Posts in category Meetings

Public Release Event

Video recording of report release event (June 8, 2016)

The advent of new gene editing tools such as CRISPR/Cas9 has enabled scientists to take advantage of naturally occurring selfish genetic elements to drive new traits into an organism. These gene drives have the potential to alter wild populations of organisms for beneficial purposes, such as disabling mosquitoes from transmitting malaria and other infectious diseases. This report provides an independent, objective assessment of the state of knowledge and responsible practices for research, risk assessment, public engagement, and the development of public policies on gene drive technologies. Co-chairs James Collins of Arizona State University and Elizabeth Heitman of Vanderbilt University Medical Center explained the report’s findings followed by a Q&A session. They were joined in the Q&A by committee members Lisa Taneyhill of the University of Maryland and Jason Delborne of North Carolina State University.

Follow the conversation: #GeneDriveStudy

Webinar: Building International Capacity for Research and Technology Assessment of Gene Drives

January 5, 2016

This webinar explored the international science policy landscape for biotechnology and ideas for building gene drive research and technology assessment capacity. The webinar was an information-gathering meeting for the committee in which the speakers are invited to provide input to the committee.

Speakers:

 International Biotechnology Policy and Research Capacity Building – Genya Dana, US State Department

Dr. Genya Dana is Senior Science Policy Officer at U.S. Department of State. Dr. Dana is an advocate for science, technology, and innovation as a key component of sustainable development and poverty alleviation. She specializes in providing advice on synthetic biology and international policy actions to the United States government and other stakeholders. Dr. Dana is the lead negotiator and expert on synthetic biology in the Convention on Biological Diversity and other international policy fora.  Due to her efforts, Dr. Dana received the 2015 Superior Honor Award for formulating the first United States government position on synthetic biology for use in international fora. She fosters partnerships between companies, universities, non-profits and governments to increase scientific and technological capacities in Africa. Dr. Dana also increases the US State Department’s technical capacity through the management of four science policy fellowship programs.

Building Capacity for Technology Assessment – Clifford Goodman, The Lewin Group

Dr. Goodman is a Senior Vice President at The Lewin Group, a health care policy consulting firm based in Falls, Church, Virginia.  Dr. Goodman has 30 years of experience in such areas as health technology assessment (HTA), evidence-based health care, comparative effectiveness research, health economics, and studies pertaining to health care innovation, regulation, and payment.  He directs studies and projects for an international range of government agencies; pharmaceutical, biotechnology, and medical device companies; health care provider institutions; and professional, industry, and patient advocacy groups.  His recent work has involved such areas as oncology, cardiovascular disease, diabetes, blood disorders, obesity, end-stage renal disease, HIV/AIDS, follow-on biologics, diagnostic testing, pharmacogenomics, personalized medicine, and organ donation and transplantation.  Dr. Goodman is an internationally recognized health policy issues moderator and facilitator of expert panels, health industry advisory boards, workshops, and focus groups, having conducted more than 170 such events over the last five years.  He is a special consultant on HTA to the China National Health Development and Research Center, Ministry of Health (National Health and Family Planning Commission), People’s Republic of China.  Dr. Goodman served as Chair of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC, 2009-12) for the US Centers for Medicare and Medicaid Services (CMS).  He served as President of the professional society, Health Technology Assessment International (HTAi, 2011-13), and is a Fellow of the American Institute for Medical and Biological Engineering (AIMBE).  He received a PhD from The Wharton School of the University of Pennsylvania, a Master of Science from The Georgia Institute of Technology, and a Bachelor of Arts from Cornell University.

Webinar: Perspectives on Environmental Benefits and Hazards of Gene Drives

December 17,  2015

This webinar explored the environmental benefits and uncertainties of gene drive research in different organisms. The webinar is an information-gathering meeting for the committee in which the speakers are invited to provide input to the committee.

