2019 Annual Symposium - The Society of Toxicologic Pathology (STP)
Contact Information
  •   11190 Sunrise Valley Dr., Suite 300, Reston, VA, 20191
  •   stp@toxpath.org
  •   703-438-7508
open
2019 STP Annual Symposium

Continuing Education Courses

 

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