Pharmaceutical & Biotech Project Management - 3rdgen - Evolve To ...


Dec 1, 2012 (4 years and 4 months ago)


Pharmaceutical & Biotech Project Management
AIPM IRC Bibliography
June, 2004

Introduction: This Overview of the Pharmaceutical and Biotech Industries collects together over 40 articles covering many
aspects of Project Management in these fields, including: case studies; use of Knowledge Management; Process improvement for
drug development; best practices; the level of PM maturity in the industry, with comparisons to others; Program Management;
staff competencies; budgets; and most importantly the positive impacts from implementing project management on the bottom
line. Please see also the existing IRC bibliographies on Knowledge Management and Program Management.

1. Mainardi, C. and Neely, J. Getting Straight Cs Booz Allen Hamilton uses the "Three Cs" - coordinate, collaborate,
change- to realize bottom-line project results. PM Network
17(12), 18-19. 2003.
Keywords: Pharmaceutical.
Abstract: Booz Allen Hamilton and the Pfizer CHC merger using "Collaborate, Coordinate and Change" to achieve bottom
line results.
2. Foti, R. What the doctor ordered: Medco health's ambitious high-tech pharmacy was completed better than
anyone expected. PM Network
17(9), 26-33. 2003.
Keywords: Project Management methodology; Pharmaceuticals.
Abstract: This article features a profile of Medco Health's OMEGA project to construct a 282,000-square-foot facility in
Willingboro, N.J. for the world largest automated pharmacy. Beginning with an integrated plan, team members established
the project office, set up reporting requirements, and identified subcomponent dependencies. Many lessons already learned
from creating the fully automated pharmacy-or 'new dispensing protocol' (NDP) -were utilized for the building project,
including mitigation strategies and contingency buffers. The master project plan itemized over 5,000 tasks, and was
flexible enough to handle major changes in project scope, including a 50 percent increase in facility capacity. The project
finished 11 weeks ahead of schedule and under budget, a result due largely to effective project management. Includes
illustrative matter.
3. Reiss, Geoff. Voyage of discovery. Project
16(4), 14-16. 2003.
Keywords: manufacturing; pharmaceutical industry; change management.
Abstract: Manufacturing isn’t just about the big things. In the pharmaceutical industry, small – even micro- really is best,
especially when it comes to developing new drugs for mass production. Looks at how one company is using project
management to help make things better.
4. Cooke Davies T.J. and Arzymanow A. The maturity of project management in different industries - An
investigation into variations between project management models. International Journal of Project Management

21(6), 471-478. 2003.
Keywords: maturity; inter-industry comparison; management by projects; leadership.
Abstract: This paper presents the results of an investigation into the nature and extent of variations between project
management practices in six industries. The investigation had the practical purpose of supporting a group of
pharmaceutical R&D organisations in their search for an optimum project management model. A total of 10 domains were
identified using qualitative methods and these formed the basis for a programme of 31 in-depth interviews with
knowledgeable project management practitioners in 21 organisations drawn from the six industries. Each interview elicited
a quantitative assessment of the practices relating the domain, using pre-determined scales, and qualitative comments on
the practices based on the experiences of the interviewee. Differences between companies and industries were found to
exist in each domain. The most highly developed project management models (which might be said to equate to measure
of project management maturity) were found in the petrochemical and defence industries, which on average scored highly
on most dimensions. Other industries, (pharmaceutical, R&D, construction, telecommunications, financial services),
displayed some interesting differences in different domains, but did not display the coherence or scores of the two leading
5. Pappas, L. The Right Prescription. Project management provides a potent ingredient to a successful drug launch
and opportunities to improve the entire cycle. PM Network
16(10), 30-37. 2002.
Keywords: drug development; project management; pharmaceuticals.
Abstract: Project managers are especially needed in the risky world of drug development projects due to its large-scale
nature and huge costs involved. By employing project management techniques, they are able to successfully plan and
execute the development process while meeting stakeholder expectations.
6. Somoncelli T, Heroux SM. Validating a pharmaceutical research and development facility: A case study. PMI
Seminars and Symposium Proceedings 2002
; 2002 Oct. 3-2002 Oct. 10; AIPM (CDRom). USA: PMI; 2002.
Keywords: pharmaceutical industry; facilities - design and construction; case studies.
Abstract: A pharmaceutical company is planning to expand its current clinical supplies manufacturing facility. Meeting
regulatory requirements (including validation) is an important part of this construction project. Good validation practices
are crucial to the success of the project and are based on sound project management principles. This ensures that the
facility meets regulatory requirements, in a cost-effective and timely manner.

