Preparing for success in modernizing the science behind the development and regulation of medical products
ACDRS 2021 Session 3: Learning and Confirming Trials: Finding and Confirming the Right Dose
Date:
Monday, June 14, 2021 - 10:00 am to Friday, June 18, 2021 - 3:00 pm
Location:
virtual/online
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
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 |
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 |
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