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Impact

Diseases transmitted by mosquitoes represent a substantial public health burden, particularly in tropical countries. The use of biotechnology in the control of these important disease vectors may offer substantial public benefit. However, these technologies cannot be deployed without first considering the potential for environmental risk. One control strategy in the early stages of development is the use of gene drive mechanisms to suppress or replace vector mosquito populations in order to reduce the incidence of malaria. The ILSI Research Foundation has partnered with the Foundation for the National Institutes of Health (FNIH) to facilitate workshops to identify risk hypotheses and data needs for future environmental risk assessment of gene drives in Anopheles gambiae for the control of malaria.

Collaborators & Partners

Foundation for the National Institutes of Health (FNIH), New Partnership for African Development

Areas of Focus

Experts on malaria and Anopheles biology, ecology, public health and regulation of biotechnology were engaged in a three-day workshop in May 2016, to consider the ways a gene drive mosquito would need to be assessed for environmental risk. These multi-disciplinary groups were involved in a process referred to as problem formulation, where existing knowledge is used to identify potential pathways to harm which should be considered in environmental or ecological risk assessment.

The consensus points from the May 2016 workshop have been published in the American Journal for Tropical Medicine and Hygiene. This publication is an important first step in encouraging dialogue and discussion on how risk assessments for the use of gene drive technology targeting malaria vectors should be conducted. Additionally, it will serve to inform researchers and regulators about areas where data collection and analysis efforts are most likely to be useful.

Current Activity

In collaboration with the New Partnership for African Development and FNIH, the ILSI Research Foundation is organizing regional workshops in Africa to encourage and facilitate dialogue among African scientists and regulators on the relevant environmental protection goals, potential harms, and data needed to inform risk assessments of gene drive technology.

Resources

Newsletters

Find out about the work being done by the ILSI Research Foundation by reading our monthly e-newsletter.

14th International Symposium on the Biosafety of Genetically Modified Organisms

Guadalajara, Mexico

Registration is open for the 14th International Symposium on the Biosafety of Genetically Modified Organisms (ISBGMO14). The ILSI Research Foundation will be presenting at ISBGMO14 during the plenary session titled “Advancing Environmental Risk Assessments of Genetically Modified Organisms – Present Challenges”.

Read more

First Consultative Meeting on Gene Drive Technology

Accra, Ghana

The ILSI Research Foundation co-organized a meeting with the New Partnership for Africa’s Development (NEPAD) and the Foundation for the National Institutes of Health on gene drive technology in Africa.

Read more

4th Annual South Asia Biosafety Conference

Hyderabad, India

The South Asia Biosafety Conference provided an opportunity to hear from leading scientists representing regulatory agencies, public sector research institutions, and the private sector in South Asia and internationally.

Read more

Problem Formulation for the Use of Gene Drive Technology in Mosquitoes

Reston, VA, United States

The ILSI Research Foundation co-organized a workshop with the Foundation for the National Institutes of Health that examined the basic principles of environmental risk assessment, the process of how environmental protection goals are translated into operation endpoints for risk assessment (“problem formulation”), and the application of this process to the use of gene drives for either population modification or population suppression in mosquito vectors.

Read more

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			About		
			Attendees		
			Program		
			Registration		
			Social Media		
				About
				

The International Symposium on the Biosafety of Genetically Modified Organisms (ISBGMO) is a biennial, international meeting organized under the auspices of the International Society for Biosafety Research (ISBR), which has previously been hosted in South Africa, Germany, Canada, China, France, Korea, New Zealand, Argentina and the USA.

The goal of ISBGMO14 is to advance the standing of biosafety research around the world and shape the ways in which genetically modified (GM) technology is applied and regulated. Over the course of four days, attendees will learn from the past, discuss the present and look ahead to future opportunities and challenges associated with GM technology.

Why attend ISBGMO14?

