Hey, guys. Welcome to the podcast. I am very excited to have this very special guest, Mandy Crum, now to be with us. Mandy, how are you? Welcome to the podcast. I'm good. Thank you, Tom. Happy Friday, and, and thank you for having me on. Yeah. I'm on location. I'm here in Boca Raton, Florida. And this episode, wanna start by inviting you guys all to Fierce Pharma Engage. This episode is sponsored by Fierce Pharma. And if you're not familiar, Fierce Pharma Engage used to be Mass West.
It's in San Diego, and it's just a premier medical affairs event. However, this year, there are cross functional teams. So it's gonna include pharma marketing, PR communications, business development and licensing, and then, of course, medical affairs. So there's gonna be a whole medical affairs community and a whole section, a medical affairs track. I'm really excited. It's gonna be a bigger event, and it's gonna be, I just think, a great opportunity to network and to meet people.
It happens, April 29 to May 1, again, in San Diego. For more information, go to Fierce Pharma Engage twenty twenty five. There's even complimentary passes. So for medical affairs professionals that wanna commit to participating in one on one meetings, you can actually go for free. So check that all out. First Farm Engage twenty twenty five, and I will see you there because I will definitely be there.
So Mandy, are you excited to talk about so, guys, what we're gonna talk about is, the name of this episode is so far to come, so far to go. Mhmm. And what we're gonna talk about today is, value and impact of medical affairs. And when it comes to that, I guess the first question I have for you, Mandy, is how far have we actually come when it comes to value? Yeah. No. So thanks, Tom. And I think it's a great question.
You know, if I look at the kind of totality of my career, over the past fifteen years, you know, the medical affairs has shifted significantly. When I started around 02/2007, '2 thousand '8, historically, medical affairs has really been been seen as a as a support function. You may have a few MSLs in the field, you know, an in house medical information, person or two as well as a a medical director.
And, really, you know, we were coming from the mindset of really being kind of a reactive function. You know, commercial gets an off label question. They'll filter it to MedInfo, or they'll filter it filter it to the MSL. And what I've seen in this fifteen years is really a shift to a more strategic mindset.
And you have the emergence of capabilities, more strategic capabilities, you know, such as evidence generation, really medical affairs being responsible for, you know, a lot of phase four evidence and post marketing evidence as well as well as, investigator initiated trials.
Also, medical communications, you'll see a lot of medical affairs organizations really with the emergence of a medical communication function, really kinda helping shape the narrative, the medical and scientific narrative of the asset. And so when you think about, you know, where it's come over the past fifteen or seventeen years, you've really seen a shift towards a more strategic mindset. But I as far as we've come, I still think we have a ways to go.
Yeah. Well and it's when in pharma, I guess, anybody that's been around long enough, like, pharma doesn't do anything quickly. It it it's it's like moving and turning trying to turn the Titanic. It's just it takes it's a slow progression. But we have seen and to your point, we've seen a lot of progress. So what would you say has led to the progress and the evolution of medical affairs? I think a number of factors kind of both intrinsically, to the company and extrinsically.
I'll touch on the latter first. I I think extrinsically, what we've seen is really the proliferation of health care information. I mean, if you look at the amount of information that HCPs and organizations have available at their fingertips, it really grows exponentially every day and every year. So there's a need to really kinda cut through some of that noise and distill down, alright, what's important for me to really kinda take to my patient and what's gonna inform patient care?
I think secondly, you also have the emergence of of more complex therapies if you're thinking back to, you know, the emergence of biologics in the late nineties and early two thousands. And recently, you know, the emergence in the early twenty twenties of of cell and gene therapy, you really have more complex, you know, ways to treat patients and, in more complex therapies. So there's also more of a consultative approach that's needed, when you're speaking to HCPs.
