Preparing for success in modernizing the science behind the development and regulation of medical products
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
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