Preparing for success in modernizing the science behind the development and regulation of medical products
ACDRS 2025 Session 3 - Learning and Confirming Trials: Finding and Confirming the Right Dose
Date:
Wednesday, April 2, 2025 - 8:00 am to Friday, April 4, 2025 - 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 2025 Course and not per session.
Session Co-Chairpersons:
Diane K. Jorkasky, MD FACP, Consultant to Pharma
Stacey Tannenbaum, PhD FISoP
Lecturers
Philip Ambery, MD FRCP |
Global Clinical Head, Cardiovascular, Renal and Metabolism, AstraZeneca |
Theodore Danoff, MD PhD | Clinical Consultant and former CMO |
Jonathan French, ScD | Fellow and Science Advisor, J&J Innovative Medicine |
Christine Garnett, PharmD | Lead, Interdisciplinary Team for Cardiac Safety Studies and Clinical Analyst, Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration |
Eric A. Hughes, MD PhD | Executive Vice President R&D and Chief Medical Officer, Teva |
Diane K. Jorkasky, MD FACP | Consultant to Pharma |
Andy Lee |
SVP, Clinical Research, Global Clinical Development |
Dominic G. Spinella, PhD | Co-Founder and Partner, Translational Medicine Partners, Inc. |
Stacey Tannenbaum, PhD FISoP | |
Islam Younis, PhD MS | Senior Director, Cardiovascular and Metabolism TA Lead, Quantitative Pharmacology & Pharmacometrics, Merck |
Additional faculty - case study proctors
Charlie Gombar, PhD | ACDRS Director |
Chris Vinnard, MD PhD MSCE MS | Clinical Development Leader, Bill & Melinda Gates Medical Research Foundation |
others to be confirmed |
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
- Model Informed drug development
- Efficient evaluation of QT in early development
- Optimization of clinical trial design
- Industry view on challenges with global clinical trials
- Conundrums of the learning phase of drug development: safety
- Proof of concept
- Data utilization for decision making at the end of the learning phase