And then I think intrinsically, you have leaders who are probably responding to, you know, a little bit, a pressure from the business and also leaders who have a more strategic capability and more strategic mindset to say, hey. You know, we can deliver more value in medical affairs, so let's start to shape what that function becomes and be a more of a strategic partner at the table. Yeah. I love that. And I think, it's it's just it shows and you you had mentioned this. Right?
And I wanted to talk to you about this. But one of the words that you used or terms that you used when we talked prior was true impact. Yeah. Can you explain what that means? Because I think we're getting into that, like, area, and I wanna talk about that a little bit. What does true impact mean?
Yeah. No. You know, if I look at myself as a medical affairs leader and, you know, and and the positions that medical affairs leaders are in, it is really you know, historically, we've operated from kind of this transactional reactive mindset. And as far as we've come strategically, I think that there's a ways to go in terms of, alright, how can we really impact patient care? There's a McKinsey article that I'm sure that many of the listeners and readers have have seen.
It's basically shaping the vision of medical affairs in 02/1930. And one point good point that the authors make is, alright. What if medical affairs leaders not saw not medical affairs as a function, but really the business unit that is responsible for shaping outcomes? So we've we're we're we have a seat at the table in terms of being a strategic partner. But in terms of are we really thinking as leaders about how do we impact the patient?
How do we impact the care of the patient and patient outcomes. It's a subtle shift, but it's more of a proactive mindset looking at, alright. What are we doing for the patient, and how does that kinda connect to back to the needs of the business unit? And and how what opportunity do we have to really kinda shape patient outcomes? It's a subtle shift, but also a significant shift in mindset. Yeah. For sure.
And so and I know that that's that's sometimes that's always the goal, but I think that sometimes everybody gets so caught up in metrics. Yeah. And their strategic objectives, which force us to do force us into activity. Yeah. And we know that that activity is all to lead to better patient outcomes. Can you give examples of how medical affairs has truly delivered impact when it comes to all these things that we're talking about? Yeah. Think there are some great examples.
I think a a couple are you know, if you're looking at patients with rare disease, it can take patients with rare diseases up to four or five years to get accurately diagnosed. They cycle between multiple specialists and subspecialists, you know, and bounce back and forth between care providers until, you know, four or five years into their disease, you know, kind of the light bulb moment goes off and and they receive an accurate diagnosis.
Shortening that time to diagnosis and having an intervention such as such as education that really informs providers around what are we looking for, you know, when we diagnose in a certain, you know, rare disease and a patient is presenting in front of us? Any intervention to kinda close that gap, and shorten that window can really significantly impact, patient care.
If you're thinking about, you know, the time around four or five years, you're a patient could be losing when they could be, you know, accurately when they could be accurately diagnosed and being treated. A second one is that, you know, establishment of patient registries. There are diseases out there, a number of number of them, with significant unmet medical need and also with which have literal natural history data.
So a number of medical affairs organizations are doing things like establishing patient registries that informs us of the natural history of a patient and how they and how they fare over time. Another one is the establishment of patient registries. If you're thinking about there are many a number of conditions out there with significant unmet medical need and which have little natural history data available.
So we don't know how a patient, an untreated patient, fares over the long term of their disease course. And if you're a number of medical affairs or organizations are establishing patient registries, which demonstrates how those patients fare over time. And oftentimes, these natural history patient registries are being used as surrogates in a registrational trial for untreated patients. So there are a number of of ways that you can really impact patient care.
A lot of these, you know, it's really hard. It can be really difficult to measure the impact of any one intervention. But a lot of these can really serve as surrogates to demonstrate, alright. How have we improved patient outcomes? Outcomes? I think I think AI is gonna help. Mhmm. And I think that having going into this digital era that we're in Yeah. What we're already in it. But I just think that being able to organize Mhmm.
The data Yeah. Keep track of the data and compartmentalize the data in a much quicker way is is going to help. I think our capabilities are just gonna skyrocket because of AI. We've already seen it. Yeah. But I think that that's the next evolution. That's just gonna make us better.
