In September, PDA will host the one-day meeting, Project Management in the Pharmaceutical Industry, in Munich. Peter Reichert,
Principal GMP Scientist, GN Hearing, and chair of the meeting, along with Garrett Van Vactor, Transformation Lead and Project Manager,
Novartis, and member of the planning committee, graciously answered some questions for Kerstin Wilken, PhD, PDA Europe Director of
Programs and Education, about the current state of project management in the industry.
Wilken: What challenges do project managers
face in the pharmaceutical industry?
Reichert: To answer this, we have to look
at what motivates typical pharmaceutical
project managers. These are high achievers,
often driven by a purpose who need
challenges, energy, experience leading,
etc. They excel at managing people, tasks,
suppliers and risk management, and at
foreseeing how a project will develop.
Their challenges come in various shapes
and forms, at least from what I know happens
in the software and device branches.
Van Vactor: From a macro perspective,
our industry has two types of projects—
molecule and nonmolecule projects.
Molecule projects are unique to pharma;
therefore, we as an industry, are the leaders.
For nonmolecule projects, i.e., those
not specific to pharma, data and observations
tell us that we are lagging behind
other industries and need to be better. Additionally,
when we look at personalized
medicines, the way in which we innovate
and deliver will continue to evolve, and, as
project managers, we have to be ready to
support this evolution.
(left) Kerstin Wilken takes the stage at the 2018 PDA Europe Project Management Conference
Wilken: From your point of view, what
are the greatest benefits of well-executed
project management within pharma?
Reichert: It is always important to
come “First to Market.” For one, every
day lost or gained is a lot of money, and,
second, it is just plain common sense. I
think that good projects are characterized
by excellent and mature project
managers who have the experience to
plan and manage well but also the courage
to cut through the fog of internal
politics. Doing so eliminates situations
that would otherwise be harmful for
both the project and the organization.
These are people who sometimes risk
their own position by challenging, in
a polite yet clear manner, the status
quo. Without them, unchallenged and
unfounded assumptions may cause a
project to fail miserably.
Van Vactor: For nonmolecule projects,
change must be both frictionless and
inclusive to achieve qualitative benefits. If
we can implement a change without much
friction or disturbance, that is key. Additionally,
if we are able to build in change
from the grassroots level, then the change
will be a) sustainable and b) a starting
point for additional enhancements. For
quantitative benefits, we should focus on
the value project management brings to
budget, schedule and scope.
Wilken: Regulatory and patient impact
considerations are important during
lifecycle changes. Do these requirements
warrant a different approach to projects in
the biopharmaceutical industry?
Van Vactor: Personally, I think focusing
on efficiency and simplification is key to
addressing regulatory concerns and patient
impact during the lifecycle.
Reichert: The pharma and device industries
have developed considerably over the
last 15 years. Complexity in the supply
chain, R&D and regulatory requirements
has grown. In a sense, the complete picture
for pharma is becoming more holistic—
which is actually a good thing.
I think the key here is to understand that
as a project manager you learn new things
every day. With this kind of attitude, a
successful project manager must be at
the forefront of what is going on regarding
new regulatory requirements, such as
recent inspection findings, and keep up to
date on new technologies or approaches.
In other words, be informed to keep sharp.
This requires a project manager to think
and reflect and build and maintain a network
So, how to build up this knowledge base?
Help can come from a variety of regional
and international organizations. Many
organizations and regulatory bodies have
contributed to developing new standards
and expanding collaboration across the
globe. For example, ICH has provided the
world with a unified approach of common
standards across regulatory agencies
and international companies. Mutual
recognition and other guidelines have
been widely adopted by many agencies as
required regulatory approaches.
Also, look at PDA. The Association offers
highly acknowledged technical reports, education
courses, conferences and workshops,
local chapters and more! I encourage project
managers who wish to excel in this industry
to take advantage of PDA’s offerings along
with ICH documents and information
from global regulatory agencies. This will make life so much easier for the pharmaceutical
Interested in attending Project
Management in the Pharmaceutical
Industry? To learn more and to register, visit the meeting website!
Wilken: Why should companies invest
in full-time, trained and certified subject
matter experts for project management?
Reichert: I believe that we should look
at the team. A pharmaceutical project
manager can be compared to the conductor
of an orchestra (i.e., the project team),
knowing the notes, the whole music piece
and having carefully made note of the difficult
parts where timing is important and
the places where tempo can impact the
whole performance. Just like a conductor
can also modify the score with their
own pauses and tempos, a pharmaceutical
project manager must be attuned to the
art of flexibility and improvising. These
skills do not come overnight. A good rule
of thumb is that it takes 10,000 hours of
experience to build a skill. Hence, training
and development adds to the skill and
agility of a project manager.
One point here, I think that members of
a project team with high responsibility
should have at least basic training in what
to do, what not to do and when to do in
terms of project management. They must
know a bit of the dynamics. This will
alleviate concerns or insecurities when the
speed increases and the focus and creative
tension builds up momentum in a project.
I think that the members of a team must
have some understanding of project management
Wilken: What is one piece of advice you
would like to share with project managers
Van Vactor: At Novartis we have a “curious
culture.” Whether it is about technical
domains, project methodologies, lessons
learned, different environments, etc., I
recommend periodically reflecting on how
we are feeding our curiosity. I find this
brings energy and inspiration.
Wilken: What is one feature every pharmaceutical
project manager should have?
Van Vactor: An “ownership mindset”
would be great as a standard. Many times
project managers act as stewards but do
not take on accountability for the budget,
schedule and scope. If project managers
feel empowered to own these dimensions,
the project will be more focused and others
will take notice.
Reichert: Let me turn this question
around, I think we should ask the industry.
I know that pharma holds many
experienced and pragmatic people who
could offer input into the characteristics
needed for successful project managers in