Wednesday, April 3


09:00 - 13:00

Session Organizers: Vibha Ahuja , Biotech Consortium India Limited, India and Joe Smith , ISBR President Elect, Australia

Keynote Speaker: ROB HORSCH, Deputy Director, Agricultural Development Bill & Melinda Gates Foundation, USA
“Innovation, Equity and Rates of Change”
The global food system is challenged to meet increasing demand for affordable, nutritious foods that are sustainably produced and equitably distributed.  This is driving rapid innovation in public and private sector research across food production, processing, distribution and delivery.  Applications of genetic engineering, gene editing, synthetic biology and nanotechnology are all being pursued to help improve the quality, quantity and safety of the foods we eat.  This session will explore considerations for the safety assessment of exogenous and endogenous novel molecules resulting from these kinds of technologies, with a particular focus on future applications.

Rob Horsch, Deputy Director, Agricultural Development (recently retired) Bill & Melinda Gates Foundation, USA
PL III – 1 Innovation, Equity and Rates of Change.

Kenneth Witwer, Johns Hopkins University School of Medicine, USA
PL III – 2 Dispatches from the frontier of fact and fiction: the past, present and future of dietary RNA studies.

Okaje Koo, ToolGen Inc., Republic of Korea
PL III – 3 Plant and Animal Genome Editing Using CRISPR/Cas9.

Allan Green, CSIRO Agriculture & Food, Australia
PL III - 4 Development and deregulation of DHA-canola - a novel and sustainable source of essential omega-3 fatty acids.

Kenneth Dawson, University College Dublin, Ireland
PL III – 5 Paradigms for the Interaction of Nanoscale Objects with Living Organisms.

10:30-11:00 Coffee Break
13:00 Lunch
    PS8: Targeted Crop Improvement: Genome Editing in the Plant Breeder’s Tool Box
    Organizers: John McMurdy, CropLife International, USA and Alessandra Salamini, Bayer CropScience, USA

    All plant breeding programs start by introducing genetic variation into the gene pool and following lengthy selection and screening may culminate with introduction of improved varieties. Genetic variation can be introduced by a variety of methods and sources, such as mutagenesis or wide species crosses, for example. As part of this continuum of breeding tools, genome editing allows plant breeders to make changes to endogenous sequences in the plant’s DNA in a targeted manner. This can significantly increase the precision of the breeding process and lead to more rapid advancement of cultivars with increased disease resistance, stress tolerance or enhanced nutrition. Innovations in plant breeding like genome editing are an important tool to advance global agriculture sustainability goals. Both policymakers and the publics’ response to products developed using genome editing tools will ultimately determine their utility to breeders.   This session will explore the role of genome editing in the context of plant breeding and will include technical, policy and governance topics related to application of these tools for crop improvement.

    Huw Jones, IBERS Aberystwyth University, Aberystwyth, UK
    PS VIII - 1
    Gene editing 101: the basics about genome editing tools.

    Johnathan Napier, Rothamsted Research, Harpenden, UK
    PS VIII - 2 Reflections on the UK’s first field trial of gene-edited plants and the impact of the ECJ ruling on European plant sciences.

    Chloe Pavely , Calyxt Roseville, MN, USA
    PS VIII - 3 Bringing consumer-focused products to market.

    Detlef Bartsch, Federal Office of Consumer Protection and Food Safety (BVL), Berlin, Germany
    PS VIII - 4 The need for consistent genome editing policies globally to foster innovation in agriculture
    PS9: Risk Assessment and Management of Gene Drive Research
    Organizer: Fabio Niespolo, Outreach Network for Gene Drive Research
    Chair: Delphine Thizy, Target Malaria, Imperial College London, UK

    J. Royden Saah , GBIRd/Island Conservation, Raleigh, USA
    PS IX - 1 Safeguarding Gene Drive Research: Measures to Support Responsible Research Using Gene Drives.

    Hector Quemada , Western Michigan University, Kalamazoo, Michigan, USA
    PS IX - 2 Building an evaluation pathway to assess gene drive technology for malaria control.

    Aaron Roberts; Claudia Emerson, Institute on Ethics and Policy for Innovation, McMaster University, Hamilton, Canada
    PS IX - 3 Ethical considerations raised by synthetic gene drive research.

