APPENDIX

A

Program and Discussion Questions

National Academy of Sciences Auditorium

Wednesday, January 27, 1999

8:30 am Welcome

Dr. Bruce Alberts, President, National Academy of Sciences

Dr. David Galas, Conference Chairman

8:50 am Remarks

Dr. Mary Clutter, Chairperson, Subcommittee on Biotechnology of the National Science and Technology Council Science Committee

9:00 am Panel 1 Resources in Biotechnology and Genomics

Moderator: Dr. David Galas, Chief Academic Officer, Keck Graduate Institute for Applied Life Sciences and Chief Scientific Advisor, Chiroscience, Inc.

Panelists:

Tom Caskey Sr. Vice President for Research, Merck and Co., Inc

Craig Venter, President and Chief Scientific Officer, Celera Genomics Corporation

Rod Wing, Coker Chair of Plant Molecular Genetics and Director, Clemson University Genomics Institute

Maria Freire, Director, Office of Technology Transfer, NIH

10:15 – 10:30 am Break

Barbara Mazur, Director, Biotechnology, E.I. Dupont de Nemours & Co.

Steven Holtzman, Chief Business Officer, Millenium Pharmaceuticals, Inc.

Fred Anderson, Attorney, Cadwalader, Wickersham & Taft

Michael Snyder, Professor of Molecular, Cellular and Developmental Biology, Yale University

11: 45 am General Discussion



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FINDING THE PATH: Issues of Access to Research Resources APPENDIX A Program and Discussion Questions National Academy of Sciences Auditorium Wednesday, January 27, 1999 8:30 am Welcome Dr. Bruce Alberts, President, National Academy of Sciences Dr. David Galas, Conference Chairman 8:50 am Remarks Dr. Mary Clutter, Chairperson, Subcommittee on Biotechnology of the National Science and Technology Council Science Committee 9:00 am Panel 1 Resources in Biotechnology and Genomics Moderator: Dr. David Galas, Chief Academic Officer, Keck Graduate Institute for Applied Life Sciences and Chief Scientific Advisor, Chiroscience, Inc. Panelists: Tom Caskey Sr. Vice President for Research, Merck and Co., Inc Craig Venter, President and Chief Scientific Officer, Celera Genomics Corporation Rod Wing, Coker Chair of Plant Molecular Genetics and Director, Clemson University Genomics Institute Maria Freire, Director, Office of Technology Transfer, NIH 10:15 – 10:30 am Break Barbara Mazur, Director, Biotechnology, E.I. Dupont de Nemours & Co. Steven Holtzman, Chief Business Officer, Millenium Pharmaceuticals, Inc. Fred Anderson, Attorney, Cadwalader, Wickersham & Taft Michael Snyder, Professor of Molecular, Cellular and Developmental Biology, Yale University 11: 45 am General Discussion

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FINDING THE PATH: Issues of Access to Research Resources DISCUSSION QUESTIONS: PANEL 1 ISSUES IN BIOTECHNOLOGY AND GENOMICS What lessons have emerged from the 7- year debate on the patentability of ESTs that might inform our evaluation of how patents on other genomic materials could impact academic research and commercial development? What insight do the experiences of different genomic research communities in the development of a common resource offer to structuring similar efforts in the future? Are duplicative public and private efforts in constructing sequence databases the inevitable consequence of competition or opposing interests, or simply a result of the uncertain effects of patent rights on the use of material described in the databases? Given advances in sequencing technology and the interest of the for-profit sector to produce sequence data, and databases, how might public policy most effectively support access to and productive use of this information by the academic and commercial communities? What are the risks to turning sequencing over to the private sector? What approaches can be used to distribute the cost of developing and providing access to a research tool such as micro-array technology so that the maximum rate of scientific progress can be achieved? What criteria can be used to evaluate different approaches to reducing cost and enhancing access to research resources? While the “research exemption” exists in concept but not law, could specific “research” uses of a patented or unpatented resource be identified and authorized in the interests of scientific progress? Would an expanded effort of the federal government to negotiate blanket licensing agreements like the NIH-Dupont “Cre-Lox” agreement serve the same purpose? In addition to intellectual property rights, what are other important legal and policy frameworks that constrain access to research resources?

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FINDING THE PATH: Issues of Access to Research Resources Wednesday, January 28, 1999 1:30 pm Panel 2 Issues at the Interface of University, Industry, and Government Policy Moderator: Bruce Alberts, President, National Academy of Sciences Panelists: Joan S. Leonard, Vice President and General Counsel, Howard Hughes Medical Institute Dennis Stone, Vice President for Technology Development, University of Texas Southwestern Medical Center Harry J. Klee, Eminent Scholar, University of Florida Department of Horticultural Sciences Tracy D. Wilkins, Professor and Director, Fralin Center for Biotechnology, Virginia Tech 2:45 – 3:00 pm Break Moderator: David Galas Panelists: Candace Voelker, Associate Director, Research Administration and Technology Transfer, Office of the President, University of California Tony E. Hugli, Research Scientist, The Scripps Research Institute Tom Caskey, Sr. Vice President for Research, Merck and Co., Inc. Chris Scott, Director, Research Development and Executive Director, ACCESS, Stanford Medical School 4:15 pm General Discussion. 5:30 pm Adjourn.

