Challenges and tasks
A global leading pharma company dedicated to the research, development and distribution of innovative prescription therapeutic products needed to:
- Create a new CMC (Chemistry Manufacturing and Controls – the ‘core’ of a Pharma R&D department) unit out of three existing departments;
- Build an organization structure and capabilities to be able to work with a larger portfolio of earlier-phase developments; and
- Improve skills for partnering with 3rd party R&D providers (CROs, CMOs).
- Mapping & documenting of the development process
- Co-designing a new organization set up for the CMC
- Supporting targeted development interventions for both Leadership and functional teams
- Supporting clarification of the critical performance indicators for the CMC and defining simple set of KPIs for process steps
Outcomes and value created
Engaged the R&D teams to speed up drug development by:
- defining core purpose and competencies of the CMC unit;
- establishing a ‘project focused organization’ approach and skillset;
- developing a ‘roadmap’ for an end-to-end view of CMC;
- designing and resourcing the new organization;
- strengthening collaboration with other R&D functions; and
allowing the company to gain marketing approval for its innovative formulation, the 1st of its kind (and doing so faster than competitors).
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