Ph.D., University of Cambridge, UK (1985)
Degree, University of Oxford, UK (1982)
ERA Consulting (UK) Ltd., Director of Regulatory Affairs, Cell and Gene Therapy (2013 - current)
Ark Therapeutics: Director of Scientific Projects (2003 - 2013)
Gendaq Ltd., Scientific Projects Manager (2001-2002)
Tim Farries is an expert in the development of Cell & Gene Therapy products with over 16 years commercial experience in biotech and big pharma. He has been Director of Regulatory Affairs – Gene & Cell Therapies at ERA Consulting (UK) Ltd. in London since 2013, heading a team of consultants focussed on CMC regulatory, non-clinical and development matters. This team has achieved a number of regulatory firsts, including a pivotal role in the first marketing authorisation in the EU for a product containing stem cells. Tim previously managed regulatory, development and manufacturing aspects of gene therapy development projects at Ark Therapeutics Ltd., dealing with FDA and European regulatory authorities. He has also held roles in management of advanced biotechnology programmes at Gendaq (acquired by Sangamo Biosciences) and Novartis.
Honors & Awards
Farries, T. Mednous Apr 2017, Commentary "An EU approval or a hospital exemption?"
Bachtarzi, H. & Farries T., Mednous June 2017, Commentary "The risks of therapeutic genome editing"
Afuwape, A & Farries T, Mednous Oct 2017, Commentary "Regulatory challenges for cell therapy manufacture"
Matching the latest scientific innovations in cell and gene therapeutics to regulatory obligations
In the field of cell and gene therapies, a range of novel features are being added to create new therapeutic possibilities. However, these advances also raise new issues for safety and product definition. ERA has been supporting development of advanced therapeutic products at the scientific cutting edge, and this presentation will review some of the lessons learned from experience of regulatory interactions and applications across Europe, US and Japan. In particular this will cover the regulatory issues associated with gene editing, pluri- and multi-potent stem cells and the latest cellular immunotherapies, including the concerns associated with off-target genomic modifications and tumorigenic potential. The presentation will report the varied positions that have been taken to these matters by different regulatory authorities, along with recommendations on how product developers should be addressing them.