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The Translational Research Working Group Developmental Pathway for Anticancer Agents (Drugs or Biologics)

Authors' Affiliations: ¹ University of Chicago, Chicago, Illinois, ² Abbott Laboratories, Abbott Park, Illinois, ³ GlaxoSmithKline, Research Triangle, North Carolina, ⁴ Burnham Institute for Medical Research, La Jolla, California, ⁵ Vanderbilt University, Nashville, Tennessee, ⁶ Science and Technology Policy Institute, Wellesley, Massachusetts, and ⁷ Johns Hopkins University, Baltimore, Maryland

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. 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 National Cancer Institute's investment in translational research and envision its future. The TRWG 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 agents—both small molecules and biologics—for the treatment and prevention of cancer. The Agents Developmental Pathway was conceived not as a comprehensive description of the corresponding real-world processes, but rather as a tool designed to facilitate movement of an agent through the translational process to the point where it can begin definitive clinical testing. This article presents the Agents Developmental Pathway and discusses key challenges associated with the processes described.

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