Introduction If you missed part one of this blog series, click here to read A new era of drug development: How regulatory changes to reduce animal
A new era of drug development: Comparing regulatory roadmaps to reduce animal testing
Introduction The poor translatability of animal models where interspecies differences limit their predictability, alongside the need for more
Do MHRA and FDA guidelines on non-animal methods in drug development align?
It’s been a landmark two weeks for the industry. The US FDA and the UK MHRA have taken monumental steps to reduce regulatory uncertainty, one of the
Taking organoids to the next level
Introduction Organoids are 3D, miniaturized organs that are generally grown from stem cells (pluripotent or adult) that self-organize in vitro
Regulatory Shifts and Validation: Key Insights from The World Congress on Alternatives and Animal Use in the Life Sciences Conference (WC13)
I, (Dr. Tomasz Kostrweski, CSO, CN Bio) recently had the pleasure of attending the 13th World Congress on Alternatives and Animal Use in the Life
Integrating In Silico Tools with Organ-on-a-Chip to advance ADME studies
Knowing a drug’s bioavailability during lead optimization is crucial as it directly influences dosing strategy, therapeutic efficacy, safety margins,
Microphysiological systems for mAbs development: how do they address animal limitations?
Welcome to part two of our blog series exploring the FDA’s announcement to phase out the animal testing requirement for monoclonal antibodies (mAbs),
Why the FDA animal testing phase-out for monoclonal antibodies?
In a groundbreaking press release on April 10th, 2025, the FDA announced its decision to phase out animal testing requirements for monoclonal
The Rise of Oligonucleotide Therapeutics: Overcoming ADMET Development Challenges with Human-Centric Approaches
New modality drugs, or advanced oligonucleotide therapeutics, refer to innovative approaches that go beyond traditional small molecule approaches to