How early is early enough for safety? And how closely should preclinical models reflect human biology before major investment decisions are made? Recent industry updates suggest that these questions are moving to the center of strategic planning, with implications for how discovery and development programs are structured.
In a recent Q&A with BioPharm International, Michael De Marco, Senior Director, Nonclinical Safety at Lonza, described how toxicology considerations are increasingly being integrated earlier in development programs to support Speed-to-IND strategies. Early safety data is no longer viewed solely as a regulatory requirement, but as an input to portfolio prioritization, funding decisions, and regulatory planning.
At the same time, industry commentary continues to highlight growing interest in iPSC-derived cells for toxicity screening. The BioInformant review discusses how specialized providers are advancing iPSC-based platforms to deliver human-specific biology in early assays and functional readouts that complement traditional approaches. This reflects continued attention on integrating more reproducible human in vitro systems into safety workflows.
Academic innovation is also contributing to this shift. Richard Davis, group leader at LUMC, recently reported on a cardiac research platform developed in collaboration with Ncardia to support drug discovery in heart rhythm disorders. The initiative focuses on evaluating rhythm stability in controlled cardiac systems, reinforcing the importance of functional assessment in translational research.
On a broader level, the Association of the British Pharmaceutical Industry (ABPI) released a landscape review of human-relevant preclinical model development in the UK. The report outlines current use of advanced in vitro systems, regulatory context, and infrastructure needs, signaling a structured evaluation of how human-based models may be integrated into development programs.
Collectively, these signals reflect a measured but consistent trend: earlier integration of safety thinking and continued evaluation of human-relevant systems within established workflows.
For teams assessing how to strengthen early decision-making with reproducible, functional human data, iPSC-based platforms are increasingly part of that conversation. Learn more about Ncardia’s human iPSC-based solutions for discovery and safety.