Topic 1:

Current issues in Method Transfer with a special focus on assets sourced from China; Key requirements and best practices to "bridge the gap" in method transfer quality and compliance; Comprehensive risk assessment and development of targeted mitigation strategies to ensure successful bioanalytical method transfers; Rough analysis of resource and cost impacts associated with transferring methods from external partners focused on late-stage; Comparison of bioanalytical rigor and quality control practices at small partner labs versus established industry standards.
Dr. Johanna Mora, Senior Director Bioanalysis, Bristol Myers Squibb

Topic 2:

Needs for Objective Statistical Assessments of Cross Validation Data of bioanalytical methods when PK data are generated across multiple laboratories in global clinical trials; Limitations of ICH M10 Guidelines Deming Regression for cross validation with Strict Criteria overly restrictive and can lead to misleading conclusions, especially with wide concentration ranges; Evaluation of Comparative data using Deming Regression, Bland Altman plots, Lin's Concordance Correlation Coefficients; Novel equivalence testing demonstrating difference between labs falls within predefined boundaries relevant to method validation acceptance criteria.
Dr. Catherine Brockus, Director ADME External Bioanalysis & Oversight, Lilly

Topic 3:

Significant Bias Impact on Cross-validation of bioanalytical methods for Total Antibody and Conjugated Antibody assessments; Bias in bioanalytical methods can lead to Misinterpretation of Data, affecting the reliability of assay results; Understanding the Sources of Bias for enhancing the reliability of bioanalytical assays; Negative bias in frozen quality controls (QC) compared to fresh calibration curves, impacting the cross-validaton; Importance of continuous monitoring to identify and mitigate biases, improving the chance of success of a cross-validation.
Dr. Claudio Crosasso, Senior SME Bioanalysis LBA Outsourcing Operations, EMD Serono

Topic 4:

Need to measure drug concentration in Rare Matrix to address specific drug development questions beyond measuring systematic exposure; Addressing bioanalytical challenges/limitations to have accurate and reproducible methods; Considerations on Fit-for-Purpose Bioanalytical Methods based on the Clinical Studies Endpoints where absolute accurate measurements may not be feasible; Limitations of sample collection/processing for saliva, human breast milk, feces, CSF; Importance of Regulatory Feedback on Context of Data use and mandatory Impact assessment on the accuracy of the reported data.
Dr. Katty Wan, Senior Director Clinical Bioanalytics, Pfizer

Topic 5:

What key factors should be considered when implementing a Fit-for-Purpose Bioanalytical Methods for Gamma Counting to support PK assessments in Radioligand Therapy (RLT) clinical trials? What is the importance of implementing proper corrections for radioactive decay, and which methodologies should be utilized to achieve reliable PK evaluation in RLT clinical trials? What procedures are required to support consistent and timely sample collection, handling, transfer, and measurement for PK assessments in RLT clinical trials?
Dr. Wenkui Li, Director Bioanalytics, Pharmacokinetic Sciences, Novartis

Topic 6:

Development challenges of Radiopharmaceuticals; How and why non-radioactive "cold" surrogates are used in the development of bioanalytical methods for Radiopharmaceuticals; Highlighting the potential impact DOTA and DOTAM molecular cages have on bioanalytical assays when conjugated; How to develop a sophisticated bioanalytical strategy to have accurate and robust quantitation of "cold" metal chelates and minimize the impact of non-selective chelation; Detail the necessity of HRMS and Tandem MS  in characterization and quantitation of Radiopharmaceuticals.
Mr. Joseph Tweed, Associate Director Bioanalysis, Quantitative Pharmacology Group, Bicycle

Topic 7:

Important considerations on when "Compliant" does NOT mean "Controlled" and meeting accuracy/precision criteria satisfies compliance but can obscure Gradual Drift or Instability; Development of Capability-based Trending to expose changes that conventional limits miss; Operationalizing Fit-for-Purpose Oversight with Guidance-based Validation; Monitoring parameters directly tied to the assay intended use to ensures Trending aligns with Scientific Purpose and data interpretation; From Compliance Limits to Capability Limits deriving control limits from Actual Performance Data. 
Mr. Jason (Jay) DelCarpini, Director Bioanalytics, Moderna

Topic 8:

