Are the deadlines for your outsourced projects often not met? Are you unsure of the status of your project at any given time?
Is the original budget of your study typically exceeded?
If most of these questions have an affirmative response, chances are your outsourced program needs more effective project
management. Project management helps prevent these problems by organizing and managing resources to ensure that project deliverables
are completed on time, within budget, and that they are of high quality.
Proactive project management is especially critical for outsourced biopharmaceutical projects, which often involve a small
biotech company that may be dealing with multiple contractors. The nature of biopharmaceutical products, with their molecular
and structural complexity, inherent instability, and sensitivity to manufacturing changes, can present numerous analytical
challenges. Biopharmaceutical testing methods are often technique-dependent, highly product-specific, and sometimes not very
robust and reproducible. Understanding and anticipating problems early can prevent major delays and budget overruns later.
Smaller biotech companies may rely on a contract organization for regulatory and technical guidance—the contractor may recommend
the most efficient methods for supporting the company's analytical needs. This fosters a solid partnership, which, of course,
is facilitated by effective project management.
A biopharmaceutical study outsourced to an analytical contract laboratory may consist of multiple tasks, including method
development and validation; method transfer; characterization of active pharmaceutical ingredient (API) and drug product (DP);
stability and release testing; and testing support for formulation and process development. There are several uncertainties
about analytical methods, formulation, the API and DP, and the manufacturing process. These unknowns create challenges in
defining the contract laboratory's scope of work, timelines, budgets, and ability to meet original goals.
Role of a Project Manager
The primary function of the project manager is to coordinate all project-related activities and to monitor progress of the
agreed-upon work, timelines, and costs. Before initiating the study, the project manager works closely with the client to
prepare a project plan outlining critical paths and milestones and determining the budget. Throughout the study, the project
manager reports the status of each task, changes in scope, and potential risk of not meeting targeted timelines and budgets.
This person often becomes the primary point of communication between the client and the contract laboratory, facilitating
the flow of information between the two parties. The person in this position should proactively assess and evaluate resource
allocation, execution of project tasks, and timelines for deliverables. He or she also drives implementation of contingency
plans and problem solutions, and is empowered to motivate and influence the project team to achieve the program's overall
goals. The term "project manager" often becomes synonymous with project champion, project coordinator, project advocate,
or project leader.
Definition and the Bidding Process
Project management starts when a contract laboratory responds to a Request for Proposal (RFP) for a study to be outsourced.
It is one of the most crucial steps in managing the relationship between the client and the contract laboratory, because
the project is defined, timelines and budgets are set, and the expectations of both parties are established.
A contract laboratory pitfall is failing to carefully assess internal capacity or capability to perform the study before committing.
The project must devote enough time and attention to the project definition stage to fully understand the scope and extent
of the work. One or more project definition meetings (Table 1a) should take place to discuss the objectives of the study,
background of the drug development program, technical information, specialized equipment or expertise needed, and other project
Table 1a. Project management communication summary