Presentations (click on title to view a PDF of the slides):

Synthetic nature and the future of conservation, Kent H. Redford

Ecological consequences of gene drives: Addressing the uncertainties, Owain Edwards

Speakers:

Owain Edwards, Commonwealth Scientific and Industrial Research Organization

Dr. Owain Edwards is Research Program Leader in Environmental Biotechnology and Genomics, at Commonwealth Scientific and Industrial Research Organization (CSIRO). His research has focused primarily on the molecular basis of aphid-host plant interactions, which includes a leadership role in the International Aphid Genomics Consortium (IAGC) and strong collaborations with the Institute of Zoology (CAS Beijing), Kansas State University (USA), INRA Rennes (France) and BGI Shenzhen (China). His work on aphids has now broadened to examine the molecular basis of all aphid interactions with the environment, including the genetic and epigenetic factors controlling aphid polyphenism. Most recently, he has embarked on innovative research applying insect metagenomics methods for biodiversity and biosecurity applications. Prior to joining CSIRO in 1998, Dr Edwards undertook postdoctoral studies at the University of Florida and the US Department of Agriculture to study ecological and genetic factors controlling the establishment of natural enemies in classical biological control programs.

Kent H. Redford, Archipelago Consulting

Kent H. Redford is the principal at Archipelago Consulting, established in 2011 and based in Portland, Maine.  In 1993 he left academia to join The Nature Conservancy (TNC) where until 1997, he directed the Parks in Peril program and ran the conservation science department in the Latin American Division.  At TNC he helped develop guidelines for ecoregion-based conservation in the US and abroad and was a member of the Conservation Committee that developed a conservation mission for the whole organization.  In 1997 he joined the Wildlife Conservation Society to work in the International Program on conservation strategy.  He was then chosen to lead the WCS Institute, created to: 1) analyze conservation and academic trends that potentially challenge WCS’s mission or provide opportunities to further conservation effectiveness; and 2) to communicate strategically with significant stakeholders, including other conservation NGOs and the private sector.  The Institute drew on WCS’s wide range of conservation issues, and disseminated WCS’s conservation work via papers and workshops, adding value to WCS’s discoveries and experience by sharing them with partner organizations, policy-makers, and the public.  Through his career Kent has continued to actively publish on conservation practice and the biology of mammals.

Follow on Twitter: #GeneDriveStudy 

Webinar: Containment Guidelines for Gene Drive Research

December 15, 2015

This webinar explored whether and how containment guidelines should be developed for research on gene drive systems. The webinar was an information-gathering meeting for the committee in which the speakers were invited to provide input to the committee.

Speakers:

Mark Benedict, Centers for Disease Control and Prevention

Dr. Mark Benedict is a Research Biologist with the US Centers for Disease Control (CDC) and Prevention.  His interests focus on the use of conventional and transgenic technologies to control of mosquito borne diseases, including the development of transgenic and other technologies, and biosafety and regulatory guidelines for research.

Steve Strauss, Oregon State University

Dr. Steve Strauss is Professor of Forest Biotechnology at Oregon State University.  His research explores genetic engineering and genomic approaches to understanding and improving trees for plantation forestry and horticulture. He also conducts interdisciplinary analysis to understand, and propose, improvements to regulations of genetically engineered crops and trees. Dr. Strauss runs an active genetic transformation (gene insertion) lab that has produced thousands of transgenic trees, and has tested many of these in the field.

Webinar: Field Research with Modified Organisms

 December 15, 2015

This webinar explored approaches, challenges, and general considerations with conducting field research and release with modified organisms in different communities. The webinar was an information-gathering meeting for the committee in which experts were invited to provide input to the committee.

Speakers:
Scott O’Neil, Monash University, Melbourne, Australia

Dr. Scott O’Neil is Professor and Dean of Science in the School of Biological Sciences at Monash University. His research interests are in insect interactions with bacterial symbionts and their potential utilization for controlling mosquito-transmitted disease. Dr. O’Neil’s research group is focusing on the biology of Wolbachia, an inherited bacterial parasite of invertebrates.Wolbachia are capable of exerting profound effects on the hosts they infect suchas inducing developmental defects like cytoplasmic incompatibility, inducing parthenogenetic development, overriding chromosomal sex determination, selectively killing males and even functioning as classical mutualists. He and colleagues are currently working on the development of Wolbachia as a novel method to interfere with the transmission of dengue fever, a disease that causes illness in more than 50 million people each year.