7. Ponterius G. Co-developments in 2 different biotechnology projects. 16th IPMA World Congress on Project
Management, Berlin 2002
; 2002 June 4-2002 June 6; AIPM. IPMA; 2002.
Keywords: pharmaceutical industry; collaboration; partnering; biotechnology.
Call Number: CON 39 Notes: PowerPoint Presentation.
Abstract: The experience from co-developments in two different BioTechnology projects will be presented. The projects
differ in size since for the large project a new diagnostic system including assay and instrument was co-developed while on
the contrary for the small project a new diagnostics assay with a device was co-developed. The partners in both projects
were companies in US, one large and one and one small, respectively. For both projects the co-development was for both
development and manufacturing. In the large project the co-development started during our own development while in the
small project it started from the beginning. For both projects it was important to define clear responsibility interfaces
during development such as; transfer of prototype design and reagents for large project, transfer of reagents for the small
project and document handling. In conclusion the differences will be highlighted. A proposal of how the collaboration
between large to large companies compared to large to small companies should be best managed will be stated.
8. Nielsen J. PMI pharmaceutical specific interest group benchmarking survey: Current situation and future plans.
PMI Seminars and Symposium Proceedings 2002
; 2002 Oct. 3-2002 Oct. 10; AIPM (CDRom). USA: PMI; 2002.
Keywords: pharmaceutical industry; benchmarking; surveys.
Abstract: Benchmarking is important to see where a profession currently stands and to measure where it is going. The
PMI Pharmaceutical Specific Interest Group Board of Directors performed a benchmarking survey of its membership. The
response was very good with 308 surveys returned (31% of membership). Results from the survey will be presented.
9. Minter AR, Henderson I, Raum K, Plank M. DynPort Vaccine company's approach to program management utilising
an integrated master plan to identify and manage risk. PMI Seminars and Symposium Proceedings 2002
; 2002 Oct.
3-2002 Oct. 10; AIPM (CDRom). USA: PMI; 2002.
Keywords: vaccines - design; case studies; project plan; project planning.
Abstract: DynPort Vaccine Company has accelerated project schedules and reduced time-to-market projections by
aggressively managing vaccine development projects using an Integrated Master Plan (IMP). The IMP is an invaluable
management tool both in terms of strategic planning and progress review. The paper presentation will demonstrate how
DVC has applied sound business practices in using the IMP to identify, manage and mitigate cost and schedule risk.
10. Lautier EB. Time to market for pharmaceuticals. 16th IPMA World Congress on Project Management, Berlin 2002
; 2002
June 4-2002 June 6; AIPM. IPMA; 2002.
Keywords: pharmaceutical industry; marketing; sales; delay; cost management.
Call Number: CON 39
Abstract: Calculating cost of delay of a pharmaceutical project is essential. It creates the right sense of urgency. Cost of
delay is the basis for operational decisions about whether to spend some extra budget to prevent delay or speed-up the
project. Cost of delay for pharmaceuticals is strikingly high in most cases. Pharmaceutical research and development
projects aim at developing new medicines and putting them on the market. Such projects include scientific research,
clinical research, registration, marketing, production and sales startup. This paper will concentrate on the cost of delay.
11. Huemann M, Stummer M. Development of competencies as a project-oriented company: a case study in the
chemical industry. 16th IPMA World Congress on Project Management, Berlin 2002
; 2002 June 4-2002 June 6; AIPM.
IPMA; 2002.
Keywords: pharmaceutical industry; project-oriented companies; programme management; portfolio management.
Call Number: CON 39
Abstract: Management processes specific for project-oriented companies are assignments of projects and programmes,
project management, programme management, quality management of projects and programmes, project portfolio
coordination, networking between projects, personnel development in the POC and organisational design of the POC. For
the performance of these processes specific competencies are required by individuals, teams and the project-oriented
company overall. The paper describes first results of developing a chemical company to become project-oriented.
12. Goldstein M, May CN. Applying project management for competitive advantage. PMI Seminars and Symposium
Proceedings 2002
; 2002 Oct. 3-2002 Oct. 10; AIPM (CDRom). USA: PMI; 2002.
Keywords: pharmaceutical industry; drug companies.
Abstract: The pharmaceutical industry is experiencing a wave of innovation in genetics, chemistry and drug production.
There has also been a shift in the way researchers work and collaborate. These changes are directly impacting how drug
companies are conducting their business. This study looks at emerging trends in pharmaceutical project management.
13. Geimer H, Eslampour R. How to boost productivity through web enabled project resource management. 16th IPMA
World Congress on Project Management, Berlin 2002
; 2002 June 4-2002 June 6; AIPM. IPMA; 2002.
Keywords: pharmaceutical industry; resource productivity management; internet technology; web technology; IT;
information technology.
Call Number: CON 39
Abstract: This paper will introduce an advanced project resource management solution in order to reach the next level of
productivity in product development. It presents real life pharmaceutical company examples to highlight the key challenges
in implementing web-based systems for resource management. Resource productivity management provides a solution to
aligning all management functions and projects involved through web enabled systems, creating visibility of project data
across the enterprise. The paper outlines how these advanced management practices and systems can be implemented and
enable companies to: gain visibility of development resource utilisation across the company, optimise project schedules,
proactively plan future capacity to avoid bottlenecks or skill outages, assign resources to projects based on more precise
resource requirements and reconcile project budgets with functional budgets.

