cytocentric visionaries ry p2Cytocentric Visionaries: Randy Yerden, CEO BioSpherix

Part Two: Physiologically-Relevant Cell-Based Assays to Reduce Wasteful Animal Testing

This post contains excerpts from an interview that Dr. Alicia Henn, Chief Scientific Officer of BioSpherix, conducted with Randy Yerden, Founder and CEO of BioSpherix.

In Part One, we talked about how the Cytocentric Principles were formed from decades of insight from top scientists about the needs of cells. Today we talk about how the total quality concepts in the Cytocentric Principles can reduce animal testing through relevant cell-based assays.

Thousands of animals are sacrificed in studies based upon cell-based assays that had been conducted in non-physiologic conditions. There is a growing ethical call to make cell-based assays more physiologically relevant to increase their predictive power, reduce the numbers of animals used, and speed therapeutics to market for the humans that need them.

Is there a potential for the Cytocentric Principles to improve the relevance of cell-based assays?

RY: Absolutely. Our industry has basically disregarded these quality issues for the last hundred years. All of the Cytocentric Principles, which are nothing more than a set of total quality concepts, will play a role in bringing these cell-based assays to deliver on all the promise.

For cell-based assays, physiologically relevant conditions are going to have to be required because that is exactly what these assays are intended to do, predict physiologic effects in vivo.

The logic is there for doing these measurements under physiologic simulation, or the correct pathophysiologic conditions, to produce the best, most relevant data. This is something I think is going to become substantiated with data very soon.

But the other part that has to be understood is that the cells that you use in these assays also have to be phenotypically true. Producing those cells means maintaining the highest quality, as high as clinical-grade cells used for cell therapy. I believe that good manufacturing practices will be required for those cells because they are the source material for the assays.

If the total quality approach in the Cytocentric Principles is used in cell-based assays, maybe we can cut down all that animal suffering, and get better predictions of what is toxic and what is therapeutically useful. Maybe we can cut out all the time and all the cost that goes into wasteful animal testing, too.

In part three of our interview, we discuss how cytocentric principles benefit cell based assays and the research community.

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alicia author iconAbout the Author

Alicia D Henn, PhD, MBA

Alicia Henn has been the Chief Scientific Officer of BioSpherix, Ltd for two years. Previously, she was a researcher at the Center for Biodefense Immune Modeling in Rochester, NY. Alicia obtained her PhD in molecular pharmacology and cancer therapeutics from Roswell Park Cancer Institute in Buffalo, NY and her MBA from the Simon School at University of Rochester in Rochester, NY.