Effective project management

One of the key factors behind a company’s decision to engage in an outsourcing partnership with a CDMO is the rising cost associated with drug development and manufacturing. CDMO partnerships are often successful and provide significant economic benefits. At the same time, they can present huge challenges. The simple fact that a critical function is now external can leave potentially serious gaps in communication, planning, and control.

Look to project management to lower costs and accelerate time-to-market

Project management for drug development is vital to the success of the project. Selecting a CDMO with project management expertise can put a company’s product on the right path from the start.

Project management typically encompasses several key tasks that take a project from start to finish, including

• initiation
• planning and coordination
• controlling
• closing

A single project manager is often designated by each partner organization. From there, a more complete project team is chosen, including members from packaging, development, process development, qualification and validation, production, regulatory affairs, quality management, and supply chain management. To maintain continuity, the pharmaceutical or biotech company’s team should mirror the CDMO’s team. This allows for true peer-to-peer communication.

A process designed for performance

Vetter’s project management approach is built for success, starting with a clear dialogue between partners and an intelligent, disciplined process.

• Structured peer-to-peer communication streamlines information flow between customers and key staff members
• Dedicated project managers follow projects from conception through final delivery, providing continuity at all stages
• Transparency into all aspects of project workflow supports efficient time-to-market
• Early, proactive life cycle management strategies strengthen market success