Specialized Workshop F1 - Friday June 23, 2023: 7am to 5:30pm - Discussion Topic List

"BMV and Regulated Bioanalysis - Latest Developments, Challenges, and Solutions"

NEW Case Studies on ICH M10 Adoption & Transition One Year after its Implementation; Special Session on US FDA Remote Regulatory Assessments (RRAs) direct experience from Pharma/CRO; Controversial Issues for Mass Spec & LBA on Stability, Dilution QC, Cross Validation, Hybrid Assays; Ongoing Evolution in Patient Centric Sampling & Sample Collection; Harmonization on GCP & Clinical Sample Management; Alternatives to Conventional QC-Based Bioanalysis; Industry/Regulators Interactive Discussions on Audits/Inspections/Submissions Outcomes

Session 1: Look into the Future of BMV ICH M10

  • Topic 1:

    Look into the Future of BMV ICH M10: How to find the Optimal Assay for Regulated Bioanalysis? Well-established Total Drug vs Free/Complexed Drug Quantification, Issues with Representative QC, Regulatory Expectations on Total Assay used for Calculation of Free Drug and QC for Complex Drug of Endogenous Binding Partners 
    Dr. Roland Staack, Strategy Area Lead Protein Bioanalysis & Biomarker, Roche Pharma

  • Topic 2:

    Look into the Future of BMV ICH M10: Can we do better than using the Conventional QC-Based way for Regulated Bioanalysis? Do QC/ISR Effectively Control Data Quality? Comparing PK Values from QC Failed vs Retested Passed vs ISR Passed runs, Considerations on Degrees of PK Data Concordance between Failed/Passed runs 
    Dr. Steve Keller, Senior Director, AbbVie

  • Topic 3:

    Look into the Future of BMV ICH M10: How to improve Data Exchangeability in and out of China? Implementation of Risk Assessment /Mitigations for Data Exchangeability, Strategies for Assay/Study Design based on Cross-validation and Across-studies Monitoring, Considerations on Pre-agreement with Chinese Authority
    Dr. Huaping Tang, Senior Director, GSK

Session 2: Interactive Session on US FDA/OSIS Remote Regulatory Assessments (RRAs)

  • Topic 4:

    US FDA Remote Regulatory Assessments (RRAs): PPD Direct Experience Pre/Post-RRA Guidance , Case Studies on Logistical/Technical/Practical Audit Challenges ,Cross-method Data Formatting/Consolidation, Reconciling SOP Differences/Best Practices Sponsor/CRO, Internal/External Communication Gaps, Suggestions for Industry/Regulators
    Mr. Edward Tabler, Director, PPD

  • Topic 5:

    US FDA Remote Regulatory Assessments (RRAs): Pfizer Direct Experience from Formal Inspection to Assess BA/BE Studies pre-approval RRA, Alignment between Sponsor QA organizing the audits with FDA RRA Practices, Challenges for QA due to Lab Assistance, Document/Records/Data Accessibility, Virtual Facilities Tours, Suggestions for Industry/Regulators
    Dr. Olga Kavetska, Global Head Clinical Bioanalytics, Pfizer

  • Topic 6:

    US FDA Remote Regulatory Assessments (RRAs): Alturas Direct Experience and Differences between 2020 Remote Audit and 2022 Remote Record Review (RRR), Case Studies, Lesson Learned from the RRR Process, Suggestions on Best Practices based upon experience for Regulators and Audit Participants
    Dr. Jennifer Zimmer, Laboratory Director, Alturas Analytics

Session 3: Special Issues in the Implementation of ICH M10

  • Topic 7:

    Implementation of BMV ICH M10: Focus on Stability and Inclusion of Dilution QC in Sample analysis, Fixed Dose Combination Products and Labelled Drug Regimens, F/T, Benchtop and LT Stability Tests, Predefined Procedure in place to guide dilution QCs and define the Associated Acceptance Criteria, presence of Co-medication Compounds 
    Dr. Wenkui Li, Director, Novartis

  • Topic 8:

