Certara’s Best of the Blog 2019

A selection of short essays from our blog, written to empower our clients with modeling and simulation (M&S), regulatory science, and real-world value assessment solutions to help them solve the toughest drug development problems. In the Best of the Blog, Certara’s scientists and regulatory experts share their learnings, technological advances, and thought leadership.

Building an MBMA Framework to Support Developing New Neuropathic Pain Drugs

In this webinar, Leticia Arrington (Merck) and Richard Franzese (Certara) discussed data considerations, analysis methods, and learnings from a recent network MBMA analysis of relevant endpoints in NP that will be used for general competitive landscaping questions to support Merck’s ongoing mission to develop better NP therapies.

Centers for Disease Control and Prevention (CDC) Selects Certara to Develop Technology Platform to Strengthen the Agency’s Death Investigation and Surveillance Systems

PRINCETON, NJ – March 5, 2019 – Certara will partner with CDC to create OpenMDI (Open Medicolegal Death Investigation), a national system that will collect and share mortality data efficiently, allowing CDC to respond rapidly to critical public health priorities, such as tracking and understanding the toxicology behind drug overdoses from opioids.
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Using Virtual Twin™ Technology to Predict Drug Exposure in Individual Patients

Physiologically-based pharmacokinetics (PBPK) is a valuable resource to support decisions throughout drug development for sponsors and regulators. PBPK is used extensively to predict drug-drug interactions (DDIs), to inform dosing and clinical study design, to predict drug exposure, to predict variation in drug clearance, and to understand mechanisms of drug disposition. Virtual Twin technology, based on … Continued

Managing Immunogenicity Using Quantitative Systems Pharmacology

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.