Project Management in Pharmaceuticals

International Journal of Pharmaceutical and Life Sciences
Volume 1, Issue 1, Serial 4: August 2012
Project Management in Pharmaceuticals

Tanzeena Sara, Sales Training Department
sanofi-aventis Bangladesh Limited
Introduction
Project management is the discipline The first challenge of project
of organizing and managing management is to make sure that a
resources in a way that the project is project is delivered within defined
completed within defined scope, constraints. The second, more
quality, time and cost constraints. A ambitious challenge is the optimized
project is a temporary endeavor allocation and integration of inputs
undertaken to create a unique needed to meet pre-defined
1
product or service. This property of objectives. A project is a carefully
being a temporary and one-time defined set of activities that use
undertaking contrasts with resources (money, people, materials,
processes, or operations, which are energy, space, provisions,
permanent or semi-permanent communication, etc.) to meet the
ongoing functional work to create the pre-defined objectives.
same product or service over and
over again. The management of Someone says that project
these two systems is often very management is an art, someone
different and requires varying says as science. Project
technical skills and philosophy, management is more, much more of
hence requiring the development of an art than a science, and the
project managements. application of project management is
not consistent across industries,
environments, and situations.2
Considering uncertain world of
pharmaceutical project management,
Author is senior officer of Sales Training
Department at sanofi-aventis Bangladesh this article will focus on the elements
Limited.
Email: [email protected] to form a pharmaceutical project.

Elements of Pharmaceutical selling, and sponsoring of the

Project Management project.
Generally six elements can be
considered for project management.2 Project objectives define target
• Project definition status at the end of the project,
• Project team and organization reaching of which is considered
• Project planning, scheduling necessary for the achievement of
and control planned benefits. They can be
• Problem solving and decision formulated as S.M.A.R.T.
making using proto-type
• Specific,
• Senior management review
• Measurable (or at least
and control
evaluable) achievement,
• Proactive and real time
• Achievable (recently
change management
Acceptable is used regularly
as well),
Project Definition
• Realistic and
This first element of a project
• Time terminated (bounded).
management framework is used to
define project scope and objectives. In a pharma industry objectives are
It outlines what is within and not dependend on some objects such as
within the project boundaries, the management/authority, development,
business case and market need, the registration, supply chain, QA,
technologies to be used to solve that patent, market and also parallely
business case, and the initiation, time & cost.
Figure 1: Objects of a Pharmaceutical Project Mangement

Management/ Authority will run the For the evaluation of a project some
project. Development department factors are important to consider
develop the product through depending on risk/benefit. Then top
galenical, analytical, clinical study management takes the deceision
etc. Registration is required for the whether the project can be started or
launching of the product which will rejected.
do the respective department.
Supply chain department will provide Projects need to be performed and
raw material necessary for the delivered under certain constraints.
development through active and Traditionally, these constraints have
excipient sourcing. QA will assure been listed as "scope or work
the quality of the product according requirements- cost, performance,"
to marketting authorization. For "time-to market," and "resources".3
business purpose patent right is to These are also referred to as the
be ensured. Marketting department "Project Management Triangle,"
will deal with the market to launch where each side represents a
the product. Here, if we broadly constraint. One side of the triangle
segment the objective,that will be cannot be changed without affecting
development of the product and then the others.
launching in the market. All these
jobs have to be performed within
time frame & budget.
Figure 2: Constraint Triangle

