Continuing Education Courses
Continuing Educations (CE) courses are 3.5 hours each and are held either Sunday morning or Sunday afternoon, with the exception of the Study Director Short Course which runs 7.25 hours (Short Course fee includes a boxed lunch). Preregistration is required and seating is limited.
Sunday, November 9
8:00 AM–3:15 PM
Study Director Short Course
Chairs: Barbara J. Mounho-Zamora, ToxStrategies Inc. and Heather Dale, Covance Laboratories Inc.
This Continuing Education course will review the essential aspects of the role and responsibilities of the Study Director. For the first half of the course, the presentations will include topics relevant for study directors including a review and history of the GLP regulations, managing and addressing the challenges of multisite studies, and selection of relevant animal models for toxicology studies. The second half of the course will include more detailed review of specific toxicology studies, including immunotoxicology, reproductive and developmental toxicology, and safety pharmacology. This course is an excellent introduction for the new study director, as well as a refresher course for experience study directors. All students will receive a certificate for course participation that can be used for continuing education credits.
8:00 AM–11:30 AM
Best Practices in Toxicologic Pathology
Chairs: Kenneth A. Schafer, Veterinary Pathology Services, and Robert C. Sills, NIEHS
During this session, members of the STP will present information from a few of the key guidance documents. The guidance documents that have been selected are those that deal with basic issues in study design and interpretation that toxicologists and pathologists can use in their conduct and reporting of toxicity studies. The Society of Toxicologic Pathology (STP) has provided a number of best practice guidance documents, STP recommendations, and points to consider in the “Regulatory Forum” section of the society's journal, Toxicologic Pathology. These publications are intended to provide guidance to toxicologic pathologists and other interested scientists on issues that involve Data Interpretation/Management, Study Design, Study Reports/Peer Review and several guidance documents dealing with organ systems and tissues that require unique approaches for evaluation. The STP strives to collaborate with allied global organizations for many of these position papers.
8:00 AM–11:30 AM
Regulatory Toxicology—In the FDA and Beyond
Chairs: Patricia Frank, Patricia Frank & Associates, Inc., and Shayne C. Gad, Gad Consulting Services
Many toxicologists are intimately involved in the design, conduct, and reporting of nonclinical studies. However, many of these professionals have a limited understanding of what happens to these reports after the studies have concluded. The aim of this course is to discuss the details of regulatory toxicology both from the perspective of regulatory affair specialists and regulatory toxicology with an emphasis on drugs and devices. A discussion of the role that toxicologists play in the regulatory environment will be presented considering both US and ex-US regulations. A regulatory affairs specialist will explain what regulators expect from toxicologist and regulatory toxicologists will explain their role in interactions with drug, biologic and device regulatory bodies. A panel discussion of all the presenters will answer specific questions from the participants.
8:00 AM–11:30 AM
Drug Line Extensions: Nonclinical Testing and Solutions
Chairs: David Jones, MHRA, and Paul Baldrick, Covance Laboratories Ltd
This Continuing Education course will examine what nonclinical testing needs to be considered for drug line extensions and/or new formulations. Talks will include EU and US regulatory agency experiences in this areas along with a perspective on nonclinical strategy and solutions for line extension development. In addition, case examples will be given for which additional nonclinical testing was needed for a change to the original drug. The session will appeal to toxicologists working in the pharmaceutical arena and also possibly consumer healthcare products.
8:00 AM–11:30 AM
Interpreting Adverse Clinical and Anatomic Pathology Results: Putting It all Together
Chairs: Mary Jane Hinrichs, MedImmune, and Lila Ramaiah, Huntingdon Life Sciences
This course will discuss the integrative approach required to interpret safety findings in toxicology studies. Specific focus will be placed on the need to evaluate the data in its entirety, as neither clinical nor anatomic pathology can be relied upon in isolation to fully understand the relationship between study findings and the test article. As such, the course content will involve a collaborative effort between clinical and anatomical pathologists, who will discuss how they work together to interpret and draw correlations between clinical pathology and anatomic pathology safety findings. The approaches used to interpret organ-specific findings and diagnose common systemic physiologic processes will be described using a combination of general principles and case examples. This course is intended for those interested in expanding their understanding of the approaches used to interpret test-article related findings in nonclinical safety studies.
