Elsevier launches new PharmaPendium, empowering pharma companies to bring novel drugs to market faster and increase success of regulatory submissions
London | 2023년 10월 10일
Comprehensive drug development and approval package data combined with predictive analytics support translational research, reduce animal testing and ensure drug safety
Elsevier 새 탭/창에서 열기, a global leader in information and data analytics, 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, 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 (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 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 (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.
About Elsevier
As a global leader in scientific information and analytics, Elsevier helps researchers and healthcare professionals advance science and improve health outcomes for the benefit of society. We do this by facilitating insights and critical decision-making with innovative solutions based on trusted, evidence-based content and advanced AI-enabled digital technologies.
We have supported the work of our research and healthcare communities for more than 140 years. Our 9,500 employees around the world, including 2,500 technologists, are dedicated to supporting researchers, librarians, academic leaders, funders, governments, R&D-intensive companies, doctors, nurses, future healthcare professionals and educators in their critical work. Our 2,900 scientific journals and iconic reference books include the foremost titles in their fields, including Cell Press, The Lancet and Gray’s Anatomy.
Together with the Elsevier Foundation 새 탭/창에서 열기, we work in partnership with the communities we serve to advance inclusion and diversity in science, research and healthcare in developing countries and around the world.
Elsevier is part of RELX 새 탭/창에서 열기, a global provider of information-based analytics and decision tools for professional and business customers. For more information on our work, digital solutions and content, visit www.elsevier.com.
연락처
TM