward, I think the involvement of patients and in the rare disease space, I think you also said that a lot of them been through quite a journey, particularly in the less severe diseases adulthood without having a proper diagnosis. 

So, I think that’s going to improve. I think with all the things that we’ve got, I mean, there are companies now that have online patient groups and information is much more readily available about rare disease. So I hope that those sorts of things will improve and that patient centricity will perform a much bigger part of a trial and it’s not just in yougo and suck it up basically. If it’s two hours to the site, that’s tough that we are going to be doing more of. Well, we can have the nurse at home or we can provide travel assistance for you. That will be a lot more of that too. 

 

Speaker 2 – Scott Schliebner (57:09): 

I totally agree. I realize we’re almost out of time here, but the concept of patient centricity and thinking about patients as again, the ultimate end stakeholder here won’t hopefully be a novel concept in the future. This will just be baked into our process. So we see other industries, we see iPhone makers putting cameras on a phone, not just, they don’t build a new phone with a camera to say, oh, I wonder if our customers will use this, right? It’s all driven by the customers. 

So, that idea of other industries are following the lead of what people want. I think we can do a little better in clinical development of following the lead of what our patients want and hopefully that’ll, and even extending beyond patient to family and starting to think about caregivers as well as part of that whole entire sort of family really that’s enrolling in a trial. I’m hoping that that gets fully kind of baked into how we design studies. 

 

Speaker 1 – Samaya (58:14): 

Wonderful. Thank you, Scott. And thank you, Alison, for all of those answers. We reached the end of the Q&A portion of this webinar, but attendees, not to worry! The team at TFS HealthScience may follow up with you later on. 

If you have further questions, you can go ahead and quickly jot this down info@tfscro.com for further questions or comments. I know that we did receive a lot more questions, so attendees keep using this if you do have more questions. 

I want to thank everyone for participating in today’s webinar. You will be receiving a follow-up email from Xtalks with access to the recorded archive for this event and a survey window will be popping up on your screen. Your participation is appreciated and will help us improve our webinars. 

I’m also about to send you a quick little link in the chat box right now. You can use this link to view the recording, so that should take about one to three business days. You can share it with your friends or colleagues, whoever might be interested in as well. 

Now, please join us in giving a big thank you to today’s speakers, Scott Schliebner and Alison Sampson for that fantastic presentation. We hope you found this webinar informative. Have a great day everyone. 

 

Speaker 2 – Scott Schliebner (59:28): 

Thanks, everyone. 

 

Speaker 3 – Alison Sampson (59:29): 

Thank you. Thank you, everyone. Thanks for coming. 

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! 

Speakers:

• Gabriel Maeztu, Co-Founder and CTO, IOMED
• Neus Valveny, Sr. Director and Head of RWE, TFS HealthScience
• Ryan Muse (Moderator)

Speaker 1 – Ryan Muse (00:06): 

Good day to everyone joining us and welcome to today’s Xtalks webinar. Today’s talk is entitled Future of Real-World Evidence, Common Data Models, and O-H-D-S-I tools used in the COVID Real case study. 

My name is Ryan Muse and I’ll be your Xtalks host for today. Today’s webinar will run for approximately 60 minutes, and this presentation includes a Q&A session with our speakers. Now, the 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 the presentation 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 which is on the right-hand side of your screen. If you require any assistance along the way, please contact me at any time by sending a message using this same chat panel. 

 

Speaker 1 – Ryan Muse (00:54): 

At this time, note that all participants are in listen only mode, and please note that the event will be recorded and made available for streaming on XTalks.com. 

At this point, I’d like to thank TFS HealthScience (TFS) who developed the content for this presentation. TFS HealthScience is a global contract research organization (CRO) that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey. In partnership with customers, they build solution driven teams working for a healthier future, bringing together nearly 700 professionals. TFS delivers tailored clinical research services in more than 40 countries. 

I would like to introduce our speakers for today’s event. With a Ph.D. in human genetics and 20+ years of experience, Neus combines a passion for statistics and epidemiology with experience in designing and running 100+ real-world (RWE) studies. Neus consults with Biopharma on the best RWE and late-phase study design and execution, helping them determine the best path forward. 

As a medical doctor and mathematician, Gabriel combines his two passions, working at the intersection of medicine and machine learning. He works with large amounts of data to build tools that help physicians to contextualize all the information and make better decisions. Gabriel believes that the cross section between medicine and data-driven technologies will define the medicine of the future. 

Without further ado, I will hand the mic over to our first speaker. You may begin when you’re ready. 

 

Speaker 2 – Neus Valveny (02:31): 

Thank you, Ryan. Welcome everybody to this webinar. We are really happy to have you here today to speak a little bit about the common data models and the OA tools used in a specific COVID case study.  

The agenda for today’s meeting includes a first part where when we will talk about the future of real- world evidence (RWE), which is, we truly believe it goes through the common data models and how these common data models can be leveraged to do a fast analysis of real-world data (RWD). Then we will explain in detail the case study that we performed together with TFS and IOMED and then we will go to the conclusion about database studies using electronic health records. 

