Earlier this year, a few of us attended DIA 2018 to represent Biorasi. While there, we were fortunate enough to be able to give a talk about some of our experiences entitled “Balancing Unity and Individuality: Leadership Skills for Managing Culturally Divergent Clinical Teams” in collaboration with Brian J. Malkin, Esq., legal counsel at Arent Fox LLP. On our behalf, Mr. Malkin shared his and our expertise on a rescue we performed, wherein cultural differences had the potential to hinder successful business relations and management of the trial. We also recently published this story as a case study. Mr. Malkin has a 20+ year history of working with food and drug law practice, including intellectual property law practice. But even more importantly for this topic is Mr. Malkin’s experience working internationally, including nations in the Asia-Pacific (AsiaPAC) region. Read more: http://bit.ly/2Ow68gE

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Balancing Unity And Individuality:
Leadership Skills For Managing
Culturally Divergent Clinical Teams
Brian J. Malkin
Counsel
Arent Fox LLP
On Behalf of
Biorasi, LLC.

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The views and opinions expressed in the following PowerPoint slides
are those of the individual presenter and should not be attributed to
Drug Information Association, Inc. (“DIA”), its directors, officers,
employees, volunteers, members, chapters, councils, Communities
or affiliates, or any organization with which the presenter is employed
or affiliated.
These PowerPoint slides are the intellectual property of the individual
presenter and are protected under the copyright laws of the United
States of America and other countries. Used by permission. All
rights reserved. Drug Information Association, Drug Information
Association Inc., DIA and DIA logo are registered trademarks. All
other trademarks are the property of their respective owners.
Special thanks to Ariel Weber, JD MS, Pharmaceuticals and
Medical Devices Agency (PMDA), and Milbhor D’Silva, Astellas
Pharma, for their help discussing the slides.
Disclaimer – Content Slide

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24 years of food and drug law practice and over 13 years of
intellectual property law practice
Practice interrelates patent and food and drug law –
drug/biologics primarily but experience with all types of FDA-
regulated products
Intellectual property experience includes FDA and patent
litigation for both innovator and generic/biosimilar companies,
as well as patent prosecution for life science companies
Clinical trial design experience including audits and
inspection/consent agreements – international experience
including Asia-Pacific region
Brian J. Malkin, Esq.

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There are obvious significant challenges:
– Language
– Time Zones
– Regulatory and Legal Environment,
both for the trial and for the workplace
These difficulties exist to some extent
in every international trial and are not
especially unique to the AsiaPAC region
AsiaPAC Trials Present Many Challenges

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Unlike collaborations between
Europe and the Americas, which
largely share similar backgrounds,
cultures, and languages, AsiaPAC
has some unique challenges:
– Culture and History
– Social Norms and Values, in the
workplace and public spaces
– Nuances in Communication and
Interpersonal Styles
– Organizational Structures and
Hierarchies
Unique Challenges of Working in AsiaPAC

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AsiaPAC cultures are different from those in the West, and
need to be understood to introduce and implement change
– Workplaces are more formal; co-worker interactions are
planned and can be more structured
– Innovation is valued; working through established
channels enables the expression of innovative ideas
– Internal AsiaPAC organization cultures can be different
from the West in that harmony is valued
Unique Challenges: Culture and History

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– AsiaPAC culture and leadership value respect. Individual
ideas are also valued, but need to be worked up through
the rungs using a process of common endorsement
– Compromise is valued and a face-saving approach in
dealing with conflict, e.g., with management, is held in
high regard
Unique Challenges: Culture and History (cont’d)

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Much heavier emphasis on uniform processes and procedures
in many AsiaPAC countries – some Western cultures may
consider this “bureaucracy”
– The outcome and process to produce an outcome are
important, but the “way to get to the outcome” may
sometimes appear more important or take additional time or
effort in the front end. The goal, however, is to avoid or
minimize negative collateral impacts through the AsiaPAC
approach
Unique Challenges: Social Norms

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Possible priority mismatches:
– AsiaPAC tends to prioritize groups over individuality, while
Western cultures often prize individuality
– An aggressive “steamrolling” approach will succeed less to
get things done; following procedures and gradually securing
the understanding and support (“nemawashi”) of each
stakeholder group is the desired & preferred approach to
achieve results over the long term; PMs should expect to
adjust deadlines and expectations as part of the process
Unique Challenges: Social Norms (cont’d)

