+ + + + + + + + + + + + + + +

INDUST
OF RY
S

AR

EX
2003 2017

TEEN YE

CEL NCE
LE
FIF
THE STATE OF THE

INDUSTRY
+ + + + + + + + + + + + + + +
Chapter Three
The Project Managers
Perspective
Managing Timelines, Budgets, and
Milestones in Multidisciplinary Teams

S. Anne Montgomery

Series
2017
B i o P r o c e s s STATE OF THE INDUSTRY
The Project Managers Perspective
Managing Timelines, Budgets, and Milestones
in Multidisciplinary Teams
S. Anne Montgomery
T
he term project management in
the pharmaceutical industry is
exceedingly broad and covers
multiple functionalities: project
planning, execution, and monitoring;
timeline and budget planning and
management; stakeholder management;
management of regulatory and
compliance strategies; environmental
safety; risk management; and team
management. For most industries,
these are important tasks. However, for
the biopharmaceutical industry all this
must be done while keeping patient
safety and efficacy of the drug the
topmost priority.
Looking at this job function on its
own, though, reveals as many
variations as there are of products and
processes in development. But project
managers share critical skills for
working with (most often these days)
interdisciplinary groups toward
common goals, weighing
considerations of time and cost against
deadlines set for technical and
financial milestones. The combination
of technical/scientific with business
(forecasting, communications, and so
on) skills is what sets such valuable
people apart in any organization.
Authors Hazel Aranha (editorial
advisor and viral clearance and
biosafety officer, Sartorius Stedim
North America Inc.) and Leonore
Witchey-Lakshmanan (principal
consultant, Pharma CMC/IP) spoke
with me about points covered in their
BPI article (1). Project management
may sometimes feel like running a
three-ring circus. In fact Barnum and
Bailey were thought to be one of the
first, nearly a century ago, to employ a
2 BioProcess International
ADOBE STOCK (HTTP://STOCK.ADOBE.COM)
detailed and disciplined project
management program to ensure their
travel logistics and the execution of
their shows was flawless.
Transformations in Project
Management: In looking at
approaches to project management
over the past 15 years, it is clear that
many more tools are available now for
monitoring the progress of, and
communicating with teams from
different departments, functions, and
sites. Notably, this functional category
has (along with the rest of the
bioindustry) been undergoing
transformation under the influence of
quality-riskbased forecasting and
assessment tools that include real-time
analytics, data-tracking software, and
process-modeling software. Project
managers benefit from the increased
transparency provided to team
members through shared information
systems. Those who oversee elements
of change and associated risks,
encourage cross-team collaboration,
troubleshoot technical problems and
clashes of personalities and priorities,
15(6) Chapter 3 of 11 State of the Industry 2017
interpret project needs to upper
management, smooth transitions from
initial stages to product launch
(commercial supply), and oversee
ongoing contractor and supplier
partnerships (the latter usually
together with supply-chain managers).
Project managers oversee progress and
continuity of outsourced elements to
multiple service providers and to
development and manufacturing sites.
Training and experience are key:
Not just any scientist or technician -
even one intimately familiar with
project details - can step into this role
effectively. However, that has often
been the approach to project
management in the past: the promotion
of a team member to project manager.
So at the outset, a key issue is the need
for improved training and access to the
skilled managers and technicians of the
future.
Biopharmaceutical project
management as a career in and of itself
may not have been much emphasized
before. But that is no longer the case: A
search for advertised positions reveals
 many variations on such roles and,
therefore, good opportunities for
people with the requisite skills to
effectively apply scheduling, risk
management, and comprehensive
quality assurance and control to the
process of bringing a drug to market in
a cost-efficient way (2). These are
people who can step outside the forest
to see the trees; who can, when they
need to, navigate smoothly between
generalist and specialist roles.
Careers in project management take
many different forms and call for a
variety of skills, levels of education, and
years of experience. Such a position can
entail managing a project across an
entire business or one specific to one
program or department/function,
applying knowledge, skills, tools and
techniques to project activities to meet
the project requirements (3). This
makes a project manager accountable
for thesuccess or failure of a project.
No matter what a companys business
goals are or how it defines management
roles, he or she needs to understand
those business goals and know how to
help a team achieve them. Especially
with increased attention to new
therapeutic categories and biosimilars,
a project manager may face both a
personal learning curve with new
technologies and a much more
competitive rush to market than in
previous years.
Survey Highlights
BPIs State of the Industry survey
section on project management
focused more on the manufacturing
trends to be managed than on the
tasks and related roles themselves. So
it mainly confirms key trends that
align with industry practices as a
whole. To this extent, survey responses
revealed no real surprises. Here are
the key issues that factor into todays
project-management decisions.
Increased Outsourcing Options: We
asked about the effect on managing
timelines and expectations from
increased outsourcing options over the
past 15 years. Most respondents agree,
if not strongly, that increased options
for outsourcing specialty work
(biosimilars, cell therapies, conjugates,
vaccines, and so on) have widened/
improved project-management choices
regarding where to make clinical
supplies, securing lower-cost materials
and labor, and conducting specialty
laboratory analyses. Available platform
technologies at CMOs/CDMOs also
are speeding technology transfer
through building shared expertise and
enabling faster process optimization.
But our small group of self-selected
respondents is not enough to support
any assertion that availability of these
wider options has significantly
changed their companies business
goals. On the contrary, whether or not
it is a larger trend, these respondents
companies appear to be staying the
course of their product development
pipelines.
Respondents did agree, some
strongly, with the statement that
Options to outsource to overseas
manufacturers are reducing our costs

