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Medical Affairs Leadership Summit, Key APAC Insights - August 2016
1. Second Annual APAC Medical Affairs
Leadership Summit: Key Insights
By Keith Morris, Linda Liong, Lynn Okamoto and Sebastian Bather
2. Second Annual APAC Medical Affairs
Leadership Summit: Key Insights
TABLE OF CONTENTS
1 Topic No. 1
Defining the Medical Affairs Vision & Mission...........................................Page 4
2 Topic No. 2
Field Medical Team Transformation.........................................................Page 8
3 Topic No. 3
Role of Medical Affairs in Late Stage Development................................Page 12
4 Topic No. 4
Medical Affairs Launch Readiness.........................................................Page 15
5 Topic No. 5
Maximizing Resources While Retaining Talent.........................................Page 17
3. Second Annual APAC Medical Affairs
Leadership Summit: Key Insights
The Second Annual APAC Medical Affairs Leadership Summit brought together
Medical Affairs leaders from a range of pharmaceutical and biotechnology
companies in March 2016 to discuss five areas of shared interest:
• Defining the Medical Affairs Vision & Mission
• Field Medical Team Transformation
• Role of Medical Affairs in Late Stage Development
• Medical Affairs Launch Readiness
• Maximizing Medical Affairs Resources While Retaining Talent
As in prior years, the Summit provided a forum for Medical Affairs leaders to share
perspectives on the most pressing challenges, learn about best practices, and
exchange strategies for achieving greater success. Medical Affairs executives are
facing a rapidly evolving healthcare landscape that demands more from their teams
than ever before. Medical Affairs organizations must reconsider the processes for
creating and communicating their vision, becoming more proactive and strategic,
and defining their value to the broader organization. And, all of this must be done
with limited resources.
This paper shares highlights from the conversations framed within the inVentiv
Consulting team’s own broad experience in Medical Affairs. It is intended to prompt
a further exchange of ideas to enhance professional Medical Affairs expertise in the
year ahead.
ABOUT MEDICAL AFFAIRS
LEADERSHIP SUMMITS
InVentiv Health Consulting hosts
three Medical Affairs Leadership
Summits per year: one each in
the United States, Europe and
the APAC Region. Each Summit
provides a forum for Medical
Affairs leaders to share their
perspectives on key challenges
facing their organizations and to
brainstorm potential solutions to
these challenges. Prior to each
Summit, inVentiv Consulting
surveys a broad group of
Medical Affairs leaders on key
industry topics, with survey
findings augmented by the firm’s
own research and experience.
This serves as a springboard for
discussion during the Summit.
Over the years, white papers
summarizing key learnings
from each Summit are shared
with industry peers to prompt
a further exchange of ideas.
This paper summarizes insights
from the Second Annual APAC
Medical Affairs Leadership
Summit held in Singapore in
March 2016.
4. Topic No. 1
Defining the Medical Affairs
Vision & Mission
An overall vision for Medical Affairs is important to help define the broader goals and
value that the function brings to the larger organization. Historically, Medical Affairs
organizations have been perceived as service providers to the larger enterprise. Today,
it’s important for Medical Affairs to be proactive, customer-centric and strategically
aligned with the Clinical and Commercial functions. In addition, as healthcare systems
evolve worldwide to increase the influence of payers, limit access to providers and
become more patient-focused, the vision for Medical Affairs must accommodate the
changing informational needs of medical customers while reflecting the importance
of engaging and partnering with a broader range of key stakeholders (Figure 1).
MEDICAL AFFAIRS VISION
• The Medical Affairs vision
should be updated to fit the
evolving role of the Medical
Affairs organization from
supporting role to
strategic partner.
• Influence of payers and
limited access to providers
are key trends that will
continue to influence the
vision for Medical Affairs.
• An internal communication
plan and defined supporting
deliverables are instrumental
to vision implementation, but
lack of time and resources
are barriers.
• Being ready and able to
provide strong regional
insights is one of the most
fruitful ways to have influence
on global strategy.
