Specialized Workshop F1Friday September 30, 2022: 7am - 5:30pm - Roundtable Discussion & Topic List

"ICH M10 BMV Guideline & Global Harmonization Day"

ICH M10 Interpretation, Adoption, and Transition; Interactive Industry/Regulators' Discussions on Audits/Inspections/Submissions Outcomes; Issues in Regulated Bioanalysis for Small & Large Molecules; Gap Analysis on New Controversial Issues; Evolving Regulatory Standards for Chromatographic & Ligand Binding Assays

(You can scroll down to see the details of each topic)

Part 1: Impact of Global Harmonization on Regulated Bioanalysis

  • Topic 1:

    Importance of Cross Validation in Regulated Bioanalysis - Understanding Current Approaches and Pitfalls based on the ICH M10 BMV Guidelines: Are there more Statistically Based Approaches to Evaluate?
    Dr. Andrew Mayer, Director & Group Leader Bioanalysis, GlaxoSmithKline

  • Topic 2:

    Method Cross Validation between Labs in China and Labs outside China: What is possible and what is not possible - Is the newly released ICH M10 helping this process?
    Dr. Tom Verhaeghe, Senior Director Bioanalysis, Janssen

  • Topic 3:

    Patient Centric Sampling Implementation in Regulated Bioanalysis, De-centralized Global trials, at-home Blood Collection for PK Bioanalysis, Assay Bridging and Regulatory Acceptance
    Dr. Olga Kavetska, Executive Director Global Clinical Assay Group Head, Pfizer

  • Topic 4:

    Harmonization of Certificate of Analysis (CoA) Content & Reference Standard Materials (RSMs) Management in Regulated Bioanalysis: Importance of having International and Well-characterized RSMs for better Quality Data - Is the ICH M10 able to harmonize the CoA?
    Dr. Joseph Bower, Senior Vice President Lab Services, Precision for Medicine

ASK THE REGULATORS!

  • Interactive Panel Discussion with the Regulators on on Impact of Global Harmonization on Regulated Bioanalysis
    • Dr. Seongeun Julia Cho (US FDA)
    • Dr. Arindam Dasgupta (US FDA)
    • Dr. Xiulian Du (US FDA)
    • Dr. Mohsen Rajabi Abhari, (US FDA)
    • Dr. Yang Lu (US FDA)
    • Dr. Li Yan (US FDA)
    • Dr. Jinhui Zhang (US FDA CDER)
    • Mr. Stephen Vinter, (UK MHRA)
    • Dr. Chris Burns (UK MHRA)
    • Dr. Akiko Ishii-Watabe (Japan MHLW)
    • Dr. Yoshiro Saito (Japan MHLW)
    • Mr. Gustavo Mendes Lima Santos (Brazil ANVISA)
    • Dr. Elham Kossary (WHO)

Part 2: Common Mass Spectrometry and Ligand-binding Assays Issues

  • Topic 5:

    The 3 Rs in Preclinical Regulated Bioanalysis: Does the current ICH M10 BMV Guideline allow to use of human plasma to dilute mice/rats plasma and reduce animals?
    Mr. James Schiller, Director Regulated Bioanalytical PK, Merck

  • Topic 6:

    Regulated Bioanalysis of Tissues & Secondary Matrices: Full, Partial, or better Fit for Purpose Validation? Implementation of the ICH M10 BMV Guideline for Tissues & Secondary Matrices Bioanalysis
    Dr. Eric Woolf, Associate Vice President Scientific, Merck

  • Topic 7:

    Stability Issues in Regulated BioanalysisICH M10 Guideline for Stability, Above ULOQ Stability, Additive/Cumulative exposure, and Stability data collected in another facility
    Dr. Katty Wan, Director, Small Molecule Group Lead Clinical Assay Group, Pfizer

  • Topic 8:

    Endogenous Compounds Validation in Regulated Bioanalysis: What have we learned from ICH M10 Draft BMV Guidance Section 7.1. for both Chromatographic & Ligand-binding Assay?
    Dr. Marianne Scheel Fjording, Scientific Officer Executive Director, BioAgilytix

  • Topic 9:

    Using Novel/Alternative Technologies in Regulated Bioanalysis: How is the ICH M10 facilitating entrance of New Technologies in the Regulated Environment? Is it possible to use LBA Emerging Technologies (ET) for Regulatory Submissions? Are Hybrid Assays (IA-MS) still considered “Novel/Alternative Technologies” after over a decade of use/application?
    Dr. Eric Thomas, Director of Method Development & Validation Global Bioanalytical Services, LabCorp

ASK THE REGULATORS!