    Implementation of BMV ICH M10: Focus on Statistical Approach for Evaluating Cross Validation Results, Decision Tree to guide Investigations when Significant Difference is Observed, Failure to meet Pre-set Acceptance Criteria, Retrospective Statistical Analysis (Bland-Altman approach) of Cross Validation Results 
    Dr. Katty Wan , Senior Director, Pfizer

  • Topic 9:

    Implementation of BMV ICH M10: Focus on recent data in Support of Hybrid Assay (IA-MS) Applications in Regulated Bioanalysis, Evaluation of PK Assay Performance, Robustness & Reproducibility as evidenced by QC performance and ISR, Experience with Support of Multiple Regulatory Submissions in various Jurisdictions
    Dr. Yue Huang, Associate Director, Astra Zeneca

  • Topic 10:

    Implementation of BMV ICH M10: Focus on Internal Standard Variability. Does it have value as a Measure of Batch Performance? Reasons for IS Response Difference, Acceptance Criteria, Use of Dilutions to normalize IS, STD/QC Matrix not Representative of Incurred Samples, Additional BMV Experiments when IS Variability is Expected
    Mr. Shane Karnik, Senior Laboratory Director, Aliri

Session 4: Focus on Sample Collection, Reconciliation, Chain of Custody

  • Topic 11:

    Recent Developments in Patient Centric Microsampling: Bioanalytical Method Development & Validation, Overall Strategy, Logistical & Technical Details, Mitra vs Tasso, Workflow to conduct PK assays, major Challenges Encountered, major Differences in BMV and Sample Analysis,  Stability & Recovery Experiment, Areas of Improvement 
    Dr. Tim Sikorski, Director, Bioanalysis, GSK

  • Topic 12:

    Overall Workflow Improvement for Sample Chain of Custody from Sample Collection through Bioanalytical Support: What is Upper Quartile for LSLV to DBL? Interpretation and impact, End-to-end process from Sample Collection to Data Release, Where Can Errors Occur, Process improvements and use of New Technologies 
    Dr. Lee Abberley, Director, GSK

  • Topic 13:

    GCP Aspects of Regulated Bioanalysis: Handling Issues Related to Sample Collection, Logistics, Reconciliation, Disposition, Informed Consent, Multiple Sources of Data Entry, How Sample Information Issues Impact Sample Integrity and Delays in Providing Data to Regulators, How Sample Reconciliation Challenges Create Resource Waste for Bioanalysis 
    Ms. Jennifer Francis, Manager, Sample Management, Regeneron

Session 5: 2023 White Paper in Bioanalysis

  • 2023 White Paper on BMV and Regulated Bioanalysis - Latest Developments, Challenges, and Solutions

    Consensus & Conclusions on BMV and Regulated Bioanalysis - Latest Developments, Challenges, and Solutions for 2023 White Paper

Session Finale: ASK THE REGULATORS! Interactive Panel Discussion with All the Regulators

  • Regulatory Feedbacks on Submitted Studies and Inspection/Audit Outcomes on Bioanalysis/BMV

    Regulatory Panelists:

    • Dr. Seongeun (Julia) Cho (US FDA)
    • Dr. Kimberly Benson (US FDA)
    • Dr. Kara Scheibner (US FDA)
    • Dr. Yiyue (Cynthia) Zhang (US FDA)
    • Dr. Gopa Biswas (US FDA)
    • Dr. Brian Folian (US FDA)
    • Dr. Mohsen Rajabi Abhari, (US FDA)
    • Dr. Yang Lu (US FDA)
    • Dr. Li Yang (US FDA)
    • Dr. Anna Edmison (Health Canada)
    • Dr. Dany Ivanova (Health Canada)
    • Ms. Emma Whale, (UK MHRA)
    • Ms. Sonja Kwadijk-de Gijsel , (Netherlands IGJ / EU EMA)
    • Dr. Akiko Ishii-Watabe (Japan MHLW)
    • Ms. Dulcyane Fernandes (Brazil ANVISA)
    • Dr. Elham Kossary (WHO)

Agenda at a Glance Agenda at a Glance