There are many elements of project management that are generic across both project and industry types; however, there are
some specific challenges within the pharmaceutical industry. The ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry (PM GPG) was developed to address those challenges with certain key aims in mind (1). This formed the basis of the business case,
which further detailed key objectives.
The first objective was to create a document to discuss and compile best practices for project-management concepts within
the context of the pharmaceutical industry, which has unique needs and challenges. The second aim was to have the PM GPG serve as a toolkit to help pharmaceutical project managers deliver successful projects quickly. The developers set out to
offer content that addresses managing risks common to pharmaceutical projects and to promote and support a common language
for the pharmaceutical project-management community.
Furthermore, in reviewing current trends in both project management and the delivery of pharmaceutical projects, a hypothesis
was developed around how the value of project management needed to be developed within the pharmaceutical industry (see Figure 1). Although the purpose of the guide was not to duplicate generic project management practices already contained in other
standard project management guidance documents, the guide should and would highlight areas of project management where improvement
was value-added (e.g., people management and risk management) even if the challenges for their management were not distinctly
different from other industries.
Figure 1: The Project Management Good Practice Guide hypothesis. (FIGURES 1-5 COURTESY OF ISPE)
Once the business case for the guide gained ISPE approval, the project for developing the guide began. A project director
and project manager were appointed, and a team of key stakeholders was formed. The team developed a vision of success for
With this key structure in place, the core team agreed that for the team to achieve success, all had to behave as "good practice"
project managers. The team had to use its combined project-management expertise to deliver quality content in an effective,
value-added way. The fundamental philosophy driving the delivery was summarized in one phrase: "practice what we preach."
In other words, the team needed to use good practice in project management throughout the guide project. The development of
a robust project delivery plan (PDP), therefore, was a key requirement.
A PDP requires a project team to fully consider all elements of project delivery before actually starting to deliver the project.
For example, in the PM GPG project, the PDP allowed the team to consider its strategy for stakeholder management before making any announcement requiring
writers or reviewers involvement.
The PDP also ensured that the team gained agreement with ISPE on the governance process for publication, agreed-on key stage
gates, and "go or no/go" decisions throughout the writing, reviewing, and publishing process. Figure 2 shows an example of the stage-gate process developed for pharmaceutical projects. It emphasizes the lifecycle approach to
project management and the value of stage gates as a way to check that progress should continue; key questions are asked and
answered with supporting data.
Figure 2: A stage-gate approach to project management.
The approach to managing stakeholders involved working as a small core team to develop the guide structure and key concepts.
Involvement of subject-matter experts (SMEs) was requested so that small chapter teams could be formed, each led by a member
of the core team. A schedule was developed based on the agreed-on stage gates, and milestones were used to review progress
with each chapter team.
In this way, the guide team avoided the usual collaborative document development process of starting with too many eager volunteers
who slowly decline to be the active team of writers. In order to effectively engage the industry, the team needed to develop
the guide quickly and in a lean manner. Those wanting to get involved, but without the time, were encouraged to get involved
in the industry review, a crucial aspect of the whole process.