Dr Houria Bachtarzi is the Principal Consultant and the Founding Director of BIOCELLGENE Consulting Ltd. She is a specialist expert in CMC regulatory and development aspects of advanced biological therapies with 20 years of experience including extensive CMC (quality) data-driven gap analyses and global regulatory and development strategies for virally vectored gene therapy products, in vivo and ex vivo genome editing, oncolytic viruses, cell-based immunotherapy, genetically modified cells for tissue regeneration, genetically engineered immune cells targeting cancer cells, stem cell-based therapies; as well as other therapeutic modalities including biologics and other innovative therapies.

Dr Elwyn Gabutero is Principal Consultant, Asia-Pacific at BIOCELLGENE Consulting, based in Brisbane, Australia. He has more than 15 years’ experience in regulatory affairs and translational development across cell and gene therapies (ATMPs), therapeutic cancer vaccines, monoclonal antibodies, recombinant proteins, biosimilars and small molecules. He advises sponsors on regulatory strategy and clinical trial pathways in Australia and New Zealand, and on aligning these with EU and US development programmes.