Summary 
25 year plus pharmaceutical development knowledge spanning chemical development, drug substance development, external collaboration/outsourcing oversight and aseptic drug product
development/manufacturing. Broad understanding of CMC development strategies and regulatory requirements in highly controlled processing environments.

Detail/CV

Degree and PhD in Chemistry from University of Strathclyde in Glasgow and 11 years at GSK in chemical development and CMC project outsourcing. 18 years at Curia Scotland, principally in role leading GMP operations. Direct responsibility for aseptic GMP manufacturing programmes at the site as well as member of site leadership team. Work in partnership with business development colleagues in new project opportunities to the Curia Scotland site as well as technical transfer of maturing programmes to our commercial sites.

Presentation Title: The Growing Complexity of Sterile Formulation

Abstract: Covered in this presentation will be the following key themes:

Integrated approaches for complex formulation, illustrated by case study, including;

Process design / development
Supportive analytics to define CPP
Particle size definition and control
Scale-up from lab to clinical supply
Aseptic processing and sterility assurance

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