Elsevier, a global information analytics business specialising in science and health, is working together with a set of evaluation partners that include industry leaders such as Boehringer Ingelheim, Eli Lilly and Company, Pierre Fabre, Sanofi, Servier, and others to develop a new and improved drug–drug interaction risk calculator (DDIRC). The updated DDIRC will help DMPK (Drug Metabolism-Pharmacokinetic) and clinical pharmacology scientists improve patient safety and outcomes and reduce risk during pharmaceutical development.
Adverse drug reactions (ADRs) are a serious problem worldwide. In Europe, 197,000 deaths per year are attributed to them, while the FDA estimates that over 106,000 people die every year due to ADRs. In the US alone, the cost to the medical care system is an estimated $200 billion per year. One reason for the increase in ADRs is the growth in prescription use—especially among aging populations where drug–drug interactions (DDIs) are more likely. Currently, 9 percent of Americans over age 55 take 10 or more prescription drugs, which greatly increases the likelihood of DDIs and ADRs. As such, pharmaceutical companies not only have to ensure that their drug is safe for use and effective at treating its primary targets, but must also ensure that the same drug is equally safe and effective when interacting with potentially thousands of other drugs—an ever more difficult task.
As DDIRC is a "mechanistic static" modeling calculator that can be used to predict interactions early on—when information on the drug candidate is limited—through to later stages of drug development. It also allows fast predictions, for quick responses to questions from regulatory bodies or physicians.
"Elsevier’s team has collected the background data, and the DDIRC can potentially help us put that data to work to broadly understand DDI implications,” said Jessica Rehmel, MS, Consultant Scientist - ADME/Investigative Drug Disposition, Eli Lilly and Company. "We look forward to quickly evaluating and helping to develop this quantitative risk assessment tool."
This joint project between Elsevier’s PharmaPendium team and a group of leading pharma companies will develop and test, for the first time, a new DDIRC that can analyse both internal and external data. It will include additional models that can, for example, assess the risk of transporter-mediated DDIs or better assess the risk of DDI due to polypharmacy, and will deliver accurate, shareable and actionable insights.
By enabling pharmaceutical companies to upload internal data, combined with the high-quality, public FDA/EMA data available in PharmaPendium, the new DDIRC will feature increased predictive power.
PharmaPendium’s updated DDIRC will continue to follow FDA Guidelines for mechanistic static prediction of enzyme-mediated DDI risk and could additionally provide information for other models of DDI prediction, such as transporter-mediated DDI risk, based on evaluation partner feedback and feasibility. This increased dataset will allow for more reliable predictions. The new DDIRC is expected to launch in 2020, leveraging the power of Elsevier’s data and analytics platform.
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