April 8, 2025 • 24 mins
In this episode, Tom Caravela and Mandy Krumnow explore the evolving landscape of medical affairs, highlighting its value and impact. They discuss what constitutes "true impact" within the field, supported by case studies showcasing successful initiatives. The conversation covers technological advancements and the challenges medical affairs faces, as well as future trends. Mandy shares insightful interview tips for candidates and emphasizes the influence of medical affairs in corporate decision-making. The episode also offers leadership advice for professionals in the field, concluding with encouraging words for the MSL community and expressions of gratitude.
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Episode Transcript
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(00:02):
Hey, guys.
Welcome to the podcast.
I am very excited to have this very specialguest, 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 meon.
Yeah.
I'm on location.
I'm here in Boca Raton, Florida.
And this episode, wanna start by inviting youguys all to Fierce Pharma Engage.
(00:26):
This episode is sponsored by Fierce Pharma.
And if you're not familiar, Fierce PharmaEngage used to be Mass West.
It's in San Diego, and it's just a premiermedical affairs event.
However, this year, there are cross functionalteams.
So it's gonna include pharma marketing, PRcommunications, business development and
(00:49):
licensing, and then, of course, medicalaffairs.
So there's gonna be a whole medical affairscommunity and a whole section, a medical
affairs track.
I'm really excited.
It's gonna be a bigger event, and it's gonnabe, I just think, a great opportunity to
network and to meet people.
It happens, April 29 to May 1, again, in SanDiego.
(01:13):
For more information, go to Fierce PharmaEngage twenty twenty five.
There's even complimentary passes.
So for medical affairs professionals that wannacommit 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 Iwill 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
(01:40):
of this episode is so far to come, so far togo.
Mhmm.
And what we're gonna talk about today is, valueand impact of medical affairs.
And when it comes to that, I guess the firstquestion I have for you, Mandy, is how far have
we actually come when it comes to value?
Yeah.
No.
So thanks, Tom.
(02:00):
And I think it's a great question.
You know, if I look at the kind of totality ofmy career, over the past fifteen years, you
know, the medical affairs has shiftedsignificantly.
When I started around 02/2007, '2 thousand '8,historically, medical affairs has really been
been seen as a as a support function.
(02:21):
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 themindset of really being kind of a reactive
function.
You know, commercial gets an off labelquestion.
They'll filter it to MedInfo, or they'll filterit filter it to the MSL.
(02:45):
And what I've seen in this fifteen years isreally 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 affairsbeing responsible for, you know, a lot of phase
four evidence and post marketing evidence aswell as well as, investigator initiated trials.
(03:09):
Also, medical communications, you'll see a lotof medical affairs organizations really with
the emergence of a medical communicationfunction, really kinda helping shape the
narrative, the medical and scientific narrativeof the asset.
And so when you think about, you know, whereit's come over the past fifteen or seventeen
(03:32):
years, you've really seen a shift towards amore strategic mindset.
But I as far as we've come, I still think wehave a ways to go.
Yeah.
Well and it's when in pharma, I guess, anybodythat's been around long enough, like, pharma
doesn't do anything quickly.
It it it's it's like moving and turning tryingto turn the Titanic.
(03:55):
It's just it takes it's a slow progression.
But we have seen and to your point, we've seena lot of progress.
So what would you say has led to the progressand the evolution of medical affairs?
I think a number of factors kind of bothintrinsically, to the company and
extrinsically.
(04:15):
I'll touch on the latter first.
I I think extrinsically, what we've seen isreally the proliferation of health care
information.
I mean, if you look at the amount ofinformation that HCPs and organizations have
available at their fingertips, it really growsexponentially every day and every year.
(04:36):
So there's a need to really kinda cut throughsome of that noise and distill down, alright,
what's important for me to really kinda take tomy patient and what's gonna inform patient
care?
I think secondly, you also have the emergenceof of more complex therapies if you're thinking
back to, you know, the emergence of biologicsin the late nineties and early two thousands.
(05:02):
And recently, you know, the emergence in theearly twenty twenties of of cell and gene
therapy, you really have more complex, youknow, ways to treat patients and, in more
complex therapies.
So there's also more of a consultative approachthat's needed, when you're speaking to HCPs.
(05:28):
And then I think intrinsically, you haveleaders who are probably responding to, you
know, a little bit, a pressure from thebusiness and also leaders who have a more
strategic capability and more strategic mindsetto say, hey.
