by Dr. Maurice Cary
In reference to peer reviewing histopathology evaluations of tissues from safety assessment or toxicity studies, there has been a lot of marketing communications announcing skill sets and capabilities over the internet, as well as discussions regarding histopathology peer review issues and challenges via blogs. Invariably, such communications and discussions are focused on the number of years of experience. And on each occasion, I ask myself “years of experience doing what?”
Purposely avoiding any discussion at this point about education and training standards, which vary greatly world-wide, and simply focusing on the point that when it comes to experience, it matters where such experience was obtained. It of course matters also on what types of studies one has years of experience working with in terms of types of compounds, administration routes, species and study duration, but in terms of proper context and where such results/interpretations fit in the safety evaluation with respect to regulatory impact, there is no substitute for actual day to day experience in a pharmaceutical or biotech company. One needs to understand the internal dynamics one faces daily in a company. Additionally, one needs to know the eventual destination in the regulatory documentation (e.g. CTD, CTA) for their interpretations of the histopathology data and, most importantly, what the results/data/interpretations need to look like when they get there. Therefore, it is imperative when companies are reviewing histopathology results, either internally or externally, they have at their service not only an experienced pathologist in terms of years, but also experience in terms of actual participation in the day to day ins and outs of drug development and have the ability to spot potential regulatory problems long before they occur.