• When well executed, the
vision articulates a branded
value for Medical Affairs that
supports staff retention and
justifies resource allocation
to meet the changing needs
of their organizations.
5. Topic No. 1
Defining the Medical Affairs
Vision & Mission
Discussion at this year’s Medical Affairs Summit confirmed opinion that a clear vision
for the Medical Affairs organization is necessary to drive a shift in mindset that sees
Medical Affairs as a key strategic player rather than a passive partner in operational
execution. The vision should define specific objectives and the behaviors needed
to achieve them. The vast majority agreed that a robust internal communications
plan and defined supporting deliverables are instrumental to making the vision real,
relevant and actionable (Figure 2). The task of clearly defining the vision for Medical
Affairs also requires soliciting and integrating input from Clinical, Commercial and
other internal partners. When well executed, the vision articulates a branded value
for Medical Affairs that supports staff retention and justifies resource allocation to
meet the changing needs of the organization.
6. Topic No. 1
Defining the Medical Affairs
Vision & Mission
Summit participants felt that being ready and able to provide strong regional insights
is one of the most fruitful ways to have influence on global strategy. As one Summit
participant put it, “When there are no strong insights coming from Medical Affairs, we
end up being a passive partner.” Identifying opportunities to provide these insights
both prior to and post-launch can influence clinical trials and launch strategies. There
is, for example, a significant opportunity for Medical Affairs to improve market
insights in rare diseases, an area where traditional market research has limitations.
But first, a more systematic and structured approach to insight gathering, such as
compiling databases of medical inquiries, is necessary for Medical Affairs to have
a more proactive, influential voice within the larger organization.
Many Summit participants felt that while regional teams clearly have opportunities
to tailor activities to their region, they perceive they have no real influence on overall
strategy (Figure 3). What influence they do have is perceived to be determined
depending on region or country, therapeutic area and product life cycle.
7. Topic No. 1
Defining the Medical Affairs
Vision & Mission
A number of factors were cited as obstacles to achieving and communicating
progress on the Medical Affairs vision. A lack of specific skills and an absence of
internal buy-in were mentioned, but the single biggest obstacle seemed to be time
and headcount constraints (Figure 4). Although these may be limited, effective and
consistent execution of the vision is critical to drive buy-in throughout the Medical
Affairs organization and with other internal partners.
8. Topic No. 2
Transforming Field Medical Teams
Today’s field medical teams face unprecedented scrutiny, expectations and
challenges. They must build and expand on their traditional scientific expertise to
successfully meet the needs of a diverse and growing range of medical customers.
For APAC field medical teams today, this range of customers includes:
• Hospital-based providers
• Academia
• Organized customers
• Managed care stakeholders
• Community-based providers
• Patient advocacy organizations
• Patients and/or caregivers
Of these, organized customers and managed care stakeholders are rising in
importance, reflecting the increasing emphasis on value-based healthcare worldwide
(Figure 5). In turn, the emergence of new customers and the evolving needs of existing
medical customers are driving significant changes in field medical team structure
and operations (Figure 6).
FIELD MEDICAL TEAM
TRANSFORMATION
• Organized customers and
managed care stakeholders
are rising in importance,
reflecting the increasing
emphasis on value-based
healthcare worldwide.
• The emergence of these new
customers, combined with
the evolving needs of existing
medical customers, is driving
significant change in field
medical team structure
and operations.
• Business acumen and
advanced communications
skills are the most relevant
competencies for future field
medical teams.
• Increasing interaction with
market access organizations
is also an emerging trend,
requiring expertise in local
reimbursement and healthcare
delivery dynamics.
• New, more systematic
approaches are needed
to measuring field team
effectiveness; one of the
most important metrics
should be how effectively
medical insights are shared.
9. Topic No. 2
Transforming Field Medical Teams
For instance, the need for greater interaction with market access organizations and a
focus on patient-centric strategies is a clear emerging trend. This means that expertise
in local reimbursement and healthcare delivery dynamics will become more important
for field medical teams in the future. It can be challenging in the APAC region,
however, due to wide variations from country to country (and even within countries,
such as China), requiring field teams to be more flexible in how they respond than
they’ve had to be in the past.
