February 23, 2017

Location:

FDA White Oak Campus, Silver Spring, MD
Building 22, Conference room 2205

I. Background

The FDA and the American Society of Clinical Oncology (ASCO) have expressed a willingness 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:

1. 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).
2. 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).
3. Expanded access programs (single patient INDs, emergency INDs, expanded access protocols).
4. Disease-specific considerations (e.g., novel endpoints in specific diseases, biomarker development, etc.).
5. Expedited development programs (breakthrough therapy designation, fast track designation, etc.).
6. Clinical trial design (eligibility criteria, endpoint selection, designing appropriate comparator arms, and use of large expansion cohorts in first-in-human trials).
7. Common errors in oncology drug development.
8. 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. 

Contact

Sherwin Sapasap
[email protected]