Regulatory and Startup Implications of Genetically Modified Viruses
Cancer immunotherapy demonstrates significant therapeutic advances toward harnessing the immune system and killing cancer cells. In developing these new agents, clients face unique regulatory requirements and startup hurdles that can threaten efficient and timely clinical evaluation. In this white paper, PPD presents solutions for navigating the challenging regulatory landscape of this promising new field.
The use of genetically modified viruses as vectors leads to a unique regulatory environment, while site selection, infrastructure and staff training require special considerations. From the perspective gained through trials conducted to evaluate genetically modified organisms (GMO) vector therapies in nearly 20 countries globally during the past five years, PPD is able to offer insight on the impact of GMO regulations and how clients can better prepare for global development programs.