Regulatory Science, Drugs & Biologics
Amanda is responsible for the design and implementation of strategic development plans, particularly on Chemistry Manufacturing and Control (CMC) aspects of biological products, such as Recombinant, Gene-therapy, Vaccines and Biosimilar Medicinal Products.
Following her BSc in Biochemistry Amanda gained a PhD from Bath University, UK in mesenchymal stem cell (MSC) biology and a post-doc preparing and studying immortalized MSCs.
Early experience in a startup tissue regeneration company, Intercytex Ltd, gave her a solid background in Regulatory Science of Advanced Therapy Medicinal Products (ATMPs). Amanda planned and managed EU and US phase II clinical trials and provided technical support to R&D teams on manufacturing process, cGMP and QA issues.
Previously Amanda was a Global Project Leader for AstraZeneca PLC-Medimmune based in the UK. She was responsible for overseeing manufacturing process development of candidate monoclonal antibodies through to delivery of clinical material for early phase oncology studies. This was achieved by leading global (EU, US, Japan) development teams and Contract Manufacturing Organisation (CMO) project managers for regulatory and manufacturing tasks, and representing CMC on the Corporate Emerging Product team to define strategy and support clinical and marketing plans.
Amanda has prior experience as a Senior Biotechnology Consultant with MDS-Pharma Services where she supported development of a variety of vaccines and biotechnology projects. She supported scientific advice meeting and prepared IMPD and Module 3 and 2.3 sections leading to EU and US submissions. In this role, Amanda liaised with EU Regulatory Agencies and Notified Bodies, managed US to EU conversions and several orphan drug designation applications. During this time Amanda was an active member of the TOPRA Biotechnology Special Interest Group.
Currently Amanda is involved in supporting clients with EU focused projects on the development and registration of cell and gene based medicinal products and monoclonal antibodies.