UCSF

ACDRS 2023 Session 2 - Learning Trials: From Discovery to First in Human

Date: 
Wednesday, March 29, 2023 - 8:00 am to Friday, March 31, 2023 - 4:00 pm
Location: 
UCDC, 1st floor meeting room

1608 Rhode Island Ave NW, Washington DC

This is Session 2 of 6. Must register for the entire 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