Thorough analysis of Bioanalytical issues from recently disclosed US FDA Recent Complete Response Letters (CRLs); Occurrence of bioanalytical issues and comparison across functional areas: DMPK, toxicology, Clinical pharmacology, BE; Discussion of bioanalytical areas identified as deficient and the impact on program and filing; Based on the CRLs Lesson Learned about bioanalytical issues: What could be done differently? What are the follow-up recommendations and Action Plan?
Dr. Sekhar Surapaneni, Executive Director DMPK & Clinical Pharmacology, Nimbus

Topic 9:

Optimizing Specimen Management at study start-up Enhances Bioanalytical data validity, streamlines operational workflows, and increases the overall efficiency of clinical trials; Adapting to ICH E6(R3) Guidelines, how can sponsors leverage bioanalytical insights to reduce patient burden and simplify certain aspects of trial operations, aligning specimen management practices with Regulatory Expectations? How can integrating specimen management considerations reduce operational complexity? What information is minimally required to reconcile samples, but still ensures data validity and integrity? 
Ms. Jennifer Francis, Senior Manager Sample Management, Regeneron

Topic 10:

State-of-the-art Partial Validation Strategy beyond ICH M10 Guidelines adopted for Biosimilars for supporting Clinical Trials in Healthy/Diseased subject matrices administered through Intravenous/Subcutaneous routes; Establishment of Bioanalytical similarity between biosimilar product, EU/US reference products in PK LBA; Basis establishment of matrix similarity and bioanalytical similarity between drug products; Bioanalytical challenges with clinical trials are conducted in subjects/patients from different geographical locations and Different Matrices and Different Routes of Administration (RoA). 
Dr. Kamala Bhavaraju, Head of Clinical Bioanalytics & Chief of Staff, Dr. Reddy's Laboratories

Topic 11:

Importance of Patient-Centric Sampling (PCS) applicability in Vulnerable Patient Populations (Pediatric & Elderly).  Considerations on the value for easily accessible sample collection to reduce the number of clinical visits. Crucial need for further research, development, potential regulatory review and approval in the future to be able to use PCS for pediatric & elderly clinical trials. Understanding the PK comparison between PCS Whole Blood and Conventional Plasma Samples to demonstrate its applicability as an alternative blood collection where PK is one of the key study endpoints evaluated in clinical trials. Advantages of PCS as a time & cost-effective technique that requires a much smaller volume of whole blood. Significance of assessing human blood-to-plasma partitioning (B/P) ratio at different drug concentrations to ensure a reliable PCS WB vs Plasma comparison. Recommendations to perform blood/plasma partitioning ratio at several drug concentration levels to enable more accurate PK concentration correction.
Ms. Yujin Wang, Senior Director DMPK & Bioanalysis, Day One Biopharmaceuticals

Topic 12:

New Lesson Learned in Comparison of Concentrations determined in Whole Blood (WB) Microsampling Device versus in Serum Samples; Optimizing Extracting drug from a WB sample collected using Tasso Mini and T-20; Development/BMV for a mAB drug using LBA; Importance of up front validation assessment of the Impact of Short/Long Term Sample Stability with/without desiccant; Interrogation of hematocrit effect on extraction, assessing the maximum and minimum expected human hematocrit levels, performed in the validation experiment.
Mr. John Eddy, Director Bioanalytical, Lilly
Dr. Quincy Carter, Advisor ADME External Bioanalysis & Oversight, Lilly

2026 White Paper on Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting

Consensus & Conclusions on Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting for 2026 White Paper

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

Regulatory Panelists:

• Mr. Brian Folian (US FDA)
• Dr. Yang Lu (US FDA)
• Dr. Li Yang (US FDA)
• Dr. Yow-Ming Wang (US FDA)
• Dr. Xiulian Du (US FDA)
• Dr. Diaa Shakleya (US FDA)
• Dr. Jinhui Zhang (US FDA)
• Ms. Emma Whale (UK MHRA)
• Ms. Anne-Marie Massip (UK MHRA)
• Dr. Fabrizio Galliccia (Italy AIFA / EU EMA)
• Dr. Anna Edmison (Health Canada)
• Dr. Dany Ivanova (Health Canada)
• Dr. Helen Renaud (Health Canada)
• Mr. Joao Tavares Neto (Brazil ANVISA)