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Comprehensive drug development and approval package data combined with predictive analytics support translational research, reduce animal testing and ensure drug safety.
Elsevier has launched the new PharmaPendium, sharpening the translational view of a platform that combines extensive preclinical and clinical data, including complete Food and Drug Administration (FDA) and European Medicines Agency (EMA) approval packages, 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, prioritise 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 (PMDA) and the top 20 global pharma companies.
“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. The platform leverages Elsevier’s expertise in curating scientific data and presents it in an intuitive and meaningful way for pharma professionals,” adds Olivier Barberan, Director of Translational Medicine Solutions at Elsevier. “This improved access to highly relevant data plus predictive tools enhances regulatory success, safeguarding the massive investments of pharma companies.”
PharmaPendium’s advanced predictive tools include the Drug-Drug Interaction Risk Calculator (DDIRC) and Safety Margin Tool. These solutions empower researchers to accurately 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 and Company, 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 with:
- Enhanced visualisation 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 (FAERS); DESI (Drug Efficacy Study Implementation) documents Meyler's 16th Edition, Mosby's Drug Consult and scientific articles.
PharmaPendium’s high-quality 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 can also access support from Elsevier’s team of domain and data science experts for their data projects.