Dan Burk, University of Minnesota, Law School

 Professor Dan Burk is the Oppenheimer, Wolff & Donnelly Professor of Law at the University of Minnesota, where he teaches courses in Patent Law, Copyright, and Biotechnology Law.  An internationally prominent authority on issues related to high technology, he is the author of numerous papers on the legal and societal impact of new technologies, including articles on scientific misconduct, on the regulation of biotechnology, and on the intellectual property implications of global computer networks.

 Professor Burk holds a B.S. in Microbiology (1985) from Brigham Young University, an M.S. in Molecular Biology and Biochemistry (1987) from Northwestern University, a J.D., cum laude, (1990) from Arizona State University, and a J.S.M. (1994) from Stanford University.

The Lessons of Biotech Patenting: Since the landmark U.S. Supreme Court decision in Diamond v. Chakrabarty, biotechnology has posed a series of challenges to conventional patent doctrines.  From the subject matter questions over the patenting of living organisms, to the ownership of self-replicating inventions; from the propriety of academic technology transfer, to the problem of overlapping intellectual property regimes; from the challenge of patented research tools, to the potential for patent thickets or anti-commons, the history of biotechnology patenting is a study in tailoring intellectual property to innovative technology.

Jeffrey Burkhardt, University of Florida, Food and Resource Economics Department

 Jeffrey Burkhardt is Professor of Agriculture and Natural Resource Ethics and Policy in the Food and Resource Economics Department (FRED), Institute of Food and Agricultural Sciences, University of Florida. He is also currently Graduate Coordinator in FRED. He received his Ph.D. in philosophy with a graduate minor in economics from Florida State University in 1979, and joined the faculty of the University of Florida in 1985. He currently teaches courses on Agriculture and Natural Resource Ethics, Science Ethics, and the Philosophy of Economics. 

 Dr. Burkhardt is co-author of two books on ethics and agricultural biotechnology, Plants, Power, and Profit (1991) and Making Nature, Shaping Culture (1995), and he has published numerous professional and popular articles on ethical issues in the agricultural and natural resource system, the ethics of food and agricultural biotechnology, ethics in science, and the philosophy of economics.  Dr. Burkhardt has served on several national panels for the United States Department of Agriculture, National Academies of Science, National Agricultural Biotechnology Council, and the National Science Foundation. From 2000 - 2002, he served on the United States Department of Agriculture's Advisory Committee on Agricultural Biotechnology (USDA-ACAB).  He recently chaired the Council on Agricultural Science and Technology’s Task Force on Agricultural Ethics.

AgBiotech Ethics at Twenty-Five: What We Have Learned (and Not Learned): This presentation addresses several of the ethical issues that have arisen in connection with food and agricultural biotechnology. Most of these issues arose because of an abiding and unreflective commitment by the agricultural establishment -- farmers, agricultural scientists, and policy-makers -- to a philosophy called "productionism." Productionism holds that "more is better," and that efficiency is ultimately the key to achieving the greatest social good. By ignoring, or refusing to acknowledge, possible negative consequences of productionism, the establishment set itself up for criticisms such as, that biotechnology is inherently unethical because it is unnatural, that agricultural biotech contributes to environmental harms and human health risks, that it has helped accelerate the concentration of corporate control over agriculture, and that it has negatively impacted small farmers across the globe.

Lawrence Busch , Michigan State University

  Dr. Lawrence Busch is University Distinguished Professor of Sociology and Director of the Institute for Food and Agricultural Standards at Michigan State University. He is coauthor or coeditor of a number of books including Plants, Power, and Profit: Social, Economic, and Ethical Consequences of the New Biotechnologies (Blackwell, 1991); From Columbus to Conagra: The Globalization of Agriculture (Kansas, 1994); and Making Nature, Shaping Culture: Plant Biodiversity in Global Context (Nebraska, 1995) and most recently, The Eclipse of Morality: Science, State, and Market (Aldine deGruyter, 2000) as well as more than 100 other publications. He is past president of the Rural Sociological Society, past president of the Agriculture, Food, and Human Values Society and a fellow of the American Association for the Advancement of Science. He recently was named Chevalier de l’Ordre du Mérite Agricole by the French government. Dr. Busch has worked in France, Norway, Kenya, Brazil, India, and a number of other nations on issues related to food and agriculture. He has been long been a consultant to the International Service for National Agricultural Research and the Food and Agriculture Organization of the United Nations. He has written and spoken on a variety of social, political, and economic issues associated with food standards, both here and abroad. Dr. Busch's interests include food and agricultural standards food safety policy, biotechnology policy, agricultural science and technology policy, higher education in agriculture, and public participation in the policy process.

