Preparing for success in modernizing the science behind the development and regulation of medical products
ACDRS 2023 Session 3 - Learning and Confirming Trials: Finding and Confirming the Right Dose
Date:
Wednesday, April 26, 2023 - 8:30 am to Friday, April 28, 2023 - 4:00 pm
Location:
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
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 |
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 |
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