In this new environment, advanced communication skills are indispensable, both to
engage with diverse external stakeholders and to effectively communicate insights
to inform the work of commercial, clinical and other teams inside the company.
Facilitation skills are critical as well. As one participant noted, “For established
products, [field teams] must be experts at facilitating the discussion while for new
products, they must be expert at translating the science.” Based on our experiences
there is a notable growing trend that in the APAC region, similar to other parts of the
world, companies are looking at multiple field medical type roles. Some companies
utilize Clinical Trial Liaisons (CTL) and in some cases transition them to the more
traditional Medical Science Liaison (MSL) role. Still other organizations within the
APAC region look to Clinical/Nurse Educators to fulfill educational needs.
10. Topic No. 2
Transforming Field Medical Teams
The increasing importance of insight-generation is another reason training should
focus more on communication skills and less on presentation skills. Skillfully
conducted conversations – asking probing questions, understanding open-ended
inquiry, conducting follow-up – produce valuable data and insights beyond what has
traditionally been expected of field medical teams.
Another important skill – and a relatively new requirement for field medical teams – is
business acumen (Figure 7). Although it was noted that field medical teams should not
be driving sales and promotional activities or involved in pricing discussions, there is
room for teams to add an understanding of marketplace dynamics to their scientific
expertise. Teams must be adept at engaging with emerging customers and be well
versed in health economics, reimbursement and other topics related to quality and
value of care.
11. Topic No. 2
Transforming Field Medical Teams
Organizations frequently lack a systematic approach to defining, collecting and
measuring field team effectiveness, and there are currently no industry benchmarks
for doing so. However, metrics for field medical teams need to be clearly defined
and easily quantifiable. One of the most important metrics of field team effectiveness
should be how well medical insights are shared (Figure 8).
12. Topic No. 3
Role of Medical Affairs in
Late Stage Development
Once a drug is approved, it becomes necessary to convince actual prescribers to use
it and payers to reimburse for it. Payers want to know, does the drug or intervention
work in the real world? Does it provide benefit or value over existing interventions? A
great deal of additional “late stage” evidence may be required to answer these questions
based on health economics and outcomes research (HEOR) or comparative effectiveness
studies, product or disease registries, low-intervention or pragmatic clinical trials, and
non-interventional studies. This real world data, when combined with other late-stage
insights, is the kind of real-world evidence that payers, governing parties and healthcare
providers – all of whom are increasingly influential in self-paid markets – are requesting.
Summit participants agreed it was important to have a Medical organization capable of
supporting real-world evidence generation. But the role of Medical Affairs in generating
this real-world evidence is still being defined. To begin with, APAC-specific, local data
to support real-world evidence is scarce, and the resources and infrastructure with
which to generate it are limited (Figure 9). There is also limited experience with the
methods and techniques for conducting late stage research, and limited understanding
about how the data can be used to support the market access mission of Medical
Affairs. Furthermore, regional Medical Affairs organizations cannot always rely on
Global expertise in real-world evidence generation because it often requires country-
specific knowledge. Consequently, there can be no such thing as “one size fits all”
and Medical Affairs must take a country-by-country approach when developing late
stage strategy.
ROLE OF MEDICAL
AFFAIRS IN LATE STAGE
DEVELOPMENT
• Payers, governing parties
and healthcare providers
are requesting real-world
evidence.
• The role of Medical Affairs
in generating this real-world
evidence is still being defined.
• Post-approval studies in APAC
are usually planned much
later than in the US or EU,
and most are planned on an
“as-needed” basis.
• Given the region’s diversity
there is no such thing
as “one size fits all” and
Medical Affairs must take
a country-by-country
approach when developing
late stage strategy.
• The process of getting
approval for late stage
studies can be long, due
to competitive priorities,
lack of internal processes
and lack of buy-in from
internal stakeholders.