 

Speaker 2 – Neus Valveny(03:23): 

A bit of introduction about TFS. Our company, as Ryan said, is a mid-size CRO (Contract Research Organization). We have offices and legal entities in 17+ counties. We have almost 700 employees and we have performed more than 250 studies over the last five years, both clinical trials and non-interventional studies, in more than 80,000 patients. 

We provide all type of real-world evidence (RWE) services including from real-world effectiveness and safety of approved drugs, also epidemiological studies, health economics, and also studies assessing electronic patient reported outcomes. Now, I hand it over to Gabriel who will explain about the common data models. Thank you. 

 

Speaker 3 – Gabriel Maeztu ( 04:14): 

So, prior to starting to talk about common data models, very fast, IOMED, what we do is we transform, and we create these common data models. We work with the OMOP CDM, which I will explain in more detail later on. 

But in the end, the idea is that at IOMED, what we do is we work with hospitals to create these common data models, and thanks to this we allow CROs like TFS to perform studies faster by accessing clinical data in a federated network work of hospitals that are connected using this common data model. So, this is part of what we do. The other part is we do transform all the clinical nodes. We are using natural language processing, but I will speak about that in more detail later on. 

 

Speaker 3 – Gabriel Maeztu (05:13): 

I will briefly talk about common data models, but the idea about a data model is that we do have many use cases that we want to perform on the same data. So, we can imagine ourselves performing an observational study. The main problem is that in every hospital, every system, that whenever we want to work with them, we face [the challenge] that they have different databases. We have a different representation of the same events. 

So, we can imagine that in one hospital, the patients and all their data, it’s totally structured in a format that is not totally compatible with a second hospital where we want to perform the same use case. So, this data is very heterogeneous. By this nature, whenever we want to store any kind of data, we have to make a decision on how and where we decide to store this data, whatever the formatting might be. 

So, if we want to have a common data model, we need to perform this normalization where, in this analogy, we can imagine ourself, that we are taking all this data from all these different data sources, the different hospitals, and what we want to do is to create a standard format where we can plug all our different use cases. Just like in this case, we will plug our observational study into multiple sites at the same time. 

 

Speaker 3 – Gabriel Maeztu (06:40): 

This is part of what a common data model solves that it’s providing the same structure for all the data. So, we could imagine that we are providing to every hospital the same plug, and because we are transforming all this data, but just as it happens with electricity, this is not enough because in the end we need not just to put all the data in the same schema and the same format, but also we need that all the data contained in these schemas has the same meaning, the same semantics. 

So, to represent that we need the common data vocabularies. In the end, a way of representing all the knowledge that is stored in this common schema, but that it’s normalized too. It’s important to normalize the data and to provide the same place or kind of structure to store it, but it’s also as important to provide the same semantics to each data point that we are storing in these databases. 

 

Speaker 3 – Gabriel Maeztu (07:38): 

In the end, from the different data sources, we might find very different ways of representing the same semantics. It’s very important to perform these both transformation. On the next slide we can see what this would mean in this case for a hospital. 

You can imagine, as we can see on the left, that source one, source two, source three could be different hospitals. Each one with our their own systems – it could be Cerner, or it could be Allscripts – whatever provider they do have for the EHR (Electronic Health Records). The problem is that we need to transform all the data from those EHRs to this common data schema to have the same database structure. But, this is just half of the work. The other half of the work is providing each data point with the same representation. So, we all need to be speaking the same language. 

 

Speaker 3 – Gabriel Maeztu (08:32): 

It’s very nice to be talking about whatever disease that we want to represent, but we need all those diseases to be represented with the same IDs in the different hospitals that we might be working with. So, that’s why we need not just to talk about a common data model, but also about the two pieces that the data model represents; the data schema and the data vocabularies. So, the structure and the semantics of both things. 

Common data models is something that is not new, it’s been something that many different entities have been working on for the latest years, but today we will focus mainly on the common data model that has been developed by the observational health data science and informatics organization (OHDSI) that it’s called the OMOP or the Observational Medical Outcomes Partnership Common Data Model. So, the OHDSI OMOP CDM (Common Data Model), as we will refer to it from now on, is a nice initiative from the OHDSI organization. 

 

Speaker 3 – Gabriel Maeztu (09:37): 

The OHDSI is an open science and collaborative effort from many, many different organizations from public and private sectors where they are working on having and providing an open community data standards. In the end, it’s just deciding between the whole community, those data schemas and those data vocabularies, how they are going to be organized to represent all that data in a huge, large network that can be used for clinical research. 

This community is an open community, which the goal is to provide clinical research, the reproducibility and collaboration and openness that it really needs to have nowadays. The network of researchers that is part of the OHDSI is working for all these open standards, but also, working on huge studies that use this network to provide new evidence on top of it. 

Next, I want to talk to you a little bit more in detail of what the OMOP CDM is. 

