ACDRS 2024 Session 2 - Learning Trials: From Discovery to First in Human

This is Session 2 of 6. Must register for the entire 2024 Course and not per session.

Session Co-chairpersons:
Paolo Vicini, PhD, MBA, Chief Development Officer, Confo Therapeutics
Gary Skiles, PhD, Independent Consultant

Topics

(subject to change)

• Pharmacokinetics (PK), pharmacodynamics (PD) and absorption, distribution, metabolism, & excretion (ADME)
• Discovery chemistry
• Discovery of biologics
• Chemistry, manufacturing, and control (CMC)
• Selection criteria for therapeutic monoclonal antibodies
• Strategies and approaches for preclinical to clinical translation
• Intellectual property in drug discovery and development
• Strategies for predicting human PK, exposure-response, and safety
• Determinants of human PK variability
• Guidelines and Beyond for nonclinical toxicology
• Strategies for successful toxicology investigations
• Devices to support early drug development
• Functional genomics approaches for drug discovery