Bioanalytics of New Drug Modalities and Cell/Gene Therapies

Monday, November 10, 2025

2:00 PM - 3:00 PM CT

Location:360 Stage #2, Exhibit Hall

Sponsored By

Partner Presentation Speaker(s)

Daniel Sikkema

Executive Director, Scientific Early Engagement and Cell & Gene Therapy
Labcorp
Greenfield, Indiana

Modern bioanalytics often require multiple complementary techniques (mass spectrometry, ligand binding, cellular, and molecular assays) to characterize biotherapeutics, antibody drug conjugates, engineered cell medicines, gene replacements, and multifunctional proteins. Gene and cell therapies may yield intracellular products requiring biopsies or biomarker analysis, while transgene expressed proteins can acquire in vivo post translational modifications, altering potency from endogenous forms. These complexities demand strategic assay selection and integration within diverse regulatory contexts (CLIA, IVDR, CDx) to support next generation drug development.

Learning Objectives:

Map emerging bioanalytical challenges across novel modalities, from ADCs to cell and gene therapies.
Select and integrate assays to address potency shifts, intracellular targets, and post translational modifications.
Navigate differing regulatory requirements to enable compliant, fit for purpose bioanalysis.