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  4. FDA Oncology Center of Excellence Public Workshop: Product Development in Hemophilia - 12/06/2018
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Workshop | In Person

Event Title
FDA Oncology Center of Excellence Public Workshop: Product Development in Hemophilia
December 6, 2018

December 6, 2018
Event Location
White Oak Campus: The Great Room
Conference Center

10903 New Hampshire Ave
Building 31, Room 1503
Silver Spring, MD 20993
United States

Organized By:

Twitter: #OCEhemophilia18

Date: December 6, 2018

Time: 8:30 am to 4:30 pm

Location: FDA White Oak Campus
Building 31, Room 1503 – Great Room
10903 New Hampshire Avenue
Silver Spring, MD 20993
FDA Campus Information, (e.g., local airports, directions, and local hotels)


The public workshop "Product Development in Hemophilia" was organized by the FDA’s Oncology Center of Excellence in collaboration with the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). The workshop discussed issues related to development and regulation of novel hemophilia products. This public workshop was intended to provide a platform for engaging in a discussion with experts in hemophilia treatment, patients, and caregivers regarding further development of patient-experience and patient-reported outcomes for use in clinical trials, reliable and interpretable measurements of factor VIII/IX activity levels for gene therapy products, to discuss the need for long-term safety assessments in gene therapy clinical trials, and discern when to enroll pediatric patients in gene therapy trials.

Webcast Replay:

FDA archived workshop webcast is available at links below:

Workshop Transcripts:

Workshop Information:


Joan Ferlo Todd, RN
Regulatory Health Project Manager
Office of Hematology and Oncology Products
Center for Drug Evaluation and Research, (CDER)
U.S. Food and Drug Administration
White Oak 22|Rm. 2139| 10903 New Hampshire Ave, Silver Spring, MD 20993


Event Contact
Office of Oncologic Diseases (OOD)
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