www.eyeforpharma.

com in Medical Affairs

Get Real
Using real-world evidence to prove value

A Bright Future
How innovation is transforming Med Affairs

Are MSLs saving the industry?

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Get Real
How Medical is using real-world
evidence to prove the value of medicines

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Contents

The Superheroes of
Pharma?
MSLs are pharma’s elite troops,
but are we asking too much of
our scientific superheroes?

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A Bright Future
Innovative technologies are
opening a plethora of exciting
opportunities for Medical Affairs

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 www.eyeforpharma.com/medicalaffairs

Welcome KABOOM!
That’s the sound of your newly-hired MSL, who in
her first week has just stormed through your office to
delicately place that Key Influencer Report on your desk,
simultaneously deploy X-ray vision to scan the latest
pharmacoeconomic data from the room next door and
whooshing down to grab a few pharmacokinetics papers
to read on the way home. All with a charming smile,
naturally.

The year is 2025, and this is now the minimum standard

expected of the MSL. One could easily argue that — with their
ability to influence doctors through medical expertise, crunch
and communicate vast amounts of real-world data, understand
the health economics implications, pinpoint the new digital
KOLs, elicit patient pathway insights, remain compliant to
a particularly stringent set of regulations… and deliver it all
with a warm handshake – they are the entire pharmaceutical
company squeezed into a single person.

Is this realistic? The challenge is not insignificant – and it’s

easy to see why the medical department should indeed be
considered the future, of most pharmaceutical companies. As
we go forward, managers will need their wits about them, as
well as full support from senior management, if they’re going
to upskill an entire department to build this microcosm and
manage this standard of work. We could move quite swiftly
from a situation where Medical is supporting the rest of the
company; into one where the company is supporting the
myriad responsibilities of Medical.

But hey, it’s all in a day’s work when saving the world from the
evil forces of disease.

Paul Simms
Chairman
eyeforpharma

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 “When you speak to pharma leaders across
many fields, they all want to know if the
drug holds up in the real world.”
GUNDULA SCHNEIDEWIND, TAKEDA

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As Medical gets more involved in real-world
evidence, what challenges does it face in proving
the value of a medicine?
With demand for real-world insights
growing across healthcare, Medical Affairs
departments are increasingly being called
upon to collect and analyze real-world data.
“We have a full division working on real-
world evidence,” says Roslyn Schneider,
Global Patient Affairs Lead at Pfizer. “We use
it at various points in the development of
our medicines; we employ it prior to starting
to work on a range of activities to better
understand the true need.”
It is not just healthcare payers who want to
know whether a new medicine will meet the
promise created by clinical trial data. “When
you speak to pharma leaders across many fields,
they all want to know if the drug holds up in
the real world,” says Gundula Schneidewind,
VP, Medical Affairs Europe & Canada, at Takeda.
Schneidewind’s Medical Affairs department
now handles all regional RWE, with 12 studies
set up in the last six months; such multi-
country studies broaden the evidence base
and improve the data quality in specialty
care fields by providing larger sample sizes.
www.eyeforpharma.com/medicalaffairs
LUCY FULFORD
They include chart review projects, registry
studies and collaborations with the global
market access department to combine data
from patient charts with healthcare resource
utilization.
“We’re seeing a significant increase in our
real-world data,” says Shontelle Dodson, Senior
VP, Medical Affairs, Americas, at Astellas. This
supplements their data from randomized
controlled trials, the number of which tend to
decline over the product lifecycle.
RWE is being collated in therapeutic areas
including prostate cancer, transplant and
overactive bladder, and is “about the clinical
aspects and looking for not cause and effect,
but trends and signals to help us better
understand the patient journey,” she says.
PATIENT PERSPECTIVES
With patient-centricity in vogue, RWE is often
lauded for providing insights into patient
experiences, especially when contrasted with
the clinical data from within the constructs of
a trial of tightly selected participants.
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 “[In Medical] we are talking more about patient-centric
outcomes and to have input from patients that tells us “Data generation
which outcomes they report are most important to them,”
says Schneider. “The body of that, as it gets reported and
has to be done in
entered into electronic systems, becomes part of the real-
world evidence, the data that becomes evidence that we can
a scientifically
then use.
“Robust data sets that can answer the questions that are
solid manner.
important for a person sat in front of a clinician as they seek Only when that
to come to a decision about the most appropriate treatment
plan could be very, very helpful for patients. However, we happens will it
have to ask the right question,” she says.
Language is important, says Stanislev Glezer, Chief Medical be of interest to
patients.”
Officer at Adocia and former VP, Medical Affairs at Novo
Nordisk. He cites a big-data analysis of diabetic patients’
social media conversations around severe hypoglycaemia
that showed the “patient angle that we can put on this data”. SHONTELLE DODSON, ASTELLAS
The study raised important issues about the way terms are
defined, finding that medical terminology was being used by
patients differently to the way that physicians would use it.
For those patients, the emotional aspect of hypoglycemia
was dominant, and they considered a severe attack as a
driver of behavioral change rather than something requiring
assistance. Such patient perspectives can change and shape
the way things are defined throughout research.
RWE can also prove to be a very rich resource for patients
themselves, says Schneidewind. “As a patient, you want to
know how well the drug does in real life, to not only look at
the clinical data but see what the experience is for others.
In a world where you can go on the internet and end up
in patient forums where people report their individual
experience or feelings about the drug, you do not know if
that’s representative or not. That’s where evidence can help
inform patients.”

