Regenerative Medicine in the 21st Century: Managing Uncertainty at the Global Level

Presenter Biographies

Kathrin Braun is currently guest professor for Political Theory at the University of Vienna and apl. Professor at the Leibniz University Hanover. Her research focuses on the nexus between biopolitics and modernity and challenges of new developments in biomedicine and the biosciences for democratic governance, human rights, and feminist politics. More recently, she has entered research into the politics of historic justice in case of historic human rights violations based on ideas of normalcy and social engineering. She is conducting the work package on oöcyte procurement for research in Europe within the REMEDiE Project, with Susanne Schultz, and a research project on reparation politics for the victims of forced sterilizations in Germany, Norway and the Czech Republic, with Svea Herrmann. Recent publications include: Biopolitics and Temporality in Arendt and Foucault, Time & Society 17(1)/2007; Processing dissent – managing uncertainty. New developments in science policy and science communication. Special Issue of Science, Technology and Human Values (forthcoming), co-edited with Cordula Kropp; Governmental Bioethics between the Technological Model and Reflexive Government, Economy & Society (upcoming), with Svea Herrmann, Alfred Moore and Sabine Könninger. R. Alta Charo (AB biology, Harvard 1979; JD law, Columbia 1982) is the Warren P. Knowles Professor of Law & Bioethics, University of Wisconsin Law School and School of Medicine & Public Health, where she teaches: Biotechnology Policy; FDA Law; Public Health Law; Bioethics; and Torts. She is currently on leave to serve in the federal government as a senior policy advisor on issues related to medical and food related applications of emerging technologies. Her previous government service has included positions as Policy Analyst in the US Agency for International Development (Office of Population) and Legal Analyst for the congressional Office of Technology Assessment (Biological Applications Program). Her service on government advisory bodies includes work as a member of the Obama-Biden Transition (areas: FDA/NIH/women’s health/stem cell policy); as a Commissioner on President Clinton’s National Bioethics Advisory

Commission (1996-2001) (reports on human subjects research; biological specimen research; cloning and stem cells); and as a member of the NIH Human Embryo Research Panel (1993-1994). She is currently a member of the National Academies’ Board on Population Health, and was a member of its Board on Life Sciences (2001-2008) and as well as a member of various IOM/NRC committees on bioterrorism, vaccination programs, and drug safety. She was one of the authors of the National Academies’ Human Embryonic Stem Cell Research Guidelines and serves as a co-chair of its Human Embryonic Research Advisory Committee. She was elected to membership in the Institute of Medicine in 2006. Herbert Gottweis is professor at the department of Political Sciences. He also directs the Life Science Governance Research Platform at the University of Vienna (http://www.univie.ac.at/LSG/intro.htm). He gained his Ph.D. from the University of Vienna (1984), was a visiting graduate student at the University of Rochester (1983/83), Assistant and Lecturer at the political science department, University of Salzburg (1985-1997), visiting research fellow (supported by a FWF Erwin Schrödinger Stipend) at the Centre of European Studies, Harvard University (1989/90), visiting research fellow (supported by the Andrew Mellon Foundation) at MIT’s program in Science, Technology, and Society (1992/93), assistant professor at the Department of Science and Technology Studies, Cornell University (1993-95), visiting professor, Department of Social Studies, Hong Kong University of Science and Technology (1997), visiting Professor at the Australian School of Environmental Studies, Griffith University (2004) and visiting professor at the United Nations University, Tokyo (2009-). Since 2005 he is also vice-president of the Austrian Research Fund (FWF). Among his book publications are Gottweis Herbert, Salter Brian & Waldby Catherine (2009): The Global Politics of Stem Cell Research: Regenerative Medicine in Transformation, London: Palgrave, 2009; Gottweis, H/Petersen A (2008), Biobank Governance in Comparison (London: Routledge); ,Gottweis, H. et al. (2004), Gottweis, H., (1998), Governing Molecules. The Discursive Politics of Genetic Engineering in Europe and in the United States (Cambridge, Mass.: MIT Press).

