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

Full map

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