ACDRS 2024 Session 3 - Learning and Confirming Trials: Finding and Confirming the Right Dose

Wednesday, April 3, 2024 - 8:00 am to Friday, April 5, 2024 - 4:00 pm
University of California Washington Center (UCDC), 1st floor meeting room

1608 Rhode Island Ave NW, Washington DC

This is Session 3 of 6. Must register for the entire 2024 Course and not per session.

Session Co-Chairpersons:
Diane K. Jorkasky, MD FACP, Consultant to Pharma
Michael J. Fossler, PharmD PhD,
Executive Consultant/Vice-President, Strategic Consulting, Cytel


(subject to change)

  • Choosing doses/exposures for first in human studies, and the role of pharmacokinetics-pharmacodynamics (PKPD) modeling and simulation
  • Biomarker strategy and qualification for efficacy and safety
  • Developing drugs from first in human dosing to understanding dose-exposure-response in patients – efficacy and safety
  • Regulatory perspective: Utilizing pharmacodynamic biomarkers in drug development
  • Quantitative principles for drug development decision-making
  • Dose-exposure ranging in early drug development
  • Exposure response and drug-drug interaction
  • Optimization of clinical trial design
  • Conundrums of the learning phase of drug development
  • Proof of concept
  • Data utilization for decision making at the end of the learning phase