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TitlePharmaceutical Project Management, Second Edition
File Size2.7 MB
Total Pages269
Table of Contents
                            Front Cover
Title Page
Preface
Contents
Contributors
Chapter 1 Strategic Project Management at theProject Level
Chapter 2 Strategic Project Managementat the Portfolio Level
Chapter 3 Project Planning: From Basic Conceptsto Systems Applicationa
Chapter 4 Project Management of Chemical, Analytical, and Formulation Development
Chapter 5 Project Management in ExclusiveSynthesisa
Chapter 6 Clinical Trials—Can They Be ProjectManaged?
Chapter 7 Regulatory Project Management
Chapter 8 Teams
Chapter 9 Project Management and OutsourcingDrug Development
Chapter 10 The Project Management Function
Index
Back Cover
                        
Document Text Contents
Page 1

CMYK
DPS_6x9_Generic_IBT.indd

PANTONE 202 C BLACK

about the book…

Encompassing the full spectrum of project management’s role and responsibility
encountered in the pharmaceutical industry, Pharmaceutical Project
Management outlines the key objectives, risks, and challenges of each stage of
the pharmaceutical lifecycle, from discovery and preclinical phases through
clinical development, manufacturing, registration, and launch.

New updated material includes:
• expert recommendations and informative articles on decision-making
• planning principles and planning systems
• management of subcontracted development
• manufacturing project management
• team leadership and skill sets
• drug development strategies

It covers primary project management objectives, functions, and descriptions of
the nature and execution of work activities in a clear and reader-friendly format
to illustrate key characteristics and objectives, assist managers in projecting
the risks and challenges of each development option, and supply concise
recommendations for successful project planning.

about the editor...

ToNy KENNEdy is Vice President of development at Trigen, Ltd in London, U.K.
dr. Kennedy, a Medical Research Council Postdoctoral Research Fellow at The
School of Pharmacy, London University, U.K., was awarded his Ph.d. by London
University, U.K. and was previously the Global Head of Project Management at
Roche, Switzerland. He was the editor of the first edition of Pharmaceutical Project
Management which was published by Marcel dekker in 1998, and his career has
been devoted to the discovery and development of novel drugs while working in
large pharmaceutical and small biotech companies. dr. Kennedy has directed
global drug development teams in several therapeutic areas including
cardiovascular, gastrointestinal, infectious disease, rheumatology and oncology,
and led the Roche-Gilead joint development team that took the flu antiviral
Tamiflu to registration three years after the discovery of the molecule.

Printed in the United States of America

DRUGS AND THE PHARMACEUTICAL SCIENCES VOLUME 182Pharmaceutical Science and Technology 182

edited by

Tony Kennedy

Pharmaceutical Project Management: Second Edition
Kennedy

Pharmaceutical
Project Management

Second Edition

Kennedy_978-0849340246.indd 1 2/5/08 3:05:00 PM

113257-K
ennedy PM

S 202 B
lack

Page 134

114 von Hippel

� custom manufacturing projects,
� contract manufacturing projects, and
� toll manufacturing projects.

Custom manufacturing projects are projects where the customer typically
has a molecule just emerging from research and perhaps a first idea of how to
synthesize it but no more information. For such a project, usually no technical
information is available, and therefore the only information to share might be
the structure or a chemical abstracts service (CAS) number. It is part of the
project partner’s job to develop a synthetic route, including all the in-process
controls required, and sometimes even to develop an analytical method for the
final product. Both customer and supplier will work together to find a workable
specification and to fulfill all requirements from the authorities. The full range of
support is required and, ideally, all functions should be in-house at the selected
partner’s site.

The best partner for such a development will be a company able to offer
the full range of technologies needed, including the strongest analytical support.
To have these technologies available not only on paper but also in reality, such
a company should have a minimum size. Without this critical mass, a company
is unlikely to have the financial and organizational power to have all relevant
analytical equipment in place and might not be the best partner in terms of broad
access to creativity to offer best solutions to the customer’s needs. This type of
company might also have the power to have a worldwide network of suppliers for
raw materials and the power to direct them. Such a company might also have most
types of the production equipment in-house leading to high flexibility in terms of
realizable processes.

On the other hand, such a company might also have its limitations. For
high-throughput screening substances, just a few milligrams are needed, so these
companies might not be the best choice. Instead, there are smaller companies
available, typically headed by a chemist with strong experimental skills, that are
able to make small amounts of products in a short time. To focus on such a type of
synthetic work needs other skills than those for production-orientated processes.

Contract manufacturing means the customer will be in the position to share a
more or less detailed process with his potential supplier. The information available
right from the initial project evaluation is more specific and therefore the need to
protect the customer’s interests will be even higher. For both parties it is easier
to understand whether the process will fit into the potential supplier’s production
equipment and how the commercial production will look. On the other hand, there
will still be a lot of open questions about how to adapt the existing process to the
supplier’s equipment and how to run the campaigns best.

