Continuing Education Course Descriptions

Final Program

CE Course Materials

The 2013 course materials are available in electronic format only. You will need to access the course materials online where you will be able to view, download, and print your materials. The links are provide below.

Each course materials page is password protected and is only accessible to those currently registered for the Course. If you are an STP Member, please use your regular member login. If you are a nonmember, please refer to the email sent in late May and early June with your login information to access meeting materials. If you are unable to find your login information, please contact STP Headquarters.

CE 1: Role of the Pathologist in GLP Studies

CE 2: Inflammatory Biomarkers—Sponsored by the STP Clinical Pathology Special Interest Group (CPIG)

CE 3: Juvenile Animal Studies in Pediatric Drug Development—Sponsored by the American College of Toxicology (ACT)

CE 4: Immunogenicity/Hypersensitivity of Biologics

Sunday, June 16—AM

CE 1: Role of the Pathologist in GLP Studies

There are many roles that toxicologic pathologists serve in regard to toxicology and carcinogenicity studies. This session will provide a summary of the many different tasks performed by pathologists throughout differing stages of evaluations, describe expectations of each phase of pathology review, and explore their relationships with the Study Director, Sponsor, and other pathologists. Also to be discussed is the issue of what constitutes study raw data and what is to be included in the toxicology report. The roles of the Study Pathologist, Peer Review Pathologists, Pathology Working Group Chairperson and participants of Pathology Working Groups (PWGs) or Scientific Advisory Panels (SAPs) will be detailed along with the applicable GLP regulations and best practices for pathology evaluations.

Career Development Workshop

Environmental Toxicologic Pathology

The 2013 Career Development Workshop will feature speakers on a wide range of topics in environmental toxicologic pathology. Dr. Jeff Wolf, of EPL, will present a basic overview of alternative models in environmental toxicologic pathology, including amphibians and fish, information on continuing training in alternative model species pathology, and the future of alternative model use. Dr. Tabitha Viner, from the US Fish & Wildlife Service Forensic Pathology laboratory, will present on the role of the veterinary pathologist in wildlife forensic investigations, focusing on forensic investigations of oil, lead, and other toxicities in wildlife. Dr. Charles Wood, from the US Environmental Protection Agency, will discuss the role of the veterinary pathologist in the regulatory field of environmental toxicology. The workshop will conclude with a roundtable discussion involving all of the speakers.

Sunday, June 16—PM

CE 2: Inflammatory Biomarkers—Sponsored by the STP Clinical Pathology Special Interest Group (CPIG)

Drug-induced toxicity to the immune and inflammatory systems encompasses a wide variety of adverse effects, ranging from exaggerated pharmacology (intended immunomodulation), to immunotoxicity (unintended immunosuppression or immune stimulation), drug-induced hypersensitivity and autoimmunity. Inflammatory biomarkers are valuable tools for the identification, characterization and monitoring of effects. Inflammatory biomarkers, often themselves mediators of inflammatory and immune responses, include cytokines, acute phase proteins, complement, and hemostatic proteins. This session explores the current use of inflammatory biomarkers in preclinical safety assessment. Topics encompass the evaluation of acute phase proteins, cytokines and complement in rodent and large animal models of inflammation. Emphasis is on relevance, utility, application, and use of inflammatory biomarkers, as well as on their translatability and predictivity from in vitro to in vivo models and from nonclinical to clinical settings. Factors that influence study design and biomarker selection, including preanalytical and analytical considerations, technologies and platforms, and species differences will be discussed. The session also includes short case studies with opportunity for open discussion with audience members.

CE 3: Juvenile Animal Studies in Pediatric Drug Development—Sponsored by the American College of Toxicology (ACT)

This course will provide guidance on the current US and EU nonclinical regulatory requirements and toxicity study considerations when preparing for pediatric clinical trials, as well as the timing of juvenile toxicity studies. Regulatory presentations will include current pediatric regulations in US and EU as well as Paediatric Investigation Plan (PIP) evaluation procedures by the Nonclinical Working Group of the Paediatric Committee (PDCO) in EMA. Speakers from the industries will share their experience in designing and conducting juvenile animal studies, and scientific considerations when designing a nonclinical program to support pediatric drug development. Both small molecule and large molecule (biologics) pharmaceuticals will be discussed. The speakers will also discuss results of surveys for juvenile animal studies conducted across the pharmaceutical industry with both new chemical entities and new biological entities. The course will end with a panel discussion where speakers will address questions or comments from attendees.

CE 4: Immunogenicity/Hypersensitivity of Biologics

Biologics are becoming more common in the pharmaceutical industry, have shown significant therapeutic benefit in many indications, and hold great promise in many other indications that are currently being studied. However, administration of biologics to animals or humans can be immunogenic, which in some cases may result in hypersensitivity reactions. These reactions can be minimal to severe, and quite variable between individuals. It can sometimes be challenging to differentiate on-target, pharmacologically-mediated effects from hypersensitivity, thus confounding study interpretation. However, such differentiation is often critical, because immunogenicity and hypersensitivity reactions in animals are generally not considered predictive of what will occur in humans, and thus associated findings are usually not considered relevant to humans (in contrast to on-target pharmacologic effects which often are relevant). This session will review different types of hypersensitivity reactions, methods of assessing immunogenicity and hypersensitivity reactions, and cover the changes that pathologists might observe in studies where these reactions are occurring.