Continuing Education Course Descriptions

CE Course Agenda

Sunday, June 24—AM

CE 1: Mechanism-Based Approaches to Cardiovascular Safety Assessment

This session will explore current understandings of mechanisms of toxicity in the cardiovascular system and put that understanding in the context of how we do our nonclinical assessments. An introductory overview will bring the audience to a common level of understanding around cardiovascular form and function, potential cellular and molecular targets of toxicity, and bridge into the compromised target patient population. Subsequent sessions will explore contemporary and mechanistically-diverse areas of toxicity. Individual presentations will review our current level of understanding with respect to mechanisms of toxicity, review how current assessment paradigms address (or not) these mechanisms, and offer biomarker recommendations.

Career Development Workshop

Presentation Skills and Scientific Advocacy

Goals and Objectives:

• Develop an appreciation for the differences between an adequate and an excellent presentation.
• Begin building the skills required to design an effective, high-impact scientific presentation with a strong rhetorical and persuasive structure and deliver it with confidence and clarity.
• Improve ability to deliver strong scientific advocacy.
• Understand the challenges of formal presentations, including US FDA Advisory Committee meeting presentations.

Sunday, June 24—PM

CE 2: Nontraditional Applications of Clinical Pathology in Drug Discovery and Preclinical Toxicology

The objective of this unique clinical pathology course is to present and discuss contemporary examples of nonroutine applications of clinical pathology endpoints used in the drug development setting. Topics will be of interest to those with or without clinical pathology experience. Area experts will discuss bone turnover markers of laboratory animal species, clinical pathology of juvenile animals and nonroutine laboratory animal species and unique applications of the Advia Hematology platform.

CE 3: American College of Toxicology-Sponsored: Drug Development 101

Drug development is a term used to define the entire process of bringing a new drug or device to the market. It is an integrated, multidisciplinary endeavor which includes drug discovery chemistry and pharmacology, nonclinical safety testing, manufacturing, clinical trials, and regulatory submissions. This workshop will overview the contributions of each area, with a focus on safety assessment, and some of the challenges that can arise. The workshop will also cover the information that should be included in INDs and NDAs submitted to US FDA as well as advice on how to write a good IND/NDA.

CE 4: The Placenta As an “Immune Organ” and Its Relevance in Toxicological Studies

The immune system plays a key role in host protection against potential pathogens, as well as foreign (nonself) proteins and altered cells with tumorigenic potential. The foreign fetal nonself proteins cause an immunologic materno-fetal conflict which has to be resolved in the placenta. The maternal rejection apparatus and the primarily fetal tolerance mechanisms involve delicate and well-controlled immune processes which take place, in large part, in the placenta.