Challenges In Global Development Of Genetically Modified Organisms Vector Immunotherapies

Genetically modified viruses serve as vectors in a growing number of cancer immunotherapies, including vector-based and dendritic cell vaccines and therapies based on modified immune cells. Clinical evaluation of these new agents poses unusual challenges since they are subject to regulations pertaining to genetically modified organisms (GMO). GMO regulations vary widely from country to country and can involve difficult, costly and often unexpected demands on clients. This paper discusses the diverse regulatory environment for agents that must comply with GMO Biosafety Level 2 requirements. Based on PPD experience, the authors present operational considerations regarding site selection, site infrastructure and staff training to support clinical trials of GMO vector immunotherapies. They also include a case study that describes PPD strategies to overcome these challenges in global trials.