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Neoantigen-Based Cancer Therapies: Regulatory Challenges and Opportunities
Session Chair(s)
Peter F. Bross, MD
Medical Review Officer OTAT, CBER, FDA, United States
Neoantigen-based cancer therapy is an approach based on the specific genetic information unique to individual tumor(s) of an individual patient. Such information can be utilized in many ways for cancer treatment, e.g., to generate antigens for vaccination or specific T-cells. Results from earlier clinical trials have shown that this approach is feasible, able to elicit the intended immune response, and in some cases generating anti-tumor activities that may mediate the tumor regression. However, this approach has many scientific and regulatory challenges, for example, optimal ways / algorithms in identifying and selecting neoantigens, and regulatory framework for regulating such products given that drug product and indications are not explicitly defined. This session is intended to address these challenges and discuss the opportunities for the neoantigen-based cancer therapies.
Learning Objective : Describe the concepts of cancer immunoediting and neoantigen;Discuss the recent advances in neoantigen-based novel cancer therapy, e.g., vaccine and cell-based therapies;Discuss scientific and regulatory challenges, focusing on pre-clinical studies and early clinical trials; Identify opportunities in facilitating and accelerating the development.
Speaker(s)
Elena Gubina, PhD
Expert Biologist, OTAT, CDER, FDA, United States
CMC Considerations: Regulatory Perspective
Karin Jooss, DRSc
Executive Vice President of Oncology and Chief Scientific Officer, Gritstone Oncology, United States
CMC Considerations: Industry Perspective
Aaron M. Miller, MD, PhD
Medical Oncologist, Assistant Professor of Medicine, University of California San Diego, United States
Clinical Consideration for Early-Phase Trials: Academic Perspective
Peter F. Bross, MD
Medical Review Officer OTAT, CBER, FDA, United States
Clinical Consideration for Early-Phase Trials: Regulatory Perspective
Alyssa K. Galaro, PhD
Biomedical Engineer, DCEPT, OTAT, CBER, FDA, United States
Panelist
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