WEDNESDAY, OCTOBER 25
DINNER | 6:15 – 9:15 PM

SC5: A Systems Pharmacology Approach for Immunogenicity Prediction

Instructors:

Xiaoying Chen, Ph.D., Senior Manager, Clinical Pharmacology, Pfizer, Inc.

Vibha Jawa, Ph.D., Director, Biologics and Vaccines Bioanalytics, Merck and Co. Inc.

Designing biologics to have minimal immunogenicity with no clinical impact is an aspirational goal for therapeutic protein development. This short course will provide a fundamental understanding of the systems-based approaches, and discuss the current state of predictive technologies for immunogenicity risk assessments. The course will showcase how immunogenicity risk factors such as genetic makeup of individuals, disease, indications can all be integrated into the systems-based approach for simulating clinical outcomes.

Topics include:

  • Get a better understanding on why fully human proteins can still have immunogenic potential
  • Predictive technologies that are applied for immunogenicity risk assessment
  • Systems biology and how to integrate complex immune responses to mechanistic biology
  • Understand how the outputs from predictive tools can be integrated into systems models

Xiaoying_ChenXiaoying Chen, Ph.D., Senior Manager, Early Oncology Development & Clinical Research, Pfizer

Xiaoying Chen is currently a clinical pharmacology lead in the Early Oncology Development & Clinical Research Department at Pfizer. Xiaoying received her Ph.D. degree (Pharmaceutical Sciences) from the University of Southern California, in 2011. She started her career at Pfizer PDM since 2011, working on mathematical modeling and simulation approaches to immunogenicity prediction for therapeutic proteins. She currently works on modeling and simulation supporting early Oncology clinical projects. Her research interests include mathematical modeling, such as empirical PK/PD modeling and system pharmacology modeling, immunogenicity prediction, drug delivery, bio-analysis, and design of recombinant fusion proteins.

Vibha_JawaVibha Jawa, Ph.D., Director, Biologics and Vaccines Bioanalytics, Merck and Co. Inc.

Dr. Vibha Jawa obtained her Ph.D. in Biochemistry and Immunology with a thesis work studying the immune mechanisms behind autoimmune diseases. This was followed by a postdoctoral fellowship at University of Pennsylvania where she did extensive work on assay development for monitoring the immune response to viral vectors. She then moved to the Bay area where she worked with a gene therapy company evaluating viral vectors for hemophilia therapy. Subsequently, she moved to Southern California where she worked for City of Hope Cancer Centre Stem Cell and Gene Therapy group prior to moving to Amgen in 2003. Until recently she was a Principal Investigator and Clinical Immunology representative on several of Amgen’s drug development teams where she provided input to develop appropriate immunogenicity risk assessment strategies. Her current research interests include evaluating immune response biomarkers for early drug development and efficacy, immunogenicity prediction using in silico, in vitro and in vivo technologies, modeling impact of immunogenicity on PK and PD, antigen processing and presentation and the role of T cells in immune response to drug products.

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