  • Network with 500+ professional colleagues representing 50 countries
  • Build relationships with biosafety decision makers and innovators in academia, business, government and non-governmental organizations
  • Attend 10+ technical sessions over four days
  • Present your research during the poster session
  • Hear outstanding keynote speakers, including Dr. Fred Gould, University Professor of Entomology & Co-Director of the Genetic Engineering and Society Center of North Carolina State University; Dr. Sheila Jasanoff, Professor of Science & Technology Studies, John F. Kennedy School of Government, Harvard University; and Professor Tim Benton, UK Champion for Global Food Security & Professor of Population Ecology, University of Leeds
Attendees

Who should attend?

ISBGMO14 brings together academics, technology developers, regulatory authorities, non-government organizations and other credible stakeholders involved in all aspects of biosafety and offers a unique opportunity to share information and experiences and engage in open and meaningful dialogue on biosafety research, risk analysis, policy and regulatory matters.

Program

The ILSI Research Foundation will be presenting at ISBGMO14 during the plenary session titled "Advancing Environmental Risk Assessments of Genetically Modified Organisms - Present Challenges" as well as the parallel session titled “GM Insects and Gene Drive Systems for Pest Control”.

To view the full symposium program, please visit the ISBGMO14 website.

Registration

Registration is open through the ISBGMO14 website.

Join over 500 of biosafety’s best and brightest at the 14th International Symposium on the Biosafety of Genetically Modified Organisms (ISBGMO14) in Mexico. ISBGMO14 offers a unique opportunity to share information and experiences as well as engage in open and meaningful dialogue on biosafety research, risk analysis, policy and regulatory matters. Advance the standing of biosafety research around the world and shape the ways in which GM technology is applied and regulated - at ISBGMO14!

Social Media

Folllow along to @ISBGMO and @ILSIRF on Twitter for updates. #ISBGMO14 is the preferred hashtag for the 14th Annual Symposium on the Biosafety of Genetically Modified Organisms.

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Presentations Now Available

About Agenda Presentations Program Poster Session Press Release Social Media About

The South Asia Biosafety Program (SABP), the ILSI Research Foundation and the Biotech Consortium India Limited (BCIL) organized the 4th Annual South Asia Biosafety Conference in Hyderabad, India from September 19-21, 2016. This conference provided an opportunity to hear from leading scientists representing regulatory agencies, public sector research institutions, and the private sector in South Asia and internationally. The conference was held at the Taj Krishna, Road Number 1, Banjara Hills, Hyderabad, Telangana 500034, India. 

To view the conference document from the 4th Annual South Asia Biosafety Conference, click here

Agenda

To view the full agenda, please visit the conference website.

Plenary Session 1: Regulation of Biotechnology in South Asia

Strengthening Environmental Risk Assessment in Indian Biosafety Regulations
Dr. K. Veluthambi, Madurai Kamaraj University, India

Update on Biosafety Regulation in Bangladesh
Mr. Mohammed Solaiman Haider Department of Environment, Bangladesh

Update on Biosafety Regulatory Framework in Bhutan
Mr. Jamyang Phuntsho, Bhutan Agriculture and Food Regulatory Authority (BAFRA), Bhutan

Update on Biosafety Regulation in Pakistan
Dr. Kauser Abdulla Malik, Forman Christian College, Pakistan

Update on Biosafety Regulation in Sri Lanka
Ms. Himali De Costa, Ministry of Mahaweli Development & Environment, Sri Lanka

There and Back Again: Reversal by the Supreme Court on the Constitutionality of GM Crop Regulations
and the New Challenge to the Philippine Biosafety System
Mr. Abraham Manolo, Biotech Coalition of the Philippines

Parallel Session 1: Biotechnology Research and Development in South Asia

Nematode Resistant GM Crops Based on RNAi - Research and Regulation
Dr. Uma Rao, Indian Agricultural Research Institute (IARI), India

