Hey, guys. Welcome to the podcast. My guest today is Khalil Ahmed. He's vice president of medical affairs for Europe and Asia at Syneos Health. And we discussed the evolving role of MSLs in field medical support for clinical trials. So this is a really awesome conversation. I think you guys are gonna love it. Don't forget to follow me on LinkedIn. Check us out on MSL talk live, which is the 1st Tuesday of every month at 1:30 PM EST, and that's on LinkedIn live.
And check out our YouTube channel where we post all of our podcast videos. Welcome to MSL talk with Tom Caravella, a podcast specifically designed for MSLs and all things field medical. Hey, Kahlil. Welcome to the podcast. Thank you for joining me. It's very nice to meet you again, Tom, and thank you so much for having me. Really appreciate it. Yeah, man. I am super excited about this.
This is I'm excited about this topic that you had brought to our attention because I think that this is something, first of all, we haven't covered before. It's very important and extremely relevant. Before we get into it, I do want to announce that Syneos Health is our sponsor for this episode. And for those of you guys out there that don't know Syneos, it's, it's an organization that's really making huge strides in our industry.
I didn't realize this, but Khalil just told me that Syneos is the world's largest contract commercial organization and the 3rd largest CRO. And if you're not familiar, Syneos is a leading and fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical medical affairs and customer, consumer insights into outcomes to address modern market reality. So for more details, please visit them at syneoshealth.com.
So, Kahlil, let's do an introduction if you wanna tell everybody a little bit about yourself. Oh, absolutely. So I'm Khalil. I'm based in UK, and I live in Seniors Health. I, look after medical affairs in Europe and Asia Pacific. I've been here for about 4 years, and in my past life, about another 12 years in, pharmaceutical side, and I'm very proud to say that I started myself in in this career as an MSL. And I worked in MSL for a number of years. And to be honest, I still feel like an MSL.
I still am very passionate about it. So I worked as an MSL. I managed MSLs and medical medical affairs functions in UK, in Europe, international level, in medium sized, large pharma, as well as the rare disease company before I arrived here. So it's it's a pleasure to, actually be here. Awesome. Well, I'm glad you're here. And, you know, as they say, once an MSL, always an MSL. Oh, absolutely. You do not want to even consider any of the role. Absolutely not. Yeah. Yeah. Awesome. So let's talk.
I know we're gonna talk today about, MSLs being brought into the clinical trial process. And I think one of the questions becomes, when would that be most optimum? So if MSLs are gonna be brought into this process, the clinical trial process, when when should that happen? Is it early? Is it a little bit later? I'm curious to hear your thoughts on this. Well, I appreciate the question. And, Tom, before I answer that question specifically, I want to just give you a little bit of context.
Sure. You know, our industry spends every year, not billions, but tens of billions in the clinical trial development from phase 1, 2, and 3. And literally, in every single clinical trial, depending on the size of the study, you could have hundreds of folks in clinical operations working on CRA, the medical monitors, operations managers. There are so many roles that you you can keep counting.
But the reality is that despite pouring it so much money, the resources, more than 80% of the trials actually run over time on their schedule. And almost always, the key issue is the patient enrollment is not going as fast as they hope or predict or they try. And that is the major problem. And it's not only that it gets delayed, but more importantly, the impact.
Not only that if you think about it, if the trials are not completed on time, this means that novel exciting new therapies are not available to the patient on time. They get delayed. So that direct impact on the patient. But more importantly, also, if you think about the pharmaceutical industry point of view, actually, every single day a clinical trial is delayed. Mhmm. There is an average cost from varies from $600,000 to up to 8,000,000 per day. Wow. I'm not talking about month, a year.
So that's a consequence for organizations. Right? So that is the backdrop of the situation where clinical development folks, they have been trying so hard, everything, to get the, trials getting on time. And I'm very excited to say that it's a very recent emerging trend in the last few years where they started to see a great value of medical affairs getting involved and having that impact.
And, of course, MSLs, actually a face of medical affairs on background in front of the KOLs, in front of the treating physicians. They are at the forefront of this trend where they are really trying to make a real impact in terms of overall performance of the study through assisting trial sites for the patient enrollment. So that that's the backdrop of it. Yeah. And in fact, in sorry. Please go ahead.
No. I was gonna say I didn't realize the magnitude I didn't realize the magnitude of, number 1, how often it is that trials are delayed and are, you know, over the time frame that that the expectation is. I assume that it was costly, but not to the extent that you just mentioned. So those are those are eye openers, I think, for me and probably for a lot of other people listening is the is the magnitude of what happens when a trial gets delayed.
