COMMUNICATE THE BLUEPRINT

After creating the foundations of the project, communicating the blueprint effectively can avoid crises during later phases. For the contractors of the Empire State Building, enabling clear and consistent communication among 3400 workers across 60 different trades may have seemed almost impossible at first. But failure to do so would have resulted in catastrophe, if the building had exceeded its timeline and budget. Regular status checks, meetings, and reminders helped create a tangible picture of the finished deliverable for everyone, so that all effort focused in the same direction: up. Drug development projects should be no different.

A skilled project manager has to coordinate communications and is responsible for ensuring that every step of the work plan is thoroughly documented and accessible to team members. Clear channels of communication help prevent misinformation from developing and spreading, reduce risk, and promote collaborative team relationships. Regular and orchestrated conference calls and team meetings, which are then well-documented and shared, help ensure project transparency and the free flow of accurate information.

Biopharmaceutical companies of any size must define a clear decision-making process for the development project to run smoothly. Smaller firms are generally more nimble than larger organizations, but regardless of how fast or slow the process is, a common understanding of who has decision-making authority and what the turnaround times are prevents frustration. Such clear lines of authority become especially important when problems arise; quick decision-making reduces delays that can eat into precious funding.

BUILDING OUT THE PROJECT

Just as poorly constructed buildings are more likely to topple, drug products have no room for error. Project managers, whether internal or CDMO based, should have the authority to acquire and coordinate resources, request and receive cooperation from team members, and make informed decisions. The project manager must be responsible for anticipating needs, overseeing costs, identifying and addressing issues that emerge, and realizing that the project is progressing as planned.

The project manager should not just be a taskmaster; he or she should also be the chief motivator—keeping people energized and positive, especially when the pressure is on and people's nerves start to fray. A project manager who can create a trusting and collaborative environment is a major asset to the project.

CONSTRUCTING A LONG-TERM PARTNERSHIP

Many smaller biotech companies produce innovative science but may have limited experience with technical and regulatory issues. These organizations may wish to partner with a CDMO throughout the development process, starting at the preclinical stage or Phase I.

Early-stage products often hit unexpected roadblocks so biotech companies should be prepared to respond quickly by analyzing the problem, developing a solution, and then swiftly updating project specifications—all while staying within timeline and budget. The depth of experience, capacity for innovation, and flexibility of an experienced CDMO can lend vital support.