RISKY DATA
The growing mountain of real-world data brings opportunities
for innovation but also great analysis challenges.
“New types of data are coming in – from wearables,
social media, for example – and an enhanced connectivity
between those data sets is starting to emerge, which creates
huge opportunities,” says Glezer. “But at the same time, it
creates a huge risk because the bigger the data the more
the chance of misleading associations and statistics. There
are lot of misinterpreted analyses that are misinforming the
entire community.” At present, there are no unified definitions for RWE across
The complexity of big data is a concern, says Astellas’ Europe or in individual markets, nor are there standards to
Dodson, as different health systems can produce very comply with, in either collection and analysis of data. “It’s
different data even with the same software or protocols. easy to say the data is low quality or not good enough when
Uniting disparate data sets and making the insights there are no standards,” says Schneidewind. “How we define
meaningful is challenging, especially given that much RWE is RWE and what standards we adopt for collection will be
still collected retrospectively. very important topics going forwards.”

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 www.eyeforpharma.com/medicalaffairs

SCIENTISTS LEAD THE CHARGE

To achieve the desired quality, the challenge is
to ensure we raise the level of scientific rigor,
says Dodson. “We require all of our protocols,
even retrospective, to be developed with
a standard protocol template that is
scientifically rigorous, and goes through
a thorough review statistically. There are
ways for us, as an industry, to raise the bar,
and that’s a challenge that we’re working
on to try and make the data better and
more usable.”
Prospective collection of RWE is
an “interesting way forward,” says
Schneidewind, yet such studies are
costly and challenging as they must be
considered very early on when planning
lifecycle development for a drug.
“Data generation has to be done in
a scientifically solid manner; it has
to be brought to congresses and
journals and be peer reviewed.
Only when that happens, and
the data is seen as an unbiased
source, will it be of interest to
patients,” she says.
By leading such studies – or
at least being heavily involved
– Medical Affairs can ensure they
have proper tracking and that the
results are appropriately consolidated
and published, adds Schneidewind.
“All of this needs to happen and it can
normally be handled better within a
Medical department than when it is mixed
up in different commercial activities – it
should be clearly separated. If you want to
collect, analyze and use real-world evidence
in a scientifically solid manner, then it is best to
involve your scientific department.”