Managing the triple constraint and After evaluation of risk-befit,

the expectations of management pharmaceutical project is defined.
with regards to the objectives
requires the development and Project Team and Organization
management of the project’s A team is a small number of people
business case with financials. The with complementary skills who are
business case for a new product committed to a common purpose,
project should include the following: performance goals, and approach for
• An evaluation of the market which they hold themselves mutually
and customer needs including accountable.5 A project team can be
appropriate market research divided in two parts- core team and
studies support team. Core team members
• An analysis of the competition are from different functions of an
including their potential organizations who have significant
products and strengths and authority & responsibility in the
weaknesses organization and have both
• A technical assessment of the specialist/technical &
capability of the organization generalist/business skills. Support
as it relates to the product teams are group of team from
competing in the market different functions. A member of core
• A statement of alignment to team can be a leader of support
the organization’s business team.
strategy
• A preliminary evaluation of the In a project management team,
financial opportunity of the every member have specific job. To
new product, which may manage the project efficiently, every
include use of return on member must have specific
• Investment, discounted cash responsibility & proper authority to
flow and internal rate of perform his/her job. The project team
return, net present value, and must have a chart which visualizes
break-even time.4 where every member is located in

project management network. It

shows the role of team members and total team results with
other relationships (to sub-teams or functional evaluations
to external units etc.) • Promotion and pay—creating
Each team member- incentives based upon team
• Ensures functional expertise results and involvement in
on the project successful new product
• Represents functional teams, and
perspective on the project • Career development—
• Ensures functional providing lateral career paths
deliverables are met across the functions that
• Proactively raises functional develop heavyweight team
issues that impact the team. members.
Team members must realize that
they are part of a team. For the team Project Planning, Scheduling and
to be most productive and effective, Control
team members must collaborate with Different method can be considered
other team members, put aside their for planning of project management
own personal or functional agenda, such as Work Breakdown Structure
and use dialogue to develop a (WBS), Critical Path method, Project
common understanding and create Evaluation and Review Technique
the best cross-functional approach (PERT). The Work Breakdown
6 Structure (WBS) is a tree structure,
for the project and the organization.
which shows a subdivision of effort
For an effective and productive required achieving an objective; for
team-oriented structure, example a program, project, and
organizations must support cross- contract.7 The WBS may be
functional teams and use these hardware, product, service, or
teams in a way that makes them process oriented. In a project of
more effective. Following contract, the WBS is developed by
approaches can be considered- starting with the end objective and
• Performance appraisal— successively subdividing it into
including team-member and manageable components in terms of
size, duration, and responsibility

(e.g., systems, subsystems, As an example, for pharmaceutical

components, tasks, subtasks, and project following points can be
work packages) which include all considered in WBS: Project master
steps necessary to achieve the plan, Evaluation of project through
objective. analysis of objectives-scope-
timeframe etc, Development
The Work Breakdown Structure Strategy- Pre-formulation study/
provides a common framework for formulation/clinical study/ analytical
the natural development of the study/stability testing/cost effective
overall planning and control of a process development etc, Raw
contract and is the basis for dividing material sourcing, Dossier
work into definable increments from compilation & Registration, QA
which the statement of work can be program, Launch to market and then
developed and technical, schedule, closure.
cost, and labor hour reporting can be
established.
Project Master Plan
Evaluation Development Raw material Dossier compilation QA program Launching

sourcing
Formulation. Registration
Production and
Study
Figure 3: Sample of WBS of a pharmaceutical project where horizontal axis

provides main project phases and vertical axis provides work packages of each
project phase.
The critical path method is a network scheduling flexibility or the least

analysis technique used to predict amount of float. This critical path
project duration by analyzing which determines the earliest completion of
sequence of activities or path most the project.1 The critical path method
likely has the least amount of relies on one estimate for the

duration of a task, whereas PERT Gantt chart is another tool by which

uses three estimates. These are the project can be scheduled. the
most likely (i.e., the critical path basic Gantt chart is an easy way to
method), worst case, and best case document schedules. It is a
estimates. In practice, PERT horizontal-bar schedule showing
becomes a very cumbersome activity start, duration, and
approach to scheduling and tracking completion. It shows the connection
time. between events and the calendar,
and provides a graphical analog of
the activity duration.
Figure 4: The Gantt chart
The Gantt schedule can illustrate the well to depict in graphical way areas
relationship between work activities where there are modified
having duration, events without expectations from the baseline plan.
duration that indicate a significant
completion, and milestones that Once a Gantt schedule has been
represent major achievements or established for a project, progress
decision points. Various annotations should be periodically plotted against
can be used to communicate the the baseline schedule. If different
progress of the project effort functional areas are involved in a
compared to the baseline plan, as project, each area may need its own