 

Speaker 3 – Gabriel Maeztu (10:52): 

As I said before, I think that it’s very interesting to just split it in two where we’ll talk first about the data schema. The structure or the representation where we will restore all this information. It’s very important to understand that the data schema in this case, in the OMOP CDM, is a patient-centric data schema. 

What that means is that everything will go around a person, in this case, because it might not be a patient, but all the information that it might be of interest for any kind of different research studies will be always linked to an individual from the databases that have been transformed to the OMOP CDM. This schema is optimized for observational research purposes, but it has been, and it’s actually used every day for other use cases such as other analytical tools or predictive analytics that they are nurturing from this data to be able to perform the inference that they might need for their own use cases. 

 

Speaker 3 – Gabriel Maeztu (12:09): 

So, the kind of information that we can find on the OMOP CDM is not just about clinical data, but it’s the main part of it. We can find out things such as drug exposure so we can see every time that the person has received a drug or maybe all the observations that clinicians and other practitioners have performed, we can see also for example, all the care sites and the different measurements that a patient might have had in the latest years. 

So, all the data points in these different domains that I just explained, all of them are normalized into what we can see on the right side of the screen and a standard vocabulary in this case represented such as a standard concept id. It’s just a unique ID where it represents the semantic that I was talking about before. So in the next slide, please, all these data vocabularies or all these concepts, in the end, what they are doing is trying to represent these semantics but not in a way that they do start building these semantics from zero or starting to try to create all these concepts against, but they are leveraging all the ontologies, terminologies and vocabularies that the healthcare communities already agree and they build up from there to start creating the representation and the semantics that are needed to be able to represent all the procedures, all the drugs, all the measurements, all the observations that a hospital can perform during the practice. 

 

Speaker 3 – Gabriel Maeztu (13:52): 

So adopting existing vocabularies is key for all the effort and all the success that the O-D-A-C-V-M almost CM has had because what it had allowed is many existing databases that were already in one of these controlled vocabularies to be remitted or transformed into TAs Opium. The next slide please. 

 

Speaker 3 – Gabriel Maeztu (14:18): 

So, in the end, these vocabularies or medical dictionaries are just standards that have been adopted by different parts of the medical community. I’m pretty sure that many of them, you already know them like the I CV 10 or maybe the SNOMED or EOR, but all these different vocabularies, they do have their own space inside the home obsidian. 

On the next slide we can see how all these concepts have a representation inside the OMOP CDM. So, in the end we can see this example for example, where if we can see the vocabulary ID that it’s the fourth row, it shows us that this concept is coming from the SNOMED vocabulary, but it already has its own concept ability. It has its own representation inside the OMOP CDM. 

But the nice thing about the OMOP CDM is that any other vocabulary or terminologies trying to describe the atrial fibrillation as it has been in the nomad. They are also mapped into the same concept ID. 

 

Speaker 3 – Gabriel Maeztu (15:35): 

We do have a unique representation for each of the semantic meanings that we might be interested, and those semantic meanings are not just invented by the OMOP CDM, they are agreed upon all these different terminologies and ontologies. The nice work that is performed by the OMOP CDM is to review all these vocabularies and to create this standard format that all of the researchers can start working on top of. 

So, we can imagine just a huge collection, it’s almost 6 million different concepts with more than 78 vocabularies that take part of them, but they are not just independent vocabularies. All those vocabularies are mapped between them. So, there is just one representation of whatever concept that we might be interested on. We can imagine them just like a stack of Legos, each of them for a different domain. Each of them is nurturing themselves from the best vocabulary that has been created for that domain. 

For example, we could imagine that for observations it’s been used at the SNOMED CV that it’s nowadays one of the best representations of the observation and diseases of the patients. But for example, for the drugs domain RX norm and their extensions are used to represent at their best the drugs that can be provided in a hospital. This huge stack of different concepts and all the normalization to understand that we can just have a unique concept to show them. 

 

Speaker 3 – Gabriel Maeztu (17:12): 

So, this is really nice and what it really provides us is a normalized way to be able to generate all the evidence that we might want to create from real-world data. It can be used mainly for patient characterization or population-level estimation and patient-level predictions. In fact, the opium is more focused on the characterization and patient-level estimations, but they are just different ways of using this existing data and this data to perform different kinds of analysis. 

For example, on the right [of the slide] we can see how you can define an observation period because we do have these tables inside the OMOP schema and inside this observation period we can define what we want to measure to be able, for example, to measure the incidence of whatever outcome that we might be interested in. 

This would allow us to perform an incidence study really easily on top of the OMOP, but not just that we might also be able to perform a case control design where we look for similar subjects and that we know that because of the data that represent themselves are very similar and we could put them just as a case control to be able to measure if the outcome of interest for example, is different between our case and our controls. 

 

Speaker 3 – Gabriel Maeztu (18:49): 

So, this is really nice, and it can be defined not just by technical people that are using all these databases, but thanks to the graphical user interface, anyone with a little bit of experience in defining observational studies can go and define by themself the cohorts of interest that they might want to work with. 

