Successful Design and Conduct of a Treatment IND Program *

Abstract

In order to maximize the success of a Treatment Investigational New Drug (IND) program, a fairly elaborate infrastructure that includes a multitude of service groups may be necessary. The program support may consist of a combination of internal sponsor groups as well as contract research organizations. The intent of this manuscript is to highlight and describe in detail the variety of services and responsibilities that may be required to conduct a Treatment IND program, while focusing on design, logistics, structure, workflow, and potential strategies for managing challenging issues relating to the program.