New executives’ scientific, operational and consulting expertise will support Simcyp’s footprint in drug development and regulatory decision-making.
April 24, 2019 – Model-Based Meta-Analysis (MBMA) is a growing methodology that leverages literature based and often external data to provide a quantitative framework to enable strategic drug development decisions. MBMA comparator models often include valuable pieces of information such as time, covariates, clinical trial efficacy and safety information.
PRINCETON, NJ – Mar. 13, 2019 – Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced that its pharmacokinetic/pharmacodynamic (PK/PD), quantitative systems pharmacology (QSP) and physiologically-based pharmacokinetic (PBPK) modeling experts will participate in 21 sessions at the American Society for Clinical Pharmacology & Therapeutics (ASCPT) 2019 […]
The Challenge of Immunogenicity in Biologics Drug Development Biologic drug development is a rapidly evolving sector in the biopharmaceutical industry. Biologically-based therapeutic drugs comprise monoclonal antibodies (MAbs), vaccines, recombinant hormones and proteins, antibody-drug conjugates, RNAi, antisense, blood factors, and other large molecules. Although the success of biologics has been demonstrated, there are inherent operational and […]
Watch this webinar to learn why many major pharma organizations are investing in QSP for its potential to improve pharma R&D productivity.
Certara’s Evidence, Value & Access Specialists to Host Symposium on Automation in Public Health Decision-making and Present 18 Posters at ISPOR Europe
PRINCETON, NJ – Nov. 8, 2018 – Certara today announced that its Evidence, Value & Access team will host an educational symposium and present 18 research posters at ISPOR Europe 2018.
Certara’s Synchrogenix Division Collaborates with Hedera Hashgraph to Offer Data Flow and Transparent Collaboration Solutions for the Life Sciences Industry
October 15, 2018 – Certara today announced that it has formed a strategic collaboration with Hedera Hashgraph. Synchrogenix®, Certara’s regulatory sciences division, has been building distributed applications in the life sciences and healthcare markets that will expand its reach in the areas of transparency and disclosure, regulatory reporting and data sharing, and collaboration/communications from drug development through market access.
Development of a Pre-clinical Quantitative Systems Pharmacology Model for E7046, a Novel PGE2 Receptor Type 4 Antagonist for Cancer Immunotherapy
Biologic drug development is a rapidly evolving sector in the biopharmaceutical industry. Immunogenicity is an inherent challenge with this complex class of drugs. A quantitative systems pharmacology approach can be used to predict and better manage immunogenicity, and as a tool to guide clinical and regulatory decision-making in biologics drug development.
Application of Tracer Kinetics in Drug Development: A Valuable but Underused Tool in Clinical Pharmacology
In this webinar, Pau Aceves, Associate Director of Consulting Services at Certara, presented case studies on how tracer kinetics were used to inform development of new drugs for lung, CNS, and liver diseases. By watching this webinar, you will learn how tracer kinetics can leveraged for PK, PD, and in silico modeling applications.