So, there is a tool called Atlas that is accessible if you look for it as “Atlas” on Google and you can define your own cohort by quite easily just asking for whatever you might be interested in. For example, you could define the index date and the index period to understand whenever a patient or whenever you want. When do you want to include a patient inside your own study? On the next slide we can go even farther on this tool, and you can see the link just down in the bottom right there. 

 

Speaker 3 – Gabriel Maeztu (19:49): 

You can go farther and not just define when do you want to be a patient included inside the cohort but also all the inclusion and exclusion criteria that a patient must comply to be able to be part of that study. So, in this case for example, and I’m going just to put one example, we are talking about the CHARYBDIS study. It’s one of the COVID studies that the OHDSI community has performed during this COVID period. 

One of the inclusion criteria was that the patient has at least one occurrence of measurements of SARS-COV-2 positive test. So, all those patients between the index date that we previously defined and that had at least one of these occurrences would be included in the cohort. You could add as many inclusion or exclusions criteria as you might want to be able to define your own cohort. 

 

Speaker 3 – Gabriel Maeztu (20:45): 

So, these command data models really help us to be able to perform near real time EHR world data studies so we can access all the information that is available in these EHR systems once we have already transformed it into this common data model. And what this gives us, is the availability to be fast and to be reproducible in different hospitals with large samples of sizes, because we are not limiting ourselves to whatever someone might be able to find out in clinical record. We are in fact using the whole hospital and all the patients that might comply with the inclusion criteria to make our sample size. 

Some disadvantages. The problem is that most of the data that is used for nurturing the common data models usually is already existing and structured information. So, information that might be in free text, for example in the clinical notes that a physician might have about their patient, or those imaging tests cannot be directly analyzed because they cannot find their place on this OMOP CDM. 

So, that’s one of the problems. Others of course are patients that might be misclassified or maybe some of the problems might be underestimated because some of data lacking. Also sometimes depending on the variables that we might want to measure, it’s very difficult to be able to compare between them. So, some of these disadvantages are ones that, for example, we’ve been working on for the latest for the last time. 

 

Speaker 3 – Gabriel Maeztu (22:34): 

And in fact, we think that this is the next generation of data collection. In the end, we can imagine ourselves that we are seeing how a new generation of occupational data collection has arrived and it’s here to just to stay. So, we’ve seen how in the past CRFs were totally digitalized thanks to e CRFs and now how EHR data have completely been used for nurturing the same observational studies. 

But in the end, by having a normalization process, what really has changed and what gives us really a lot of power to be able to perform the huge studies is that it changes who is making the effort to make the data available. Up until now, we were dependent on having someone on being able to go through all the medical records and to store all that data in a database. 

Nowadays, thanks to these normalizations process with the common data models, it’s a huge effort that is performed by technical companies or that are able to perform these transformations and they are not limited to the effort of one person looking for many people looking for all that data. 

 

Speaker 3 – Gabriel Maeztu (23:53): 

So, other challenges that we are facing is that almost 80% of the data in a hospital is in a sector format, almost like 65 to 85 feet depending on the hospital is stored. For example, as a free text, it’s just clinicians writing about their patients, all their narrative of what’s happening to them. So, this is very nice for the clinicians because they can understand really easily what’s happening with the patient. But the problem is that if we want to analyze this kind of data, even if we do have a common data model, it is not enough because we need to go a step farther. 

 

Speaker 3 – Gabriel Maeztu (24:36): 

And that’s what we are mainly working at IOMED. What we do is we use machine learning and what we have done is to create, you can imagine small bots that are able to read all these clinical records and are able to find all the data points that are of interest in these clinical records. So, as you can see on the right, there is a part and extractive clinical record where we see that a patient has diabetes. 

So, in diabetes in this case it’ll be a condition, the colors are wrong here, but in the end what we are doing with all these machines are extracting all these data points of interest and transforming into these OMOP CDM representation. So, in the end, by having the same semantics that we were explaining before and by external all the data in the same common data model, we can enrich more than 15 times the available data thanks to mining all the data that’s available in the technical records. 

 

Speaker 3 – Gabriel Maeztu (25:41): 

This is really nice, but one of the main problems that has worked at hospitals a lot is having to share their own data with a third party. So, the nice thing about the OMOP CDM and the OHDSI effort in general is that they are very privacy concerned and that they do not want to have a centralized way of accessing all the data. 

In the end, what they do is they push the analysis to all the data to all the hospitals. So, on the left we could imagine the systems in a hospital that it might be a data partner between inside the OHDSI network and on the right ,we could imagine ourselves or some performing some clinical study. So, once we have defined the study of interest and we know and for example using Atlas, we can define the cohorts and all the variables that we want to compute. 

 

Speaker 3 – Gabriel Maeztu (26:29): 

What is usually performed is a study that can be computed inside the hospital and just the results of the analysis are shared with those study coordinators. So in this sense, all the hospitals that might be taking part of one of these studies, they are just sharing the analysis and the results of their studies. 

