Managing Complex Biomarker Data Archives - Page 2 of 5

Duration: 30 minutes

Register for the Webinar:

Translational and clinical research teams spend more than 70% of their time wrangling information from disconnected clinical trial data sets.

Data ends up in silos, making it hard to compile information and surface insights.

Watch this short webinar, where Adam Brown and Mike Waters will demonstrate how integrating exploratory biomarker, PK, and clinical data in a unified data platform enables teams to interrogate trends and identify insights as data is generated on-study.

Register for the Webinar:

Translational and clinical research teams spend more than 70% of their time wrangling information from disconnected clinical trial data sets.

Data ends up in silos, making it hard to compile information and surface insights.

Watch this short webinar, where Adam Brown and Mike Waters will demonstrate how integrating exploratory biomarker, PK, and clinical data in a unified data platform enables teams to interrogate trends and identify insights as data is generated on-study.

Join QuartzBio at the 8th Annual Bioinformatics Strategy Meeting East Coast USA for the “Omics-Driven Approaches” track on 23 May 2022.

ROUNDTABLE DISCUSSION: “Turning Multi-omic Data Chaos into Translational Insights”

Mike Waters of QuartzBio will facilitate a discussion among 10-15 industry leaders around critical topics relevant to biomarker-rich clinical trials:

January 10, 2022 — With immuno-oncology assets progressing in the clinic, a growing biotechnology company we work with faces an increasingly common challenge:

Their trials are generating large datasets across a wide range of assay modalities (Figure 1), but the data remains siloed.

In addition to clinical data coming from the clinical research organization (CRO), the velocity of data coming from an assay services laboratory continuously delivering biomarker data from flow cytometry, immunohistochemistry, and genomics platforms quickly becomes overwhelming. Still another, separate data stream comes from a specialty laboratory delivering T-cell receptor (TCR) profiling data.

August 31, 2021 — Clinical samples are moving across an increasing number of physical/virtual locations and data is delivered in an expanding array of file formats as clinical trials become increasingly more complex and data rich (report).

Biospecimens are analyzed using a variety of assay technologies, each generating its own set of reportables, quality control metrics and data/file formats. Data is delivered through multiple, disconnected pipelines (Figure 1).

This complexity creates obstacles for many functional groups within sponsor organizations:

Register for the webinar here

Title: Transcending Biomarker Data Chaos: How Integrating Disparate PK, Clinical & Exploratory Data Enables Deep Translational Insights

Duration: 30 minutes

You will see how teams unlock translational intelligence:

Navigate vast exploratory data – identify trends and data points of interest
Surface insights – analyze biomarker trends in collaborative dashboards across subject IDs, time points, response status, and treatment groups
Access data rapidly – point and click navigation to underlying data files to interrogate the raw data behind the summary values
Interrogate cross assay – map to a common data dictionary to enable rapid interrogation of trends across assay modalities: within and across studies

July 29, 2021 — Translational research teams producing large datasets from biomarker-rich trials quickly face the next challenge: generating actionable insights from their data.

As we described in a previous case study, we have been working with many teams to enable deep mechanistic insight generation from their biomarker data to aid in signature development for selecting patients, predicting therapeutic response, and informing key development decisions.

May 19, 2021 — Biomarker data generated to support clinical development has multiple roles:

Inclusion in end-of-study regulatory submissions. As such, data must conform to FDA data exchange standards and need SDTM programming for analysis and submission.
Supporting on-study decisions. Data must be stored in an accessible, flexibly structured format to adapt to on-study needs. These diverse needs include data visualization, mock TLFs, materials for investor meetings, posters, and reporting for safety review, data monitoring, and dosing decisions.
Enable deep exploration to generate translational insights. Biomarker data generated during clinical trials presents opportunities for sponsors to further characterize mechanism of action and prioritize additional target pathways for their pipelines.

May 5, 2021 — As the data generated during a modern clinical trial has dramatically expanded, sponsors must continuously evaluate novel approaches to help bridge the gap between millions of data points and breakthrough scientific insights (a goal we describe as delivering Translational Intelligence). One such example is assessing signatures of “hot” and “cold” tumors.

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.

Synthesis and Integration of Genomics Data in Clinical Trials

April 21, 2021 — A modern clinical trial, with well-characterized subjects studied over periods of time, presents unmissable opportunities for sponsors to characterize mechanism of action, prioritize target pathways for their pipelines, and generate as much data as possible to support regulatory filings.