(05:48):
You know, we can deliver more value in medicalaffairs, so let's start to shape what that
function becomes and be a more of a strategicpartner at the table.
Yeah.
I love that.
And I think, it's it's just it shows and youyou had mentioned this.
(06:10):
Right?
And I wanted to talk to you about this.
But one of the words that you used or termsthat 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?
(06:32):
Yeah.
No.
You know, if I look at myself as a medicalaffairs 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 transactionalreactive mindset.
(06:55):
And as far as we've come strategically, I thinkthat 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 thatmany of the listeners and readers have have
seen.
It's basically shaping the vision of medicalaffairs in 02/1930.
(07:17):
And one point good point that the authors makeis, alright.
What if medical affairs leaders not saw notmedical affairs as a function, but really the
business unit that is responsible for shapingoutcomes?
So we've we're we're we have a seat at thetable in terms of being a strategic partner.
But in terms of are we really thinking asleaders about how do we impact the patient?
(07:43):
How do we impact the care of the patient andpatient outcomes.
It's a subtle shift, but it's more of aproactive mindset looking at, alright.
What are we doing for the patient, and how doesthat kinda connect to back to the needs of the
business unit?
And and how what opportunity do we have toreally kinda shape patient outcomes?
(08:07):
It's a subtle shift, but also a significantshift in mindset.
Yeah.
For sure.
And so and I know that that's that's sometimesthat's always the goal, but I think that
sometimes everybody gets so caught up inmetrics.
Yeah.
And their strategic objectives, which force usto do force us into activity.
(08:32):
Yeah.
And we know that that activity is all to leadto better patient outcomes.
Can you give examples of how medical affairshas 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'relooking at patients with rare disease, it can
(08:58):
take patients with rare diseases up to four orfive years to get accurately diagnosed.
They cycle between multiple specialists andsubspecialists, 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 offand and they receive an accurate diagnosis.
(09:19):
Shortening that time to diagnosis and having anintervention such as such as education that
really informs providers around what are welooking for, you know, when we diagnose in a
certain, you know, rare disease and a patientis presenting in front of us?
Any intervention to kinda close that gap, andshorten that window can really significantly
(09:43):
impact, patient care.
If you're thinking about, you know, the timearound 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, establishmentof patient registries.
(10:05):
There are diseases out there, a number ofnumber of them, with significant unmet medical
need and also with which have literal naturalhistory data.
So a number of medical affairs organizationsare doing things like establishing patient
registries that informs us of the naturalhistory of a patient and how they and how they
(10:31):
fare over time.
Another one is the establishment of patientregistries.
If you're thinking about there are many anumber of conditions out there with significant
unmet medical need and which have littlenatural history data available.
So we don't know how a patient, an untreatedpatient, fares over the long term of their
(10:53):
disease course.
And if you're a number of medical affairs ororganizations are establishing patient
registries, which demonstrates how thosepatients fare over time.
And oftentimes, these natural history patientregistries are being used as surrogates in a
(11:16):
registrational trial for untreated patients.
So there are a number of of ways that you canreally impact patient care.
A lot of these, you know, it's really hard.
It can be really difficult to measure theimpact of any one intervention.
(11:39):
But a lot of these can really serve assurrogates 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 digitalera that we're in Yeah.
What we're already in it.
But I just think that being able to organizeMhmm.
(12:03):
The data
Yeah.
Keep track of the data and compartmentalize thedata in a much quicker way is is going to help.
I think our capabilities are just gonnaskyrocket 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 equippedto truly make an impact because we are we're
(12:29):
doing a better job in in tracking the data andthe information and knowing what to to do to
utilize it and really show the value.
But what would you say are some of thechallenges and roadblocks that medical affairs
might face in as we get into as we start tomove into the future a little bit?
(12:49):
Yeah.
I think as as with any business, you know, itreally can find if you're if you're thinking
about shifting a mindset, particularly in alarge organization where you have a number of
people and processes in place that reallydetermine the end that you get to, it can
really be hard to kinda take a step back andtake a moment to say, alright.
(13:13):
How do we shift our mindset to rethink abouthow we're delivering care to patients and
patients and and how we have impact.
You know, I think for many people, often, youknow, the the the path of least resistance is
the one that's most familiar.
