QuartzBio Team, Author at QuartzBio

About QuartzBio Team

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Entries by QuartzBio Team

Webinar: Overcoming Clinical Sample Chaos — A Critical Step in Biomarker-Rich Trials

Register for the webinar: Title: Overcoming Clinical Sample Chaos: A Critical Step in Biomarker-Rich Trials Duration: 45 minutes You’ll see how a technology-enabled approach to clinical sample inventory management delivers: Sample KPI dashboards for clinical, translational, & data management teams Visibility into sample collection, processing, and consent status Dynamic visualizations to quickly review expected […]

Connecting LIMS to a Master Sample Inventory to Provide Sponsor-Centric Visibility for Biomarker Clinical Operations

Complex biospecimen operations are inherent in modern clinical trials. For recent protocols, biospecimen collections are designed to be broad and to enable flexible selection from the variety of biomarker assay technologies that are available. Biomarker clinical operations are critical to realizing the potential of biomarker data generation plans. Multiple Labs, Multiple LIMS; Lack of Sponsor-Centric […]

A Technology-Driven Solution for Optimized Statistical Analysis of Clinical Trial Biomarker Data

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. […]

Translational Intelligence: Exploring Immunotherapy Response Signatures with Clinical Trial Genomics Data

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.

Webinar On Demand: Exploring IO Signatures in Clinical Trial Genomic Data

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 […]

Translational Intelligence: 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.

Delivering CDISC-Compliant Submissions 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 […]

Folate pathway gene expression in metastatic colorectal cancer patients treated with arfolitixorin/5-FU-based chemotherapy

April 2, 2021 — Gene expression biomarkers can help predict clinical outcomes in response to treatment with pathway-targeting therapeutics, thereby helping to identify patient subgroups likely to respond. In a collaboration with investigators at Isofol Medical AB, the QuartzBio team analyzed the correlation between expression of folate pathway genes and clinical outcomes in response to […]

Recap: SCOPE 2021 Panel Discussion on Winning Biomarker & Biospecimen Strategies

March 8, 2021 — At last week’s SCOPE 2021 virtual summit for clinical operations executives and their partners, an overarching theme was the increased speed of clinical operations in response to the COVID-19 pandemic. “Speed — is this the new normal? Can we as organizations support that ramped-up speed … with the resources that we […]

Novel markers to predict virological and clinical relapse onset following antiviral treatment discontinuation in chronic hepatitis B patients

March 5, 2021 — Applying algorithms to interconnected biomarker and clinical data can yield scientific insights, not only into therapeutic mechanisms, but also into predicting long-term response to treatment. In a collaboration with investigators at Janssen, the QuartzBio team sought to identify genetic markers correlated with protection against chronic hepatitis B early relapse in patients […]