Toxicologic Pathology Associates (TPA) provides excellent on-site pathologist services to the FDA’s National Center for Toxicologic Research (NCTR) to include NCTR’s collaborative research efforts with the National Toxicology Program (NTP), FDA’s Center for Tobacco Products (CTP), and FDA’s Center for Drug Evaluation and Research (CDER). Our pathologist services also include a productive interactive collaborative involvement in the dynamic investigative environment of the NCTR research community.
Scheduled necropsies at NCTR are conducted under the direct supervision of a TPA pathologist. The pathologist reviews all tissues and any gross lesions prior to signing the individual animal necropsy report (IANR) following a necropsy.
TPA pathologists provide histopathologic evaluation (slide reading and diagnoses) of protocol-specified tissues.
TPA pathologists evaluate studies for the NCTR and record microscopic findings accurately, consistently and precisely without duplications in topography and/or morphology. As a routine, the study pathologist’s approach to tissue evaluation is to initially evaluate several control animals and then to alternate between control and high-dose groups. Periodically, it may be necessary to review previously evaluated slides to establish definitive criteria for normal versus treatment-associated changes and to establish consistent grading criteria for the severity of treatment-associated changes.
Pathologist Collaboration with NCTR Investigators
TPA’s pathologist services also includes productive interactive collaboration with NCTR’s investigators, supporting their research needs not only with accurate and timely traditional toxicologic pathology services, but also identifying, validating and applying innovative, pathology-based technologies for more accurate predictive toxicology. Whether providing traditional pathology services or innovative end-point measurements, TPA is determined to do so with the most efficient, least labor-intensive methods. TPA features a progressive integrated blend of solid traditional methods and new more sensitive, target-specific technologies. We must accurately identify molecular, cellular and tissue abnormalities and provide solid interpretation and accurate diagnoses of these changes. TPA views this as a primary and mandatory requirement of the pathologist services to NCTR. The “omics revolution” has spawned a long and growing list of technology innovation and a corresponding set of tools of which traditional toxicologic pathologists could only dream about in the past. Therefore, to fulfill the FDA mission and NCTR’s objectives, the pathologist services continue to explore new technologies, develop and revise novel approaches to this new set of tools. Solid, responsive, focused and consistent collaboration of TPA’s pathologist with NCTR’s investigators is essential.