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Diagnostics Microbiology and immunology, Oncology, Quality assurance and quality control, COVID-19

Pathology’s Best-Kept Secret

sponsored by Q2 Solutions

What role do pathologists play in clinical trials?
Pathologists have a variety of responsibilities, including identifying suitable patients and evaluating biomarkers expressed in tissue biopsies. From a diagnostic and prognostic viewpoint, we function similarly to community pathologists. At Q2 Solutions, we focus 60 percent of our work on oncology – but we also regularly deal with other therapeutic areas.

Clinical trial pathologists are as essential to the development of novel therapies as frontline oncologists – and, together, we help bring cutting-edge drugs to market. A striking example of this is the significant contribution clinical trial pathologists made with PD-L1 expression case review in several tumor types, which led to the approval of both immune-checkpoint inhibitors and companion diagnostics that later demonstrated major clinical success.

What are the differences between practicing pathologists and those in clinical trials?
Our work is a lot more quantitative than qualitative, especially when it comes to diagnostic immunohistochemistry. Our pathologists are trained on many different numerical cutpoints for immunohistochemical and FISH markers, with their skills tested by the assay manufacturers. To determine whether a patient can be enrolled in a trial, the pathologist identifies positive cases around a cutoff value predetermined by the pharma partner. Working in clinical trials also offers a unique opportunity for exposure to what would otherwise be considered rare cases. For instance, we often work with relatively rare tumors over a short time – one of my colleagues once reviewed 1,800 cases of glioblastoma multiforme over a six-month period. That exposure is equivalent to 10 years of neuropathology fellowship training.

How do regulations differ between the two?
All of our labs are fully licensed and accredited, just like any other clinical diagnostic lab – but we also have to submit detailed data to the FDA and other international bodies. The various regulatory agencies for clinical trials ensure that patient safety is paramount and provide confidence in clinical trials to encourage patient participation.

Are there any differences in the client base?
Pathologists in private practice communicate with clinicians about one patient at a time. In contrast, clinical trial pathologists communicate with entire biopharmaceutical companies, including their clinicians, oncologists, radiologists, gastroenterologists, translational scientists, and manufacturers of assay kits and instruments. Pathologists working in clinical trials can’t hide behind the paraffin veil. Instead, we must liaise regularly with clients who want to monitor the progress of their studies. For that reason, one criterion for a pathologist to work in clinical trials is excellent communication skills.

What technologies are pathologists working in clinical trials exposed to?
One of the things that excites me most about working with Q2 Solutions is the ability to evaluate cutting-edge technologies, sometimes years before they’re introduced to the clinical diagnostic commercial market. We were among the first labs globally to employ PD-L1 as a diagnostic assay – and we’re currently examining image analysis and artificial intelligence algorithms to help diagnose cancers. Earlier this year, one of our labs purchased a digital spatial profiling platform. Although in its infancy for clinical trials, this technology holds huge promise and is probably the highest order of multiplex immunohistochemistry available by leveraging anatomic pathology and genomic technologies.

How has COVID-19 affected clinical trials?
It’s clear that the pandemic has adversely affected everyone’s lives and many businesses, including clinical trials. The whole industry has seen COVID-19’s impact on cancer trials, with many patients’ visits canceled. It was clear from the beginning that fighting COVID-19 would require new therapies and vaccines – and their discovery and development are areas in which Q2 Solutions and its pharma partners excel. Many of our scientific divisions adjusted operations to support our partners in their unprecedented efforts to identify effective drugs and vaccines. To this end, we deployed SARS-CoV-2 qualitative and quantitative, sequencing and serology (total Ig, IgG, and IgM) assays. At our peak, we performed approximately 3,000 SARS-CoV-2 PCR tests each day.

How do career opportunities compare?
When I was training, my professors rarely mentioned opportunities in biopharma and clinical trials. Typically, they discussed the three major practice settings: academia, community pathology, and commercial reference labs. It wasn’t until I had been practicing for five years that I became aware of the real need for pathologists in clinical trials. For me, it’s one of the bestkept secrets in our specialty – and I want to spread the word that there is another avenue through which pathologists can contribute to medicine. One of the best things about working in clinical trials is that our work impacts the lives of thousands or millions of patients.

John Cochran is the Chief Pathologist at Q2 Solutions.

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