Danilo Carvalho, International Atomic Energy Agency, Vienna

Mr. Carvalho works for the International Atomic Energy Agency (IAEA) and is a doctoral student at the University of Sao Paolo, Brazil. Mr. Carvahlo’s interests are in host-pathogen relationships, with a focus on the mosquitoes Aedes aegypti and Culex quinquefasciatus. Prior to his position IAEA, Mr. Carvahlo was the manager for the Transgenic Aedes Project,  a partnership between Oxitec, Moscamed Brazil, and the University of Sao Paolo. The goal of the Transgenic Aedes Project is to evaluate field release of a transgenic Aedes aegypti (OX513A) as population suppression control and ultimately reduce the spread of Dengue in Brazil.

John Marshall, University of California, Berkeley

Dr. John Marshall is Assistant Professor in Residents of Biostatistics and Epidemiology at the University of California, Berkeley. Dr. Marshall’s research interests span genetic control of mosquito-borne diseases, parasite genomics, and mathematical modeling of infectious diseases.  He completed his postdoctoral research on malaria epidemiology at Imperial College, population genetics at the California Institute of Technology, and field research at the Malaria Research and Training Center in Mali.  Dr. Marshall has also studied and published on gene drive systems for suppression of insect populations.

Follow on Twitter: #GeneDriveStudy 

Webinar: US Regulation of Biotechnology

December 9, 2015

This webinar explored the  landscape of US regulations on biotechnology and how they apply to gene drive research and development. The webinar was an information-gathering meeting for the committee in which the speakers were invited to provide input to the committee.

Gene Drives and the U.S. Biotechnology Regulatory System – Sarah R. Cater, J. Craig Venter Institute (Click title for PDF of the slide presentation. No video recording available.)

Speakers:

Sarah R. Carter,  J. Craig Venter Institute

As a Policy Analyst at JCVI,  Dr. Sarah R. Carter focuses on the policy and societal implications of the institute’s scientific advancements. Previously, Dr. Carter was a Policy Analyst at the White House Office of Science and Technology Policy (OSTP) where she worked on a wide range of issues relating to climate change and sustainability.  Dr. Carter has a broad science policy background and has held multiple science and technology policy fellowships, including an American Association for the Advancement of Science (AAAS) Fellowship at the Environmental Protection Agency and a Mirzayan Fellowship at the National Academies. She earned her bachelor’s degree in Biology from Duke University in 2000 and her Ph.D. in Neuroscience at the University of California-San Francisco in 2007, where she focused on molecular mechanisms of gene transcription and protein trafficking.

Larisa Rudenko, US Food and Drug Administration

Dr. Larisa Rudenko is the Senior Advisor for Biotechnology and Director of Animal Biotechnology Interdisciplinary Group at the US Food and Drug Administration. She  develops and implements science-based policy for the regulation of the products of animal biotechnology. Dr. Rudenko also directs and coordinates an interdisciplinary group of scientific, regulatory, and legal professionals to continue to refine and implement regulations, and serves as the technical expert in development of domestic and international policy regarding new technologies.  She received to AB degree in Biology at Bowdoin College in 1976 and her Ph.D. in Cellular and Molecular Pharmacology at the State University of New York at Stony Brook in 1989.

Alan Pearson , US Department of Agriculture

Dr. Alan Pearson is the Branch Chief of Plant Pest and Protectants within the Biotechnology Regulatory Services (BRS) of the Animal and Plant Health Inspection Service of the US Department of Agriculture. Dr. Pearson has been with BRS for 6 years, serving as a biotechnologist for the last 3 years conducting plant pest risk assessments and environmental assessments on regulated genetically engineered plants. Prior to working as a biotechnologist, Dr. Pearson worked in BRS’ Office of Science. Dr. Pearson has a Ph.D. in Biology with a focus on cell biology in animal systems.

Follow on Twitter: #GeneDriveStudy 

Webinar: Species Interaction Dynamics and Ecological Community Structure

November 20, 2015

This webinar explored the structure and function of ecological communities, and how species interactions might change with the introduction of an organism modified with a gene drive.

The webinar is an information-gathering meeting for the committee in which the speakers were invited to provide input to the committee.

