The Role of Medical Affairs
Dr. Len Walt
In the seventh episode of our fourth season, our host Peter Brenders talks with Dr. Len Walt, VP Medical at SSI Strategy, about the role of the medical science liaison, the relationship between medical affairs and physicians, and the united front of medical and commercial.
LIONA DESAUTELS (LD):
From the Chronicle Podcast Network, this is the NPC Podcast of the National Pharmaceutical Congress for June 9 2021. The NPC Podcast was created to discuss and consider the purpose, process and people of the pharma industry during the year of Covid. And today, we're continuing the healthcare conversation by answering questions from listeners, just like you.
This program is presented in cooperation with Impres, Canada's next generation commercial partner. The industry is rapidly evolving and Impres is designed to help you evolve with it. Learn more about Impres tailored best in class solutions at www.impres.com.
On today's podcast, our guest is Dr. Len Walt. He is the VP of Medical at SSI Strategy in Toronto. Len will join your host Peter Brenders in conversation. But first, here is Mitch Shannon, CEO of Chronicle Companies
MITCH SHANNON (MS):
Medical Affairs personnel do not have the easiest jobs in pharma. For one thing, they routinely experience sounds like these:
*coughing and sneezing sound effects*
Dr. Len Walt has worked in medical affairs for companies such as GSK, Hoffman-LaRoche, Sanofi and Biogen, since graduating from medical school in South Africa in the 1980s. There is nothing that happens in a physician practice that could surprise him.
Here he is in discussion with Peter.
PETER BRENDERS (PB):
Welcome to the NPC Podcast. I'm Peter Brenders your host. In our continuing look at the purpose, process, and people in pharma in Canada, this episode takes a look into the world of medical in the pharmaceutical industry, and how that world complements what one may typically think of as pharma as sales and marketing. Joining us today is 30 year pharma medical executive, Dr. Len Walt, VP medical and SSI strategy. Welcome to the NPC Podcast, Len.
DR. LEN WALT (LW):
Good to be here Peter. Thank you.
So Len, your career has spanned a host of functions in pharma and biotech industry, from clinical research manager, medical adviser, medical director or even VP of research and development for these global pharma companies.
And I was thinking it might help our listeners if you could set the stage and describe what the many aspects of medical and pharma, I mean, are these just different titles for the same jobs?
It really depends on the company, whether it's a large company or a small company, whether it's an affiliate or a head office, but essentially, you've got, you know, your R&D Group, which does all the research, right, whether it's the basic research going into preclinical animal models, and then going into the clinical research side, which takes most of the time.
And coming out of that, you know, you may get an approved drug from a regulatory authority. And then the handover is to the commercial team, right. And that's will be the team that will sell the drug, and will engage with physicians on the characteristics of that drug. But in the middle, you have what's called medical affairs and medical affairs plays a key role in really bridging that gap between the research and development organization, and the commercial organization. And I'm assuming we're going to talk a little bit about the role of medical affairs. But essentially, you know, that's the continuum of research on the one end, and at the other end, you have the commercial engagement with the customers, both physicians and patient groups.
Okay, so it's not what people are usually thinking about in terms of just selling a drug, you're telling me it's bridging, and it differs by company, company size, or affiliate on that one.
So do all companies have all of these roles in Canada? Or is it like, what would you typically find out of a Canadian company? Does that depend on the company?
Right, so in a typical Canadian company, there are very large Canadian companies that have a research and development capability here within Canada. Now, that could be the clinical research piece, it could even include some of the basic research and preclinical animal model work as well. Typically, what you'll find with these large companies is that they have a few large R&D facilities around the world, you know, where the United States, Europe, and that's where a lot of the earlier research is conducted.
As we move into the clinical research phase, that's when what you could call affiliates of these big companies. So Canada would have an affiliate, that would represent Canada, and they would engage in clinical research. And this is quite common. And this is very important, because what you want to do is you want to engage Canadian investigators and experts in your clinical research activities, so that when the product does come out, they have some level of familiarity with having worked with that compound during the research and development process.