Christian Haddad is a Ph.D researcher in Political Science and a member of the Life-Science-Governance research platform at the University of Vienna, Austria. In the REMEDiE project he works together with Herbert Gottweis in WP3 “EU and global politics: transnational science”. His research focuses on governance issues related to clinical trials and the development of regenerative therapies in a comparative global context. Derek Hei received a Ph.D. in Biochemical Engineering from the University of California at Berkeley in 1993. Following his Ph.D., he worked in industry for seven years developing recombinant protein and cell-based biotherapeutics at Genentech and Cerus Corp. In 2000, he joined the Waisman Center at UW-Madison to lead development of the Waisman Clinical Biomanufacturing Facility (WCBF). As the Technical Director of the WCBF, Derek leads a team of scientists and engineers that support academic researchers and start-up biotech companies that are involved in developing biotherapeutics for early-stage human clinical trials. Derek previously served as Principal Investigator for the National Stem Cell Bank program and currently serves as the Principal Investigator for the NHLBI-funded Production Assistance for Cellular Therapeutics (PACT) program at the UW. Stuart Hogarth is a member of the Global Biopolitics Research Group at the Centre for Biomedicine and Society at King’s College London, where he is currently working on the REMEDiE project, conducting a comparative analysis of the innovation strategies

employed by European states to support the field of regenerative medicine. His broader research interests include the innovation processes in the drugs and diagnostics industries and the regulatory issues emerging from novel healthcare technologies. Stuart has a longstanding interest in the field of molecular diagnostics, with a particular focus on the regulation of pharmacogenetics and susceptibility testing and the impact of gene patents on innovation and clinical use of new tests. He has produced two policy reports for Health Canada on the regulation of genetic tests, as well as briefings for the UK Human Genetics Commission and the European Commission, and has received an FDA Leveraging / Collaboration Award for his work in this area. Stuart has been on the organising committee for international meetings on genetic testing in the United States and Japan and continues to play a role in the development of regulation in this area, most recently as a member of the UK working group which is developing a Common Framework of Principles for direct-to-consumer genetic testing. Linda F. Hogle is a member of the Regenerative Medicine faculty cluster and Professor of Medical Social Sciences in the School of Medicine & Public Health at the University of Wisconsin-Madison. Her research focuses on social, organizational and regulatory issues in emerging areas of biomedical engineering and regenerative medicine. In particular, she analyzes processes of standardization as novel technology concepts move from bench to bedside, including those which may involve disruptions and disjunctures with conventional ways of conducting and regulating science. Her current research examines how collaborations in multi-disciplinary teams of life scientists, engineers, materials scientists, biophysicists and others affect the nature of research work, and how such collaborations may produce novel concepts and problem definitions in engineering and the life sciences. She has published papers on standardization processes and regulatory pathways for novel biological materials in journals such as Social Studies of Science, Science Technology & Human Values, and The Journal of Law & Ethics. A book in progress is based on ethnographic research among tissue engineering and stem cell researchers. She serves on the Stem Cell Research Oversight Committee and the Executive Committee of the Stem Cell & Regenerative Medicine Center at UW. Suzanne Holland, Professor of Ethics and Philip M. Phibbs Research Professor, has been a member of the University of Puget Sound Department of Religion since 1997, having served as its chairperson from 2002-2009. In 2008, she was honored as the recipient of the University of Puget Sound President's Excellence in Teaching Award, the college’s highest teaching honor. This year, she received the university’s Outstanding Faculty Award, conferred by the Puget Sound Students Association. Since 2001, Holland has been Affiliate Professor at the University of Washington School of Medicine, Department of Bioethics & Humanities. She was elected to the Board of Directors of the American Society of Bioethics & Humanities (ASBH) 2006-09, and is on the Advisory Board of the Institute for Stem Cell and Regenerative Medicine at University of Washington. Holland’s scholarship has focused on stem cell research and ethics, as well as on the ethics and justice of new genetic technologies; biotechnologies; science and technology; and more broadly, issues in religion, gender, and culture. With U Washington colleagues, Holland is writing a book to be published by Oxford University Press in 2011, titled, Making Good on the Promise of Genetics: The Challenge of Justice Along the Translational Pathway. She is currently working on a third book, Technologies of Desire. In this monograph, she examines the ways in which Americans seek to satiate fundamental human desires (for sex, children, self-esteem, immortality) by way of technologies of the body, and asks whether or not this pursuit makes us better persons, and whether it is a responsible use of our human freedom. Holland is also co-editor of the first book published on the stem cell issue, The Human Embryonic Stem Cell Debate: Science, Ethics, and Policy (The MIT Press 2001), later translated into Portuguese.

