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Public | In Person

Event Title
FDA/CDER Office of Clinical Pharmacology and American Association for Cancer Research Public Workshop
February 15 - 16, 2024

Hybrid Event

Date:
February 15 - 16, 2024
Day1:
Thu, Feb 15 8:00 a.m. - 04:50 p.m. ET
Day2:
Fri, Feb 16 8:00 a.m. - 12:20 p.m. ET

FDA/CDER Office of Clinical Pharmacology and American Association for Cancer Research (AACR) Public Workshop: Quantitative Approaches to Select Dosages for Clinical Trials

The meeting will be held February 15 – 16, 2024 at the Grand Hyatt in Washington, DC, and as a virtual event.  AACR meeting link. 

  • Day 1: February 15- 8:00 am – 4:50 pm
  • Day 2: February 16- 8:00 am – 12:20 pm

Goals and Objectives:

  • To discuss best practices and methods for evaluating all nonclinical and clinical data and incorporating modeling and simulation to identify optimized dosages
  • To consider innovative clinical trial designs
  • To highlight ongoing efforts in academia, industry, and regulatory agencies

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, translational scientists, statisticians, patients, and patient advocates.

Contact

If to AACR:

Nicholas Warren, PhD
Assistant Director, Science and Regulatory Policy
American Association for Cancer Research
1401 H Street, NW, Suite 740
Washington, DC 20005
Email: RegSci@AACR.org

If to FDA:

Bernadette Johnson-Williams, DHSc, MEd
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Clinical Pharmacology/OTS
10903 New Hampshire Avenue 
Building 51, Office 5308
Silver Spring, MD 21029
Email: bernadette.johnson-williams@fda.hhs.gov
Tel: 301-796-8514

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