Scientific and Regulatory Policy Committee Best Practices: Documentation of Sexual Maturity by Microscopic Evaluation in Nonclinical Safety Studies

The sexual maturity status of animals in nonclinical safety studies can have a significant impact on the microscopic assessment of the reproductive system, the interpretation of potential test article–related findings, and ultimately the assessment of potential risk to humans. However, the assessment and documentation of sexual maturity for animals in nonclinical safety studies is not conducted in a consistent manner across the pharmaceutical and chemical industries. The Scientific and Regulatory Policy Committee of the Society of Toxicologic Pathology convened an international working group of pathologists and nonclinical safety scientists with expertise in the reproductive system, pathology nomenclature, and Standard for Exchange of Nonclinical Data requirements. This article describes the best practices for documentation of the light microscopic assessment of sexual maturity in males and females for both rodent and nonrodent nonclinical safety studies. In addition, a review of the microscopic features of the immature, peripubertal, and mature male and female reproductive system and general considerations for study types and reporting are provided to aid the study pathologist tasked with documentation of sexual maturity.

Seven Days in January

Worries over the economy and wheat prices led to the formation of a new (previously unknown) executive policy committee operating in parallel with the War Council. During the fourth week of January 1915, the new Food Price committee met ahead of the War Council. In this forum, Asquith and his senior advisors were finally convinced of the severity of the wheat problem. They further decided that rather than introduce food rationing, it would be simpler to force the Dardanelles and open the path to Russian wheat—thereby not only lowering wheat prices but also permitting Russia to solve its financial problems by resuming wheat exports. At the subsequent War Council meeting of January 28, 1915, Asquith overruled the objections of Admiral John Fisher to the Dardanelles operation. A review of the concerns displayed by each voting member demonstrates that the majority favored attacking the Dardanelles for mainly economic reasons.

EDTAKI: A Nephrology and Public Policy Committee (NPPC) Platform Call for More European Involvement in AKI

Acute Kidney Injury (AKI) is an often neglected but crucial element of clinical nephrology. The aim of the Nephrology Public Policy Committee (NPPC) of the European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) is to promote several key aspects of European nephrology. One of the targets proposed by NPPC was to advance European nephrology involvement in AKI. We undertook literature analyses to define the current position of European nephrology in the field of AKI compared to other regions, and about how different European countries compare to each other. It appeared that vis-à-vis countries with a comparable socio-economic status (the US, Australia, New Zealand, Canada), the European contribution was almost 50% lower. Within Europe, Central/Eastern Europe and countries with a lower gross domestic product (GDP) showed lower scientific output. Nephrologists contributed to less than half of the output. There was no trend for a change over the last decade. It is concluded that there is room to improve the contribution of European nephrology in the field of AKI. We propose a model on how to promote clinical collaboration on AKI across Europe, the creation of a pan-European nephrology network of interested units is proposed, to improve clinical outcomes, increase nephrologist involvement and awareness outside nephrology, and stimulate research on AKI in Europe. Accordingly, we also propose a list of research priorities and stress the need for more European funding of AKI research.

Policy Series: Interdisciplinary Public Policy Discussion

Aging and health care public policy in Washington can be driven and influenced by the work of GSA researchers, educators, and practitioners from across the nation. This session will examine and explore public policy priorities from an interdisciplinary perspective and consider opportunities for communicating these policies with key policymakers. This session is an interdisciplinary look at policy issues in aging with the speakers representing views from the six sections of GSA. This session, organized by the GSA Public Policy Committee, will provide both GSA section leadership and attendees an opportunity to have an open dialogue on important public policy issues of significance in the field of aging. The session discussant will help to facilitate a robust discussion of the presentations by speakers. Organized by the GSA Public Policy Committee, this dialogue will benefit the work of the Committee in 2021.