Avoiding Late-Stage Failure in Oncology Through MIDD
Late-stage attrition in oncology drug development represents a substantial scientific and economic inefficiency, with Phase III failure rates often exceeding 50%
A guide to the FDA announcement to phase out animal testing
The landscape of preclinical drug development is undergoing a paradigm shift driven by the need for more human-relevant evidence and a global regulatory movement toward ethical safety testing.
Dose optimization in oncology: a hidden MIDD challenge in the era of project Optimus
For decades, oncology followed a simple principle: administer the maximum tolerated dose. With modern therapies, this paradigm no longer holds — discover how MIDD addresses the FDA's new Project Optimus expectations.
MIDD: stop guessing, start modeling.
MIDD transforms drug development: predictive modeling, optimized dose selection, and stronger regulatory dialogue — from the earliest stages of development.
10 good reasons to use Modeling and Simulation in your drug development
Modeling expertise is an essential cornerstone for a robust and optimal drug development strategy.
Publication: Development of a PBPK Model for ADC (oncology)
A first-in-class PBPK model for CLDN18.2-targeted ADCs using PK-Sim® and MoBi®. Read and discover the full article!
FDA announces plan to phase out animal testing requirement for mAbs and other drugs
The FDA is taking a groundbreaking step to advance public health by replacing animal testing in the development of mAbs therapies and other drugs.
Modeling & Simulation integrated in drug development
Modeling and simulation play an increasingly crucial role in the development of drug candidates.
New article: Unlock the power of PBPK Prediction!
In the ever-evolving landscape of pharmaceutical research, the quest for developing safer and more effective drugs is a continuous endeavor.
MIDD and FDA: What Biotechs need to know about ICH M15
The ICH M15 guidance introduces a harmonized framework that allows these models to be formally recognized as “MIDD evidence” by regulatory authorities such as the FDA.