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More than simply a language barrier, a lot of communication relies on
shared experiences and understanding – lacking that context often
results in overlooking critical pieces of information or plans being
impeded
– E.g., Biorasi found that contracting with Japanese partners required far
more specificity and explicit lists of what was covered, compared with
much looser contracts with US and European partners. This reflects
the culture where decision-by-consensus is the desired mechanism. An
individual’s contribution in the overall decision making process is part
of the process-journey. Actions once executed can be relied upon to
have received overarching management support
Before meetings, management often secures outcomes to reduce debate
or discussion, giving the potentially false appearance that
brainstorming/creative sessions or solutions are frowned upon
Unique Challenges: Communication Nuances

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Concept of “sontaku” (the idea that staff should always be able
to infer the will and preferences of their superiors from subtle
cues or other indirect behavior)
– Example: A Japanese businessman may not say “no” but instead
verbally agree and then either dodge the question later or do
something different. Here, understand when someone is trying to say
“no” but cannot share behind-the-scenes information or concerns
Tip: Set aside time for teams to speak directly with their
Japanese counterparts to understand each other’s typical
modes of going about the actual “desk work” of different tasks,
any concerns, perceived or anticipated obstacles, or
contradicting protocols to maximize long-term achievements
Unique Challenges: Communication Nuances (cont’d)

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Varying levels of organizational and hierarchical structure
between US/Europe and AsiaPAC
– Much more respect for chain of command-a close communication
linkage exists between employees & management in AsiaPAC. This
attribute aims at avoiding costly business mishaps or to engineer the
best business decisions, since the data landscape differs between
employees and management
– E.g., When negotiating project deliverables, Biorasi ran into a much
more cohesive and unified voice with Japanese contractors, compared
to other organizations
Unique Challenges: Organizational Structure

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Superficially, the two represent the differences between
traditional views of Western (individualistic) and AsiaPAC
(collective) cultures (most specifically Japanese culture)
and their approach to projects, teams, and organizations
But projects have dual natures
– They are a united effort that drives toward common goal
– They are executed by individuals and small groups that
often differ from each other
Why Balancing Unity and Individuality?

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Need to temper goals and expectations for a
potentially slower decision-making pace to
ensure a project’s mid- and long-term success
AsiaPAC managers invest much more in careful
detailed proactive planning, consider “what-if”
scenarios, and de-risk those scenarios in the
planning phase. Once execution is decided, the
team is clear and confident with moving ahead
swiftly
How Do You Find That Balance in PM?

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A structured approach lets you understand and plan for
different contingencies, and allows you to deviate from them in
a controlled manner
The more specific your plan, less can be lost in translation and
less time is lost identifying problems and obtaining the
necessary approvals for changes
Structured Project Management

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Take time in advance to learn the cultural
mores of the team you are working
Small gestures can have a large impact
– E.g. Biorasi PMs using the proper form of
address for Japanese collaborators made a clear
difference in attitude and cooperation
Expect to compromise
Appreciate the aim and intent of the
process-journey
Respect for the chain of command allows
smoother operations and less business risk
Cultural Training

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Adjustments based on cultural and organizational differences
need to be planned well in advance to avoid delays
– E.g., In contracting partners in Japan, Biorasi found many
Japanese organizations required direct approval from top
management. Middle management’s views and input count
in top management’s decision-making, but did not have final
approval authority
– Save time by planning for access to decision-makers, so
when you have access, aim to accomplish several goals at
one time rather than piece-meal
Forward Planning

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Maintaining constant communication can go a long way toward
overcoming obstacles
Take time to explain directions, pausing frequently to confirm
comprehension
Keep Communication Clear and Open

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Having someone local that can resolve escalated
issues is critical, whether they are on your team,
a contractor, or the sponsor
– E.g. Biorasi relied on the sponsor’s local
team for issue escalation that had to be
settled quickly and confidently
– Specific Example: Many sites in Japan
did not understand concept of “rescue”
in a trial and would not accept Biorasi
as the CRO until they spoke directly to the
Sponsor, and Biorasi needed to send a
PM to meet with many of the sites and
apologize for disrupting their study
Leverage Local Resources

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Asian and Western teams often require different approaches,
and the prospective manager needs to remember that using
one approach with everyone can produce variant outcomes,
some of them less desirable than others
Allow extra time for AsiaPAC projects to initiate and complete
to provide more detailed procedures and processes to be
developed initially and for specific decision-making during the
project as issues arise. This ensures the team can embrace
change when needed
Flexibility in Approach

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Biorasi recently called in to rescue a complex, multi-national
study with heavy Japanese component
– Study was lagging in screenings and enrollment
– Many Japanese sites would not work with Biorasi initially – it took a
visit to meet with the sites in person, apologize for the break in
protocol, and understand their point of view to get recruitment resumed
– Ultimately, they beat targets by 50%
out-recruiting all other geographies
Is It Worth It?
Japan Visit

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Brian J. Malkin
Counsel
Arent Fox LLP
On Behalf of
Biorasi, LLC.
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