Pharmacogenomics: The Legal, Ethical and Clinical Challenges

February 26, 2002 - 8:30am to 5:00pm
Cowles Auditorium, Hubert H. Humphrey Center

8:30am
Welcome
Senior Vice President Frank Cerra, MD, University of Minnesota
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8:45am
Framing the Issues
Prof. Susan Wolf, JD, Law School; Medical School; Director, Joint Degree Program in Law, Health & the Life Sciences; Chair, Consortium on Law and Values in Health, Environment & the Life Sciences
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9:00am
The Pharmacogenomic Revolution & Societal Implications
Prof. Leon Rosenberg, MD, Department of Molecular Biology, Princeton University; former President, Bristol-Myers Squibb Pharmaceutical Research Institute

9:30am
Issues in Drug Development & Pharmacoeconomics
Arthur L. Holden, MBA, Chief Founder, Chairman and CEO, First Genetic Trust, Inc.; Chairman, The SNP Consortium, Ltd.
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10:00am
Commentators
Dean Marilyn Speedie, PhD, College of Pharmacy
Prof. Colin Campbell, PhD, Department of Pharmacology and Joint Degree Program in Law, Health & the Life Sciences
Prof. Rick Wagner, PhD, College of Pharmacy
Prof. Stephen Schondelmeyer, PharmD, PhD, Department of Pharmaceutical Care & Health Care Systems
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10:20am
Q&A
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10:45am
Break

11:00am
The Regulatory Challenges -- Testing, Approval, Labeling, and Post-Marketing Surveillance
Prof. Richard Merrill, MA, LLB, University of Virginia School of Law; former chief counsel, U.S. Food and Drug Administration
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11:30am
Commentators
Prof. James C. Cloyd, PharmD, College of Pharmacy
Prof. Jeffrey Kahn, PhD, MPH, Director, Center for Bioethics
Mark Rotenberg, Esq., General Counsel, University of Minnesota
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11:45am
Q&A
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12:15pm
Lunch in Atrium

12:30pm
Speaker: Greg Koski, MD, PhD, Director, Office of Human Research Protections, Department of Health and Human Services
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1:00pm
Break

1:15pm
Ethical Problems -- Orphan Genotypes, Vulnerable Subpopulations, and Risk of Post-Marketing Harm
Prof. Patricia King, JD, Professor of Law, Medicine, Ethics & Public Policy, Georgetown University Law Center
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1:45pm
Legal Problems -- Liability and New Standards of Care, Genetic Privacy and Discrimination
Prof. Mark Rothstein, JD, Institute for Bioethics, Health Policy and Law, University of Louisville
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2:15pm
Commentators
Prof. Carl Elliott, MD, PhD, School of Medicine, Center for Bioethics
Rep. Phyllis Kahn, Minnesota House of Representatives
Prof. Susan Wolf, JD (see above)
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2:30pm
Q&A
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3:00pm
Break

3:15pm
Clinical Challenges Posed by Genomic Medicine
Prof. Richard Weinshilboum, MD, Mayo Clinic Foundation
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3:45pm
Commentators
Prof. Stella Davies, MD, Pediatrics, Division of Hematology/Oncology
Prof. Harry Orr, PhD, Director, Institute of Human Genetics
Prof. Bonnie LeRoy, MS, Director, Graduate Program in Genetic Counseling
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4:00pm
Q&A
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4:30pm
Wrap-Up
Prof. Jeffrey Kahn, PhD, MPH, Medical School; School of Public Health; Department of Philosophy; Director, Center for Bioethics
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5:00pm
Adjourn