Elsevier, an information analytics firm specializing in health data, will collaborate with pharmaceutical giant Novartis to develop a novel safety margin risk assessment prediction solution, in large part relying on the company’s PharmaPendium Data. The project will aim to enable comprehensive target profiling and clinical interpretation, arising from a combination of data curation and technological expertise.
According to Elsevier, the FDA estimates adverse drug reactions lead to more than 106,000 patient deaths in the US alone. In addition to the cost in human lives, these reactions can cost the healthcare system as much as $200bn each year.
Outsourcing-Pharma spoke to an Elsevier representative, who told us, “The tool we are developing will accelerate the existing manual processes that are contributing to these issues. The blend of technical acumen and scientific nuance will make drug submissions and communications with regulatory agencies more effective and efficient and speed up the process of getting safe therapies to patients who need them.”
What’s more, the representative told OSP, drug safety problems are vital for researchers and drug developers to work toward solving.
“Safety issues are one of the main reasons for a drug to fail during late-stage clinical trials, by preventing this, safe medicines can be provided to patients faster,” they said. “Drug attrition, including many post-market drug withdrawals, is often a result of unanticipated toxicity due to off-target drug activity.”
The representative added, “If researchers can mitigate these risks early in drug development, they can optimize lead candidate selection and better mitigate the risk of seeing serious adverse effects during clinical trials. Not only does this save time and money for the companies conducting research, but more importantly, it ensures that much-needed therapeutics can get to patients faster.”
Solving such issues can present a number of formidable challenges, but the collaborative tool developed via the Novartis-Elsevier partnership aims to address them, the representative said.
“Predicting the clinical significance of potential off-target toxicity, and minimizing the resulting risk, relies on a researcher’s ability to estimate the drug safety margin for a specific target,” they told us. “To successfully generate safety margin estimates for a broad set of targets requires a large volume of data, including data on already marketed and withdrawn drugs.”
Other challenges involve difficulty in identifying reliable test systems.
“Today, researchers can only access these data if they manually mine literature and regulatory documents for drug safety and pharmacokinetic data – which is incredibly laborious and limiting. The new tool we are creating will be served by the highest quality data available and enable comprehensive target profiling rapidly,” the representative commented.
Cameron Ross, managing director for life sciences solutions with Elsevier, said the partnership with Novartis will seek to avoid risk and protect patients.
“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,” he said.