14. Donahue J. The steps to the path of a successful training program. PMI Seminars and Symposium Proceedings 2002
2002 Oct. 3-2002 Oct. 10; AIPM (CDRom). USA: PMI; 2002.
Keywords: employees - training of - methodology; pharmaceutical industry.
Abstract: Today's business environment is a climate of high speed and complexity. To successfully fulfill the business
requirements numerous new tools, techniques and processes are being developed and implemented. Individuals and teams
are being bombarded with dozens of new systems and models to produce more efficient and effective work. Individuals
and/or teams will require training to either learn how to use a tool or application, or to understand the whys and hows of
business models, processes, and project management techniques. The following paper will examine the eight steps
followed at AstraZeneca to get the most out of training for individuals and the business.
15. De Falco MNME. A complexity analysis model for management of good manufacturing practice and ISO 9000-
2001 compliancy simultaneous projects. Case study in the pharmaceutical industry. 16th IPMA World Congress on
Project Management, Berlin 2002
; 2002 June 4-2002 June 6; AIPM. IPMA; 2002.
Keywords: pharmaceutical industry; quality; ISO 9000-2001; construction.
Call Number: CON 39
Abstract: This paper aims to develop a project evaluation and management model for a program of plant adaptation to
meet simultaneously both GMPs and ISO 9000-2001 standards; such a model is based on a complexity analysis procedure
for process modification and updating. It is focused on exploiting potential synergies among adaptation project activities.
16. Bower DA, Smith NJ, Fish E. The design and implementation of project management processes in a small
chemical company. 16th IPMA World Congress on Project Management, Berlin 2002
; 2002 June 4-2002 June 6; AIPM.
IPMA; 2002.
Keywords: pharmaceutical industry; project management implementation; best practice.
Call Number: CON 39
Abstract: This paper briefly reviews an exemplar chemical company and proposes a system of project management based
on best practice. This paper assesses current and best practice for project management from a literature review. The main
sources of information are the PMBOK, the APM Body of Knowledge and BS6079. Based on the literature review a project
management system is proposed for the company with a number of areas and procedures highlighted showing specific,
rather than generic, best practice. The means to successfully develop and introduce this change are also described.
17. Talley JJ. Discovery of Celebrex - project management for a blockbuster drug. PMI Seminars and Symposium
Proceedings 2001
; 2001 Nov. 1-2001 Nov. 10; AIPM (CDRom). USA: PMI; 2001.
Keywords: drugs; arthritis drugs; pharmaceuticals.
18. Posner DA. Tracking multiple clinical projects using metric prioritisation and WEB-based technology for CROs.
PMI Seminars and Symposium Proceedings 2001
; 2001 Nov. 1-2001 Nov. 10; AIPM (CDRom). USA: PMI; 2001.
Keywords: contracting out; monitoring; research, industrial; software measurement.
Abstract: The relationship between Sponsor Companies and CROs (Contract Research Organizations) is changing. Over the
past 3 years outsourcing by pharmaceutical and biotech companies to CROs has increased 20% per year. CROs are
increasingly required to document daily activities to sponsor. Management of interface activities between sponsor
companies and CROs has become an essential and demanding activity.

CROs face a challenge in tracking and prioritizing multiple concurrent projects. A WEB based integrated project tracking
system was installed at IBAH allowing over 110 projects to be tracked simultaneously. The projects are reviewed on a
monthly basis and prioritized based on predefined metrics. Senior Management then reviews projects by exception,
focusing on those issues that don't meet defined metrics. The 80/20 rule states that 20% of the projects are causing 80%
of the problems. Most project management systems have difficulty in identifying the 20%; this system locates, identifies,
and prioritizes the projects.

