Continuing Education Courses

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.

  The Changing Landscape of Immune System Evaluation: From Immunotoxicology and How to Navigate in the Brave New Work of Immunotherapies
  Tracey L. Papenfuss, DVM, MS, PhD, DACVP, StageBio

  Relevant Tox Species and Translational Aspects Relating to Immune System
  Ashwini Phadnis Moghe, MS, PhD, DABT, Takeda

  Spontaneous and Immunotoxic Pathology Findings in the Hematolymphoid System
  Lauren E. Himmel, DVM, PhD, DACVP, AbbVie

  WOE (Weight of Evidence), Holistic Interpretation, Regulatory Guidances: Practical Approaches for Various Therapeutics
  Ana Goyos, PhD, The Janssen Pharmaceutical Companies of Johnson & Johnson

  This program (20-1194488) has been approved for 4.00 hours of continuing education credits in jurisdictions that recognize RACE approval.

  

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CE2 (Sunday PM) 1:30 PM–5:30 PM

• Nonclinical Safety Evaluation of Long-Acting Injectables (LAI) 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.

  Practical Considerations in Evaluating LAI Injection Site Reactions in Animal Models: Study Design and In-Life Evaluations
  Tyler Plachta, MS, Charles River Laboratories

  Practical Considerations in Evaluating LAI Injection Site Reactions in Animal Models: Post-Life Considerations and Evaluation
  Keith G. Nelson, DVM, PhD, DACVP, Inotiv

  Nonclinical Strategy for Developing a Long-Acting Injectable Drug Product
  Doris Zane, MS, PhD, DABT, Gilead Sciences, Inc., and Bhanu P. Singh, BVSc, MS, DACVP, DABT, FIATP, Gilead Sciences, Inc.

  Communicating the Clinical Risk of Injection Site Reactions (ISR) from LAI Drugs
  John L. Vahle, DVM, PhD, DACVP, Eli Lilly and Company

  The Temporal Evolution and Characterization of Histopathology and Immunological Changes Associated with Five Different LAI Drug Nanosuspensions
  Ronnie Chamanza, BVSc, MSc, FRCPath, MRCVS, FIATP, Johnson & Johnson Innovative Medicine

  This program (20-1190808) has been approved for 2.50 hours of continuing education credits in jurisdictions that recognize RACE approval.

  

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Virtual Continuing Education Courses

Friday, September 13, 2024, 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.

  Design and Discovery of Medical Devices for Cardiovascular Indications: Use of Animal Models in the Discovery of Medical Devices for Pediatric Cardiovascular Disease
  Christopher K. Breuer, MD, Nationwide Children’s Hospital

  Nonclinical Development of Medical Devices for Cardiovascular Indications: Medical Device Toxicological Risk Assessment
  Kelly P. Coleman, PhD, Medtronic

  Nonclinical Development of Medical Devices for Cardiovascular Indications: Study Design Considerations for Nonclinical Development of Medical Devices for Cardiovascular Indications
  Allison Ostdiek, DVM, PhD, DACLAM, University of Chicago

  Nonclinical Development of Medical Devices for Cardiovascular Indications: Pathologic Assessment of Medical Devices for Cardiovascular Indications
  Nicole Kirchhof, DVM, DACVP, Medtronic

  Regulatory Considerations for the Development, Submission, and Approval of Medical Devices for Cardiovascular Indications: General Considerations for Nonclinical and Clinical Development of Medical Devices
  Annabelle Crusan, DVM, MS, US FDA

  Regulatory Considerations for the Development, Submission, and Approval of Medical Devices for Cardiovascular Indications: Specific Considerations and Examples of Regulatory Guidance on Medical Devices for Cardiovascular Disease
  Natalie Miller, VMD, PhD, US FDA

  Application of Medical Devices for Cardiovascular Indications in the Clinic
  Aloke Finn, MD, CVPath Institute

Friday, October 4, 2024, 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.

  Overview of Spatial Profiling Technologies
  Kerstin Hahn, DVM, PhD, DECVP, Roche

  Spatial Transcriptomics Applications in Animal Models
  Elijah F. Edmondson, DVM, PhD, DACVP, DABT, Frederick National Laboratory for Cancer Research

  Spatially Resolved Proteomics in Investigative Pathology
  Milind Pore, PhD, Frederick National Laboratory for Cancer Research

  Applications and Challenges of Spatial Transcriptomic Technologies in FFPE Sections of Toxicology Species
  Byunghak Kang, DVM, PhD, DACVP, Novartis Institutes for Biomedical Research

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Held 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.

  Clinical Description and Mechanisms of Seizures
  Judy S. Liu, MD, PhD, Brown University

  Identifying Seizure Liability in Nonclinical Studies
  Marcus Delatte, PhD, Allucent

  General Design Elements of a Nonclinical EEG Study
  Simon Authier, DVM, MSc, MBA, PhD, DSP, Charles River Laboratories

  Risk Assessment: Management and Mitigation of Drug Products with Seizure Liability
  Owen McMaster, PhD, US FDA

  Active Practice 1: Identify Seizure Liability in Nonclinical Studies
  Moderator: Marcus Delatte, PhD, Allucent

  Active Practice 2: General Design Elements of a Nonclinical EEG Study
  Moderator: Simon Authier, DVM, MSc, MBA, PhD, DSP, Charles River Laboratories

  Active Practice 3: Risk Management and Mitigation of Drug Products with Seizure Liability
  Moderator: Owen McMaster, PhD, US FDA

  This program (20-1159230) has been approved for 3.50 hours of continuing education credits in jurisdictions that recognize RACE approval.

  

Continuing Education Chair:
Melanie Greeley, DVM, PhD, DACVP, Charles River Laboratories

Continuing Education Co-Chair:
Debra A. Tokarz, DVM, PhD, DACVP, EPL, Inc.