Connecting CMC and Regulatory Affairs Objectives

Philippa A. Whiteside

Philippa is a graduate in Natural Sciences from Trinity College, Cambridge, where she also obtained her M.A. degree. Since leaving university, she worked in Germany and then in London, UK, amassing experience in the CRO and pharmaceutical company environments. In 2009, she set up her own business to continue providing regulatory consulting, with a client base in both the USA and Europe, and her working style transcends different time zones and business cultures.

Philippa is an acknowledged expert in regulatory CMC for biologics with a proven record of nearly thirty years in technical and classical regulatory affairs at a senior level (strategy and consulting) and has accrued experience in product development from early stage clinical through scientific advice, centralised and national, to marketing application. In addition to project and people leadership, her technical expertise covers all aspects of the quality of products, specializing in biological products, co-/authoring of quality overall summaries (QOS). She is highly respected by technical staff for scientific- and experience-based interpretation of regulatory guidelines.

Philippa has managed regulatory interactions and projects for a wide range of products with both global or regional regulatory footprints. Notable achievements range from first in class to register sera with the EDQM to address TSE concerns in the 1990s, addressing complex CMC requirements from the agency for a glycosylated protein (CHO) to working with gene therapy products where design parameters link into mechanism of action.

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