Mark Milton

Mark Milton

Company: Novartis

Job title: Area Head of Ophthalmology


Mark is currently the Global Head of the Pharmacokinetic Sciences Ophthalmology Therapeutic Area and Department lead for Gene Therapies.
He received a B.Sc. in Biochemistry and Soil Science from UCNW, Bangor, a M.Sc. in Toxicology and Ph.D. in Biochemical Toxicology from the University of Surrey, England. Mark has over 25 years’ experience in the nonclinical and clinical PK/PD of NCEs, Biologics and Gene Therapies. Prior to joining Novartis in 2009, Mark worked at GD Searle, Millennium Pharmaceuticals, and Tempo Pharmaceuticals. At Novartis Mark leads scientists who provide nonclinical and clinical PKPD support to the development of biologics (antibodies, therapeutic proteins, gene therapies and cell-based therapies) and is an internal expert in Immunogenicity Risk Assessment and Gene Therapies.

Mark is the past-chair of the BioSafe PKPD EWG, a member of the BioSafe LC, IQ Board of Directors, a member of the AAPS pre-existing antibody and Immunogenicity Risk Assessment Working Groups and was the BIO observer to the ICHS3A Q&A WG. He has published over 30 peer-reviewed publications and book chapters and presented extensively on the development of both NCEs and Biologics. His current interests include the PK/PD and immunogenicity of biotherapeutics, the contribution of PK (biodistribution) and IG to the development of gene and cell-based therapies, ocular immunology, the selection of the clinical starting dose based upon the MABEL calculation, and alternative designs for FIH Clinical Trials of monoclonal antibodies in Healthy Volunteers.


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Immunogenicity Risk Assessment for AAV Gene Therapies – the What, the Why, & the How 9:00 am

• Immunogenicity Risk Assessment is a commonly used tool for monoclonal antibodies • The approach consists of identifying potential risks followed by risk evaluation and identification of a risk mitigation strategy • The outcome is an appropriate, cost-effective, testing approach to describe the immunogenicity of AAV gene therapies and its impact on safety and efficacyRead more

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