Okay, so when we get into beyond that research, development, clinical, we get into this medical affairs, let's start to dive into this a little bit, as well, as Canada, as these Canadian affiliates, or companies set up their domestic medical affairs. Is that kind of the same as all around the world? Do we just match the US in terms of our structure or is something a little bit different or unique to Canada and how we do this?
I think there's some subtle differences. But for the most part, the medical affairs function is pretty standard, whether it's Europe, North America, Canada, US and the function of medical affairs really, depending on the phase, but if you look at the pre launch phase, that's when the product has not been approved yet. But there is clinical data out there. The clinical studies may have been published. So physicians are aware of this compound that is being investigated in a specific disease.
Well, medical affairs is perfectly positioned with scientifically and medically qualified people to go and engage in discussions with the physicians on the science, talk about the data and they're able to do this because regulations allow them to engage in certain discussions in a pre-approval setting, certainly with investigators who both have been engaged in clinical trials, and are also asking questions about a new therapy that could be of use to their patients.
So medical affairs really is a very important connection between the organization and the external, we call them key opinion leaders, they could be investigators, they could be clinical experts, both physicians and nurse practitioners and the nursing community.
That connection is really important. I think it's important from a company perspective, because it develops solid scientific relationships with these folks, it's also important for the company that what you can do is you can collect key insights from these investigators. And that is going to help you understand the positioning of this product helps you understand the disease a little bit more.
And then there's benefits to the investigators and key opinion leaders themselves, because they are hearing from the company, the presentation of the data in a fact based, unbiased form, so that they really do understand what this data is telling them, and what it could potentially do for their patients.
And you talked a little bit about regulations decide what can be said. Can you tell us a little bit about those regulations in Canada is there clearly a definition that says you can only do X, Y and Z by certain people?
There are ways that medical can engage with external physicians, and they are ways that commercial can be engaged with and there are globally held principles about what can and cannot be done. But then there are more specifics about what exactly what can and cannot be done and how they can act with the external community at a country level. And there's some subtle differences, for example, between Canada and the United States. So typically, you want to have a clear separation between medical and commercial.
And there's a very good reason for this, because you want clarity around roles and responsibilities. You know, it's a business, and there are drugs that have been approved for specific indications. And so if a drug has been approved for a specific indication, then the sales team is able to go out there and speak about that specific indication under that approval, and speak to the data under which it was approved. And that is more of a proactive communication. They call it messaging, where you're really trying to communicate the features and benefits of your product. And it's essentially a selling role to physicians.
Medical does not sell, what medical does is medical provides scientific information that is of benefit to the physician so that they can more more appropriately utilize those products.
You’re listening to Dr. Len Walt on the NPC Podcast.
Just so I understand that so I get the benefit there. But does that suggest then that the sales team doesn't provide such information like that? Or is it just different information, I'm going to try to understand the difference between what medicals providing and I get the sales has a hey, right my drug aspect behind it, but is the information not similar.
So it can be quite similar. The guide book for the sales team is the approved label, right? Where it’s the approved product monograph or approved label, whatever that country calls that approved document and they cannot deviate from that document. Right, all information provided externally needs to come from the document because there is the approved document. Whereas medical has more flexibility. They will speak to the benefits of the product. But I always like to look at medical as going broader and going deeper than what the sales team does.
So what the sales team communicates is very specific, and it has parameters. Whereas medical can go, as I said, broader and deeper based on what the physician wants to understand. But there is you know, the medical team cannot go out there and just spread whatever I want to talk about this has to be done in a compliant fashion. And one of the key ways to do this is to do it in a reactive fashion.
So a physician will go to a, call it medical science liaisons, these are field based medical folks. And they will say, you know what, I'd like more information on this product, but in a different population that was studied in the trial. Can you provide that to me? Or has there been any additional safety data specifically on the safety aspect on this product? Or is there you know, what do you think about using this product, not in diabetes, but in hypertension, for example, was it studied in hypertension? And then the medical team is able to go in and engage in a discussion based on their request for additional information.
And how does that differ from med info?
