Spotlight: Dr. Elizabeth, DVM, DABT, Toxicological Pathologist Blog by InstaPath
What is your educational background?
As a toxicological pathologist, we have a long, intense curriculum. I started my journey at the University of Belgium in order to get my DVM degree, then moved to the Netherlands to complete my residency in veterinary pathology at the University of Utrecht. This took me another 4 years. Because I needed to integrate the drug development environment and toxicology, I moved to North America – first to Montreal to start my career as a staff pathologist within global contract research organizations (CRO’s). During my daily workload, I started my applications for a dual Board certification. I was successful in one of them and became an American Diplomate of the College of Toxicologists. I also passed the first parts of my American Boards in Veterinary Pathology. In 2018, I certified in digital pathology in order to offer this ultimate expertise and skill to my clients.
In undergrad, what did you see as your career path?
I always loved mechanisms of diseases and did great at my exams of histology. I did not feel that I had to study for these sections. When I had my first courses in pathology, I felt at home so I continued on a daily basis to read about and study pathology. When I applied to my residency, my future mentors told me that they accepted me because of my interest in research and enthusiasm for research. I think they were right as I accepted during my residency several research projects and presented twice at international meetings with first research awards. My love for teaching was identical – I was also recognized as best junior lecturer in pathobiology at the University of Utrecht.
What is a translational digital toxicological pathologist?
As the name tells us, a translational pathologist is a pathologist conducting translational research or preclinical research related to drug development. We are conducting toxicological or safety studies for regulatory authorities in order to submit data to the FDA which will support first-in-human trials. Now, when telling someone you are conducting pathology digitally this means we are using digital technologies to diagnose potential adversities in tissues and organs of laboratory animals. Usually, we target a minimum of 200 slides per day, and we need high consistency and quality throughout our work. Since a couple of years ago, digital pathology is making progress in translational research and regulators are giving us opportunities to implement this new technology within the GLP (Good Laboratory Practice) environment. Personally, I am really excited to have achieved this additional milestone within my workflow and clients are happy as it moves their projects efficiently and within a productive manner.
When did you decide on your specialty, and how?
I remember during my residency in pathology, I was enrolled in a master’s degree program and I had to follow a list of courses such as laboratory animal medicine. The course lasted 2 weeks and I met students from different backgrounds. We learned a lot about experimental medicine, experimental procedures, ethics, animal welfare, statistics and data interpretation. From there, we had discussions about drug development and toxicological effects mainly diagnosed during pathology and histology workflows. I did some additional research and talked to people from specific toxicological institutes in the Netherlands. This led me to be chosen to integrate a leading CRO during my residency. I immersed myself in reading safety studies related to food additives. I was in heaven and could not stop thinking about a career in the pharmaceutical industry and global CRO. I guess this was the trigger to leave academia and I jumped into a new, often hidden and secret, environment.
How can pathology be brought into the limelight as an interesting and rewarding career option?
This is a very good question as nobody wants to spend their lifetime behind the scenes, right? But I think pathology is not boring; pathologists do care for patients and they make a huge impact on the diagnosis and therapeutics. Pathology offers rewarding collaborations with an interesting variety of clinicians and practices, which physicians early in their career may not realize. I remember that the pathology department at the University of Utrecht had few meetings and not much communication with the clinics and clinicians. I dedicated my practice to bridging this gap. I did research on Mast cell tumors; I received all excision biopsies from clinics and investigated the current grading systems. I collaborated with leading pathologists in publications and we made a new universal grading system available for clinicians. As this first collaboration was successful, I joined a second collaboration; this time it concerned oral neoplasm. The second experience resulted a similar story with successful outcomes. I think beginning pathology residents are not aware of the potential impact they can have through the collaborative opportunities that exist.
How did your interest in digital pathology begin?
Since the start of my career as a toxicological pathologist, I’ve had the chance to see the digital pathology revolution before there was a common interest. Digital pathology came quickly in my life during my experience with global CRO laboratories. Clients requested to see their slides without coming to our site in Montreal. In the beginning we had no regulatory concepts to manage so it remained informal. Digital pathology became more of a daily request. When I started to write my business plan for my consultancy firm, I knew that I should offer some certified skills in digital pathology. In collaboration with the Digital Pathology Association (DPA) and the National Society of Histotechnology, I earned a digital pathology certification.
What are you really excited about as it relates to the growth of digital pathology?
I think finally we are moving into a huge advancement period for toxicological pathologists. One of the reasons I decided to leave the busy CRO environment was the repetitive work of evaluating 50% normal tissues, as you need to compare the treated organs/tissues with the normal background lesions of laboratory animals. I have hopes that digital pathology tools such as AI and algorithms will be able to provide us with GLP-compliant screenings and provide us a heat map indicating where the potential drug induced changes are located. This would help us to focus on more complex diagnostics for which we are trained.
What do you feel are key barriers to acceptance and widespread use of digital pathology in the states?
When considering digital implementation for translational research, the US and Europe are on the same line – running the same marathon. I am part of digital pathology working groups that include toxicological pathologists and I am contributing to the upcoming digital pathology publications related to regulation. Overall, we need to comply with regulations and guidelines set forth by the FDA in 21 CFR Part 11. Also, digital pathologists will need to be able to prove the gold standard, comparing observations under the microscope versus what is on the screen. Overall, I think we will achieve this within a timeframe of 5 years, but then additional milestones will need to be achieved such as the artificial intelligence applications.
I think the major labs and hospitals across the globe are already in the transition towards digital pathology. I know from personal experience that many of them would like to start the transition but investments are still not negligible and financial stakeholders want to evaluate the return on investments. The good news is that although GLP-driven environments and workflows are the main goals, a lot of translational research is conducted in non-GLP compliance settings and this is for sure acceptable. I often give advice to companies and academic institutions in order to help with the question of whether or not to implement digital workflows, which investments to make, which goals to achieve and what kind of milestones to target. The major shift will happen once FDA regulators as well as European regulators have settled the major discussion points, such as: Can you guarantee that the digital pathology evaluations are not inferior to the classical microscope? How are you going to prevent ambiguity of subtle toxicological lesions? What are the standards to maintain at a global level for GLP compliance? My advice when moving to digital: take it step by step but be excited as digital pathology is a new revolution that has been accelerated during this pandemic.
