ACDRS 2025 Session 2 - Learning Trials: From Discovery to First in Human

Date: 
Wednesday, March 5, 2025 - 8:00 am to Friday, March 7, 2025 - 4:00 pm
Location: 
UCDC, 1st floor meeting room

Full map

1608 Rhode Island Ave NW, Washington DC

This is Session 2 of 6. Must register for the entire 2025 Course and not per session.

Session Chairperson:
Paolo Vicini, PhD, MBA, Chief Development Officer, Confo Therapeutics

Lecturers

Leslie Floren, PharmD PhD MA

Associate Dean of Fellowships and Professor, Clinical Pharmacy, School of Pharmacy, UCSF

  
Diane K. Jorkasky, MD FACP Consultant to Pharma  
Paolo Vicini, PhD MBA Chief Development Officer, Confo Therapeutics  
others to be confirmed    

Additional faculty - case study proctors

Charlie T. Gombar, PhD ACDRS Director
others to be confirmed  

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
  • 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
  • Artificial intelligence and machine learning in translational and early clinical applications