SAfety Biomarker Expert Resource (SABER) helping drive PHC
We are a global cross-functional group of biomarker experts across gRED Dev Sci, pRED Pharmaceutical Sciences, Product Development Safety, Research and the Chugai SABER team.
We are a global cross-functional group of biomarker experts across gRED Dev Sci, pRED Pharmaceutical Sciences, Product Development Safety, Research and the Chugai SABER team.
Our Vision is to advance patient safety, drug development, and safety science through innovative, seamless and strategic integration of safety biomarkers across Roche.
Our overarching goals are to provide expertise and infrastructure to generate or access safety biomarker data for internal experience and reference ranges; to predict and address non- or poorly-monitorable toxicities; to harmonize assay and informatics solutions, and to centralize resources.
A safety biomarker is a biomarker measured before or after an exposure to a medical product or an environmental agent to indicate the likelihood, presence, or extent of toxicity as an adverse effect (BEST [Biomarkers, EndpointS, and other Tools] FDA Guidance, 2016). Common to all safety biomarkers is the ability to detect or predict these adverse drug or exposure effects.
Safety biomarkers can be sub-defined according to other biomarker types by its intended use for safety. SABER is pursuing work in each of these uses.
Signal toxicity by the detection of or change in a biomarker, allowing dose modification or treatment interruption before toxicity becomes severe and/or can indicate the type of needed treatment.
Identify individuals with increased or decreased likelihood of experiencing a particular toxicity when an individual is subjected to drug exposure.
Identify individuals without clinically apparent disease for whom particular therapies should not be initiated (or should be monitored more closely) because of significant potential to develop toxicity when subjected to drug exposure. This can be either predictive or monitoring-based biomarkers, as the later may provide a more sensitive assessment of baseline organ health and thus the potential to exacerbate baseline otherwise “silent” disease.
Provide current and innovative scientific and technical expertise to guide overall SABER strategy, deliverables and project team guidance; pro-actively positioning safety biomarkers according to global portfolio needs through biomarker prioritization and generating foundational knowledge.
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