Submitted by Mitchell R. McGill, PhD, Clinical and Translational Toxicology Specialty Section Postdoc Representative
Dr. Laura James is a force to be reckoned with in the field of toxicology. Her research has taken her from exploring the basics mechanisms of acetaminophen-induced liver injury and subsequent regeneration to the development of a new medical device for diagnosis of acetaminophen overdose in patients. In her spare time, she has been integrally involved in pharmacokinetic studies of drugs in children, as well as synthetic cannabinoid research and surveillance. For her illustrative career bridging basic and clinical sciences, she is the recipient of the 2017 Society of Toxicology (SOT) Translational Impact Award.
In addition to receiving this award from SOT, Dr. James will be the keynote speaker for the Clinical and Translational Toxicology Specialty Section reception at the 2017 SOT Annual Meeting on the evening of Wednesday, March 15. The reception will begin at 6:00 pm in the Hilton Baltimore, Key Ballroom 8. Refreshments will be served. The reception is following her Translational Impact Award lecture at 5:00 pm.
Please summarize your professional history and current position.
I graduated from the University of South Carolina School of Medicine in 1989 and completed pediatrics residency training in 1992, followed by fellowship training in pediatric emergency medicine at the University of Alabama at Birmingham in 1994, and clinical pharmacology/toxicology training at the University of Arkansas for Medical Sciences (UAMS) and Arkansas Children’s Hospital in 1996. Over time, my focus has grown toward research and increasingly toward translational research, particularly in clinical applications of pharmacology and toxicology. I have been a faculty member of the Department of Pediatrics at UAMS since 1994. I continue to see patients at Arkansas Children’s Hospital as a clinical pharmacologist, which typically involves the management of acute poisonings or the tapering of sedation drugs in critically ill children. In 2014, I was appointed Director of the Translational Research Institute at UAMS, which houses the institution’s Clinical and Translational Sciences Award.
How did you become interested and involved in basic and translational research?
My interest in basic research grew from my interest in identifying better ways to diagnose and treat patients with drug toxicity, particularly acetaminophen toxicity. As a clinician, I was struck by the lack of accurate diagnostic approaches to identify drug-induced toxicity. I received a K08 award from the National Institutes of Diabetes and Digestive Diseases (NIDDK) that allowed me the time to delve into basic research that would help to “fill the gap” in the clinical management of acetaminophen toxicity patients. This award really started my interest in translational research.
You have been the main driver in the development of the point-of-care AcetaSTAT test for diagnosis of acetaminophen overdose, and your group recently published a nice validation study of the device. With positive and negative predictive values of 90‒100% and 100%, respectively, the results were impressive. Can you tell us what the future looks like for the AcetaSTAT device? Where are you in the process of regulatory approval and how soon might the device become commercially available?
As described above, AcetaSTAT performed well in a proof-of-concept study conducted in collaboration with the Acute Liver Failure Study Group. The results of this study will be published in the April issue of Clinical Gastroenterology and Hepatology. AcetaSTAT was developed through Small Business Technology Transfer funding from the NIDDK. At this stage, Acetaminophen Toxicity Diagnostics, LLC has developed a definitive clinical protocol that is under review by the US Food and Drug Administration to bring AcetaSTAT to market. We hope to launch the trial later this year.
Why is basic and translational research important to you?
I enjoy taking on new challenges and being involved in medical innovation. To move toxicology forward, multidisciplinary approaches are needed and I enjoy facilitating that work. As a clinician, I’ve been able to help bring the clinical perspective to the basic science laboratory. Understanding the diverse perspectives of clinicians and basic scientists and leveraging that understanding for medical innovation is where I feel I can make unique contributions. The gaps in clinical medicine are huge. Applying scientific discovery to meet the needs of patients is a driver for me.
What advances do you hope to see in translational toxicology research in the future?
Precision toxicology is where I hope we will see new growth in the future. We will be able to understand at the gene or molecular level why some individuals are more at risk for drug toxicity than others. The ability to personalize therapy to the individual will be a tremendous accomplishment. As part of this, I anticipate tremendous growth in the development and application of predictive toxicology-based biomarkers. We need to understand “early signals” that herald “risk” for the individual patient. From my viewpoint, this progress is dependent on mechanistic studies that address the etiology of drug-induced cellular injury. Understanding mechanisms will pave the way for the development of predictive toxicity-based biomarkers.