So the way med info typically works is that there are what's called medical information requests or medical information request form, right? So that's a physician saying, hey, I want to know more about this. They may tell that to the sales rep. They may tell that to the MSL.
No matter where it goes to, that will be channeled through to medical information. And medical information may have what's called a standard response to that question, or they may have to do up a non standard response. And then that will be communicated a number of different ways they could send an email with attachments to their physician, or they can get the MSL to actually disseminate that information. So essentially, it's the same thing. But I think the difference is the MSL are field-based, they're face to face, and they actually engage in a dialogue with the physician, whereas medical information is done through the dissemination of standard response letters.
How do clinicians know the difference between that person in front of them, whether they can ask broad questions, or stuck to the label kind of question?
Well, I think many of them don't know the difference, to be perfectly honest with you. And because, number one, physicians are very busy, they got lots of patients, and they see numerous sales reps and MSLs, from many different companies, you know, so
I think certain physicians will know the difference based on the expertise and professionalism of those that are calling on it.
Makes for an interesting dynamic, I would think, within a company in terms of again, I get in terms of the skill set between whether it's a classic commercial rep versus a medical field person out there. But does that lead to tension within a company, do you think?
There's no question that there could well be a lot of tension between the commercial and the medical groups. And I've seen this in numerous companies that I've worked for. That's where the leadership comes into play to make this a productive relationship and not a counterproductive one.
You know, talking about the benefits of an effective relationship between medical and commercial has huge benefits both internally and externally. And this is very achievable. And you know, that has been one of the things that I focused on as a leader in medical affairs and in pharma to make that happen, because the benefits are tremendous for the company, and for KOLs out there. And I think this is achieved really with making sure that the two functions are collaborating on what they're doing, and they're in alignment with each other's plans.
So this goes towards sitting together at the same table, doing joint planning, but it's not a combined plan, as such. There is a specific medical component and there's a specific marketing or commercial component, but these plans are aligned. And there's ongoing communication between these two teams. But there is a very high awareness of the compliance that needs to be maintained between these two groups. So people know what they can and cannot do. They know where their responsibility begins and ends. But a collaborative relationship leads to great benefits.
So when you say compliance, so that's like, stay in your lane: medical, you don't sell, commercial, you don't go off label. Okay, so that makes some sense.
But what I'm hearing you say, though, because, you know, I've heard rumors that, you know, medical and commercial shall never come together because they could taint each other, or, frankly, medical could be tainted by commercial.
But what I'm hearing from you is “no, that doesn't make any sense.” It's like, there's nothing wrong with the two coming together and actually coordinating and collaborating so that you present a common face to the company to the product to whatever to the externalizes did I get to that, right?
I think it's essential that they come together, I think that it becomes a competitive advantage to the company, when their medical and commercial teams are working in lockstep.
To me, it's a no brainer, that this is exactly what needs to occur, it comes with a lot of heavy lifting, and a lot of strong leadership. You know, what you get typically, in any company is a little bit of territorialism, you know, holding on to “this is us, this is my customer, only I can speak to this customer.” And really, at the end of the day, there's enough, there's enough for everyone.
I think if it's done correctly, everyone wins, the company certainly wins, the physicians get true value from the company. And ultimately, the big winner at the end of the day is the patient that is receiving a therapy that is appropriate for their condition, and can hopefully, you know, lead to a better quality of life for that patient.
You’re listening to the NPC Podcast. I’m Peter Brenders, your host.
Let's do a future gaze here. I mean, the pandemic has changed a lot of interactions, like we've gone from in person face to face to remote zoom meetings and calls and I see both commercial and medical, has anything else fundamentally changing, do you think? I mean, what does the future of medical going to look like? What should it look like? you have any thoughts on that? Yeah, you know,
Yeah, I think, obviously, I'm hoping that we return to normalcy and that people are back, engaging face to face, I think it's really important. And I'm hopeful that that will happen. But I think beyond that, you know, what we’re seeing is, I believe a technical revolution in the pharma and biotech worlds,
I think we're seeing very sophisticated technologies coming in, we're seeing it in some of the bigger diseases, and we've seen a lot of it in the rare diseases
We're seeing exciting things like gene therapies coming, and digital therapeutics, I mean, these are all really exciting areas, but they're technologically quite sophisticated.