The methods required to design an integrated project tracking system will be discussed in detail along with the WEB
technology. These methods will include identifying the critical success factors, tracking plan to actual, isolating key metrics,
and designing trigger points. A secure WEB site allows the key data to be collected from the global staff, financial systems,
and project managers. Data is downloaded to spreadsheets for analysis, prioritization and status colour-coding. Historical
trending allows linear regression graphs to be supplied to management for proactive problem identification. This
methodology facilitates posting results to provide visibility of continuous improvement efforts.

The original one-year implementation plan called for reduction of crisis projects to 0 and margins increase of 2-3%. These
annual goals were achieved in only 6 months, showing the robust effect of this methodology. These results along with
others will be discussed in detail during the presentation.
19. Happy R, Meyer C. Establishing an effective PM culture. PMI Seminars and Symposium Proceedings 2001
; 2001 Nov.
1-2001 Nov. 10; AIPM (CDRom). USA: PMI; 2001.
Keywords: organisational change - management - case studies.
Abstract: JUST DO IT is the approach most organizations take when they first start managing projects. Project leaders
dive right into implementation, disregarding or misunderstanding the whole of project management as a practice, which
requires undergoing critical steps prior to execution. This approach can be effective when few projects are being
implemented, but will quickly run into problems when a critical mass of projects is reached. The typical problems that arise
are the "Big 4" in implementing a project: 1) cost overruns, 2) time overruns, 3) customer dissatisfaction, and 4) staff
turnover/low morale. Project management is successful only when it is conducted within a framework involving process,
tools and skills. This presentation explores how organizations learn to crawl, walk and run as they move through a
development process in establishing an effective project management culture.


Establishing an effective PM culture contd…

Experiences with hundreds of organizations representing large and small companies, involving thousands of individuals
working on projects, have led to the creation of this development process. A case study will be presented to illustrate this
development process involving the implementation of a project management process within drug development for the
pharmaceutical division of a Fortune 50 healthcare company. The case study presented involves a global drug development
project and many scientific and manufacturing disciplines across the U.S., Europe and Japan, over a two-year timeframe.
Also, other organizational experiences with project management implementation within the same company contributed in
making this project implementation successful.


Organizations move through a three-stage development process in implementing an effective project management culture.
These stages are defined as Recognition, Acceptance and Effectiveness.

Recognition is the stage in which an organization recognizes that project management is an issue and they need to take
action. This stage is typically initiated by a single person or small group in an organization and not recognized as important
by senior management. Project management is the "accidental profession," an assignment given to a department member
who is viewed as a department expert. For these reasons,, there is no real commitment or long lasting solutions
implemented. Usually a "band aid" approach is taken by throwing two days of PM training and perhaps purchasing MS
Project for the desktop. No lasting results are obtained and key problems still persist.

Acceptance is the stage an organization goes through when they accept the commitment of investing in expanded project
management solutions beyond a "hit & run" approach. Experiences from Stage 1 gain some visibility and attention from
higher levels of management. The organization begins to see that a process for managing projects is needed. Solutions
include looking at process and tools together. However, there is still no funding dedicated to full time internal resources to
support the project management practice. As a result some benefits are obtained, but there are still major inconsistencies
existing between departments.

In the final stage, Effectiveness, of implementing project management, organizations fund internal full time resources to
establish and maintain a common methodology (processes, tools, skills and language) to support the overall mission, vision
and strategy of an organization. Top management becomes a champion for the project management process and successful
project managers are recognized as project management professionals within their organization.

