September 15, 2017
FDA White Oak Campus
Building 22, Conference Room 2205
Silver Spring MD
The FDA and the American Society of Clinical Oncology (ASCO) have expressed a willingness to leverage their combined strengths for the joint development 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, 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.
Sherwin Sapasap- firstname.lastname@example.org