2026 Biomarker Assay Conference

Virtual | June 23-24, 2026

Conference Info

This virtual conference highlights the latest advances in biomarker analytical techniques and assay methodologies that support every stage of product development from early discovery through clinical programs, with particular focus on flow cytometry, genomics, and immunohistochemistry. Sessions will explore best practices in

Assay platform selection,
Streamlined development,
Validation strategies
Management of clinical samples
Regulatory considerations
Reference standards,
Bridging strategies

We will focus on biomarker analysis for a variety of therapies including: genetic and blood‑based markers, exosomes, vaccine biomarkers, and applications of flow cytometry.

By uniting scientific, regulatory, and technical perspectives, the event aims to accelerate the translation of biomarkers into reliable clinical tools, reduce development risk, and enhance patient stratification and decision‑making across the industry. This conference is designed for industry professionals working in biomarker discovery, translational sciences, clinical and nonclinical bioanalytics, QC and regulated assay development, as well as regulatory and CMC teams responsible for ensuring biomarker assays are fit‑for‑purpose throughout the product lifecycle.

Quick Links

June 23-24, 2026

Virtual Conference

Deadlines

Abstract Submission: Feb. 27, 2026
Next Price Increase: June 5, 2026
Registration Closes: June 19, 2026

Registration

Registration is open for our Virtual 2026 Biomarkers Conference.

Registration fee includes access to our 2-half days of podium presentations.

Registration closes Friday, June 19th.

Virtual 2-Day Event Standard Prices:
Prices increase end-of-day June 5, 2026.

Group Discounts (only applicable to Industry tickets):

Agenda

The draft 2026 Virtual Biomarkers Conference agenda is here! Check the agenda for updates as we finalize our schedule.

2026 Biomarker Assay Abstracts

Coming out of the Shell: Building Scalable Influenza Assays for both Egg- and Cell-Based Vaccines

Speaker To Be Announced

Harmonization of Inflammatory Biomarker Assay Results using Common Reference Materials to Support Drug Development

Enrique Dalmasso, Principal Scientist, USP

Abstract:

Background: As development and implementation of complex therapies continues to expand, comparability and harmonization of analytical results for translational biomarkers to support drug development and adaptive trial designs become essential.

Objectives: This study demonstrates the variability of assay measurements across different immunoassay platforms and kits and evaluates the feasibility of using common reference materials to normalize results.

Methods: Ten proinflammatory cytokine biomarkers were used to compare single-plex and multi-plex immunoassay kits from several vendors. Each run included the vendor’s kit calibrant plus common external reference materials. Patient samples with elevated cytokine levels and plasma or serum spiked with supernatants from stimulated cell cultures were assayed along with spiked control samples. Evaluation parameters included calibration curves, parallelism in plasma and serum, accuracy and precision, dilutional linearity, and commutability across platforms.

Results: Absolute concentration values between vendors and platforms varied up to 10-fold for both patient samples and spiked controls when only using kit standards. In contrast, good parallelism and dilutional linearity were demonstrated when external reference materials were used. External reference materials also facilitated successfully harmonizing patient values and normalizing spiked samples within 70-130% of their nominal expected recovery.

Conclusion/Impact: We demonstrate the need for, and value of, common reference materials for harmonizing immunoassay results, investigating lot-to-lot variations, and understanding supplier or platform differences. Use of common reference materials can support more robust trending, bridge datasets from interlaboratory and longitudinal studies, and should be incorporated into routine practice in the development of assays for novel disease markers and technologies.

Contributing Authors:
Enrique Dalmasso, Bharani Thangavelu
US Pharmacopeia, Rockville, United States

Evolution of Industry Views on Assessment of Immunogenicity of Biotherapeutics

Speaker To Be Announced

Assessment of Surrogate Platforms for the Evaluation of Antibody Responses Against Highly Pathogenic Influenza Viruses

