Elsevier, a global information analytics business specializing in science and health, is collaborating with the pharmaceutical company Novartis to develop a safety margin risk assessment prediction tool, largely using PharmaPendium data.
 
PharmaPendium provides users with fully searchable drug approval documents and extracted data to inform critical drug development decisions.
 
The FDA estimates more than 106,000 people die every year due to adverse drug reactions (ADRs). 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. The new solution from Elsevier and Novartis is expected to enable the most comprehensive target profiling and clinical interpretation due to the combination of deep scientific data curation and technological expertise. Mitigating safety liabilities early on in drug development helps to select promising candidates early, optimize 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safety margin estimates for a broad set of targets, researchers need the context of clinical data from marketed and withdrawn drugs.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 today requires researchers to manually mine literature and regulatory documents for drug safety and pharmacokinetic data, which is laborious, and thus limits 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 in order to monitor and mitigate safety risks throughout clinical drug development. The collaboration between Elsevier and Novartis seeks to address this need, in order to also make drug submissions and communications with regulatory agencies more effective and efficient.
 
“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,” commented 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 optimization will help researchers build confidence in critical go/no-go decisions.”