detailed schedules to support the _ Identify which tasks can be started

project master schedule. In such today, based availability of
cases it is important that working information not upon availability of
schedules be linked to a common resources.
master schedule in a way that they _ Identify which tasks can be started
can be easily updated. Each activity after the initial tasks are completed,
or event on the schedule should which tasks can be completed after
have a responsible individual that and so forth to the end of the
assigned, so there is clear ownership project or the next major milestone.
and so schedule status can be 4. Obtain team member
updated without a lot of fuss. commitments to deliverables—
usually best accomplished after the
A popular approach for team first planning meeting.
members to develop a project 5. Negotiate between project
network diagram is a concept known milestone dates and team member
as the ‘‘yellow sticky’’ method. This deliverable dates.
method uses post-it notes, roll-paper,
and markers and the team to PROBLEM SOLVING AND
develop a network diagram. The DECISION MAKING USING
suggested steps of the ‘‘yellow PROTOTYPES
sticky’’ methods are as follows: Pharmaceutical development
1. Identify the milestones that the projects consist of different phases,
project team will track with technology transfer processes,
management along with target milestone and problem solving
completion dates. issues. To understand the progress
2. Identify the team member of projects, these constraints need to
deliverables or responsibilities that be understand to visualize the
need to be completed prior to the project status and for communication
milestone dates (this provides ending purposes. For examples-
linkages for deliverables). • The phases of clinical
3. Create the network diagram as development for a
follows: pharmaceutical development

project: phase I, II, III, IV and Another basic building block of any
post-marketing; product development project is
• The technology transfer from design–build–test cycles. These
research to development and cycles use prototypes to serve as a
from development to focal point for problem solving,
manufacturing; testing, communication, and conflict
• The major milestones of a resolution. Using these cycles
pharmaceutical project: FDA provides feedback on decisions
submission and first lot to made so far and identifies issues that
stock; need to be resolved. Examples of the
• The use of different product prototyping cycles for a clinical
prototyping cycles and their development project are-
value towards solving • Identify the bulk drug vendor
problems, communicating • Determine formulation
results, and making progress. feasibility
• Complete engineering runs
For a technology transfer processes, • Produce clinical and/or
two types approaches can be used- stability samples
sequential and overlapped. In • Ramp-up manufacturing
sequential approach, upstream process
group waits for completion of work • Produce first lot to stock
before starting next step and after product for sale.
completion of work communicate These examples are shown to
with downstream group. Simply, this illustrate the importance of the
is called one after one work. In design-build-test cycle process.
overlapped approach, different work Cycles will vary from project to
can be performed parallel and can project. Completing each of these
be taken input from downstream cycles is a very effective approach to
groups. Communicating with cross tracking and demonstrating project
functional groups, different work can progress. Prototpyes can provide
be completed more successfully. very focused communication about
the progress to date and the

remaining tasks required to complete portfolio and the aggregate

8
the project. set of projects that will
achieve their strategic
objectives.
• Senior management should
SENIOR MANAGEMENT REVIEW be actively involved in
AND CONTROL assigning the type of project
Senior management provides the team and type of project, i.e.,
sponsorship, championship, and where this project falls in the
funding for the pharmaceutical portfolio.
development projects that new • Senior management should
product teams are working on. They develop and support a project
need to be involved and understand review process that
the importance of the project, its link encourages early involvement
to business strategy and growth, the in the project to validate the
risks and issues that the project is business assumptions and
facing, and the status of the project. decrease project surprises.9
This understanding is important
throughout the life of a project Project reviews with senior
particularly at the start of the project. management are a key element of
the new product process. The project
Senior management involvement, manager should have the ability to
especially at the start of the project, interface directly with senior
is key to successful project management. As previously
outcomes. Some process guidelines mentioned, a hierarchy of reviews is
to assure management involvement important to assure timely, continual
2
are as follows : communication of project status and
• Senior management should issues. Also, stage gate reviews are
define strategic direction that a very popular process for clarifying
will be used to drive new project definition and evaluating the
product development. project’s business case and technical
• Senior management should issues. Senior management should
define the new product project get involved in these reviews to

