Topic 1:

What's the Future of Bioanalytical LIMS? What are the drivers for changing LIMS platforms and why now? What is the current landscape and what options are available and viable? What are the possibilities for the integration of LIMS & ELN into one platform? What about other workflows and report analysis tools? What are the resources required to develop and implement a new LIMS, both from the IT and business side? How to deal with running studies, accessibility of old data after the switch?

Topic 2:

Have the LIMS Vendors followed the Recommendations issued in the 2020 White Paper in Bioanalysis? An Update on the Common Issues with LIMS Based Software for LBA Support; Need for a Separate tool ADA validation tables; Ability to calculate S/N in relation to numbers rounding of the numbers; Extra flexibility  needed to enable run selection; Need to name controls as LPC and HPC, when generating summary tables; Need to expanded unit choice;  Missing summary tables; Regression model and weighting function need improvement.

Topic 3:

Overcoming Current LIMS Integration Hurdles: Strategies for Large-Scale Automation. Balance Harmonization with Flexibility: Functionality needs to be flexible to accommodate various assays while providing capability to implement controls; Inconsistent Data Structures: Samples, reagents, instruments have their own system of record, leading challenges with integration; Automation/Robotics: Current processes lack the speed & agility needed. Leveraging Data: Need for a centralized/searchable database. Integration Challenges: New hardware/software lack integration process.

Topic 4:

Implementing Laser Microdissection (LMD) for Tissue-based Mass Spec Clinical Assays: Why is LMD essential for tissue-based MS assays? What is the projected timeline for implementing LMD in Clinical Setting for Routine Resting? Issues with Current Absence of Regulatory Guidelines for integrating LMD into validated assays? Does ICH M10 apply? If not, what strategies can be pursued to proactively address this regulatory gap? How to leverage AI/ML to enhance LMD effectiveness? 

Topic 5:

Artificial Intelligence/Machine Learning (AI/ML) in Regulated Bioanalysis: Recognize potential challenges with AI/ML and how they impact implementing AI/ML in regulated laboratory; Factors to consider when implementing AI/ML, project specific requirements, data quality, integration challenges, long term impact; Process for implementing AI/ML using Robotic Process Automation; Assess how GAMP 5.2 influences AI/ML implementation and validation, affecting compliance, process 

Topic 6:

Evolution of Biospecimen Storage and Need for Automation in Sample Management: A significant paradigm shift in sample management from traditional upright freezers, boxes, and handheld scanners to automated systems; Enhanced efficiency by allowing personnel to work in parallel, increasing throughput and data delivery; Key benefits are  improved sample integrity, reduced manual errors, and increased operational capacity; Critical challenges are costs, integration complexities, and  need for specialized personnel.

Topic 7:

Challenges encountered during the Collection & Bioanalysis of Tears for Ophthalmology Studies to provide insight into the movement of drug on the ocular surface and within the eye; Evaluation of multiple collection techniques tested in a rabbit model to compare concentrations and variability from each; Variety of collection inconsistencies at the Clinic; Issues with limited sample size and consideration for tests that might need to be conducted.

Topic 8:

Troubleshooting Total Drug Assay Development when very High Levels of Target are present: Overcoming soluble target interference in measurement of Total Antibody (TAb) concentrations with LBA; How to mitigate high-dose hook effect (prozone effect) during sample analysis; Effects of reagent limitations, sample dilution, monoclonal antibody & target affinity; Challenges in the development of ADA  Assay in serum samples with high levels of soluble target.

Topic 9:

Considerations for a Fit-for-Purpose BMV for the Accurate Measurement of Monoclonal Antibody in the presence of Interfering Target Molecule: Unusual negative interference observed due to endogenous target molecule; Evaluation of various approaches tried to overcome interference; Application of a newly developed target molecule depletion procedure that effectively removed interference; Need to apply a fit-for-purpose approach to method validation for the assessment of accuracy & precision, selectivity, and stability. 

Topic 10:

Revisiting the Bioanalytical Challenges Associated with Multi-Laboratory PK Assay Cross-Validation: ICH M10 provides specific experimental requirements however does not provide acceptance criteria for bias or how to apply the statistical estimates in the evaluation of the data from the analysis of incurred samples by participating laboratories; Operational challenges from the development, conduction, and data analysis from a 6-way laboratory cross-validation for an LC-MS/MS bioanalytical assay. 

Topic 11:

Is the Current Recommended ISR Paradigm the Right Approach? The way ICH M10 recommends performing ISR can be ambiguous, leading to extensive analysis especially in long-duration programs; Evaluation of ISR performance for a long-term clinical program, looking at several different variables, including disease type, analyst, platform, laboratory site, critical reagents; Data statistically assessed and plotted to evaluate the impact of each variable on the overall ISR performance.

Topic 12:

Widely adoption of Patient-centric Sampling (PCS) & Capillary Microsampling in Regulated Bioanalysis vs ICH M10 Limitations: Is the demonstration of concordance between data derived via VAMS and venous plasma still needed? Application of impact-assisted extraction for the elimination of recovery bias due to blood hematocrit for VAMS samples; Use of capillary microsampling for toxicokinetic evaluation in regulated juvenile rat toxicology studies; Bioanalytical strategy and suitability evaluation for labile conjugates modality.

2025 White Paper on Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders

Consensus & Conclusions on Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders for 2025 White Paper

Panel Discussion with All the Regulators:

Have an Open Dialogue with the Regulators including US FDA, EU EMA, UK MHRA, Dutch IGJ, Health Canada, and 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