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 & BMV

Chair: 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"
08:20am–08:30am: Mr. Stephen Vinter, Operations Manager, GLP Monitoring Authority and Laboratories Group, UK MHRA
"MHRA Requirements for Bioanalytical E-Data"
08:30am–08:40am: Dr. Anna Edmison, Senior Clinical Assessment Officer, Division of Biopharmaceutics Evaluation, Health Canada
"Observations from Health Canada During the Review of Pharmaceutical Drugs "
08:40am–08:50am: Dr. Arindam Dasgupta, Deputy Director, Division of New Drug Study Integrity, OSIS, US FDA
"Year of the Pandemic- Recent Observations from Remote Record Reviews"
08:50am–09:00am: Dr. Sandra Prior, Senior Scientist, Biotherapeutics Division, UK MHRA
"Recent Advances in Biotherapeutics International Standards"
09:00am–09:10am: Dr. Catherine Soo, Acting Manager, Clinical Trials Division, Health Canada
"Health Canada: Challenges experienced During Review of Biologic Drugs"
09:10am–09:20am: Dr. Jinhui Zhang, Chemist, Division of Product Quality Research, US FDA
"BMV of Biotherapeutics using Mass Spectrometry: Building on WRIB Recommendations"
09:20am–09:30am: Mr. Gustavo Santos, General Manager of Medicines and Biological Products, Brazil ANVISA
"ANVISA Updated Regulation and ICH Initiatives"
09:30am–09:40am: Dr. Elham Kossary, Technical Officer Inspector, WHO
"WHO Inspections of Bioequivalence (BE) Studies: The Process of Inspection Performance "
09:40am–09:50am: 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"

Interactive Panel Discussion with the Regulators on Bioanalysis & BMV Guidance

09:50am–10:40am: Ask the Regulators on Bioanalysis, BMV Guidance/Guidelines:
Regulatory Panelists:
  • Dr. Seongeun Julia Cho (US FDA)
  • Dr. Arindam Dasgupta (US FDA)
  • Dr. Sam Haidar (US FDA)
  • Dr. Mohsen Rajabiabhari (US FDA)
  • Dr. Yow-Ming Wang (US FDA)
  • Dr. Nilufer Tampal (US FDA)
  • Dr. Diaa Shakleya (US FDA)
  • Dr. Jinhui Zhang (US FDA)
  • Drs. Jan Welink (EU EMA)
  • Mr. Stephen Vinter (UK MHRA)
  • Dr. Sandra Prior (UK MHRA)
  • Dr. Anna Edmison (Health Canada)
  • Dr. Catherine Soo (Health Canada)
  • Mr. Gustavo Santos (Brazil ANVISA)
  • Dr. Elham Kossary (WHO)
10:40am-11:00am: Short Break

DAY 2C: Regulators' Inputs on Immunogenicity, Biomarkers, Gene Therapy, Cell Therapy & Vaccine

Chair: 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"
01:00pm-01:20pm: Short Break
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 "

Interactive Panel Discussion with the Regulators on Immunogenicity, Biomarkers, Gene/Cell Therapy & Vaccines

02:30pm–03:40pm: Ask the Regulators on Immunogenicity, Biomarkers, Gene/Cell Therapy & Vaccines
Regulatory Panelists on Immunogenicity:
  • Dr. Susan Kirshner (US FDA CDER)
  • Dr. Daniela Verthelyi (US FDA CDER)
  • Dr. Joao Pedras-Vasconcelos (US FDA CDER)
  • Dr. Haoheng Yan (US FDA CDER)
  • Dr. Kimberly Maxfield (US FDA CDER)
  • Dr. Mohsen Rajabi Abhari (US FDA CDER)
  • Dr. Günter Waxenecker (Austrian AGES/EU EMA)
  • Dr. Meenu Wadhwa (UK MHRA)
  • Dr. Isabelle Cludts (UK MHRA)
  • Dr. Elana Cherry (Health Canada)
  • Dr. Lucia Zhang (Health Canada)
Regulatory Panelists on Biomarkers:
  • Dr. Soma Ghosh (US FDA CDRH)
  • Dr. Kevin Maher (US FDA CDRH)
  • Dr. Yow-Ming Wang (US FDA CDER)
  • Mr. Abbas Bandukwala (US FDA CDER)
  • Dr. Shirley Hopper (UK MHRA)
  • Dr. Yoshiro Saito (Japan MHLW)
Regulatory Panelists on Gene/Cell Therapy and Vaccine:
  • Dr. Nirjal Bhattarai (US FDA CBER)
  • Dr. Heba Degheidy (US FDA CBER)
  • Dr. Vijaya Simhadri (US FDA CBER)
  • Ms. Leslie Wagner (US FDA CBER)
  • Dr. Therese Solstad (Norway NoMA/EU EMA)
  • Dr. Dean Smith (Health Canada)
  • Dr. Akiko Ishii (Japan MHLW)
03:40pm-04:00pm: Short Break Followed by Main Workshp Day 2A from 4pm to 6pm

Agenda at a Glance Agenda at a Glance