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Translational Research Working Group Developmental Pathway for Immune Response Modifiers

Authors' Affiliations: ¹ Fred Hutchinson Cancer Research Center, Seattle, Washington; ² Center for Cancer Research and ³ Office of Communications, National Cancer Institute, Bethesda Maryland; ⁴ Lombardi Comprehensive Cancer Center, Georgetown University, Washington, District of Columbia; ⁵ Duke University, Durham, North Carolina; ⁶ Science and Technology Policy Institute, Wellesley, Massachusetts; and ⁷ Johns Hopkins University, Baltimore, Washington

Requests for reprints: William G. Nelson, Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University School of Medicine 1650 Orleans Street, CRB 116, Baltimore, MD 21231. Phone: 615-322-0375; Fax: 615-343-4539; E-mail: bnelson{at}jhmi.edu.

Abstract

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.

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