Using Quantitative Systems Pharmacology (QSP) Modeling for Oncology Dose Optimization On-Demand Webinar Using Quantitative Systems Pharmacology (QSP) Modeling for Oncology Dose Optimization The FDA’s Project Optimus initiative aims to reform dose optimization and selection for oncology therapies…CertaraAugust 19, 2024
Optimizing Clinical Development: Saving Time and Costs Case Study Optimizing Clinical Development: Saving Time and Costs Strategic mechanistic modeling solutions help an immunoncology biotech accelerate their clinical development of novel therapeutics.CertaraAugust 16, 2024
Medicines that matter: Biohaven’s Nurtec™ drug development journey Case Study Medicines that matter: Biohaven’s Nurtec™ drug development journey In February 2020, Biohaven Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved…CertaraAugust 15, 2024
Model-Informed Confidence in Oncology Dose Selection Case Study Model-Informed Confidence in Oncology Dose Selection Discover an oncology-focused company that gained confidence in their dose selection for an AML trial…CertaraAugust 9, 2024
Certara’s MIDD Oncology Capabilities Video Certara’s MIDD Oncology Capabilities Improve Oncology Study Decisions with Certara's MIDD Team Transcript: The pace of oncology drug…CertaraAugust 7, 2024
Dosing Strategies and Quantitative Clinical Pharmacology for Bispecific T-Cell Engagers Development in Oncology Publication Dosing Strategies and Quantitative Clinical Pharmacology for Bispecific T-Cell Engagers Development in Oncology CertaraJuly 23, 2024
Systems Modeling Delivers Efficiencies and Savings in Clinical Development Case Study Systems Modeling Delivers Efficiencies and Savings in Clinical Development Discover how an IO-focused company developing immunotherapies applied QSP modeling solutions for cost-effective clinical development.…CertaraJuly 12, 2024
Accelerating the Progress of Kinase Inhibitors in Oncology Press Coverage Accelerating the Progress of Kinase Inhibitors in Oncology The potential of PBPK modeling in answering key questions around these drugs. Hannah Jones, PhDMasoud…CertaraMay 20, 2024
How to Navigate the FDA Landscape for an Orphan Drug Blog How to Navigate the FDA Landscape for an Orphan Drug Rare diseases are a public health priority. FDA has launched several programs and a final…CertaraFebruary 21, 2024
Incorporating Pragmatic Elements in Study Designs to Enhance Oncology Randomized Clinical Trials Publication Incorporating Pragmatic Elements in Study Designs to Enhance Oncology Randomized Clinical Trials A FRIENDS OF CANCER RESEARCH WHITE PAPER The article explores the complex landscape of determining…CertaraDecember 19, 2023