This workshop is the core component of the sixth and final module in the Going Global program. It will provide a deep dive into the pre-authorisation product development of existing and emerging cell and gene therapies from a regulatory scientific and strategic perspective, and through global regulatory pathways.
The workshop will provide in depth insights into the pre-authorisation development of cell and gene therapies, from a focused regulatory scientific perspective and a strategic global regulatory pathway. In particular, it will highlight divergence in scientific technical considerations (notably in aspects of quality and non-clinical testing) and regulatory expectations for cutting-edge technologies. Guidance will be provided on how to accommodate regulatory variabilities and uncertainties to build a more efficient and robust global development program.
ERA Consulting (UK) Ltd will discuss strategies for engagement with regulatory health authorities to optimise plans in a rapidly evolving field. They will also explore accelerated pathways and incentives that can be leveraged to facilitate the development of advanced therapies/regenerative medicines, and how to prepare for success in attaining these.
Finally, the workshop will address the safety and logistical issues incurred in getting a cell therapy from donation to the site of manufacture and then to the patient.
The workshop will be interactive, centred around themed presentations and finishing with a summary of key learning points. Sessions will be designed to address often overlooked or poorly planned issues in product development.
In addition to attendance at the workshop for one company representative, registration includes:
The fee is $550 (incl. GST) if this is your first Going Global module, or $440 (incl. GST) if you have participated in earlier modules.
Registration confirmation: Please note that places are strictly limited and registration is subject to confirmation by BioMelbourne Network.
Cancellation policy: A full refund is given up to 14 days prior to the module. No refunds within 14 days of the module.
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 for ERA Consulting (UK) Ltd. Houria has 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 and Member of the Brighton Centre for Regenerative Medicine 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 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, in joint collaboration with Benitec Biopharma. 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 gene therapy and has presented posters and platform presentations at many international and national scientific meetings. In 2014, she received a Rising Star Award from the University of Brighton.
Dr Dianne Jackson-Matthews
Chief Scientific Officer, ERA Consulting Group
Director of Regulatory Affairs (Australia)
Dianne has over 25 years of experience in pharmaceutical product development, spanning the areas of drugs, biotech/biologics/biosimilars and cell/gene therapies in the US, Europe and Australia. She has experience in development of regulatory and technical strategies, conducts regulatory agency interactions worldwide, prepares regulatory documentation and submissions, and performs regulatory and technical due diligence assessments supporting funding and licensing opportunities for the investment community and the industry.
Prior to joining ERA in 2001 as the Director of the Washington DC office, Dianne was the Director of Regulatory Affairs at a biotech company in New Jersey, where she gained extensive experience with biotechnology products over a 12 year period, covering GMP production, GLP and bioanalytical testing, and regulatory submissions and approvals. She also has 6 years’ experience with in vitro diagnostic device development in the US. Dianne has held an Adjunct Associate Professor position at the University of Queensland, Australia, since 2010.