Five lessons to be learned:
- Enroll All Actors in the Supply Chain
- Compete and Cooperate
- Gain by Sharing
- Regulate Through the Entire Supply Chain
- Line Up All the Ducks in Order to Sell Products Effectively

Kenneth David , Michigan State University

 Dr. Kenneth David, Ph.D., M.B.A. is Associate Professor of Anthropology and Trans-cultural Management at Michigan State University (USA). He received his B.A. (Honors) at Wesleyan University of Connecticut in 1965, his M.A. and Ph.D. Socio-Cultural Anthropology, University of Chicago in 1968 & 1972, and his M.B.A. in International Business and Business Policy at Michigan State University in 1981. He has done Organizational Anthropology research in France, Holland, India, South Korea, Sri Lanka and the United States, focusing first on country-company relationships and later on inter-organizational relationships (acquisitions, joint ventures, long-term consulting relationships, and strategic alliances). His theoretical direction is best described as boundary-spanning project studies: an anthropological reconsideration of management and communications studies. The most recent boundary-spanning research deals with cultural and power issues that affect project activities. He is co-PI on an NSF sponsored grant studying geographically-dispersed and culturally disparate teams of engineers doing design work. This is a tri-discipline (Anthropology, Engineering, Telecommunication), six-country (ChinaMexico, Netherlands, Russia, Spain, United States) research consortium. This research will be highly useful in dealing with Nanotechnology projects that are designed, implemented, and evaluated by organizations from different locales and cultures.

Setting Nano-fears and Nano-befefits in context: Powers and Representations

George Gaskell, London School of Economics and Political Science

 George Gaskell, Professor of Social Psychology, is Director of the Methodology Institute at the London School of Economics. 

 He is associate director of BIOS, the Centre for the study of Bioscience, Biomedicine, Biotechnology and Society and a member of CARR, the Centre for the Analysis of Risk and Regulation at the LSE.  From a background in social psychology, his research focuses on science, technology and society, in particular the issues of risk and trust, how social values influence people’s views about technological innovation, and the governance of science and technology.  He was coordinator of ‘Life Sciences in European Society’, a European comparative study of biotechnology in the public sphere funded by the European Commission’s 5^th Framework Programme and is a member of the International Biotechnology Survey Group. 

 He is vice-chair of the European Commission’s Science and Society Advisory Committee for the 6^th Framework Programme and is a member of the Science in Society Committee of the Royal Society, the Expert Group on Risk Communication of the European Food Standard Authority and the Advisory Board of the Toronto Programme on Applied Ethics and Biotechnology.

Values matters: Science, technology and social values: The European experience of modern biotechnology provides a number of lessons for forthcoming technological innovations nanotechnology and the like.  At a very general level these lessons point to the dangers of group think centered on hubris and hype among the promoters of the technology.  More specific lessons include the need to anticipate the consequences of signing up to international agreements and, in particular, the cost of ignoring the current political realities; the fall out of ignoring and/or dismissing the repeated warning signals of concerned public opinion; the problems of adhering rigidly to a narrow sound scientific approach to the assessment of risks and benefits; the failure to appreciate that the hurdles to successful innovation go beyond regulation and the traditional definition of the market; the assumption that science trumps all other consideration including social values, and not recognizing the need to pave the way for innovations as they enter the public domain.

John Lloyd , Michigan State University

  John R. Lloyd is a University Distinguished Professor of Mechanical Engineering at Michigan State University. He is a Fellow of the American Society of Mechanical Engineers, and he has received the Melville Medal and the Heat Transfer Memorial Award from ASME International. He currently serves as Governor of ASME International.

  He was awarded the degree Doctor of Technical Science Honorus Causa by the Russian Academy of Sciences, and was recently elected as a member of the European Academy of Sciences. He is an editor of several international technical journals. He has received teaching awards including the SAE Ralph R. Teetor Educational Award. His current areas of research interest include the development of MEMS sensors for application to bio and other engineering systems.