  • Interactive Panel Discussion with the Regulators on Common Mass Spectrometry and Ligand-binding Assays Issues
    • Dr. Seongeun Julia Cho (US FDA)
    • Dr. Arindam Dasgupta (US FDA)
    • Dr. Xiulian Du (US FDA)
    • Dr. Mohsen Rajabi Abhari, (US FDA)
    • Dr. Yang Lu (US FDA)
    • Dr. Li Yan (US FDA)
    • Dr. Jinhui Zhang (US FDA CDER)
    • Mr. Stephen Vinter, (UK MHRA)
    • Dr. Chris Burns (UK MHRA)
    • Dr. Akiko Ishii-Watabe (Japan MHLW)
    • Dr. Yoshiro Saito (Japan MHLW)
    • Mr. Gustavo Mendes Lima Santos (Brazil ANVISA)
    • Dr. Elham Kossary (WHO)

Part 3: LBA Unique Challenges

  • Topic 10:

    LBA Single Well Analysis (Singlicate) a Decade of Discussions in Regulated Bioanalysis – Where do we stand? Why are many companies not adopting it yet? What are the guidelines for Single Well Analysis in the ICH M10?
    Mr. Kevin Carleton, Associate Scientific Director, Janssen

  • Topic 11:

    How to Address the Change of the Critical Reagents in Regulated Bioanalysis: “KISS - Keep It Simple & Straightforward” - Is ICH M10 following the KISS approach for Critical Reagents changes?
    Dr. Nisha Palackal, Director Protein Biochemistry, Regeneron

  • Topic 12:

    Application of Automated PK LBA to overcome low sensitivity/interference and LBA Carryover Assessment in Regulated Bioanalysis - Understanding the ICH M10 requirements for Carryover
    Ms. Kathi Williams, Senior Principal Scientific Researcher Assay Development and Technology, Genentech

  • Topic 13:

    Current Strategies for using Commercial, RUO & Diagnostic LBA Kits in Regulated Bioanalysis – What extra validation is needed? How is ICH M10 addressing repurposes kit validation?
    Dr. Danielle Salha, Senior Director Immunology & Immunochemistry, Altasciences

ASK THE REGULATORS!

  • Interactive Panel Discussion with the Regulators on LBA Unique Challenges
    • Dr. Seongeun Julia Cho (US FDA)
    • Dr. Arindam Dasgupta (US FDA)
    • Dr. Xiulian Du (US FDA)
    • Dr. Mohsen Rajabi Abhari, (US FDA)
    • Dr. Yang Lu (US FDA)
    • Dr. Li Yan (US FDA)
    • Dr. Jinhui Zhang (US FDA CDER)
    • Mr. Stephen Vinter, (UK MHRA)
    • Dr. Chris Burns (UK MHRA)
    • Dr. Akiko Ishii-Watabe (Japan MHLW)
    • Dr. Yoshiro Saito (Japan MHLW)
    • Mr. Gustavo Mendes Lima Santos (Brazil ANVISA)
    • Dr. Elham Kossary (WHO)

Part 4: White Paper in Bioanalysis

  • 2022 White Paper on BMV Guidance & Global Harmonization:

    Consensus & Conclusions on BMV Guidance & Global Harmonization for 2022 White Paper

 

Topic DETAILS of F1

Part 1: Impact of Global Harmonization on Regulated Bioanalysis
  • Topic 1

    Importance of Cross Validation in Regulated Bioanalysis - Understanding Current Approaches and Pitfalls based on the ICH M10 BMV Guidelines: Are there more Statistically Based Approaches to Evaluate?
    Dr. Andrew Mayer, Director & Group Leader Bioanalysis, GlaxoSmithKline

    • Cross Validation in Regulated Bioanalysis
      • Current approaches & their limitations
      • Acceptance criteria
      • Historical view 2012 EU EMA BMV & 2018 US FDA BMV
      • 2022 ICH M10 BMV
    • Is it possible to develop a more thorough Cross Validation process?
      • Do multiple runs over multiple days better assess the variability between labs?
      • Consideration on incorporating inter-assay variability
    • Are there more statistically based approaches for improving cross validation reliability?
      • Statistically based approaches to evaluate systemic bias in cross validation data as opposed to the current industry acceptance criteria
    • Are cross validation experiments needed for
      • Biomarker Assays?
      • Immunogenicity Assays?
      • If so, how do they different from assessments for PK based endpoints?
    • Case Studies: Current & newly proposed approaches to cross Validation in regulated bioanalysis
  •  

