Sunday, November 17

Continuing Education (CE) courses are 3.5 hours each and are held either Sunday morning (AM: 8:00 AM–11:30 AM) or Sunday afternoon (PM: 1:00 PM–4:30 PM). Preregistration is required, and seating is limited.

Continuing Education course books will be provided exclusively in electronic format and will be available to course registrants in advance of the Annual Meeting.

Morning Courses (AM) 8:00 AM–11:30 AM

This Continuing Education course will review the essential aspects of the role and responsibilities of the study director. For Part A, the presentations will include topics relevant for study directors, including a review and history of GLP regulations, managing and addressing the challenges of multisite studies, and designing toxicology studies to meet evolving animal welfare expectations. This course is an excellent introduction for new study directors and a great refresher course for experienced study directors. All students who complete the course will receive a certificate for course participation, which can be used for continuing education credits.

The immune system consists of four major components: (1) mediators that call in and activate immunological cells, (2) cells mediating innate immunity, (3) cells mediating cell-mediated immunity, and (4) cells responsible for humoral immunity. In addition, the vast network of lymphoid cells interacts with both lymphoid and nonlymphoid cells as well as cellular products to create a functionally intact immune system. Positive and negative feedback control mechanisms govern many of the circuitous immune networks. If the normal function of a network of cell-to-cell or cell-messenger interaction is perturbed or altered, the host may risk disease or death. Either a decrease (immune suppression) or an increase (immune enhancement) in the interactions or production of cellular products may cause deleterious health effects. The physiologic ideal is a homeostatic network of interactions and cascade effects with the proper positive and negative controls. Many assays are available to evaluate potential immunotoxic effects of small molecule pharmaceuticals and chemicals. The advent of biologics, their species specificity, and changes and advances in that field have posed some unique challenges in assessing immunotoxicity. This course will provide an introduction to the immune system and information on how to utilize existing and novel assays to design a thorough immunotoxicology safety assessment that evaluates all three arms of the immune response: innate immunity, cell-mediated immunity, and humoral immunity.

Functioning effectively as a toxicologist to advance development of a new drug product requires a breadth of skills beyond classical scientific training. Before even designing a toxicology study, critical data need to be obtained from colleagues in CMC, pharmacology, pharmacokinetics, clinical, and management roles. As data is generated, it needs to be thoughtfully interpreted but also thoughtfully communicated to a range of audiences to guide decision-making. This course will discuss how to initiate a toxicology program, how to communicate with team members to facilitate everyone’s progress toward the next milestone, and how to meet a range of challenges encountered in evaluating safety in diverse business contexts, such as moving from late-stage discovery to early-stage development and through to marketing application across various therapeutic modalities and disease areas.

Pharmaceutical impurities are a natural part of drug development. Chemistry, Manufacturing, and Controls (CM&C) and toxicology experts work together to test and control impurities. Lack of control for impurities can result in concerns for both the safety and the quality of a pharmaceutical. Throughout pharmaceutical development, impurities are evaluated for mutagenic concern. Mutagenic impurities are typically controlled to lower levels than nonmutagenic impurities. Nonmutagenic impurities are controlled at or below the qualification threshold, and higher exposures may require additional animal testing. These presentations will describe the regulatory, scientific, and toxicological aspects of impurities. They will also discuss recent developments and scientific/regulatory changes on the horizon.

It is well known that successful preclinical safety assessment studies depend on reliable and accurate data, which usually include critical contributions from anatomic and clinical pathology. There are numerous pathology publications that provide insights and recommendations that reliably improve pathology data and overall study outcomes when implemented. This Continuing Education course will present 10 of the most important pathology-related concepts, with practical recommendations that toxicologists can utilize in their preclinical studies. These concepts include using recommended anatomic and clinical pathology study designs, communicating information with the study pathologist before the evaluation, understanding what constitutes a properly trained toxicologic pathologist, following recommended histopathology evaluation practices, how best to determine and use adverse pathology data optimally, using pathology diagnostic terminology that is globally harmonized and SEND compliant, knowing when and when not to use pathology historical control data, implementing pathology quality control measures such as pathology peer review, and following recommended pathology reporting practices. This course will be presented by globally recognized toxicologic pathologists that have actively promoted and authored publications on these topics.

Afternoon Courses (PM) 1:00 PM–4:30 PM

This Continuing Education course will review the essential aspects of the role and responsibilities of the study director. Part B will concentrate on the science involved in toxicology studies and will help attendees understand how to evaluate data generated. Presentations will be made regarding immunotoxicology, biomarkers, anatomic pathology, and regulatory expectations for an IND package. This course is an excellent introduction for new study directors and a great refresher course for experienced study directors. All students who complete the course will receive a certificate for course participation, which can be used for continuing education credits.

This Continuing Education course is intended to be an overview of the nonclinical testing practices and paradigms for gene and cell therapy products, with perspectives from industry, CROs, and the US Food and Drug Administration.

There are myriad opportunities to meet with regulators during all stages of drug development—from early discussions before any formal submission to formal meetings at prescribed stages of development. Across the various regions (the US, the EU, and China), there are important differences in timing of submission, submission content, meeting expectations, and regulatory feedback. This session will take a step-by-step approach, focusing on the US, the EU, and China separately. The final presentation will bring together some general principles of meeting preparation, etiquette, and tips for a more successful and effective interaction.

This course will provide an overview of safety assessment of metabolites in pharmaceutical drug discovery and development while incorporating key contemporary topics. The objective of this course is to provide participants with an understanding of current guidance, safety implications of metabolites, approaches for metabolite assessment, and key challenges. After providing the groundwork of existing guidance, basic concepts of new chemical entity (NCE) metabolism will be discussed. This will include CYPs and transporters as well as metabolic considerations for non-small molecules (e.g., linkers). Challenges that may be encountered with disproportionate human metabolites will be reviewed and relevant case studies provided. A US Food and Drug Administration perspective on safety assessment of metabolites, along with case studies, will be presented. The course material will ensure participants are familiar with guidance expectations and the challenges that may be encountered in metabolite assessments.

Numerous nonclinical-related ICH guidances are currently under development, undergoing revisions, or developing question and answer documents to clarify issues. In this session, speakers will provide background information regarding the current ICH guidances S1, S7B/E14, M7, S5, and S11 and will update the audience on current activities of the Expert Working Groups. These include a new S11 guidance addressing the need for and conduct of juvenile animal studies, a newly developed Concept Paper on clinical QT assessments, a Q&A document for ICH M7 as well as addition of new compounds to the addendum, a revised S5 guidance on developemental toxicity, and a current exercise evaluating the need for two carcinogenicity studies (S1).