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

Full map

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

Lecturers

Theodore Danoff, MD PhD Chief Medical Officer, Pathalys Pharma, Inc.
Dennis Fisher, MD Principal, The “P Less Than” Company

Michael J. Fossler, PharmD PhD

 Vice President, Quantitative Sciences, Trevena
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
Andy Lee Senior Vice President, Global Clinical Trial Operations, Merck & Co., Inc. 
Dominic G. Spinella, PhD Co-Founder and Partner, Translational Medicine Partners, Inc.
Stacey Tannenbaum, PhD FISoP Vice President, Scientific Engagement, Metrum Research Group

Additional faculty - case study proctors

Philip Ambery, MD FACP Global Clinical Head, CVRM, AstraZeneca
Joshua Galanter, MD

Senior Medical Director, gRED OMNI Early Clinical Development, Genentech
Divya Mohan, MD PhD Global Development Leader, Genentech
 

 

Topics

  • 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
  • Industry view on challenges with global clinical trials
  • Exposure response and drug-drug interaction
  • Optimization of clinical trial design
  • Conundrums of the learning phase of drug development: efficacy and safety
  • Proof of concept
  • Data utilization for decision making at the end of the learning phase