Right.
On Time.
Commitment to your project
and needs is embraced
all the way to our leadership

Im committed to your goal of

getting new therapies to patients
Supervisor, Development Support, UPD, Seattle, Facility

COMPETITIVE ADVANTAGE WITHOUT COMPROMISE

CMC Biologics oers a CDMO relationship where your needs are
prioritized across our organization. Consequent decision-making,
agility, exibility and our collaborative approach reduce timelines
without any compromise in exacting quality.

www.cmcbio.com United States +1 425 485 1900 Europe +45 7020 9470
3 BioProcess International 15(6) Chapter 3 of 11 State of the Industry 2017
through providing access to their local
labor/talent pools; longer-term
planning can be leveraged through
reserving added manufacturing
capacity in geographical regions new
to the industry.
All agree that such options are
increasing and that such advantages
are possible to achieve. But increased
access to external expertise may
explain why one respondent from the
AsiaPacific (APAC) market
emphasizes the need for a strong
global rather than regional business
perspective. Does this signal a trend
toward greater participation from
APAC in the worldwide industry? He
writes, For a successful player,
building a global biotherapeutic
footprint is more important than the
cost. Unlike chemical processes,
bioprocesses do not support shortcuts.
Another person notes that, as a
CDMO, his company is benefiting
from being able to offer improved
platform technologies and increasing
familiarity and expertise with new
types of products.
Alignment of regulations is
clarifying and helping to speed
completion of documentation at
different sites and with various
partners. Respondents who agreed
strongly with this statement appear to
be those working in regions for which
regulatory pathways are emerging
through newly harmonized
regulations. Those respondents in
particular agreed with the statement,
I see a trend toward better
alignment and understanding of IT
needs with regulatory documentation
and data tracking over a products
lifecycle.
And a final question asked how
managers go about finding a contract
service provider with specific expertise
(e.g., analytical testing, cell-line
development) - to which most
respondents say they rely on colleague
recommendations and existing
contractual relationships with
analytical laboratories. The APAC
respondent notes that his company
brings in a trusted industry
consultant to make sure we are current
with development and documentation
needs.
4 BioProcess International
Communication Amid Complexity
It is easy to talk about the importance
of communication, but not so easy to
encapsulate what it really means in the
context of any one job position. For
project management - even when
communications occur within one
company and supposedly the same
corporate culture - some people are
better able than others to translate
needs and even key terms across the
different departmental/functional
disciplines in a project. And because a
project manager does not, him- or
herself, perform the work of the teams
involved, he or she may come into a
project needing to be brought up-to-
speed on unfamiliar areas of personal
expertise before being able to envision
the combined goals of the project.
We asked BPI author Marcos
Simn (founder of the Bolt-On
Bioreactor Project) to comment on
this from the perspective of managing
his ongoing bioreactor project (4).
Given that (for example) bioreactor
automation requires the collaboration
of experts in biology, mechanical/
electrical engineering, and computers/
software, I asked What challenges
come when such different functions
must come together and communicate
with one another?
His response: Specialists from
different fields approach the same
challenges from surprisingly different
perspectives. Therefore, each of them
tends to apply solutions that proved
successful in their past experiences,
neglecting considerations that are
irrelevant in their respective fields of
expertise. Besides, very often the same
word has a different meaning in
different areas of technology. And
tacit understanding is completely
different in every discipline.
This cocktail of perspectives
provides a great opportunity to merge
solutions from different fields, but it
requires constant surveillance to
alleviate the strains created by
alternative solutions. In this situation,
it is important to share a common goal
and ensure that the development team
has clear priorities when setting
product specifications that evolve
constantly during initial stages of
product development.
15(6) Chapter 3 of 11 State of the Industry 2017
Therefore, as Simn concludes, the
project manager becomes essential to
keep the team on the right path and
translate functional specifications into a
language that allows the specialist to set
the right technical specification to
fulfill the need. At the same time, the
project manager keeps an
understanding of the global evolution of
various aspects of the product to ensure
compatibility and harmonization.
Managing SupplierManufacturer
Projects: Managing a project within
one company may introduce conflicts
in communication and goal setting,
but as mentioned elsewhere in this
special issue, the industry is also
experiencing a strong trend toward
partnering and long-term supplierend
user relationships. Driven in part by
earlier warnings about shortfalls in
manufacturing capacity and potential
supply-chain interruptions as well as
by the need to ensure continuity and
comparability of supplier materials,
this trend further emphasizes the need
for skilled project management in our
industry. Sobering examples of supply-
chain disruptions over the past 15
years include shipping delays due to a
major volcanic eruption and supply
shortages after the Japanese tsunami.
I asked editorial advisor Miriam
Monge (director of marketing,
integrated solutions at Sartorius
Stedim Biotech) to comment on the
role of project management in these
long-term business relationships. She
said, As suppliers work with end users
to implement fully single-use
technologies, analytics, and services
(full platforms so to speak), the end-
users are really outsourcing to a third
party quite a lot of what they would
previously have managed internally. It
is therefore the nature of this
relationship that drives the trend
toward long-term supplier-
manufacturer relationships because a
strong level of trust needs to be
established between both parties.
Sartorius worked with Synthon for
end-to-end integration of single-use
technologies for commercial
manufacturing. This study was
presented at the ISPE annual meeting
in Barcelona in April 2017 of Upstream
Biotechnology. Nienke Vriezen director