So, they are pretty sure that all the privacy concerns that they usually have and all the problems that the regulatory might find in the European unions are avoided because all the exploitation of the data but also the transformation is performed inside the own installations of the hospitals themselves. And that really helps us to perform much faster studies and to go faster because we just have to be worried about our study design and to being able to execute those analysis inside their own hospitals. 

 

Speaker 3 – Gabriel Maeztu (27:25): 

There are also some challenges. As I told you there might be some cohort definition problems. So, whenever we want to define a cohort we might be, we need to be sure that that kind of data point will be found on the hospital’s database. So, it’s pretty important to be sure to that kind of data point will be there. Also, there are a lot of confounding information that might lead to spirit associations because of the large amount of data that it’s available ECC to over or underestimate whatever that we might be interested on our own study. 

There are a lot of biases that are the typical ones that we might find in any observational study and also there are problems whenever there is some missing or data such as for example, a patient that might have changed from a hospital or it might have died in a non-hospital environment. 

 

Speaker 3 – Gabriel Maeztu (28:31): 

So that kind of information is not recorded on their systems. Also, just as a little detail, it is very important how clinicians also define their own work because one of the things that one might find out is that hospitals from Europe and from the U.S. 

Some kind of procedures or diagnosis, they perform from following different kinds of rule sets and that might give them different semantics. So, even if we are provided with the same encoding for each of those diseases, because how they do perform their own diagnosis changes how the data can be represented. Next slide please. 

So, without further delay, I will give the presentation back to you [Neus].  

 

Speaker 2 – Neus Valveny (29:23): 

Thank you very much, Gabriel, for this overview and detailed overview of the common data models and the vocabularies that are used by OMOP. 

Now we are going to explain an example of how all these tools, or these new technologies can be applied in a specific example. And this was a study that was started in March, 2020 and it was entitled Real-world Characteristics Management and Outcomes of Such Screen or Diagnosed with COVID-19 in Spain. And this was really a truly collaborative effort from multiple stakeholders. 

On one side we have five public hospitals that wanted to participate, two from Barcelona and three from the Basque country. The study included patients diagnosed or hospitalized with COVID-19 and also additional controls and diagnosed with influenza prior to COVID pandemia. In order to compare the characteristics of these patients, it finally included almost 3000 cases hospitalized in hospital del mar. 

 

Speaker 2 – Neus Valveny (30:32): 

The design was observational retrospective and database study. The sponsors were Dr Cossio from Vall d’Hebron hospital and Dr. Horcajada from hospital del mar. And the partners executing the study were TFS in charge of project management, regulatory and medical writing and also IOMED for data extraction, codification and analysis and the OHDSI community that provided the core definition using the OMOP and an Atlas definition as Gabriel explained before. 

Also, the analysis packages in AIR program for doing the analyzing the outcomes and also technical support for all data partners around the world educating their packages because this is a global study that included partners around the world. So, we were in charge of some data sources in Spain only. Also, there was some partial funding from the EHDEN initiative to the hospitals, the participating hospitals, and also from Oxford University with funding from the Bill Gates Foundation. 

 

Speaker 2 – Neus Valveny (31:48): 

How all started this study? The first lockdown in Spain was the 14th of March, 2020 and at the same week it was going to happen the OHDSI symposium in Oxford and we were going to attend [TFS] and they of course canceled that symposium and replace the symposium by a global COVID study in order to provide real evidence to inform about the new disease that was happening around the world. 

So, the entire OHDSI community decided to focus all the scientific efforts. More than 300 people around the world were collaborating in this global effort. So TFS and IOMED wanted to collaborate in this effort, and we engaged three hospitals in the first meeting that took place the 17th of March. The three hospitals, we must say that they were very, very engaged in the study. They had a high interest in getting data from their patients because they didn’t know what was happening with those patients. 

 

Speaker 2 – Neus Valveny (32:50): 

They didn’t know the characteristics or the outcomes. They also had known us from prior collaborations; private clinical trials and observational studies. They also knew the main challenge that we found at that moment was that they didn’t know about OMOP. They didn’t know about OHDSI, they didn’t know that the power of the electronic health records (EHR) in the hospital and that they could be analyzed in a fast way. Let’s say also another challenge was the IT department of the hospitals should be involved. Also, the infectious department because the principal investigator was an infectious physician. But also, we needed the IT because the IT needed to give us access to the hospital recourse. The IT departments were very, very busy at that moment, as you can imagine. Also, there were some legal constraints that we will explain in the next slide. 

 

Speaker 2 – Neus Valveny (33:47): 

The regulatory pathway that we had to undergo for this study was the standard one for retrospective observational study in Spain. So, one central ethics committee (EC), which is the KIB NF IRB. In the U.S. we needed the approval for secondary data use. We obtained disapproval within five days only when the standard is between one and two months. 

So, at that moment the ethics committee (EC) was focused only on COVID studies. To obtain this approval, we chose to write an umbrella protocol because OHDSI was in parallel developing their own protocols with several objectives. One was characterization, the protocol was named Charybdis. Another protocol was focused on effectiveness of the drug was called Scylla, et cetera. 

