Continuing Education Courses
STP will offer two continuing education courses in-person at the 2024 Annual Symposium and three virtually at other times. More information about the virtual courses is below.
Sunday, June 16
CE1 (Sunday AM) 8:00 AM–12:00 Noon
- Immunotoxicology from a Pathology Perspective
Co-Chairs: Tracey L. Papenfuss, DVM, MS, PhD, DACVP, StageBio; and Daniel Weinstock, DVM, PhD, DACVP, Independent Consultant
The field of immunotoxicology originated in the early 1970s when it was recognized that therapeutics and chemicals can affect the function of the immune system. While immunosuppression was a primary endpoint evaluated in early immunotoxicology evaluation, the field has evolved over time. With an increased understanding the role that the immune response plays in numerous diseases and the development of numerous therapies that are designed to modulate the immune system, the field of immunotoxicology looks very different than its beginnings half a century ago. In this course, we intend to provide pathologists with a better understanding of the current considerations pertaining to the pathologic evaluation of the immune system, factors to consider in adversity determination, relevant toxicologic species and translational aspects relating to the immune system, clinical and anatomic pathology findings indicative of immunotoxic changes (as well as background or incidental findings), and to provide a holistic interpretation and concepts important for a weight-of-evidence (WOE) approach during the development and regulatory review of therapeutics and relevant clinical examples.
CE2 (Sunday PM) 1:30 PM–5:30 PM
- Nonclinical Safety Evaluation of Long-Lasting Injectables in Animal Models
Co-Chairs: Bhanu P. Singh, BVSc, MS, DACVP, DABT, FIATP, Gilead Sciences, Inc.; and Keith G. Nelson, DVM, PhD, DACVP, Inotiv
The use of persistent, long-lasting injectables for consistent ongoing dosing of pharmaceuticals is an ever-growing field. The use of these long-lasting injectables is valuable in maintaining consistent dosing, ensuring patient compliance with dosing, and providing long-term pharmaceutical therapy with a single treatment. Safety evaluation of these products carries with it numerous challenges; including the formulation and development of the compound in conjunction with the carrier, development of the product, consideration of appropriate study design for evaluation of chronic responses to a single “dose,” evaluation of the compound together and separate from the carrier that forms the eluting depot, and determination of adversity or tolerance of the test material.
Virtual Continuing Education Courses
Friday, April 12, 2024, 12:00 Noon–3:45 PM EDT
- Identifying and Understanding Seizure Liability in Pharmaceutical Development
(Sponsored by the American College of Toxicology)
Co-Chairs: Katie B. Sokolowski, PhD, DABT, Denali Therapeutics; and Brad Bolon, DVM, MS, PhD, DACVP, DABT, FATS, FIATP, FRCPath, GEMpath, Inc.
Drug-induced seizures are a major concern for central nervous system neuroactive pharmaceuticals during development. Currently, there are no guidelines for interrogating and mitigating seizure liability associated with new pharmaceuticals. Because of the risks to patient safety during clinical trials, the understanding of nonclinical characterization that informs the translation of risks to humans is an area of intense interest among drug developers and regulators. The goals of this session are to (1) understand the diverse mechanisms of seizures; (2) examine typical findings in nonclinical studies indicating seizure liability; (3) understand objectives and the elements of a screening and a pivotal nonclinical electroencephalographic (EEG) study; and (4) implement the principles of risk mitigation to de-risk seizure liability in clinical trials. To achieve these goals, we will bring together a practicing clinical neurologist with primary knowledge of patients experiencing seizures, a pharmaceutical consultant with expertise in identifying seizure liability in nonclinical studies, a director of a contract research organization with experience in designing nonclinical EEG studies, and a US FDA regulator to discuss mitigation strategies. After the session, attendees will have a better understanding of how to mitigate risks of pharmaceutical products that carry a seizures liability and understand the limitations of the current state of the art to inform research in this area.
Summer TBD, 12:00 Noon–3:45 PM EDT
- Cardiovascular Medical Devices: From Bench to Bedside
Co-Chairs: Rebecca A. Kohnken, DVM, PhD, DACVP, AbbVie; and Jaime Paulin, DVM, MSc, DACVP, StageBio
The discovery, development, approval, and application of medical devices for cardiovascular indications presents a unique niche within the medical device industry. General toxicologic pathologists have little exposure to this field which is a segment of medical therapies with more rapid innovation and regulatory submission compared to pharmacological therapies. This course will provide information, insight, and perspectives from different points of view by scientists that contribute to each life stage of a cardiovascular medical device.
This CE course will cover the topic from bench to bedside, beginning with the biomedical research behind the discovery of medical devices for the treatment of cardiovascular disease, and ending with their use in the interventional cardiology setting. In between, of course, are the dedicated scientists that design nonclinical animal studies, as well as non-animal-based investigations, into assessing the efficacy and safety of these devices, those that review the toxicology and pathology data from these studies, and those that provide regulatory guidance and approval for the devices. This course will therefore provide the general audience of the STP membership with a one-stop-shop overview of the field of cardiovascular medical devices and provide attendees with an opportunity to ask questions of experts in this area.
Summer TBD, 12:00 Noon–3:45 PM EDT
- Spatial Profiling in Toxicologic Pathology and Drug Discovery
Co-Chairs: Chandra Saravanan, DVM, MS, PhD, DACVP, Novartis Institutes for Biomedical Research; and Elijah F. Edmondson, DVM, PhD, DACVP, DABT, Frederick National Laboratory for Cancer Research
Spatial biology is a rapidly developing frontier, driven by rapidly advancing technologies including multiplexing methods, transcriptomics, proteomics, and MALDI mass spectrometry. These techniques allow a holistic and unbiased assessment of molecular changes as informed by histologic features. Spatially resolved cellular phenotypes, interactions, and neighborhoods offer mechanistic insights into physiological and pathological processes and hold promise to revolutionize the practice of pathology. The technological advancements occurring in the field of spatial biology rely on the expertise that well-trained pathologists and toxicologists can provide. In this CE course, experts in this field will highlight available technologies and their applications, including data analysis and integration to other data sets.
Continuing Education Chair:
Melanie Greeley, DVM, PhD, DACVP, Charles River Laboratories
Continuing Education Co-Chair:
Debra A. Tokarz, DVM, PhD, DACVP, EPL, Inc.