Problem Solving with a Purpose
Alumnus Richard Graham, PhD ’06 is taking on the widespread issue of sample switching – and building a business along the way
Story by Ryan McDaniel| Photo credit Faye Dawdy | Published January 24, 2023
A child faced with a debilitating disease enters a clinical trial for a new therapeutic treatment. Part of this clinical trial requires a cerebral spinal fluid (CSF) draw, a painful procedure. The CSF sample is spun in a centrifuge before being shipped to the testing lab for analysis. But when the technician processing the sample uses a tube filled with water to balance the centrifuge, they instead send the tube of water to the lab – and discard the CSF sample. Now the pediatric patient must once again undergo the painful procedure of a CSF draw.
This is not a work of fiction – it happened to a real child during a clinical trial. It is not the only such case of a simple mistake profoundly impacting a patient. Errors like this and many others happen regularly during clinical trials. Alumnus Richard Graham, PhD ’06, has set out to fix this.
“In nearly every clinical trial that I’ve ever been a part of, there is a problem with the data [obtained from biological samples],” says Rick. “The problem is the data don’t make scientific sense. And the reason they don’t make sense is because samples get switched all the time in clinical trials.”
The first time Rick really dug into this issue was when he was working at a Bay Area biotech company leading a task force to sort out the path a sample takes from collection at the clinical site to the time it is reported in a new drug application to the FDA. “We mapped it out,” Rick recalls. “There are about eight ‘swim lanes’ and probably 36 manual steps. All this potential for human error. And in the analytical lab where the samples are tested and stored, the FDA found labels falling off, labels with handwritten sharpie that’s smeared and illegible – clear evidence of sample switching.”
From this and other experiences, as well as through conversations with colleagues, Rick knew this was a widespread problem. As a colleague of Rick’s stated, “This is everyone’s problem and no-one’s problem.” So, Rick took it on as his problem. He collaborated with another Tar Heel, Scott Ogle, to found TruLab, a software company with an app that tracks samples end-to-end using the barcodes that the central labs put on sample tubes. “As a clinical pharmacologist, I always assumed that clinical trial sites were using the barcodes that were already on the tubes,” Rick admits. “The only place the barcode is really used is after the samples leave the sites.”
TruLab allows users throughout the lifecycle of a biological sample (from collection to destruction) to scan the barcode on the tube and the associated sample level data is automatically added to the TruLab database, giving the trial sponsor full transparency on the progress/status of each sample. Through blockchain technology, the information is validated and kept safe from tampering. And, slowly but surely, this solution is proving successful. Rick reflects on the TruLab journey, “Three years later, the company employs approximately 30 full-time employees and continues to grow, we have an office space in Durham, we have real revenue, we have more than 20 clients, and we have a phenomenal product.”
Rick attributes his success in the biotechnology industry to the amazing mentorship he’s had throughout his life. He grew up in a small farming community in eastern Iowa where the typical career path was a factory or a farm. Rick’s high school tennis coach essentially created a mentorship program through a community tennis program where Rick played on 3 state-championship teams. Through this, Rick received a scholarship to play tennis at Coe College. From there, he transferred to Iowa State University to earn his combined BS/MS degrees in biochemistry/biophysics.
After undergrad, Rick moved to Kansas City where he worked for a contract research organization (CRO), XenoTech LLC. There, he connected with another mentor, Ed LeCluyse, a faculty member at the UNC School of Pharmacy. Ed offered Rick the opportunity to join his lab and pursue a PhD at the School. “So I took the GRE, sold all my things, applied, ended up getting accepted to the program, and joined in August of 2001.”
Two years later, Ed left UNC to start his own company. Rick thought about going back into the work force or transferring to another school. Two other mentors stepped up to help: Dean Bob Blouin and Dr. Dhiren Thakker. “Bob agreed to be on my dissertation committee and Dhiren pulled me into his lab. I felt like they really had my back—I’ve remained in continuous contact with Dhiren ever since and he continues to mentor me today.” With their support, Rick successfully defended his dissertation in 2006.
Sixteen years later, with a successful career in biopharma and a thriving startup, Rick is passionate about giving back through mentorship. He has long understood the positive impact mentors have had on his career and aims to do the same for the next generation. Rick has served on dissertation committees at the School for over 20 years, lectures for classes at the School, and currently serves on the Eshelman School of Pharmacy Foundation Board as well as the Therapeutics Advisory Board for the Eshelman Institute for Innovation. Most recently, Both he and his wife, Hiba Graham, PharmD ’04, have volunteered for the School’s new mentorship program.
“Earning my PhD from the UNC School of Pharmacy program had an extraordinarily favorable impact on my life,” says Rick. “The long-standing relationships that began for me through exceptional training and mentorship at the school in 2001 have inspired me to reciprocate.”