Parallel session 9: Problem formulation: a step to engage stakeholders in risk assessment for gene drives
Tracks
Breakaway 1
| Wednesday, May 3, 2023 |
| 14:00 - 15:30 |
| Illinois / NY Central |
Details
Organized by Samantha O'Loughlin, Imperial College London, UK.
Gene drive research has been progressing rapidly in the last years making the prospects of future potential field evaluations more plausible. And with this prospect comes the need for a robust and science-based risk assessment. The question of whether risk assessment for gene drive research is possible and of the adequacy of the existing risk assessment frameworks for doing so have been a recurring topic in the last years, whether at the Convention on Biological Diversity, the European Union, or other national policy discussions. In 2021, researchers from Target Malaria, a not-for-profit consortium developing genetic approaches to suppress malaria-transmitting mosquitoes, has published a paper presenting its problem formulation exercise for the investigational releases of a suppression drive to control malaria-transmitting mosquitoes in West Africa. In this session, we will examine the journey to and from this paper and how it represents another step in the important process of risk assessment. This session will provide the audience an understanding of the method followed by these researchers to identify and analyze plausible pathways to potential harm but also examine the value of engaging stakeholders in this process. It will be an opportunity to demonstrate the importance of early identification of these pathways to potential harm in the research and development progression as well as in the dialogue with risk assessors and regulators. It is hoped to contribute to the broader dialogue on responsible research for gene drive development./
14:00 - 14:05 Chair: Brinda Das Introduction
Gene drive research has been progressing rapidly in the last years making the prospects of future potential field evaluations more plausible. And with this prospect comes the need for a robust and science-based risk assessment. The question of whether risk assessment for gene drive research is possible and of the adequacy of the existing risk assessment frameworks for doing so have been a recurring topic in the last years, whether at the Convention on Biological Diversity, the European Union, or other national policy discussions. In 2021, researchers from Target Malaria, a not-for-profit consortium developing genetic approaches to suppress malaria-transmitting mosquitoes, has published a paper presenting its problem formulation exercise for the investigational releases of a suppression drive to control malaria-transmitting mosquitoes in West Africa. In this session, we will examine the journey to and from this paper and how it represents another step in the important process of risk assessment. This session will provide the audience an understanding of the method followed by these researchers to identify and analyze plausible pathways to potential harm but also examine the value of engaging stakeholders in this process. It will be an opportunity to demonstrate the importance of early identification of these pathways to potential harm in the research and development progression as well as in the dialogue with risk assessors and regulators. It is hoped to contribute to the broader dialogue on responsible research for gene drive development./
14:00 - 14:05 Chair: Brinda Das Introduction
Speaker
Dr Anastasia Matthies
Scientific Officer
Federal Office For Consumer Protection And Food Safety (BVL))
The importance of the problem formulation step in the risk assessment process for LMOs
14:20 - 14:35Biography
Dr. Anastasia Matthies is scientific officer and risk assessor at Federal Office for Consumer Protection and Food Safety, BVL (German national competent authority for genetically modified organisms). In this role, she is responsible for the risk assessment of LMO for placing on the market and for deliberate release into the environment. She is involved in discussions regarding the risk assessment LMO containing engineered gene drives and in corresponding deliberations leading to decisions within Cartagena Protocol.
Dr Alexandre Quach
Senior Stakeholder Engagement Manager
Target Malaria
Ms Camilla Beech
Director
Cambea Consulting Ltd
Advancing problem formulation for investigational releases of a population suppression gene drive to control the human malaria vector Anopheles gambiae in West Africa
14:50 - 15:05Biography
Camilla Beech is currently the Director of her regulatory consultancy business specializing in novel biotechnology products and particularly genetically modified insects. For more than 30 years she has been involved in the forefront of contributing to policy, guidance, regulation, and risk assessment for genetically modified organisms, including GM crops and other products. In the last decade, she has specialized predominantly in obtaining regulatory outcomes for genetically modified insects for both agriculture and public health including obtaining permission for use of genetically modified mosquitoes at the contained, field, or area-wide levels. She has also been a faculty member of training courses on GM vectors (funded by WHO-TDR) in Latin America, Africa, and SE Asia and is currently a member of the WHO Vector Control Advisory Group. Prior to setting up her own business in 2015, she led the biotechnology regulatory affairs department at Oxitec Ltd and was a global regulatory lead at Syngenta (and its legacy companies). She is currently working on projects covering the Nagoya protocol for shipment of insects and impact assessments for gene drive mosquitoes for a variety of clients. Having managed various regulatory portfolios and compliance programs for a variety of biotechnology products worldwide she has a deep understanding of the attributes required for their safe use and efficacy.
Dr Heidi Mitchell
Director – Contained Dealings Evaluation Section
Office of the Gene Technology Regulator
Problem formulation for gene drive organisms
15:05 - 15:20Biography
Dr Heidi Mitchell
Heidi Mitchell is the Director of the Contained Dealings Evaluation Section at the Office of the Gene Technology Regulator (OGTR). The Section conducts scientific risk assessments and develops risk management plans for work with GMOs in contained facilities (including maintaining guidelines and certifying contained facilities) and for clinical trials of GM vaccines or gene therapies.
Heidi joined the OGTR in 2006 as an evaluator, preparing risk assessments for a range of GMOs. She has also worked in the Regulatory Practice section of the OGTR at the interface between scientific risk assessment and operational regulatory policy. Heidi has been involved in work around the scope of the gene technology legislation. She has represented Australia at OECD and CBD SBSTTA meetings and presented talks at domestic and international conferences on regulation of GMOs in Australia.
Heidi has a PhD in plant biochemistry and post-graduate research in plant-fungal interactions and on using bacteria other than Agrobacterium for plant transformation. She has published research papers in peer-reviewed journals including Nature.
Chair
Brinda Dass
Deputy Director, GeneConvene Global Collaborative
FNIH
