Streamlining GMO Applications in Clinical Trials: Global Framework and Strategic Considerations

Published on: June 25th, 2025

In this webinar, we provided an overview of key regulatory and strategic considerations for clinical trials involving investigational medicinal products consisting of or containing genetically modified organism (GMO-IMPs), such as gene therapies, viral vector-based vaccines, genetically modified bacteria, etc.

The covered topics include: 

• The presentation of regulatory frameworks (EU, US, UK, Switzerland)
• The building of an efficient submission strategy and associated required data set
• Recommendations regarding collaboration with sites, vendors, and regulatory authorities to support compliance and reduce potential delays

We wish to provide insights for regulatory and clinical development professionals acting as decision makers/key stakeholders, who want to understand the challenges related to GMO applications.

FEATURED SPEAKERS

Anne Schlegel, PhD

Associate Director, CMC

Darius Vagrys, PhD

Associate Director, Regulatory