Experiences for Approval of Bt Brinjal in Bangladesh
Dr. G.P. Das, Feed the Future South Asia Eggplant Improvement Partnership, Bangladesh

Recent Advances in Breeding Golden Rice in Bangladesh
Dr. Partha Biswas, Bangladesh Rice Research Institute (BRRI), Bangladesh

Potato Transgenics in India: Status and the Way Forward
Dr. S.K. Chakrabarti, Central Potato Research Institute, India

Parallel Session 2: Research Efforts to Address Climate Change

National Innovations in Climate Resilient Agriculture
Dr. Srinivasa Rao, Central Research Institute for Dryland Agriculture (CRIDA), India

Developing Plant Resources for Stress Tolerant Molecular Breeding in Rice
Dr. Zeba Seraj, University of Dhaka, Bangladesh

Transgenic Strategies for Enhanced Abiotic Stress Tolerance in Grain Legumes: Retrospect and Prospects
Dr. Pooja Bhatnagar, International Crops Research Institute for the Semi-Arid Tropics (ICRISAT), India

Water Efficient Maize for Africa
Dr. Sylvester Oikeh, African Agricultural Technology Foundation (AATF), Kenya

Plenary Session 2: New Technologies in Genetically Engineered Development

Introduction to New Technologies
Dr. Andrew Roberts, ILSI Research Foundation, United States

CRISPR/ CAS 9
Dr. Amitabh Mohanty, DuPont Pioneer, India

Biosafety Considerations for the Use of Gene Drives in Anopheles gambiae for Malaria Control
Dr. Andrew Roberts, ILSI Research Foundation, United States

Genetic Biocontrol for Snails Utilizing a Cas9-Mediated Gene Drive
Dr. John Teem, ILSI Research Foundation, United States

Plant Breeding Innovation: Towards Consistent Global Policy
Dr. Usha Barwale Zehr, Mahyco, India and Chair, Breeders Committee, International Seed Federation, India

Plenary Session 3: Meeting Regulatory Challenges and Approaches to Regulatory Support

South Africa’s Evolving Biosafety Regulatory System
Dr. Hennie Groenewald, Biosafety South Africa, South Africa

India’s Regulatory Framework: Evolution and Reforms
Dr. S.R. Rao, Department of Biotechnology, India

Biosafety Regulatory Framework in Kenya: Challenges and Approaches
Dr. Willy Tonui, National Biosafety Authority, Kenya

Guidance for the Biosafety Regulatory Process in Bangladesh
Ms. Khorsheda Yasmeen, Ministry of Environment and Forests, Bangladesh

Regulatory Challenges for Small Companies
Dr. Keith Redenbaugh, Arcadia Biosciences, United States

Addressing Regulatory Challenges in a Federated System: An Australian Plant Science Industry Perspective
Mr. Osman Mewett, CropLife Australia, Australia

Plenary Session 4: Dossier Preparation: Planning and Generation of Regulatory Data

Regulatory Data Generation, Analysis, and Interpretation
Dr. Donald MacKenzie, International Rice Research Institute (IRRI), Philippines

Writing Regulatory Dossiers: Good Reports, Good Dossiers, Good Stories
Dr. Monica Garcia-Alonso, Estel Consult, United Kingdom

Development of a Genetically Engineered Virus Resistant Fruit Tree - From Concept to Product Release
Dr. Ralph Scorza, United States Department of Agriculture (Retired), United States

Testing of GE Silk Moths: Challenges in Interpreting Regulatory Requirements
Dr. P.J. Raju, Andhra Pradesh State Sericulture Research and Development Institute, India
Dr. V. Satyavathi, Centre of Excellence for Genetics and Genomics of Silkmoths, Centre for DNA Fingerprinting and
Diagnostics, India

Building Support for our Science: Four Keys to Successful Stakeholder Engagement & Communication
Ms. Jill Kuehnert, Seed Stories, United States

