New FDA Drug-testing Guidelines Open Door for Use of Data 

New FDA Drug-testing Guidelines Open Door for Use of Data 

Generated by Microfluidic Organ-On-A-Chip Devices

For decades the U.S. Food and Drug Administration has depended upon results from animal trials to prove the safety and efficacy of pharmaceuticals. Yet the methodology is far from reliable. Only 10% of the drugs that move from animal testing to human clinical trials succeeds.

Such low yields from a very expensive and time-consuming process has led academic and industry researchers into a race to find a better system. It now seems that the long-expected viability of microfluidic technology in drug testing has become a front-runner in replacing animal testing.

Organ On a Chip

Microfluidic devices are perhaps best known as Point-Of-Care testing platforms using tiny amounts of fluids for fast, economical patient diagnostics. The Organ On a Chip concept is derived from the same underlying physics, engineering, and biological principles but takes the technology a step further.

By lining the tiny channels in a microfluidic device with human organ and blood vessel cells, a controlled microenvironment can be created to mimic human physiology and function of an organ. When drugs are introduced to the ecosystem, specific interactions can be observed and data regarding toxicity and other effects can be collected.

The scientific literature is filled with papers reporting lab results that demonstrate how various Organ On A Chip platforms, from Lungs at the Los Alamos National Lab to Corneas at Hong Kong University, perform. Now we are seeing systematic and quantitative evaluations of Organ-Chips’ predictive value in the drug-testing system.

Emulate Study Validates Organ-Chips for Predictive Toxicology

In the December 2022 issue of Communications Medicine [a part of Nature], Emulate, Inc. based in Boston, MA, reported strong findings on the use of Organ On a Chip for predictive toxicology in drug discovery. Scientific founder Dr. Donald Ingber told us that while the new FDA guidelines are already in place, it is necessary to qualify an organ chip for a specific context of use, and that it must be robust, reproduceable, accurately mimic organ function, and of course, present statistically significantly results. The Emulate study met all criteria.

In the study, Emulate analyzed 870 Liver-Chips to determine their ability to predict drug-induced liver injury caused by small molecules identified as benchmarks by the Innovation and Quality consortium. These guidelines define criteria for qualifying preclinical models in drug testing.

Emulate showed that the Liver-Chip met the qualification guidelines across a blinded set of 27 known hepatotoxic and non-toxic drugs with a sensitivity of 87% and a specificity of 100%. The results of this study show how new microfluidic devices can speed up and reduce cost of drug testing.

Do You Kill a $100 Million Investment?

Dr. Ingber described to us the complexity of modern medicine. “There are often conflicting results between rat and dog tests and a researcher has to guess which is correct. It is often a subtle difference and in the end do you kill a $100 Million investment when you guessed incorrectly?”

Emulate hopes to make that decision easier with better test data from microfluidic-based Organ On A Chip platforms.

Advanced Manufacturing

For decades Potomac Photonics has helped microfluidic companies create innovative solutions to the pathway from rapid prototyping to high volume production runs. With decades of Design for Manufacturing expertise we can get new product designs onto the factory floor with the fastest turnaround in the industry.

Our toolbox always has the right machine for the job. From ultra-high precision laser micro-machining to 3D Printing, SU-8 lithography to micro-molding, and everything in between, Potomac is the partner of choice for the microfluidics industry.