Workshop | Mixed
Event Title
FDA Office of Clinical Pharmacology and International Society of Pharmacometrics (ISoP) Public Workshop: Using Modeling and Simulation to Select Dosages for Combination Therapies and New Indications
November 9, 2023
- Date:
- November 9, 2023
- Time:
- 8:00 AM - 4:45 PM ET
About
The meeting will be held as a hybrid event, hosted from the Gaylord National Resort and Convention Center in National Harbor, Maryland, on November 9, 2023, 8:00am-4:45pm.
Goals and Objectives:
- To discuss best practices and methods to incorporate quantitative methods into the clinical development of oncologic products as a means to support dosage optimization that has been strongly advocated for in recent engagements.
- To describe the impact of dosage exploration on the benefit/risk assessment for oncologic drugs and highlight ongoing efforts from regulatory agencies, academic centers, and industry to shift current practices used to select dosages for investigation in clinical trials and identify the recommended dosage for marketing applications and labeling.
- To discuss development of investigational and approved drugs in new combination or disease setting using model-based approaches to select, support and investigate dosing regimen(s).
Who Should Attend:
This workshop is intended for interested parties regarding ongoing efforts; parties interested in continued advocacy for alternatives to traditional dose finding for oncologic drugs. The primary audience includes, clinical pharmacologists, pharmacometricians, pharmacologists/toxicologists, clinicians/healthcare providers, statisticians, patients, and patient advocates.
Registration:
Visit the ISOP website to register.
Agenda and Presenter Bios
Contact:
If to ISoP:
Jennifer Pastore Monroy, CAE
Executive Director, International Society of Pharmacometrics
jennifer.monroy@go-isop.org
Bridgewater, NJ 08807
If to FDA:
Bernadette Johnson-Williams, DHSc, MEd
Office of Clinical Pharmacology/OTS/CDER
Silver Spring, MD 21029
bernadette.johnson-williams@fda.hhs.gov