  • Topic 2

    Method Cross Validation between Labs in China and Labs outside China: What is possible and what is not possible – Is the newly released ICH M10 helping this process?
    Dr. Tom Verhaeghe, Senior Director Bioanalysis, Janssen

    • Global Multi Site Clinical Studies
      • Impact of Global Harmonization
      • China NMPA participation in the ICH M10
      • Expected impact for Bioanalysis in China, if any?
    • Impossibility to ship the PK samples collected in China to CROs outside of China
      • Setting up a copy of the assays in China from Phase 2 onwards to analyze samples locally
      • Assays need to be cross validated between the lab in China and the lab outside of China
      • Are there any potential approaches to perform cross validation with Chinese Labs?
    • Current 2018 US FDA Guidance
      • Regulatory requirements If two methods/labs are being used within the same clinical study
      • “…cross validation with shared matrix QCs and non pooled subject samples should be conducted at each site or laboratory to establish interlaboratory reliability…”
    • Recent Complicating factor
      • Difficulty to import subject samples into China because of regulations around COVID-19.
      • Is it acceptable to limit cross validations to QCs only?
      • Is the newly released ICH M10 helping this process?
    • Case Studies: Strategies for Cross Validation between Labs in China and Labs outside China
  •  

  • Topic 3:

    Patient Centric Sampling Implementation in Regulated Bioanalysis, De-centralized Global trials, at-home Blood Collection for PK Bioanalysis, Assay Bridging and Regulatory Acceptance
    Dr. Olga Kavetska, Executive Director Global Clinical Assay Group Head, Pfizer

    • Patient Centricity Sampling as a new strategy in Pharmaceutical Clinical Development
      • Easy access for participants
      • Build-in regulatory rigor and best possible solutions
      • Decentralized clinical trials, science, technology, and logistics behind
    • Current Regulatory Requirements
      • Is the 2022 ICH M10 BMV Guideline flexible enough to allow Patient Centricity Sampling?
      • Build-in regulatory rigor and best possible solutions for Biological Sampling at patient home or local diagnostics labs
    • COVID-19 pandemic impact on rapid implementation of Patient Centricity Sampling
      • Need for out-patient studies because of quarantine requirements for COVID-19 patients
      • Out-patient study design
    • PK sampling at-home using Tasso M20 device
      • Tasso M20 bionalytical feasibility (dried blood, < 100 mcL total per time point)
      • Sensitivity, Stability, Recovery, P&A testing, Blood/Plasma ratio
      • Bridging strategy
    • Case Studies: Patient Centricity Sampling implemented in three Phase 3 studies used to support the emergency use authorization (EUA)

  • Topic 4:

    Harmonization of Certificate of Analysis (CoA) Content & Reference Standard Materials (RSMs) Management in Regulated Bioanalysis: Importance of having International and Well-characterized RSMs for better Quality Data - Is the ICH M10 able to harmonize the CoA?
    Dr. Joseph Bower, Senior Vice President Lab Services, Precision for Medicine

    • Significant progress made by the ICH M10 in Regulated Bioanalysis Global Harmonization
      • Global regulatory standard governing Bioanalytical Method Validation (BMV)
      • Was the ICH M10 also able to harmonize the CoA?
    • High degree of inconsistency in the content of the Certificate of Analysis (CoA) for reference standards used in regulated bioanalysis
      • Recent harmonization efforts by the industry
      • Good agreement from BMV Guidance/Guideline (2022 ICH M10, 2018 US FDA, 2012 EU EMA) of the requirements for the type of information which needs to be provided in CoA for reference materials
      • Present lack of consistency in the quality and content of CoA provided by vendors & manufacturers
    • Complications from internal procedure issues
      • Laboratory lacking of robust internal reference standard management processes
      • Poor inventory system to ensure appropriate oversight of these materials
      • Highlighting some of the most typical and most impactful gaps regarding common deficiencies encountered in CoA
    • Providing insight into recent developments regarding reference standard management focused on regulated bioanalysis
      • Best practice of implementing a robust critical reagent inventory process
      • Use of new electronic tools available that provide a more robust and streamline critical reagent inventory system.
    • Case Studies: Harmonization of Small and Large Molecules reference materials used in regulated bioanalytical studies

 

Part 2: Common Mass Spectrometry and Ligand-binding Assays Issues
  • Topic 5:

