Launch Projects / Readiness

Committed to success (or damned to success)

• NCE / NBE launches are multi-disciplinary and long-lasting programs with a high degree of complexity
• Successful launches contribute significantly to the long-term competitiveness of a pharmaceutical company, i.e. they have to be mastered effectively – time is money and zero-error-tolerance is a must
• The role and program contribution of Technical Operations are essential and require detailed preparation and planning
• Starting point for Technical Operations is a guiding mission clarifying scope and expected outcome of Technical Operation

 

 

Depending on the mission, the scope and complexity of implementation projects may vary – in general, launches address 10 major work streams in Production:

• Launch supply chain design – e.g. definition of first / second manufacturer
• Market demand forecast
• Capacity demand planning inclusive gap analysis
• Capacity and infrastructure build-up
• Design to cost roadmap and CoGS optimization
• Quality readiness with regard to manufacturability of DS and DP
• Transfer program between R&D and first manufacturer
• Launch supply strategy – i.e. definition of launch capacity, safety stocks, pipeline filling
• Accompanying launch program planning and monitoring
• Handover to routine phase

 

For each stream, we can provide project WBS – Work Breakdown Structure – templates ensuring completeness of activities and giving guidance regarding reachable best-in-class processing times.

The set-up of the corresponding program organization should follow some basic design principles: effective, focused, simple, manageable, and no overlaps. Very often these are not considered adequately, which leads to considerable delays during program execution.

Program organization should follow the motto “coming in parts but winning together” – the PMO (Program Management Office) is the integrating platform.

Typically, PMO is accountable for program planning, progress monitoring & reporting; the overall demand & capacity planning, the budget control (CapEx / OpEx), as well as accompanying communication & change management.

 

We at JSC have many years of experience in launch program management and have developed a tool box enabling the PMO to monitor and manage the program effectively and pro-actively (e.g. program with 10 workstreams, more than 30 projects, and ~ 2500 activities).