ACDRS 2023 Session 3 - Learning and Confirming Trials: Finding and Confirming the Right Dose

Wednesday, April 26, 2023 - 8:30 am to Friday, April 28, 2023 - 4:00 pm
UCDC, 1st floor meeting room

1608 Rhode Island Ave NW, Washington DC

This is Session 3 of 6. Must register for the entire 2023 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


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
Steven Shafer, MD Professor Emeritus, Anesthesiology, Perioperative and Pain Medicine, Stanford University
Brian Smith, PhD Executive Director, Biostatistics, Novartis
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

David Chu, MD PhD FAAD VP, Clinical Development, Arcutis
Brian Gilleland

Director, PCM Deliverable Teams, Immunology-Neurology TA Lead, AbbVie

Dustin Little, MD Global Clinical Lead, Nephrology, AstraZeneca
Victoria Sanjurjo, MD

Director, Clinical Development, Ionis


  • 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