Presentations

Plenary Session 1: Regulation of Biotechnology in South Asia

Strengthening Environmental Risk Assessment in Indian Biosafety Regulations (presentation)
Dr. K. Veluthambi, Madurai Kamaraj University, India

Update on Biosafety Regulation in Bangladesh (presentation)
Mr. Mohammed Solaiman Haider Department of Environment, Bangladesh

Update on Biosafety Regulatory Framework in Bhutan (presentation)
Mr. Jamyang Phuntsho, Bhutan Agriculture and Food Regulatory Authority (BAFRA), Bhutan

Update on Biosafety Regulation in Sri Lanka (presentation)
Ms. Himali De Costa, Ministry of Mahaweli Development & Environment, Sri Lanka

Parallel Session 1: Biotechnology Research and Development in South Asia

Recent Advances in Breeding Golden Rice in Bangladesh (presentation)
Dr. Partha Biswas, Bangladesh Rice Research Institute (BRRI), Bangladesh

Parallel Session 2: Research Efforts to Address Climate Change

National Innovations in Climate Resilient Agriculture (presentation)
Dr. Srinivasa Rao, Central Research Institute for Dryland Agriculture (CRIDA), India

Developing Plant Resources for Stress Tolerant Molecular Breeding in Rice (presentation
Dr. Zeba Seraj, University of Dhaka, Bangladesh

Plenary Session 2: New Technologies in Genetically Engineered Development

Biosafety Considerations for the Use of Gene Drives in Anopheles gambiae for Malaria Control (presentation
Dr. Andrew Roberts, ILSI Research Foundation, United States

Genetic Biocontrol for Snails Utilizing a Cas9-Mediated Gene Drive (presentation)
Dr. John Teem, ILSI Research Foundation, United States

Plenary Session 3: Meeting Regulatory Challenges and Approaches to Regulatory Support

South Africa’s Evolving Biosafety Regulatory System (presentation)
Dr. Hennie Groenewald, Biosafety South Africa, South Africa

Biosafety Regulatory Framework in Kenya: Challenges and Approaches (presentation)
Dr. Willy Tonui, National Biosafety Authority, Kenya

Guidance for the Biosafety Regulatory Process in Bangladesh
Ms. Khorsheda Yasmeen, Ministry of Environment and Forests, Bangladesh (presentation)

Regulatory Challenges for Small Companies (presentation)
Dr. Keith Redenbaugh, Arcadia Biosciences, United States

Plenary Session 4: Dossier Preparation: Planning and Generation of Regulatory Data

Regulatory Data Generation, Analysis, and Interpretation (presentation)
Dr. Donald MacKenzie, International Rice Research Institute (IRRI), Philippines

Writing Regulatory Dossiers: Good Reports, Good Dossiers, Good Stories (presentation)
Dr. Monica Garcia-Alonso, Estel Consult, United Kingdom

Development of a Genetically Engineered Virus Resistant Fruit Tree - From Concept to Product Release (presentation)
Dr. Ralph Scorza, United States Department of Agriculture (Retired), United States

Building Support for our Science: Four Keys to Successful Stakeholder Engagement & Communication (presentation)
Ms. Jill Kuehnert, Seed Stories, United States

Program

This conference featured sessions on:

  • Regulation of Biotechnology in South Asia
  • Research and Development in South Asia
  • Research Efforts to Address Climate Change
  • New Technologies in GE Development
  • Meeting Regulatory Challenges and Approaches to Regulatory Support
  • Dossier Preparation: Planning and Generation of Regulatory Data
  • Poster Session
  • Facility Visits

To view the full agenda, please visit the conference website.

Poster Session

The 4th Annual South Asia Biosafety Conference Poster Program provided an opportunity for individuals to share their research, findings and achievements with colleagues at the conference. Presenting a poster is a noteworthy way to share expertise or accomplishment. Poster presenters had dedicated time to present and discuss their work with the diverse group of conference attendees.

