Continuing Education Courses

Sunday, June 14 (AM)

CE1 (Sunday AM) 8:00 AM–12:00 Noon

• Vaccine Development from the Pathologist Perspective

  Co-Chairs: Rani Sellers, DVM, PhD, DACVP, Pfizer Inc.; and Cynthia Rohde, PhD, Pfizer Inc.

  The design and execution of toxicology studies supporting vaccine development have several unique elements relative to the conduct of traditional small molecule- or monoclonal antibody-supporting studies. This course is designed to give an overview of vaccine development, with emphasis on the regulatory guidances and special considerations in vaccine development (prophylactic and therapeutic), study design (including species selection), unique technical considerations, and anatomic and clinical pathology findings.

  Introduction to Vaccine Developments
  Cynthia M. Rohde, PhD, DABT, Pfizer Inc.

  Animal Models to Support Vaccine Development
  Rani Sellers, DVM, PhD, DACVP, Pfizer Inc.

  Points to Consider in Vaccine Study Design and Implementation
  Keith G. Nelson, DVM, PhD, DACVP, Charles River Laboratories

  Anatomic and Clinical Pathology Interpretation and Correlations
  Niraj K. Tripathi, BVSc, MVSc, PhD, DACVP, Covance; and Bindu Bennet, DVM, MSc, MS, PhD, Voyager Therapeutics

  Determining Adversity: Contributions of Local Tolerance, Acute Phase Reactants, and Systemic Reactivity
  Panel Presentation

CE2 (Sunday AM) 8:00 AM–12:00 Noon

• 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, Inotiv

  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 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
  Corinne Metzger, PhD, Indiana University Medical School

  Considerations for Study Design and Tools Used to Evaluate Changes to Bone
  Aurore Varela, DVM, MSc, DABT, Charles River Laboratories

  Regulatory Approaches to the Nonclinical Evaluation of Drug-Related Bone Toxicity
  Gemma Kuijpers, PhD, CDER, US FDA

  Pathology of Bone: Changes Associated with Different Classes of Compounds
  Kathryn E. Gropp, DVM, PhD, DACVP, Pfizer Inc.

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Sunday, June 14 (PM)

CE3 (Sunday PM) 1:30 PM–5:30 PM

• Antibody Drug Conjugates (ADCs) as Cancer Therapies

  Co-Chairs: William O. Iverson, DVM, AstraZeneca; and Nancy E. Everds, DVM, DACVP, Seattle Genetics

  Antibody-drug conjugates (ADCs), which use a specific antibody to deliver a toxic payload to target cells, hold great promise to increase efficacy and reduce adverse side effects, especially for oncology drugs. Six ADC molecules have received marketing approval in the US over the past 18 years. Nonclinical safety assessment has proven challenging as many ADCs still have steep dose-response curves and low therapeutic indices. Toxicities in many different organs and tissues have been seen, including bone marrow, skin, liver, kidney, eye, gastrointestinal tract, and nervous system. ADC-related toxicities may be more challenging to predict and manage than those seen with small molecules or unconjugated antibodies. This has led to more sophisticated engineering of antibodies, linkers, and drugs to increase internalization of drug by target cells, decrease off-target toxicity, and decrease bystander effects. This course will give an overview of synthesis and mechanisms of representative ADCs, and the clinical and anatomic pathology findings associated with different classes of agents, including immunomodulatory molecules and PROTACS.

  Immune Modulatory Activity of Traditional and Nontraditional ADCs
  Shyra J. Gardai, PhD, Seattle Genetics

  Recent Progress in Antibody Drug Conjugates and PROTACs as New Modalities: Application to Oncology Drug Discovery
  Lakshmaiah Gingipalli, PhD, AstraZeneca

  Clinical Pathology Effects of Antibody Drug Conjugates in Toxicology Studies
  Niraj K. Tripathi, BVSc, MVSc, PhD, DACVP, Covance

  Anatomic Pathology Associated with Antibody Drug Conjugates
  Matthew D. Smith, DVM, PhD, DACVP, Charles River Laboratories

CE4 (Sunday PM) 1:30 PM–5:30 PM

• The Safeguarding of Your Vital Organ Systems Depends on Safety Pharmacology: What Is It?
  (Sponsored by the American College of Toxicology)

  Co-Chairs: Michael K. Pugsley, MS, FBPhS, PhD, Cytokinetics; and Steve Tichenor, PhD, Charles River Laboratories

  This continuing education course will include lectures that describe fundamental areas of safety pharmacology studies (CNS, Respiratory, Cardiovascular systems) for both new chemical entities (NCE) as well as biotechnology-derived products. It will also include some discussion of clinical issues (and methods) as well as novel non-clinical methods and approaches that may be added to the core ‘battery’ of tests used to explore the safety of novel therapeutic agents. Attendees will be introduced to discussion regarding the role safety pharmacology has as an integral component within the safety program for drug development. We will also introduce the Comprehensive In Vitro Proarrhythmia Assay (CIPA) cardiovascular paradigm being developed for hazard identification, elimination and risk assessment that would help to obviate conduct of the clinical “Through QT” (TQT) study. Furthermore, this course will provide attendees with a crucial resource that explains the important role safety pharmacology has in the overall pharmaceutical drug development process.

  An Introduction to the Principles and Practice of Safety Pharmacology
  Michael K. Pugsley, FBPhS, PhD, DSP, Cytokinetics

  Core Battery 1: The Cardiovascular System
  Michael K. Pugsley, FBPhS, PhD, DSP, Cytokinetics

  Core Battery 2: The Central Nervous System
  Susan M.G. Goody, PhD, Pfizer Inc.

  Core Battery 3: The Respiratory System
  Steve Tichenor, PhD, Charles River Laboratories

  A Safety Pharmacology Evaluation of Biopharmaceuticals
  Michael J. Engwall, DVM, PhD, Amgen Inc.

Continuing Education Chair:
Kate Hammerman, VMD, PhD, DACVP, Pfizer Inc.

Continuing Education Co-Chair:
Darlene Dixon, DVM, PhD, DACVP, NIEHS/NTP