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

Olena Barbash, PhD

Vice President, Biomarkers and Translational Research, EMU, GSK

  
Leslie Floren, PharmD PhD MA

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

  
Brandon W. Higgs, PhD Vice President, Translational Data Sciences, Genmab  
Diane K. Jorkasky, MD FACP Consultant to Pharma  
Lois D. Lehman-McKeeman, PhD ATS Vice President, Pharmaceutical Candidate Optimization, Bristol Myers Squibb  
Michael Maitland, MD PhD

Vice President, Clinical Development, Pathos

  
Saileta Prabhu, PhD Senior Director, Clinical Pharmacology, Regeneron  
Bill Richards, PhD Vice President, Target & Drug Discovery, 23andMe  
Gary Skiles, PhD Independent Consultant  
Paolo Vicini, PhD MBA Chief Development Officer, Confo Therapeutics  
Scott Wasserman, MD Chief Medical Officer, Kailera Therapeutics  
others to be confirmed    

Additional faculty - case study proctors

Charlie T. Gombar, PhD ACDRS Director
David Holtzman, MD PhD Clinical Development Leader, Bill & Melinda Gates Medical Research Foundation
Christopher Vinnard, MD PhD MSCE MS Clinical Development Leader, Bill & Melinda Gates Medical Research Foundation

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
  • Co-development of biomarkers, companion diagnostics and devices
  • Guidelines and beyond for nonclinical toxicology
  • Strategies for successful toxicology investigations
  • CRISPR
  • Artificial intelligence and machine learning in translational and early clinical applications