TRAVEL WITH PEOPLE YOU KNOW AND TRUST
The key to getting this process in motion—and keeping it moving—is the project manager. The ideal project manager will have
a background in natural sciences and significant experience in assembling and directing teams that include researchers, technical,
and economic experts. The project manager will pull together a team of highly skilled individuals who are ready to solve existing
and potential problems from the laboratory to the production line.
A diversity of specific skills among team members is vital and should include individuals with experience in:
- packaging development
- process development
- qualification and validation
- regulatory affairs (including a range of US, European, and other national and regional bodies)
- quality management
- supply chain management.
Because small biotech companies often lack the staffing and the expertise to assemble their own project management teams,
the CMO and its designated project manager are critical and will create a team that suits each project's specific needs, keeping
in mind that small-biotech staff members may not be familiar with all the details involved in bringing a drug to the clinic.
This may be particularly true in the case of regulatory issues where a CMO can provide extensive regulatory expertise and
bring even greater value to the project.
HITTING THE ROAD
Putting in the time and effort to develop a thoroughly integrated plan during the early phases of drug development will reap
many benefits by identifying and eliminating existing and future problems before the plan is initiated. This time is well
spent, and will not only help avoid crises during the later phases, but will help shorten time-to-market and maximize return
SUCCESSFUL TRAVEL THROUGH COMMUNICATION
The road to a sound partnership and project success is paved with clear and regular communications. The project manager is
responsible for ensuring that every step of the work plan and its execution is thoroughly documented and accessible to team
members. The importance of good communication among team members cannot be overstated. Executed consistently, clear channels
of communication will help prevent misinformation from developing and spreading, reduce or eliminate risks, and promote collaborative
team relationships. Regular and pre-prepared conference calls and team meetings that are well-documented help ensure project
transparency and the free flow of accurate information. Creating a simple communications plan that includes a list of phone
numbers and contact info of whom to call in case of emergency, project issues, etc., is well worth the little effort needed
to construct it, and is a valuable tool not just for communications as a whole, but to help speed up decision-making in the
event of a crisis or other problem.
MOVING DOWN THE ROAD
The real effort in moving a drug forward in the early stages of the project is in the development and validation phases. In
this stage, the plan's tasks and responsibilities yield the actual product. Throughout these phases the project manager is
responsible for checking on the progress of the project, anticipating needs, overseeing costs, identifying and addressing
any issues that may crop up, and ensuring the project is progressing as planned. Regular communication in these phases is
critical. Milestones should be kept in sight and adjustments made to be sure they're reached. The project manager that can
cultivate a trusting and collaborative environment between the CMO and the customer is a major asset to the project. The focus
on each others' needs beyond the project at hand will make for a better outcome now and in the future.