AGENDA - Main Workshop DAY 2BC - Wednesday Sep. 29, 2021: 8am – 4pm
"Regulators’ Inputs and 'Ask the Regulators' Panel Discussions"
DAY 2B: Regulators' Inputs on Regulated Bioanalysis & BMVChair: Dr. Fabio Garofolo, Chief Scientific Officer, BRI Biopharmaceutical Research
|08:00am–08:10am:|| Drs. Jan Welink, Senior Clinical Assessor, EU EMA
"Updates on the Status of the ICH M10 BMV Guideline"
|08:10am–08:20am:|| Dr. Seongeun Julia Cho, Director, Division of Generic Drug Study Integrity, OSIS, US FDA
"Office of Study Integrity and Surveillance (OSIS) Response to the Pandemic"
|| Mr. Stephen Vinter, Operations Manager, GLP Monitoring Authority and Laboratories Group, UK MHRA
"MHRA Requirements for Bioanalytical E-Data"
|| Dr. Anna Edmison, Senior Clinical Assessment Officer, Division of Biopharmaceutics Evaluation, Health Canada
"Observations from Health Canada During the Review of Pharmaceutical Drugs "
|| Dr. Arindam Dasgupta, Deputy Director, Division of New Drug Study Integrity, OSIS, US FDA
"Year of the Pandemic- Recent Observations from Remote Record Reviews"
|| Dr. Sandra Prior, Senior Scientist, Biotherapeutics Division, UK MHRA
"Recent Advances in Biotherapeutics International Standards"
|| Dr. Catherine Soo, Acting Manager, Clinical Trials Division, Health Canada
"Health Canada: Challenges experienced During Review of Biologic Drugs"
|| Dr. Jinhui Zhang, Chemist, Division of Product Quality Research, US FDA
"BMV of Biotherapeutics using Mass Spectrometry: Building on WRIB Recommendations"
|| Mr. Gustavo Santos, General Manager of Medicines and Biological Products, Brazil ANVISA
"ANVISA Updated Regulation and ICH Initiatives"
|| Dr. Elham Kossary, Technical Officer Inspector, WHO
"WHO Inspections of Bioequivalence (BE) Studies: The Process of Inspection Performance "
|| Dr. Yow-Ming Wang, Associate Director for Biosimilars and Therapeutic Biologics, US FDA
"Updates on Biosimilars and Therapeutic Biologics in The Office of Clinical Pharmacology"
Day 2B: ASK THE REGULATORS!
Interactive Panel Discussion with the Regulators on Bioanalysis & BMV Guidance
Ask the Regulators on Bioanalysis, BMV Guidance/Guidelines:
DAY 2C: Regulators' Inputs on Immunogenicity, Biomarkers, Gene Therapy, Cell Therapy & VaccineChair: Dr. Fabio Garofolo, Chief Scientific Officer, BRI Biopharmaceutical Research
|11:00am-11:10am:||Dr. Daniela Verthelyi, Chief Laboratory of Immunology, Office of Biotechnology Products, CDER, US FDA
"New Tools to Inform Immunogenicity Risk Assessments: Possibilities and Challenges "
|11:10am-11:20am:||Dr. Günter Waxenecker, Senior Expert Nonclinical and Biological Assessor, Austrian AGES/EU EMA
"Experience with the Integrated Summary of Immunogenicity in the EU"
|11:20am-11:30am:||Dr. João Pedras-Vasconcelos, Sr. Staff Fellow, Office of Biotechnology Products, CDER, US FDA
"Immunogenicity Risk Assessment and COVID19 - Current Perspectives from CDER Office of Biotechnology Products"
|11:30am-11:40am:||Dr. Haoheng Yan, Product Quality and Immunogenicity Assay Team Leader, CDER, US FDA
"FDA Regulatory Perspective on Neutralizing Antibody Assays"