upstream, Synthon Biopharmaceuticals,
explained key success factors behind
executing the project in record time.
They included the close collaboration
between the project management and
engineering teams, regular face-to face
meetings, understanding of the
limitations and drivers for decisions,
and ensuring fully scalable bioreactor
technologies from development
through to production-scale. Vriezen
noted that this attention to
communication and understanding
shared goals enabled the first
engineering batch to be started in
under 12-months.
As Vriezen put it, The engineering
principles represented in the Sartorius
bioreactor portfolio were essential in
the smooth scale-up of cell culture
from lab scale to a disposable 2,000-L
reactor. Face-to-face meetings were
instrumental in the design and quick
implementation of all process
equipment.
The Influence of Platform
Approaches: Development and
implementation of platform
technologies also contribute to
streamlining project management.
Platform approaches take many forms
in our industry, but as Monge
explains, the benefits have been
greatest in the context of managing
projects that use disposable
technologies. A platform approach
builds a standard end-to-end single-
use process from process development
to commercial and aims to ensure a
consistent approach for all products/
processes, services, and analytics. Such
an approach enables us to develop full
support and guidance through the life
cycle of our clients projects.
Standardization of single-use designs
ensures supply-chain security,
facilitates technology transfers,
facilitates operator training, enhances
flexibility, ensures better predictability
reducing risk, and enables us to build
up knowledge to fine-tune platforms
and optimize cost. This integrated
technology, service, and analytics
platform approach enables us to
considerably speed up project
implementation.
Risk Assessments and Cost-
Modeling Tools: Finally, modern
5 BioProcess International
Advisors and Authors Speak Up on Scope Management
Interdependencies are inevitable among groups, and a project manager (PM) has to
ensure adequate communication within sites and across sites. This gets even more
challenging when working globally. In general, projects have a way of morphing into
enormous entities, and a key function of the PM is scope management.
With the dramatic changes in the global political landscape (e.g., Brexit), it is
mandatory to have professionals available who can keep their finger on the pulse of
the various changes and regulatory requirements
Sensitivity with regard to culture, be it the company or country culture, is essential.
It is necessary to be informed about the norms of the teams you are working with.
Adequate communication is at the core to keep programs on track toward the desired
result. The expansion of the scope of work, or scope creep, needs to be kept in
check, or the result can suffer.
Timely communication includes periodic reports to keep all stakeholders informed
and aligned. How much detail to include in a report is essential to know, always
keeping in mind the audience and their specific needs.
Responsible communication, while not always discussed, must always be on our
radar. The project manager must practice ethical communications and ensure that
accurate information is provided so that the right decisions are made. It is important
to remember that the stockholder is not the only stakeholder or even the key one; all
the activities are carried out to ensure patient safety. Corporate management has to
be aware of the issues. Remember that when a Consent Decree is issued, it is the CEO/
COO of the company that would be named as defendant. So although the PM may
not always be the decision maker, it is he or she who drives the decision-making
process.
Hazel Aranha (PhD, RAC, technology expert, viral clearance and biosafety oficer,
Sartorius Stedim North America Inc.), and Leonore C. Witchey-Lakshmanan (PhD,
principal consultant, Pharma CMC/IP)
project management also benefits from action (CAPA) plans that are in place
availability of cost-modeling tools and and necessary in all pharmaceutical
current techniques for risk-assessment, facilities.
which can model a process from end Many software options are
to end (512). Such tools influence key available. Selection will be based on
decisions and encourage increased your needs. A balanced framework
integration of end-to-end single-use during selection focuses not only on the
processes, analytics, and services in bells-and-whistles associated with the
commercial biomanufacturing. software but also barriers to
Aranha and Witchey-Lakshmanan implementation - the stakeholders
note that any discussion of project buy-in and commitment. It is
management-tools evokes visions of intuitively obvious that the software
Program Evaluation and Review you select has to be compatible with
Technique (PERT) and Gantt charts the IT infrastructure of the company
that help identify tasks, timelines, and (e.g., some commercial software may
critical path issues. Tools such as these not be compatible with a Mac system).
are also beneficial in managing the
foreseeable risks with known impact: Risk Management
the known-knowns. Examples of via Project Management
managing known-knowns include Identifying risks at the right stage and
development tasks required for developing an effective mitigation plan
product registration and licensing, are key factors for success, both