assure that the project continues to

be on target and meet the overall
goals for new product development. PROACTIVE, REAL TIME CHANGE
Senior management reviews should MANAGEMENT
evaluate: Managing scope changes requires
• The business issues and the proactive installation of a scope
goals of the project change process for projects that
• Issues related to the includes a method for identification
customer’s needs and the and management of project risks. A
marketplace suggested process for managing
• Resource management scope changes is the following:
• Corporate and business unit • State the real problem
direction and product line fit • Gather the relevant facts
• Sales and payback • Develop several alternative
expectations solutions
• Project schedule • Analyze and review impact for
• Timely introduction to market alternatives
• The availability and maturity of • Adopt the best alternative
the technology to meet quality • Tell everyone (communicate
and cost targets with all stakeholders)
These reviews can be scheduled to • Audit the outcome
occur on a regular basis (e.g., after a Senior management needs this
phase is completed or every quarter, information to understand the
as stage or phase gates propose) or financial impact on the business and
on an as needed basis by senior the project manager must provide it.
management or the project team. The project manager should use a
These reviews need to be used to financial model for the project and
determine whether or not to continue understand:
with the project (e.g., make go/no go • The cost/benefit of time
decisions) or change project delays or improvements
direction (e.g., scope change). • The financial impact of
increased or reduced product
cost and/or project investment

• The benefit of improved pharmaceutical arena plays a key

product use, indications, role in bringing teams together,
functionality, or features. integrating solutions across
Risk due to uncertainty is reality in all functions, and providing a generalist
projects including pharmaceutical view of projects to balance the more
projects. Further decision need to be scientific/technical perspective. For
taken considering risk assessment. the most optimal results,
Risk assessment to be performed organizations need to recognize the
considering probability of occurrence importance and support the role of
and financial impact. project managers.
CONCLUSION
In this paper, project management of
a pharmaceutical industry is
discussed from project planning and
evaluation to project closure. The
1950s marked the beginning of the
modern project management era. In
1950s, project management
structure is formed depending on
work breakdown structure and Gantt
chart. In this paper, project
management is studied using the
knowledge of PERT, Gantt chart,
Yellow sticky method and work
breakdown structure. This more
flexible form of the application works
well within a decentralized, team-
oriented environment—an
environment that is conducive to
successful pharmaceutical new
product development. Project
management within the

REFERENCES
1. Project management institute (PMI) standards committee. In Project

Management Body of Knowledge; PMI, 1995.
2. Jerome, J. G.; Cara, R. F.; Project management, Encyclopedia of

Pharmaceutical Technology, pp. 3015-3026 (2006)
3. Reinertsen, D.G. Managing the Design Factory; Free Press: New York,
1997.
4. House, C.; Price, R. The return map: tracking product teams. Harvard Bus.
Rev. 1991, Jan/Feb.
5. Katzenbach, J.R.; Smith, D.K. The Wisdom of Teams; Harper Business,

1994.
6. Issacs, W. Dialogue, The Art of Thinking Together; Currency Doubleday,

1999.
7. Work Breakdown Structure, Wikipedia,

http://en.wikipedia.org/wiki/Work_breakdown_structure, (15 July 2012)
8. Wheelwright, S.C.; Clark, K.B. Revolutionizing Product Development; Free

Press: New York, 1992.
9. Wheelwright, S.C.; Clark, KimB.. Leading Product Development; Free

Press: New York, 1994.

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International Journal of Pharmaceutical and Life Sciences

Volume 1, Issue 1, Serial 4: August 2012