News & Insights2021-02-08T17:22:09-05:00

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

Trends & Insights|

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.

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Webinar May 12: Exploring IO Signatures in Clinical Trial Genomic Data

Conferences & Events, Trends & Insights|

Register now for the latest Translational Intelligence webinar:

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

Date/Time: Wednesday, May 12 | 12:00 PM EDT • 9:00 AM PDT • 5:00 PM CET

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.

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Translational Intelligence: Synthesis and Integration of Genomics Data in Clinical Trials

Trends & Insights|

April 22, 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.

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Delivering CDISC-Compliant Submissions of Biomarker and Specialty Lab Data

Trends & Insights|

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.

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

Conferences & Events, Trends & Insights|

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 a combination therapy targeting this pathway in metastatic colorectal cancer, as part of a Phase III clinical trial.

They identified potential prognostic markers with clinical benefit, and presented the results at the 2021 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI).

View the poster

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