And I think if unless you're really startingfrom scratch and building an organization, it
(13:37):
can be difficult to say, alright.
We need to take a beat and take a moment to toreally think rethink the way that we do things
and reverse engineer the processes and themindsets to shift the way that we think about,
impacting how the the outcomes that we'rehaving with patients.
(13:57):
What's next for medical affairs?
Like, what do you think needs to happen to movethings further into the right direction?
Yeah.
Yeah.
And this is a good question.
I think that, you know, historically, if we'relooking at you know, I can point to any medical
affairs function.
It can be medical strategy.
(14:17):
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 toserve kind of as a foundational element and
(14:38):
maybe not even a necessary element in allcases.
But you'll start to see medical affairs leadershire for different capabilities in in terms of
thinking, alright.
Does this candidate have the capability to lookat what they're doing, how it impacts patient
(14:59):
care, and tie that back to the needs of theorganization.
So I think as we're really evolving over, Iwould say, the next five to ten years, you'll
really start to see an emergence of candidateshired for different capabilities than what they
may have historically been hired for.
(15:21):
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 totie impact back to the needs of the business
(15:43):
and their work?
Well, I think first off, that's a greatmessage.
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 pointthat we try to stress a lot.
I know in my coaching program, I we try tostress the importance of leading with your
(16:03):
strengths and make sure that you're expressingand fully showing the value that you bring to
the organization and how you can best beutilized as an impactful player.
So you just hit the nail on the head.
There people may get hired for differentthings.
Yeah.
What's your thing?
What are you a subject matter expert in?
(16:25):
What are you best at?
And make sure that as you're interviewing, thatcomes out because that's what's gonna
differentiate you and separate you from some ofthe 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 isfrom having a seat at the executive table as we
(16:45):
talk about the business side?
Yeah.
I think we're only as far away as as leaderswho make the moment.
You know, leaders tying back to the McKinseyarticle in terms of what have you thought about
medical affairs as a business unit that isresponsible for improving patient outcomes
versus just a function.
I think we're only as far as leaders who kindameet that moment and can shift their mindset to
(17:11):
more of an enterprise leadership capacity.
There are a number of examples, and I won'tmention which organizations, in which, you
know, the head of medical affairs has a seatat, has a seat at the executive leadership
table.
You know, they're chief medical affairsofficer.
And so there are people who have really, youknow, elevated profile and capability of
(17:35):
medical affairs to drive value at theleadership at the executive level.
Yeah.
You know, it's funny.
I had a conversation with a leader on thecommercial side who was telling me, who's who's
an old timer.
He's been around for a long time and wastelling me how amazing he because he's noticed
(17:58):
the evolution and the progress that thatmedical affairs has made since he's been Yeah.
A leader.
And he's also very he's one of these guys thatis very medical affairs centric.
He's a commercial guy that has always developedstrong partnerships with his medical affairs
counterparts.
But he was we were literally just having thisconversation, like, this week about how far
(18:21):
medical affairs has come and, how important thefunction is for the organization strategically.
We talk about patient care and you know?
But to hear that from the commercial side, fromsuch a heavy hitter, I thought it was really
interesting.
And maybe he was telling me he was mentioningthat to me because I'm so entrenched in medical
(18:44):
affairs, but he seemed very genuine about it.
So, let me ask you this.
What else do you think is important for let'stalk 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 topof mind, Tom.
(19:05):
Number one is that the only thing that'sconstant 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 thathave a negative data readout, and it's a no go
from, you know, to phase three development.
(19:26):
And, also, there are just natural ebbs andflows in our industry that are impacted by
factors much broader than anything that we cancontrol.
It's, you know, factors in, you know, policymaking.
It's factors in, you know, regulatoryenvironments.
A lot of things that that are really beyond thebounds of our control.
(19:51):
And I think as leaders, we really need to leadfrom 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 whenthings don't go your way and say, alright.
(20:12):
How am I?
What am I taking into the next role, and andhow can I lead better?
And then also, you know, I think one of thethings that's really been impressed upon me the
past few years is to lead with a lens ofpatient centricity.
You know, I think that my time in rare diseasehas really reshaped my why and really kind of
(20:37):
forced me to reckon with, why am I doing this?
And I think that time in rare disease will dothat because you often know the patients and
the families on the other side of what you'redoing.
And I think to lead with a lens of patientcentricity is tremendously important to ensure
(20:59):
that you're driving to the route rightoutcomes.