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FINDING THE PATH: Issues of Access to Research Resources DISCUSSION QUESTIONS: PANEL 2 ISSUES AT THE INTERFACE OF UNIVERSITY, INDUSTRY, AND GOVERNMENT POLICY What criteria/experience exists to evaluate appropriate returns (including IPR rights, rights to data) to industry funded projects of academic research at institutions receiving public research funds? How do different federal programs affect access to research tools (e.g. CRADAs, SBIR, SBTT, Advanced Technology Program and the Bayh-Dole Act)? How does corporate support of (and rights to) university research affect the university's ability to negotiate straightforward access to the research tools of other commercial bodies (which, for example might also seek rights to research results in order to protect its IPR)? What minimum level of administrative management of these issues should be expected of all institutions receiving federal funds? What obligations do universities have to educate their researchers on IPR issues, material transfer agreements, and their responsibilities under the law? What is the proper role of the Materials Transfer Agreement (MTA) and how can the process be made less burdensome? How realistic is it to monitor recipients for their use of transferred materials ? Universities are in the awkward position of being both user and producers of research resources, of providing a setting where the pure knowledge is pursued and shared freely while at the same time launching small companies. Which has priority? If universities regard the products of their academic labs as potential income streams, should products that can be identified as research tools be considered in the same way as any other licensable product? What criteria might be developed to determine the “value” of research tools for the purpose of licensing agreements? What responsibility does the for-profit sector have to the progress of science? Is it within the enlightened self-interest of firms (and all resource-holders, like universities for that matter) to recognize and respond to academia's needs for straightforward access to research resources, or is that a luxury only large firms and wealthy universities can afford?

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FINDING THE PATH: Issues of Access to Research Resources Thursday, January 28, 1999 8:30 am Panel 3 Issues of Access to Research Resources Across the Disciplines: Exploring common and unique issues in crystallography, microbiology, biodiversity, anthropology, sociology, psychology, and computer science. Moderator: David Galas Panelists: Ray Cypess, CEO and President, American Type Culture Collection Helen Berman, Professor of Chemistry, Rutgers University Cletus Kurtzman, Director, Microbial Properties Research, National Center for Agriculture Utilization Research, USDA Leonard Krishtalka, Professor of Ecology and Evolutionary Biology, University of Kansas Jim Reichman, Director, National Center for Ecological Analysis and Synthesis, University of California, Santa Barbara 10:00 – 10:30 am Break Vladek Minor, Department of Molecular Physiology and Biological Physics, University of Virginia Lynn Jorde, Professor, Department of Human Genetics, University of Utah Sarah Friedman, National Institute for Child Health and Development J. Richard Udry, Professor, Department of Maternal and Child Health, University of North Carolina, Chapel Hill James Miller, Associate Curator and Head, Applied Sciences Division, Missouri Botanical Garden 12:30 pm Conclusion and adjournment

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FINDING THE PATH: Issues of Access to Research Resources DISCUSSION QUESTIONS: PANEL 3 ISSUES OF ACCESS TO RESEARCH RESOURCES ACROSS THE DISCIPLINES As research resources with exciting new potential are developed, how can we ensure the advancement of knowledge while protecting the rights of the individual? What types of experimental data or materials should scientists be asked to deposit in publicly accessible databases, repositories or collections that is not currently deposited? Under what circumstances is it acceptable to request that access to parts of that data or material be withheld for a certain period of time? What criteria should determine who gets access to data, a resource, or samples and how it can be used? How should the scientific community evaluate the individual research effort of a) the collection of data or samples that are used by the community, b) the analysis of community generated data or materials c) the development of research resources, their maintenance and improvement? Are criteria available to determine the best way to provide access to a research resource? How should the costs (time and money) of providing access (supplying, delivering, maintaining, developing) research resources be assessed? What intellectual property rights considerations might affect future use of or access to these resources? Should there be a research exemption for non-commercial use of patented materials? Do patents make any difference to a bench scientist? What are the implications of recent legislation extending the Freedom of Information Act to scientific data?

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FINDING THE PATH: Issues of Access to Research Resources SUPPLEMENTARY QUESTIONS FOR PARTICIPANTS IN PANEL THREE Crystallography Are there types of experimental data that structural biologists should be asked to deposit in the Protein Data Base that is not currently deposited? Under what circumstances is it acceptable to request that access to structural coordinates be withheld? How would academic research or industrial strategy be affected if coordinates are granted patents? Software and Hardware What aspects of hardware (beam lines) and software limit progress in structural biology research? What influences access to electron beam line facilities? How does software development as a research activity receive recognition? What obligations do academic software developers have to the community that uses it as a tool (and vice versa)? How should software be distributed to the research community and on what terms? Microbiology Should journals require that organisms cited in papers be deposited in a national collection in order to ensure their access to the research community? How should the costs of this requirement be assessed? Sociology How can individuals' privacy be safeguarded when sociological data is made public? What determines who gets access to data and what data is given out? How should credit be given for the maintenance and improvement of access to large data sets?

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FINDING THE PATH: Issues of Access to Research Resources Psychology When and on what terms should raw data from large studies be released? Should those who collected the data be able to reserve its use for further research? What reward system or cultural changes will encourage collaboration, data sharing and the secondary analysis of data? Ecology What are the positives and negatives associated with the deposit of unanalyzed ecological data in publicly accessible databanks? What control should scientists have over their raw data? How will new databases be maintained and what cost, and how is credit for resource maintenance allocated? Anthropology What are the positives and negatives associated with the systematic collection of human genetic diversity data? What considerations, safeguards or restrictions on access to this data are needed for the successful development of this kind of resource? How should analytical software be shared within this community? Biodiversity What criteria are appropriate in determining permission of access to or sampling of material in museum collections? On what terms should access to and sampling of national (U.S. and foreign) biodiversity resources (both data and samples) be permitted? What intellectual property rights considerations might affect future use of or access to these resources?