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"

Day 2B: ASK THE REGULATORS!
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
Immunogenicity:
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)"
Biomarkers:
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 "

Day 2C: ASK THE REGULATORS!
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