Nick Lyon
About Nick Lyon
Nick Lyon is the Director of Regulatory Affairs - CMC at Geron Corporation, with extensive experience in regulatory approvals and product development in the pharmaceutical industry. He has held various leadership roles at notable companies, including Actavis Biologics and Pfizer Pharmaceuticals, and possesses in-depth knowledge of regulatory guidelines and therapeutic areas.
Current Role at Geron Corporation
Nick Lyon serves as the Director of Regulatory Affairs - Chemistry, Manufacturing, and Controls (RA - CMC) at Geron Corporation. He has held this position since 2020, working from Garstang, England, United Kingdom. In this role, he has successfully led various regulatory approvals, including Centralised, MRP/DCP, National, and US NDA approvals for products from early phase development.
Previous Experience in Regulatory Affairs
Prior to his current position, Nick Lyon held several key roles in regulatory affairs. He worked at Actavis Biologics Ltd as Director EU from 2011 to 2015 in Liverpool, United Kingdom. He also served as Head of Regulatory Affairs Europe at Protherics from 2007 to 2009. His earlier experience includes positions at Pfizer Pharmaceuticals, Johnson & Johnson, GlaxoSmithKline, and Chugai Pharma Europe Ltd, where he contributed to various regulatory functions.
Education and Professional Background
Nick Lyon studied at the University of Leeds, where he gained foundational knowledge that supports his extensive career in regulatory affairs. His professional background spans over two decades, during which he has developed expertise in regulatory strategies for both small molecules and biological products.
Expertise in Regulatory Guidelines and Submissions
Nick Lyon possesses in-depth knowledge of EU directives, CHMP guidelines, and ICH guidelines. He is recognized for his expertise in electronic Common Technical Document (e-CTD) and 'NeeS' submissions. His experience includes managing the production and lifecycle of Clinical Trial Applications (CTAs), Investigational Medicinal Product Dossiers (IMPDs), and US Investigational New Drug applications (INDs) for Phase 1-3 clinical trials.
Therapeutic Areas and Regulatory Strategies
Nick Lyon has extensive experience in oncology, vaccines, viral diseases, immunology, central nervous system (CNS), cardiovascular system (CVS), and renal therapeutic areas. He has developed registration and risk mitigation strategies for a variety of products, including monoclonal antibodies and orphan drugs. His work has included completing EMEA scientific advice procedures and FDA End-of-Phase II meetings and Special Protocol Assessments.