Catherine has over 20 years’ experience in cell and gene therapy, regenerative medicine, pharmacology, biochemistry, molecular & cellular biology, within the academic, biotechnology, CDMO & pharmaceutical sectors.

She has managed pre-clinical, clinical and commercial phases cell and gene therapy programs (pre-clinical, technology process transfers, Phase I/II/III- product life cycle, comparability study, process and analytical qualification & validation, APV, raw materials testing, regulatory dossier: IMPD, IND), and commercial launch (process and analytical validation, regulatory dossier: MMA, BLA).

She has additional experience in product and process CMC life cycle management including commercial pre-launch, launch and post approval of cell and gene therapy products with significant regulatory experience (FDA, EMA and corporate GMP compliance audits; regulatory submission dossiers- IND, IMPD, BLA, and MMA).

She provides the interface between the customer, supply, quality, business development, operations, and regulatory to deliver and execute client contracts to manufacture cell and gene therapy products. Her experience extends to contract negotiations (quality technical agreement, project plans, budget, time planning and staffing) and she is an efficient communicator of complex issues, both orally and in written reports having authored a number of scientific papers and presented at conferences and symposiums.