Healthcare analytics company Elsevier has teamed up with Novartis to develop a safety margin risk assessment tool to combat adverse drug reactions.
Drug Safety
The tool will be largely developed using Elsevier’s PharmaPendium drug data safety resource. The companies hope to make it the most comprehensive tool for target profiling and clinical interpretation due to the combination of deep scientific data curation and technological expertise.
The new tool will help researchers optimise the selection of drug candidate leads by conducting translational off-target safety risk assessments. By mitigating safety liabilities early on in drug development, companies will be able to select potentially more promising drug candidates that are able to avoid late stage failures.
In the US, adverse drug reactions (ADRs) are thought to kill over 106,000 people every year, costing the medical system an estimated $200 billion per year. Unanticipated drug safety concerns often stem from off-target drug activity and are a major cause for drug attrition during drug development, including many post-market drug withdrawals.
Researchers need the context of clinical data from marketed and withdrawn drugs to better generate safety margin estimates for a broad set of targets. This can help them predict the clinical significance of potential off-target toxicity. Reliable testing systems are also needed to help with proper translation safety assessments. Performing this today requires researchers to manually mine literature and regulatory documents for drug safety and pharmacokinetic data, which is laborious, and limits the number of targets for which safety margin estimates are made.
The FDA states that there is a need for better justification around target selection related to human safety interpretation of clinical significance, and early submission of this data in order to monitor and mitigate safety risks throughout clinical drug development.
“Drug safety issues are one of the major causes of late-stage drug failure in pharmaceutical development, and the new solution we are developing is designed to help drug development teams avoid this outcome,” said Cameron Ross, managing director Life Sciences Solutions, Elsevier. “We are looking forward to combining our skills with those of the Novartis team, to accelerate R&D. Providing the most comprehensive resource for off-target risk assessments that can be used as early as lead optimisation will help researchers build confidence in critical go/no-go decisions.”