Yeah. Absolutely. If you think I'll give you an example. If you think about, Lipitor, you know, he has gone by. It's it's, generic now. But Lipitor, when it got extension of the life, before it came to the pay, actually the patent, cliff. It fall off. Life extension by about 6 months in US. And that 6 month extra month was worth more than $3,500,000,000 extra revenue for Pfizer in US alone. Forget about the rest of the world. Right?
And if you think about it, that at the early end of that, if the clinical trial is delayed by 6 months, so towards the end of it, it's costing that kind of money because you have limited time for the to come off patent. The the the clock starts ticking when a product is an asset is registered. It is patented. And then you have limited time to develop it and bring it to the market. And then the rest of the time left, typically, it's about 25 years.
You from patent to the actually falling off the cliff of that game becoming generic and losing the like exclusivity. So during that time, you have to develop it and then make money out of it after that. Right. So that's why every single day lost, it actually cost 1,000,000 to organization. Right. And that is something we, we need to remember, but it's also the patients are deprived of life saving drugs as well. You know? Longer it goes on, the the the patients are suffering as well. Absolutely.
So that obviously get getting back to medical affairs, field medical getting involved. Absolutely. It makes sense to have and not necessarily an all hands on deck, but it makes sense that the folks that are available that are that are in the capacity where they can move the needle, MSLs being the the face of an organization, having FaceTime and being in a position to help, they get involved. Would you say earlier, better? No. Absolutely. Earlier, the better. And, don't get me wrong.
MSL have been, for years, been involved in the clinical trials. Their organizations do time to time ask them to help and support the clinical folks, but I will close that. And I have been in that kind of, experience myself in my past life with, our, actually, the clinical folks would request our okay. We are not getting a particular response from this side or that hospital. You know that, KOL, can you go in and check what's going on?
So I would class that that this historically, that soft touch always be as a part of, typical MSL role. Mhmm. But what's happening in the last few years is and I'm very proud to say this, the senior self is at the forefront of it. Clinical development are realizing that bringing MSLs and medical affairs collaborating early on has a massive value.
So if you think about a clinical typical clinical trial, different stages, so first is the site identification and site recruitment, then it is, a site startup, and then the maintenance phase where they actually recruit the patients. Now a lot of time, actually, the reason the the patient recruitment is a challenge that, you end up the site at the site selection stage with some sites which might not be as, efficient in practice as they hoped or as they promised.
So bringing MSL very early on at the site selection stage because MSL essentially not only the therapeutic KD expert, but they also know their keys treating centers. They know the KOLs. Mhmm. So they have that in-depth knowledge which helps them to actually filter out and recommend the best possible size to site ID team. So, you know, when you lay the foundation right, the rest of the building actually goes pretty well and on a solid grounds.
So, actually, there is a huge value that MSL coming in at a very early stage helping the site ID and selection team. And there are different ways. They could actually expand the number of sites which are recommended to site ID because they're in high knowledge. Secondly, is that quite often the site ID team, they struggle to have a effective and efficient communication with the sites when they are going through the feasibility state.
MSLs could go in the site in person and actually, overall, accelerate that communication between between the site ID team and the site and the QLs themselves. And the third thing is that a lot of time, site ID team, when they do that visibility, quite often, they miss some important information. And for that reason, our sites' slow response, they top some sites. And and my sales could go in and having that in-depth discussion with, actually, the QLs and the site stuff.
And quite often, they bring in those sites that have been initially been dropped for one reason or another, and they could rescue them. So MSL could play very, important role, and they do, in that phase. And when it comes to the study startup, MSL can take and and they do nowadays, I'm very proud to say that they are taking the role of providing the full scientific and clinical training about, asset, about the study protocol, about all the ins and out of it in an ongoing basis.
But, here is the thing. It's a clinical development, but very crucially, we have found that there are specific gaps where no clinical function is engaging with the site. And this is where MSL are started to have engagement and make a significant difference. And a good example is that when a site is selected and the legal contract has been done, then site ID team's time is finished. Then the site is waiting for activation, right, the training, and formally open it.
And sometime, there could be gap of weeks or 2, 3 months between those 2. And during that gap, despite having dozens of different roles and functions within clinical, no function actually engages with the site during that period. And quite often, sites even forget that they have signed up a study. So MSI could go during that period, what we call is the pre site activation.
And not only they start to engage with them and and actually keep the study in their mind, but more importantly, they with their advanced communication skill, actually encourage them to start prescreening. So even before officially study started, they start looking at their data and identifying the patient where they could bring in. So as soon as they have the training inside is officially open, they have the patient actually early on identified straight away.