And so that's really the two factors that Iwould impress upon medical affairs leaders and
professionals.
Number one, resilience, and number two, patientcentricity.
Is there anything you wanna say to, we talkedabout leaders.
(21:20):
Is there anything you wanna say to the MSLcommunity, the the field based MSL that's out
there, and they're grinding every day, andthey're trying to make impact?
And what what message do you have for thoseguys?
I think a a couple of things.
You know, number one, focus on buildingpartnerships.
(21:40):
Really, where are where can you build, andwhere are the opportunities to build
partnerships with your HCPs and the broaderhealth care community?
And one of one of the things that I often liketo talk about is, you know, medical affairs is
really kind of now best positioned to to dealwith the stakeholders, the wide variety of
(22:05):
stakeholders across the health care ecosystem.
So if you're an MSL in the field thinking youknow, I'd encourage you to think about,
alright.
How can I build partnerships, with the peoplethat I'm working with and with the different
stakeholders that I'm engaged with?
That goes well beyond relationships, and thatgoes well beyond, you know, Doctor.
Caravella.
How can I how can I answer you know, whatquestions do you have?
(22:28):
And it it goes to, you know, alright, doctorCaravella.
Let's talk about the opportunities, and and theways that we can work together.
And then also really approach your role with amindset of curiosity, understanding the the
(22:49):
challenges of the people that you're workingwith, you know, your fellow teammates, get to
know the functions and people that work outsideof medical affairs and their challenges.
And, also, you know, I think number numberthree, which is really important to me, is is
to give back.
You know, I've been lucky to have a long careerover the course of seventeen years in this
(23:14):
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 haveenvisioned, the opportunities that I have now.
So pay it forward.
Invest in the next generation of, you know, thePhD scientist or the PharmD student that has
(23:38):
aspirations, you know, to go into industry.
Invest in their development and invest in theirgrowth 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 thisconversation because we no.
We're talking about medical affairs and valueand impact, but one of the greatest things that
(23:59):
we can do as individuals is to help others togrow and develop.
I was at a a conference last week, and and oneof the guys I was with said, one of the
speakers said, be the best part of someoneelse's day.
Yep.
And that was one of those things that I pulledaway.
Like, coming out of that meeting, I'm like,man, that's such a great reminder.
(24:21):
So I I that ties right into what you were justsaying.
Yep.
In in helping others, elevating others.
Because when we elevate others, you know, as agroup, 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.
(24:41):
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.
Hey, guys.
Welcome to the podcast.
I am very excited to have this very specialguest, 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 meon.
Yeah.
I'm on location.
I'm here in Boca Raton, Florida.
And this episode, wanna start by inviting youguys all to Fierce Pharma Engage.
(00:26):
This episode is sponsored by Fierce Pharma.
And if you're not familiar, Fierce PharmaEngage used to be Mass West.
It's in San Diego, and it's just a premiermedical affairs event.
However, this year, there are cross functionalteams.
So it's gonna include pharma marketing, PRcommunications, business development and
(00:49):
licensing, and then, of course, medicalaffairs.
So there's gonna be a whole medical affairscommunity and a whole section, a medical
affairs track.
I'm really excited.
It's gonna be a bigger event, and it's gonnabe, I just think, a great opportunity to
network and to meet people.
It happens, April 29 to May 1, again, in SanDiego.
(01:13):
For more information, go to Fierce PharmaEngage twenty twenty five.
There's even complimentary passes.
So for medical affairs professionals that wannacommit 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 Iwill 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
(01:40):
of this episode is so far to come, so far togo.
Mhmm.
And what we're gonna talk about today is, valueand impact of medical affairs.
And when it comes to that, I guess the firstquestion I have for you, Mandy, is how far have
we actually come when it comes to value?
Yeah.
No.
So thanks, Tom.
(02:00):
And I think it's a great question.
You know, if I look at the kind of totality ofmy career, over the past fifteen years, you
know, the medical affairs has shiftedsignificantly.
When I started around 02/2007, '2 thousand '8,historically, medical affairs has really been
been seen as a as a support function.
(02:21):
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 themindset of really being kind of a reactive
function.
You know, commercial gets an off labelquestion.
They'll filter it to MedInfo, or they'll filterit filter it to the MSL.