It's gonna make medical affairs better equipped to truly make an impact because we are we're doing a better job in in tracking the data and the information and knowing what to to do to utilize it and really show the value. But what would you say are some of the challenges and roadblocks that medical affairs might face in as we get into as we start to move into the future a little bit?
Yeah. I think as as with any business, you know, it really can find if you're if you're thinking about shifting a mindset, particularly in a large organization where you have a number of people and processes in place that really determine the end that you get to, it can really be hard to kinda take a step back and take a moment to say, alright. How do we shift our mindset to rethink about how we're delivering care to patients and patients and and how we have impact.
You know, I think for many people, often, you know, the the the path of least resistance is the one that's most familiar. And I think if unless you're really starting from scratch and building an organization, it can be difficult to say, alright. We need to take a beat and take a moment to to really think rethink the way that we do things and reverse engineer the processes and the mindsets to shift the way that we think about, impacting how the the outcomes that we're having with patients.
What's next for medical affairs? Like, what do you think needs to happen to move things further into the right direction? Yeah. Yeah. And this is a good question. I think that, you know, historically, if we're looking at you know, I can point to any medical affairs function. It can be medical strategy. It can be, you know, field medical. It can be medical communications. And almost every JD, you'll see, you know, PharmD, PhD, MD required. And and that is is often the goal.
I think that that will really just start to serve kind of as a foundational element and maybe not even a necessary element in all cases. But you'll start to see medical affairs leaders hire for different capabilities in in terms of thinking, alright. Does this candidate have the capability to look at what they're doing, how it impacts patient care, and tie that back to the needs of the organization.
So I think as we're really evolving over, I would say, the next five to ten years, you'll really start to see an emergence of candidates hired for different capabilities than what they may have historically been hired for. You know, you're taking a you're shifting from, alright. Can this person memorize, you know, you know, all of this information at their fingertips and regurgitate it to an HCP to alright.
Do they have strategic mindset in being able to tie impact back to the needs of the business and their work? Well, I think first off, that's a great message. There's a lot of people listening to this that, that may be interviewing right now. There's job seekers out there. Yep. And I think you bring up a really good point that we try to stress a lot.
I know in my coaching program, I we try to stress the importance of leading with your strengths and make sure that you're expressing and fully showing the value that you bring to the organization and how you can best be utilized as an impactful player. So you just hit the nail on the head. There people may get hired for different things. Yeah. What's your thing? What are you a subject matter expert in? What are you best at?
And make sure that as you're interviewing, that comes out because that's what's gonna differentiate you and separate you from some of the other people that you're interviewing with or interviewing against. How let me ask you this, though. How far off do you think medical affairs is from having a seat at the executive table as we talk about the business side? Yeah. I think we're only as far away as as leaders who make the moment.
You know, leaders tying back to the McKinsey article in terms of what have you thought about medical affairs as a business unit that is responsible for improving patient outcomes versus just a function. I think we're only as far as leaders who kinda meet that moment and can shift their mindset to more of an enterprise leadership capacity.
There are a number of examples, and I won't mention which organizations, in which, you know, the head of medical affairs has a seat at, has a seat at the executive leadership table. You know, they're chief medical affairs officer. And so there are people who have really, you know, elevated profile and capability of medical affairs to drive value at the leadership at the executive level. Yeah. You know, it's funny.
I had a conversation with a leader on the commercial side who was telling me, who's who's an old timer. He's been around for a long time and was telling me how amazing he because he's noticed the evolution and the progress that that medical affairs has made since he's been Yeah. A leader. And he's also very he's one of these guys that is very medical affairs centric. He's a commercial guy that has always developed strong partnerships with his medical affairs counterparts.
But he was we were literally just having this conversation, like, this week about how far medical affairs has come and, how important the function is for the organization strategically. We talk about patient care and you know? But to hear that from the commercial side, from such a heavy hitter, I thought it was really interesting. And maybe he was telling me he was mentioning that to me because I'm so entrenched in medical affairs, but he seemed very genuine about it. So, let me ask you this.
