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New Member Spotlight: Trailhead Biosystems

“Today, we pay for, and expect a pill!” said Jan Jensen, Founder and CEO of Trailhead Biosystems, “But a pill is not the answer. We cannot expect to cure all diseases with drugs.”

Trailhead Biosystems, headquartered in Cleveland, Ohio, merges developmental biology and cell therapeutics with cutting edge hardware, computerized experimental design, and analysis to perform process-specific parameter optimization in the development of cell therapies. The company is the pioneer of HD-DoE Technology (High-Dimensional Design of Experiments). Trailhead Biosystems enables the exploration of cell biology to predict how additives will create desirable cell culture fates.

“At Trailhead Biosystems, we take out the complexity from making specialized human cells,” Jensen emphasized.

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Trailhead enables the manufacturing, organ printing, and clinical testing of human cells and tissues by identifying the critical process parameters using mathematical models of a biological system to understand the effector-response relationship in cell culture. This, in turn, provides a systems biology analysis of the differentiation space.

“The continuing business model of a pharmaceutical company is to go from an old pill to a new pill – but that does not transform medicine, cell therapies will,” Jensen said adding, “Making cells is very difficult and the complexity of the human biology is blocking us –so how do you get to through the complexity? You do experiments by the 1,000’s in record time and for lower costs.”

Founded in 2015, and growing as it serves an increasing number of projects, Trailhead Biosystems’ novel approach is utilized in multiple partnerships and engagements to create industrial grade conditions for various cell types. When the company engages with a partner or a client, it performs computer-based experimental designs executed for advanced cell culture and develops that knowledge into how a specific cell culture affects cellular phenotype and function.

Div Trivedi, Head of Operations & Analytics, joined the company to help create value around this novel technology and was fascinated by the power of HD-DoE, “In a nutshell, we do science differently – the old school way was to have an idea and then to do one experiment at a time, testing results in a multiple protocol version,” Trivedi continued, “When we have an idea at Trailhead, we use Quality by Design (QbD)-based high dimensional analysis and then the idea goes directly into a protocol. So, a transformation happened from the older OFAT (One Factor at a Time) to QbD almost immediately, driven by very large data matrices.”

Trailhead notes that the scientific community currently performs single-factor optimization work which fails to identify combinatorial effector requirements in cell cultures. “Classical empirical testing is tedious and expensive, and not optimized for maximal information gathering. We use computerized DoE, executed through robotic media preparation, to test the entirety of a multidimensional factor space, then we use Multi-Variate Data Analysis (MVDA) to mathematically model the differentiation space and identify effector contributions, interaction terms, and definitions of optimal conditions for reaching specific cell fates,” Trivedi noted.

“Our HD-DoE technology is a powerful tool that can extract conditions for making all types of human cells including- brain neurons, insulin cells, endothelial cells, pigment epithelium, collecting duct cells, and bronchiolar cells to name a few,” Jensen explained, adding “This is relevant, as it addresses the optimization challenges of cell purity and potency to understand the variance in cell manufacturing methods.”

Trivedi said, “Regenerative Medicine (RM) is not the future - it is today.  Here at Trailhead, we are developing novel industrial-grade cells  in the RM space by applying industrial Quality by Design (QbD) principles to advanced mammalian cell culture and we can then offer deep insight into the combinatorial space of morphogen signaling in developmental systems,” continuing, “We will increasingly serve the unmet global need for understanding cell manufacturing and potency in the RM industry as we develop robust manufacturing conditions for any specialized human cell, using modeling” he said.

“Right now, one of our projects is developing a cure for Type I Diabetes and another is to create specialized neuronal cells to address Alzheimer’s diseases, Parkinson’s disease and amyotrophic lateral sclerosis (ALS),” Trivedi said adding, “We look forward to collaborating with other ARMI Members on the future of medicine. Together we can address the needs related to any type of human cell, and we do this flexibly with multiple partners.”

“This technology is here to stay, and our purpose is to apply it to touch society,” concluded Jensen.