sourcing supply chain management, financially and technically. The
analytical testing and QA release complex drug development and
activities, packaging and labeling, and registration process includes
distribution management. These management of multiple business
activities might also include training, processes, such as technical
documentation, facility maintenance development using quality by design,
and any corrective-and-preventative regulatory strategy, clinical studies, and
15(6) Chapter 3 of 11 State of the Industry 2017
supply-chain management. Multiple
challenges and decision points mandate
a realistic and robust risk management
model. The integration of risk
management into product development
is imperative. Parallel issues exist also
for products and devices that are
commercialized.
What to Watch For: BPI author Ben
Locwin (13) described common
mistakes that managers make when
attempting to apply a risk-based
approach: What I seemost oftenis
that organizations take risk assessment
and risk-based decision making too
lightly: After conducting exhaustive
risk assessments and prioritizing the
most critical elements, the
organizations will sometimes then try
to pick-and-choose their favorite
themes to spend time and resources on.
This goes against the very nature of
quantitative risk assessment. An
ordinal list tells you exactlywhereto
focus your efforts, and if you then take
that risk registry and subject it to
personal opinion, you undermine its
objective value and clarity. This is
exactly the same as whats called
p-hacking, or conducting hypothesis
Increasingly Global
Patient populations for clinical trials are
increasingly global. Clinical trials are
expensive, and cost management may
be a factor when deciding where to
conduct trials. It is necessary to
recognize that trials may be conducted
in countries where there are low barriers
to patient enrollment or other
incentivization programs. For example,
conducting clinical trials in India or
Eastern Europe may be more cost
effective because, in general, costs are
lower compared with the those of the
Uniter States. However, the patient
populations are not always accepted in
the country of the eventual filing. Some
countries subsidize clinical trials by as
much as 4060%, which makes them
more attractive choices. Managing data
input from multiple global sites requires
considerable PM skills to ensure that
there is harmonization among the sites
so that data can be extrapolated
appropriately to target patient
populations. Hazel Aranha and
Leonore C. Witchey-Lakshmanan
6 BioProcess International
testingaposteriori: You cant peek at
data from a scientific study
tothendecide what you will use as a
threshold for success.
Similarly, you cant take a list of
highest-leverage risk factors in your
business model (that your experts have
decided upon) and then choose what
to work on based on what feels right.
If working on what feels right was
the key to success, then businesses
wouldnt haveanylatent risks to
resolve or defects/deviations in their
backlogs, nor any quality issues
because their gut instincts would have
led them to perfection.
Sometimes choosing between
courses of action can be hard for
managers and leaders, and a good risk-
based decision-making program can
make divorcing emotion from such
decisions much easier and more
effective for the business. This way,
pet projects and favorite goals dont
survive at the expense of objectively
favorable courses of action. Project
management activities should always
incorporate relative probabilities of
something occurring properly (or not).
This is just good forecasting, and its
also one of the biggest stumbling
blocks that I see for groups and
companies. A good Gantt-view of the
world (a complex project) should be
replete with probabilistic assessments
of the uncertainty of each task
occurring properly.
What the Industry Is Doing Well:
Further elaborating on decision-
making tools, Locwin continues:
There has been an overall greater
incorporation of risk management
themes into the industrys vernacular.
However, deep and thorough
understanding of how to actually
apply it and execute it has been
lagging. Risk is a tricky entity to wrap
ones arms around. Its asking about
things that havent happened yet, and
directing businesses to spend resources
(time and money) on preventing a
potential issue before it occurs. It
comes down to avoidance of certain
significant events, which may or may
not have occurred anyway. Locwin
adds that Its this mindset of proving
a negative demonstrating that your
15(6) Chapter 3 of 11 State of the Industry 2017
risk prevention worked at preventing
something that hadnt occurred yet
that makes it so difficult to pin down
for users.
Aranha and Witchey-Lakshmanan
spoke further about the importance of
identifying known unknowns. Risk
management has become more and
more important in our global
environment, in particular in light of
issues such as contaminated heparin
products and such. Thus,
biopharmaceutical teams must assess
risks of all kinds, identifying ones with
known certainty and known impact
(known-knowns). However the teams
also must assess the potential of
unknown risks and their associated
unknown impact (unknown-
unknowns). Consequently, project
management becomes more complex
when addressing these as well as the
known-unknowns. Managing known-
unknown risk may include contingency
planning in multiple areas:
globalization in shipping, distribution
