Internationally recognised expert in immunogenicity, immunology, and (bio)analytical sciences, with experience spanning small molecules, biologics, vaccines, drug delivery systems, and gene & cellular therapies - GMP, GLP, and GCP manufacturing, non-clinical, and translational development
Experience includes:
- Product Development: Has held senior roles working on a variety of indications that includes, but aren't limited to, infectious disease, oncology, cardiovascular disease and auto-immune diseases.
- Technical Expertise: Extensive technical experience in the lifecycle of assay development & validation spanning early and late-stage development. This covers preclinical, non-clinical, clinical and CMC elements, such as pK, pD, biomarkers and immunogenicity that includes neutralising assays. Furthermore, expertise in potency and host cell protein (HCP) assays
- Compliance: Experience of working in GxP and ISO environments for both development and manufacturing to European and US standards
- Regulatory: Familiarity with FDA, EMA & MHRA regulations for medicines including dossier submissions, BLAs and regulatory interactions
- Training: Performs training internationally on both bioanalytical and analytical related activities including immunology, immunogenicity as well as method development including potency assays. Expertise in assay related QbD and DoE based upon ICH Q14 guidance
- Immunogenicity Strategy: Drafting of immunogenicity risk assessments, supporting clients with Integrated Summary Immunogenicity (ISI) for IMPD & IND support. Member of the European Immunogenicity Platform (E-I-P) and Dutch Society for Immunology (NVVI)
- Vendor Management: Utilising broad network of CDMOs and CROs to help identify partners for clients. Furthermore, experienced at managing the CDMO and CRO programmes to ensure forward momentum and value addition. Manages collaborations and relationships with industry, academia, regulatory bodies and NGOs
