Continuing Education Course Descriptions

Program Agenda

Sunday, June 19—AM

CE 1: Interacting with Regulatory Authorities: What to Do and What Not to Do (Repeats as CE 5)

During the process of drug development, a Sponsor will need to interact with regulatory authorities (RA), such as the FDA, PMDA, and the EMA. In order to effectively interact with these agencies, the Sponsor must remember that the RA are partners in the drug development process. Similar to sponsors, RA have a genuine concern about the well being of the patients. Sponsors and patients will also benefit from the considerable institutional knowledge of RA about study designs, toxicity, pharmacology, and drug disposition of other drugs. This course will discuss how to effectively interact with the RA so that Sponsors and RA can gain the greatest benefit from their meetings.

CE 2: Novel Biomarker Discovery, Qualification, and Application in Drug Development: What’s New, What’s Used, and What’s New, Used and Successful

Staying abreast of the biomarker field is no longer a pursuit of interest only to early drug discovery and safety scientists. The success of consortium driven biomarker discovery efforts and their recent approval by regulatory agencies has thrust the biomarker field to the forefront across all facets of drug development. Remaining up to date on the most promising novel biomarker discoveries, being alert to biomarkers currently seeking regulatory approval and understanding the utility and translational impact of newly approved preclinical safety biomarkers is a daunting task that falls primarily on the shoulders of safety pathologists. The first part of this course is aimed to highlight novel biomarker discovery efforts in carcinogenicity and genomics; two fields poised to revolutionize safety biomarkers in their respective fields. The second part of the course is devoted to revisiting recent advances, new regulatory submissions and examining the real world impact and utility of the more familiar renal and cardiac toxicity biomarkers. Practical aspects of study design, sample collection, techniques, analysis and interpretation will also be addressed to provide the participant with a well rounded and applicable session.

Career Development Workshop

Leaving the Rat Race: Consulting As a Career Choice in Toxicologic Pathology

(Free Event; Registration Required)

So, you’ve been laid off! Or, maybe you just retired but still want to keep the cash flowing. Maybe all those mindless meetings are starting to get to you. Perhaps you are seeking new ways to use your special knowledge and skills. Even in this tight economy, becoming a full-time or part-time consultant in toxicologic pathology might provide you with an exciting and viable new career path. But, do you know what it takes, and do you have what it takes to successfully operate as a consultant? This workshop, led by long-time consultants with experience in anatomic and/or clinical pathology as well as management of preclinical programs, will help you answer these questions. Partially based on the compiled results of a questionnaire recently completed by members of TOPIC, this workshop will provide a practical approach for successfully planning, starting, and maintaining a consulting career. A panel discussion will allow the audience to interact further with consultant colleagues to gain the most benefit from their tips, tricks, troubles, and triumphs.

Workshop Flyer

Sunday, June 19—PM

CE 3: Histopathology of the Rodent Lymphoid and Hematopoietic Systems

This continuing education session will set the stage for the general meeting by providing a broad overview of histopathology of the lymphoid and hematopoietic organs and tissues. The first lecture is designed to provide attendees with a comprehensive review of normal morphology of bone marrow, thymus, spleen, lymph nodes and MALT as a basis for appreciating material in subsequent sessions. The use of specialized techniques important for the identification and observation of hematopoietic cells and tissues will be explored. Immunohistochemistry enables pathologists to study normal antigen expression in hematopoietic cells, identify cell populations in inflammatory lesions and diagnose hematopoietic disorders. In vivo intravital microscopy is an exciting recent modality that allows the activities of fluorescently labeled living cells to be observed in intact tissues in real time. Some of the more challenging aspects of diagnostic immunopathology will be discussed, including the differentiation of reactive and neoplastic lesions and the diagnosis of hematopoietic neoplasia in CD1 mice.

CE 4: Ultrastructural Analysis and Toxicologic Pathology

Electron microscopy is a powerful technique that can help illustrate the subcellular localization of toxic injury. It can serve to provide useful insights into the nature of the toxicologic insult, its mechanism, and may even help in risk assessment. As such electron microscopy can effectively compliment other molecular techniques in developing a comprehensive toxicologic assessment of a molecule. This continuing education course aims to re-enforce the technique for practicing toxicologic pathologists and to fill knowledge gaps vis a vis the latest advances in the field of electron microscopy. Following an introduction in ultrastructural landmarks, the speakers will attempt to highlight the role of ultrastrucutral investigations in variety of toxicologic processes. By drawing on specific case studies the speakers will attempt to elucidate the techniques, proper interpretation of electron microscopy data, and its synergies with various other investigative molecular techniques. Finally, latest advances in the field such as dual beam tomography and role in nanoparticle research will be discussed.

CE 5: Interacting with Regulatory Authorities: What to Do and What Not to Do (Repeats as CE 1)

During the process of drug development, a Sponsor will need to interact with regulatory authorities (RA), such as the FDA, PMDA, and the EMA. In order to effectively interact with these agencies, the Sponsor must remember that the RA are partners in the drug development process. Similar to sponsors, RA have a genuine concern about the well being of the patients. Sponsors and patients will also benefit from the considerable institutional knowledge of RA about study designs, toxicity, pharmacology, and drug disposition of other drugs. This course will discuss how to effectively interact with the RA so that Sponsors and RA can gain the greatest benefit from their meetings.