Speakers:

David Lodge,  University of Notre Dame

Dr. David Lodge is a Professor of Biological Sciences and Director of the Environmental Change Initiative at the University of Notre Dame. His research focuses on ecological forecasting to better inform environmental risk assessment, policy development, and natural resource management. Dr. Lodge combines basic and applied ecological research to contribute to conservation of the world’s fresh waters, with a particular emphasis on the causes, effects, and management of biological invasions.  Through field and laboratory experiments as well as short- and long-term natural observations, he explores the complex interactions that occur among plants, invertebrates, fish, and other organisms and how aquatic communities change over time. Dr. Lodge is also researching novel technologies such as environmental DNA (eDNA) surveillance to improve the study and management of invaders, imperiled species, and other species of interest.  As part of his work, we collaborates extensively across experts in different disciplines to link ecology with other fields such as economics to understand how changes in aquatic systems influence human use and perceptions.

George Roderick, Univeristy of California, Berkeley

Dr. George Roderick is the William Muriece Hoskins Professor and Chair of the Department of Environmental Science, Policy, and Management at the University of California, Berkeley. Dr. Roderick’s research focuses on biological invasions and the history and structure of populations, both especially related to biodiversity science and global change. His work addresses basic and applied questions, taking advantage of the opportunities associated with the geography of Pacific Basin, Pacific Islands, and Pacific Rim, including California. Research in Dr. Roderick’s lab includes studies of the origins of endemic, indigenous and non-indigenous organisms, processes associated with colonization and invasion, species interactions, and population structure.  Approaches include population genomics, computational biology, GIS, niche modeling, and other tools. Some of this work deals with older colonizations and deeper history, such as the assembly of ecological communities in the South Pacific. Other work examines the recent biological invasions and their impacts, including biological control.

Follow on Twitter: #GeneDriveStudy 

Webinar: Biosecurity Implications of Gene Drive Research

November 19, 2015

This webinar will explore some of the implications gene drive research has on biosecurity, including entomological warfare and agricultural security. The webinar is an information-gathering meeting for the committee in which the speakers are invited to provide input to the committee.

Speakers:

General considerations for biosecurity– Edward You, Federal Bureau of Investigations  bio

Mr. Edward You is a Supervisory Special Agent with the Federal Bureau of Investigations (FBI). Mr. You is responsible for creating countermeasures, programs, and activities to coordinate and improve FBI and interagency efforts to identify, assess, and respond to potential intentional biological threats or incidents. These efforts include expanding FBI outreach to the Biological Sciences community and supporting efforts to identify and address potential security challenges in emerging biotechnology, such as synthetic biology and the use of big data in the life sciences.

Implications of gene drives for agricultural security – Jacqueline Fletcher, Oklahoma State University  bio

Dr. Jacqueline Fletcher is Regents Professor, Sarkeys Distinguished Professor, and Director of the National Institute for Microbial Forensics and Food and Agricultural Biosecurity (NIMFFAB) at Oklahoma State University. Dr. Fletcher’s research focuses on molecular biology and gene regulation of phytopathogenic molecutes (bacteria that lack a cell wall), insect transmission of phytopathogenic mollicutes, and phytobacterial disease of importance to agriculture in Oklahoma. As Director of NIMFFAB she oversees the institutes programs to assess and support U.S. capabilities in the use of microbial forensic to detect plant pathogens and monitor food safety.

Potential for the use of gene drives in entomological warfare— Amesh Adalja, University of Pittsburgh Medical Center  bio

Dr. Amesh Adalja is a Senior Associate at the UPMC Center for Health Security, Clinical Assistant Professor in the Department of Critical Care Medicine, Clinical Assistant Professor in the Department of Emergency Medicine, and Adjunct Instructor in the Department of Medicine’s Division of Infectious Diseases at the University of Pittsburgh School of Medicine and UPMC. He also serves on the City of Pittsburgh’s HIV Commission. Dr. Adalja expertise spans infectious disease, pandemic policy, emerging infections, and preventing bioterrorism. He is board certified in internal medicine, emergency medicine, infectious diseases, and critical care medicine.

Follow on Twitter: #GeneDriveStudy 

Webinar: Key Principles and Considerations for Risk Assessment of Gene Drive Research and Applications

November 5, 2015

This webinar reviewed approaches to and key principles of environmental and human health risk assessment and considerations for gene drive research and applications.

