Continuing Education Course Descriptions

Program

Sunday, June 22—AM

CE 1: Biomarkers of Endocrine Effects and Reproductive Toxicity

The evaluation of endocrine and reproductive clinical pathology endpoints in nonclinical safety studies presents a unique set of preanalytical, analytical, and interpretative challenges to the regulatory scientist. Regulatory guidance does not require the inclusion of these endpoints in traditional safety studies; however, they are sometimes incorporated without appropriate consideration for their use. These sessions will provide an overview of the current principles and approaches to assessing toxicity of the endocrine and reproductive systems with an emphasis on the appropriate selection and utility of endocrine biomarkers. Discussions will focus on regulatory requirements for the inclusion of these markers as well as strategies used in the pharmaceutical industry and drug development. These sessions will be of interest to both industry and regulatory pathologists and scientists.

Career Development Workshop

Effective Communication of Pathology Results in Regulatory Studies

Information to come.

Sunday, June 22—PM

CE 2: Scientific and Regulatory Considerations in the Safety Evaluation of Stem Cell-derived Therapies in Preclinical Studies

Stem cell-derived products have the potential to treat a diversity of medical conditions, many with unmet medical needs. The properties of stem cells, such as their differentiation and proliferative potential, pose safety concerns unique from those of small molecule drugs and other macromolecule biologics. These cellular products carry risks associated with localized host tissue response, long term persistence, ectopic tissue formation, differentiation to undesired cell and tissue types, off-target distribution, tumorigenicity, and immunogenicity. These risks are generally evaluated in preclinical studies as part of a comprehensive preclinical safety program prior to administration in humans. However, safety assessment for these products can be challenging due to inadequately defined host tissue responses to these products and due to the lack of standardized approaches in evaluating in vivo host responses. A primary goal of this session is to introduce this product class to the toxicologic pathology community and provide a forum for discussion of the scientific and the regulatory considerations in the evaluation of host responses to stem cell-derived therapies.

CE 3: Fundamentals of Translational Neuroscience in Toxicologic Pathology: Optimizing the Value of Animal Data for Human Risk Assessment

Extrapolation of animal data to predict possible human outcomes is an elemental conundrum in drug discovery and development. This problem often is of particular significance when investigating therapuetic candidates with neuractive properties or that induce structural alterations in the central nervous system (CNS), especially when the portfolio management process and/or regulatory review are given to individuals with limited or no formal training in neurobiology. This session is designed to impart fundamental information on basicneurobiological principles necessary for pathologists, toxicologists, and regulators to gain confidence in their abilities to translate CNS structural changes in test animals for risk assessment in humans. The last talk is included as a practical example regarding the application of such principles to address a current issue facing many pharmaceutical companies and regulatory agencies.

CE 4: The Art of Study Monitoring and Pathology Peer Review: How to Maintain a Relationship of Mutual Respect with CROs

One of the most important decisions a company can make is to outsource the responsibility of conducting regulatory required studies. Therefore, oversight of this activity can be imperative to assure that adequate protection and safety are involved to maintain the quality and integrity of the resulting data. While the study director is ultimately responsible for the study, with proper oversight and communication the sponsor standards can still be met. Effective study monitoring and peer review through preparation, transparency, continuing education and effective communication can help remediate unexpected findings, clarify discrepancies, and decrease the time for issue resolution within expedited timelines if a solid working relationship has been established with the contract research organization (CRO). Establishing a working relationship with CROs may require visits to the facilities, an in-depth review of data, QA, AALAC, and laboratory procedures and reviewing interim updates. It also requires an in-depth knowledge of individual CRO capabilities and study management skills. This CE will focus on expectations of study monitors, peer review pathologist, CRO study directors, and CRO pathologist; and will offer skills to reduce program drift, late reporting, conflicting deadlines and corrective actions. This would appeal to pharmaceutical, chemical, contract, and medical device industries.