ACDRS 2022 Session 3 - Learning and Confirming Trials: Finding and Confirming the Right Dose

Date: 
Monday, April 11, 2022 - 10:00 am to Friday, April 15, 2022 - 3:00 pm
Location: 
virtual/online

This is Session 3 of 6. Must register for the entire 2022 Course and not per session.

Session Co-Chairpersons:
Diane K. Jorkasky, MD FACP, Consultant to Pharma
Michael J. Fossler, PharmD PhD, Vice President, Quantitative Sciences, Trevena

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 (FDA)
Charlie T. Gombar, PhD ACDRS Director
Eric A. Hughes, MD PhD Senior Vice President, Clinical Development, Vertex

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 Senior Director, Pharmacometrics US, Clinical Pharmacology and Exploratory Development, Astellas Pharma

Additional faculty - case study proctors

Daniel Abramzon, MBS Project Team Leader, gRED Portfolio Management & Operations, Genentech, A Member of the Roche Group
Kemal Asik, PhD

Lead Clinical Scientist, Product Development Neuroscience, Genentech, A Member of the Roche Group
Lisa Boyette, MD PhD Vice President, Medical Affairs, Recursion
David Chu, MD FAAD Executive Director, Clinical Development, Arcutis
Joshua Galanter, MD

Lead Medical Director, gRED OMNI Early Clinical Development, Genentech, A Member of the Roche Group
William Haddock, MD MPH MSHS Vice President, Pharmacovigilance and Safety, Ovid Therapeutics
Dustin Little, MD Global Clinical Lead, Nephrology, AstraZeneca
Robert Schuck, PharmD PhD Deputy Director (Acting), Division of Translational and Precision Medicine, Office of Clinical Pharmacology, CDER, US FDA
Edmond Teng, MD PhD Senior Medical Director, gRED Early Clinical Development, Genentech, A Member of the Roche Group
others to be confirmed  

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: Efficient evaluation of QT in early 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