Meet our
contributors
Roslyn Schneider Gundula Schneidewind Shontelle Dodson Stanislev Glezer
Global Patient Affairs Lead VP Medical Affairs SVP Medical Affairs, Americas Chief Medical Officer
Pfizer Europe & Canada Astellas Adocia
Takeda

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 MSLs are pharma’s elite, with the knowledge
and interpersonal skills to engage and
collaborate with customers. But is pharma
asking too much of its scientific superheroes?
he Medical Science Liaison (MSL)
has come a long way in a short time.
While pharma never stands still
for long, the need for scientifically
credible partners to help customers
understand the growing complexity
of new medicines and navigate
the choppy waters of real-world
evidence and health outcomes, has seen the MSL
come to the fore in ways few might have imagined.
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ADAM HILL
While the core competencies of the MSL remain unchanged,
new capabilities will be needed – both for MSLs and MSL
leaders – to meet the demands of the changing roles. But
what does the modern MSL look like and what skills will
they need now and in the near future?
For Cesar Sanz Rodriguez, Associate VP, Medical Affairs
Lead Mid-Europe Region, at MSD, the MSL should be a
medical resource for the scientific leader and add value
by being able to “explain what the treatment means to the
patient, what it means in terms of adherence and quality
 www.eyeforpharma.com/medicalaffairs

of life — and eventually what value it brings to the patient, the

physician and the healthcare system.”
“Healthcare landscapes are changing so quickly, and the roles Meet our
in the different landscapes are changing to keep up,” says Walter contributors
Sheloff, Customer Facing Medical Excellence Lead, Europe, Pfizer.
“But it’s going to vary by healthcare market. Countries are evolving
at different speeds and rates.”
He points to how MSLs in countries like Sweden or the UK
are potentially engaging different customers than MSLs in, for
example, Spain or Russia. “In some countries, decisions on which
medicines to use are made by HCPs, which in others it may be
government, HTA groups and payers, and Medical Affairs has Cesar Sanz Rodriguez
adapted its role to meet these changing and differing needs.” Assistant VP, Medical Affairs Lead
Mid-Europe Region
MSD
MAP READING
Despite this variation, Sheloff sees a few clear capabilities that
MSLs will need to navigate around today’s health landscape.
These include:

Scientific and technical – “critical for success”

Stakeholder management, with “proactivity

Walter Sheloff
and developing solutions for stakeholders’ Customer Facing Medical Excellence
challenges” as key attributes Lead, Europe
Pfizer

Excellent interpersonal and communication skills is

“another crucial success factor”

Building on this, Helen Kane, Managing Director of consultancy

Pivot MSL, sees four core competencies for today’s MSLs.
“Five years ago, only the first two – scientific knowledge and
communication skills – were considered strictly necessary for Helen Kane
Managing Director
an MSL but now they also need scientific expertise and business Pivot MSL
acumen,” she says. “Now, with the contribution of the MSL
manager to insight and strategic planning, there has been a shift
in the view of the MSL as a partner. Emotional intelligence should
be pretty high on the list too.”

“Healthcare landscapes are changing so

quickly, and the roles in the different
landscapes are changing to keep up.”
WALTER SHELOFF, PFIZER

