Pathology Peer Review
EPL developed peer review approaches in conjunction with the NCI/NTP Carcinogenicity Bioassay Program in the late 1970s. These procedures have been widely adopted internationally as the preferred approach for peer review of pathology data from all studies performed during drug development. EPL has provided pathology peer review services to the National Toxicology Program for over 35 years for all sub-chronic and chronic studies conducted in rats and mice. We also conduct pathology peer review for pharmaceutical and chemical companies, contract laboratories, and industrial trade organizations in the United States, Canada, Japan, Great Britain, and Europe.
There are many advantages to using EPL to conduct third-party peer review for your studies, whether conducted at your facility or at a Contract Research Organization (CRO). The added value to the study when it reaches the regulatory agencies in the United States, Europe, or Japan include increased credibility with reviewers, increased confidence by the study sponsor, increased accuracy of the data, and potentially reduced scrutiny of the pathology report by the reviewing agency’s compliance groups. This should result in reduced time to gain regulatory approval of your studies and allow a faster return on your investment.
There are also many intangible benefits that can result from using EPL for third-party peer review of your development programs. By relying on the experience and expertise of EPL’s peer review pathology staff supported by EPL’s unique computerized peer review software, you can be assured that the data are handled in a consistent and complete manner. EPL pathologists will provide standardized nomenclature and diagnostic criteria across all studies in a drug development program, regardless of the location of the study. This will allow the study sponsor and the regulatory agencies to easily compare the results of all studies in a submission package.
Currently, peer review is required by regulation only by a few agencies. The US EPA requires peer review on all submissions requesting re-consideration of carcinogenicity peer review decisions based on changes in the pathology diagnoses. Additionally, peer review is required for all carcinogenicity studies submitted to the European Agency for the Evaluation of Medicinal Products. While not required by FDA and other regulatory authorities, it is generally recognized that the reliability of pathology diagnoses is greatly enhanced by comprehensive quality assurance and peer review.
EPL’s proprietary peer review software is capable of interfacing with pathology data from all testing laboratories ensuring the accurate transfer of data. This allows EPL pathologists to follow the protocols included in the standard software, or to change the approach to meet the requirements of the client’s Standard Operating Procedures.
Pathology Working Groups (PWG)
EPL pathologists have extensive experience in conducting and participating in Pathology Working Group (PWG) Reviews. PWGs, also known as Expert Panel Reviews, are often requested by regulatory agencies or other interested parties to resolve any differences of opinion or provide additional data interpretation for the study in question.
EPL has arranged PWGs worldwide and can organize 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 all participating pathologists. EPL also has experience in representing the expert panel and assisting with discussions at the regulatory agency. Manuscripts of the PWG process and conclusions can also be prepared by the PWG Chairperson, if requested.
Scientific Advisory Panels
EPL has a broad network of consulting pathologists and toxicologists, as well as industrial and academic experts in disciplines pertinent to toxicity testing, risk assessment and regulatory agency interactions that can be brought together quickly to assist clients with scientific and regulatory issues impacting the progression of product development and registration.
Regulatory and Drug Development Consultation
EPL has extensive and diverse expertise and work experience in support of the pharmaceutical and biotechnology industries. This includes direct experience presenting information to regulatory agency officials and participating in discussions and follow-up actions to resolve safety issues arising from animal toxicity or efficacy studies. In addition to a deep understanding of international pharmaceutical regulations and expectations of health authorities, our experts have broad knowledge of pathophysiology and target organ toxicity related to the administration of biopharmaceuticals to animals.
EPL is prepared to assist clients in formulating preclinical testing strategies for candidate pharmaceuticals, address regulatory concerns regarding test article-related effects, possible or proven mechanisms of toxicity, and the toxicological significance of morphological effects.
Regulatory and Drug Development Services
- Scientific review of general toxicology study reports and other documents submitted to regulatory agencies
- Due diligence review and critical advice for drugs or chemicals for in-licensing
- Preparation of expert reports, specialized overviews, and integrated summaries of data derived from nonclinical drug safety studies, such as:
- Common Technical Document (CTD) Overview (Section 2.4)
- Common Technical Document (CTD) sectional summaries (Section 2.6)
- Investigational Medicinal Product Dossier (IMPD)
- Investigational New Drug (IND) Application Overview
- Preparation of position and review papers for perspective on effects of concern seen in toxicity studies
- Strategies for nonclinical development programs
- Interactions with global health regulatory authorities and responses to regulatory queries
For many years EPL has been developing and conducting in-house training seminars to assure consistent, uncompromised skills in our staff. Now the EPL Training/Education Unit offers these same unique seminars to the industry at large. Our experienced, diversified staff has developed seminars that present detailed organized instruction for both routine and highly technical procedures. Additional seminars can be designed utilizing either your SOPs or EPL-based procedures, customizing each seminar to meet your specific needs.
EPL seminars are conducted using PowerPointÒ presentations as well as high-quality, state-of-the-art lecture materials for each participant. The rodent necropsy seminar also includes a 30-minute video presentation and handbook. As appropriate during each seminar, students will participate in classroom and/or laboratory “hands-on” sessions. Completion certificates are provided for training documentation.
Seminars for the following procedures are currently available for presentation at your laboratory or at one of EPL’s laboratories in Sterling, VA or Research Triangle Park, NC.
- Necropsy – Rodents
- Perfusions Techniques – Whole body or Organ
- Tissue Identification for the Histologist
- Histology Techniques
- Pathology for the Non-Pathologist
For more information, Contact Us