Veterinary Pathologists Adopting Digital Pathology Faster than MDs

This is a guest blog note written by Steve Potts, PhD. Steve is the CEO of Flagship Biosciences, a pathologist-owned CRO and provider of digital pathology services in the pharmaceutical and medical device industries.

There are approximately 1,200 board-certified veterinary pathologists in the U.S. working in a variety of settings including veterinary schools, clinics, pharmaceutical companies, governmental agencies, and contract research organizations (CROs). Approximately 500 veterinary pathologists work in the U.S. pharmaceutical industry with a consistent industry average of about one pathologist per one billion dollars in annual company revenue. I have had the privilege of working closely with many of these veterinary pathologists for the last three years after working for a large reference laboratory that employs hundreds of MD pathologists.

My work with both MD and DVM pathologists has lead me to the following observation: DVM pathologists are "going digital" faster than their MD colleagues. Nearly all of the top 15 pharmaceutical companies have completed multisite-integration with digital pathology. The result of such conversions is that a pathologist working in one location can access slides at any other one or participate in an informal peer review or pathology working group. Veterinary pathologists have proposed GLP [Good Laboratory Practice] standards and agreed on the requirements required of digital pathology vendors in order to meet the FDA compliance guidelines in preclinical testing. The regulations imposed on preclinical toxicology testing prior to first-use in human trials are more strict than clinical trial regulations. Despite this, veterinary pathologists are well prepared for the use of digital slides in these assessments.

A group called VIPER (Virtual Imaging in Peer Reviews) has been organized to propose digital pathology validation procedures for peer reviews, a key part of preclinical testing. The VIPER group is composed of veterinary pathologists from one CRO, a half dozen pharma's , and a medical device company. Some of the leading toxicologic pathology government organizations like the NIEHS, NCTR, and a leading government pathology support organization, EPL, were early adopters of whole slide scanners. The first two Aperio digital pathology customers were both veterinary schools. A number of digital pathology image analysis blogs have been launched by veterinary pathologists and many veterinary pathologists at pharmaceutical companies are beginning to adopt quantitative analysis as a part of their job description.

This is not to say that all segments of veterinary pathology are adopting digital pathology. The primary "read" in preclinical pharma studies is still performed with a microscope for reasons of speed, workflow, and regulatory uncertainty. Clinical veterinary diagnostics are also performed almost entirely with glass slides. While quantitative image analysis is growing quickly in the field, only a small subset of veterinary pathologists have acquired the training and experience and made the time investment necessary to manage their own image analyses.

To contrast the situation in veterinary pathology with healthcare, I would ask the following question: How many of the largest 15 hospital systems use digital slides, and if so, to what extent? Rather than belabor this point, let’s ask the following question: Why are veterinary pathologists adopting the technology more quickly? As usual, the easy answers are probably wrong. One response might be that veterinary pathologists have lower regulatory hurdles. However and as already mentioned, the 21 CFR, Part 11 guidelines that govern pharmaceutical electronic processes are more strict for preclinical veterinary testing than clinical trials for humans. A second easy answer is also wrong: There is more money in pharma pathology than in hospital pathology testing. Salaries of veterinary pathologists are highest in pharma companies and yet these are at best one third to one-half of those that their MD colleagues earn. Stay tuned for what I think are the correct answers to this overarching question.

To be continued tomorrow with the second portion of this guest blog in which Steve presents his arguments why the veterinary pathologists are "going digital" faster than their MD colleagues.

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