Moving Research from the Laboratory for Field Trials: Regulatory Pathway for Genetically Engineered Organisms and their Derived Products

Advancing from research to product development and eventual commercialization requires regulatory approval from designated national government agencies. However, information on how to navigate international and national regulatory frameworks is not widely shared among oversight review committees, principal investigators, senior scientists, post-docs, and other investigators. On November 19, 2019, the Foundation for the National Institutes of Health (FNIH) organized a workshop in Baltimore, Maryland with the aim of providing a basic understanding of regulatory considerations and internationally recognized issues related to field trials of investigational genetically engineered organisms and their derived products, for applications in public health, agriculture, and protection to the environment. This workshop was designed for those who have limited experience with regulatory processes within and external to the United States. During the workshop, regulatory sciences and decision-making processes that will help bridge the gap between conducting basic research and translating that research into product development were discussed.

As part of Session 3: Risk Assessment and Mitigation Tools, Dr. Andrew Roberts, Deputy Executive Director, was invited to conduct a guided problem formulation exercise with participants.