Qualifications
Regulatory Affairs
Practical Regulatory Affairs experience was obtained over a 4 year period as the lead scientist in a small pharmaceutical company, organising requirements for the characterisation, licensing and distribution of a complex biological product. This was followed by experience in a Regulatory Affairs consultancy liaising with clients and preparing, reviewing and submitting documents for submission to European authorities. Specialist areas included:
- Orphan Medicinal Drug Designation
- Paediatric Investigation Plans/Waivers
- Biopharmaceuticals
- Potency/Bioassays
Biotech Industry
Knowledge of technical aspects of pharmaceutical product development and manufacture gained from experience in the pharmaceutical industry facilitates the preparation of technical documents for product - related documentation and licence applications. Pharmaceutical experience includes:
- Manufacturing process development and product characterisation and analysis
- Functional assay (bioassay/potency assay) development
- Biochemical and cell biological assays of product structure purity, stability and function.
Oncology experience
Extensive experience (24 years) of academic studies of cancer drug delivery and tumour biology and targeting provides a depth of understanding to projects involving the development of anti-cancer therapies and targeted drug delivery to tumour sites. Specific experience includes:
- The design and use of antibody-drug/toxin conjugates
- Liposome-mediated delivery of drugs/toxins to cancer cells
- Vascular targeting and proteomics
- Organelle-specific targeting via the vasculature
- Animal models of disease
- Pharmacokinetics of antibody-drug conjugates
Cell Biology experience
A broad range of techniques has been mastered to investigate the binding, uptake and intracellular transport of drugs and toxins in a range of cell types in vitro and in vivo. Research has focussed on:
- Vascular endothelial, mesothelial and tumour cell biology
- Intracellular trafficking pathways
- Membrane domains (caveolae and lipid rafts)
- Electron microscopy, ultracryomicrotomy and confocal microscopy and imaging