So, we wrote an umbrella protocol covering all these of course and objectives and endpoints. Then we also asked the informant consent exemption. This was critical to run the study because we fight the ethics committee that the analysis, the people who did the analysis, only had access to IOMED data and the access to data would be controlled, because as you can imagine, we were asking access to an entire hospital database. 

 

Speaker 2 – Neus Valveny (35:10): 

So, this was very important to convince the ethics committee and they agreed, so they approved the study. We also had to go to the local ethics committee that assessed the local aspects only. Again, very fast. We had to perform additional steps like registration in the EU register for observational studies, as we recommend for all sponsors. Also, we had to sign an agreement with all the hospitals. So, the standard timelines for the agreements is between two and four months for these types of studies. 

But in this case, we must admit that we required more months. It was a long process because the legal departments were fully collapsed with a lot of studies starting at that moment. And also, there were some comments regarding the GDP compliance for this study that we ensure that all sponsors, CRO (Contract Research Organization) and investigators (PIs) were compliant with this European guidance for data protection. Also, we had to use open wording for the sample size because as you can imagine, the COVID numbers were increasing very fast. So, we didn’t know how many patients would be in the study. We used open wording that you can read here [ see slide on video]. 

 

Speaker 2 – Neus Valveny (36:34): 

Once we had all the regulatory process in place, we could go to the technical part. The technical part comprised five steps. One was a separate contract between IOMED and the IT departments at the hospitals so that they could access the hospital data, which was, as you can imagine, not anonymized. 

Then this company had a data anonymization process because they have a process where they remove all the personal attributes from the electronic health records (EHR). This is really important. Then in the anonymized database, they converted it to OMOP, as Gabriel explained before. They converted all the terms in the electronic health records (EHR) into a single number or concept ID. So, all the variables, the drugs, the conditions, et cetera are converted into a number. Then in this converted database, they executed the air package from OHDSI is the same air package was executed in the U.S., Korea, Italy, and in countries around the world. 

 

Speaker 2 – Neus Valveny (37:39): 

And you can find this package mentioned here on this webpage [URL on the slide]. And finally, we obtained such a great amount of results that we had to upload them to a web application called Shiny app, where you can easily review these results because otherwise it’s impossible. It’s not user-friendly to review them as you receive from the output. And the Shiny app is in this link here [on the slide]. 

On the next slide you can view the QR code. I encourage you to go to this webpage and review these results so that you can see not only from Spain but from results around the world. On the next slide you can see the main characteristics of the results. We want to explain because this is really important. Once we had access to the hospital records in OMOP, all the package was run in only one week. 

 

Speaker 2 – Neus Valveny (38:44): 

So, this is very important. In this one week we had access to more than five hospitalization and visit information, more than half a million subjects with information from the last 20 years in the hospital. As you can see, how powerful is this tool? 

We had information for all inpatient care, outpatient specialist care, emergency room visits, and partial information from other settings. We obtained the outputs containing more than 2 million covariates in four domains. So one domain is the cohorts, the other is the demographic data, the drugs and the conditions. 

All these variables were obtained for more than 1000 cohorts or different strata that comprised the small variations in the observation period requested to the cohort, the prior follow-up the comorbidities, et cetera. So, for example, we divided results between patients with diabetes without diabetes, with hypertension, with hypertension, et cetera. And these are in the next slide. 

 

Speaker 2 – Neus Valveny (39:48): 

You can see how these results looked like at the beginning when we started directly from the package. So these were CSB files and they were received seven of them. And these CSB files, some of them contain the dictionary of the covariates because the covariates are all defined by a number and also the cohorts and the features. The cohorts is the group of individuals and the feature is a group of covariates. 

So, for example, the feature diabetes Milus comprises several covariates. One covariate is diabetes as a condition. Another covariate, for example, is an antidiabetic drug, et cetera. So, the feature, diabetes is composed by multiple concept ID. And here you can see the main results are in the fourth table here. 

And on this slide, which is the covariate value. In this table you can see in column A, cohort identification number. For example, 1 1 1, the Covariate, 1 0 0 0 0 1, has a mean value of zero point 27. In this case, this is a categorical variable. So, even if it says it refers to mean it’s a proportion, okay, that means that 27% of patients had discovery it in this cohort. 

 

Speaker 2 – Neus Valveny (41:14): 

On the next slide, you can see how all this research was combined into a single file. That couldn’t happen in Excel because it’s so large. As you can see here, it contains almost 4 million rows. So, it cannot be opened in Excel. We open for example here in Power BI and here you can see for example several prevalences of conditions in different cohorts. 

This is an example only in the next slide you can see the user-friendly format of the results. And this is the Shiny app that we were referring to before. And in this additional app there are some dropdown menus where you can pick up the database, you can pick up the core that you want to look at, you can pick up the strata, you can pick up for example two core, the target and the operator and the domain. And you can look also to the time window. 