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 “MSL functions have
to be clear about
communicating
their successes and
understanding their
value. There is room for
improvement here.”
WALTER SHELOFF, PFIZER
Kane draws a distinction between scientific knowledge
(in which she includes understanding the therapy area,
drugs, clinical data, competitor data, key patient groups,
reimbursement models and healthcare systems) and
‘expertise’ (in which she includes medical writing and the
ability to critically analyze papers).
Communication skills are vital when it comes to delivering
an impactful presentation or explaining complex – or even
flawed – data, while also generating insight.
The key for Pfizer’s Sheloff is tailoring the information
to the needs of the customer. “It’s about identifying the
landscape and having common goals or shared agendas
with stakeholders, for instance, around doing research on
a population of patients in a given country to understand
how a medicine might fit into a particular group.”
TRUST ME, I’M AN MSL
For Sanz Rodriguez, MSLs must play a leading role in
building trust between doctors and industry. “Excellence
in MSL activities becomes an opportunity to create a true
bidirectional relationship; we need partnership between
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pharma companies and scientific leaders based on their need for
informed dialogue more than ever,” he says.
MSLs must balance scientific exchange and medical information.
“The value is not in the data but in the insights the MSL contributes
to the discussion, which translate into value for physicians and
their patients. The MSL must ask the right questions and listen to
the answers; they need to maintain, and be seen to be maintaining,
their credo of unbiased, peer-to-peer scientific exchange.”
Interpersonal and communication skills are essential is MSLs are
to create value for stakeholders and help companies to “separate
the signal from the noise”. Those who create and capitalize on
interpersonal networks, both within and across organizations,
are valued. “This is where MSL managers feel their teams are
less effective and there is greatest room for improvement,” says
Sanz Rodriguez.
Yet, MSLs are also representatives of their company and must
have a rounded view, says Kane. “If a doctor wants to have a moan
about the cost of drugs, it doesn’t matter what role you have, it’s
important that you understand the story of your company. You
need to respond with some level of credibility. You are the face
of the company.”

SUPERHUMANS
Finding people with this long list of capabilities is
a challenging task, says Sanz Rodriguez. “With the
need for a range of skills beyond simply a scientific
background, people are scarce in the market. Hence,
there is a pressing need to develop or enhance these
skills through effective training programs.”
“There is also an increasing need for training on
health economics, for example,” he says “As scientific
leaders become increasingly involved in managing
care and integrated delivery systems, they are
increasingly asking questions of the MSL. Digital skills
will also become increasingly important.”
Unsurprisingly, Kane says there has been a drive to
attract those from near the top of the academic tree.
“More organizations are looking for individuals with
post-doctoral degrees, the ‘D Club’,” she says. “Yet,
people brought into the industry from academia need
to understand how pharma works.”
Training and support resources are also often
scarce. “What can happen is that there is a huge
recruitment drive to bring in people with, say, a PhD in
oncology, but companies don’t have the infrastructure
to support them. They become confused about what
they are meant to be doing.”
Sanz Rodriguez agrees that MSLs generally expect
more training from their employers, while Sheloff
says that Medical “hasn’t necessarily given the time
to training that Commercial and Sales & Marketing
colleagues give”. It is vital, he adds, that anybody
who has customer-facing responsibility has initial
‘onboarding’ training whether they are new to the
company or not.
For Rodriguez, investment in training is the best
retention strategy, given the high level of competition
among pharma companies for the best MSLs.
www.eyeforpharma.com/medical-affairs
LEAD FROM THE FRONT
With MSL leaders, Sheloff sees on-the-job guidance
and the ability to coach others as essential, while
Sanz Rodriguez highlights the need for the MSL leader
to evolve beyond the manager role and set a vision
for the team (and lead that change).
MSL leaders who have not been MSLs themselves
may struggle, says Kane. “MSL leaders need to
understand exactly who the MSL is – the role and
value of the function,” she insists.
MSL leaders could advocate for the role better,
says, Sheloff. “Commercial functions do well in
demonstrating the benefit of their activities. MSL
functions have to be clear about communicating
their successes and understanding their value. There
is room for improvement here – are they aligned
with the business as a core part, or are they a bolt-
on, supporting existing strategies? This will be
increasingly important going forward.”
The MSL role has evolved beyond recognition
in recent years but what does the future hold? For
Sheloff, the term ‘MSL’ may even disappear altogether
as all those who work in Medical Affairs take on
the characteristics now associated with the role.
“This could lead to a more over-arching Medical
Affairs approach. This makes sense from a resource
perspective as there’s barely a Medical Affairs role
now that doesn’t involve seeing customers.”
Assuming MSLs have a future as a distinct entity,
Kane believes that standards of excellence are required
to ensure independence. “Some organizations will
employ individuals they define as MSLs but who
are really representatives in disguise,” she warns. “It
only takes a few companies to muddy the waters to
damage the trust we’ve built between physicians and
pharma.”
Sanz Rodriguez adds: “I hope the approach different
pharma companies take to the MSL role becomes
more consistent, as there is risk if the perception
builds that the MSL profession today is driven by
internal pressure not the true needs of scientific
leaders.”
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 Innovation is disrupting the entire healthcare continuum,
creating opportunities for Medical Affairs in new and
exciting places, says BMS’ Lav Parvathenani.
LUCY FULFORD

