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R&D Programme Management

The aim of the R&D programme is to develop a successful and safe product, which can be manufactured cost effectively, is clinically effective, complies with the regulatory requirements and has market potential. 

Pyrus offers expertise in: 

  • Strategic programme planning and management
  • Preparation and maintenance of development plans and budget tracking
  • Detailed strategy recommendation and review of formulation, stability, process development requirements (Pharmaceutical Development and Chemistry Manufacturing Control (CMC))
  • Development of product manufacturing strategies, identifying risks and implications
  • Recommendation of CRO’s and co-ordination of associated activities
   
Case Study


US Biotech Company

Task
The company had identified several novel cancer compounds and required the lead compound to be tested in a proof of concept clinical study.

Assignment/ Deliverables
Pyrus managed the internal and external members of a project team to develop the project strategy, team structure, and project plans and documentation to carry out a Phase I study. External CRO resource was identified to carry out the key activities required for non-clinical and clinical packages. The restructured project allowed a clinical study to be commenced successfully within 12 months.