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
DECISIONS BIG AND SMALL
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
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.