Beth Kewell joined The York Management School as a Lecturer in Public Sector Management in 2005. She is an Affiliated Research Fellow at the Science and Technology Studies Unit (SATSU), Department of Sociology, University of York. Her research is empirically positioned at the apex of science, health and business. As part of her involvement in the REMEDiE project, Dr. Kewell is coordinating an evaluation of the financial performance and risk governance aspects of the tissue engineering and regenerative medicine industries. Additionally, she is co-investigating funded research in the areas of health risk and medical innovation (with Professors Andrew Webster and Brian Salter). In addition, Dr Kewell has published on the social construction of risk epistemologies and socially institutionalised understandings of reputation, uncertainty and ignorance within health science and medicalised contexts. Daniel Lee Kleinman is the Director of the Robert F. & Jean E. Holtz Center for Science and Technology Studies at the University of Wisconsin, where he is also Professor and Chair of the Department of Community and Environmental Sociology. His research explores the culture and political economy of contemporary science, sitting at the intersection of the social sciences and humanities. He is the author of three books, including Impure Cultures: University Biology and the World of Commerce and the co-editor, with biologist Jo Handelsman, of a series of edited volumes entitled Controversies in Science and Technology, which seek to reach a broad public audience. György Kovács Attorney at law, deals with corporate management, intellectual property, antitrust, energy and real estate related matters. Regularly lecturing at the Pázmány Péter Catholic University, Deák Ferenc Post-Graduate Institute in the field of EU IP law and EU law; György Kovács holds is also lecturing IP law and business law in the Moholy Nagy University of Arts in Budapest. He joined the CELAB REMEDiE research team in 2008. György Kovács has published in the fields of European Union Law, comparative constitutional law and business law. He was a Fulbright Scholar in the Boston University School of Law. Additionally, he has done research at the Harvard European Law Research Center. Michael Morrison is currently working on the European Commission’s FP-7 supported Regenerative Medicine in Europe (REMEDiE) project where he is responsible for co-ordinating work detailing the commercial development of European regenerative medicine products. His research interests include the study of innovation and commercialisation of biotechnology in the life sciences, and the ethical, legal and social issues associated with emerging technologies. He holds a first degree in Biology (BSc Hons, 2000) from the University of St. Andrews and completed his MA (2002) and PhD (2008) with the Institute for Science and Society at the University of Nottingham. His doctoral thesis presented a socio-technical history of human growth hormone and examined its contested role as an agent of human enhancement. Other previous work has addressed topics such as personalised medicine, gene therapy and genomics, and he is co-author, with Dr Paul Martin (University of Nottingham), of the report Realising the Potential of Genomic Medicine (2006). Michael is based in the Science and Technology Studies Unit (SATSU) at the University of York where he has been a research fellow since 2009. Ubaka Ogbogu is an Adjunct Associate Professor of Law at the University of Minnesota Law School, Affiliate Faculty at the Center for Bioethics, University of Minnesota, and the Associate Director of Research and Education at the University of Minnesota's Consortium on Law and Values in Health, Environment, and the Life Sciences and Joint Degree Program in Law, Health and the Life Sciences. He holds a Master of Laws degree from the University of Alberta, a Bachelor of Laws degree from the University of Benin, Nigeria, and is currently completing a doctorate degree (SJD) in law at the University of Toronto. He is also an adjunct Research Associate with the Health Law Institute, Faculty of Law, University of Alberta, and a barrister and solicitor of the Supreme Court of Nigeria.

Ubaka's scholarly interests include the ethical, legal and social issues associated with emerging biotechnologies (with particular interest in stem cell research), health and biotechnology law, history of science regulation, and the connections between law and science generally.

Pilar N. Ossorio is Associate Professor of Law and Bioethics at the University of Wisconsin at Madison. She was previously Director of the Genetics Section at the Institute for Ethics at the American Medical Association. Dr. Ossorio received her Ph.D. in Microbiology and Immunology in 1990 from Stanford University and her JD from the University of California at Berkeley School of Law in 1997. She went on to complete a post-doctoral fellowship in cell biology at Yale University School of Medicine. Dr. Ossorio has contributed to federal ethics and policy programs, including the program on the Ethical, Legal, and Social Implications (ELSI) of the Human Genome Project, the Ethics Working Group for President Clinton’s Health Care Reform Task Force, the National Advisory Council for Human Genome Research and contributed to several reports for the National Academies of Science, including work on the guidelines for human embryonic stem cell research. At UW, she is a member of the Institutional Review Board and the Embryonic Stem Cell Research Oversight Committee. Dr. Ossorio is a fellow of the American Association for the Advancement of Science’s (AAAS), a member of the editorial board of the American Journal of Bioethics.

