Regulatory Issues

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. FDA and the National Cancer Institute/National Institutes of Health.

Click here to view a complete listing of these institutions.

U.S. FDA Liaison

NCI/NIH Liaison



Raj K. Puri, MD, PhD

James L. Gulley, MD, PhD

Director, Division of Cellular and Gene Therapies
Office of Cellular, Tissue and Gene Therapies
FDA, Center for Biologics Evaluation and Research
Chief, Genitourinary Malignancies Branch
Senior Investigator
Head, Immunotherapy Section
Director, Medical Oncology Service, CCR Office of the Clinical Director
National Cancer Institute