13. Topic No. 3
Role of Medical Affairs in
Late Stage Development
Multiple functions contribute to the development of post-approval/real-world study
plans but there are notable differences from company to company with regard to
planning process and strategy. Post-approval studies in APAC are usually planned
significantly later – less than two years prior to launch – than in the US or EU, and
most are planned on an “as-needed” basis (Figure 10). The process of getting
approval for late stage studies can be long, due to competitive priorities, lack of
internal processes and lack of buy-in from internal stakeholders.
ROLE OF MEDICAL
AFFAIRS IN LATE STAGE
DEVELOPMENT
• Opportunities exist for
clinical research organizations
and other partners with
late stage expertise and
appropriate APAC experience
to provide support.
14. Topic No. 3
Role of Medical Affairs in
Late Stage Development
Overall, the lack of expertise and skills within the Medical Affairs organization along
with lack of time and headcount resources are the biggest obstacles that make
implementing real-world evidence studies in Asia difficult (Figure 11). Opportunities
exist for clinical research organizations and other partners with late stage expertise
and appropriate APAC experience to provide support.
15. Topic No. 4
Medical Affairs Launch Readiness
The perceived value of Medical Affairs involvement at launch varies greatly across
markets, therapeutic areas and products. To demonstrate value, Medical Affairs
organizations in APAC must continue to identify and leverage opportunities to
encourage thoughtful and balanced investment in launch-critical Medical
Affairs activities.
Because some APAC markets typically represent a smaller contribution to revenue
expectations, launch in APAC can be significantly delayed (often by years) compared
to US or EU markets. Consequently, launch-funding allocation in APAC (especially
compared to the US or EU) may disproportionately favor some functions at the
expense of others. Indeed, limited headcount and insufficient planning are considered
the key challenges that Medical Affairs faces during launch. With a reduced requirement
for field medical team work in advance of launch comes limited flexibility to plan and
execute. This may reinforce a tendency among some MSLs to maintain a focus that
is too narrow and KOL-centric (Figure 12). MSLs can be encouraged to appropriately
prioritize KOL activities and develop engagement plans for a broader audience.
A related challenge is that APAC Medical Affairs team must balance how to run
consistent launch planning for groupings of smaller, heterogeneous markets, such
as Southeast Asia, while attempting to prioritize launch plans for larger, more critical
markets, such as Japan and China, often in response to the larger challenges of
pricing pressure and a short product life cycle.
MEDICAL AFFAIRS
LAUNCH READINESS
• The perceived value of
Medical Affairs involvement at
launch varies greatly across
markets, therapeutic areas
and products.
• To demonstrate value,
Medical Affairs organizations
must continue to identify
and leverage opportunities
to encourage thoughtful and
balanced investment into
launch-critical Medical
Affairs activities.
• It is important for MSLs
to appropriately prioritize
KOL activities and develop
engagement plans for a
broader audience.
• Risk of program failure can
be mitigated with earlier
involvement of Medical Affairs
in program strategy.
• Early involvement may also
be relevant for therapeutic
areas where geography
influences epidemiology,
or for highly complex trials.
16. Topic No. 4
Medical Affairs Launch Readiness
Similar to the situation with regard to late-stage development, for many organizations
the role of Medical Affairs at launch is still being defined. In APAC, the majority of
Medical Affairs launch readiness activities begin after the start of phase 3 (Figure 13).
A strong case can be made for earlier Medical Affairs involvement on several fronts.
For instance, the impact of failed programs due to disproportionate allocation of
local resource to global initiatives or trials is often magnified in APAC. Such risk can
be mitigated with earlier involvement of Medical Affairs in program strategy. Early
involvement may also be relevant for therapeutic areas where geography influences
epidemiology, or for highly complex trials. In these cases, there may be opportunity
to help optimize evidence generation with early scoping during phase 3, to gather
insights in advance from a broad set of stakeholder, or to leverage advanced market
data to gain traction.
Each of these approaches will help emphasize the important contributions Medical
Affairs can make to a successful APAC launch.
MEDICAL AFFAIRS
LAUNCH READINESS
• Taking advantage of
opportunities to gather
insights in advance from a
broad range of stakeholders
or leverage advanced market
data can help emphasize
the important contributions
Medical Affairs can make to
a successful APAC launch.