    Martin Lema, Biotechnology Directorate, Ministry of Production, Buenos Aires, Argentina
    PS IX - 4 Perspectives from a regulator on biosafety assessment of products containing gene drives.
    PS10: Fall Armyworm IPM in Africa and Asia - The Challenge Of Creating An Enabling Environment for Knowledge, Policy And Tools
    Organizers: Alan Raybould , Syngenta Crop Protection AG, Basel, Switcherland

    Joe Huesing , United States. Agency for International Development, Washington DC, USA
    PS X - 1 The Fall Armyworm In Africa and Asia – Lessons on Controlling an Invasive Pest in the Developing World.

    Paul Jepson, College of Agricultural Sciences, Oregon State University, Corvallis, USA
    PS X - 2  Risk Considerations in Technology Selection for FAW and Other Invasive Pests

    Mao Chen , Bayer Crop Science, Singapore
    PS X - 3 Fall Armyworm Spodoptera frugiperda in Asia, an update from Thailand.

    Alan Raybould, Syngenta Crop Protection AG, Basel, Switzerland
    PS X - 4 Aligning policy and science for effective regulatory decision-making.
    PS11: Open Session 3 - A Medley of Biosafety Risk Assessment and Regulation Topics
    Chair: Pamela Bachman, Bayer Crop Science, USA


    Patrick Rudelsheim, Perseus BVBA, Sint-Martens-Latem, Belgium
    PS XI - 1 Gene drives in the environment – facts and experience to inform risk assessment

    Anthony Shelton
    , Cornell University, US
    PS XI - 2 The first field release of a genetically engineered, self-limiting insect in North America and its potential for pest management.

    Lijo John
    , Export Inspection Agency, Kochi, India
    PS XI - 3 Advances in Genetic Modification Techniques and Challenges in Detection of GMOs on a Regulatory Perspective.

    Ana Martin Camargo
    , European Food Safety Authority, Parma, Italy
    PS XI - 4 Assessing the risk of resistance development of the target pest Sesamia nonagrioides to Bt maize in the EU.

    Rubens José Nascimento
    , National Biosafety Technical Commission, Brasília, Brasil
    PS XI - 5 Regulation of Genetically Modified Organisms and New Breeding Technologies: Brazilian Experience.
15:30 Coffee Break
    PS12: Developing Innovative Genetic Technologies for Malaria Control: Risk Assessment and Stakeholder Engagement for Field Testing
    Organizer: Delphine Thizy, Target Malaria

    Target Malaria is a not-for-profit research consortium seeking to develop new genetic technologies to reduce malaria transmission. As part of this research, the project is planning small-scale releases of genetically modified sterile male mosquitoes at a site in a malaria-prone region of Burkina Faso. This represents the first release of genetically modified insects on the African continent. A rigorous process of risk assessment and risk management was required in preparation for the application for the permission to do the small-scale field releases. This session will seek to examine the lessons that can be drawn from this process, and the ways in which they could be applied to evaluate the potential risks of other similar approaches and for the next phases in the development of Target Malaria’s technology. It will bring together perspectives from project team members involved in different aspects of the risk assessment process, detailing how the project evaluated the possibility and plausibility of different hazards, but also how important elements, such as feedback from stakeholders, can help inform the risk assessment.  Finally, the session will look at the next steps involved in Target Malaria’s work, and what challenges the project may face in terms of risk assessment for future genetic (gene drive) technologies.

    Delphine Thizy, Target Malaria, Imperial College London, UK
    PS XII - 1 Introduction to Target Malaria: co-development for success.

    Charles Guissou, Institut de Recherche en Sciences de la Santé, Bobo Dioulasso, Burkina Faso
    PS XII - 2 The importance of preparedness – plans and steps for innovation in the field of genetic technologies for malaria control.

    Brinda Dass, Foundation for the National Institutes of Health, Bethesda, USA
    PS XII - 3 Pathway to Deployment of Gene Drive Mosquitoes as a Potential Biocontrol Tool for Elimination of Malaria in Sub-Saharan Africa.

    Geoff Turner, Imperial College London, UK
    PS XII - 4 Mapping inputs and evidence to support regulatory decision making for Target Malaria gene drive strategies
    PS13: Opportunities and Challenges in Public Sector Biotechnology Crop Improvement
    Organizer: Donald MacKenzie, Institute for International Crop Improvement, Donald Danforth Plant Science Center, St Louis, USA

    For more than two decades, governments, non-governmental organizations, and academic institutions have invested tens of millions of dollars in research and development of promising genetically engineered (GE) crops. The research areas include addressing productivity constraints due to abiotic (e.g., drought, salt, and soil nutrient deficiency) and biotic (e.g., insect pests and viral or bacterial disease) stresses and increasing levels of limiting micronutrients (e.g., provitamin A, iron, and zinc) in range of crops, including cassava, banana, maize, potato, rice, and sorghum. However, while public research creates promising technical solutions, up to now there are few examples of these crops being deployed due to lack of institutional capacity in GE product development within a regulated environment, and uncertain and shifting biosafety policies in target geographies. In addition, public entities are often “swept up” in the negative advocacy and public perception focused on large transnational companies whom have, to date, been the dominant force in GE crop commercialization.

