The project was about supporting a filing of a drug product in US and Europe. A combination of Accelerando and agile Program Management techniques were used.
Accelerando, as used in music terminology, means ‘going steadily faster’. The meaning in the Pharma R&D setting is about accelerating major phase transitions: from phase IIA to IIB, Phase II to III and Phase III into NDA/MAA submissions. As an additional project management function, the "Acceleration Manager" is added to the regular project management support for the Development Team, especially when these processes are new to the company or team. The Acceleration Manager is an expert in phase transition management and steps into the team to guide them throughout the complex, intense and multi-functional phases of product development. Best practice (generic) processes are translated into very specific, tailor-made process descriptions and planning overviews, resulting in more pro-active management of scenarios and issues. To do this, we can rely on a well-documented set of generic work packages, resource requirements and sub processes in the fields of chemical, pharmaceutical, preclinical, clinical and regulatory affairs. The generic work packages and processes are continuously updated based on real life experience and lessons learned. This methodology can also be used to straighten out processes, in the instance where stage gate transitions for different projects are coinciding. Interlinking is a multi-team effort going into the detail of each individual component. The result is a very visible and reproducible tool to guide a team through the most critical time periods in pharmaceutical development.
Key steps to success
- Stakeholder management analysis and communication plan
- Create/visualize Team Process (Flow Chart) with high level and detailed milestones and deliverables, including interactions
- Meetings with area-experts
- Alignment between all involved parties
- Clear communication
- Train key players including assistant/support
- Acceleration Workshop with all stakeholders involved to agree on way forward
- Follow-up on execution
- Lessons learnt meetings with area's - after each subprocess
- Consolidate Lessons Learnt, act on actions, update Flowchart and Documentation
- Follow-up on implementation for document finalisation, central agenda planning; manage conflicts