STP Virtual Continuing Education Courses

Data To Decision: Bias Awareness in the Drug Development Journey

Friday, April 11, 2025, 12:00 Noon–3:45 PM EDT

Co-Chairs: Rachel Peters, DVM, DACVP, Sanofi; and Steven T. Laing, BVMS(Hons), PhD, DACVP, Genentech

Pathologists both generate and consume data: they are also often tasked individually and within a team setting to provide a diagnosis, a finding or an assessment of hazard and risk. We are told that as scientists we should “follow the data” or “follow the science.” However, it is important to understand how the data is obtained and that the data does not make decisions, it is people and teams that do. Both data generation and decision making (individual and group) can be influenced by bias. The purpose of this course is to 1) generate awareness of bias and its origin in neuroscience; 2) understand the potential impact of bias on science and decision making; and 3) offer mitigating strategies to offset bias.

Neuroscience of Racial Bias
Jeni Kubota, PhD, University of Delaware

Dataset and Analysis Bias—Know Thy Data Sources: Bias Mitigation in Creation of Virtual Control Groups
Laura Lofti, PhD, Charles River Laboratories

Dataset and Analysis Bias—Know Thy Data Sources: Bias Awareness and Mitigation in In Vitro Systems
Sean De al O, PhD, Genentech

Bias in Clinical Decision Making
Catherine Saunders, PhD, MPH, Dartmouth University

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Juvenile Toxicology Three Years After ICH S11: Where Are We Now?

(Sponsored by the American College of Toxicology)

Friday, August 22, 2025, 12:00 Noon–3:45 PM EDT

Co-Chairs: Dana Minnick, PhD, DABT, RAC, SciLucent, Inc.; and Bert Haenen, PhD, Johnson & Johnson Innovative Medicine

Since the early 2000s, regulatory legislation has been enacted in several regions to encourage pediatric drug development. As part of this legislation, plans are required to assess the clinical benefit and safety of therapeutics for pediatric patients. As part of these plans, nonclinical safety studies may be needed. It has been approximately 3 years since ICH S11 came into effect to provide international guidance for the nonclinical safety studies needed to support the development of pediatric medicines. The guidance provides a weight of evidence approach to determine when nonclinical toxicity studies are recommended in juvenile animals. If studies are warranted, the guidance provides recommendations for study design. In this course, we will review the regulatory expectations regarding the need for clinical and nonclinical safety assessment of therapeutics for pediatric populations, weight of evidence approaches to determine the need for juvenile toxicity studies, and when needed, best practices for the design of nonclinical toxicity studies to support pediatric drug development. We will hear a regulatory perspective regarding implementation of the new guidance, and several case studies will be presented including an interactive discussion with an in-depth review of a couple case studies.

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Embracing the Future: Clinical Pathology and the Use of Big Data and AI⁠-Assisted Tasks

Friday, September 12, 2025, 12:00 Noon–3:45 PM EDT

Co-Chairs: Lila Ramaiah, DVM, PhD, DACVP, Johnson & Johnson Innovative Medicine; Nancy E. Everds, DVM, DACVP, ABBM Consulting LLC; and Caitlyn Carter, DVM, DACVP, AbbVie

There is a continually growing interest in the development and implementation of improved tools for clinical pathology data generation, interpretation and reporting in preclinical safety studies. This course will explore emerging computational tools and their utility and application in cytologic image analysis, data visualization, AI-assisted data interpretation, and automated report generation and QC. The session will begin with an introduction to existing and emerging methods, including a discussion of responsible use of mathematical and AI-based tools in toxicologic clinical pathology. The second presentation will discuss available slide scanning technologies, with a focus on considerations for quality and use in evaluating cytological specimens digitally, benefits and limitations for use, and current options for computer assisted data interpretation and report generation. This will be followed by a presentation of artificial intelligence-assisted medical decision support systems currently being developed in human medicine as well as veterinary medicine, to support the identification and prioritization of differential diagnoses or to predict outcomes. Finally, an overview of the guidance for use of artificial intelligence (AI) as a medical device and for clinical decision support and the progression of the preclinical and clinical data sets to the US FDA will be presented, with consideration of how the US FDA views the data and uses metadata analysis to inform decisions.

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Complex In Vitro Models and Pathology

Friday, October 3, 2025, 12:00 Noon–3:45 PM EDT

Co-Chairs: Steven T. Laing, BVMS(Hons), PhD, DACVP, Genentech; and Nadine Stokar-Regenscheit, DVM, DECVP, Roche

Complex in vitro models (CIVM), including spheroids, organoids, and microphysiological systems, offer the potential of increasing the clinical relevance of preclinical drug assessments while reducing animal use in the process. Pathologists have a key role to play in the conception, definition of context of use, and validation of such models; however, many have limited exposure to these novel approach methodologies and the scientists involved in their fabrication. Furthermore, the technical aspects of sampling media for biomarker assessment, obtaining imaging or functional endpoints over time, and processing small tissues for morphological assessment are not standard and often require creative approaches. The purpose of this CE course is to familiarize pathologists/ scientists with the current state of the art of CIVM, provide a framework for the approach to validate their use, and provide technical guidance on their handling. Attendees will leave with an understanding of the capabilities and limitations of CIVM and the language to allow them to integrate with the diverse teams of engineers and biologists working in this exciting new space.

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