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.

Topic 2:

Needs for Objective Statistical Criteria for Cross-validation 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.

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.

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.

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?

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.

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. 

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?

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? 

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). 

Topic 11:

Investigation on Analyte Performance in Patient Centric Sampling (PCS) approaches as attractive viable alternatives to traditional sampling by venipuncture; Best Options for WB/DBS collection devices with 510(K) or CE-marked status commercially available; Key importance to confirm of analyte integrity during the sample collection, processing; storage process in delivering valid PK data for decision making; Essential evaluation of analyte non-specific binding, high hemolysis and extended WB/Benchtop stability in understanding impact on collected samples.

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.

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

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

Panel Discussion with All the Regulators:

Have an Open Dialogue with the Regulators including US FDA, UK MHRA, Italy AIFA / EU EMA, Health Canada, Brazil ANVISA
Ask the Regulators any Questions You Have on BMV and Regulated Bioanalysis and Hear Their Feedbacks on Submitted Studies and Inspections/Audits Outcomes