  His research programs includes the emerging areas of energy transport at the micro and nano length scales, which will have application in developing such diverse areas as thermal energy transport in Agrifood systems, thermoelectric devices, fuel cells, and energy efficiency in phase change heat transport in structured, micro and nano thin film coatings on particles such as seeds and agri-elements.

Concluding Remarks

Alan McHughen, University of California-Riverside

 Alan McHughen is a public sector educator, scientist and consumer advocate. After earning his doctorate at Oxford University and lecturing at Yale University, Dr.  McHughen worked at the University of Saskatchewan before joining the University of California, Riverside. A molecular geneticist with an interest in applying biotechnology for sustainable agriculture and safe food production, he served on recent National Academy of Science, Institute of Medicine and OECD panels investigating the environmental and health effects of genetically novel plants and foods.

 Dr. McHughen also served for six years as President of the International Society for Biosafety Research. Having developed internationally approved commercial crop varieties using both conventional breeding and genetic engineering techniques, he has first hand experience with issues from both sides of the regulatory process, covering both recombinant DNA and conventional breeding technologies. As an educator and consumer advocate, he helps non-scientists understand the environmental and health impacts of both modern and traditional methods of food production. His award winning book, ‘Pandora's Picnic Basket; The Potential and Hazards of Genetically Modified Foods’, uses understandable, consumer-friendly language to explode the myths and explore the genuine risks of genetic modification (GM) technology.

Phil Macnaghten, Institute for Environment, Philosophy & Public Policy (IEPPP)
Lancaster University, United Kingdom

 Phil Macnaghten, Senior Lecturer, is Director of Research at the Institute for Environment, Philosophy and Public Policy, Lancaster University. Macnaghten's research has focused broadly on the cultural dimensions of environmental and innovation policies and everyday practices. Currently he is directing a major ESRC funded project on ‘Nanotechnology risk and sustainability: moving public engagement upstream.’ The project focuses on specific applications of nanotechnology so as to open up wider ethical and socio-political issues for public discussion. The project asks how in the light of recent experiences with biotechnology socially and environmentally-sensitive governance processes might be developed by moving the site of public involvement further ‘upstream’ within R&D processes.

 He advises the UK Economic and Social Research Board on Nanotechnology and Society matters, is a founding member of the International Nanotechnology and Society Network, a member of the UK Nanotechnologies Standardization Committee NTI/1, and a research partner on the Sciencewise project ‘The Nanodialogues: Four experiments in upstream engagement.’

From Bio to Nano: Learning the Lessons, Interrogating the Comparison: In this paper we consider the political, institutional and regulatory contexts in which contemporary considerations of, and debates about, nanotechnology are currently situated. We draw upon an analysis of the public and political controversy which overtook GM plants and crops in the UK in the 1990s. Given the starkness of the 'GM Controversy', it is not surprising there is now speculation in many quarters as to whether nanotechnologies might not be expected to experience a similarly rough passage. Here, it is being suggested, is a further potentially transformative technology, now arguably at roughly the stage of development as was biotechnology in the late 1970s or early 1980s, and subject to similar levels of utopian promise, expectation and dystopian fear. Some NGOs are already suggesting that the issues and problems nanotechnology raises are of such far-reaching political and social importance that 'governments [should] declare an immediate moratorium on commercial production of new nanomaterials and launch a transparent global process for evaluating the socioeconomic, health and environmental implications of the technology.' (ETC 2003, 72)

Crudely put, the GM experience represents a warning, a cautionary tale of how not to assess an emerging technology and allay public concern. For many, addressing the question 'Is nanotechnology the next GM?' is critical to the commercial success and public acceptability of emerging applications in the field. As such the 'GM experience' has been portrayed as a model 'to be avoided' in the future development and governance of nanotechnology. As with all such stories, however, the comparison between GM and nanotechnology is more complex than may first appear. They are both very different technical endeavors, emanating from different disciplines, with vastly different scope. Therefore a direct comparison between GM and nanotechnology is probably of limited value. What we address here is not a direct comparison between GM and nanotechnology. Rather we ask in what ways the GM experience can inform and shape contemporary political and regulatory debates in which the development of nanotechnologies will be negotiated. We ask whether there are any instructive lessons to be learned from this experience: how likely is it that the emergence of nanotechnology could precipitate socially divisive rows over the coming decade? Are there steps that can be taken now to give coherence and order to the necessary discussions and arguments? Does the GM experience give any insight into how such public issues arise? And if so, what scope may there be for political and institutional innovation that help arrive at sensible decisions?

