As cell and gene therapies continue to advance, so too do the regulatory frameworks that surround these products. Researchers and industry organisations can find navigating the regulatory guidelines a challenge as they endeavour to interpret legal and safety protocols, and seek to understand the geographical variations and unique challenges that exist in different regions, while facilitating product development.
In this BioBriefing seminar, Dr Houria Bachtarzi (Senior Consultant in Regulatory Affairs for Gene and Cell Therapies, ERA Consulting (UK) Ltd) will take both seasoned tourists and novices alike on a guided tour of the global cell and gene therapy industry. Dr Bachtarzi will explore the range of advanced biological therapies currently in development and what lies ahead for the cell and gene therapy space. The ‘Science of Safety’ for new cell and gene therapy technologies will also be examined, and illuminating features of advanced therapy medicinal product development within the global regulatory framework will be presented.
Who should attend:
R&D scientists, biotech entrepreneurs, industry related professionals, doctoral students and post-doctoral scientists
For a more in-depth look at this topic, you may be interested in participating in Module 6 of our Going Global Program – Navigating cell and gene therapies through global regulatory pathways.
Date: Tuesday 13 August
Time: 3.45 pm registration, presentation & discussion 4.00 pm – 5.00 pm, followed by networking until 6.00 pm
Venue: Allens, 37/101 Collins Street, Melbourne
Cost: NOW SOLD OUT
BioMelbourne Network Members: $65
Non Members: $130
(Prices include GST.)
Note: Participants registered for the Going Global program will receive three registrations for this event.
A full refund is given up to 7 days prior to the event. No refunds within 7 days of the event.
INTERNATIONAL GUEST SPEAKER
Dr Houria Bachtarzi
Senior Consultant Regulatory Affairs – Gene and Cell Therapies
ERA Consulting (UK) Ltd
Dr Houria Bachtarzi is a Senior Consultant, Regulatory Affairs – Gene and Cell Therapies, with strong scientific and regulatory experience in the field of advanced biological therapies including virally vectored gene therapy, in vivo and ex vivo gene editing, cell-based immunotherapy, genetically modified cells for tissue regeneration, genetically engineered immune cells targeting cancer cells, and stem cell-based therapies.
She was previously a Lecturer in Biopharmaceutics and Biotechnology within the Pharmacology and Therapeutics Division at the School of Pharmacy and Biomolecular Sciences, University of Brighton, UK. Houria completed her PhD in cancer gene therapy/viral gene delivery at the University of Oxford, Department of Clinical Pharmacology (now Department of Oncology), followed by Post-Doctoral research work in AAV-based gene therapy and shRNA therapeutics for degenerative neuro-muscular disorders at the Centre for Biomedical Sciences, Royal Holloway-University of London.
Houria holds a First-Class Master of Pharmacy Degree (with honours) from the University of Bath, UK and is a Registered Pharmacist with the General Pharmaceutical Council in the UK. She is also a Member of the Royal Pharmaceutical Society of Great Britain (RPSGB) and a Member of the British Society for Gene and Cell Therapy (BSGCT).
Houria has published a number of peer-reviewed papers in the field of advanced therapies and has presented platform presentations at many international and national scientific meetings. In 2014, she received a Rising Star Award from the University of Brighton.