Each of these three stages has its own symptoms, solutions and results that define the level of success that can be realized
at each stage of development. These stages are fully described along with examples of organizational experiences at each of
these stages.
20. Crockett CH. Cost management for development of new therapeutic entities. PMI Seminars and Symposium
Proceedings 2001
; 2001 Nov. 1-2001 Nov. 10; AIPM (CDRom). USA: PMI; 2001.
Keywords: drug development - management; Eli Lilly and Company; cost management; pharmaceutical industry -
economic aspects.
Abstract: The current financial systems in place at Lilly for drug development projects are able to report costs (plan and
actual) only at the project level, and not at the activity level. Project Cost Management for drug development projects is
essentially nonexistent compared to expected standards as defined by the PMBOK Guide. This gap will be closed when the
enterprise-wide system of SAP is implemented for project and portfolio management. The SAP tool will allow for projects to
be planned and controlled at the activity level. The SAP team for Lilly spent several months to define the standard work
breakdown structure (WBS) and associated standard network of activities for development of new therapeutic entities. The
CM&C component tested the feasibility of the proposed WBS by conducting a pilot within the current hours reporting
system. This presentation will describe the CM&C cost management pilot and the associated lessons learned in preparation
for migration to SAP in late 2001. The WBS for CM&C was confirmed to be appropriate, however, several communication
and cultural issues were identified. The SAP implementation team will be addressing these issues as they prepare for full
roll-out of SAP during 2001.
21. Brown RA. Integrating project management with knowledge management to improve the speed and quality of
drug discovery. PMI Seminars and Symposium Proceedings 2001
; 2001 Nov. 1-2001 Nov. 10; AIPM (CDRom). USA: PMI;
Keywords: drug development; knowledge management; pharmaceutical industry.
Abstract: A dazzling array of new technologies has driven major paradigm shifts in pharmaceutical discovery, but their
coherent integration is key to advancing incremental change to breakthrough improvements of project performance. Web-
enabled Project Management (PM) and Knowledge Management (KM) applications are both part of and means to manage
the oncoming Tsunami, with potential to transform project and organizational performance. Fully integrated pharmaceutical
companies have adopted broadly similar discovery processes, ranging from 'Target Identification' through 'Lead Generation'
and 'Lead Optimization' to compound selections for Clinical Development. Smaller (bio)-pharmaceutical companies typically
operate within selected steps of the broader process. New technologies have driven initial process logistics, but increased
market competition has driven further moves from conventional scientific and project logic, risk-aversive, sequential
activities to dramatically greater risk-responsiveness and acceptance of concurrent activities wherever possible. However,
as discovery becomes more modeled and competition intensifies, the need for creative management and innovation grows.

Integrating project management with knowledge management contd…

Importantly, well-described research process creates a robust framework for formalized (Research) PM and the need to
develop the attendant skills and models. This presentation describes how to enable enhanced PM, project delivery,
innovation and organizational effectiveness in the (bio)-pharmaceutical discovery setting through full integration with KM.

"Communication, Co-ordination and Collaboration" embody some core features of PM. "Context, Content, Communities and
Connectivity" can characterize KM. A Project Manager must ensure that project communications are fully addressed. Often
under-estimated, this is a major task, particularly in sizeable, late-phase projects and when a Project Manager also has
significant "line" or scientific responsibilities. An important step is to recognize that most research generates data and
information relating compounds and systems to pre-set criteria and enabling decisions on project progression. Reducing
time from "data to decision" is an important attribute of well-applied KM. However, if improved portfolio and project
lifecycle management is the goal, any KM system considered should reach well beyond document management and access,
reflecting the organizational matrix interactions and alignment: management, functions, processes and projects. It should
reflect the vertical and horizontal relationships (internal and external), roles and responsibilities of the groups (Knowledge
Communities) within this matrix, and provide seamless "radial" access by individual staff to any/all of these. Thus, KM
should be a comprehensive scaleable business (discovery) integration tool, providing a routine working environment with
"workspace" for all communities and individuals.

Critical success factors:
*Rapid intuitive navigation and a high level of individual control
*Project workspace for all team members and a site for project plans, reports, information and "discussions."
*Intimate informational links and collaboration between projects and functions.
*Project leaders/managers and section/group leaders
*Teams and representatives.
*Comparable PM systems and approaches within functions
* Full, secure integration with external collaborators.
*Open, vertical integration of projects with management
*Supports issue resolution and quality decisions e.g. process transitions, project milestones

Such highly developed levels of community connectivity and knowledge sharing are central to successful KM
implementation, but can challenge conservative cultures. Many common time-stealers will be eliminated by KM, but
sustained value can be gained through x-fertilization of projects and disciplines directly and through high quality search
and enriched visualization media, stimulating creativity and innovation, cornerstones of competitive research.
22. Chemical reaction. Project
Keywords: Outsourcing; Logistics; Pharmaceutical.
Abstract: Moving and storing hazardous products calls for specialist knowledge and experience. So when a leading
chemical company decided to go down the outsourcing route, it was imperative to find the right logistics partner.
23. WIles M, Waterman S. Treating it right. Project
Keywords: Health; Pharmaceutical; Biomedix; Drug development/Genome Project; Healthcare; Health; International Co-
operation; International Project.
Abstract: Looks at the costly and time consuming path required for the successful development and introduction of a new
drug onto the market. Looks at the issues that face the project teams.
24. Juhre F, Heinen C. Managing international cross-cultural projects. Connections 2000. PMI Seminars and Symposium.
; 2000 Sept. 7-2000 Sept. 16; AIPM (CD-Rom). USA: PMI; 2000.
Keywords: global project management; international business enterprises; program management office; PMO; team
development; information distribution; project integration management.
Abstract: What, why and where?
The fact that most companies do not derive growth only from their domestic markets is well known among the business
community. Moving the focus successfully to an unknown international environment is becoming more and more important
for a company to keep a competitive advantage and increase shareholder value. Since operations are brought to an
international level, projects have to be executed increasingly across borders and cultures. This setting has a strong impact
on the known universe of successful project management. Additionally, to managing the project's scope, cost, time, and
quality, cultural issues as well as resource constraints have to be taken into account.

