ACDRS 2021 Session 3: Learning and Confirming Trials: Finding and Confirming the Right Dose

Monday, June 14, 2021 - 10:00 am to Friday, June 18, 2021 - 3:00 pm

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


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
Charlie T. Gombar, PhD ACDRS Director
Eric A. Hughes, MD PhD Global Head Clinical Development & Analytics (CD&A) and DCN China Head, Novartis Pharma AG

Diane K. Jorkasky, MD FACP

Consultant to Pharma
Sarah Schrieber, PharmD Pharmacologist, Scientific Review Staff, Office of Therapeutic Biologics and Biosimilars, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA)
Steven Shafer, MD Professor of 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

Gustavo Büchele, MD PhD Executive Director, Clinical Development, Ionis Pharmaceuticals
Natalia I. Chalmers DDS MHSc PhD Dental Officer, Division of Dermatology and Dentistry, CDER, US FDA
William Haddock, MD MPH MSHS Vice President, Safety, Ovid Therapeutics
Thomas Hucko, MD Clinical Research Medical Director, Cardiovascular/Metabolic Diseases, Amgen
Deena Kegler-Ebo, MD MBA MS Associate Director, Medical Affairs, Clinical Development, Acorda Therapeutics
Joseph Park, MD PhD Clinical Research Medical Director and Molecular Genetics Director, Amgen
Holly Roberts, MD Vice President, Medical Affairs, Ovid Therapeutics
Robert Schuck, PharmD PhD Deputy Director (Acting), Division of Translational and Precision Medicine, Office of Clinical Pharmacology, CDER, US FDA
Gary Skiles, PhD Consultant


  • 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