April 2021 - QuartzBio

Watch the webinar on demand:

Title: Translational Intelligence: Exploring IO Signatures in Clinical Trial Genomic Data

Duration: 30 minutes

You will learn how to:

Visualize gene alterations and tumor mutational burden (TMB) using heatmaps and tables, with subject and time point granularity.
Identify genes of interest and candidate signatures using visualization and statistical methods to relate clinical response data and gene expression data to regions of genomic alteration.
Correlate genomic data with known signatures of immuno-oncology (IO) response through integrations with public data, knowledgebases and sponsor data.
Define patient subgroups to generate deeper biological/ mechanistic insights.

CDISC-Compliant Submission of Biomarker and Specialty Lab Data

April 9, 2021 — With the rise of biomarkers used in clinical trials (e.g., prognostic, predictive, pharmacodynamic) and biomarker assay modalities (e.g. flow cytometry, multiplex protein detection, gene expression profiling), biomarker and specialty lab data are increasingly incorporated into FDA submissions. This data provides insights into key clinical objectives, including pharmacological effects, and drug safety and effectiveness.

Drug developers face operational challenges, however, in preparing complex, often unstructured, biomarker and specialty lab data in compliance with regulatory requirements.

Any study that began as of December 17, 2016 must use Clinical Data Interchange Standards Consortium (CDISC) standards, formats, and terminologies specified in the FDA Data Standards Catalog for New Drug Application (NDA), Abbreviated NDA (ANDA), and certain Biologic License Application (BLA) submissions.