 

Speaker 2 – Neus Valveny (42:10): 

You look before the index date or after the index date that cover it. And here this is only an example, it has very nice plots where you can compare the prevalence between one cohort and the other. And for example, this.in red is the prevalence of hypertension between compare between patients who entered intensive care versus those not entering in the intensive care. And as you can see, it was much more prevalent. Patients in intensive care had more hypertension. 

In the next slide you can see another example. I encourage you to go to the Shiny app and look at several results because it’s really nice to see the powerful and how many cobar and information is there. For example, if you want to compare the use of anti in patients with and without diabetes, you can see that the use is more than three times in patients with diabetes. 

 

Speaker 2 – Neus Valveny (43:09): 

They had also more hypertension. This is a comparison between hospitalized patients. The next slide here, I will explain the three publications that have been already been in the public domain including results from this study. And this is the first one. This is descriptive study of the entire course from around the world. 

It contains more than 4 million COVID cases and it has really nice pictures displaying, for example, the age and gender distribution of patients entering the hospital and entering the intensive care units across the data sources. Here, you must remember that not all data sources enter it in the same wave of COVID. This can or in the same wave or month. 

So, you can explain some of the differences between the age and gender distribution. This is the second manuscript that was accepted in British Medical Journal and describes the use of repurpose drugs in COVID pandemia. 

 

Speaker 2 – Neus Valveny (44:20): 

For example, the line in yellow, the yellow line is hospital del mar. You can see at the beginning of March, more than 75% of patients were receiving hydroxy chlorine because it seemed that it was effective. But after a few months more evidence was available showing that hydroxychloroquine was not effective. So, all hospitals declined to use it. In the next slide you can see another publication. This is the third one is accepted by British Medical Journal Open and it’s a comparison of outcomes between patients with hypertension and without hypertension. In this course, and for example, if you can see the mortality in hospital del mar was 14% in patients with hypertension versus less than 4% in patients without hypertension. This clearly indicates that hypertension is a risk factor for COVID, worse COVID prognosis. And also, you can compare, for example, the outcomes between several data sources. 

 

Speaker 2 – Neus Valveny (45:27): 

For example, hospital Delmar was similar outcomes versus op database from better and affairs in the us. However, the mortality in Optum database was slower and you always need to take into account the sociodemographic characteristics of the data sources. In this case, Optum had younger patients and more women than hospital del Mar. So, a basic quality check that you need to do when you compare resources between data sources is always take a look, at least at demographics because agent gender are correlated with almost all outcomes. 

It’s very important to take that into account. I think this was the last one. Yeah, let’s go to the conclusion. We have reviewed database studies using electronic health records and common data models. In this case, in this example, using OMOP, the advantages are that you can have relatively quick results. 

 

Speaker 2 – Neus Valveny (46:32): 

Some weeks only after all the regulatory process is in place, they have lower costs versus a traditional non-interventional study. Because you don’t need an EDC system, you don’t need to transpose data into A CRF, et cetera. It’s not time consuming for the investigators other than of course involving them in study design and core definitions and so on it we recommend to do of course the study design with investigators. 

It allows a federated approach, which means that you can replicate the study across many countries and data sources very fast. And also, of course, allows to obtain a big amount of data. The main challenges are the potential misclassification or missing data in the electronic health records, potential biases as in all retrospective studies. For example, indication bias in mortal time bias. So, it’s very important to very well the core and also to analyze the data very well. 

 

Speaker 2 – Neus Valveny (47:32): 

For example, if you want to compare cores, you may need probably multivariable analysis or to adjust by confounders or for example, propensity score matching. You also may need to use positive or negative controls in order because you cannot adjust for multiplicity because you are doing so many analysis that if you adjust the P values, you simply get lost. 

So, for example, the OHDSI is using positive and negative controls to ensure that the comparisons are fine. And finally, maybe if you want to extrapolate the ratio, you may need empirical calibration of the model parameters. And that’s all we encourage in the next slide. 

We encourage all of you to use these common data models to do your real-world evidence (RWE) studies. We really think that the initiatives around the world like the European Health Data and evidence network that is providing funding to the European hospitals for doing this conversion will help in this process because in the next five years, we expect more than 100 data partners to have this hospital databases in this model. So, we are looking forward to working with all of you on these type of studies. Thank you very much. 

 

Speaker 1 – Ryan Muse (48:50): 

Well thank you very much, both of you, for that insightful presentation. Before we move on to our Q&A session, we have a poll question for audience members. This should be appearing on everyone’s screen right now. You can participate by selecting any of the answers you see in front of you and then clicking submit. 

The question that we have for you asks, 

“Would you consider this data collection method for your next study?” 

Your answer options are: 

1. Yes 

1. Yes, but only using structured data. No NLP. 

1. No, I prefer an ECRF. 

 

We’ll give everyone a few seconds to consider their answer, how it best applies to themselves, their company. The question again being would you consider this data collection method for your next study? 

 

Speaker 1 – Ryan Muse (49:34): 

It looks like most of you have voted. Thank you very much for participating. Let’s take a look at your results. We have 69% of you have said yes, 23% no, and then 8% at yes, but only using structured data. 

