Although a Sponsor can never know exactly how a regulatory authority will respond to toxicity data, there are great examples of how a Pathology Working Group (PWG) can be beneficial. Recently, the study pathologist for a mouse carcinogenicity study identified a relatively low number of renal tumors that raised the concern of the involved regulatory authority. A review of the tumors by an internationally renowned expert concluded that the neoplasms were spontaneous in origin and not due to the test article. A PWG composed of five prominent pathologists including the study pathologist and the expert was chaired by Dr. Jerry Hardisty and reaffirmed the findings and conclusions of the expert. The PWG report was submitted to the regulatory authority for their consideration. A response came that they reviewed the evidence presented in the PWG re-evaluation and concurred with the PWG that the renal neoplasms were not due to the test article. While an outcome like this cannot be guaranteed, the PWG was quite valuable in the decision in favor of the Sponsor.
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