Main Workshop DAY 2 - Wednesday May 08, 2024: 7am to 5:45pm
"AGENDA - Regulators' Inputs and 'Ask the Regulators' Panel Discussions"
| 07:00am-08:00am: | Start your day at WRIB with Networking Continental Breakfast in the Exhibit |
DAY 2A: Regulators' Inputs on Regulated Bioanalysis / BMV and Biomarkers, IVD/CDx and BAV
Chair: Dr. Fabio Garofolo, CSO, BRI - A Frontage CompanyRegulated Bioanalysis / BMV
| 08:00am-08:10am: |
Mr. Brian Folian, Deputy Office Director, US FDA "Revisiting Semler: Current Posture of Data Integrity in Bioanalysis for Bioavailability and Bioequivalence Studies" |
| 08:10am-08:20am: |
Dr. Anna Edmison, Senior Clinical Assessment Officer, Health Canada "Assessing Internal Standard Response Variation: ICH M10 & Bioavailability Studies at Health Canada" |
| 08:20am-08:30am: |
Dr. Arindam Dasgupta, Deputy Director, Division of New Drug Study Integrity, US FDA "Addressing Challenges in In Vitro Bioequivalance Studies: The Dilemma of Reserve Samples" |
| 08:30am-08:40am: |
Mr. Stephen Vinter, Head of Compliance Team , UK MHRA "New approaches to compliance and inspections" |
| 08:40am-08:50am: |
Dr. Li Yang, Pharmacologist, US FDA "Challenges and Best Practices for Matrix Effect Evaluation using HPLC/MS-MS in Generic Drug Applications" |
| 08:50am-09:00am: |
Mr. Joao Tavares Neto, Regulation and Health Surveillance Expert, Brazil ANVISA "Newly published ANVISA Guidelines based in ICH M10" |
| 09:00am-09:10am: |
Mr. Reza Salehzadeh-Asl, National Supervisor, Health Canada "Navigating Success: Strategies for high quality data in bioequivalence laboratories" |
| 09:10am-09:20am: |
Ms. Sonja Kwadijk-de Gijsel, Senior GCP Inspector, Dutch IGJ / EU EMA "Inspections during the COVID-19 pandemic" |
| 09:20am-09:30am: |
Dr. Yang Lu, Senior Pharmacologist, US FDA "Considerations for Data Rejection and Sample Reanalysis in Bioanalytical Analysis in Abbreviated New Drug Applications (ANDAs)" |
| 09:30am-10:10am: | Networking Coffee Break with Morning Snacks in the Exhibit |
| 10:10am-10:20am: |
Mr. Michael McGuinness, Head of GLP & Laboratories, UK MHRA "UK MHRA Bioanalytical Observations and Findings from recent Inspections" |
| 10:20am-10:30am: |
Dr. Dany Ivanova, Clinical Assessment Officer, Health Canada "Case Studies from Health Canada Review: Comparative Bioavailability Studies for Chemical Drugs" |
Biomarkers, IVD/CDx and BAV
| 10:30am-10:40am: |
Mr. Abbas Bandukwala, Biomarker Qualification Program Science Policy Analyst, US FDA "21st Century Cures: Biomarker Qualification" |
| 10:40am-10:50am: |
Dr. Joerg Engelbergs, Scientific-Regulatory Assessor (Quality, Non-Clinic, Biomarker, CDx), Germany PEI / EU EMA "An Update on Clinical Biomarker and CDx Regulation in EU - Part 1 Regulatory and Analytical Aspects" |
| 10:50am-11:00am: |
Dr. Hilke Zander, Clinical Assessor, Germany PEI / EU EMA "An Update on Clinical Biomarker and CDx Regulation in EU - Part 2 Scientific and Clinical Aspects" |
| 11:00am-11:10am: |
Dr. Shirley Hopper, Deputy Director of Innovative Medicines, UK MHRA "Overview of the MHRA's International Recognition Procedure (IRP)" |
| 11:10am-11:20am: |
Ms. Leslie Wagner, Consumer Safety Officer, US FDA "Biomarker Development: A Regulator's Perspective" |
| 11:20am-11:30am: |
Dr. Alessandra Buoninfante, Scientific Officer, EU EMA "Perspective on clinical vaccine assays validation and studies to support approval" |
Day 2A: ASK THE REGULATORS!
