cytocentric visionaries ry p1Cytocentric Visionaries: Randy Yerden, CEO BioSpherix, Ltd.

Part One: Origin of the Cytocentric Principles

Randy Yerden is the Founder and Chief Executive Officer of BioSpherix, Ltd. He created the Cytocentric Principles as a way to describe the fundamental biologic factors that drive the development of all of the products at BioSpherix. Here Chief Scientific Officer, Alicia Henn interviews Randy about how the Cytocentric Principles were formed. In part one of a multi-part series, we discuss applying cytocentric principles in future science research.

Thank you for taking time to share your experiences as the original Cytocentric Visionary, the person that put the Cytocentric Principles into words. What were the early experiences that helped form your thoughts about them?

RY: There were many, many customer conversations over the years, casually done, that were clues to these principles. I just didn’t recognize them as principles until later.

As a scientist by training, I have had an opportunity to talk on a personal level with many of my customers. They would tell me the significance of their work. I always loved to hear their thoughts, but I didn’t recognize them at the time for really what they were. Over the years, I had collected a lot of insight from PIs at the top of their fields.

Top scientists have a deep understanding of the edge of knowledge and they are always trying to advance that edge. They try to project out into the unknown, into the future. These people in different fields all had a common need, to meet the needs of cells.

The role that I played, as a tool builder for 19 years, was to provide equipment for what these customers needed. That’s why we came up with the byline “Going beyond the needs of people to meet the needs of cells.” That also represented where conventional equipment left off and our equipment carried on, beyond existing technology, beyond that norm.

Once I realized that there was a bigger trend that was going on here, it was easy for me to consolidate all of those insights from all of these people, insights into the future. A lot of that future is still unfolding.

What kind of insights did these experts have?

RY: I remember angiogenesis researchers in the mid-‘90s telling me that the factors that govern gene expression were virtually unexplored. It was a new finding then that VEGF was so dramatically affected by changes in oxygen. Nobody had ever imagined that.

I remember them saying that there was a wealth of other phenotypes and molecules that were regulated by oxygen that would be discovered in the future. Sure enough, people are still discovering factors that are regulated by oxygen or reactive oxygen metabolite levels. It is still unfolding.

There is also nitric oxide. I remember researchers making projections about how nitric oxide was very difficult to understand because it had such a variety of effects, and it had to be controlled to the physiologic level. Now, it is a named gasotransmitter - and this might have been twenty years ago that a nitric oxide expert said that to me. Even to this day, other than our equipment, there is no good way to control nitric oxide in a cell culture. There are publications coming out all the time how nitric oxide has a big effect on phenotypic expression and in some cases, it’s the key thing.

Carbon monoxide and hydrogen sulfide, and other gases, they are still not out there in the mainstream yet. The prediction of many of the people who studied these and talked to us about building the equipment for them was that these gases were going to play a big role in the future, as researchers dissect these signaling mechanisms.

It was just a fortuitous position that I was in, talking with all of these different people in different fields, but it gave me a vantage point that was fairly unique. It gave me a lot of confidence, too. This wasn’t this just one special project that one scientist had, it was an indication of what everybody was going to be doing and needing and thinking in the future.

As you see this unfold over time, what do you think the potential is for the impact of the Cytocentric Principles on the entire market?

RY: I think the total quality approach, which is basically what the cytocentric principles are, not just cell quality but quality in the whole cell operation, I think it will absolutely become more and more the accepted standard. That’s my conviction.

If you look at the cytocentric principles as total quality control concepts for the cell culture world, then it’s logical to look at the other industries where quality management/quality control approaches were introduced. This has had tremendous impacts on all other industries, so it makes sense that using quality concepts in our industry will eventually become standard.

Looking back, it’s hard to believe that we used to do aseptic technique on an open bench with a Bunsen burner. There are a lot of young people now that can’t even imagine doing cell culture without a BSL2 hood.

Someday in the future, people will say “Geez! I can’t believe we used to let our cells be open to the room and to people. I can’t believe we put up with all those contaminations. I can’t believe that we allowed these critical process parameters to fluctuate wildly and randomly. How did we imagine that we would get anything done?”

That’s my conviction. I’ll probably be long gone, but that’s my conviction. At some point Cytocentric research will be standard, because fundamentally, it’s got to be. Total quality management and quality control will have a large impact on this industry, just like it has in virtually every other industry.

In the 2nd part of our interview, we discuss reducing animal testing with relevant cell based assays through application of Cytocentric Principles.g.

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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.