Topic 1:

Strategies for Bridging Biomarker Assays to support PD Assessments in Clinical Development: Requirements to demonstrate precision over time, with minimal assay drift even as new lots of critical reagents are introduced; Using Sandwich LBA to measure longitudinal changes in a Protein Biomarker; How can lot bridging acceptance criteria be defined to minimize assay drift over time? What are the appropriate actions if assay drift criteria are not met?

Topic 2:

Strategies for Trending Vaccine Biomarker Assay: Understanding strengths and limitations of trending methodologies to avoid missing trends or starting unnecessary investigations; Different trending methodologies are more sensitive to different patterns in data, which can result in differences in when trending alarms show up; Assessing whether a trend is real, when a trend shows up with one methodology and not with the other, more investigation is needed.

Topic 3:

Latest Bioanalytical Consideration for Tissue Biomarker Quantification: Pro and cons of non-liquid tissue structure proteins as PD/response biomarkers. Challenges of developing tissue structure proteins as biomarkers; How to generate appropriate reference material if target protein is an endogenous protein? How to demonstrate the assay signal specificity if no true negative control can be obtained? How to minimize matrix interference and demonstrate minimum matrix effect and good dilution linearity?

Topic 4:

Defining Vaccine Biomarker Assay Range: Statistical implications with regards to limits definition and considerations on clinical trial analysis and reporting; Defining assay boundaries as one of the main missions of the assay characterization effort; LLOQ/ULOQ defined based on precision & accuracy or dilutional linearity; Pros/cons of the different approaches considering the conditions in which each approach seems the most appropriate.

Topic 5:

How to Control Impact of a Major Change in a Vaccine Biomarker Assay? Minor changes as new reagent lot qualification requesting simple bridging testing to ensure assay performance vs Major changes requesting specific control strategies based on a Risk Assessment as method transfer and Assay Automation; Risk assessment outcome, type of change made on the assay, intended use of the assay, justifying the change strategy proposed. 

Topic 6:

Understanding the Pros & Cons of Automating Biomarker Assays: Pros - improved data reproducibility, increased throughput through miniaturization, increased capacity per analyst, reduced physical injury to analysts; Cons - costs that need to be considered, including upfront capital investment, time needed for design/install/testing of system, equipment malfunction and maintenance, technically skilled analysts, and more; Evaluation for automation implemented in assays with great success vs less success.

Topic 7:

Strategies for Implementing Automation for Protein Biomarkers Assays and Vaccine Biomarker Assays: Method development, assay validation, and application of LBA Singlicate Analysis; Evaluation of different strategies for implementing automation; Workflow for singlicate analysis and key decision-making points; Assessment of Performance comparison between automated and manual assays and between singlicate and duplicate with focus on repeatability, intermediate precision, and sensitivities.

Topic 8:

Impact of Assay Formats on Readouts of Biomarker Assays: How the result are impacted by the format may not be intrinsically obvious; Direct impact on readout of step titer vs continuous titer and whether a value is above or below a threshold; Impact on measured antibody concentrations by assays  run on solid matrix vs a liquid matrix; killing assay vs an uptake assay, 96-well vs 384-well format, and multiplexed assays.

Topic 9:

Advancements in Autoantibody Profiling, Emerging Technologies and their Clinical Impact: Critical role of autoantibodies as early biomarkers for cancer and autoimmune disorders; Evaluation of high-throughput profiling technologies and their capabilities/technical highlights; Technical challenges  with single plex Autoantibody assay during assay development and validation; Diving deeper into  technical aspects, addressing optimizing detection sensitivity and improving antigen stability; Approaches in identifying disease-specific autoantibodies and aiding in patient stratification.

Topic 10:

Novel Proteomics-based Biomarker Approaches for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): Value of using plasma proteomics and Autoantibodies Detection for identification of novel, quantifiable biomarkers in complex autoimmune disease; Development of a new tool for quantitative screening of CIDP-relevant autoantibody; Understanding Plasma cytokine and chemokine dynamics in patients with CIDP compared to healthy controls.

Topic 11:

Application of Singlicate Testing for New Emerging Influenza Biomarker Assay:  Use of surrogate biomarkers of efficacy to allow accelerated approval of vaccines on new emerging strains & technologies; Insights on HAI assay measuring antibody response to HA antigen and on Neuraminidase Inhibition Assay (NAI) measuring antibody responses to flu NA antigen; Employing singlicate testing with acceptable Precision & Trending to provide actionable insights into clinical response.

Topic 12:

Recent Advancements in Fluid Biomarker Development Strategies Supporting Late-Stage Clinical Trials: Overcoming challenges in the implementation of Neurofilament Light Chain (NfL) Biomarkers Assay for patient enrollment; NfL Protein Biomarker used in neuromuscular diseases to help diagnose, monitor, and treat conditions; Highlighting the path from method development to implementation of neurofilament in clinical trials; Discussing the importance of early definition of COU for biomarkers to support clinical trials.

Topic 13:

Updated considerations on EU IVDR & US FDA Final Rule and their significant impact on Patient Selection Biomarkers: IVDR in implementation since 2022, but continues to be amended, under pressure of different stakeholders; Final Rule was published only in 2024 but has already stirred a large reaction in the US impacting the use LDTs that could also have an effect on the conduct of clinical trials.

Topic 14:

Necessity for Biomarkers/CDx Assays to Detect Preexisting anti-AAV antibody based on Regulatory Agencies Requirements, Patient Selection Criteria, and the Assessment of Risks and Benefits: For anti-AAV antibody detection, there is no standard cut-off  since it depends on  CDx assay, clinical study, and drug product; Determining viable cut-off from in vitro transduction inhibition, in vivo animal studies as well as passive immunization in rodents. 

Topic 15:

Evolution of Biomarkers/CDx Assay Development and where it might be going: Development for Biomarkers/CDx assay moving from Target-oriented design to Personal Medicine; How Biomarkers can help to shift medicine from reactionary to preventative; Use of Biomarkers/CDx assay outside oncology; Development of Biomarkers/CDx for  Immunology, Neurology and Cardiovascular Clinical Trials; Strategies for  Selection of Biomarkers/CDx to find the best candidates for the therapy.

2025 White Paper on Biomarkers Discovery, Development, Validation & Regulatory Approval - Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders

Consensus & Conclusions on Biomarkers Discovery, Development, Validation & Regulatory Approval - 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 (CDRH, CDER, CBER, NCTR), EU EMA, UK MHRA, and Japan MHLW
Ask the Regulators any Questions You Have on Biomarkers & Companion Diagnostics and Hear Their Feedbacks on Submitted Studies and Inspections/Audits Outcomes