17. Topic No. 5
Maximizing Resources While
Retaining Talent
As the vision for Medical Affairs evolves to meet the challenges of a rapidly changing
healthcare environment, it’s inevitable that a close look is being taken at how best to
attract, train, manage and retain talent. As it turns out, finding and retaining qualified
Medical Affairs personnel appears to be the most significant “pain point” for Medical
Affairs organizations in APAC (Figure 14). The pain is likely compounded when
Medical organizations are already under-resourced and “stretched too thin.”
MAXIMIZING RESOURCES
WHILE RETAINING TALENT
• Finding and retaining qualified
Medical Affairs personnel
appears to be the most
significant “pain point” for
Medical Affairs organizations
in APAC.
• Communication skills and
an advanced degree are the
most sought after skills for
Medical Affairs hires.
• The lack of a clearly defined
career path and lack of
work-life balance are the
biggest perceived threats
to talent retention.
• Optimizing resource
utilization – putting the right
person in the right roles with
the right motivation – has
become key. A robust training
and onboarding program can
help to accomplish this.
18. Topic No. 5
Maximizing Resources While
Retaining Talent
But as one participant explained, “Finding qualified talent is not a problem. Retaining
talent, however, is a huge issue.” Lack of a defined career path and lack of work-life
balance are the biggest perceived threats to talent retention. In some companies,
for example, only a select few may be chosen for advanced talent management
programs leaving the rest unable to see opportunities to advance. Organizations
with “flat” management structures may discourage those who see little or no
opportunity for career growth. To address these issues, Medical Affairs teams
should look for opportunities to re-think and more clearly define career paths for
roles beyond Medical Manager, for example, or reevaluate the position of MSLs
within the broader Medical hierarchy.
Consistent with the need for Medical Affairs staff to engage more deeply with
a broader range of stakeholders, communication skills (along with an advanced
degree) are the most sought after skills for Medical Affairs hires (Figure 15).
Emotional intelligence, the ability to fit to team dynamics and learning agility were
also mentioned as desired qualities. However, assessing communication skills and
emotional intelligence can be challenging. And the ability of Medical Affairs
organizations to hire appropriate talent is hampered by the small (and potentially
over-paid) talent pool available throughout Asia.
19. Topic No. 5
Maximizing Resources While
Retaining Talent
High turnover may also result when the desire for “fast track” financial rewards and
status come at the expense of pursuing a longer-term development path with the
company. There may be opportunities to better align organization and incentive
compensation structures to advance value-added roles. In addition, arduous
compliance and risk management procedures are a significant source of frustration
for field team members. Creating more proactive human resource policies and
procedures can have a significant impact on retention.
Given these recruitment and retention challenges, optimizing resource utilization –
putting the right person in the right roles with the right motivation – becomes key.
As was pointed out at the Summit, although medical knowledge is a requirement for
new hires, other skills are “trainable.” A robust training and onboarding program can
go far to improve resource utilization and better position Medical Affairs to have a
more proactive, strategic and influential voice within the larger organization.
20. Second Annual APAC Medical Affairs
Leadership Summit: Key Insights
CONCLUSION
Medical Affairs is undergoing a transformation globally and the changes taking place
in Asia are similar in some ways – although quite distinct in others – to those discussed
at Summits in the United States and Europe. Medical Affairs teams are now required
to have greater flexibility in responding to the complex and quickly evolving challenges
of the marketplace, regardless of where the changes are taking place. Medical Affairs
teams need new and expanded skills and the ability to demonstrate value across the
organization through clearly articulated vision and strategic planning. The topics for
the APAC Summit addressed these issues and more. Conversations highlighted the
need to expand capabilities, engage new stakeholders, be more proactive, develop
new skills, and define new career paths. inVentiv Consulting, along with our industry
Medical Affairs colleagues, continues to find these meetings a unique, global forum
for the open exchange of ideas and best practices, and we look forward to continuing
them in the coming year.