1:00 PM–4:30 PM
Toxicology and Pathology of the Respiratory System
Chairs: Daniel T. Kirkpatrick, WIL Research Laboratories, LLC, and Torrie Crabbs, Experimental Pathology Laboratories, Inc.
The respiratory tract is a common target organ in toxicology studies. In order to determine the toxicological significance of effects in the nose, larynx, trachea, and lung, it is important to understand the basic structure and function of these tissues. Designing protocols for inhalation toxicology studies also requires knowledge of the current methods for evaluating respiratory structures and function. This session includes detailed reviews of nose, larynx, trachea, and lung of common laboratory species. There will also be a discussion on biomarkers, different tools used to determine treatment-related effects, and spontaneous and induced changes observed in each part of the respiratory tract.
1:00 PM–4:30 PM
(Q)SAR—A Tool for the Toxicologist
Chairs: Samantha Gad-McDonald, Gad Consulting Services, and Thomas J. Steinbach, Experimental Pathology Laboratories, Inc.
(Quantitative) Structure-Activity Relationships [(Q)SAR] methodologies use predictive computer modeling based on pre-defined rules or statistical tools to correlate biologic activity with the molecular structure or properties of a compound. (Q)SAR has applications in risk assessment, drug discovery, and regulatory decision making. Pressure within industry to reduce the cost of drug development and societal pressure for government regulatory agencies to produce more accurate and timely risk assessment of drugs and chemicals has necessitated the use of (Q)SAR. Producing a high-quality (Q)SAR model depends on many factors including the choice of statistical methods and descriptors, and the quality of the data input into the model. Understanding how a (Q)SAR model is developed and applied is critical to the successful use of such a powerful tool. This session will cover, from a toxicologist’s perspective, how to interpret (Q)SAR results; how regulatory agencies use and interpret (Q)SAR; practical applications of (Q)SAR in toxicology; and potential future application of (Q)SAR.
1:00 PM–4:30 PM
Managing Anti-Drug Antibody Responses during Biologics Drug Development
Chairs: Joerg Bluemel, MedImmune, and Suzanne Wolford, Covance Inc.
Immunogenicity of biotechnology-derived pharmaceuticals is frequently observed in nonclinical studies but can also affect clinical development. Anti-drug antibodies (ADA) are endogenous antibodies directed against a therapeutic protein which can also cross-react to other endogenous epitopes. The presence of ADA can have various biological consequences ranging from no biological relevance, to impact on pharmacokinetics or pharmacodynamic or even the occurrence of toxicities due to ADA. The impact of the occurrence of ADA on development strategies, their relevance for risk assessment and the necessity of mitigation strategies is highly dependent on their functional consequences.
1:00 PM–4:30 PM
Metabolites: Guidance and Considerations in Drug Development
Chairs: Holly Dursema, Boehringer Ingelheim Pharmaceuticals, Inc, and Kate E. Lane, Cubist Pharmaceuticals Inc.
This course will review guidance that currently exists for nonclinical assessment of metabolites discovered during drug development. This topic has matured over the last five years, therefore a review of the existing guidance and their application is timely. The objective of this course is to provide participants with and understanding of guidance and tools they may use to investigate human metabolites encountered during development. The first speaker will review current guidance documents and present ways to incorporate those assessments into drug development. The second speaker will discuss use of this guidance in assessment of a metabolite that is present in both animals and humans. The third speaker will discuss assessment of a disproportionate human metabolite and/or unique human metabolite. The final speaker will provide FDA perspective on evaluation of human metabolites. Time will be allotted for discussion of each aspect. The staging of the speakers has been done to familiarize the audience with guidance and progress them through the challenges that may be encountered in metabolite assessments. This course will be of interest primarily to members in the pharmaceutical field.