They started to go the in the in the recruitment phase straight away. So there are number of phase in each and every stage. The MSL do play an important role, and that's the reason that there is so much interest. The MSL coming in more and more and early on and have much more rather than having a light touch, hands on, full fledged involvement clinical trial and become the part of the, actually, the clinical operation.
Yeah. And I think that by doing that, getting involved early at the site selection and the ID phase, you know, the MSL is gonna now take a bit more ownership than if they were brought in after, because now they're involved from the beginning. So they're a part of the process. Right? As opposed to, okay. Well, I'm just coming in. I don't really know what's going on. I'm gonna try to help now. But, right, would you say that that's a critical piece of it?
You put it beautifully, Tom. In fact, that importance of that is that effectively, MSLs are almost, actually core responsible Mhmm. For the site performance along with the CRA. You know, traditionally, we always think that it is the case. The CRA is the primary point of contact from clinical, point of view at the site.
Mhmm. But then, effectively, MSLs become a business partner with the CRA and actually take some responsibilities and make a difference with CRA in terms of their set of skills or in terms of their role and responsibility, they cannot. The kind of the scientific knowledge, and it's not only about the protocol or the asset knowledge. By definition, MSLs, they do understand in-depth her acuity area, the clinical practice, how the patient journey works.
So the basis of that relationship with the side staff is purely on the scientific, which is very different from a CRA rule, which is more an operational and a process driven. Mhmm. So that allows them to take the ownership of that very critical part, which is the how actually the site staff gonna invest, take some initiatives to identify the patient, and look at that patient, screening funnel and how effectively they identify the right patient for it.
So this is where MSLs become essentially a bridge between clinical and the side staff. And I go to person for the side. If they are having any issues, their problems, anything they are not clear about, MSLs are there to provide them the support, the answers, and also the training. So all the way, MSL not only become an extension of the clinical operations team, but they almost become extension of the PR and study coordinator. So they've come kind of stakeholder at the site level.
And this is what you expect with their not only the scientific knowledge, but advanced communications skill. And that relationship then have a meaningful impact on overall performance of the study to the accelerated, patient enrollment. Yeah. I'm wondering, you know, you mentioned the word value. And, you know, every time we hear that, you know, what is the value of the MSLs? Or how do the MSLs prove value?
Or the and I don't wanna put you on the spot here, but are there is there any any evidence or proof of the value? Meaning, when MSLs get involved in the clinical trial process early, the results are this. Oh, absolutely. So, actually, we have number of case studies. So we have been running, for number of years quite a few projects where MSLs are providing that full on service from very early on.
And, actually, I have very, wonderful study that one of our, client who is, one of the top 20 pharmaceutical company, and they have chosen to have a team of MSLs, in part of one of their CNS study in Europe and in Asia Pacific with us. Whereas, they decided to not have a similar team in in US. And they decided to have their own MSL team with typical that, you know, I call the soft touch. Typically, traditionally, as it work.
And I'm very proud to tell you that this project is running for more than, two and a half years. And in terms of the overall screen screen failure rates, which actually one of the key parameters that how effectively the the patient the eligible patient are selected and what is the ultimate goal of how quickly you can actually enroll patient.
There was a beautiful, actually, result that a marked difference between sites which are outside US where our MSL team is working with that full on taking responsibility of engaging site almost biweekly basis versus their own team in in in the US. A good example was that, actually, what percentage of sites which have first patient enrolled within 30 days 1st 30 days of after activation. So in the sites, ex US, we we were covering in that deep involvement, the rate was 29% of the sites.
29.2% of the sites have patient enrolled within 30 days of activation. And in US, it was 16.3%. So almost double the difference. So you cannot have a more, actually, clear picture of the impact the MSL, could have there. And in fact, their the clients then last year requested me that if our team can train their MSL and get involved much more closely in US as we're doing in in in the rest of the world purely because they saw that so much clear difference.
Similarly, we have number of examples which shows that how greatly the MSL and medical affairs general make a meaningful impact overall in the study or performance of the study? Yeah. Well, I gotta play devil's advocate just to see, you know, what the risk factors might be. And, you know, as a recruiter, sometimes we see this as a piece of the job descriptions. A lot of times, we don't.
It's just isn't always something that's included in the person's responsibilities if you're an MSL working x y z company. So is there any risk of kind of 2 part question. Is there any risk of the MSL's overstepping their balance in the clinical development process? And is there any risk that maybe having the MSL's do this might cause the MSL to say, well, right, this isn't really my job. So talk about that a little bit.