channels, global compliance and in
clinical, analytical, production,
packaging, labeling, and so on. In
addition, continual regulatory changes,
from development through marketing
and labeling, scale up and process
improvement even postapproval risk
assessments are areas where
contingency planning is essential and
has to be customized specifically for
the project.
Project management encounters
even greater challenges when
encountering unknown-unknown
risks. These can also be considered
risks that have high uncertainty of
occurring and yet would have an
unknown impact. To minimize such
events, teams can gather and evaluate
process effects on critical quality
attributes of a product or a device.
Often this translates to a color-coded
matrix pairing processing steps with
product/device critical quality
attributes. Then each cell of the
matrix is coded with green for low
impact low uncertainty or red for high
uncertainty and high impact. Yellow
and orange can be used for
intermediate risks. In this way a team
can anticipate high risk issues and
circumvent them as best as possible.
 Key Indicators of Results and
Performance: According to Aranha
and Witchey-Lakshmanan, many
industries are moving toward a matrix
approach in PM to include other
players such as functional managers
and upper management, each group
with its own role and responsibilities.
The project managers are challenged
with keeping this interrelationship
viable to benefit the project. We are
all familiar with key performance
indicators (KPIs). Todays focus is also
on key results indicators (KRIs). A
KRI is the result of many behaviors
and activities (performance indicators).
KRIs report on the results of many
activities, so are backward looking;
they measure the effect of activities
without focusing on the cause. KRIs
reflect the wins, and the actions are
tracked with suitable KPIs. If you
meet your KPIs, the wins will take
care of themselves.
Training the Project Managers
of the Future
Adapting to change is easier to say
than to accomplish, and the past 15
years have introduced radical changes
to biopharmaceutical development
and manufacturing. The QbD
mandate alone has affected just
about every operation in drug
development, from process design to
contract relationships, to packaging
and shipping. Biomanufacturers
embrace of single-use technologies
introduced greater possibilities for
flexibility in manufacturing along
with more complex risk-assessment
needs in an industry that long has
needed more people trained in
interpreting statistical findings.
I asked Jan Schfer (manager of
process applications at Sartorius
Stedim Systems GmbH Integrated
Solutions) about the impact of the
above on project management career
preparation. In the past decades we
were focusing on traditional stainless
steel project management by
concentrating on well-established
schedules, tasks and deliverables
during basic design, detailed design,
and execution of bioprocess
equipment. Since the introduction of
single-use technologies some years
ago and todays proven implementation tremendous gap in offerings between
of complex single-use process what the industry needs and what
equipment, there is a demand to brand-new candidates have for
adapttraditional bioprocess project- training (1315). This is true on the
management activities. In particular, R&D side (especially in
customers needs for flexible facility pharmacovigilance, PV), as well as
arrangements and for platform on the manufacturing and
processing (including various media/ commercial side. There are some
buffer distribution concepts) are excellent offerings, for example
increasing the need for extensive through NBC2 (the Northeast
single-use technology integration Biomanufacturing Center and
concepts (SUTIC). As these concepts Collaborative http://
move engineering work packages and biomanufacturing.org), BTEC (the
procurement processes to earlier Biomanufacturing Training and
project phases, the industry is Education Centerhttps://www.btec.
rethinking its traditional bioprocess ncsu.eduthrough North Carolina
project execution models. All this State University), and other groups.
requires new training concepts and Locwin notes that for those who
updated project execution models to are interested in careers in project
do the right thing at the right time management, the first step to
and to benefit from fast-track project approaching any field or career path
execution. That is one of the most properly is to see whats out there for
relevant reasons for moving into a body of knowledge (BoK). In the
single-use processing. project management world, this is
Training Gaps: I asked Locwin fairly easy because organizations such
how new people coming into the as the Project Management Institute
biopharmaceutical industry receive have amassed and compiled targeted
management training beyond BoKs to serve as a basis for minimum
academic preparation. He and other expertise (3). That establishes a
authors agree that there is still a baseline for a person to follow and to
The Dawn of a NEW Manufacturing Paradigm
Introducing our SCALE-OUT approach
...that eliminates cell culture scale-up risks
. for ultimate flexibility and scalability
using only disposable bioreactors
.to achieve metric ton outputs
Contact us to learn more about our "scale-out" approach utilizing the
world's largest single-use bioreactor manufacturing plant (14 x 2,000 L).
info@wuxibiologics.com
www.wuxibiologics.com