So, I think there will always be a role for sales, but I think the role of medical is going to become even more important as we move along this area of more sophistication around products and it will require companies with medical personnel that really understand the science to understand the technology and they can translate that into value for customers that need to understand this information.
In your sense is medical a reactive way to share that information or can medical be proactive and not to say “sales write my drug” but proactivity in the sense is selling science and information is that a an approach medical can deploy?
It is. So, if you look at you know when can medical actually go out there and provide information that currently doesn't exist in the sales reps bag, right? But if you break it up into safety and efficacy.
Safety number one, you know, Hippocratic Oath is do no harm right. So, if new safety information comes to the fore you know, once as we know clinical trials are done in a defined group of patients, right, but once it goes into the broader population, you know, things can happen, and certainly safety signals can occur. And so, if safety signals are seen and safety concerns arise, then absolutely medical team is obligated to go out there and inform physicians about new safety signals. So, safety is important.
On an efficacy perspective, ongoing research is done all the time, right? Like the phase three trial gets the approval, but then there's ongoing research looking at different questions. And that information comes out all the time, it may be presented at a conference, maybe a poster presentation at a conference, there may be a publication in a peer reviewed journal.
But from an efficacy point of view, then the medical team has an opportunity to go out and say, Hey, you know, we've just got some really interesting data hot off the press. And I think it's going to be important to you because it's relevant to you and your practice and your patients. So that is something that's unique to medical, commercial would never be able to do that. But medical has the ability to do that.
It's about bringing information that is needed and appropriate for those that are prescribing drugs to patients.
It's an interesting point, I want to dive on that just a little bit longer.
So, to your point, when these global medical conferences come out in their poster presentations, and abstracts and a whole bunch of new stuff that's been released out there, which would help a clinician be better informed on a particular product.
So, what I'm hearing you saying is like, not only can they, a smart company actually almost has an obligation to cascade that information out to the clinicians that may not have been at that conference, so that they understand sort of a greater breadth of information on a particular product.
That is what I'm saying. But at the same time, it's not as easy as that, right? Because as you know, you know, there could be a poster presentation that was done with five patients at one center with one physician, and that's presented. And so not all data is created equal. You cannot compare that to a publication in the New England Journal of Medicine or the Lancet. You know, it's two different ballgames.
Everything is risk benefit, right? You know, the benefit here is you're providing information, but the risk is that it could be seen as well, this isn't really robust scientific information, or is it that needed by physicians? Or are you just trying to do a sales job, or you're trying to expand the indication because this worked in, you know, five patients, you know, in some center around the world, so you need to be really careful about the decision making process.
And that's the role of leaders in the organization is how far are we prepared to go? Because everything is a risk benefit decision.
And the one other thing we haven't really spoken about, which is a very important component of the medical first group is ongoing research. If a physician would like to engage in an area of research, there's a process and it's called the investigator initiated trial and seen initiated by the investigator. So the company cannot solicit this in any shape or form. But as an investigator can go to an MSL and say, “you know what, I really want to test this drug in another indication.” And the company is able to facilitate that by providing a grant or providing drug or their research project and then that's another way to generate ongoing data in use in other populations or in other disease areas, but this is obviously the domain of medical and it's has to be done in the appropriate fashion that it's not seen as soliciting in any shape or form.
Which can again lead to that new information and the help sort of better patient care all around.
We've been speaking with Dr. Lin Walt on the NPC podcast. Thank you for listening.
Thanks to Len and Peter. If you want to know more about SSI Strategy, their website is www.sssistrategy.com.
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I’m Mitch Shannon of Chronicle Companies. Your Podcast Producer is Jeremy Visser and his assistant is Arija Empakeris. The announcer was Liona Desautels. The musical theme is performed with precision by the NPC Podcast Orchestra under the direction of Maestro Aegon Millbrook.
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