Preparing for success in modernizing the science behind the development and regulation of medical products
ACDRS 2024 Session 3 - Learning and Confirming Trials: Finding and Confirming the Right Dose
Date:
Wednesday, April 3, 2024 - 8:00 am to Friday, April 5, 2024 - 4:00 pm
Location:
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
Topics
(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