honestly assess his or her knowledge
against a benchmark.
Aranha and Witchey-Lakshmanan
note that training programs focus on
both hard and soft skills. In addition
to developing several basic
competencies organizational
leadership and decision making,
technical and leadership skills,
strategic and business management
training programs also include courses
in professional communications and
negotiations and conflict resolution.
Formal training and certification as a
project management professional can
be obtained either through
professional associations or
universities. Boot camps for
additional coaching are also offered.
Locwin says that to be credible, you
need targeted training to build your
foundational knowledge. There are
plenty of project managers who just
took their jobs because of opportunity.
But although they can function in a
certain pocket of performance, as teams
or projects get more complex, they
wont have the depth of skills and tools
that are available if they just happened
into the role and learned it in a trial by
fire.
So where are the best project
managers found? In-house? Outside
the organization? According to
Aranha and Witchey-Lakshmanan,
this debate is akin to the one weve
had related to outsourcing other
functions such as R&D and
manufacturing. Do you have the
required expertise in-house to address
the complexities of PM at various
stages of the development cycle?
Assuming you do, do your employees
have the bandwidth to take on the
additional functions on the critical
path to drug development?
Boutique Consulting: Given the
difficulties in grooming in-house
talent, pharmaceutical companies both
large and small have been touring
outside their own walls. Aranha and
Witchey-Lakshmanan continue:
Boutique consulting companies
8 BioProcess International
offering specialized services are
gaining prominence. Such companies
offer targeted expertise for the specific
stage of product development and stay
focused on the key decisions relevant
to each phase. Built into their
functions of strategic planning and
tactical deployment are scope
management and risk mitigation.
Boutique consulting currently
benefits from availability of a big
talent pool with significant expertise
and talent. Currently, theres a bigger
cadre of ex-pharma managers who can
provide both business and technical
insights. Choosing between a boutique
approach and hiring a single PM
consultant depends on a teams
specific needs.
Aranha and Witchey-Lakshmanan
conclude that the efforts toward
establishing good project management
pay off literally. Pharma industry
data suggest that companies
implementing project management
improvement initiatives have seen
appreciable return on investment
(ROI). Decision makers recognize
this, and in spite of competing
demands for resources, project
management professionals whether