The webinar was an information-gathering meeting for the committee in which the speakers were invited to provide input to the committee.

Speakers:

Katherine von Stackelberg, ScD, Harvard University bio

Dr. Katherine von Stackleberg is Principal and Owner of NEK Associates LTD, is a Consulting Scientist at E RiskSciences, and a Research Scientist at the Harvard Center for Risk Analysis. Dr. von Stackelberg has spent many years developing risk-based tools to support environmental decision making. That has led to an interest in tools and methods to support sustainable approaches to making environmental decisions, particularly in terms of economic benefits related to ecosystem services. A key interest is the development of methods for quantifying changes in ecosystem services and relating those to changes in benefits using stated preference methods. Dr. von Stackelberg’s work also focuses on methods that integrate economics and risk assessment to better quantify the benefits of proposed risk reductions as a result of management or regulatory actions for use in cost-benefit, cost-effectiveness, and value of information analyses. Much of her work has
focused on incorporating quantitative uncertainty analysis (e.g., analytical, probabilistic, and fuzzy methods) into the risk assessment process, and she has been at the forefront of the effort to promote uncertainty analysis and methods for communicating uncertainty to support environmental decision-making. Dr. von Stackelberg received an A.B. cum laude from Harvard College, and a Sc.M. and Sc.D. from the Harvard School of Public Health in Environmental Science and Risk Management.

Bruce K. Hope, PhD,  retired  bio

From 2011 until his retirement in 2014, Dr. Bruce Hope was a principal environmental toxicologist with the international consulting firm CH2M HILL, where he worked on projects involving environmental toxicology, ecological and human health risk assessment, chemical bioaccumulation modeling, development of air and water quality guidelines, and regulatory-science policy strategies. From 1995 to 2011, he was a senior environmental toxicologist with the Oregon Department of Environmental Quality (DEQ), where he was instrumental in identifying persistent pollutants in Oregon’s municipal effluents, developing ambient benchmark concentrations for air toxics, completing the Umatilla chemical weapons incinerator post-trail burn risk assessments, and reviewing human health and ecological risk assessments. Prior to joining DEQ in 1995, he was a consultant in the private sector managing human health and ecological risk assessment projects for
commercial and government clients throughout the U.S. and the Pacific Rim. In 2000-01, he was an American Association for the Advancement of science (AAAS) risk policy fellow in Washington DC, working on food safety, microbial risk assessment, and bioterrorism issues. He has served on the North American Board of Directors for the Society of Environmental Toxicology and Chemistry (SETAC) and was previously on the editorial boards of Human and Ecological Risk Assessment, Environmental Toxicology and Chemistry, and Risk Analysis. He has also served on several U.S. EPA national advisory and review panels addressing cumulative risk, wildlife, ecological, probabilistic, and environmental modeling issues, as well as on two National Research Council committees: one evaluating human health risk assessment practices and the other examining ecological risk assessment in the context of FIFRA and the ESA. He holds M.S. and Ph.D. degrees in biology from the University of Southern California and a B.A. degree from the University of California, Santa Barbara.

Follow on Twitter: #GeneDriveStudy 

Webinar: Considerations for Commercial Applications of Gene Drives

Monday, November 2,  12:00-1:00pm

This webinar focused on the potential for commercial applications of gene drives and how a business model might develop and evolve. The webinar is an information-gathering meeting for the committee in which the speakers are invited to provide input to the committee.

Speaker:

Luke Alphey, The Pirbright Institute
Dr. Alphey’s major research focus is on the use of modern genetic methods to improve the Sterile Insect Technique (SIT) in agricultural pest species. Another area of interest in genetic control is the “refractory insect” strategy, which is based on (i) the production in the laboratory of a strain of insects refractory to transmission of a disease agent (e.g. malaria or dengue fever) and (ii) the introgression of this refractory gene into the wild population, so that the disease-transmitting insect population is rendered harmless. Dr. Alphey is a founder of Oxitec, a biotech company developing transgenic methods to control insect pests that spread disease or damage crops, and served as Oxitec’s Chief Scientific Officer for more than a decade.