EPL – Independent and Employee-Owned Pathology Peer Reviews and Pathology Working Groups
EPL is an internationally recognized pathology-related and toxicology-related services provider. By design, EPL is able to leverage a unique combination of responsive, personal attention and extensive histopathology expertise to meet your specific pathology-related needs. EPL offers the benefits of a classic “scale without mass” approach – delivering the highest level of scientific quality in the most cost-effective manner. Renowned for having experienced pathologists with extensive organ system expertise, and along with their Aclairo non-clinical drug development consultants, EPL is uniquely positioned to facilitate your drug development program.
Specific examples of EPL’s pathology-related services that benefit from an independent expert approach are Pathology Peer Reviews and Pathology Working Groups.
Pathology Peer Review – Generally considered more objective than in-house reviews, third-party peer review has become the de facto industry gold standard essential to assuring accuracy and data quality in a toxicologic study. The primary purpose of a peer review is to improve the quality of the pathology data and narrative. The ultimate goal of any toxicology study is to attain the most accurate data giving the sponsor confidence in decisions that most efficiently facilitate their development program. Peer reviews can confirm the target organs identified in the original evaluation and confirm the No Observed Effect Level (NOEL). A peer review is not a re-read of a study as the peer review focuses on a defined subset of slides from the study as the peer review pathologist does not generate a second set of data, but rather a refinement of any data and data interpretation essential to development decisions. For small companies’, peer reviews by an independent third party like EPL, can help to alleviate unnecessary diagnostic drift across multiple studies in a compound’s development timeline making interpretation complicated and, in some cases, erroneous. Peer reviews are most efficiently conducted at the study pathologist’s site allowing for one on one interactions between the study pathologist and the peer review pathologist regarding any discrepancies in data recording and interpretation. Similarly, one on one interactions can be obtained through the use of digital images with the study pathologist and peer review pathologist at different sites, eliminating travel as may be desired in the current pandemic situation. Improved data accuracy and consistency, scientific data interpretation, enhanced reviewer credibility, and increased study sponsor confidence are just a few of the reasons you should consider EPL as a third-party peer reviewer for your studies. Finally, EPL has developed a software program for capturing pathology data that not only makes the peer review process efficient and accurate, but also allows for a high level of documentation regarding the original diagnoses and the peer review diagnoses, and thereby provides the sponsor and reviewing agency confidence in the accuracy of the data.
Pathology Working Group (PWG) – A PWG is a specialized type of review. Unlike the routine third- party peer review described above, PWGs are convened to answer specific questions regarding study results and in some instances their relevance to human risk assessment. The PWG panel is most often composed of a group of pathologists assembled to review select histologic slides and associated data in order to answer specific questions and provide an independent unbiased opinion regarding the results of a particular study, group of studies, or focused scientific topic. Like routine peer reviews, EPL has experience in conducting virtual PWGs using digitized slide images and teleconference calls for overviews and deliberations.
PWG reviews may be convened by study sponsors, consortia, or regulatory agencies. Members of the PWG typically originate from academia, government, and industry, and panelists are selected based on their experience in toxicologic pathology, as well as their expertise in the specific target area of interest.
EPL pathologists have extensive experience in both chairing and participating in PWG reviews. EPL has organized PWGs in various worldwide locations, and can coordinate all aspects of the PWG, simplifying the process and saving time and resources for all parties involved. An EPL pathologist, serving as an independent chairperson, conducts the PWG and is responsible for the preparation of the final report signed by the participating pathologists. EPL can also represent the expert panel and assist with scientific discussions at regulatory agency hearings. Upon request, the PWG Chairperson may prepare a manuscript of the PWG proceedings and conclusions for submission to a peer-reviewed journal.
EPL’s toxicology-related services use Aclairo’s highly experience drug development scientists with backgrounds from large and small pharmaceutical companies, FDA pharm/tox reviewers, CRO’s and Academia. They can provide expert support and guidance in areas of toxicology, reproductive and embryofetal development, safety pharmacology, abuse liability, scientific and regulatory writing, nonclinical study planning and management, preclinical ADME and clinical pharmacology to best position your drug for regulatory success.
These are just a few illustrations of ways in which EPL can offer an independent, knowledgeable, objective and unbiased approach to solving study problems, with the ultimate goal of providing the highest quality histopathology and drug development services available.
Experimental Pathology Laboratories, Inc. (EPL) is an independent, private, employee-owned company that is recognized internationally for its ability to meet the needs of the scientific community and the challenges of preclinical safety testing and development with high quality histopathology services. EPL was founded in 1971 and became an employee-owned company in 1992. EPL is proud of its scientific heritage, and the experience gained from providing service to the private sector, governmental agencies, academia, and other clients for nearly 50 years. As an employee-owned company, EPL creates value for its employees though organizational and business success, while avoiding the bureaucratic complications associated with complex corporate structures and the external financial pressures experienced by publicly traded entities.