Translational Intelligence: Synthesis and Integration of Genomics Data in Clinical Trials
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.
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 and effectiveness.
Drug developers face operational challenges, however, in preparing complex, often unstructured, biomarker and specialty lab data in compliance with regulatory requirements.
Folate pathway gene expression in metastatic colorectal cancer patients treated with arfolitixorin/5-FU-based chemotherapy
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).
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 all have?” asked moderator Michael Tanen, Director, Clinical Biomarker Specimen Management, Merck & Co., at last Tuesday’s panel discussion in the Clinical Biomarkers Operations & Innovations track.
QuartzBio’s SVP of Data Management and Systems Integration, Tobi Guennel, joined leaders from Bristol-Myers Squibb, Eli Lilly, AbbVie, and Covance for this live panel.
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 after withdrawal from treatment. The team identified several genes that were, for the first time, associated with protection against early onset of relapse.