The creative part of route design in these cases is more limited, but fre-
quently there are still a lot of questions to be answered and such projects are still
demanding. The transfer of knowledge from one company to the other is partic-
ularly important, and again, the nature of the interaction between the companies
determines the level of success.

Page 135

Project Management in Exclusive Synthesis 115

Toll manufacturing is the last type of project. Here the project sponsor not
only provides the detailed process but also some of the key raw materials. This
will be very interesting for both parties in the event that special technologies are
requested and both companies in combination can offer an advantage that they do
not have independently. This is the most extreme level of cooperation at the other
end of the scale: While custom manufacturing requires a spirit of invention, toll
manufacturing takes advantage of special technologies and the availability to run
them.

For the responsible project managers of the two companies, the job is again
more difficult than in the case of pure contract manufacturing: Even more functions
of the two companies have to work together and interact to make the project a full
success. Depending of the regulatory status of the product—non-GMP [not fol-
lowing good manufacturing practices (GMP)], c-GMP [current GMP], registered
intermediate, or API—the complexity grows. Only open communication and a per-
manent comparison of the expectations of the two development partners allows
both parties to optimize and reach a level they could not achieve independently.

ORGANIZATIONAL CONSEQUENCES AND
PORTFOLIO MANAGEMENT

A chemical company dealing with exclusive synthesis is typically almost over-
whelmed with work and inquiries. To manage this permanent overload and to
keep it workable is part of the management function of the organization. Having
products produced on a campaign basis means also that the utilization of the plants
and the equipment varies permanently and has to be managed as well. In addition,
the different levels of project complexity and different levels of requirements have
to be balanced all the time.

Figure 2 shows, in a general way, how such a project-driven organization
might look. The whole process is driven by the project managers who have an
exceptional role within the organization. These managers need the support of all
the relevant functions, for example, R&D, production, procurement, and QA/QC
(quality control). On a project basis, colleagues from these areas will report func-
tionally to the project manager who is supervising the project and keeping an
eye on the targets. In a multiclient and multiproject environment, the different
project managers themselves need supervision to deal with shifting priorities and
allocations of resources. This is necessary to balance all the different projects with
the requirement to reach an optimized utilization of resources.

From a project portfolio perspective, a company has to develop tools to
balance the different requirements and to work with the tasks of multiproject man-
agement. There are not too many examples of organizations working almost totally
in a project structure: The most common example is the consulting industry: This
type of service is clearly driven by projects alone and therefore these companies
give most of the power to their project managers. The rest of the organization
has to support the projects activities, and conflicts of interest have to be settled
by a steering committee. Such a company structure, typically matrix organized,

Page 268

248 Index

venture capital, 106, 110
versatility, 53

warfarin, 13, 16
Waxman�Hatch legislation, 28

weighted scoring models, 39
work packages, in drug development, 62, 64,

70�71, 76, 81, 112
Wyeth Business Process Outsourcing Model,

208

Page 269

CMYK

DPS_6x9_Generic_IBT.indd

PANTONE 202 C BLACK

about the book…

Encompassing the full spectrum of project management’s role and responsibility
encountered in the pharmaceutical industry, Pharmaceutical Project
Management outlines the key objectives, risks, and challenges of each stage of
the pharmaceutical lifecycle, from discovery and preclinical phases through
clinical development, manufacturing, registration, and launch.

New updated material includes:
• expert recommendations and informative articles on decision-making
• planning principles and planning systems
• management of subcontracted development
• manufacturing project management
• team leadership and skill sets
• drug development strategies

It covers primary project management objectives, functions, and descriptions of
the nature and execution of work activities in a clear and reader-friendly format
to illustrate key characteristics and objectives, assist managers in projecting
the risks and challenges of each development option, and supply concise
recommendations for successful project planning.

about the editor...

ToNy KENNEdy is Vice President of development at Trigen, Ltd in London, U.K.
dr. Kennedy, a Medical Research Council Postdoctoral Research Fellow at The
School of Pharmacy, London University, U.K., was awarded his Ph.d. by London
University, U.K. and was previously the Global Head of Project Management at
Roche, Switzerland. He was the editor of the first edition of Pharmaceutical Project
Management which was published by Marcel dekker in 1998, and his career has
been devoted to the discovery and development of novel drugs while working in
large pharmaceutical and small biotech companies. dr. Kennedy has directed
global drug development teams in several therapeutic areas including
cardiovascular, gastrointestinal, infectious disease, rheumatology and oncology,
and led the Roche-Gilead joint development team that took the flu antiviral
Tamiflu to registration three years after the discovery of the molecule.

Printed in the United States of America

DRUGS AND THE PHARMACEUTICAL SCIENCES VOLUME 182Pharmaceutical Science and Technology 182

edited by

Tony Kennedy

Pharmaceutical Project Management: Second Edition
Kennedy

Pharmaceutical
Project Management

Second Edition

Kennedy_978-0849340246.indd 1 2/5/08 3:05:00 PM

113257-K
ennedy PM

S 202 B
lack

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