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Immuno-Oncology Product Development: Overcoming Scientific and Regulatory Challenges
Session Chair(s)
Laurie Iciek, PHD
Senior Consultant, Nonclinical
Biologics Consulting, United States
The development of immuno-oncology products has spanned decades, culminating in approvals for the use of immune modulating cytokines, monoclonal antibodies, fusion proteins, genetically modified T cells, cancer vaccines and oncolytic vectors, for the treatment of cancer. Currently there are hundreds of immuno-oncology products in clinical trials.
This session will provide an overview of immuno-oncology products, highlighting the relevant preclinical safety regulations and potential safety concerns ascribed to different categories of products. Preclinical development challenges, such as, selecting the relevant pharmacology and toxicology models, distinguishing pharmacologic from toxicologic responses, and justifying first in human dose, will be discussed. Case examples highlighting the preclinical testing strategies that are being applied to evaluate the pharmacology and safety of immuno-oncology drugs will also be presented.
Learning Objective : Describe immuno-oncology products, including the potential safety concerns ascribed to different immunotherapeutic modalities; Identify the regulatory requirements (and/or challenges) associated with preclinical safety evaluation for different modalities of immuno-oncology drugs; Discuss the preclinical testing strategies that are being applied to evaluate the pharmacology and safety of immuno-oncology products through case study presentations.
Speaker(s)
New Challenges for Developing HER2-Targeted Cancer Immunotherapeutics
Karin Staflin, PHD
Genentech, A Member of the Roche Group, United States
Senior Scientist
Strategies for Preclinical Safety Assessment of Immune-Oncology Biologics
Simone Nicholson, PHD
AstraZeneca, United States
Toxicologist
Challenges in Predicting Animal-to-Human Safety for Immune-Stimulatory Agents from Toxicology Studies
Theresa Sweeney, PHD
Nektar Therapeutics, United States
Vice President, Safety Assessment