(02:45):
And what I've seen in this fifteen years isreally 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 affairsbeing responsible for, you know, a lot of phase
four evidence and post marketing evidence aswell as well as, investigator initiated trials.
(03:09):
Also, medical communications, you'll see a lotof medical affairs organizations really with
the emergence of a medical communicationfunction, really kinda helping shape the
narrative, the medical and scientific narrativeof the asset.
And so when you think about, you know, whereit's come over the past fifteen or seventeen
(03:32):
years, you've really seen a shift towards amore strategic mindset.
But I as far as we've come, I still think wehave a ways to go.
Yeah.
Well and it's when in pharma, I guess, anybodythat's been around long enough, like, pharma
doesn't do anything quickly.
It it it's it's like moving and turning tryingto turn the Titanic.
(03:55):
It's just it takes it's a slow progression.
But we have seen and to your point, we've seena lot of progress.
So what would you say has led to the progressand the evolution of medical affairs?
I think a number of factors kind of bothintrinsically, to the company and
extrinsically.
(04:15):
I'll touch on the latter first.
I I think extrinsically, what we've seen isreally the proliferation of health care
information.
I mean, if you look at the amount ofinformation that HCPs and organizations have
available at their fingertips, it really growsexponentially every day and every year.
(04:36):
So there's a need to really kinda cut throughsome of that noise and distill down, alright,
what's important for me to really kinda take tomy patient and what's gonna inform patient
care?
I think secondly, you also have the emergenceof of more complex therapies if you're thinking
back to, you know, the emergence of biologicsin the late nineties and early two thousands.
(05:02):
And recently, you know, the emergence in theearly twenty twenties of of cell and gene
therapy, you really have more complex, youknow, ways to treat patients and, in more
complex therapies.
So there's also more of a consultative approachthat's needed, when you're speaking to HCPs.
(05:28):
And then I think intrinsically, you haveleaders who are probably responding to, you
know, a little bit, a pressure from thebusiness and also leaders who have a more
strategic capability and more strategic mindsetto say, hey.
(05:48):
You know, we can deliver more value in medicalaffairs, so let's start to shape what that
function becomes and be a more of a strategicpartner at the table.
Yeah.
I love that.
And I think, it's it's just it shows and youyou had mentioned this.
(06:10):
Right?
And I wanted to talk to you about this.
But one of the words that you used or termsthat 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?
(06:32):
Yeah.
No.
You know, if I look at myself as a medicalaffairs 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 transactionalreactive mindset.
(06:55):
And as far as we've come strategically, I thinkthat 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 thatmany of the listeners and readers have have
seen.
It's basically shaping the vision of medicalaffairs in 02/1930.
(07:17):
And one point good point that the authors makeis, alright.
What if medical affairs leaders not saw notmedical affairs as a function, but really the
business unit that is responsible for shapingoutcomes?
So we've we're we're we have a seat at thetable in terms of being a strategic partner.
But in terms of are we really thinking asleaders about how do we impact the patient?
(07:43):
How do we impact the care of the patient andpatient outcomes.
It's a subtle shift, but it's more of aproactive mindset looking at, alright.
What are we doing for the patient, and how doesthat kinda connect to back to the needs of the
business unit?
And and how what opportunity do we have toreally kinda shape patient outcomes?
(08:07):
It's a subtle shift, but also a significantshift in mindset.
Yeah.
For sure.
And so and I know that that's that's sometimesthat's always the goal, but I think that
sometimes everybody gets so caught up inmetrics.
Yeah.
And their strategic objectives, which force usto do force us into activity.
(08:32):
Yeah.
And we know that that activity is all to leadto better patient outcomes.
Can you give examples of how medical affairshas 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'relooking at patients with rare disease, it can
(08:58):
take patients with rare diseases up to four orfive years to get accurately diagnosed.
They cycle between multiple specialists andsubspecialists, 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 offand and they receive an accurate diagnosis.
(09:19):
Shortening that time to diagnosis and having anintervention such as such as education that
really informs providers around what are welooking for, you know, when we diagnose in a
certain, you know, rare disease and a patientis presenting in front of us?
Any intervention to kinda close that gap, andshorten that window can really significantly
(09:43):
impact, patient care.
If you're thinking about, you know, the timearound 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, establishmentof patient registries.
(10:05):
There are diseases out there, a number ofnumber of them, with significant unmet medical
need and also with which have literal naturalhistory data.
