Managing Immunogenicity Using Quantitative Systems Pharmacology

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 … Continued

A Beginner’s Guide to Performing Clinical Trial Simulation

The astronomical cost of conducting clinical drug trials means that a suboptimal trial design adds significant risk to a drug program. Clinical trial simulation allows drug developers to test different trial designs in silico before exposing patients to an experimental drug. In this blog post, I’ll explain how Certara’s Trial Simulator balances ease-of-use with robust … Continued