What about a real-life business case?
The company is a worldwide operating pharmaceuticals company headquartered in the US. Just recently created as a joint
venture, the company initiated a $100 million business transformation initiative including both internal costs and external
advisor fees. This transformation initiative was aimed to create a single corporate identity with common business processes
and systems to take full advantage of the company's global presence. The vision was to form a highly integrated and
globally managed company and this resulted in the decision to redesign business processes and implement SAP R/3
globally as the core enterprise-wide IT system. The project was planned to be managed at the company's major sites in the
US (60%) and Europe (40%) over two years. The project consisted of three stages. The first six months were scheduled for
global design and re-engineering of all major business processes except the company's R&D. Furthermore, the SAP R/3
development was piloted during this first stage. The second stage of six months was used to fine tune the global design by
implementing SAP R/3 at the first site in Europe. In the last stage, SAP was fully implemented at four major sites in the US
and Europe as well as in sales offices in Europe, the Americas, and Asia. Which methodologies and tools made the project
successful? Program Management, Integration Management Culture Management, and Knowledge Transfer.

25. Hynes MD, Usemichel AD, Konechnik TJ, Phipps CS, Winiarski K, Byers LK. The development of a core competency
model for pharmaceutical project managers. Proceedings of the 30th Annual Project Management Institute 1999
Seminars and Symposium
; 1999 Oct. 10-1999 Oct. 16; AIPM. Project Management Institute; 2000.
Keywords: Pharmaceutical Industry/Core Competencies/Development.
Call Number: 0013
Abstract: Project management, as a formal discipline, is still relatively new to the pharmaceutical industry. For years, the
focus of managing drug development projects was solely scientific in nature. This was evidenced by the fact that discovery
scientists would provide leadership for a drug development team as well as for a discovery laboratory. This unidimensional
focus began to expand in the mid-1980s in response to a changing business environment. Eli Lilly and Company
established a full time project management group.
26. Hynes MD, Konechnik TJ, Burris SL, Broughton MC, French SA. Enhancing drug development planning through the
use of facilitated planning. Connections 2000. PMI Seminars and Symposium. Proceedings
; 2000 Sept. 7-2000 Sept.
16; AIPM (CD-Rom). USA: PMI; 2000.
Keywords: healthcare; drug development; pharmaceutical industry; cross functional teams; success factors; milestone
Abstract: The development of new drugs is a long, complex and costly process. Given these factors, it is important to have
a well thought-out and documented drug development plan. Historically, a variety of different approaches have been
utilized to build these plans with variable success. During the past year, we have dramatically changed our approach to the
planning of new drug development activities. These changes have focused on a facilitated "rolling wave" approach to
planning which includes building a detailed plan to the next major milestone. A higher level plan to milestones that are
further out is also developed.

These detailed plans are created during intensive sessions which are usually several days in duration. The development
plans are built by a cross-functional group of scientists and project managers assigned to the drug development team.
These team members are supported by trained facilitators who assist the team in the development and documentation of
the plan. These facilitated planning sessions include the following activities:

1. A review of background scientific and development data.
2. Developing an in-depth understanding of each team member's roles and responsibilities during the drug development
3. The development of Critical Success Factors that provide the basis for decision making as the project progresses.
4. The development of a detailed timeline to the next major milestone utilizing critical path methodology and a high level
timeline to future milestones, i.e., in
IND or NDA submission.
5. A risk management evaluation which identifies major risks for which prevention and contingency plans are created.

The development plan is documented in a Program Team Plan which includes a Microsoft Project timeline and budget
spreadsheets. This document is approved by a management committee and serves as the team's guide for all activities
through the next major milestone. This document is then published to the global development organization.

The benefits of these facilitated planning sessions include:

1. The intensive time spent during the session leads to a reduced time for plan development.
2. A high level of interaction leads to greater ownership of the plan by the cross-functional team members.
3. Team members obtain a greater understanding of key hand-offs and cross-functional dependencies in the plan.
4. The overall quality of planning is greatly improved.
5. The interactive, cross-functional team building leads to higher performing teams.
6. Increased probability of achieving the milestones as described in the plan.