    In this parallel session, we will provide a brief overview of public sector crop biotechnology efforts and focus on three projects as illustrative examples of the challenges faced by public and small developers. Lessons from the virus resistant cassava for Africa (VIRCA) project, which focuses on Kenya and Uganda, will be used to exemplify the impact of uncertain regulatory and policy environments on the delivery of public sector products. Effective product stewardship and the need for regional approaches to biosafety regulation will be illustrated using pod borer resistant cowpea, which is targeted for release in Nigeria, Ghana, and Burkina Faso. And finally, the challenge of delivering a nutrient biofortified staple crop, while managing communications and outreach for a project with high global public visibility, will be highlighted using the Golden Rice project.

    Andrew Kiggundu, Donald Danforth Plant Science Center, St. Louis, USA
    PS XIII - 1 Uncertain regulatory and policy environments. Lessons from the Virus Resistant Cassava for Africa Plus (VIRCA Plus) project in Kenya and Uganda.

    Francis Onyekachi, African Agricultural Technology Foundation, (AATF) Nairobi, Kenya
    PS XIII - 2 Public sector efforts on agricultural biotechnology development – Case of PBR cowpea in Africa.

    Partha S. Biswas, International Rice Research Institute., Gazipur, Bangladesh
    PS XIII - 3 Recent Advances on Research and Development of Golden Rice in Bangladesh.
    PS14: Biosafety Considerations for the Use of Genetic Variation in Plant Breeding
    Organizer: Maria Fedorova, Corteva Agriscience, USA

    Genetic variation is the source of genetic material for plant breeders to develop new varieties with desired characteristics. This session will focus on various plant breeding methods and genetic variation they introduce in untargeted or targeted ways. We will compare the types and extent of genetic variation introduced by various breeder’s tools, such as spontaneous mutations, tissue culture, genetic transformation, chemical and irradiation mutagenesis, and genome editing. A key from the biosafety perspective is to consider the biological relevance of the collateral genetic changes that may occur in addition to the desired, or targeted, change. As evidenced by the plant breeding history along with a wealth of genome sequencing data, plants appear to have an inherent ability and plasticity to tolerate significant DNA variations and rearrangements without an impact on food, feed, or environmental safety. The question then becomes whether it is relevant to consider those additional DNA changes as ‘unintended effects’ from the biosafety perspective, especially that they occur with essentially any plant breeding technique used. What are the true unintended effects and what processes are in place in commercial breeding programs that allow to mitigate them, irrespective of the breeding method? Breeding and selection processes used to develop new commercial plant varieties have an impressive track record of being an effective approach to identify and discard potentially unfavorable genetic variation and develop crops that are safe for human and animal health and the environment.

    Robert Stupar, University of Minnesota, Saint Paul, USA
    PS XIV - 1 Sources and uses of genetic variation in conventional plant breeding: Spontaneous mutations, untargeted induced mutagenesis, and tissue culture.

    Mai Tsuda, University of Tsukuba, Japan
    PS XIV - 2 Comparison in mutation frequency among wild types, tissue cultured mutants, genome-edited mutants, and transgenic lines in rice.

    Sandeep Kumar, Corteva Agrisciences, Johnston, USA
    PS XIV - 3 Evaluation of S. pyogenes Cas9 specificity in maize genome editing and its relevance in crop improvement.
    PS15 Open Session 4 - Experiences with Communication and Stakeholder Engagement
    Chair: Gabriela Levitus, ArgenBio, Argentina


    Sarah Evanega, Cornell University, Ithaca, USA
    PS XV - 2 The Alliance for Science: Partnering for Impact.

    Maria Luz Zapiola, ArgenBio, Argentina
    PS XV - 3 Challenges and achievements communicating the safety of GMOs.

    Samuel Timpo, African Biosafety Network of Expertise, Dakar, Senegal
    PS XV - 4 Safeguarding Africa’s interest in ongoing international negotiations on regulating emerging technologies.

    Adriana Brondani, CIB - Council for Information on Biotechnology, São Paulo, Brasil
    PS XV - 5 Food innovation dialogue: how gene editing could benefit from the GMO experience.
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