    The 3 Rs in Preclinical Regulated Bioanalysis: Does the current ICH M10 BMV Guideline allow to use of human plasma to dilute mice/rats plasma and reduce animals?
    Mr. James Schiller, Director Regulated Bioanalytical PK, Merck

    • Importance of implementing the 3Rs in Bioanalysis
      • Replacement, Reduction and Refinement in practice
      • Current efforts to improve welfare of animals used in research
    • Exploring the current BMV Guidance/Guideline on flexibility to apply the 3Rs
      • Does the 2022 ICH M10 BMV Guideline allow to use of human plasma to dilute mice/rats plasma and reduce animals?
      • Review current efforts in non-clinical safety
    • Implementation of liquid plasma Microsampling for GLP rat studies
      • Evaluation of sample collection techniques
      • Pilot studies and results
    • Organizational strategy
      • Impact of utilization of microsampling on datasets
    • Future efforts to reduce required volumes
      • Use of surrogate matrices
      • Large molecule microsampling
    • Case Studies: Application of the 3 Rs in preclinical Regulated Bioanalysis implementing the ICH M10

  • Topic 6:

    Regulated Bioanalysis of Tissues & Secondary Matrices: Full, Partial, or better Fit for Purpose Validation? Implementation of the ICH M10 BMV Guideline for Tissues & Secondary Matrices Bioanalysis
    Dr. Eric Woolf, Associate Vice President Scientific, Merck

    • Regulated Bioanalysis of Tissues and other Non-liquid matrices
      • 2018 US FDA BMV Guidance and 2012 EU EMA BMV Guideline
      • Interpretation of the ICH M10 Guideline
      • Do changes in matrices still require full validation?
      • Can the concept of Fit for Purpose Validation replace the confusion of Partial/Full Validation for Tissue/Non-Liquid/Secondary matrices?
    • Challenge of Fully validating methods in tissues
      • Typically homogenized prior to analysis
      • The issue of stability in tissue and how it might be addressed
    • What are Secondary Matrices?
      • PBMCs, Genital Tissue, Liver Biopsies, Adipose
      • Why are secondary matrices analyzed?
      • What decisions does their analysis drive?
      • If a Partial Validation is used what should be included?
    • Urine as Primary or Secondary Matrix
      • Do secondary matrices such as urine need a Full Validation?
      • Current industry approaches to urine analysis
    • Case Studies: Proposed implementation of the ICH M10 for BMV of Tissue, Non-Liquid and Secondary Matrices.

  • Topic 7:

    Stability Issues in Regulated Bioanalysis – ICH M10 Guideline for Stability, Above ULOQ Stability, Additive/Cumulative exposure, and Stability data collected in another facility
    Dr. Katty Wan, Director, Small Molecule Group Lead Clinical Assay Group, Pfizer

    • Overview of the ICH M10 requirements for Stability Evaluations
      • What’s new versus previous Guidance/Guideline requirements?
    • Above ULOQ Stability
      • Dilution QC (above ULOQ) stability issues due to solubility limitations
      • Decision tree for conducting different types of treatments to combat non-specific binging and solubility issues
      • Strategies to overcome solubility issues with different approaches
    • Additive/Cumulative Exposure
      • Considerations on the acceptability of Additive/Cumulative exposure and why this approach best represents how study samples are handled
      • Scientific rationale behind Additive/Cumulative exposure when determining the short-term exposure during sample analysis
      • Current regulatory requirements for adding up time from each freeze-thaw evaluation
    • Stability Data collected in another Facility
      • What are the background information and scientific justification needed in support stability data collected in another facility?
      • Is ICH M10 supporting the acceptability of this procedure?
      • How may method bias impact stability results? Risk of repeating stabilities at each facility and obtaining different results
      • Sponsors concerns on availability of documentation to use stability results from a different CRO
      • Are CRO willing to provide full access to all stability data on short notice, in case of an inspection and supporting information?
    • Case Studies: : Implementation of ICH M10 for Stability Evaluation for Above ULOQ Stability, Additive/Cumulative exposure, and Stability data collected in another facility

  • Topic 8:

    Endogenous Compounds Validation in Regulated Bioanalysis: What have we learned from ICH M10 Draft BMV Guidance Section 7.1. for both Chromatographic & Ligand-binding Assay?
    Dr. Marianne Scheel Fjording, Scientific Officer Executive Director, BioAgilytix