Like, how does this how are what are the risk factors involved in getting MSLs more involved in this? Well, that's an excellent question. And I'll tell you, Tom, that the fundamental risk factor in this situation is clear and effective communication. And by that, what I mean it, I'll explain. So typically, MSL, when they are working in their traditional playground, I would call it prelaunch, postlaunch phase, working essentially supporting commercial folks. Right? It's a sales team.
It's a marketing team. It's a market access team. It's regulators. All of them. So they are well accustomed to working in that cross functional environment and very fluidly. Right? Spontaneously, very comfortable. Now clinical development, that environment is not only a little bit different. It's highly matrixed, and roles and responsibilities are absolutely well defined. And the lines of communication are in much more detail in writing laid out.
And if you deviate a little bit, it creates absolute chaos. Mhmm. So it is critical that when MSL actually start working and their ambition is and the goal is to become a kind of a bridge between the trial sites and the clinical function. But the way they need to do is that, first of all, the role and responsibility needs to be absolutely clear.
So what CRA is doing, what they are not supposed to do, what a medical monitor is doing and not supposed to do, and then in that conjunction, what MSL is doing and not doing. The second part is that in terms of information flow, that needs to be triaged in most efficient manner to the right people within the clinical. So site has a question, say, about study eligibility criteria.
Then MSL needs to be absolutely clear that who is the right person to go to medical director in that clinical study team who will answer that question. If it is about the payment at the site level, who is the right person to go to? If it is about adverse event, who need to go to? So these things are absolutely set in stone when a clinical study is right. And you will not be surprised that if you look at us, our clinical study management plan, that could easily goes into hundreds of pages.
They layout each and everything. Similarly, study communication plans is very detailed. So critical parties where the MSL gets involved there, then they need to operate under, a very customized MSL communication plan, which complements study management plan and study communication plan, which defines what is exactly their role and responsibility and what piece of communication, how they will actually, lay out both to the sides as a clinical trial. So that is a fundamental part.
And this is where I would say that, of course, individual MSL, their own communication skill and, ultimately, I would interpersonal skill really make that happen. But it's also then accountability and responsibility of leaders like myself to make sure that we lay out that communication plans and role collected to them very, very clear from the start. Yep. Got you. Yeah. There was a lot to unpack in there.
As I'm listening, I could no. I could see that there's some nuance to this, and it makes me think what, like, would the MSL now have to develop a new skill set or, develop new, a new understanding in a lot of ways to be successful in in handling that part of their job. So now they they are going to get more intimately involved in the clinical trial process. What is there anything that they need to develop as far as skills, knowledge? How do they become prepared for success?
That's once again, it's a wonderful question. And what I'll say to you is that in my humble opinion, when we talk about MSLs, then, essentially, there are number of different set of skills or the competencies which are essential for an MSL to be excellent what they do. Mhmm. But there are 2 fundamental, actually, skills of scientific acumen. Mhmm. So and the second is the communication skills. So these are the 2 fundamental.
But if you take those 2 as the most essential to be successful, then if you look at a product life cycle Mhmm. So from clinical development so we're talking about from early stage clinical development to the prelaunch, launch, and establish phase. By establish phase, we mean that we're closer to the, actually, the patent expiry. Then in each and every phase, I happen to think that all of the fundamental skills required, those 2 remain the same.
But in terms of what is expected of them, potential outcomes in different stages are slightly different. And that this is where actually tweaking up some of the other software skills and the competency is important, which are driven by their, actually, the key performance indicator. Think about this, in a prelaunch phase, one of the key fundamental things they are expected to do is that, first of all, identify the key clinic center KOLs, engage with them.
The second is awareness, awareness about disease, awareness about, unmet medical need, awareness about the clinical and the scientific profile of the organization of the asset in appropriate manner. And the other part is the medical insight. But the same asset, when it goes to the launch and a post launch, you are having the same scientific based conversation, but the expected outcomes are slightly different now.
Because here, you are appropriately trying to support your commercial colleague to actually support their objective, whether then in that case, you will end up, supporting, speaker programs for them. So what you see is that, in a way, you end up in traditional MSL space, 3 different almost versions of MSL. MSL in pre launch space with set of skills required slightly different and because the expected outcomes are different or the medical strategy is different in a post launch.
And when it is at established phase, it's slightly different. Now I almost add another version of it, which is MSL in clinical development state.
And without going too much detail, what I would suggest is that in that space, when we think about the how MSLs would be very successful and very effective, then slight tweak of their skill set will be, first of all, their ability to work in a highly complex matrix environment of the clinical we just touched upon in a very seamless manner and very effective. This is very important.