here has never been a better time to work in

Medical Affairs. The disruptive technologies
transforming every aspect of healthcare
– from big data to precision medicine –
will change the rules of engagement with
pharma’s customers, creating new
and exciting opportunities
in the future. What’s more, health
technologies are having a huge impact
on patients’ lives, perhaps the greatest
impact in the history of medicine.

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“An AI-based interface can
find the relevant information,
and deliver it tailored to an
individual patient.”
Lav Parvathenani
These are the opinions of Lav Parvathenani, Director,
Hematology Publications and Scientific Content, at Bristol-
Myers Squibb. “This is an incredibly exciting time to be in
Medical Affairs,” he says. “We are at the start of an amazing
revolution and we are at the forefront of it all.”
Any fears of a dystopian future are unfounded, he says.
“While it’s really hard to predict ‘technology destruction’
in the long term – and, in some cases, even in the short
term – the sheer amount of innovation means that jobs we
couldn’t imagine existing ten years ago will be created and
existing jobs will evolve in new ways. The entire function is
going to be more dynamic as roles and skillsets change, all
through the revolution in medicine and technology, which
are feeding into each other.”
Innovation is arising in both directions, as health
companies experiment with technology and tech
companies experiment with health, says Parvathenani.
Wearable technology offers the opportunity to capture
patient-reported outcomes in a “new way” in real time and
continuously as opposed to a periodic paper or electronic
questionnaire of today.
Technological developments are allowing greater
collection of real-world evidence, generating valuable
insights for Medical Affairs. “10 to 15 years ago, our
involvement of real-world evidence was very small but
it’s importance has grown, and I can see it becoming even
more so going forward.” (For more on how Medical Affairs
is using RWE, see Get Real on page 4).
As partnerships are built between pharma and tech
firms, Medical Affairs is facing many new opportunity for
www.eyeforpharma.com/medicalaffairs
Meet our
contributor
Lav Parvathenani
Director, Hematology Publications
and Scientific Content
Bristol-Myers Squibb
innovation, says Parvathenani. “How do we partner with
these groups to find out what works and what doesn’t?” he
asks. “Because there’s truth and there’s hype and it can be
difficult to sort out what will be beneficial going to work
from a medical affairs perspective.”
The seismic shift has been the change in the flow of
information – customers who were dependent on sales
reps and medical teams for their information even 5-10
years ago, are now able to get it from the web, including
third-party sources like webMD, Medscape and the ever-
popular wikipedia. The challenge, however, has been
finding the right information in the midst of inaccurate and
incomplete information found on the web, he says.
Knowledge might be power, but there can be too much
of a good thing. “Physicians have less time as they are
doing many more things than just treating patients, plus
they’re being bombarded by information.”
Effective data mining that can filter and analyze research
to provide synthesized medical information is a promising
solution, says Parvathenani. “You have hundreds of
oncology clinical trials going on at any one time, across
many types of cancer. An average physician cannot keep up
with even a fraction of this information. A good AI-based
interface, using a certain patient’s parameters, can pull out
relevant information.”
He hopes that, by acting as the interface between
healthcare professionals and the continuing evolution in
technology and precision medicine, Medical can continue
to provide value well into the future.
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