So a number of medical affairs organizationsare doing things like establishing patient
registries that informs us of the naturalhistory of a patient and how they and how they
(10:31):
fare over time.
Another one is the establishment of patientregistries.
If you're thinking about there are many anumber of conditions out there with significant
unmet medical need and which have littlenatural history data available.
So we don't know how a patient, an untreatedpatient, fares over the long term of their
(10:53):
disease course.
And if you're a number of medical affairs ororganizations are establishing patient
registries, which demonstrates how thosepatients fare over time.
And oftentimes, these natural history patientregistries are being used as surrogates in a
(11:16):
registrational trial for untreated patients.
So there are a number of of ways that you canreally impact patient care.
A lot of these, you know, it's really hard.
It can be really difficult to measure theimpact of any one intervention.
(11:39):
But a lot of these can really serve assurrogates 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 digitalera that we're in Yeah.
What we're already in it.
But I just think that being able to organizeMhmm.
(12:03):
The data
Yeah.
Keep track of the data and compartmentalize thedata in a much quicker way is is going to help.
I think our capabilities are just gonnaskyrocket 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 equippedto truly make an impact because we are we're
(12:29):
doing a better job in in tracking the data andthe information and knowing what to to do to
utilize it and really show the value.
But what would you say are some of thechallenges and roadblocks that medical affairs
might face in as we get into as we start tomove into the future a little bit?
(12:49):
Yeah.
I think as as with any business, you know, itreally can find if you're if you're thinking
about shifting a mindset, particularly in alarge organization where you have a number of
people and processes in place that reallydetermine the end that you get to, it can
really be hard to kinda take a step back andtake a moment to say, alright.
(13:13):
How do we shift our mindset to rethink abouthow we're delivering care to patients and
patients and and how we have impact.
You know, I think for many people, often, youknow, the the the path of least resistance is
the one that's most familiar.
And I think if unless you're really startingfrom scratch and building an organization, it
(13:37):
can be difficult to say, alright.
We need to take a beat and take a moment to toreally think rethink the way that we do things
and reverse engineer the processes and themindsets to shift the way that we think about,
impacting how the the outcomes that we'rehaving with patients.
(13:57):
What's next for medical affairs?
Like, what do you think needs to happen to movethings further into the right direction?
Yeah.
Yeah.
And this is a good question.
I think that, you know, historically, if we'relooking at you know, I can point to any medical
affairs function.
It can be medical strategy.
(14:17):
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 toserve kind of as a foundational element and
(14:38):
maybe not even a necessary element in allcases.
But you'll start to see medical affairs leadershire for different capabilities in in terms of
thinking, alright.
Does this candidate have the capability to lookat what they're doing, how it impacts patient
(14:59):
care, and tie that back to the needs of theorganization.
So I think as we're really evolving over, Iwould say, the next five to ten years, you'll
really start to see an emergence of candidateshired for different capabilities than what they
may have historically been hired for.
(15:21):
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 totie impact back to the needs of the business
(15:43):
and their work?
Well, I think first off, that's a greatmessage.
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 pointthat we try to stress a lot.
I know in my coaching program, I we try tostress the importance of leading with your
(16:03):
strengths and make sure that you're expressingand fully showing the value that you bring to
the organization and how you can best beutilized as an impactful player.
So you just hit the nail on the head.
There people may get hired for differentthings.
Yeah.
What's your thing?
What are you a subject matter expert in?
(16:25):
What are you best at?
And make sure that as you're interviewing, thatcomes out because that's what's gonna
differentiate you and separate you from some ofthe 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 isfrom having a seat at the executive table as we
(16:45):
talk about the business side?
Yeah.
I think we're only as far away as as leaderswho make the moment.
You know, leaders tying back to the McKinseyarticle in terms of what have you thought about
medical affairs as a business unit that isresponsible for improving patient outcomes
versus just a function.
I think we're only as far as leaders who kindameet that moment and can shift their mindset to
(17:11):
more of an enterprise leadership capacity.
There are a number of examples, and I won'tmention which organizations, in which, you
know, the head of medical affairs has a seatat, has a seat at the executive leadership
table.
You know, they're chief medical affairsofficer.
And so there are people who have really, youknow, elevated profile and capability of
(17:35):
medical affairs to drive value at theleadership at the executive level.
Yeah.
You know, it's funny.
I had a conversation with a leader on thecommercial side who was telling me, who's who's
an old timer.