The information flow in that is critical because in scientific information, what they exchange with the KOLs in the, commercial or pre commercialization phase is very different in nature what to do in clinical space because that information is not only very sensitive, but it's very confidential as well, a lot of that information about the trial.
Because if any information which you are actually handling, it goes in the wrong hands, in the wrong ears, then it could compromise overall the, actually, integrity of the study. The second part is that, essentially, I'll give you the practical element of it.
That when you go to a, actually, a a site, to a principal investigator or or, study coordinator or sub PR, then you would immediately think that I am there to help them, so they will be absolutely ecstatic to, actually welcome me to open up. The reality is that as they have, they will see you oh, not again. Another person coming from a CRO, a sponsor, telling me what to do and what not to do. And so I'm already overstretched. I am doing teaching. I'm doing clinics. I'm doing multiple study.
And the last thing I want to know is, as a PI or as a study coordinator, another person coming in from sponsor or CRO side of that what to do.
So that 1st critical piece is that how your communication skills makes it possible for you to actually change that initial perception in their mind that you are not there again to tell them something, but actually making them realize that you are not you are only there to help understand what's going on their side, what are the issues and problems, and how we can help them. So, ultimately, you become their go to person as a business partner. Right? So that is very critical thing.
It's not the first time. The door almost always will be open the first time when you go to trial site because representing CRO or or or the the sponsor. But how you build that partnership where they are overworked, but then they see a value what you bring in, and they, every time, actually welcome you. And that is for communication scale, I would say, at another level, which you need to get to. Yeah. That's awesome. And so then what happens when the trial is complete?
What how does that relationship evolve with the KOL, or what happens at that point? Well, the the beauty of MSLs getting involved so early on is that it's win win win situation. Mhmm. How? 1st win is the MSL having that meaningful impact in overall performance of the study and hopefully studies being completed on time or ahead of the time, meaning that actually that product could be launched much earlier than anticipated so the patients are getting the essential treatments earlier.
Mhmm. The second one is that, essentially, the PIs, which you start, actually engaging with, these are more often than not the same PIs who are later become the KOLs as well. Or they are already established KOLs in that therapeutic area. That's why they are chosen in the first place. So your relationship with them starts very early. So the strength of relation over time builds up. But there there is another benefit to it.
These very KOLs who are the PI, that means that they are also the folks who have the hands on experience of that product. They have the confidence in that product because they have delivered themselves and see the results in the clinical trial. So later on, they will be your champion KOLs as well, you know, when it we're thinking about the the pre commercialization and commercialization.
And if you think about your relationship with them, then that relationship, which carries on, is gold for patients, for those QLs because you become their essential actually, the partner throughout their life cycle, but also goal for your organization as well.
And the third thing, which is the third win I call it, is that when you are early on, actually embark on that journey from preclinical stage, prelaunch launch and establish phase, then as I earlier mentioned alluded to that you actually acquire and enhance your essential set of skills, which broaden your horizon. And it's not only the skill set, but your experience and knowledge about the whole life cycle is such that that it really boosts your career to another level.
And I cannot advocate more than this that I personally benefit so much with this kind of journey. I was lucky enough to embark on this journey when I was in MSL in much more in-depth way, and it's, in fact, actually rocket boosted my own career. And I'm absolutely passionate that When MSLs are doing all of it and delivering for the patient and their organization, along the way, they also actually take a lot of reward out of it. Yeah. Well, I can hear the passion in your voice.
I could see that Absolutely. I am so glad that this. Yeah. Absolutely. And I'll tell you what, anybody who has been involved in that way of working, they want to always try that again and again. It's like a addictive situation. I love it. I love it. Well, you're great, Khalil. Thank you for joining me. Let's leave it there. Guys, don't forget to check out syneoshealth.com so you can learn more about the awesome things that Syneos is up to.
And, you get you know, there with leaders like Khalil, man, come on. You gotta see. You know, obviously, the organization is doing things right. So, Khalil, thank you again for joining me. You were awesome. This was a great conversation. No. It was a absolute pleasure, and it was an honor to be on your, on your podcast. I am absolutely thrilled, and I hope even if one person I could motivate them to thinking about actually getting involved in clinical trial, I will take it as success.
Absolutely. Great opportunity. Thank you so much. Awesome. Thanks, guys. Thanks for listening. Take care. Thank you so much for listening to the show. And if you enjoyed it, please subscribe so that you don't miss an episode in the future, and feel free to leave a rating or a review or a comment. Thanks again, and we look forward to seeing you soon.