First Place Winner

The first place winner is: Lourdes D. Taylo, Joseph C. Banasihan and Desiree M. Hautea for their poster on “Baseline Susceptibility to Bt Cry1Ac Protein of Eggplant Fruit and Shoot Borer (EFSB), Leucinodes orbonalis Guenée (Lepidoptera:Crambidae) in the Philippines.”

The first place winner will be sponsored to participate in the 14th International Symposium on the Biosafety of Genetically Modified Organisms (ISBGMO), to be held in Guadalajara, Mexico in 2017. ISBGMO is a biennial, international meeting organized by the International Society for Biosafety Research (ISBR), which offers a unique opportunity to share information and experiences as well as engage in open and meaningful dialogue on biosafety research, risk analysis, policy and regulatory matters. This 1st place prize includes:

  • Economy class airfare to Guadalajara
  • Standard hotel accommodations during the ISBGMO
  • Per diem allowances in an amount to be determined by SABC
  • Payment of the winner’s ISBGMO registration fee
  • A two-year membership to ISBR

Second Place Winner

The second place winner is: Mark Gabriel S. Sagarbarria, Joane Rachel C. Mosico, John Carlo M. Marasigan, Lourdes D. Taylo and Desiree M. Hautea for their poster on “Mitochondrial cytochrome oxidase I (COI) DNA Sequence and Morphometric Traits of Eggplant Fruit and Shoot Borer, Leucinodes orbonalis Guenée (Lepidoptera: Crambidae) in Southern Luzon, Philippines.”

The second place winner of this competition received a USD $100 cash prize and a two year membership for the International Society of Biosafety Research. The International Society for Biosafety Research, ISBR, aims to promote scientifically sound research that supports biosafety assessment by improving communication among scientists who study plants, animals, and microbes with new characteristics due to altered DNA and produced using modern biotechnology.

 

 

Press Release

Experts from 13 Nations Discuss Biosafety Regulations

"The prominent government and non government organizations came together to discuss biotechnology, environmental risk assessment and biosafety regulation at South Asia Biosafety Conference at Hyderabad."

By BioVoice News Desk published on September 21, 2016 View the news release on the BioVoice website here.  Social Media

Follow along to @CERA_ILSI on Twitter for updates. #SABC2016 is the preferred hashtag for the 4th Annual South Asia Biosafety Conference.

