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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: Read more →

July 12, 2021 — 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 Visibility In previous webinars and articles, we have analyzed key challenges facing biomarker operations. Given the expanding footprint of sites, labs, and biorepositories, there is no sole source where sponsors can find information on biospecimens and get insights into the whereabouts Read more →

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. Read more →

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. Read more →

February 12, 2021 — Integrating clinical and biomarker data enables both operational insights as well as scientific insights that can help teams make clinical trial decisions on-study. Our last article defined the synthesis of these insights as translational intelligence, with the potential to illuminate key insights in drug development just as business intelligence is used to optimize business performance. We showed that, for example, having all the biomarker and clinical data linked together enables sponsors to quickly explore the relationship between drug response status and specific biomarkers of interest. In this post, we further illustrate how translational intelligence works in Read more →

February 3, 2021 — In this brief, we explore Translational Intelligence – that is, navigating the vast biomarker data ecosystem to quickly uncover insights that would be missed by visual inspection alone, and which enable translational teams to focus on the right pathways, biological mechanisms, and / or patient populations. Read more →

December 10, 2020 — Biomarker-guided trials frequently have an international footprint of sites to reach targeted patient populations and involve a complex network of specialty labs. Join us for our upcoming webinar, where QuartzBio's Tobi Guennel will discuss how his team is breaking down data siloes to create actionable insights into availability and quality of samples and data. These insights allow clinical and translational teams to streamline trial operations and enable early course correction. Read more →

November 12, 2020 — In this article, QuartzBio Managing Director Scott Marshall discusses critical steps to integrating clinical, PK, and exploratory data on-study to advance operational and translational insights (without all the manual effort that has become all too common). With our experience working across dozens of clients and hundreds of studies, we’ve identified four key components necessary to efficiently centralize. Read more →

July 16, 2020 — Computational approaches using COVID-19 data can be invaluable in quickly generating insights for drug repurposing, target pathway selection, and many other challenges. In this webinar, QuartzBio’s Renee Deehan will discuss how teams are combining deep biological knowledge with computational and machine learning approaches. The global pandemic caused by SARS-CoV-2 has resulted in an incredible mobilization of biopharma resources and attention. Agile research groups are recognizing the valuable opportunity for computational approaches to accelerate paths to insight generation. Mechanistically-guided methods have significant potential to inform and expedite critical decisions that would have previously required time consuming and Read more →

June 8, 2020 — As the QuartzBio team’s efforts have progressed with the selection and integration of SARS-CoV-2 / COVID-19 data sets, I am pleased to share our first public update on analysis. This work builds on an evaluation of IFN-α2b treatment, and supports the rationale that interferons are upregulated as part of the antiviral defense, specifically for COVID-19. We are also sharing this work as a demonstration of the potential for translational research and drug repurposing while mitigating the time, expense, and reproducibility challenges inherent in drug/treatment combination discovery. This need for speed and flexibility is, of course, at Read more →