|11:40am-11:50am:||Dr. Isabelle Cludts, Scientist Biotherapeutics Department National Institute for Biological Standards and Control, UK MHRA
"Development of Reference Material as Positive Controls for ADA Assays "
|11:50am-12:00pm:||Dr. Mohsen Rajabiabhari, Pharmacologist, Office of Study Integrity and Surveillance, CDER, US FDA
"Recent FDA Observations of Immunogenicity Assays"
|12:00pm-12:10pm:||Dr. Kimberly Maxfield, Guidance and Policy Lead, Office of Clinical Pharmacology, CDER, US FDA
"FDA CDER Immunogenicity Review Committee (IRC)"
|12:10pm-12:20pm:||Dr. Soma Ghosh, Branch Chief for Molecular Pathology and Cytology, CDRH, US FDA
"FDA’s Perspective on Liquid Biopsy In Vitro Diagnostic Tests: Challenges and Opportunities"
|12:20pm-12:30pm:||Dr. Shirley Hopper, Medical Assessor, UK MHRA
"Using Biomarker-based Assays in Drug Trials – A Regulator’s Perspective "
|12:30pm-12:40pm:||Dr. Kevin Maher, Regulatory Scientist, Office of In Vitro Diagnostic Device, CDRH, US FDA
"Validation of Flow Cytometric In Vitro Diagnostic Devices "
|12:40pm-12:50pm:||Dr. Yoshiro Saito, Director, Division of Medicinal Safety Science, Japan MHLW
"Points to Consider Document on Biomarker Assay Validation in Japan "
|12:50pm-01:00pm:||Mr. Abbas Bandukwala, Science Policy Analyst, Biomarker Qualification Program, CBER, US FDA
"21st Century Cures: Biomarker Qualification and Analytical Guidance"
Gene Therapy, Cell Therapy & Vaccines:
|01:20pm-01:30pm:||Dr. Nirjal Bhattarai, Principal Investigator and Product Reviewer, Division of Cellular and Gene Therapies, CBER, US FDA
"Immunogenicity of Chimeric Antigen Receptor (CAR) T Cells"
|01:30pm-01:40pm:||Dr. Dean Smith, Associate Director, Center for Biologics Evaluation (CBE), Health Canada
"Where Clinical and Quality Analysis Meet - Dose Ranging Immunogenicity Data Supports Vaccine Development and Harmonized Specifications"
|01:40pm-01:50pm:||Dr. Vijaya Simhadri, Biologist, Division of Plasma Protein Therapeutics, CBER, US FDA
"Understanding and Navigating the Immune Responses to CRISPR-associated Nuclease Cas9"
|01:50pm-02:00pm:||Dr. Therese Solstad, Senior Scientific Advisor, Head of Team for Quality Assessment of Biological Medicinal Products, Norway NoMA/EU EMA
"Navigating the European Regulatory Landscape for Gene Edited Cell Therapy Products and Vaccines"
|02:00pm-02:10pm:||Dr. Heba Degheidy, Staff Scientist, Division of Cellular and Gene Therapies, CBER, US FDA
"Advancement in Bioanalytical Techniques to improve Cell Therapy Product Quantification: Regulatory Considerations"
|02:10pm-02:20pm:||Ms. Leslie Wagner, Consumer Safety Officer, Office of Vaccines Research & Review, CBER, US FDA
"The Bioassay Challenge: A Reviewers Perspective "
|02:20pm-02:30pm:||Dr. Akiko Ishii-Watabe, Director, Division of Biological Chemistry and Biologicals, Japan MHLW
"Evaluation of Anti-SARS-CoV-2 Antibody Tests in the COVID-19 Project of Japan "
Day 2C: ASK THE REGULATORS!
Interactive Panel Discussion with the Regulators on Immunogenicity, Biomarkers, Gene/Cell Therapy & Vaccines
Ask the Regulators on Immunogenicity, Biomarkers, Gene/Cell Therapy & Vaccines
Regulatory Panelists on Immunogenicity:
|03:40pm-04:00pm:||Short Break Followed by Main Workshp Day 2A from 4pm to 6pm|