C&G/RegMed TIN Seminar: Preclinical Development of Cell Based Therapies

This event organised in collaboration with COVANCE will focus on the preclinical development of cell-based therapies.

If you are interested in the development of autologous, allogenic or xenogenic cell-based drugs for regenerative medicine or immunotherapies, Dr Bruce Hamilton and his team will guide you through the background of these approaches, aspects to consider in relation to the regulatory frameworks for these products and how these novel medicines may differ in their requirements when compared with more traditional drug modalities. You will also hear from Dr Assa Oumie (COVANCE) about the challenges facing the cell and gene therapy industry in the field of potency assay development. Then, finally Dr Qasim Rafiq (Dept of Biochem Engineering, UCL) will provide case studies for the development of automated process development and manufacturing strategies for hMSCs and CAR-T cell. This includes case studies of vessel and technology development for automated platforms and methods for process intensification of CAR-T and other ATMPs, including fed-batch and perfusion culture.

Agenda:

Cell and Gene Therapies/ Regenerative Medicine TINs introduction (Dr Asha Recino- TIN coordinator) - 5 mins

Preclinical Development of Cell Based Therapies (Dr Bruce Hamilton -Drug Development Leader, COVANCE) - 40 mins

Potency Assay Development Challenges for Cell and Gene Therapy (Dr Assa Oumie - Biopharm CMC Principal Scientist, COVANCE) - 15 mins

Automated Process Development and Scalable Manufacturing Strategies for ATMPs (Dr Qasim Rafiq - Associate Professor in Cell & Gene Therapy Bioprocess Engineering, Department of Biochemical Engineering, UCL) - 10 mins

Panel discussion (Dr Hamilton, Dr Oumie, Dr Evans, Dr Mcluckie- COVANCE, Dr Rafiq-UCL) + Q&A - 20 mins