She is currently researching emerging legal and policy issues in biobanking, and is completing NIH-funded projects on race and genetics as well as community consent and returning research findings to human subjects who participate in trials. Brian Salter is Professor of Politics of Biomedicine and Director of the Global Biopolitics Research Group in the Centre for Biomedicine and Society at King’s College London. A political scientist specialising in the analysis of public policy, he has studied the political forces at work in the policy arenas of education, health and, most recently, the life sciences. Here his work focuses on the global politics of new health technologies and the national and transnational governance issues associated with the challenges posed by biomedicine to science, society and the market, particularly with regard to the emerging economies of China and India. Current and recently completed projects in the field of global innovation governance include ESRC projects funded under the Stem Cell Initiative and Rising Powers programme and EU FP7 projects in the domains of regenerative medicine and GM animals. He has published nine books and over 100 articles. Closely integrated with his academic work is his role as policy adviser to government, funding agencies, professional and international bodies and his contribution as ethical adviser to the European Framework Programmes. Dietram A. Scheufele is the John E. Ross Chaired Professor and Director of Graduate Studies in the Department of Life Sciences Communication at UW—Madison, with affiliate appointments in European Studies, Science and Technology Studies, and the Nanoscale Science and Engineering Center (NSEC) on Templated Synthesis and Assembly at the Nanoscale. He is also Co-PI of the NSF-funded Center for Nanotechnology in Society at Arizona State University (CNS-ASU). Scheufele co-chairs the National Conference of Lawyers and Scientists, a joint committee of the American Association for the Advancement of Science and the American Bar Association, and is a former member of the Nanotechnology Technical Advisory Group to the U.S. President's Council of Advisors on Science and Technology. His scholarship and teaching has won national and international awards, including the Robert M. Worcester Award and the Naomi C. Turner Prize from the World Association for Public Opinion Research, the Young Scholar Award for Outstanding Early Career Research from the International Communication Association,

the Young Faculty Teaching Excellence Award from the College of Agriculture and Life Sciences at Cornell University, and the Pound Research Award from the College of Agricultural & Life Sciences at the University of Wisconsin. Robert Streiffer is an Associate Professor of philosophy and bioethics at the University of Wisconsin-Madison. He holds affiliate appointments in Veterinary Medical Sciences, Agricultural and Applied Economics, and the Nelson Institute for Environmental Studies. He is a member of the UW-Madison Stem Cell and Regenerative Medicine Center, the Neuroscience and Public Policy Program, and the Holtz Center for Science and Technology Studies. His research focuses on ethical and policy issues arising from modern biotechnology. Recent publications include “Informed Consent and Federal Funding for Stem Cell Research” in The Hastings Center Report, “Chimeras, Moral Status, and Public Policy: Implications of the Abortion Debate for Public Policy on Human/Nonhuman Chimera Research” forthcoming in The Journal of Law, Medicine, and Ethics, and “At the Edge of Humanity: Human Stem Cells, Chimeras, and Moral Status” also in The Kennedy Institute of Ethics Journal. Professor Streiffer served until recently on UW’s Stem Cell Research Oversight Committee and now chairs the Letters and Sciences Animal Care and Use Committee. Andrew Webster is Director of the Science and Technology Studies Unit (SATSU), and recently Head of Department of Sociology at the University of York. He was Director of the £5m ESRC/MRC Innovative Health Technologies Programme, is member of various national Boards and Committees (including the UK Stem Cell Bank Steering Committee and UK National Stem Cell Network Steering Committee) and was Specialist Advisor to the House of Commons Health Select Committee. He was national co-ordinator the ESRC’s £3.5m Stem Cells Initiative (2005-9), and was a member of the Royal Society’s Expert Working Group on Health Informatics. He is currently coordinating a European (EC) grant on Regenerative Medicine (REMEDiE). He is Co-Editor of the Health Technology and Society Series: Palgrave Macmillan (launched at the Royal Society, October 25 2006). His most recent book is Health, Technology and Society: A Sociological Critique (Palgrave Macmillan) 2007. He was elected a Fellow of the Academy of the Social Sciences in 2006. Catherine Waldby is Professorial Research Fellow in the Department of Sociology and Social Policy, Sydney University, and Visiting Professor at the Centre for Biomedicine and Society, King’s College London. She researches and publishes in social studies of biomedicine and the life sciences. Her books include AIDS and the Body Politic: Biomedicine and Sexual Difference (1996 Routledge), The Visible Human Project: Informatic Bodies and Posthuman Medicine (2000 Routledge), Tissue Economies: Blood, Organs and Cell Lines in Late Capitalism (with Robert Mitchell, Duke University Press 2006) and The Global Politics of Human Embryonic Stem Cell Science: Regenerative Medicine in Transition, (with Herbert Gottweis and Brian Salter, Palgrave 2009). She is a foundation member of the global biopolitics research group, an international consortium of scholars who investigate the effects of cultural, political and economic globalization on the social relations of biomedicine. She has received national and international research grants for her work on embryonic stem cells, blood donation and biobanking.