"Regulators' Advice on Immunogenicity, Gene Therapy, Cell Therapy, and Vaccines"
Session 1: Immunogenicity
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US FDA:
Tools to Assess Immunogenicity Risk and New Computational Methods
Dr. Daniela Verthelyi, Chief, Lab of Immunology, US FDA -
Japan MHLW:
Using S/N ratio of screening assay as an alternative to titer
Dr. Akiko Ishii-Watabe, Director, Japan MHLW -
US FDA:
Updates of the OCP Efforts on Evaluating Clinical Impact of Immunogenicity
Dr. Mohsen Rajabi Abhari, Clinical Pharmacologist, Biologics lead , US FDA -
US FDA:
An update on Biosimilar Biological Product Authorization Performance Goals and Procedures
Dr. Kimberly Maxfield, Lead for BsUFA III Reg Sci Program, US FDA -
US FDA:
An Update on FDA Immunogenicity Review Committee Activities
Dr. Sophie Shubow, Senior Scientist, US FDA -
US FDA:
NAb Assays: Current Perspective from OBP
Dr. Joao Pedras-Vasconcelos, Senior Staff Fellow, US FDA
ASK THE REGULATORS!
Interactive Panel Discussion with the Regulators on Immunogenicity
- Regulatory Panelists on Immunogenicity
- Dr. Daniela Verthelyi (US FDA CDER)
- Dr. Joćo Pedras-Vasconcelos (US FDA CDER)
- Dr. Kimberly Maxfield (US FDA CDER)
- Dr. Sophie Shubow (US FDA CDER)
- Dr. Kara Scheibner (US FDA CDER)
- Dr. Mohsen Rajabi Abhari, (US FDA CDER)
- Dr. Meenu Wadhwa (UK MHRA)
- Dr. Isabelle Cludts (UK MHRA)
- Dr. Christian Mayer (Austria AGES/EU EMA)
- Dr. Akiko Ishii (Japan MHLW)
Session 2: Gene Therapy, Cell Therapy, and Vaccines
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US FDA:
Recent Advances on Cell and Gene Therapies
Dr. Nirjal Bhattarai, Chief, Tumor Vaccine and Biotechnology Branch, US FDA -
Health Canada:
Assessment of qualified laboratories for cell and gene therapies: Health Canada's approach
Dr. Omar Tounekti, Manager, Health Canada -
US FDA:
Vaccine Assay Validation
Ms. Leslie Wagner, Consumer Safety Officer, US FDA -
EU EMA:
Vaccine Assay Validation: Regulatory Perspective
Dr. Alessandra Buoninfante, Scientific Officer, EU EMA -
Austria AGES:
Current Developments at the EMA
Mr. Christian Mayer, Quality Assessor, Austria AGES -
US FDA:
Recent updates on Flow Cytometry and Cell Therapy
Dr. Heba Degheidy, Biologist/ Senior product reviewer, US FDA -
UK MHRA-NIBSC:
International Reference Standards for Flow Cytometry
Ms. Sandra Diebold, Principal Scientist, Head of Immunotherapy, UK MHRA-NIBSC -
US FDA:
Benchmarking and Improving Indel Calling from Oncopanel Sequencing Data
Dr. Joshua Xu, Branch Chief, US FDA -
Japan MHLW - NIHS :
Bioanalysis of adenovirus vector by qPCR and digital PCR
Dr. Yoichi Tanaka, Senior researcher, Japan MHLW - NIHS
ASK THE REGULATORS!
Interactive Panel Discussion with the Regulators on Gene Therapy, Cell Therapy, and Vaccines
- Regulatory Panelists on Gene Therapy, Cell Therapy, and Vaccines
- Dr. Nirjal Bhattarai (US FDA CBER)
- Dr. Heba Degheidy (US FDA CBER)
- Dr. Leslie Wagner (US FDA CBER)
- Dr. Joshua Xu (US FDA NCTR)
- Dr. Alessandra Buoninfante (EU EMA)
- Dr. Christian Mayer (Austria AGES/EU EMA)
- Dr. Sandra Diebold (UK MHRA)
- Dr. Omar Tounekti (Health Canada)
- Dr. Yoichi Tanaka (Japan MHLW)
