STP Virtual Continuing Education Courses

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.

Complex In Vitro Models: State of the Art and Definitions
Jessica Klein, PhD, Genentech

The Role of CIVM in a Biological Questions-Based Approach to Safety Assessment
Brian R. Berridge, DVM, PhD, DACVP, B2 Pathology Solutions

Towards the Use of CIVM in Regulatory Drug Development
Graham Marsh, PhD, Critical Path Institute

Processing CIVM for Morphological and Immunohistochemical Assessment
Charles Havnar, BS, Genentech; and Eliah Shamir, MD, PhD, Genentech

Digital Pathology Endpoints in CIVM Assessment
Nadine Stokar-Regenscheit, DVM, DECVP, Roche

Appropriate and Inappropriate Use of In Vitro Cardiomyocytes to Address Cardiovascular Toxicities Characterized by Advanced Safety Pharmacology
Tanja S. Zabka, DVM, DACVP, DSP, Genentech

CVIMs to study testicular toxicity: What are the options?
Camila Dores, DVM, MSc, PhD, DACVP, Altasciences

Code Yellow: An Example of Understanding a Species-Specific Toxicity Using Complex In Vitro Systems
Rachel Peters, DVM, DACVP, Sanofi

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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.

Social 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
T. William O'Neill, DVM, MPH, Charles River Laboratories

Towards Bias Awareness and Mitigation in In Vitro Systems: Building an Inclusive Model of Human Toxicity in Intestinal Epithelium
Sean de la O, PhD, Genentech

Patients, the Public, and Clinicians: What Is the Role of Community-Based and Participatory Science in Toxicology and Beyond
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.

Whether a Juvenile Toxicology Study Is Warranted? And If Yes, When?
Susan Laffan, PhD, Amgen

The Who, When (Age), and How of Juvenile Toxicity Study Design
Alan Hobermann, PhD, DABT, FATS, Charles River

Implementation of ICH S11 in the EU Regulatory Review of Pediatric Investigation Plans (PIPs)
Karen Van Malderen, PharmD, MSc, ERT, European Medicines Agency (EMA)

Navigating ICH S11: How to Design a Nonclinical Strategy to Support Pediatric Development
Katie Turner, PhD, Johnson & Johnson Innovative Medicine

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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. The final presentation will focus on preparing data to be “AI-ready” by utilizing knowledge graphs. It will highlight the significance of constructing a robust, integrated data foundation to quickly unlock new insights and expedite the discovery of new drug targets.

Overview of Data Visualization, Advanced Statistics, and AI-Based Tools
Lila Ramaiah, DVM, PhD, DACVP, J&J Innovative Medicines

Digital Aids for Clinical Pathology Slide Scanning/Viewing and Report Writing: Availability, Utility, and Considerations for Cytology Slide Scanning in Preclinical Studies
Liza Bau-Gaudreault, DVM, MSc, DES, DACVP, Charles River Laboratories

Digital Aids for Clinical Pathology Slide Scanning/Viewing and Report Writing: Considerations for Automated Generation of Clinical Pathology Reports
Adam Aulbach, DVM, DABT, DACVP, Inotiv

From Insight to Impact: AI’s Role in Veterinary Clinical Care
Jonathan Lustgarten, MS, PhD, VMD, CSPO, Mars Veterinary Health

Integration of Preclinical and Clinical Data Within and Across Programs Utilizing Knowledge Graphs
Bhupinder Bawa, DVM, MVSc, PhD, DACVP, AbbVie

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