Transforming the Core of a Pharma R&D

Challanges 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).

OXYGY's Approaches

  • 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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