    • Draft vs Final: Comparing & Contrasting the ICH M10 Section 7.1.
      • What was the purpose of such comprehensive & thorough Section 7.1. in the draft ICH M10 Guideline?
      • Why is Endogenous Compounds Validation in Regulated Bioanalysis so important that a whole chapter of how to validate bioanalytical PK assay has been dedicated in the ICH M10?
    • Endogenous Compounds
      • Section 7.1. does not cover quantitation of biomarkers as the scope of ICH M10 is dosed drug quantification
      • Dosed Drug Endogenous Counterpart vs Biomarkers: differences and similarities
      • Bioanalytical Method Validation vs Biomarker Assay Validation (BMV vs BAV)
    • Standard curves & QCs for Endogenous Compounds
      • STDs & QCs should be prepared in the same matrix as the study samples so that the matrix effect is the same in both the standard and study samples
      • The matrix should be free of matrix effect and interference
    • When using matrix with interference four different approaches can be used for quantification of drug level
      • Surrogate matrix
      • Surrogate analyte
      • Background subtraction
      • Standard addition
    • Enzyme Replacement Therapies (ERT)
      • Challenge to quantitate the dosed drug
      • Method cannot distinguish between the therapeutic drug and the endogenous counterpart.
    • Case Studies: Interpretation of the ICH M10 for the validation of dosed drug in cases where matrix without interference is not available.

  • Topic 9:

    Using Novel/Alternative Technologies in Regulated Bioanalysis: How is the ICH M10 facilitating entrance of New Technologies in the Regulated Environment? Is it possible to use LBA Emerging Technologies (ET) for Regulatory Submissions? Are Hybrid Assays (IA-MS) still considered “Novel/Alternative Technologies” after over a decade of use/application?
    Dr. Eric Thomas, Director of Method Development & Validation Global Bioanalytical Services, LabCorp

    • ICH M10 requirements for implementing New or Alternative Technologies in Regulated Bioanalysis
      • When is Cross Validation required between conventional and new/alternative technologies?
      • Is Cross Validation only required to support comparison of data rather than to establish validity?
      • No need to refer to a “primary methodology” unless the technology itself is unproven, or the mechanism of detection / quantitation is not well understood
    • Ultra-sensitive LBA
      • Implementation of ultra sensitive LBA in Regulated Bioanalysis
      • Importance to have well-characterized reference material for Ultra-sensitive LBA
      • Understanding in vivo processing of the molecule to be sure of what it is measured
      • Even if Biomarkers are outside the scope for ICH M10, there is a lot of experience in this field and lessons learned on Ultra-sensitive LBA for additional considerations for quantitation
    • Hybrid Assays (IA-MS)
      • Industry over a decade of experience in the bioanalysis of proteins by Mass Spec in support of drug development
      • LBA or Mass Spec assays decision taken based on the needs of the study rather than considering Mass Spec to be a “secondary approach”
      • LBA is not a “gold standard” but it is a “historical standard” and often presents better sensitivity, but is not necessarily more specific nor more robust
    • Platforms used for Gene & Cell Therapy
      • Extending the discussion to other platforms currently used for Gene and Cell Therapy and entering the regulatory space
      • Flow Cytometry, qPCR/ddPCR, ELISpot
    • Case Studies: Implementation of Novel/Alternative Technologies in Regulated Bioanalysis meeting ICH M10 requirements

 

Part 3: LBA Unique Challenges
  • Topic 10:

    LBA Single Well Analysis (Singlicate) a Decade of Discussions in Regulated Bioanalysis – Where do we stand? Why are many companies not adopting it yet? What are the guidelines for Single Well Analysis in the ICH M10?
    Mr. Kevin Carleton, Associate Scientific Director, Janssen

    • “What are we waiting for!” [Mickey Goldmill in Rocky II, 1979]
      • ICH M10 BMV Guideline is Single Well Analysis friendly
      • Single Well Analysis is scientifically sound
      • Regulatory support and no Regulatory 483/Observations
      • Industry/Regulators’ White Papers support
    • LBA have significantly improved
      • Widespread use of Automated Platforms
      • Better Critical Reagents generation and characterization
    • Advantages of Single Well Analysis
      • More efficient drug development
      • Less costly treatment options for patients
    • What is really the hesitation in making the switch?
      • Missing well-defined acceptance criteria
      • Workflows
      • Automation
      • LIMS support
      • Training
      • Others – Resistance to perform/transfer Single Well Analysis LBA in China
    • Case Studies: Understanding and overcoming the hesitation to fully implement Single Well Analysis for LBA even if it is supported by ICH M10

