Continuing Education Courses
Sunday, June 27
CE1 (Sunday AM) 8:00 AM–12:00 Noon
- Stem Cell-Derived Therapy Nonclinical Safety Assessment
Co-Chairs: Kevin Keane, DVM, PhD, FIATP, Novo Nordisk A/S; Jerrold M. Ward, DVM, PhD, DACVP, Global VetPathology; and Ricardo Ochoa, DVM, PhD, DACVP, Pre-Clinical Safety Inc.
This continuing education course will cover the nonclinical aspects of stem cell-derived therapies intended for human disease indications requiring replacement tissues such as type I diabetes, Parkinson’s disease, ocular (macular) degeneration, and myocardial infarction. An introductory lecture on the current state of stem cell differentiation protocols and in vitro characterization will begin the course. The presentations will emphasize the design, implementation, and interpretation of nonclinical studies which are required for regulatory submissions. The topics covered will include considerations of the animal model, cell implant methods, immunological evaluation, and cell fate determination methods. Current regulatory guidances will be also covered and end-of-course panel discussion will be used to wrap up the course.
CE2 (Sunday AM) 8:00 AM–12:00 Noon
- Applications of Artificial Intelligence and Machine Learning in Toxicologic Pathology
Co-Chairs: Famke Aeffner, DVM, PhD, DACVP, Amgen; Oliver C. Turner, BSc(Hons), BVSc, MRCVS, PhD, DACVP, DABT, Novartis Institutes of Biomedical Research; and Manu S. Sebastian, DVM, PhD, DACVP, DABT, ACLAM, MD Anderson Cancer Center
Artificial intelligence (AI) and machine learning (ML) are transforming all aspects of health care—including drug development. This CE course aims at introducing this technology to toxicologists and toxicologic pathologists, as well as highlighting promise and pitfalls. To illustrate the power of machine learning, the session concludes with presentations highlighting practical applications, presented by colleages with hands-on experience.
CE3 (Sunday PM) 1:30 PM–5:30 PM
- Moving a Drug into the Clinic: Using PK/PD Modeling to Assess Benefit/Risk and Guide Dosing in Early Trials
(sponsored by the American College of Toxicology)
Co-Chairs: Ryan J. Hansen, PhD, Eli Lilly & Company; and Andrew Vick, PhD, Charles River Laboratories
The process of advancing potentially therapeutic molecules from discovery to early clinical trials can be costly, time consuming, and be associated with considerable uncertainty and risk. There are three key areas where uncertainty and risk need to be evaluated, and important decisions made regarding the future of a candidate molecule: transition to first-in-human development, predicting the human efficacious dose, and selecting the maximum recommended starting dose and dosing scheme for the first in human trial. In this session we will discuss how PKPD and other quantitative pharmacology approaches can be applied to provide a more quantitative assessment of feasibility and risk, and inform better decision making for drug candidates.
CE4 (Sunday PM) 1:30 PM–5:30 PM
- Biomarkers of Drug-Induced Liver Injury: The Past, Present, and Future
Co-Chairs: Tara P. Arndt, DVM, DACVP, Covance; and Shashi Ramaiah, DVM, PhD, DACVP, DABT, Pfizer, Inc.
Drug-induced liver injury (DILI) remains a primary cause of clinical attrition during drug development. To mitigate clinical attrition, there is a need for hepatic biomarkers that will improve accurate diagnosis, inform prognosis and mechanistic aspects of DILI. While traditional clinical laboratory biochemical tests are the basis of monitoring for liver toxicity in preclinical drug development; however, more sensitive and specific novel biomarkers may out-perform the current paradigm. This half-day session will review the performance of traditional and novel hepatic injury biomarkers and highlight recent progress in non-alcoholic steatohepatitis (NASH) biomarkers.
Continuing Education Chair:
Darlene Dixon, DVM, PhD, DACVP, NIEHS/NTP
Continuing Education Co-Chair:
Sanjeev Gumber, BVSc, MVSc, PhD, DACVP, Yerkes National Primate Research Center, Emory University