Government Relations

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: Policy@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

Cellular Therapy Regulatory Summit

The number of cellular and gene therapy-based oncology treatments being developed by the field has grown exponentially over the past ten years. As a result of this rapid advancement, many hurdles exist in the field that are causing delays in development and regulatory review of these important products. To help address this, the Society for Immunotherapy of Cancer (SITC) convened a Cellular Therapy Strategic Taskforce in 2021. The purpose of this taskforce was to formulate a strategic plan for the society aimed at increasing SITC’s overall impact in advancing the most promising cellular therapies to improve oncology patient care. The strategic plan consisted of three key pillars including groundbreaking science, balanced educational content, and regulatory consensus. As a first step in facilitating regulatory consensus, SITC hosted the Cellular Therapy Regulatory Summit. This summit consisted of cellular therapy experts from academia, industry, and government meeting hybridly to further the goals of the SITC cellular therapy strategic plan. 

Meeting Report

The results and outputs of this summit have been distilled into a meeting report. Click Here to access the full report, and learn more about the discussion and outcomes of the summit.