Translational Research Working Group developmental pathway for immune response modifiers.

Publication Type:

Journal Article


Clinical cancer research : an official journal of the American Association for Cancer Research, Volume 14, Issue 18, p.5692-9 (2008)


2008, Cancer Vaccines, Clinical Research Division, Clinical Trials as Topic, Humans, Immunologic Factors, IMMUNOTHERAPY, National Institutes of Health (U.S.), Neoplasms, Organization and Administration, Program Development, Software Design, United States


The Translational Research Working Group (TRWG) was created as a national initiative to evaluate the current status of the investment of National Cancer Institute in translational research and envision its future. The Translational Research Working Group conceptualized translational research as a set of six developmental processes or pathways focused on various clinical goals. One of those pathways describes the development of immune response modifiers such as vaccines and cytokines. A hallmark of the Immune Response Modifier Developmental Pathway is the coordinated development of multiple components. The Immune Response Modifier Pathway was conceived not as a comprehensive description of the corresponding real-world processes but rather as a tool designed to facilitate movement of a candidate assay through the translational process to the point where it can be handed off for definitive clinical testing. This paper discusses key challenges associated with the immune response modifier agent development process in light of the pathway.