Title: "A Middle-Out Approach to Systems Pharmacology of Immunogenicity of Therapeutic Proteins"

Time: 16 Feb 16:00 - 18:00 

Location: Genentech Building 82 cafeteria

No registration fee  Click Here to RSVP

Plan: ~1 hr presentation, ~1 hr networking

Speaker: Dr. Paolo Vicini, Research Fellow, Pfizer Worldwide Research & Development

Abstract: Immunogenicity of therapeutic proteins is a complex, multi-factorial problem. Immune response following administration of a biotherapeutic can be linked to a great variety of factors, including T and B lymphocyte levels, patient genetics and immune status (host-related factors) and delivery routes, purity, aggregates and B and T cell epitopes (drug-related factors). Complex systems are best studied by a comprehensive modeling and simulation approach, but in this case the abundance of potential causal factors and the heterogeneity of the data makes such a process daunting. A middle-out approach to complexity management can be used to start where the information is most readily available – in this case, an empirical exposure-response framework inspired by PK-PD provided insights in the process of anti-drug antibody (ADA) generation, based on ADA-impacted drug profiles. Subsequently, and using lessons from this approach, a systems pharmacology model was proposed that incorporates both host- and drug-related factors in a parsimonious representation of the immune system. Learning opportunities from this work for the understanding and the prospective simulation of immunogenicity will be presented.

Bio: Paolo Vicini received his Ph.D. (Bioengineering) from the Polytechnic of Milan, Italy, and his M.B.A. from the University of Southern California. He joined the University of Washington faculty in 1998 as a Research Assistant Professor and became an Associate Professor of Bioengineering in 2004. His work at the University of Washington was on the development of data analysis software and the application of modeling and simulation techniques to diabetes, cancer, pharmacokinetics and pharmacodynamics. In 2008, he joined Pfizer Worldwide Research and Development in San Diego, CA, as a Research Fellow in the Pharmacokinetics, Dynamics and Metabolism Department. His current research focuses on translational modeling and simulation in support of various discovery programs. Dr. Vicini is a member of the American Diabetes Association, the Biomedical Engineering Society, the American Association of Pharmaceutical Scientists, the American Society of Clinical Pharmacology and Therapeutics and the IEEE Engineering in Medicine and Biology Society. He is a Fellow of the AAPS, a member of the Editorial Advisory Board of the Journal of Pharmacokinetics and Pharmacodynamics and an Associate Editor of Clinical Pharmacology and Therapeutics: Pharmacometrics and Systems Pharmacology.

ISoP: ISoP (http://www.go-isop.org) is the sponsor for ACoP meeting (American Conference of Pharmacometrics), and is the society to promote the discipline of Pharmacometrics. The ISoP Northern CA Local Group will aim to promote local scientific knowledge exchange, training workshops, and networking for Pharmacometrics and related areas.