AGENDA - Main Workshop DAY 2B & 2C
June 22, 2020, 11am to 4pm ET: DAY 2B & 2C - Part 1
June 23, 2020, 11am to 4pm ET: DAY 2B & 2C - Part 2

Regulators' Advice - Part 1: June 22, 2020 (EDT time listed)

DAY 2B Part 1: Regulators' Inputs on Regulated Bioanalysis & BMV

11:10am-11:20am: Drs. Jan Welink, Sr. Clinical Assessor, EU EMA
"Updates on the Status of the ICH M10 BMV Guideline"
11:20am-11:30am: Mr. Stephen Vinter, Operations Manager GLP Monitoring Authority and Laboratories Group, UK MHRA
"Data Integrity in Bioanalysis - Current Regulatory Perspective and New Regulatory Findings from UK MHRA"
11:30am-11:40am: Dr. Nilufer Tampal, Acting Deputy Director Office of Bioequivalence, US FDA
"Data Integrity in Bioanalysis - Current Regulatory Perspective from Generic Drug Products at US FDA"
11:40am-11:50am: Dr. Sam Haidar, Senior Science Advisor Office of Study Integrity and Surveillance, US FDA
"US FDA Regulatory Perspectives on Stability Testing of Biotherapeutics"

Ask the Regulators!
Interactive Panel Discussion with Regulators on Bioanalysis, BMV Guidance/Guidelines

11:50am-12:20pm:
Ask the Regulators on Bioanalysis, BMV Guidance/Guidelines
Regulatory Panelists:
  • Dr. Tahseen Mirza (US FDA)
  • Dr. Arindam Dasgupta (US FDA)
  • Dr. Sam Haidar (US FDA)
  • Dr. Mohsen Rajabiabhari (US FDA)
  • Dr. Nilufer Tampal (US FDA)
  • Dr. Suman Dandamudi (US FDA)
  • Dr. Patrick Faustino (US FDA)
  • Dr. Diaa Shakleya (US FDA)
  • Dr. Jinhui Zhang (US FDA)
  • Drs. Jan Welink (EU EMA)
  • Mr. Stephen Vinter (UK MHRA)
  • Mr. Michael McGuiness (UK MHRA)
  • Dr. Anna Edmison (Health Canada)
  • Dr. Catherine Soo (Health Canada)
  • Dr. Susan Stojdl (Health Canada)
  • Mr. Gustavo Mendes Lima Santos (Brazil ANVISA)
12:20pm-12:50pm: Social Networking - Time to "Visit" Exhibitors and Posters

DAY 2C Part 1: Regulators' Inputs on Immunogenicity, Biomarkers and Clinical Pharmacology

12:50pm-01:00pm: Dr. Joao Pedras-Vasconcelos, Sr. Staff Fellow Office of Biotechnology Products, US FDA
"Harmonized ADA Assay Validation Templates and Integrated Summaries of Immunogenicity: Make your FDA Regulator’s Day!"
01:00pm-01:10pm: Dr. Elana Cherry, Division Manager Biologics and Genetic Therapies Directorate, Health Canada
"Health Canada Evaluation of Immunogenicity Data for Biotherapeutics during Clinical Review: Issues and Solutions from a Series of Case Studies"
01:10pm-01:20pm: Dr. Mohsen Rajabi Abhari, Pharmacologist Office of Study Integrity and Surveillance, US FDA
"Recent FDA Observations of Immunogenicity Assays"
01:20pm-01:30pm: Mr. Abbas Bandukwala, Science Policy Analyst Biomarker Qualification Program, US FDA
"21st Century Cures: Biomarker Qualification and Key Analytical Performance Characteristics"
01:30pm-01:40pm: Dr. Yow-Ming Wang, Associate Director for Biosimilars and Therapeutic Biologics, US FDA
"Opportunity for A Holistic Approach in Communicating Bioanalysis for Therapeutic Proteins – A Clinical Pharmacology Perspective"
01:40am-01:50pm: Dr. Peter Tobin, Chemist Division of Program Operations and Management, CDRH, US FDA
"CDRH CLIA Categorization Processes"

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

01:50pm-02:20pm:
Ask the Regulators on Immunogenicity, Biomarkers, Gene/Cell Therapy & Vaccines
Regulatory Panelists on Immunogenicity:
  • Dr. Joao Pedras-Vasconcelos (US FDA)
  • Dr. Haoheng Yan (US FDA)
  • Dr. Meiyu Shen (US FDA)
  • Dr. Susan Kirshner (US FDA)
  • Dr. Daniela Verthelyi (US FDA)
  • Dr. Mohsen Rajabi Abhari (US FDA)
  • Dr. Isabelle Cludts (UK MHRA)
  • Dr. Elana Cherry (Health Canada)
  • Dr. Lucia Zhang (Health Canada)
  • Dr. Akiko Ishii (Japan MHLW)
Regulatory Panelists on Gene/Cell Therapy and Vaccines:
  • Dr. Sara Gagneten (US FDA CBER)
  • Dr. Nirjal Bhattarai (US FDA CBER)
  • Dr. Heba Degheidy (US FDA CBER)
  • Dr. Xiaofei Wang (US FDA CBER)
  • Dr. Andrew Exley (UK MHRA)
  • Dr. Therese Solstad Saunders (Norway NoMA)
  • Dr. Richard Siggers (Health Canada)
Regulatory Panelists on Biomarkers & Clinical Pharmacology:
  • Dr. Yow-Ming Wang (US FDA)
  • Dr. Abbas Bandukwala (US FDA)
  • Dr. Kevin Maher (US FDA)
  • Dr. Peter Tobin (US FDA)
  • Dr. Yoshiro Saito (Director, Japan MHLW)
02:20pm-03:00pm: Social Networking - Time to Check out Exhibitors and Posters