So, thank you very much again for that participation. And now I would like to invite the audience to continue sending your questions or comments right now using the questions window for this Q&A portion of the webinar. I’ve already received some questions, so we’ll get ourselves started with those. 

The very first question that we have for you asks,  

“If a subject from the study must be re-identified, for example has a rare adverse reaction, can this be done and how?” 

 

Speaker 3 – Gabriel Maeztu (50:21): 

Sure, happy to answer that. So, this is a process that it can be performed. It’s not easy process because usually all the data, as we said, once it’s outside the hospital because all the analyze process has finished and the results go outside the hospital, all the data is anonymized. So we cannot in any way re-identify that patient. 

But usually all the hospitals, well usually they have to all the hospital, they store the results of all the analysis, but also all the audits. So, they do have all the information about all the participants of that study, but the hospital is the one that has all that data. And they are the ones who are able to identify the patients in case there is a react adverse effect that you don’t need to identify the patient. So, it’s possible, but not by the ones working on the study, just by the hospitals and using a very specific process that takes. 

 

Speaker 1 – Ryan Muse (51:23): 

Excellent. Thank you very much. The next question that we have for you asks, 

“Which quality controls must be done to the outputs? Can code mis classifications be identified and corrected?” 

 

Speaker 3 – Gabriel Maeztu (51:37): 

Okay, I’ll take it one too. So yeah, indeed. One of the things that is very, very important is to perform a data verification and a data validation process. So, in that sense, whenever a normal CDM transformation process is going on, it’s very important to understand how the information is represented in the hospital and what’s the semantics behind it of it. 

So, it’s very typical to work with your own hospital to understand how they are storing the information, but also with the clinicians to understand if all the, for example, all the data represented, and the results have a meaning that might have a sense or not. Because sometimes you might find out that there is some misclassification on something that can be easily redone and recheck. 

So, that’s why there is a data validation and data verification process that take part of these kind of studies to check with the clinicians that all the data makes sense, and the results are something that will be expected. 

 

Speaker 1 – Ryan Muse (52:41): 

Wonderful, thank you very much. Another question we have for you here would like to know, 

“Can data from several hospitals be pooled at an individual level and if so, what steps are needed?” 

 

Speaker 2 – Neus Valveny (52:55): 

I can take that one Gabriel. Yes, it’s possible to pull data from several hospitals provided that the ethics committee (EC) and the site contract allows for that. So, of course, when we run the analysis, we need access to individual data from the hospital, but the site contract defines whether this data can be pulled or not with data from the other hospitals. 

So, it’s part of the regulatory process to think ahead when you design the study. And if you foresee that you will need to pull data because for example it’s a rare disease and you need to have only few cases from each hospital, you need to convince, let’s say both the ethics committee and the hospital agreement and include and specify very well, then you will fulfill again the GDPR or the IPA or whatever confidentiality law is in place that we’ll fulfill this law. 

 

Speaker 1 – Ryan Muse (53:55): 

Alright, thank you for that. The next question we have asks, well first states that, 

“There are differences in the way of diagnosing and therefore coding the pathologies and procedures between countries and continents. What consequences can this have in the study?” 

 

Speaker 3 – Gabriel Maeztu (54:14): 

Sure, so that’s a known limitation and that must be checked whenever the study is designed. So, that’s a design limitation that you must take into account whenever you are defining the study to understand whatever information you’re looking for, how that information is managed by the different clinician in the different hospitals. So, that’s a very important part that the scientific writing and the design part, design part of the study must take part of it to be able to really take into account those kind of problems. But once those problems are diagnosed before defining the cohorts, you can define different cohorts that might be not exactly the same for each region. So, you can really compare them much better or maybe to have more smaller cohorts. That can be even changed in a second iteration because one of the nice things about this kind of studies is that you can really iterate easily without having to have all the data collection and acquisition process. That is usually the huge and painful part of any study because you can really change a definition, have an okay from everyone, keep on going on the study. 

 

Speaker 1 – Ryan Muse (55:38): 

Excellent. Thank you very much for that answer and for all of the answers today. However, we have reached the end of the Q&A portion of this webinar. 

Now, if we couldn’t attend to your questions, the team at TFS HealthScience may follow up with you or if you have further questions, you can direct them to the email addresses that are up on your screen. I want to thank everyone for participating in today’s webinar. You’ll be receiving a follow-up email from Xtalks with access to the recorded archive for this event. A survey window will be popping up on your screen as you exit, and your participation is appreciated as it will help us to improve our webinars. 

Now I’m about to send you a link in the chat box and with this link you’ll be able to view the recording of this event on this page and you can also share this link with your colleagues when they register for the recording here as well. So, I encourage you to do that now. 

Please join me once more in thanking our speakers for their time here today. We hope that you all found the webinar informative. Have a great day everyone, and thanks for coming. 

 

Speaker 2 – Neus Valveny (56:35): 

Thank you, Ryan. Thank you all for attending. 

 

Speaker 3 – Gabriel Maeztu (56:40): 

Thank you very much. It was a pleasure.