Meleri Jones, Senior Project Team Leader, UKHSA

Abstract: Highly pathogenic avian influenza (HPAI) H5Nx clade 2.3.4.4b viruses began circulating in wild birds in 2020. The virus reached North America in December 2021 and expanded to South America by 2022. Notably the first cattle infections were detected in the United States (US) in 2023, underscoring that the outbreak is unprecedented in both the diversity of affected hosts and its geographic spread. Human infections during this outbreak have been sporadic, however, HPAI infection remains a public health concern. Effective pandemic preparedness for HPAI depends on the development of standardized assays to reliably assess the performance of vaccines and antiviral countermeasures against diverse and evolving HPAI strains
Using surrogate platforms based on lentiviral pseudotypes and recombinant influenza viruses, we developed haemagglutination inhibition (HAI) and neutralisation assays suitable for use under lower biocontainment. Assay performance was evaluated through direct comparison between platforms and benchmarked against CL3/SAPO4 wild‑type influenza virus assays.
Lentiviral pseudoviruses expressing the firefly luciferase protein and displaying either the (haemagglutinin) HA alone or in combination with the NA (neuraminidase) protein were generated for several HPAI strains representing clade H5Nx 2.3.4.4b viruses. The ACGM2 recombinant influenza viruses are 6+2 re-assortants consisting of internal genes from A/Puerto Rico/8/1934 (PR8) and the HA and NA genes from the HPAI viral strains. HAI and microneutralisation assays were developed and qualified to quantify antibody responses using both platforms. Data generated across the surrogate platforms demonstrated comparable performance, and the suitability of these assays for clinical evaluation was further supported by concordance with results obtained using live virus assays
Both platforms provided a suitable CL2 compatible alternatives to the live virus assays and can be added to the suite of assays that UKHSA are developing to support the serological evaluation of vaccine candidates, therapeutic antibodies, and surveillance studies essential for HPAI pandemic preparedness.

Fit-for-Purpose Biomarker Assays for Infectious Disease: Development, Validation, and Clinical Sample Readiness

Speaker To Be Announced

Establishing Analytical Rigor in Clinical Flow Cytometry: Instrument Equivalence, QC Donor Strategy, and ICS Method Transfer

Ane Ogbe, Associate Scientific Director, Moderna Therapeutics

Abstract:

The delivery of reliable clinical biomarker data using flow cytometry requires robust analytical frameworks that ensure consistency, reproducibility, and in our case, cross-site comparability. Here, we describe an integrated approach implemented within the Clinical Biomarker Laboratory (CBL) UK to establish analytical rigor across instrumentation, assay performance monitoring, and method transfer of a 19-colour intracellular cytokine staining (ICS) assay (FCP005-ICS001).

Instrument equivalence was achieved through a global harmonisation strategy across seven spectral cytometers, combining bead-based signal alignment with PBMC-based biological equivalence assessments. Harmonisation acceptance criteria were met across instruments and sites, demonstrating technical and biological consistency.

To support ongoing assay performance monitoring, a QC donor strategy was established using PBMCs evaluated across 16 repeat runs, incorporating multiple operators, instruments, and reagent lots to intentionally capture routine sources of variability. Data-driven acceptance criteria (mean ± 3 SD) were defined for key T-cell subset frequencies and cytokine responses, demonstrating robust inter-assay and inter-operator precision and enabling longitudinal assay trending.

Finally, method transfer of the ICS assay from CBL Norwood (US) to Harwell (UK) was conducted under a fit-for-purpose validation framework, assessing intra-assay, inter-analyst, inter-instrument, and inter-site precision. Acceptance criteria were met for the majority of validated parameters supporting successful transfer and cross-site reproducibility.

Collectively, these efforts—underpinned by robust operational infrastructure including validated LIMS, reagent governance, and controlled instrument onboarding—establish a scalable, audit-ready framework for clinical flow cytometry. This integrated approach strengthens data integrity, ensures regulatory compliance, and enables reliable generation of clinical biomarker data across global clinical biomarkers laboratories.

Contributing Authors:
Ane Ogbe
Moderna Therapeutics, Harwell, United Kingdom

Statistical Considerations for Clinical Bioassays

Ivan Ordonez, Senior Statistician, Sanofi

Bridging Discovery and Diagnostics: Early Biomarker Strategies Using the Example of Checkpoint Inhibitors

Julia Schueler, Therapeutic Area Lead Oncology, Charles River Laboratories

Spatially Resolved System Level Biomarker Framework for Tumor Immunotherapy Development

Speaker To Be Announced

2026 Planning Committee

Enrique Dalmasso
USP

Siân Estdale
ACM Global

Ulrike Herbrand
Charles River Labs

Laureen Little
BEBPA

Jane Robinson
BEBPA

Anton Stetsenko
BioQual Consulting

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April 23, 2026

May 27-29, 2026

June 23-24, 2026

September 23-25, 2026

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October 21, 2026

November 4-6, 2026

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December 9-10, 2026

March 8-10, 2027

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2026 Biomarker Assay Conference

Virtual | June 23-24, 2026

Conference Info

Quick Links

Deadlines

Registration

Virtual 2-Day Event Standard Prices:Prices increase end-of-day June 5, 2026.

Group Discounts (only applicable to Industry tickets):

Agenda

2026 Biomarker Assay Abstracts

2026 Planning Committee

Virtual 2-Day Event Standard Prices:
Prices increase end-of-day June 5, 2026.