This second edition of Pharmaceutical Project Management is published one
decade after the first edition. What has changed over the past decade in drug
development? Actually, a lot. The move to outsourcing has intensified and the
successful management of relationships between sponsor and contractor is recognized
to be a critical competence. Productivity as measured by the number of new
medicines marketed each year declined dramatically in spite of the optimism about
new science and technology. Despite spending more on research and development
we are not getting any smarter in picking out the medicines from the molecules.
Drug development times for the fewer drugs taken to market were faster and
regulatory authorities reduced approval times. We also witnessed a change in the
landscape as faltering pharmaceutical giants broke up the colossus into potentially
nimbler, smaller therapeutic units in discovery and development.
What does it mean for pharma project management today? It means that
companies cannot rest on their laurels, but have to continuously find better ways to
develop drugs. Decision making clearly needs to be better. Novel drug development
“projects” actually are a series of projects subsumed under a strategic intent.
Sequential investments are made. The quality of the planning, execution, review,
and decision making for each investment cycle will set apart future winners from
“also rans.” Speed to market will always be important. As development times
have been reduced, the chemistry, manufacturing, and controls team increasingly
is under pressure to deliver to demanding schedules. Most companies now have
a mixed model in which a significant proportion of “development parts” are
outsourced. The effective management of contracted development is a central
theme in future drug development project management. The second edition has
been designed to focus on the strategic and operational strategies that will enable
companies to compete effectively in this new landscape of drug development.
Encompassing the full spectrum of project management roles and responsibilities encountered in industry, this Second Edition outlines the key objectives, risks, and challenges of each stage of the pharmaceutical lifecycle, from discovery and preclinical phases through manufacturing and launch. Collecting expert recommendations and informative articles on decision-making, resource allocation, system selection, and team leadership, this Second Edition reflects best practices in the field and assembles skill sets, strategies, and planning principles that every pharmaceutical project manager must acquire.