New Approach Methodologies Improve Drug Development
The U.S. Food and Drug Administration is leading efforts to transform how drugs are evaluated. The purpose of New Approach Methodologies is to replace or reduce animal testing and advance other methods to predict how medicines work in people.
Purdue University researchers have developed several novel platform technologies for drug screening and modeling available for licensing and commercializing.
solution 1
Researchers have developed a nondestructive in vitro platform to measure extracellular matrix (ECM) stiffness and provide fast readouts. ECM stiffness has been found to be a contributing factor in cancer or fibrotic disease development.
The Purdue method includes a noninvasive on-chip platform that characterizes ECM stiffness with up to 93% accuracy. The highly selective, biocompatible sensors can be implemented in drug screening, drug discovery, and 3D cell cultures.
The efficiency and long-term stability of the method was validated in various hydrogels with different stiffness levels. Additionally, in vitro cell culture tests showed a reasonable cell viability and survival rate inside the platform.
solution 2
Pharmaceutical and biotech R&D teams face persistent bottlenecks in CNS drug development due to unreliable predictions of blood-brain barrier (BBB) permeability and neurotoxicity, resulting in high attrition rates and costly late-stage failures.
Researchers have developed a human brain model that uniquely layers astrocytes, pericytes, and brain microvessel endothelial cells with brain parenchymal cells. It enables distinct assessment of BBB integrity and neuronal or inflammatory responses.
The model is validated at the lab scale, reproducible, and ready for moderate-throughput screening.
solution 3
Researchers have developed bioactive hydrogel scaffolds that incorporate physiologically relevant architectural and biochemical cues to support extremely rapid formation of functional intestinal epithelium.
Unlike traditional systems that require weeks of culture and producing non-physiological transport behavior, the Purdue platform demonstrates fast epithelial coverage and selective barrier performance consistent with native intestine.
Validation was conducted using benchtop epithelialization studies and barrier assays demonstrating formation of functional monolayers and selective transport behavior. Additional studies confirmed barrier response to toxic challenges and performance differences across regions mimicking healthy and disease-like morphologies.
solution 4
Researchers have designed a microfluidic platform for the assembly and maintenance of 3D assembloids and control over the soluble microenvironment.
Conventional methods to form assembloids rely on passive aggregation strategies, which leads to limited spatial control over and difficulty in regulating the microenvironment. Microfluidic systems are a promising tool for assembloid formation, but current systems cannot support their formation and maintenance with scalability.
The Purdue platform’s design can be modified into a pump-free configuration, enabling controlled delivery of soluble factors without syringe pumps, thereby simplifying operation and broadening accessibility for experimental settings.
Industry partners interested in developing or commercializing the innovations should contact Joy Wu, Licensing Associate – Life Sciences, jwu@prf.org.