Margaret Mellon, Union of Concerned Scientists, Washington, DC  

 Margaret Mellon came to the Union of Concerned Scientists (UCS) in 1993 to direct a new program on agriculture. The program promotes a transition to sustainable agriculture and currently has two main focuses: critically evaluating the use of biotechnology in plant and animal agriculture and assessing animal agriculture’s contribution to the rise of antibiotic-resistant diseases in people.

 Prior to joining UCS, Dr. Mellon was the Director of the Biotechnology Policy Center at the National Wildlife Federation. Trained as a scientist and lawyer, Dr. Mellon received both her Ph.D. and J.D. degrees from the University of Virginia. Before joining the National Wildlife Federation, she worked at Beveridge & Diamond, P.C., and the Environmental Law Institute in Washington, D.C. Dr. Mellon is a visiting professor at the Vermont Law School, where she teaches a popular summer course in biotechnology and the law. In 1994, she was honored as a fellow of the American Association for the Advancement of Science.

Of Hype, Home, and Handles: A Biotechnology Activist Looks at Nanotechnology: A conference entitled "What Nano Can Learn From Bio" might be based on the premise that biotechnology somehow stumbled on its way to the marketplace and that if nanotechnology wants a smoother path, its proponents could learn from the biotechnology experience and avoid its mistakes.  As a participant in the biotechnology debate, I am happy to provide insights to the proponents of nanotechnology from that perspective.  But perhaps the most important insight I have to offer is that for many participants in the biotechnology debate, the story is not primarily that of a technology that stumbled.  It is rather the story of how society has attempted to get a handle on the direction of new technology, to devise--on the run--new approaches to making the decisions about technology in a democratic way, reflective of a wide set of societal interests.  While the biotechnology industry could have done a better job of introducing its products and handling its critics, the fundamental issue for many is not the acceptance of the technology, but how decisions were made about its direction. We would like to see a more transparent, more democratic process for nano than we had for bio.  The talk begins with two threshold issues: whether nanotechnology encompasses a coherent set of products for purposes of public debate and whether such products are inherently dangerous.

Sonia Miller, Converging Technologies Bar Association, New York, NY

 An attorney and principal of S.E. MILLER LAW FIRM, Ms. Miller’s boutique law firm represents, advises and consults industry, individuals, companies, organizations, and government on the legal, ethical, policy, regulatory and legislative issues related to the convergence of technologies at the nanoscale. She is the owner and director of SciTechEngine, the legal consulting division of S.E. MILLER LAW FIRM; MISC – Miller International Seminars & Conferences, the training division of S.E. MILLER LAW FIRM and SciTechEngine; as well as founder and global president of the Converging Technologies Bar Association.  She is a columnist for the New York Law Journal, and an adjunct professor in the Executive MBA Program of the Institute for Technology & Enterprise at Polytechnic University, teaching the first university-level business class in the world on converging technologies.

 Ms. Miller serves on the National Materials Advisory Board’s Committee to Review the National Nanotechnology Initiative, in accord with the 21^st Century Nanotechnology Research and Development Act of 2003.  She is a member of the Executive Committee and chair of the Subcommittee on International Law & Intellectual Property for Committee E56 on Nanotechnology at ASTM International, and a member of the American National Standards Institute – Nanotechnology Standards Panel. Ms. Miller is a Senior Fellow for the Alden March Bioethics Institute at Albany Medical College. Additionally, she serves on the Advisory Panel for the Center on Nanotechnology and Society for The Institute on Biotechnology and Human Futures at the Illinois Institute of Technology – Kent Law School in Chicago.

Legal Lessons Learned from Agri-Food Biotechnology and GMOs: Nano, the four-letter buzzword of the 21st century, stirs continual debate around the issue of regulation. To regulate or not to regulate remains the ongoing question. Its unleashed advance is oftentimes compared to the debacle created by genetically modified organisms. Two diverse schools of rhetoric prevail.

U.S. regulators maintain that the unique size and properties of nanoscale materials do not warrant new regulation. In the absence of scientific evidence to the contrary, their position is that current safety and health regulations are adequate to address the risks associated with nanotechnology, and advocate more research and study.

