Tim Farries

Tim Farries is a highly skilled specialist expert in regulatory affairs and development of advanced therapy medicinal products, focusing on viral vectors, genome editing, stem cell, and CAR-T products.

With extensive senior-level experience in the development of biotherapeutics across commercial biotech and big pharma sectors, Tim brings a wealth of knowledge in biotechnologies including advanced therapies, gene therapy, cell therapy, tissue engineered products, protein therapeutics, biosimilars, and functional genomics.

His proficiency extends to regulatory aspects for ATMPs in various regions such as the EU and US, encompassing activities like Marketing Authorization Applications (MAA), Investigational Medicinal Product Dossiers (IMPD), Scientific Advice, ATMP classification, PRIME, Orphan Designations, and interactions with regulatory bodies like the FDA (IND, SPA, Fast Track), PMDA, and TGA.

Tim's expertise also spans manufacturing processes for biologicals, Good Manufacturing Practice (GMP), testing, and validation, as well as translational medicine, platform technologies, intellectual property (IP) matters, and program/project management with a focus on collaborations and Contract Research Organization (CRO) management.

His background features strong skills in proteins, molecular biology, drug discovery, viruses, and cells, along with experience in product partnering, business development, and technical assessments for due diligences.

Tim Farries pursued his education diligently, earning a Ph.D. in Biochemistry and Molecular Biology from the University of Cambridge, completing A Levels at Woking Sixth Form College, and obtaining a BA and MA in Biochemistry from the University of Oxford.

Currently, Tim serves as the Chief Scientific Officer at ERA Consulting, where his expertise is instrumental in navigating the intricate landscapes of advanced therapy medicinal products and regulatory affairs.