Industry Insider: An Inside Look at PathoGenius Laboratories

An interview with John P. Kennedy, RPh, PhD, clinical advisor, PathoGenius Laboratories TWC: How did you enter wound care? JK: My career started as a researcher in the pharmaceutical industry. I did not have a direct link to wound care in “Big Pharma,” unless you consider antibiotics, but I did get a relatively strong background in chronic diseases. As it turned out, many of the same biological signals and pathways are involved in inhibiting tissue growth (cancer) as promoting tissue growth (wounds); therefore, that experience has proven to be more relevant than I would have anticipated. I began to focus on chronic infection in 2000, which led me to biofilm-based investigations that included chronic wounds. In 2006, I started working more in academia, which included a clinical component. Coming full circle, I now had the opportunity to work again with patients as a clinician while pursuing my wound research interests. At this academic post, I continue to focus my clinical and research efforts on bioburden and biofilm-based wound care strategies. TWC: What’s your day-to-day role? JK: Serving as a clinical advisor to wound care providers treating patients, especially those that leverage our diagnostic services. Diagnostic reports, no matter how advanced and accurate, must be translated into treatment regimens in order to impact patient outcomes. Therefore, quite early in our history we began to identify expert clinical advisors as a resource to our provider network. My other focus is the expansion of current service offerings through development and continuous improvement. Due to the significant differences I have witnessed our services make in the lives of patients, our work to date has to be some of the most rewarding work I have been a part of professionally. TWC: What do you find most rewarding about providing for your industry? JK: This is an easy answer - impacting the quality of patients’ lives. When I was an industry-based researcher, I lost sight of the patients who ultimately benefitted from our research. The patients were simply too far downstream, almost virtual. Too often, we also had little input into what “problem” we would attack with the research resources at our disposal. Now that I am independently back in the clinic, I see on a daily basis the impact our work has on our patients’ quality of life. It’s real, tangible, and unfiltered — and it gets personal. Such a perspective drives an expediency that, like it or not, you personally “feel.” The expediency is impossible to avoid and you don’t have the luxury of scheduling a roundtable of scientists to debate it. TWC: What’s new with PathoGenius? JK: Technically, I would say the expansion of our rapid detection panel leads the charge. This will significantly increase the utility of our 24-hour, level 1 report, especially for chronic wound specimens. This new panel should decrease the time from diagnosis to treatment for many patients. “Time is tissue,” so we are always looking to move patients from diagnosis to therapy as soon as possible. Even a couple of days is not a trivial time period to us. Clinically, I would highlight that we have more outcomes data than ever before. We certainly expect that to continue, but the evidence has now surpassed critical mass. The adoption of our services by clinical sites across the nation has expanded our clinical experience and successes immensely. It’s the kind of “win-win” we hoped for. Historically, we have focused on outpatient services; however, in 2012 we are introducing our services to more acute settings than ever. It’s a logical progression that we are glad to see transitioning to institutions. TWC: How is your company unique? JK: Literally, we are as unique as every wound on every patient. That is the nature of DNA-guided personalized medicine. While the process for wound evaluation and diagnosis is protocol-driven, the actual therapy cannot be automated or mass-produced due to the microbial diversity within wounds. For chronic wounds, the diversity is broad. Bacteria, yeast, and fungi have all proven significant; therefore, the treatment consults generated by our discipline-specific clinical advisors reflect that diversity. The result is an extremely targeted therapeutic regimen that’s unique to each patient. That said, this integrated diagnostic/treatment protocol essentially provides wound care the ability to diagnose microbial bioburden accurately, and then to treat. No more trial and error. That is not unique in medicine. One could argue this defines modern medicine; regardless, this is the first time such an objective approach has been available in wound care, especially for bioburden. TWC: Why are you passionate about your company? JK: I know firsthand from the clinic the difference it makes in outcomes and the quality of life for our patients. At the same time, that is our primary challenge. What can we do more, or better, to encourage providers to simply try an integrated and personalized approach? As a clinical advisor, my contribution requires personal relationships, which take time. Creating relationships one clinician at a time, often regarding a single patient, is the only approach I really know. Besides, I am a clinician myself, and, if I’m honest, I can be quite skeptical. While I like to think I am open to alternate approaches, ultimately I need to see for myself, regardless of any recommendation or even (dare I say it) evidence. As a researcher, I know far too well what a fleeting imposter some “evidence” can be when transferred to a real-world clinic. That said, when I start working with a clinical site, I am never anxious. I am more impatient for the results than the clinic! I am eager and comforted by the fact that I know with confidence a priori that their patients will indeed get improved outcomes. TWC: How is your company approaching challenges in wound care? JK: Improved patient outcomes. We are confident of the impact our protocols have on absolute healing and average days to healing. We have internal challenges as well. While effective, DNA-guided personalized medicine is still new to many clinicians, including wound care specialists. Therefore, we will always bear the burden of education for adoption in routine practice. TWC: What are your most popular products/services? JK: The integration of molecular diagnostics and personalized wound care. It’s nothing short of DNA-guided personalized medicine for wound care providers and the patients they serve. (Or, as my students would say, “Pretty cool stuff, Dr. K.”) TWC: How do you ensure proper training on products and services? JK: We provide webinars, live continuing education, video, and print materials. The most common subject areas are biofilms, specimen collection, report interpretation, treatment options, and how to handle specific clinical scenarios such as combination with other treatment options like dermal substitutes. Clinical advisors such as myself are also available to address any specific case directly. TWC: What are the future goals for you and your company? JK: Expanding our diagnostic capabilities and treatment options. Our rapid detection panel will be expanded significantly to increase our 24-hour turnaround utility, a significant improvement for specimens as diverse as chronic wounds. We are constantly expanding our bioinformatic scope, making our library of DNA and associated therapeutics more comprehensive. For more information on PathoGenius Laboratories, call 806-771-1134 or email info@pathogenius.com.