Speakers

SABP2016 Speaker Barwale Zehr

Dr. Barwale Zehr

Mahyco, India

Chakrabarti, SK

Dr. Chakrabarti

Central Potato Research Institute, India

Bergvinson, David

Dr. Bergvinson

ICRISAT, India

Das_GP

Dr. Das

Feed the Future South Asia Eggplant Improvement Partnership, Bangladesh

Bhatnagar-Mathur, Pooja

Dr. Bhatnagar-Mathur

ICRISAT, India

de Costa, Himali

Ms. De Costa

Ministry of Mahaweli Development & Environment, Sri Lanka

Biswas, Partha

Dr. Biswas

BRRI, Bangladesh

Garcia-Alonso, Monica

Dr. Garcia-Alonso

Estel Consult, United Kingdom

Goenewald, Hennie

Dr. Groenewald

Biosafety South Africa, South Africa

Haider, Mohammed Solaiman

Mr. Haider

Department of Environment, Bangladesh

Family portraits

Ms. Kuehnert

Seed Stories, United States

MacKenzie, Don

Dr. MacKenzie

International Rice Research Institute, Philippines,

Manalo, Abraham

Mr. Manalo

Biotech Coalition of the Philippines, Philippines

Mewett, Osman

Mr. Mewett

CropLife Australia, Australia

Raju, PJ

Dr. Raju

Andhra Pradesh State Sericulture Research and Development Institute, India

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Dr. Srinivasa Rao

Central Research Institute for Dryland Agriculture, India

Scorza, Ralph

Dr. Scorza

United States Department of Agriculture (Retired), United States

Redenbaugh,Keith

Dr. Redenbaugh

Arcadia Biosciences, United States

Roberts, Andrew

Dr. Roberts

ILSI Research Foundation, United States

Satyavathi, VV

Dr. Satyavathi

Centre of Excellence for Genetics and Genomics of Silkmoths, India

Seraj, Zeba

Dr. Seraj

University of Dhaka, Bangladesh

Teem, John

Dr. Teem

ILSI Research Foundation, United States

Tonui, Willy

Dr. Tonui

National Biosafety Authority, Kenya

Veluthambi, K.

Dr. Veluthambi

Madurai Kamaraj University, India

Yasmeen, Khorsheda

Ms. Yasmeen

Ministry of Environment and Forests, Bangladesh

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The International Symposium on the Biosafety of Genetically Modified Organisms (ISBGMO) is a biennial, international meeting organized under the auspices of the International Society for Biosafety Research (ISBR), which has previously been hosted in South Africa, Germany, Canada, China, France, Korea, New Zealand, Argentina and the USA.

The goal of ISBGMO14 is to advance the standing of biosafety research around the world and shape the ways in which genetically modified (GM) technology is applied and regulated. Over the course of four days, attendees will learn from the past, discuss the present and look ahead to future opportunities and challenges associated with GM technology.

Why attend ISBGMO14?

  • Network with 500+ professional colleagues representing 50 countries
  • Build relationships with biosafety decision makers and innovators in academia, business, government and non-governmental organizations
  • Attend 10+ technical sessions over four days
  • Present your research during the poster session
  • Hear outstanding keynote speakers, including Dr. Fred Gould, University Professor of Entomology & Co-Director of the Genetic Engineering and Society Center of North Carolina State University; Dr. Sheila Jasanoff, Professor of Science & Technology Studies, John F. Kennedy School of Government, Harvard University; and Professor Tim Benton, UK Champion for Global Food Security & Professor of Population Ecology, University of Leeds
Attendees

Who should attend?

ISBGMO14 brings together academics, technology developers, regulatory authorities, non-government organizations and other credible stakeholders involved in all aspects of biosafety and offers a unique opportunity to share information and experiences and engage in open and meaningful dialogue on biosafety research, risk analysis, policy and regulatory matters.

Program

The ILSI Research Foundation will be presenting at ISBGMO14 during the plenary session titled "Advancing Environmental Risk Assessments of Genetically Modified Organisms - Present Challenges" as well as the parallel session titled “GM Insects and Gene Drive Systems for Pest Control”.

To view the full symposium program, please visit the ISBGMO14 website.

Registration

Registration is open through the ISBGMO14 website.

Join over 500 of biosafety’s best and brightest at the 14th International Symposium on the Biosafety of Genetically Modified Organisms (ISBGMO14) in Mexico. ISBGMO14 offers a unique opportunity to share information and experiences as well as engage in open and meaningful dialogue on biosafety research, risk analysis, policy and regulatory matters. Advance the standing of biosafety research around the world and shape the ways in which GM technology is applied and regulated - at ISBGMO14!

Social Media

Folllow along to @ISBGMO and @ILSIRF on Twitter for updates. #ISBGMO14 is the preferred hashtag for the 14th Annual Symposium on the Biosafety of Genetically Modified Organisms.

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Results from the Workshop “Problem Formulation for the Use of Gene Drive in Mosquitoes”

Reducing the incidence of malaria has been a public health priority for nearly a century. However, before new technologies and associated vector control strategies  can be developed and exploited, it will be necessary to understand and assess the likelihood of any potential harms to humans or the environment. To begin this process, the Foundation for the National Institutes of Health and the ILSI Research Foundation organized an expert workshop to consider the potential risks related to the use of gene drives in Anopheles gambiae for malaria control in Africa.

Read more

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