Part 2 of this blog series dives further into the June 2022 podcast with R&D World editors, Paul Heney and Aimee Kalnoskas, having their minds blown — multiple times! — which explores Certara’s Simcyp COVID-19 Vaccine Model, a 2021 R&D 100 Awards winner, revealing the genesis of the model, as well as some stunning possible … Continued
Author: Piet van der Graaf
R&D World editors, Paul Heney and Aimee Kalnoskas, have their minds blown — multiple times! — in this June 2022 Podcast, which delves into Certara’s Simcyp COVID-19 Vaccine Model, a 2021 R&D 100 Awards winner… about the genesis of the model, as well as some stunning possible future uses for it. Developed within a few … Continued
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
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.