Linda Randall | Associate Vice President
Pharmaron
Linda is Associate Vice President of the Biologics Business at Pharmaron in Liverpool, UK. Linda has worked in the Pharma and Biotech industry for 25+ years, leading the CMC development of small molecule drugs initially and for last 18+ years the development of innovative biological drugs, gene therapies and biosimilars.
In her current role, Linda and her group support the development of new drugs (antibodies and other mammalian expressed products, microbial proteins, gene therapies, viral vectors,) for customers from candidate selection through to IND and manufacture for Clinical Trials and onto Process Validation in readiness for marketing approval. Linda’s group also provide CRO-analytical services for a wide range of biologic drugs.
Appearances:
Festival of Biologics Day 2 @ 17:10
Successful CMC Development & Manufacturing is Built on Highly Effective Partnerships
As biologics, conjugates and advanced therapeutic modalities become increasingly complex, successful CMC development and manufacturing relies not only on scientific and technical excellence, but also on highly effective partnerships. This presentation will explore how integrated global development and manufacturing strategies can accelerate programs from preclinical development through to clinical supply, while maintaining quality, flexibility, and speed. Using Pharmaron's end-to-end biologics platform as an example, we will discuss globally aligned mammalian technology platforms and approaches to supporting both regional and global market strategies. Particular focus will be placed on how trusted partnerships enable successful CMC execution for biologics programs across organisations, geographies, and time zones.
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