Project Management and CMO–Sponsor Relations - Pharmaceutical Technology

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Project Management and CMO–Sponsor Relations
Using basic project management tools and ideas in the transfer process saves time and money and ensures high success rates.

Pharmaceutical Technology

Project planning and execution

Day-to-day operations drive the transfer process. The basics include project leaders, team design and support, and project-scope control. When any one of these areas is not supported properly, projects are often inefficiently handled or mismanaged. Success depends on good leadership and team support at the sponsor company's and CMO's facilities.

Project leaders. A dedicated project leader is critical to the success of the transfer process. This is the one person at each site who will see the project through to completion. Project leaders have the responsibility of making sure timelines are met and project scope is maintained. They are the primary contact point within the respective organizations and follow up with team members to ensure the project moves forward. Moreover, they communicate key information with the other parties involved (e.g., team members and management).

Project team design. Cross-functional project teams are best suited for success. The scope of the project defines specific team-member needs and requirements, which may change over the life of the project. For example, engineering support may be required early in the project if facility modifications are required. Team members must be accountable and prepared to make decisions for their areas of responsibility in a timely manner. If decision-makers are not on the project team, then task execution is slower and lead times are longer. This may not be a problem, as long as both sides recognize the need to factor adequate contingency into the timeline.

Educate team members about the entire project. This is self-evident but critical to a clear understanding of all requirements. Ensure team members understand the project goal, the terms of the project agreements, and the timeline for completion. Also, discuss the team members' roles and specific areas of responsibility. Address the obvious. For example, is this the first time someone has participated in a project team? Is a team member new to your organization and not familiar with the proper channels of company operations? Are they comfortable reading or editing a timeline? When team members are knowledgeable, experienced, and prepared and have worked through the technical aspects and process flow, informed decisions can be made and tasks completed on track and on time.

Schedule a formal project kick-off meeting. Face-to-face meetings are best because they give project team members an opportunity to get to know each other. Be prepared—a thorough kick-off meeting takes time. Plan at least one full day or more depending on the scope of the project. During the kick-off meeting, teams can work together to finalize the project scope and develop a project timeline based on their detailed discussions. Determine the tasks that are needed and whether the beginning of one task is dependent on the successful completion of another. Define facility, staffing, equipment, and supplies required. Who is responsible for providing the resources? Who is responsible for performing the various tasks or stages of the project? Will the resources be available when they are required? A well-defined project timeline is an essential tool in supporting and controlling the project.

Project control. As part of routine meetings, team members review progress and delays and discuss future steps. They update the project timeline to reflect the current status of the project and flag critical-path items. Frequency of meetings should be based upon current project activities. Meetings may be scheduled biweekly, weekly, or even twice per week if necessary. Before routine meetings, both teams should meet separately to discuss progress and identify challenges. The routine meeting should not be the first time individual team members have spoken to each other about the project since the previous meeting. Following each routine meeting, team members should take care of the next task item, alerting management if a date will be missed.

Communication is essential to the execution of a successful project; however, this is often the most challenging part of any project. Both sides must communicate company needs early in the game. Team members must be willing and able to share information relevant to the project at hand.


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