Regulatory Issues

Society for Immunotherapy of Cancer (SITC) leaders have prioritized the following areas of focus in addressing regulatory issues relating to the field of cancer immunotherapy:

  • Adverse Events Reporting
  • Clinical Trial Design/Endpoints
  • Combination Approaches

SITC has forged strategic relationships with government and regulatory entities from around the world to address key regulatory issues including formal liaison relationships with the U.S. Food and Drug Administration (FDA) and the National Cancer Institute/National Institutes of Health (NCI/NIH).

Contact SITC

If you have partnership or policy-related questions, please contact SITC staff at: SITCExecOffice@sitcancer.org.

Click here to view a complete listing of these institutions.

U.S. FDA Liaison

NCI/NIH Liaison

Related image

Gulley-James.jpg

MARC tHEORET, MD

James L. Gulley, MD, PhD


Lead Medical Officer
Center for Drug and Research - CDER,
Office of Medical Products and Tobacco - OMPT,
Office of Hematology and Oncology Products - OHOP, 
Office of New Drug Quality Assessment - OND,
U.S. Food and Drug Administration - FDA

Chief, Senior Investigator
Genitourinary Malignancies Branch,
Head, Immunotherapy Section, 
Director, Medical Oncology Service,
CCR Office of the Clinical Director
National Cancer Institute

Toxicity Management Workshop

There is an urgent need among practicing oncologists and nurses for treatment algorithms that guide management of immunotherapy-related toxicities. Similarly, standardized templates for reporting adverse events in clinical trials are needed in order to facilitate monitoring and reporting of toxicities, an effort which is considered a high priority by the U.S. Food and Drug Administration.

To this end, SITC took the lead to convene a one-day Toxicity Management Workshop on Friday, March 31, 2017, in Washington, D.C. Click here to learn more about this event.