CE 1: First-in-Human Dose Selection: Translational Strategies and Special Considerations across Modalities and Organ Systems

Accurate and scientifically justified first-in-human (FIH) dose selection is a critical component of drug development and fundamental to patient safety. This Continuing Education course will provide a comprehensive and integrated overview of approaches used to translate nonclinical findings into safe and pharmacologically relevant FIH doses across therapeutic modalities, routes of administration, and target organ systems. In addition, special cases such as oncology indications, gene/cell therapy, and rare diseases will be discussed. The course will begin with a review of established methodologies (e.g., no-observed-adverse-effect level (NOAEL)-based and allometric scaling) and will progress to advanced model-informed strategies. Building on this foundation, subsequent sessions will explore the unique challenges of dose translation for therapeutics administered to specialized compartments such as the central nervous system, eye, and the respiratory tract. Particular emphasis will be placed on modalities for which conventional guidance may be limited or not directly applicable, including gene and cell therapies, and other targeted delivery technologies.

CE Course Chair: Ewa Budzynski, PhD, DABT – Boehringer Ingelheim
CE Course Chair: Helen Booler, DVM, DipECVP, PhD – Novartis
CE Course Speaker: Todd Bourcier, PhD – White Oak Regulatory Tox, LLC
CE Course Speaker: Leanne Bedard, PhD, RAC, DABT – Bedard ADME-Tox Solutions
CE Course Speaker: David R. Compton, PhD, DABT – Akkeri, Inc.
CE Course Speaker: Renee Bergeron, MS, PhD, DABT – Novartis Biomedical Research