- November 16, 2021
9:00 AM - 3:00 PM ET
FDA-ASCO Hematology and Oncology Fellows Day Workshop. The meeting will be held November 16, 2021, as a virtual event.
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.
Who Should Attend:
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.
Applications are due Monday, September 27, 2021.
If to ASCO: Nike Alade firstname.lastname@example.org
If to FDA: Caitlin Drew email@example.com