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, Vice President, Scientific Engagement, Metrum Research Group

Lecturers

Philip Ambery, MD FRCP

Global Clinical Head, Cardiovascular, Renal and Metabolism, AstraZeneca
Theodore Danoff, MD PhD CMO and VP, Clinical Development. Pathalys
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
Charlie T. Gombar, PhD ACDRS Director
Eric A. Hughes, MD PhD Executive Vice President R&D and Chief Medical Officer, Teva
Diane K. Jorkasky, MD FACP Consultant to Pharma
Rajanikanth Madabushi, PhD Associate Director, Guidance and Scientific Policy, Office of Clinical Pharmacology, Office of Translational Sciences, CDER, US FDA (to be confirmed)
Stacey Tannenbaum, PhD FISoP Vice President, Scientific Engagement, Metrum Research Group
others to be confirmed  

Additional faculty - case study proctors

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
  • FDA’s Quantitative Medicine Center of Excellence
  • 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