He's been around for a long time and wastelling me how amazing he because he's noticed
(17:58):
the evolution and the progress that thatmedical affairs has made since he's been Yeah.
A leader.
And he's also very he's one of these guys thatis very medical affairs centric.
He's a commercial guy that has always developedstrong partnerships with his medical affairs
counterparts.
But he was we were literally just having thisconversation, like, this week about how far
(18:21):
medical affairs has come and, how important thefunction is for the organization strategically.
We talk about patient care and you know?
But to hear that from the commercial side, fromsuch a heavy hitter, I thought it was really
interesting.
And maybe he was telling me he was mentioningthat to me because I'm so entrenched in medical
(18:44):
affairs, but he seemed very genuine about it.
So, let me ask you this.
What else do you think is important for let'stalk 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 topof mind, Tom.
(19:05):
Number one is that the only thing that'sconstant 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 thathave a negative data readout, and it's a no go
from, you know, to phase three development.
(19:26):
And, also, there are just natural ebbs andflows in our industry that are impacted by
factors much broader than anything that we cancontrol.
It's, you know, factors in, you know, policymaking.
It's factors in, you know, regulatoryenvironments.
A lot of things that that are really beyond thebounds of our control.
(19:51):
And I think as leaders, we really need to leadfrom 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 whenthings don't go your way and say, alright.
(20:12):
How am I?
What am I taking into the next role, and andhow can I lead better?
And then also, you know, I think one of thethings that's really been impressed upon me the
past few years is to lead with a lens ofpatient centricity.
You know, I think that my time in rare diseasehas really reshaped my why and really kind of
(20:37):
forced me to reckon with, why am I doing this?
And I think that time in rare disease will dothat because you often know the patients and
the families on the other side of what you'redoing.
And I think to lead with a lens of patientcentricity is tremendously important to ensure
(20:59):
that you're driving to the route rightoutcomes.
And so that's really the two factors that Iwould impress upon medical affairs leaders and
professionals.
Number one, resilience, and number two, patientcentricity.
Is there anything you wanna say to, we talkedabout leaders.
(21:20):
Is there anything you wanna say to the MSLcommunity, the the field based MSL that's out
there, and they're grinding every day, andthey're trying to make impact?
And what what message do you have for thoseguys?
I think a a couple of things.
You know, number one, focus on buildingpartnerships.
(21:40):
Really, where are where can you build, andwhere are the opportunities to build
partnerships with your HCPs and the broaderhealth care community?
And one of one of the things that I often liketo talk about is, you know, medical affairs is
really kind of now best positioned to to dealwith the stakeholders, the wide variety of
(22:05):
stakeholders across the health care ecosystem.
So if you're an MSL in the field thinking youknow, I'd encourage you to think about,
alright.
How can I build partnerships, with the peoplethat I'm working with and with the different
stakeholders that I'm engaged with?
That goes well beyond relationships, and thatgoes well beyond, you know, Doctor.
Caravella.
How can I how can I answer you know, whatquestions do you have?
(22:28):
And it it goes to, you know, alright, doctorCaravella.
Let's talk about the opportunities, and and theways that we can work together.
And then also really approach your role with amindset of curiosity, understanding the the
(22:49):
challenges of the people that you're workingwith, you know, your fellow teammates, get to
know the functions and people that work outsideof medical affairs and their challenges.
And, also, you know, I think number numberthree, which is really important to me, is is
to give back.
You know, I've been lucky to have a long careerover the course of seventeen years in this
(23:14):
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 haveenvisioned, the opportunities that I have now.
So pay it forward.
Invest in the next generation of, you know, thePhD scientist or the PharmD student that has
(23:38):
aspirations, you know, to go into industry.
Invest in their development and invest in theirgrowth 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 thisconversation because we no.
We're talking about medical affairs and valueand impact, but one of the greatest things that
(23:59):
we can do as individuals is to help others togrow and develop.
I was at a a conference last week, and and oneof the guys I was with said, one of the
speakers said, be the best part of someoneelse's day.
Yep.
And that was one of those things that I pulledaway.
Like, coming out of that meeting, I'm like,man, that's such a great reminder.
(24:21):
So I I that ties right into what you were justsaying.
Yep.
In in helping others, elevating others.
Because when we elevate others, you know, as agroup, 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.
(24:41):
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.
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