The central role of veterinary pathologists in animal disease diagnostics is evident, but how about in other fields such as preclinical research? What particularly is the role of a veterinary pathologist in this? Continue reading to find out!
What are preclinical studies?
Drug development is a cumbersome and lengthy process commonly conducted by pharmaceutical and contract research organizations (CROs). The process entails drug discovery, preclinical studies, and clinical studies. The preclinical study phase encompasses those activities that determine if a drug discovery candidate is safe enough to proceed to human clinical studies. Often this involves extensive safety evaluations, using cell and animal models of disease. This phase is not only scientifically demanding but it is also under the mandatory control of regulatory agencies and review boards worldwide.
Due to the scientific demand and regulatory nature of the phase, several different scientific experts, such as veterinary pathologists, are largely involved in the process. In fact, veterinary pathologists have a highly versatile and central role in the preclinical process, mainly due to their working knowledge of laboratory instrumentation, methodologies, physiological chemistry, and internal medicine, as well as excellent written and oral communication skills.
Why are veterinary pathologists an integral part of preclinical studies?
Veterinary pathologists contribute to preclinical studies by engaging in the drug discovery process in many ways. They are involved in hypothesis development, study design, and development of the appropriate cell and animal models to assess the effect of the potential candidates. Following candidate discovery, veterinary pathologists actively participate in the overall design and conduct of the preclinical safety and efficacy studies, which are at the core of preclinical research. With their unique training and knowledge, they are a valuable asset in these studies by providing deep insights into the basic pathophysiology and drug mechanisms of action.
The veterinary medicine background that veterinary pathologists possess makes them experts when it comes to making clinical observations such as identifying drug-related effects and trends at both, animal group and individual levels. As an example, they evaluate whether an abnormal observation from an individual animal in a group is significant or not in the light of the study. Among these, veterinary pathologists are in general needed for interpreting different clinical and morphological pathology data acquired from the animals used in the development of new drugs.
Another important aspect of preclinical studies is to evaluate the potential cause of possible encountered toxicity in safety studies. For instance, assessing whether the toxicity stems from pharmacologically mediated mechanisms or from non-pharmacologically mediated mechanisms. An expert in this area is a veterinary pathologist since the safety evaluations largely rely on a variety of the core veterinary pathologist skills such as hematology, hemostasis, clinical biochemistry, urinalysis, cytology, histology, and internal medicine. Because of these key skills they are also experts in assessing the efficacy of different drug candidates targeted at a disease.
Future of veterinary pathologists in the preclinical field
Veterinary pathologists are highly proficient at performing all these preclinical assessments and are crucial in preclinical investigation. However, they, like pathologists in other fields, have been relying on technology that is over 150 years old; manual and bias-prone microscopy. Fortunately, technology is evolving and methodology is shifting towards more automated research and assessment. As a part of this transformation, veterinary pathologists will become experts in new areas, such as artificial intelligence (AI) pathology. This will not only accelerate their current workflows in preclinical studies but will also improve tasks such as image analysis by making them, for instance, more consistent.
As an example, veterinary pathologists Dr. Agathe Betard and Dr. Aleksandra Zuraw at Charles River Laboratories (CRL) have demonstrated this field evolution with their proof of concept preclinical research study on creating an AI model for dextran sulfate sodium (DSS) induced colitis using Aiforia’s cloud-based AI software. In short, DSS colitis mice models are commonly used for rapid candidate compound screening in preclinical studies. Because the toxicopathology safety studies in these DSS models commonly rely on challenging, subjective, and tedious microscopic scoring of histopathological screening, this study by the CRL veterinary pathologists assessed if AI could be used for this.
Indeed, this AI-powered image analysis approach turned out to be successful in segmenting different tissue compartments with a high level of concordance. This is only one of many examples demonstrating the beneficial use of AI in preclinical studies. As the field evolves, veterinary pathologists will have the tools they deserve to enhance preclinical workflows and to take on new intriguing methodology in preclinical research.