Specialized Workshop F1 - Friday May 10, 2024: 7am to 5:30pm - Discussion Topic List

"Advanced Strategies for Regulated Bioanalysis & BMV"

Understanding the Critical Importance of GCP & Clinical Sample Management/Reconciliation in Mass Spec & LBA Regulated Bioanalysis; Sample Collection/Integrity and Direct Impact of Discrepancies in Bioanalysis; Fit for Purpose (FFP) vs Full Validation for Automated Methods, Cross-Validation, Protein Binding and Urine Analysis; Are ICH M10 Implementation being Successfully Completed or are there still Issues for Mass Spectrometry & Ligand Binding Assays? Ongoing Evolution in Microsampling Preclinical 3R and Patient Centric Sampling in Regulated Bioanalysis; Validation of Emerging Technologies and ELN in Regulated Bioanalysis; Industry/Regulators Focused and Interactive Discussions on Regulated Bioanalysis/BMV and Recent Controversial Issues

Session 1: Current Crucial Challenges with ICH M10 Implementation and Interpretation

  • Topic 1:

    Current Crucial Challenges with ICH M10 Implementation: Actual need to include excessive amount of data in reports, clarifications with positive pre-dose samples reanalysis for confirmatory purpose, ongoing challenges with fixed dose stability for combination of small and large molecules, case studies, possible solutions, Regulatory Perspective
    Dr. Tom Verhaeghe, Senior Scientific Director & Global Head of Development PK Bioanalysis, J&J Innovative Medicine

  • Topic 2:

    Incurred Sample Reanalysis (ISR) Requirements according to ICH M10: ISR requirements for clinical study/disease population, impact of back-conversion of free drug from ADC on ISR, sample inhomogeneity caused by incorrect sample collection/handling, importance of sample preparation, ISR Failure due to unique matrix effect in patient population
    Dr. Weili Yan, Principal Bioanalytical Assay Manager, Genentech

  • Topic 3:

    Industry/Regulators' Agreement of ICH M10 Interpretation for Certificate of Analysis (CoA): How to handle the bridging of fully-certified with poorly-certified RSM to demonstrate method validity, test to include for RSM bridging such as stock comparison, QCs performance, LTS in matrix, challenges with synthesis and characterization of Glucuronides from bioreactions
    Dr. Wenkui Li, Director, Bioanalytics, Novartis

Session 2: Ensuring Data Integrity in Automated Biospecimen Management and ELN Migration

  • Topic 4:

    Challenges & Solutions in Biospecimen Management and impact in Regulated Bioanalysis: Considerations on an efficient sample management plan, sample chain of custody, how to streamline physical movement from sites to labs and data flow, enhancing the quality of sample collection to reduce inconsistencies, implementing automation in the sample management
    Ms. Liliana Colligan, Director, Sample Management Bioanalytical Sciences, Regeneron

  • Topic 5:

    Improving Sample Management by Automation: Issues with Sample Information and where mistakes happen, reducing the rate limiting steps to accelerate the reconciliation process, how to shorten timelines by using novel automation/technologies and existing capability/LIMS, navigating China Regulations, large biobank for long-term storage, Patient Centric Sampling
    Dr. Lee Abberley, Scientific Director, Bioanalysis, Biomarkers and Immunogenicity, GlaxoSmithKline

  • Topic 6:

    New and Old Challenges in the Migration from Paper to Electronic Lab Notebook (ELN) in Regulated Bioanalysis: Ensuring data integrity while moving a GxP laboratory to electronic experimental documentation, lab work digitization, sample inventory, reagent tracking, assay documentation, use of validated cloud infrastructure, ensuring compliance with Electronic Records and Electronic Signatures by complying regulations
    Dr. Markus Dudek, Lab Head Translational Biomarkers, Sanofi

Session 3: FFP Validation for Automated Methods, Three Way-Cross Validation and Urine Analysis

  • Topic 7:

    Incorporating Automation in BMV Activities and New Applications of Automation to Support Bioanalysis in Regulated Environment: Understanding differences full automation vs. hybrid automation, procedures for validate an assay on an automated system, extra parameters to be incorporated in FFP BMV, high throughput analysis, increased accuracy/precision, reduction failure rate
    Mr. Matthew Andisik, Director, Bioanalytical Operations, Regeneron