Interactive Panel Discussion with the Regulators
| 11:30am-12:15pm: |
Ask the Regulators on Regulated Bioanalysis / BMV and Biomarkers, IVD/CDx and BAV
Regulatory Panelists on Regulated Bioanalysis / BMV:
|
| 12:15pm-01:15pm: |
Sit-down Networking Lunch on the 2nd Floor Note: Lunch Desserts and Coffee/Tea are served in the Exhibit Room |
DAY 2B: Regulators' Inputs on Immunogenicity of Biotherapeutics, Gene Therapy, Cell Therapy, and Vaccines
Chair: Dr. Fabio Garofolo, CSO, BRI - A Frontage CompanyImmunogenicity of Biotherapeutics
| 01:15pm-01:25pm: |
Dr. Daniela Verthelyi, Chief, Laboratory of Immunology, US FDA "Assays Supporting Immunogenicity Risk Assessments: The Road Ahead" |
| 01:25pm-01:35pm: |
Dr. Meenu Wadhwa, Section Head, R&D Biotherapeutics & Advanced Therapies Division, UK MHRA "Observations from review of immunogenicity of biotherapeutics" |
| 01:35pm-01:45pm: |
Dr. Akiko Ishii-Watabe, Director, Division of Biological Chemistry and Biologicals, Japan MHLW "Points to consider for using ADA screening assay signal-to-noise ratio (S/N) as an alternative to titer in immunogenicity assessment: Report using international reference ADA" |
| 01:45pm-01:55pm: |
Dr. Mohanraj Manangeeswaran, Staff Fellow, Immunogenicity, US FDA "Assessing the immunogenicity risk of generic peptides: What information can support regulatory decision?" |
| 01:55pm-02:05pm: |
Dr. Adrian Wong, Clinical Reviewer, Health Canada "Health Canada considerations for review and labeling of immunogenicity data for pre-market biologic drug submissions" |
| 02:05pm-02:15pm: |
Dr. Seth Thacker, Staff Fellow, Immunogenicity, US FDA "Fit for Purpose assays to assess innate immune response modulating impurities." |
| 02:15pm-02:25pm: |
Dr. Zuben Sauna, Director, Division of Hemostasis, US FDA "The use of MHC Associated Peptide Proteomics (MAPPs) Assays in the Immunogenicity Risk Assessment of Therapeutic Proteins and Novel Modalities." |
Gene Therapy, Cell Therapy, and Vaccines
| 02:25pm-02:35pm: |
Mr. Christian Mayer, Quality Assessor, Austria AGES / EU EMA "Development and Approval of Adeno-Associated Virus Vector Based Medicines: Challenges and Pitfalls" |
| 02:35pm-02:45pm: |
Dr. Omar Tounekti, Manager, Health Canada "Creating a Forward-Looking Review Framework for Cell and Gene Therapies in Canada" |
| 02:45pm-02:55pm: |
Dr. Vijaya Simhadri, Biologist, US FDA "De-immunization of the full-length SaCas9 protein" |
| 02:55pm-03:05pm: |
Dr. Sarah Wassmer, Senior Biologist/Reviewer, Health Canada "Bridging Non-clinical and Quality Modules for Marketed Authorization: Experience of a Quality Reviewer Evaluating Non-Clinical Modules" |
| 03:05pm-03:15pm: |
Dr. Chad Irwin, Senior Scientific Evaluator, Health Canada "Use of International Standards in the Development and Control of Vaccines" |
| 03:15pm-04:15pm: |
Networking Break with Afternoon Snacks, and Wine and Beer Reception in the Exhibit |
| 04:15pm-04:25pm: |
Dr. Sandra Diebold, Head of Immunotherapy, UK MHRA "Effect of Mesenchymal Stromal Cells derived Extracellular Vesicles bioprocessing on their identity, purity and immunomodulatory potency" |
| 04:25pm-04:35pm: |
Dr. Joshua Xu, Branch Chief, US FDA "The Landscape of Fusion Transcripts in Reference Samples Characterized by Targeted RNA Sequencing" |
| 04:35pm-04:45pm: |
Dr. Sandra Prior, Principal Scientist, Cell-Based Assays, UK MHRA "Immunomonitoring by ELISpot: SARS-CoV-2 T cell response evaluation in vaccine studies" |
| 04:45pm-04:55pm: |
Dr. Julie Joseph, Senior Scientific Evaluator, Health Canada "Regulatory Considerations for Accelerated Vaccine Development" |
