Elsevier, a global information analytics business specialising in science and health, has announced its collaboration with the pharmaceutical company Novartis to develop a safety margin risk assessment prediction tool, primarily using the PharmaPendium data.
The FDA estimates more than 106,000 people die every year due to adverse drug reactions (ADRs); in the US alone, the cost to the medical care system is an estimated $200 billion per year. Unanticipated drug safety concerns often stem from off-target drug activity and are a significant cause for drug attrition during drug development, including many post-market drug withdrawals. This new solution from Elsevier and Novartis is expected to enable the most comprehensive target profiling and clinical interpretation due to the combination of in-depth scientific data curation and technological expertise. Early on in drug development, mitigating safety liabilities helps to select promising candidates early, optimise drug design and avoid late-stage failures.
Key to predicting the clinical significance of potential off-target toxicity is the estimation of the drug safety margin for a specific target. To generate safety margin estimates for a broad set of targets, researchers need the context of clinical data from marketed and withdrawn drugs. They also need to navigate the challenges of identifying reliable test systems that can lead to proper translational safety assessment. Performing this requires researchers to manually mine literature and regulatory documents for drug safety and pharmacokinetic data, which is laborious, limiting the number of targets for which safety margin estimates are made.
As highlighted in a 2015 FDA publication, there is a need for better justification around target selection related to human safety, interpretation of clinical significance, and early submission of this data to monitor and mitigate safety risks throughout clinical drug development. The collaboration between Elsevier and Novartis seeks to address the need, also to make drug submissions and communications with regulatory agencies more effective and efficient.
PharmaPendium provides users with fully searchable drug approval documents and extracted data to inform critical drug development decisions.
Brought to you by Scope e-Knowledge Center, a trusted global partner for digital content transformation solutions - Abstracting & Indexing (A&I), Knowledge Modeling (Taxonomies, Thesauri and Ontologies), and Metadata Enrichment & Entity Extraction.Click here to read the original press release.