  • Topic 8:

    Importance of Cross-Validations to Ensure Data Reliability among Labs: Challenges in a three way-cross validation among USA and China labs, root cause analysis of cross-validations passing QCs and failed incurred samples, use of popPK model as substitute for lack samples in/out of China, impact of difference in a buffer protein, biotransformation effect on PK
    Dr. Christine O'Day, Sr. Director, Pfizer

  • Topic 9:

    Urine Clinical Analysis for Large Molecules: When and how often? Unsolved challenges, overcoming STD and QC preparation issues, stability of large molecules in an urine at different storage temperatures, Method development, validation, and sample analysis of a fusion protein for kidney disease treatment in urine, understanding the PK profile in urine vs serum
    Dr. Marcela Araya, Group Leader, Bioanalysis, Pfizer

Session 4: ICH M10 Regulatory Queries: Protein Binding, Micro/Patient-Centric Sampling and Hybrid Assays (IA-MS)

  • Topic 10:

    Recent Regulatory Queries on Plasma Protein Binding & Patient Centric Microsampling: Is it possible to use FFP validation for protein binding? What extra/specific validation tests are needed? Should incurred or pre-dose samples be used? Are hematocrit effect & lot-to-lot variation evaluations necessary with VAMS? Should cross-validation or bridging be used to compare conventional venipuncture vs microsampling?
    Dr. Katty Wan, Senior Director, Clinical Assay Lead, Pfizer

  • Topic 11:

    Current Status of Microsampling Bioanalysis according to 3R Principles reinforced by ICH M10: Microsampling Wing Device & Tasso self plasma collection, considerations for stabilizer/additive at collection, bridging study design in multiple preclinical species, statistical approaches to establish correlation/concordance/equivalence & data comparison in support of GLP studies
    Ms. Lina Luo, Scientific Director, Regulated Bioanalysis, Bristol Myers Squibb

  • Topic 12:

    Recent Developments of Patient Centric Technologies for PK Assay: Advantages of decentralized clinical trials and impact on regulated bioanalysis, pharmacokinetics of large and small molecules, comparison of conventional venipuncture vs capillary microsampling technologies, bridging considerations, lesson learned from implemented studies
    Dr. Sally Fischer, Senior Director, BioAnalytical Sciences, Genentech

  • Topic 13:

    Status of the Hybrid Assays (IA-MS) two years after the release of the ICH M10 Guideline: Regulatory insights for risk and knowledge-based Hybrid Assay BMV, focus on analyte, sample processing, what to monitor, detection system, data acquisition, Hybrid Assays for ADC, mAb, Transition Product and Peptide Conjugates used in submission to highlight US FDA Regulatory Experience and how Hybrid Assays performance was assured during method implementation
    Dr. Jinhui Zhang, Chemist, US FDA

Session 5: 2024 White Paper in Bioanalysis

  • 2024 White Paper on Advanced Strategies for Regulated Bioanalysis & BMV

    Consensus & Conclusions on Advanced Strategies for Regulated Bioanalysis & BMV for 2024 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. Brian Folian (US FDA)
    • Dr. Julia Cho (US FDA)
    • Dr. Arindam Dasgupta (US FDA)
    • Dr. Kimberly Benson (US FDA)
    • Dr. Yang Lu (US FDA)
    • Dr. Li Yang (US FDA)
    • Dr. Jinhui Zhang (US FDA)
    • Mr. Stephen Vinter (UK MHRA)
    • Mr. Michael McGuiness (UK MHRA)
    • Ms. Emma Whale, (UK MHRA)
    • Ms. Sonja Kwadijk-de Gijsel, (Dutch IGJ / EU EMA)
    • Dr. Anna Edmison (Health Canada)
    • Dr. Dany Ivanova (Health Canada)
    • Ms. Reza Salehzadeh-Asl (Health Canada)
    • Mr. Joao Tavares Neto (Brazil ANVISA)
    • Ms. Dulcyane Neiva Mendes (Brazil ANVISA)

Agenda at a Glance Agenda at a Glance