This meeting will be held on September 15, 2017, in Silver Spring, MD.
FDA White Oak Campus
10903 New Hampshire Avenue
Silver Spring, MD 20993
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, etc)
- Expedited development programs (breakthrough therapy designation, fast track designation, etc)
- 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 will be open to physicians who have completed at least one year of hematology/ oncology fellowship training in an accredited U.S. training program and are currently in good standing in their fellowship program.