Specialized Workshop F1 - Friday May 10, 2024: 7am to 5:30pm
"AGENDA - Advanced Strategies for Regulated Bioanalysis & BMV"
| 07:00am-08:00am: | Start your day at WRIB with Continental Breakfast |
Session 1: Current Crucial Challenges with ICH M10 Implementation and Interpretation
Chair: Mr. Stephen Vinter, Head of Compliance Team, UK MHRA| 08:00am-08:20am: |
Dr. Tom Verhaeghe, Senior Scientific Director & Global Head of Development PK Bioanalysis, J&J Innovative Medicine "Implementation of ICH M10: consequences for documentation and co-stability." |
| 08:20am-08:40am: |
Dr. Weili Yan, Principal Bioanalytical Assay Manager, Genentech "Clinical PK Incurred Sample Reanalysis: Case Studies of ISR Investigation and Evolved Clinical ISR Strategy Based on ICH-M10" |
| 08:40am-09:00am: |
Dr. Wenkui Li, Director, Bioanalytics, Novartis "Certificate of analysis (CoA) of reference standard in regulated LC-MS bioanalysis" |
| 09:00am-09:20am: |
Dr. Tom Verhaeghe, Senior Scientific Director & Global Head of Development PK Bioanalysis, J&J Innovative Medicine
Dr. Weili Yan, Principal Bioanalytical Assay Manager, Genentech Dr. Wenkui Li, Director, Bioanalytics, Novartis "Panel Discussions on Current Crucial Challenges with ICH M10 Implementation and Interpretation" |
| 09:20am-09:50am: | Coffee Break with Morning Snacks |
Session 2: Ensuring Data Integrity in Automated Biospecimen Management and ELN Migration
Chair: Dr. Kimberly Benson, Deputy Director, US FDA| 09:50am-10:10am: |
Ms. Liliana Colligan, Director, Sample Management Bioanalytical Sciences, Regeneron "Biospecimen Management: Framework for a Compliant Laboratory" |
| 10:10am-10:30am: |
Dr. Lee Abberley, Scientific Director, Bioanalysis, Biomarkers and Immunogenicity, GlaxoSmithKline "Clinical sample management evolution at GSK" |
| 10:30am-10:50am: |
Dr. Markus Dudek, Lab Head Translational Biomarkers, Sanofi "Transition from a paper- to a cloud-based GxP-eLN in an agile & iterative manner" |
| 10:50am-11:10am: |
Ms. Liliana Colligan, Director, Sample Management Bioanalytical Sciences, Regeneron
Dr. Lee Abberley, Scientific Director, Bioanalysis, Biomarkers and Immunogenicity, GlaxoSmithKline Dr. Markus Dudek, Lab Head Translational Biomarkers, Sanofi "Panel Discussions on Ensuring Data Integrity in Automated Biospecimen Management and ELN Migration" |
Special Session: ASK THE REGULATORS! Interactive Panel Discussion with All the Regulators
| 11:10am-11:50am: |
Regulatory Feedbacks on Submitted Studies and Inspection/Audit Outcomes on Bioanalysis/BMV Regulatory Panelists:
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| 11:50am-12:50pm: | Sit-down Lunch on the 2nd Floor |
Session 3: FFP Validation for Automated Methods, Three Way-Cross Validation and Urine Analysis
Chair: Dr. Zhenmin Liang, Executive Director, Head of Bioanalysis, Vertex| 12:50pm-01:10pm: |
Mr. Matthew Andisik, Director, Bioanalytical Operations, Regeneron "Enhancing Bioanalytical Laboratory Efficiency through Automation" |
| 01:10pm-01:30pm: |
Dr. Christine O'Day, Sr. Director, Pfizer "Legacy Assays and Cross Validation" |
| 01:30pm-01:50pm: |
Dr. Marcela Araya, Group Leader, Bioanalysis, Pfizer "Drug Quantitation in an Unconventional Matrix: Clinical Urine Analysis" |
| 01:50pm-02:10pm: |
Mr. Matthew Andisik, Director, Bioanalytical Operations, Regeneron
Dr. Christine O'Day, Sr. Director, Pfizer Dr. Marcela Araya, Group Leader, Bioanalysis, Pfizer "Panel Discussions on FFP Validation for Automated Methods, Three Way-Cross Validation and Urine Analysis" |
Session 4: ICH M10 Regulatory Queries: Protein Binding, Micro/Patient-Centric Sampling and Hybrid Assays (IA-MS)
Chair: Mr. Fred McCush, Director, Clinical Bioanalytics, Pfizer| 02:10pm-02:30pm: |
Dr. Katty Wan, Senior Director, Clinical Assay Lead, Pfizer "Regulatory Expectations and Assay Considerations for Plasma Protein Binding and Microsampling Methods to Support Clinical Studies" |
| 02:30pm-02:50pm: |
Ms. Lina Luo, Scientific Director, Regulated Bioanalysis, Bristol Myers Squibb "Innovative approaches of micro-sampling & patient-centric sampling in support of regulated bioanalysis" |
| 02:50pm-03:20pm: | Coffee Break with Afternoon Snacks |
| 03:20pm-03:40pm: |
Dr. Sally Fischer, Senior Director, BioAnalytical Sciences, Genentech "Evaluation of patient centric sampling technologies for pharmacokinetic assessment of large and small molecules" |
| 03:40pm-04:00pm: |
Dr. Jinhui Zhang, Chemist, US FDA "Hybrid assay (IA-LC-MS): two years after M10" |
| 04:00pm-04:20pm: |
Dr. Katty Wan, Senior Director, Clinical Assay Lead, Pfizer
Ms. Lina Luo, Scientific Director, Regulated Bioanalysis, Bristol Myers Squibb Dr. Sally Fischer, Senior Director, BioAnalytical Sciences, Genentech Dr. Jinhui Zhang, Chemist, US FDA "Panel Discussions on ICH M10 Regulatory Queries: Protein Binding, Micro/Patient-Centric Sampling and Hybrid Assays (IA-MS) " |
Session 5: 2024 White Paper in Bioanalysis
| 04:20pm-05:20pm: |
Mr. Stephen Vinter, Head of Compliance Team, UK MHRA Dr. Kimberly Benson, Deputy Director, US FDA Dr. Zhenmin Liang, Executive Director, Head of Bioanalysis, Vertex Mr. Fred McCush, Director, Clinical Bioanalytics, Pfizer "Recommendations on BMV and Regulated Bioanalysis and Panel Discussions for 2024 White Paper in Bioanalysis" |
