Managing Complex Biomarker Data Archives - Page 4 of 5

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.

September 24, 2020 — The COVID-19 pandemic has forced clinical trial stakeholders to rethink the paradigm as sponsors adapt to site restrictions, remote monitoring, and updated regulatory guidance. This is especially true in precision medicine programs, which have developed global footprints in order to reach targeted patient populations and rely on specialty labs running complex assays to assess safety, characterize patient response and drug MoA, and provide insights into efficacy. In the absence of consistent and predictable in-person presence, how can sponsors maintain the timely visibility necessary to optimize operations of these complex trials?

September 21, 2020 — What does precision medicine actually mean and how can AI and ML impact it?

QuartzBio’s Renee Deehan and panelists explore AI and ML’s impact on precision medicine and what the industry needs to do to prepare for it, tackle challenges as they evolve and develop appropriate solutions.

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August 13, 2020 — Cell therapy clinical trials typically generate a significant quantity and diversity of biologic data intended to characterize disease and patient biology, as well as data intended to demonstrate evidence of therapeutic mechanisms. QuartzBio’s Cliff Culver et al., explores the benefits of capturing and integrating molecular biomarker data within clinical trials to build foundations for data assets. Read the article in the latest issue of Applied Clinical Trials Magazine.

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April 28, 2020 — COVID-19 is at the forefront of many research and development agendas. How can the integration of publicly available data help accelerate these efforts? The QuartzBio team is building and making available a unified SARS-CoV-2 / COVID-19 data ecosystem to support our own work and that of the broader research community. In the midst of the global pandemic, research and development teams face unprecedented operational hurdles affecting data generation.

March 10, 2020 — In the years to come, public data will play an increasingly important role in drug discovery and development.

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In this brief, learn how biotechs are strategically using publicly available data to:

Accelerate their path to the clinic by circumventing time-consuming, expensive data generation
Increase the likelihood of success by mitigating the reproducibility risks inherent in preclinical models
Quickly incorporate data-driven evidence to guide critical decisions related to indication matching, patient stratification, and MOA investigation
Build data assets that support their eventual regulatory filings

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February 4, 2019 — Pharmaceutical and healthcare organizations have zettabytes of data at their disposal, literally. They have spent the last decade accumulating information from electronic health records, insurance claims, lab results and more. Whatever frustrations one might have with the industry at large, it can’t reasonably be suggested that companies were caught unaware by the data and analytics revolution. If anything, they have veered in the direction of over-collection and analysis.

January 15, 2020 — With public data set to play an increasingly important role in drug discovery and development, an integrated, data-driven approach to clinical planning can optimize the probability of success. The increasing availability of public data sets, such as The Cancer Genome Atlas (TCGA) and the Alzheimer’s Disease Neuroimaging Initiative (ADNI), offers a transformational opportunity for insight-driven planning at all phases of the drug development life cycle. The size and scope of these public data sets are often considerable, compiling billions of data points across multiple modalities and representing data that would have previously required many years and millions of dollars to generate.

November 13, 2019 — Quizartinib, a once-daily, oral, highly potent and selective FLT3 inhibitor, demonstrated a significant improvement in survival vs SC in FLT3-ITD-positive R/R AML in the global, randomized, phase 3 QuANTUM-R study (Cortes et al. Lancet Oncol, 2019; NCT02039726). Patients with R/R FLT3-ITD-positive AML were randomized 2:1 to receive single agent quizartinib or investigator’s choice of pre-selected SC.

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November 8, 2019 — This article explores biomarker data trends and challenges, and shares how drug developers, translational scientists, and clinical researchers evaluating biomarkers in early-phase studies can reduce time and cost.