Being a team of results-oriented scientists working to address the medical challenges of an unprecedented pandemic has fueled Certara’s propensity for innovation. Since the early days of COVID-19, we have been working alongside pharmaceutical companies, global health foundations, academia, and regulators to advance therapies and vaccines. Key to our work has been building upon our … Continued
Author: Piet van der Graaf
By: Dr. Piet van der Graaf, SVP
This blog explains how using the Gene Therapy Virtual Twin™ Platform can help optimize dosing for patients.
QSP can inform designing First-in-Human clinical trials to help determine the starting dose and subsequent dose escalations to ensure human subject safety.
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
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.