Elsevier, a global leader in information and data analytics, has launched PharmaPendium, sharpening the translational view of a platform that combines extensive preclinical and clinical data. In addition it includes complete Food and Drug Administration and European Medicines Agency approval packages, combined with predictive tools to accelerate drug development.
PharmaPendium enables companies to make faster, more informed decisions about what drug candidates to advance. Pharma professionals and researchers can use the tool to benchmark against competitors, prioritize safety and efficacy and develop effective strategies for regulatory submissions. The depth and reliability of the platform’s data means PharmaPendium is already trusted by the FDA, Pharmaceuticals and Medical Devices Agency and the top 20 global pharma companies, Elsevier said.
“Translation of preclinical research findings to humans in an efficient but safe way is one of the greatest challenges facing drug developers. We designed the new PharmaPendium to solve this," said Olivier Barberan, director of translational medicine solutions at Elsevier. "The platform leverages Elsevier’s expertise in curating scientific data and presents it in an intuitive and meaningful way for pharma professionals. This improved access to highly relevant data plus predictive tools enhances regulatory success, safeguarding the massive investments of pharma companies.”
PharmaPendium’s predictive tools include the Drug-Drug Interaction Risk Calculator and Safety Margin Tool. The company said these solutions empower researchers to predict harmful drug-drug interactions and off-target related clinical adverse events, and to optimize nonclinical studies and reduce animal testing. They were co-designed to meet industry needs and align with regulatory guidance. Elsevier collaborated with Novartis on the Safety Margin Tool, and with Boehringer Ingelheim, Eli Lilly, Pierre Fabre, Sanofi, Servier and others on the DDIRC.
Today, 93% of drugs entering clinical trials fail to secure regulatory approval. Better understanding of first-in-human dose selection, optimal study endpoints and mitigating adverse events improves regulatory success. Yet translation from preclinical studies to post-market data analysis is time-consuming and expensive. The new PharmaPendium helps overcome these challenges in the following ways:
- Enhanced visualization tools to more easily gain insights from vast quantities of data;
- Intelligent autocomplete to increase discoverability and identify important concepts;
- Improved search results interface to quickly access key data, such as drug metabolism and pharmacokinetics (DMPK), efficacy and chemistry, extracted from leading data sources, including:
- Complete FDA and EMA approval packages and FDA advisory committee documents;
- 19 million reports from the FDA Adverse Event Reporting System; and
- Drug Efficacy Study Implementation documents, Meyler's 16th Edition, Mosby's Drug Consult and scientific articles.
PharmaPendium’s datasets are machine readable and available for off-platform use, allowing companies to embed data into their workflows and employ predictive and scenario modelling. Customers also can access support from Elsevier’s team of domain and data science experts for their data projects, the company said.