Continuing Education Courses
STP will offer one continuing education course in-person at the 2022 Annual Symposium and three virtually at other times during the year. More information on the dates for the virtual courses will be posted soon.
Sunday, June 19
CE (Sunday PM) 1:30 PM—5:30 PM
- No Bones About It: Considerations for Bone Toxicity, Healing, and Remodeling Studies
Co-Chairs: Kathleen A. Funk, DVM, PhD, DACVP, EPL, Inc.; and Maralee McVean, PhD, DABT, Loxo Oncology at Lilly
This course will focus on bone toxicity as a potential off target effect based on the class of compound or an early and unexpected pathology signal rather than on drugs specifically designed to affect bone. The first presentation will cover normal anatomy and histology of the various bones which may be affected by drug administration and introduce animal models as a strategy to elucidate bone issues. A discussion of the various tools used to monitor bone toxicity, healing, and remodeling will be considered as they relate or drive the study design including model, species selection, and age followed by a discussion of regulatory requirements for bone therapeutics and a regulatory perspective on strategies to de-risk compounds with potential bone effects. Finally, a synopsis of the type of pathologic changes seen in bone together with various histopathologic techniques for processing and evaluating bone and integrating these pathologic changes with the other tools for measuring bone toxicity will be discussed. Pathology characteristic of certain drug classes will be covered.
More Than a Framework: Understanding Bone Biology and Histology
S. Serra Ucer Ozgurel, PhD, University of Texas at Austin
Considerations for Study Design and Tools Used to Evaluate Changes to Bone
Aurore Varela, DVM, MSc, DABT, Charles River Laboratories
Pathology of Bone: Changes Associated with Different Classes of Compounds
Kathryn E. Gropp, DVM, PhD, DACVP, Pfizer Inc
Regulatory Approaches to the Nonclinical Evaluation of Drug-Related Bone Toxicity
Rogely W. Boyce, DVM, PhD, DACVP, Beechy Ridge ToxPath LLC
This program (20-903136) has been approved for 2.00 hours of continuing education credits in jurisdictions that recognize RACE approval.
Virtual Continuing Education Courses
Friday, August 12, 2022, 12:00 Noon–3:45 PM EDT
- From Anticipated Immunomodulation to Safety Concern: Use of Immune Biomarkers in Preclinical Studies
Co-Chairs: Caitlyn Carter, DVM, DACVP, Charles River Laboratories; and Michael Logan, DVM, PhD, DACVP, AbbVie
Biomarkers of the immune system are being applied to preclinical safety studies with increasing frequency as the availability of method and platform options continues to expand. This course will focus on the use of traditional and novel biomarkers of the immune system that are being used on preclinical safety studies. Practical considerations for their appropriate, and sometimes inappropriate use will be presented including biomarker selection, application in various preclinical settings, study design, sampling collection optimization (matrix, kinetics, timing and collection), and interpretative considerations. Method limitations, pitfalls to avoid, and successful implantation strategies will also be discussed with supporting case examples. Finally, topics related to immunology biomarker components specific to emerging novel therapeutic platforms (e.g., CD3 engagement, bispecific antibodies, cell and gene therapies) will be presented.
Overview and Considerations for the Use of Biomarkers of the Immune System in Preclinical Safety Studies
Adam Aulbach, DVM, DACVP, Inotiv
Getting It Right: The Correct Assays, Matrices, and Intervals Result in a Robust Data Set. Now…How Do We Interpret Them?
Erin Vaughn, PhD, AbbVie
Possible vs. Advisable: How Do We Optimally Use (and Not Abuse) Immunology Biomarkers in a Preclinical Setting?
Rob Caldwell, PhD, AbbVie
Platform Specific Considerations: What Biomarkers Provide the Best Value for My Specialized Target/Mechanism/Modality?
Danice Wilkins, PhD, MS, Charles River Laboratories
Friday, August 26, 2022, 12:00 Noon–3:45 PM EDT
- Optimizing Toxicologic Pathology Data: Fundamental Concepts and Recommended Practices
(sponsored by the American College of Toxicology)
Co-Chairs: Daniel J. Patrick, DVM, DACVP, DABT, Eli Lilly & Company; and Noel D. Horton, PhD, DABT, Inotiv
It is well known that successful preclinical safety assessment studies depend on reliable and accurate data, which usually include critical contributions from anatomic and clinical pathology. There are numerous pathology publications that provide insights and recommendations that reliably improve pathology data and overall study outcomes when implemented. This Continuing Education course will present 10 of the most important pathology-related concepts, with practical recommendations that toxicologists can utilize in their preclinical studies. These concepts include using recommended anatomic and clinical pathology study designs, communicating information with the study pathologist before the evaluation, understanding what constitutes a properly trained toxicologic pathologist, following recommended histopathology evaluation practices, appropriately determining the adversity of pathology data, using pathology diagnostic terminology that is globally harmonized and Standard for Exchange of Nonclinical Data (SEND) compliant, knowing when and when not to use pathology historical control data, implementing pathology quality control measures such as pathology peer review, and following recommended pathology reporting practices. This course will be presented by globally recognized toxicologic pathologists who have actively promoted and authored publications on these topics.
Recommended Anatomic and Clinical Pathology Study Designs and Prestudy Communication
Armando R. Irizarry, DVM, PhD, DACVP, Eli Lilly and Company
Prudent Practices for Prepping Pathologists, Handling Histopathology, and Assigning Adversity
Brad Bolon, DVM, MS, PhD, DACVP, DABT, ATS, FIATP, FRCPath, GEMpath Inc.
SENDing the Pathology Data We Have INHAND and Factors to Consider When Using Pathology Historical Control Data
Charlotte M. Keenan, VMD, C.M. Keenan ToxPath Consulting
Histopathology Quality Control and the Reporting of Pathology Data and Interpretations
James D. Fikes, DVM, PhD, DABVT, DACVP, Biogen
Friday, September 16, 2022, 12:00 Noon–3:45 PM EDT
- Toxicologic Pathology and Risk Assessment of Environmental Exposures
Co-Chairs: Arun K. Pandiri, BVSc&AH, MS, PhD, DACVP, DABT, NIEHS/NTP; and Maria L.Z. Dagli, DVM, MS, PhD, Universidade de São Paulo
Environmental toxicologic pathology is a specialized area that addresses the effects of contaminants and pollutants on human, animal, and ecological health. The common animal models to examine the potential hazards associated with environmental exposures include rodents, birds, amphibians, fish, and worms. The health hazards frequently resulting from environmental xenobiotic exposures include metabolic diseases and cancer. This session will aim to examine the common toxicologic pathology lesions and the regulatory assessments related to endocrine disruption and cancer. In addition, the use of adverse outcome pathways to understand disease and environmental risk assessment may also be discussed where ever it is appropriate.
Risk Assessment Approaches in Environmental Toxicology
George M. Woodall Jr., PhD, US EPA
A Toxicologist’s Perspective on Neuroendocrine Disruption Due to Environmental Exposures
Sue Marty, PhD, DABT, Dow Chemical Company
Comparative Neuroendocrine Pathology Due to Environmental Exposures
Jeffrey C. Wolf, DVM, DACVP, EPL, Inc.
In Silico or In Vitro Approaches in Environmental Toxicology Using Zebrafish and/or C. elegans
Robyn L. Tanguay, PhD, Oregon State University
Continuing Education Chair:
Sanjeev Gumber, BVSc, MVSc, PhD, DACVP, Boehringer Ingelheim
Continuing Education Co-Chair:
Maria L.Z. Dagli, DVM, MS, DACVP, Universidade de São Paulo