In contrast to this argument are positions proffered by advocacy groups and non-government organizations, who allege that current regulations are not sufficiently elastic to address the unique and novel risks to people and the environment posed by nanoparticles. They reason that simply tinkering with existing regulations will not address the broad social, health, environmental and economic concerns of technologies converging at the nanoscale, and propose the drafting of new regulations.

This presentation will explore whether nano raises unique issues requiring new regulations and laws and what its advocates should learn from biotechnology.

David Sparling, Department of Agricultural Economics and Business, University of Guelph

 David Sparling is an Associate Professor in the Department of Agricultural Economics and Business at University of Guelph.  He combines an agri-food experience with a science and business education. He has been president of an agricultural production company, agri-business insurance company and a biotechnology start-up commercializing a fibre-optic DNA identification technology. His teaching and research interests are in the areas of operations and supply chain management and commercialization of new technologies. David is a Senior Associate at the University of Melbourne teaching in the electronic Master of Agribusiness Program and he recently developed and taught the MBA course Managerial Issues in Biotechnology at the Australian Graduate School of Management in Sydney.

 David has organized and spoken at numerous biotechnology and supply chain conferences and industry workshops in the United States, Canada, Australia, New Zealand and Ireland.  David recently completed a study of biotechnology IPOs in Australia and Canada.

Building a new technology business: A framework for translating biotechnology experiences to nanotechnology: The changes brought about by biotechnology were not only science based.  Biotechnology innovations have resulted in the redesign of business models, business operations and the structure of industries adopting them.  The impacts of nanotechnology promise to be even more widespread, affecting industries based on physical, as well as biological, sciences.  However, the experiences with biotechnology offer an opportunity to anticipate the challenges and opportunities associated with nanotechnology.   This paper considers the business of new technology development and introduction.  A framework for understanding the new technology introduction process within a broader societal context is developed using the experiences of biotechnology.  We consider how this framework could be applied to nanotechnology and the implications for both business managers and policy makers.

Hans Geerlings, Shell Research and Technology Centre, Amsterdam, The Netherlands

Hans Geerlings holds a PhD in Physics from the University of Amsterdam. Today he works for the Shell Research and Technology Center as an exploratory researcher. Geerlings' research interests include hydrogen storage in metal and complex hydrides, as well as carbon dioxide sequestration through mineralization.

Chris Phoenix, Center for Responsible Nanotechnology, Brooklyn, New York

Chris Phoenix, is the Director of Research for the Center for Responsible Nanotechnology. Phoenix has studied nanotechnology for more than 15 years. He obtained his BS in Symbolic Systems and MS in Computer Science from Stanford University in 1991. From 1991 to 1997 he worked as an embedded software engineer at Electronics for Imaging. In 1997, he left the software field to concentrate on dyslexia correction and research. Since 2000 he has focused exclusively on studying and writing about molecular manufacturing. Chris is a published author in nanotechnology and nanomedical research, and maintains close contacts with many leading researchers in the field. Chris lives in Miami, Florida.

Amy Wolfe, Oak Ridge National Lab, Oak Ridge, Tennessee.

Amy Wolfe leads the Economics and Social Sciences Group within the Environmental Sciences Division at Oak Ridge National Laboratory. In this role, Dr. Wolfe provides managerial and intellectual leadership for a group of 25 social scientists and support staff. Her research centers on the processes by which society makes and implements decisions about controversial and complex science, technology, and environmental issues. Wolfe’s work often combines theory-based research with application, particularly in her efforts to integrate science with decision-makers’ needs and to develop and implement communication strategies for scientific research programs and facilities.

Manish Mehta, National Center for Manufacturing Sciences, Ann Arbor, Michigan

Dr. Manish Mehta has been the Director of Collaboration Programs at the National Center for Manufacturing Sciences in Ann Arbor, MI since 2001.  His responsibilities include identifying new manufacturing technology needs, conducting emerging technology assessments, and developing sponsored collaborative research projects with NCMS’ defense and industry partners and U.S. government agencies.

14 Critical Issues Impacting U.S. Nanomanufacturing Commercialization - 2005 NCMS-NSF Industry Survey: Dr. Mehta will discuss selected results of a recent NSF-sponsored survey on commercialization efforts in nanotechnology which targeted multiple cross-industry sectors and senior executives.  He will assess key trends, strategies, risks and concerns of U.S. industry as it adopts and implements nanomanufacturing.