Regulators' Advice - Part 2: June 23, 2020 (EDT time listed)

DAY 2B Part 2: Regulators' Inputs on Regulated Bioanalysis & BMV

11:10am-11:20am: Dr. Arindam Dasgupta, Deputy Director of the Division of New Drug Study Integrity, US FDA
"Observations from US FDA Inspections and Evaluation of Case Studies"
11:20am-11:30am: Dr. Anna Edmison, Senior Clinical Assessment Officer Division of Biopharmaceutics Evaluation, Health Canada
"Health Canada: Challenges During the Review of Small Molecule Drugs"
11:30am-11:40am: Dr. Catherine Soo, Sr. Clinical Evaluator Clinical Evaluation Division, Health Canada
"Health Canada: Canadian Regulatory Perspective on Biosimilars"
11:40am-11:50am: Mr. Gustavo Santos, General Manager of Medicines and Biological Products, Briazil ANVISA
"Anvisa ICH Initiatives and Updated Regulation"

Ask the Regulators!
Interactive Panel Discussion with Regulators on Bioanalysis & BMV Guidance

11:50am-12:20pm:
Ask the Regulators on Bioanalysis, BMV Guidance/Guidelines
Regulatory Panelists:
  • Dr. Tahseen Mirza (US FDA)
  • Dr. Arindam Dasgupta (US FDA)
  • Dr. Sam Haidar (US FDA)
  • Dr. Mohsen Rajabiabhari (US FDA)
  • Dr. Nilufer Tampal (US FDA)
  • Dr. Suman Dandamudi (US FDA)
  • Dr. Patrick Faustino (US FDA)
  • Dr. Diaa Shakleya (US FDA)
  • Dr. Jinhui Zhang (US FDA)
  • Drs. Jan Welink (EU EMA)
  • Mr. Stephen Vinter (UK MHRA)
  • Mr. Michael McGuiness (UK MHRA)
  • Dr. Anna Edmison (Health Canada)
  • Dr. Catherine Soo (Health Canada)
  • Dr. Susan Stojdl (Health Canada)
  • Mr. Gustavo Mendes Lima Santos (Briazil ANVISA)
12:20pm-12:50pm: Social Networking - Time to Check out Exhibitors and Posters

DAY 2C Part 2: Regulators' Inputs on Gene Therapy, Cell Therapy and Vaccines

12:50pm-01:00pm: Dr. Therese Solstad, Sr. Scientific Advisor, Head of Team for Quality Assessment of Biological Medicinal Products, Norway NoMA
"Conservative Bioanalysis, Gene Therapy and Vaccines: Regulatory Perspective and Case Studies from Norway NoMA"
01:00pm-01:10pm: Dr. Andrew Exley, Medical Assessor Biologicals and Biotechnology Unit, Licensing Division, UK MHRA
"MHRA Regulatory Perspective on Immunogenicity and Gene & Cell Therapies"
01:10pm-01:20pm: Dr. Sara Gagneten, Assoc. Director Division of Viral Products, CBER, US FDA
"FDA Perspective - Bioassays for the Assessment of Clinical Endpoints: Biomarkers and Assay Agreement"
01:20pm-01:30pm: Dr. Richard Siggers, Sr. Scientific Evaluator Bacterial and Combination Vaccine Division, Health Canada
"Immunogenicity Assay for Vaccine Development"
01:30pm-01:40pm: Dr. Nirjal Bhattarai, Principal Investigator and Product Reviewer Division of Cellular and Gene Therapies, CBER, US FDA
"An Update on Status of Cellular and Gene Therapy at US FDA"
01:40pm-01:50pm: Dr. Heba Degheidy, Staff Scientist Division of Cellular and Gene Therapies, CBER, US FDA
"Validation of Assays Performed by Flow Cytometry for Cell & Tissue Therapies: A Regulatory Perspective"

Ask the Regulators!
Interactive Panel Discussion with the Regulators on Immunogenicity, Biomarkers, Gene Therapy & Vaccines

01:50pm-02:20pm:
Ask the Regulators on Immunogenicity, Biomarkers, Gene/Cell Therapy & Vaccines
Regulatory Panelists on Immunogenicity:
  • Dr. Joao Pedras-Vasconcelos (US FDA)
  • Dr. Haoheng Yan (US FDA)
  • Dr. Meiyu Shen (US FDA)
  • Dr. Susan Kirshner (US FDA)
  • Dr. Daniela Verthelyi (US FDA)
  • Dr. Mohsen Rajabi Abhari (US FDA)
  • Dr. Isabelle Cludts (UK MHRA)
  • Dr. Elana Cherry (Health Canada)
  • Dr. Lucia Zhang (Health Canada)
  • Dr. Akiko Ishii (Japan MHLW)
Regulatory Panelists on Gene/Cell Therapy and Vaccines:
  • Dr. Sara Gagneten (US FDA CBER)
  • Dr. Nirjal Bhattarai (US FDA CBER)
  • Dr. Heba Degheidy (US FDA CBER)
  • Dr. Xiaofei Wang (US FDA CBER)
  • Dr. Andrew Exley (UK MHRA)
  • Dr. Therese Solstad Saunders (Norway NoMA)
  • Dr. Richard Siggers (Health Canada)
Regulatory Panelists on Biomarkers & Clinical Pharmacology:
  • Dr. Yow-Ming Wang (US FDA)
  • Dr. Abbas Bandukwala (US FDA)
  • Dr. Kevin Maher (US FDA)
  • Dr. Peter Tobin (US FDA)
  • Dr. Yoshiro Saito (Director, Japan MHLW)
02:20pm-03:00pm: Social Networking - Time to Check out Exhibitors and Posters




Final Agenda Agenda at a Glance