What else do you think is important for let's talk about medical affairs leaders Yeah. For a second in this day and age. I think there are it's a good question. I think that a few things really kinda come top of mind, Tom. Number one is that the only thing that's constant in in our industry is change. You know? There are organizations shift from, you know, changes in priorities of development programs.
You know, you'll have development programs that have a negative data readout, and it's a no go from, you know, to phase three development. And, also, there are just natural ebbs and flows in our industry that are impacted by factors much broader than anything that we can control. It's, you know, factors in, you know, policy making. It's factors in, you know, regulatory environments. A lot of things that that are really beyond the bounds of our control.
And I think as leaders, we really need to lead from a perspective of, you know, instilling resilience into our teams and into our people, and also having kind of the personal resilience to, you know, really pick pick back up when things don't go your way and say, alright. How am I? What am I taking into the next role, and and how can I lead better?
And then also, you know, I think one of the things that's really been impressed upon me the past few years is to lead with a lens of patient centricity. You know, I think that my time in rare disease has really reshaped my why and really kind of forced me to reckon with, why am I doing this? And I think that time in rare disease will do that because you often know the patients and the families on the other side of what you're doing.
And I think to lead with a lens of patient centricity is tremendously important to ensure that you're driving to the route right outcomes. And so that's really the two factors that I would impress upon medical affairs leaders and professionals. Number one, resilience, and number two, patient centricity. Is there anything you wanna say to, we talked about leaders.
Is there anything you wanna say to the MSL community, the the field based MSL that's out there, and they're grinding every day, and they're trying to make impact? And what what message do you have for those guys? I think a a couple of things. You know, number one, focus on building partnerships. Really, where are where can you build, and where are the opportunities to build partnerships with your HCPs and the broader health care community?
And one of one of the things that I often like to talk about is, you know, medical affairs is really kind of now best positioned to to deal with the stakeholders, the wide variety of stakeholders across the health care ecosystem. So if you're an MSL in the field thinking you know, I'd encourage you to think about, alright. How can I build partnerships, with the people that I'm working with and with the different stakeholders that I'm engaged with?
That goes well beyond relationships, and that goes well beyond, you know, Doctor. Caravella. How can I how can I answer you know, what questions do you have? And it it goes to, you know, alright, doctor Caravella. Let's talk about the opportunities, and and the ways that we can work together.
And then also really approach your role with a mindset of curiosity, understanding the the challenges of the people that you're working with, you know, your fellow teammates, get to know the functions and people that work outside of medical affairs and their challenges. And, also, you know, I think number number three, which is really important to me, is is to give back. You know, I've been lucky to have a long career over the course of seventeen years in this industry.
And, you know, had I looked at the, you know, the 25 year old Mandy coming out of pharmacy school, I don't think that I ever would have envisioned, the opportunities that I have now. So pay it forward. Invest in the next generation of, you know, the PhD scientist or the PharmD student that has aspirations, you know, to go into industry. Invest in their development and invest in their growth and give people the same opportunity that was given to you. I love it. That's such great advice.
It's a great way to kind of round out this conversation because we no. We're talking about medical affairs and value and impact, but one of the greatest things that we can do as individuals is to help others to grow and develop. I was at a a conference last week, and and one of the guys I was with said, one of the speakers said, be the best part of someone else's day. Yep. And that was one of those things that I pulled away.
Like, coming out of that meeting, I'm like, man, that's such a great reminder. So I I that ties right into what you were just saying. Yep. In in helping others, elevating others. Because when we elevate others, you know, as a group, medical affairs is gonna get elevated. So I love that. Well, Mandy, thank you for being here. You're awesome. So much fun. Thank you, Tom. Thanks for the opportunity. Hey, guys. Thank you for joining us.
And, as always, if you got value out of this, please share it with others and then come back next time. We love to see you. We appreciate all your support of the show. See you guys soon. Love you all. Thanks, Tom.