Continuing Education Courses Schedule
Sunday, June 23
Sunday, June 23 (AM)
CE1 (Sunday AM) 8:00 AM–12:00 Noon
- Data Interpretation, Visualization, and Statistics for Nonclinical Toxicity Studies
Co-Chairs: Michael Logan, DVM, PhD, DACVP, AbbVie; and Susan G. Emeigh Hart, VMD, PhD, DACVP, DABT, ERT, VenatoRx Pharmaceuticals Inc.
Analysis of anatomic and clinical pathology data is central to the safety assessment of new molecules. Technologic advancement and the push for additional measures for both toxicity and risk prediction have expanded the pathologist’s toolbox for data presentation and analysis. This course will explore the application of new data visualization tools and their application to toxicologic pathology with examples that are applicable to both anatomic and clinical pathology. In addition, the more traditional statistical analysis tools for data analysis will be scrutinized. The appropriate (and sometimes inappropriate) use of these techniques will be presented in a user friendly and toxicologic pathology focused manner.
Introduction to Data Visualization Technology—Evolution, Functionality, Data Requirements, Pitfalls, and Regulatory Considerations
Sean Troth, DVM, PhD, DACVP, Merck & Co., Inc.
Data Visualization; Practical Applications
Brian Knight, DVM, PhD, Boehringer Ingelheim Pharmaceuticals Inc.
Data Visualization Strategies and Limitations for Clinical Pathology Endpoints
Bill Siska, DVM, MS, DACVP, Charles River Laboratories
Statistical Methods, an Overview of Their Application to Clinical Pathology Data from Toxicologic Pathology Studies
Lila Ramaiah, DVM, PhD, DACVP, Bristol-Myers Squibb
Practical Limitations of Statistical Analysis of Clinical Pathology Data from Toxicologic Pathology Studies
Kirstin Barnhart, DVM, PhD, DACVP
Statistical Applications in Biomarker Development and How Not to Torture Data
Jacqueline Tarrant, BVSc, PhD, DACVP, Gilead Sciences
CE2 (Sunday AM) 8:00 AM–12:00 Noon
- Medical Device Safety Assessment: The Frontiers of Safety Assessment Pathology
Co-Chairs: Maureen T. O’Brien, DVM, MS, DACVP, Charles River Laboratories; and Serge D. Rousselle, DVM, DACVP, Alizee Pathology
Pathology of medical devices poses unique, ever-evolving challenges and considerations that often cannot be answered by employing traditional toxicologic pathology methods. Furthermore, medical device specimens may be limited and/or expensive; therefore, having a structured approach to pathology is particularly essential for study success. Medical device regulation differs from that of drugs, and knowledge of the regulatory pathways is an asset when providing pathologic evaluation of medical devices. This course provides an introduction to basic medical device pathology, including specialized methods for pathology such as plastic embedding, unique considerations for the pathologic evaluation, topical discussion of pathology, and an overview of the regulatory path to market for medical devices.
Basic Techniques in Medical Device Pathology
Nicolette D. Jackson, DVM, DACVP, AccelLab
Overview of the Regulatory Approval Process for Medical Devices in the United States
Karen Manhart, VMD, MA, DACVP, US FDA, CDRH
Biocompatibility: Key Concepts for Medical Device Safety Assessment
William C. Stoffregen, DVM, PhD, DACVP, Northstar Preclinical and Pathology Services, LLC
A Primer of Common Medical Device Biomaterials
Michael N. Helmus, PhD, Consultant
Medical Device Bioabsorption
Serge D. Rousselle, DVM, DACVP, Alizée Pathology
Hernia Mesh Implants
John H. Keating, DVM, DACVP, CBSET, Inc.
Sunday, June 23 (PM)
CE3 (Sunday PM) 1:30 PM–5:30 PM
- Cardiac Effects Commonly Encountered in Drug Development: Mechanisms and Clinical Relevance
(sponsored by American College of Toxicology)
Co-Chairs: Matthew M. Abernathy, PhD, DSP, Eli Lilly & Company; and Donald N. Jensen, DVM, MS, US FDA, CDER
The cardiovascular system is an intricate meshwork of organ structures regulated by multiple feedback loops to maintain organ perfusion, deliver fuel, and remove cellular waste. Due to the range of CV targets that are dispersed throughout our many tissues, it should be of no surprise that a high percentage of drug attrition falls at the feet of cardiovascular findings both preclinically and clinically. Given the high exposures achieved and techniques used to assess CV safety in preclinical models, the number of preclinical observations of CV effects generally exceeds the prevalence of effects observed clinically. Findings may range from cardiomyopathy to arrhythmia, and not all CV safety signals carry the same weight when deciding to continue to develop a compound. Thus, safety margin and target patient population heavily influence judgment-based development decisions beginning early on in compound discovery. This course will focus on mechanisms for both histological and functional cardiac effects encountered during drug development. Additionally, decision-making strategies for unexpected CV effects and use of in silico models to predict the mechanism and translation of cardiac effects to the clinic will be covered in depth.
Cardiac Toxicity: Options from a Regulatory Perspective
Donald N. Jensen, DVM, MS, US FDA, CDER
Integrative Cardiovascular Toxicologic Pathology—Building Translational Bridges
Brian Berridge, DVM, PhD, DACVP, NIEHS/NTP
Measuring, Interpreting, and Decision Making Based on Drug-Induced Hemodynamic Effects, Case Studies in Diabetes and Oncology
Derek J. Leishman, PhD, DSP, Eli Lilly & Company
Safe QTc Prolongation? How the Comprehensive In Vitro Proarrhythmia Assessment Will Spare Nontorsadogenic Molecules that Prolong Cardiac Repolarization (QTc Interval)
Wendy Wu, PhD, US FDA, CDER
In Silico Modeling in Cardiorenal Safety Assessment
K. Melissa Hallow, PhD, University of Georgia
CE4 (Sunday PM) 1:30 PM–5:30 PM
- Otic Toxicologic Pathology
Co-Chairs: Kenneth A. Schafer, DVM, PhD, DACVP, Vet Path Services, Inc.; and Bradley L. Njaa, BSc (Hons), DVM, MVSc, DACVP, Kansas State University
The ear is infrequently evaluated in toxicologic pathology, and only so when there are very specific drivers to evaluate it. These include known compound classes where otic toxicity may be anticipated or when the intended therapeutic is applied directly to the ear. This session will cover an overview of otic anatomy, otic physiology, techniques in otic toxicology, otic pathology, and regulatory considerations for otic toxicology studies.
Comparative Anatomy and Physiology of the External and Middle Ear
Bradley L. Njaa, BSc (Hons), DVM, MVSc, DACVP, Kansas State University
Anatomy and Physiology of Hearing and Balance
Teresa Southard, DVM, PhD, DACVP, Cornell University
Nonclinical In-Life Study Requirements to Assess Ototoxicity
Rachel Tapp, MS, Charles River Laboratories
Otic Toxicologic Pathology
Kenneth A. Schafer, DVM, PhD, DACVP, Vet Path Services, Inc.
Regulatory Considerations for Otic Toxicology Studies
Christopher Toscano, PhD, DABT, US FDA, CDER
Continuing Education Chair:
Gopakumar Gopalakrishnan, DVM, MS, DABT, DACVP, Supernus Pharmaceuticals
Continuing Education Co-Chair:
Kate Hammerman, VMD, PhD, DACVP, Pfizer