- November 05, 2019
08:30 AM - 04:00 PM EST
Co-Sponsored by the:
U.S. Food & Drug Administration (FDA) and American Society of Clinical Oncology (ASCO)
Date: November 5, 2019
Time: 8:30 am to 4:00 pm
Location: FDA White Oak Campus
Building 2, Conference Room 2058, 10903 New Hampshire Avenue, Silver Spring, MD 20993
The FDA and the American Society of Clinical Oncology (ASCO) intend to leverage their combined strengths for the joint development of the substantive actions of this workshop to provide current hematology and oncology fellows with a solid foundation in the process of oncology drug development and regulatory science.
Goals and Objectives:
At the close of this intimate, day-long workshop with intensive interaction with approximately two dozen FDA oncologists, the participants will have a basic knowledge of:
- Oncology drug regulation (overview of U.S. drug laws, the role of the FDA, drug shortages, direct-to-consumer advertising, and globalization of drug development).
- The Investigational New Drug (IND) process (what an IND is, when an IND is required, and what criteria are used by the FDA to decide if a research study may proceed).
- Expanded access programs (single patient INDs, emergency INDs, expanded access protocols).
- Disease-specific considerations (e.g., novel endpoints in specific diseases, biomarker development).
- Expedited development programs (e.g., breakthrough therapy designation, fast track designation).
- Clinical trial design (eligibility criteria, endpoint selection, designing appropriate comparator arms, and use of large expansion cohorts in first-in-human trials).
- Common errors in oncology drug development.
- Matching the right drug to the right patient through biomarker and companion diagnostic development.
This workshop is intended for current hematology/oncology fellows who have completed at least one year of fellowship training in an accredited U.S. training program and are currently in good standing in their fellowship program.
Dwayne Keels- firstname.lastname@example.org