This webinar highlights how early pathology involvement and centralized approaches improve consistency in tissue evaluation and data interpretation across clinical trials.
Highlights alternative whole blood preservation methods and solutions for stability and logistics in global trials.
Strategies to improve RNA extraction and sequencing from difficult tissue samples.
Practical approaches for effective nucleic acid extraction in cell and gene therapy testing.
Insights on calibration, validation, and standardization for reliable flow cytometry results.
Development and validation of sensitive qPCR assays for viral shedding studies.
Covers assay development critical to successful vaccine clinical trials.
Guidance on timelines and key steps to advance biotherapeutic projects from lab to data reporting.
Reviews flow cytometry use in ADA/NAb assays for evaluating humoral immune responses.
Addresses challenges in analyzing low viral load samples and strategies to enhance NGS sensitivity.
Covers enzyme-free digital gene expression analysis for accurate RNA measurement.
Introduces nanoString technology and its advantages over qPCR and RNASeq for gene expression analysis.
Examines strengths and limitations of PCR methods in vaccine and biotherapeutic research.
Guidance for designing and validating rare event flow cytometry assays in research and regulated settings.
Highlights precision and sensitivity considerations for pivotal vaccine trials.
Covers NGS procedures for detecting viral variants and meeting FDA submission requirements.
Explains ELISpot assay specificity, T-cell activation measurement, and outsourcing considerations.
Discusses qPCR and TCID50 assays for viral shedding, biodistribution, and regulatory considerations.
Presents new data comparing neutralizing antibody versus total IgG responses to vaccination.
Strategies to improve assay sensitivity and accurately detect neutralizing antibodies.
Current approaches and regulatory requirements for therapeutic and vaccine bioanalytical assessments.
Methods to manage assay reagents efficiently while maintaining performance and reducing timelines.
Explores applications of genomic profiling to support oncology therapy development.
Focuses on quantifying rare cells and its application in immunotherapy drug development.
Highlights flow cytometry’s power for simultaneous, high-resolution measurement of multiple parameters.
Solutions and best practices for harmonizing PBMC handling across global trials.
Guidance to inform early decisions in biosimilar drug development.
Tips for selecting the right assay platform to meet drug development needs.
Insights into leveraging flow cytometry throughout drug development studies.
Strategies to overcome matrix interference in ligand-binding assays for accurate results.