ASH | FDA Collaboration: A Workshop on Regulatory Science in Hematology

ASH is committed to educating its members on the workings of the U.S. Food and Drug Administration (FDA) and to provide a rigorous understanding of regulatory medicine. New in 2022, ASH and the FDA are co-launching a new workshop. This workshop would be applicable to future careers in academic medicine with a focus on clinical or translational research, drug development, or regulatory medicine. This program will provide ASH members with a better understanding of the FDA and allow for an exchange of information and contact sharing.

During this two-day workshop ASH members will learn more about the FDA and allow ASH members and Agency representatives to learn from each other. Sessions at the workshop will be presented in several engaging formats that will encourage active participation (e.g., panel format, small roundtables, speed networking with FDA reps).

This workshop is planned to be held in-person at ASH Headquarters in Washington, DC on the following dates:

• Tuesday, October 25, 2022, and Wednesday, October 26, 2022.

Workshop Goals

At the close of this intimate, multi-day workshop, participants will have a basic knowledge of:

• The FDA’s role in hematology/oncology product 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., endpoints in specific diseases, biomarker development).
• Expedited development programs (e.g., breakthrough therapy designation, fast track designation).
• Clinical trial design (eligibility criteria, endpoint selection,).

Eligibility Requirements

This workshop is intended for current hematology/oncology fellows, physicians, and researchers. Applicants must 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. Applicants cannot be employed by a pharmaceutical company or industry.

Application Requirements

A complete application must include:

• Completed application form.
• Letter of intent from the candidate. The candidate should include why they want to participate in the workshop, how they are qualified, what hematology topics interest them, and what outcome they hope to gain from this experience. The candidate should also demonstrate their background, interest, and any experience in hematology and policy work. The letter should be no longer than one (1) page.

Questions?

For more information, contact ASH Policy and Practice Manager Katherine Stark at [email protected].