Key Considerations for Risk Assessment of Gene Drive Technologies

The second webinar of the 2022 Gene Drive Webinar Series provided participants with an overview of the regulation and oversight of gene drive technologies. An initiative led by the Outreach Network for Gene Drive Research and the ISAAA SEAsia Center, the panel Key Considerations for Risk Assessment of Gene Drive Technologies focused on discussing the appropriateness of current guidelines, best practices, and gaps in the processes through which gene drive technologies are being developed and implemented.

The session was moderated by Dr. Saturnina Halos (Biotechnology Coalition of the Philippines). The first panellist, Dr. Heidi Mitchell, Director of the Contained Dealings Evaluation Section, (Office of the Gene Technology Regulator) iterated that existing regulatory frameworks are suitable for evaluating gene drives. Through her presentation, she demonstrated the risk analysis principles that the Office of the Gene Technology Regulator (OGTR) applies to all new types of genetically modified organisms to showcase how risk assessment is carried out in Australia. Some of these principles include focusing on plausible pathways to harm, adopting and adapting to the existing guidelines and always relying on regulatory science and data for decision-making. Dr. Mitchell emphasized that regulators could build on existing frameworks for risk analyses and may even borrow principles from other relevant disciplines instead of reinventing a whole new framework from scratch.

The second panellist, Dr. Vibha Ahuja, Chief General Manager (Biotech Consortium India Limited) emphasized the importance of capacity building to enable understanding of a complex technology such as gene drive. This, she emphasized, is key to implementing appropriate regulations and facilitating evidence-based decision-making with regards to risk assessments for gene drives.

Dr. Hector Quemada (Western Michigan University) provided the audience with an overview of gene drive risk assessment in practice. Through his presentation, he highlighted that existing regulatory frameworks and guidelines can help conduct risk assessments for gene drives if they don’t lose sight of additional challenges related to these new technologies. He also mentioned the need to learn from the experiences and results of other risk assessment disciplines in order to design a robust risk assessment framework for gene drives.

The next and final webinar of the series will focus on ways to integrate social, economic, and health aspects of gene drive technology into decision-making processes and will be held on July 28. Registration to open soon!