FDA-ASCO-Friends Workshop on Development of Tissue-Agnostic, Biomarker-Based Indications

Co-Sponsored by the:
U.S. Food & Drug Administration (FDA), American Society of Clinical Oncology (ASCO) and Friends of Cancer Research (Friends)

Twitter: #FDATissueAgnostic19

April 26, 2019

8:30 am to 4:00 pm

FDA White Oak Campus, Building 31, Room 1503 - Great Room

10903 New Hampshire Avenue, Silver Spring, MD 20993

Register HERE: https://www.research.net/r/XDF38C8

The FDA, ASCO, and Friends are convening this public workshop to identify clinical trial designs and strategies to accelerate drug development based on biomarkers that are agnostic to tissue types. The workshop is intended to explore concepts in research and development that would assist the research community and regulators in understanding how to optimize product development and patient access to safe and effective biomarker-driven therapies that have clinical use across a variety of cancer types.

Workshop Objectives:

• Seek feedback from industry, academia, patients, and other stakeholders on trial designs and analysis approaches that will aid in understanding the effect of a biomarker and its related diagnostic assay across multiple tissue types,
• Ensure that cancer patient advocates and the leading experts in clinical research, pharmacology, drug manufacturing, and clinical care have an opportunity to contribute to the discussion about how to demonstrate safety and efficacy of a drug across multiple cancer types and how to communicate that information to the clinical community, and
• Obtain input from multiple stakeholders on approaches the FDA uses to review applications for drug products that are intended to treat cancers based on the presence of a biomarker, rather than specification of the tissue type.

Webcast Information:

FDA will provide a free-of-charge, live webcast of this workshop. Further information regarding the webcast, including the web link for the webcast, will be made available closer to the workshop date. FDA plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.

Meeting Information:

Agenda and speakers list coming soon

Contact:

If to ASCO:  
Anna Jinkerson, MScM
Anna.Jinkerson@asco.org
(571) 483-1577

If to FDA:     
Sonia Swayze
Sonia.Swayze@fda.hhs.gov
(301) 796-6132

Dianne Spillman
Dianne.Spillman@fda.hhs.gov
(301) 796-1467

If to Friends: 
Ryan Hohman, JD
rhohman@focr.org
(202) 944-6708

Mark Stewart, PhD
mstewart@focr.org
(202) 944-6700