ACDRS 2026 Session 3: Learning and Confirming Trials: Finding and Confirming the Right Dose

Must be registered in advance to attend.

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
• 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

Speakers

• Philip Ambery, MD FRCP, Global Clinical Head, Cardiovascular, Renal & Metabolism, AstraZeneca
• Theodore Danoff, MD PhD, Clinical Consultant and former CMO
• Jill Fiedler-Kelly, MS, President of Clinical Pharmacology and Pharmacometrics Services, Simulations Plus, Inc.
• Christine Garnett, PhD, Lead, Interdisciplinary Team for Cardiac Safety Studies and Clinical Analyst, Division of Cardiovascular and Renal Products, OND, CDER, US Food and Drug Administration (FDA)
• 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, Merck & Co, Inc.
• Rajanikanth Madabushi, PhD, Associate Director, Guidance and Scientific Policy, Office of Clinical Pharmacology, US FDA  
• Dominic G. Spinella, PhD, Co-Founder and Partner, Translational Medicine Partners, Inc.
• Stacey Tannenbaum, PhD FISoP, Consultant and Coach for the MIDD Community, SJTPharm LLC
• Islam Younis, PhD MS, Senior Director, Cardiovascular and Metabolism TA Lead, Quantitative Pharmacology & Pharmacometrics, Merck