This presentation will review the objectives and deliverables of these facilitated planning sessions. It will also review the
processes used to meet these objectives and deliverables. The presentation will also review implementation suggestions for
those companies who are interested in initiating these intensive facilitated planning sessions.
27. Foulkes J. Art or science? How - and even does - the pharmaceutical industry apply the discipline of project
management? Project Management Research at the Turn of the Millenium. Proceedings of PMI Research Conference 2000.
21-24 June 2000. Addendum
; (21-24 June 2000); AIPM. Pennsylvania, USA: Project Management Institute; 2000.
Keywords: Research; Conference Proceedings; Pharmaceutical Industry.
Call Number: 00PRO1 ADD
28. Sanchez-Pescador R. The Biotech R&D Budget: A Process for Project Success. PM Network
1999;13(5): 29-32.
Keywords: Budgeting - Biotechnology R & D - Case studies.
29. Stephens CH, Kasher J, Welsh A, Plaskoff J. How to transfer innovations, solutions, and lessons learned across
product teams: Implementation of a knowledge management system. Learning, Knowledge, Wisdom. PMI Seminars
and Symposium. Proceedings 99
; 1999 Oct. 10-1999 Oct. 12; AIPM (CD-Rom). USA: PMI; 1999.
Keywords: pharmaceutical; knowledge management; organisational learning; Eli Lily and Company.
Abstract: This paper focuses on how Eli Lilly and Company has established a shared learning program for all product
teams, and includes how to implement a sharing network, develop an interactive learnings database, communicate the
benefits, establish behavioral contracts with management, establish the infrastructure to ensure support, publicize the
program, and establish reward and recognition incentives to increase motivation.

30. Posner D, Kurtz J. Utilizing an expert system for development of an integrated project management system for
CROs. Learning, Knowledge, Wisdom. PMI Seminars and Symposium. Proceedings 99
; 1999 Oct. 10-1999 Oct. 12; AIPM
(CD-Rom). USA: PMI; 1999.
Keywords: pharmaceutical; research and development contracts.
Abstract: Increased utilization of Contract Research Organizations (CROs) in the Pharmaceutical/Biotech Industry has
resulted in increased expectations in the area of Project Management. High quality project management is more than just
patient enrollment. A simple integrated project management system for project management can provide the competitive
edge. The system consists of segmentation of activities, deliverables, accountability and a database to automate the
process. This paper describes a real life system that provides high quality customized project management in a rapidly
changing industry.
31. Louie PH. Creating an online project management status database. Learning, Knowledge, Wisdom. PMI Seminars and
Symposium. Proceedings 99
; 1999 Oct. 10-1999 Oct. 12; AIPM (CD-Rom). USA: PMI; 1999.
Keywords: pharmaceutical; communication management; communication in organisations; technological innovations.
Abstract: A key to project success is communication. Maintaining communication within the project team and with
management can be time-consuming. ALZA created a custom on-line status and project information database to provide
current and historical data in a searchable medium. How does it look? What did it take? Read the paper to find out.
32. Lewis N. Implementing risk management on pharmaceutical product development projects. Learning, Knowledge,
Wisdom. PMI Seminars and Symposium. Proceedings 99
; 1999 Oct. 10-1999 Oct. 12; AIPM (CD-Rom). USA: PMI; 1999.
Keywords: pharmaceutical; new products; risk management.
Abstract: New product development projects require companies to commit capital and resources with the potential of no
return. Consequently risk management is one of the key responsibilities for the project managers, but also one of the most
difficult to manage. This paper will look at the PMBOK aspects of risk management, examine what makes them so difficult
to manage, and how we can improve our implementation of risk management.
33. Lawler TP, Dieterle K. Leveraging project management for process improvement. Learning, Knowledge, Wisdom. PMI
Seminars and Symposium. Proceedings 99
; 1999 Oct. 10-1999 Oct. 12; AIPM (CD-Rom). USA: PMI; 1999.
Keywords: pharmaceutical; process improvement.
Abstract: In order to improve performance, companies must build an environment that facilitates continuous learning. This
paper is a practical case study review of the development of a performance metrics process for a team-based organisation.
Specifically concentrated on experiences from the perspective of the pharmaceutical company, this paper discusses the
advantages gained by leveraging the current and emerging project management environment for the development and
implementation of a metrics process.
34. Kloppenborg TJ, Smith SM. Identify improvement opportunities by assessing your project management maturity .
Learning, Knowledge, Wisdom. PMI Seminars and Symposium. Proceedings 99
; 1999 Oct. 10-1999 Oct. 12; AIPM (CD-
Rom). USA: PMI; 1999.
Keywords: pharmaceutical; maturity model; organisational change management.
Abstract: This paper describes an assessment performed for the PMO located within research and development of a large
pharmaceutical manufacturer. The primary focus of the assessment was to evaluate the organisations project management
practices and identify areas for improvement. The findings provided the framework to recommend an improvement
program that when implemented would enable the PMO to more efficiently and effectively carry out their mission.
35. Cruise MJ. Developing and using templates for project planning and control. Learning, Knowledge, Wisdom. PMI
Seminars and Symposium. Proceedings 99
; 1999 Oct. 10-1999 Oct. 12; AIPM (CD-Rom). USA: PMI; 1999.
Keywords: pharmaceutical; templates; planning; control.
Abstract: This paper discusses the process of developing a template for use in planning and tracking projects. Starting
with process mapping of work flows, processes and procedures were documented. Responsibilities, inputs, approvals, and
quality criteria were outlined for each work package. Experience at Boehringer-Ingelheim isused to illustrate the process.
36. Wirth I. The Japanese pharmaceutical industry: R&D management and the new product development process.
Tides of Change '98 PMI. Proceedings of the 29th Annual Project Management Institute 1998 Seminars and Symposiums;
AIPM. PMI; 1998.
Keywords: New Product Development; Japan; Pharmaceutical Industry.
37. Wilson E. Supporting drug development projects and optimal CRO selection through development of an internal
CRO information database. Tides of Change '98 PMI. Proceedings of the 29th Annual Project Management Institute 1998
Seminars and Symposiums; AIPM. Pennsylvania, USA: PMI; 1998.
Keywords: Pharmaceutical; Healthcare; Drug Development; CRO; IT; Information Technology.
38. McDonough JP. Rolling wave planning in the pharmaceutical environment: balancing innovation, risk and speed
to market. Tides of Change '98 PMI. Proceedings of the 29th Annual Project Management Institute 1998 Seminars and
; AIPM. Pennsylvania, USA: PMI; 1998.
Keywords: Pharmaceutical; Healthcare; Rolling Wave Planning; Risk Management; Innovation.
39. Hynes MD, Schrock BP, Miller NL, Perez RR. The use of the communication fundamentals to facilitate the drug
development process. Tides of Change '98 PMI. Proceedings of the 29th Annual Project Management Institute 1998
Seminars and Symposiums
; AIPM. Pennsylvania, USA: PMI; 1998.
Keywords: Pharmaceutical; Healthcare; Communication; Drug Development.