  • Topic 11:

    How to Address the Change of the Critical Reagents in Regulated Bioanalysis: “KISS - Keep It Simple & Straightforward” – Is ICH M10 following the KISS approach for Critical Reagents changes?
    Dr. Nisha Palackal, Director Protein Biochemistry, Regeneron

    • Implementation of 2022 ICH M10 BMV Guideline to for Critical Reagents
      • 2012 EU EMA BMV & 2018 US FDA BMV guideline/guidance vs 2022 ICH M10 BMV Guideline
    • The KISS approach for Critical Reagent Changes
      • Impact of changing the source of a critical reagent for PK Assay
      • What can cause significant impact on a PK assay
      • Keep It Simple & Straightforward” as in previous FDA/EMA Guidance/Guideline
      • Industry confusion with minor/major changes, what’s major & what’s minor?
      • Is changing the source of a critical reagent considered a minor change? What if it causes a “major” impact on the PK assay?
    • Stability Tests for Critical Reagents and the importance of evaluating them on the assay
      • Overall industry experience with the stability programs
      • Re-evaluation intervals for select reagents
      • Extension of stability based on assay performance or only by the vendor
      • Retest dates vs expiration dates for critical reagents
    • Importance of Selecting the best Critical Reagent for assay development
      • Recent Industry/Regulators’ recommendations
    • Case Studies: Changes of the Critical Reagents, Stability Tests for Critical Reagents, Selection of Critical Reagent in Regulated Bioanalysis in compliance with ICH M10

 

Part 4: Novel Applications in Bioanalysis
  • Topic 12:

    Application of Automated PK LBA to overcome low sensitivity/interference and LBA Carryover Assessment in Regulated Bioanalysis – Understanding the ICH M10 requirements for Carryover
    Ms. Kathi Williams, Senior Principal Scientific Researcher Assay Development and Technology, Genentech

    • Are the Automated PK LBA Platforms prone to Carryover?
      • ICH M10 requirements for Carryover evaluation vs FDA/EMA Guidance/Guideline
      • Similarities and differences in carryover evaluation for LBA vs Chromatographic Assays
    • Carryover assessment not required for LBA
      • Is carryover evaluation expected for Automated LBA?
      • If yes, what criteria to follow for Automated LBA?
      • What are the regulatory expectations for methods using Automated LBA?
      • Designing specific protocol for Automated LBA platform
      • Industry experience on how Automated LBA Platforms handle carryover and remedies to overcome this issue
    • Advantages in using Automated LBA Platforms vs Conventional LBA for PK Assays
      • Specific instances where Automated LBA Platforms have solved problems that Conventional LBA could not
      • Overcoming interferences
      • Overcoming low sensitivity
    • Case Studies: Application of Automated PK LBA platforms to overcome low sensitivity/interference and LBA Carryover Assessment in Regulated Bioanalysis

  • Topic 13:

    Current Strategies for using Commercial, RUO & Diagnostic LBA Kits in Regulated Bioanalysis – What extra validation is needed? How is ICH M10 addressing repurposes kit validation?
    Dr. Danielle Salha, Senior Director Immunology & Immunochemistry, Altasciences

    • How often are Commercial, RUO & Diagnostic LBA Kits used for PK assay in Regulated Bioanalysis vs newly developed LBA?
      • Commercial Kits are often used for Biomarker Assay but rarely used for PK Assay due to the unique characteristics of the administered drug
      • Consideration on when it is valuable to use a repurposed commercial kit instead of developing a brand-new assay to measure drug concentrations
      • Regulatory requirements for assessing kit validation to ensure that it conforms to ICH M10 Guideline
    • Challenges when validating a commercial kit for drug quantitation to support a regulated PK study
      • What feasibility assessment is performed in Method Development to choose the appropriate Commercial Kit when used for a preclinical or clinical PK study
      • What typical optimization strategies are used when kit components are modified
      • What typical pre-validation assessments are performed in method development to ensure the method is validation ready
    • Selectivity issue with Commercial Kits for PK Assays
      • Problems observed during validation of a Commercial kit
      • Mitigation strategy to resolve selectivity issues
    • Issues with New Lots of Commercial Kits
      • Qualification procedure for new lots
      • Problem with New Lots of Commercial Kits not meeting acceptance criteria during sample analysis
      • Investigation & Corrective actions taken
    • Case Studies: Method development/validation and method transfer for multiple Isoforms biomarkers




Agenda at a Glance Agenda at a Glance