A year ago, the US announced the FDA Modernization Act 2.0. An essential step for the NAMs and CIVMs (Complex In Vitro Models) ecosystem, which includes organs-on-chip. Indeed, preclinical research, essential to the development of new therapies, often fails to predict outcomes in humans due to reliance on current models; however, advances in human models such as organoids and organs-on-chip (O&OoC) offer more accurate and predictive alternatives, particularly in terms of efficacy and toxicity. End of February 2024, this was followed by the FDA Modernization Act 3.0.

And a month ago… The FDA’s Center for Drug Evaluation and Research (CDER) has accepted the first letter of intent (LOI) into its ISTAND Pilot Program for organs-on-chip technology. This LOI is for a human Liver-Chip used to assess the risk of DILI in adults to create relevant data for a drug’s investigational new drug (IND) submission. This LOI acceptance marks a major step forward for CIVM in general.

NETRI, a global player in CIVM and data management, offers the healthcare industry organs-on-chip technologies based on its neuron as a bio digital sensor approach. Combining microfluidics, biology with hiPSC culture and software, with its AI-trained digital library, NETRI licenses to pharmaceutical, dermo-cosmetics and nutritional health industries its NeuroFluidics™ MEA platforms.

NETRI focused adverse event (pain, oncology, vaccine and emetic response), neurological disorders (Alzheimer Disease, Amyotrophic Lateral Sclerosis, Parkinson Disease) and neurotoxicity (food and chemical safety).