40. Gove N, Salcedo R. Project management of a bio-pharmaceuticals improvement project in a team-based
environment. Tides of Change '98 PMI. Proceedings of the 29th Annual Project Management Institute 1998 Seminars and
; AIPM. Pennsylvania, USA: PMI; 1998.
Keywords: Pharmaceutical; Healthcare; Project Teams; Improvements.
41. Cabassa-Latoni LA. A state of the art project management in the pharmaceutical contract manufacturing
industry. Tides of Change '98 PMI. Proceedings of the 29th Annual Project Management Institute 1998 Seminars and
; AIPM. Pennsylvania, USA: PMI; 1998.
Keywords: Pharmaceutical; Healthcare; Contracts; Manufacturing.
42. Gibson LR, Marlow SP. A practical approach to portfolio management in the pharmaceuticals industry. 14th World
Congress on Project Management. June 10-13, 1998 Proceedings, Volume 1
; AIPM. Slovenia: International Project
Management Association; 1998.
Keywords: Conferences; IPMA; Slovenia; Slovenian Project Management Association; Strategy; Pharmaceutical Industry;
Portfolio Management.
Call Number: CON 1
Abstract: A portfolio management system has been implemented to support the variety of Information Technology (IT)
projects in a Pharmaceuticals Research and Development business. The style of IT project management in Pharmaceuticals
R&D is functionally distributed, often with poor detailed planning, integration and tracking of activities. It is more difficult
in this environment to capture actual performance figures and relate these to clear work plans because of rapidly changing
goals compounded with poor time management and business comprehension. Successful introduction of portfolio
management concepts in this environment requires extensive staff coaching, must have full backing of senior
management, and must involve minimal intrusion so as to integrate easily with current work practices.
To obtain copies of any of the above documents please refer to the AIPM website under IRC - Document
Delivery for instructions or contact the IRC Manager on 02-9252 7277 or