Texas Biomed advancing new approach methodologies (NAMs)

SAN ANTONIO, April 20, 2026 /PRNewswire/ -- Texas Biomedical Research Institute is advancing new tools – known as new approach methodologies (NAMs) – that can accelerate discoveries and drug development by complementing required studies to ensure new medicines are safe for people.

NAMs are tools, such as AI-based computer modeling, advanced cell culture and microphysiological systems, that aim to study diseases and test treatments primarily using human tissues and cells.

"These tools, which have been under development for decades, are showing exciting progress to help answer important questions about human health and disease and to test new drugs and therapies," said Larry Schlesinger, MD, Texas Biomed President/CEO. "We are excited to be involved in developing, using and testing these tools to ensure they are accurate and reliable."

NAMs tend to include three categories: organoids, organ-on-a-chip systems and machine learning/AI. Organoids are 3D cellular structures that are simplified, miniature representations of individual tissues or organs, such as lung, liver, heart and brain. Organ-on-a-chip systems – also called microphysiological systems (MPS) – are devices that aim to mimic dynamics within tissues, including cell interactions and flowing fluids. Machine learning and artificial intelligence promise to help model and predict potential treatment targets, drug compounds and interactions.

Texas Biomed has been collaborating on NAM development for many years with researchers nationwide, including brain organoids for studying epilepsy, intestinal organoids for testing antivirals and placental organoids to understand fetal development.

Dr. Schlesinger's lab has developed a system for generating cells that reside deep in the lungs, making them expensive and difficult to access from human patients. With a simple blood draw, researchers can now generate alveolar macrophage-like cells. The lab is working to integrate their cell culture system with new lung-on-a-chip technologies recently acquired by Texas Biomed, which will help accelerate research into a wide range of respiratory conditions and diseases, such as influenza, tuberculosis and aging. 

With specialized facilities and expertise in high-containment research, Texas Biomed is also positioned to develop, test and study NAMs for pathogens like Ebola and Marburg viruses, among other global health threats.

Texas Biomed hosts the Southwest National Primate Research Center, one of seven nationally supported centers dedicated to humane and ethical biomedical research with nonhuman primates. Nonhuman primates are the gold standard for required preclinical studies to evaluate how a new therapy or vaccine will behave in a complete immune system, before it is tested in clinical trials in people.

SNPRC is applying its deep expertise in establishing and refining research models to help establish biological standards for NAMs. A key focus is robustly studying how NAMs demonstrate safety and efficacy of a particular therapy, compared to well-established animal models. In this regard, investigators are incorporating animal cells into NAMs to help bridge the gap.

However, at this time, even when combined, NAMs cannot fully replicate a complete immune system, so the question remains whether unintended side effects could be missed if using only NAMs for preclinical safety studies.

"We are very hopeful that NAMs will be able to reduce the number of animals required for necessary safety and efficacy studies of new treatments," Dr. Schlesinger said. "We anticipate an integrated approach that combines both NAMs and animals will be the way forward for the foreseeable future to help ensure that people are kept safe and healthy."

For more information, please visit txbiomed.org

SOURCE Texas Biomedical Research Institute