as in house or outsourced expertise
are deployed to facilitate projects.
References
1 Aranha H, Witchey-Lakshmanan L.
How Project Management Fits into the Drug
Development Continuum. BioProcess Int. 8(5)
2010: 1017.
2 Bateman L. Of Projects and Programs.
Rabb School of Continuing Studies Division of
Graduate Professional Studies, Brandeis
University, February 2012: projectmgmt.
brandeis.edu; http://projectmgmt.brandeis.edu/
downloads/BRU_MSMPP_WP_Feb2012_
Pharma.pdf.
3 PMI. A Guide to the Project Management
Body of Knowledge (5th Edition, Project
Management Institute, Inc. Newtown Square:
PA, 2013).
4 Simn M. Bioreactor Design for Adherent
Cell Culture: The Bolt-On Bioreactor Project. Part
1: Volumetric Productivity, BioProcess Int. 13(1)
2015: 2833; Part 2: Process Automation,
BioProcess Int. 13(4) 2015: 4047; Part 2:
Containment, Sterility, BioProcess Int. 13(5)
15(6) Chapter 3 of 11 State of the Industry 2017
2015: 3440; and Part 4: Process Economics,
BioProcess Int. 13(8) 2015: 2229.
5 Forgione P. Bioprocess Data
Management. Industry Yearbook 20102011:
99; www.bioprocessintl.com/wp-content/
uploads/2014/07/
BPI_A_100807AR57_O_104314a.pdf.
6 Torres M. Challenges in Implementing
Quality By Design: An Industry Perspective.
BioProcess Int. 13(6) 2015: 1825.
7 Boddins JR et al. CMC Forum:
Evolution of Biopharmaceutical Control
Strategy Through Continued Process
Verification. BioProcess Int. 15(1) 2017: 1019.
8 Little TA. Quality Risk Management for
Drug Products and Drug Substances. BioProcess
Int. 12(5) 2014: 2431.
9 Pentia DC et al. Reducing Clinical-
Phase Manufacturing Costs: Collaborating for
Savings without Compromising Quality or
Performance. BioProcess Int. 14(11) 2016: 4453.
10 Pollard D et al. Standardized Economic
Cost Modeling for Next-Generation MAb
Production. BioProcess Int. 14(8) 2016. 1423.
11 Price S, Marr James Jr. Shrink Your
Inventory Costs and Make Your Staff Happier.
BioProcess Int. 12(11) 2014: 5255.
12 Sinclair A, Monge M, Brown A. A
Framework for Process Knowledge
Management. BioProcess Int. 10(11) 2012: 2229.
13 Locwin B. Quality Risk Assessment and
Management Strategies for Biopharmaceutical
Companies. BioProcess Int. 11(11) 2013: 5257.
14 Langer ES. Hiring and Staffing in
Biopharmaceutical Manufacturing: Five-Year
Trends Indicate Difficulty in Filling Positions.
BioProcess Int. 14(1) 2016: 1417, 35.
15 Humphrey R. Recruiting and Market
Locations. BioProcess Int. 13(1) 2015: 48. c
Share Reshape Life Sciences Facilities and
S. Anne Montgomery is cofounder and
editor in chief of BioProcess International,
PO Box 70, Dexter, OR 97431;
amontgomery@bioprocessintl.com.
This is an extended version of the article
published in BPIs June 2017 print issue.
To share this article in a PDF or professionally
printed format, contact Rhonda Brown,
rhondab@fosterprinting.com, 1-866-879-9144
x194.