Agenda and Videos


8:30am
Opening Remarks
Susan M. Wolf, JD, University of Minnesota

Welcome
Mihail C. Roco, PhD, National Science Foundation (NSF)
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8:45am
Translation of Nanotherapeutics and Nanodiagnostics to Clinical Practice: Overview and Examples
Moderator: Susan M. Wolf, JD, University of Minnesota
Samuel Wickline, MD, Washington University in St. Louis 
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9:15am
The Challenges Posed by Nanomedicine Research in Human Beings
Andrew Maynard, PhD, University of Michigan 
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9:45am
Discussion 
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10:00am
Break

10:15am
Ethical Conduct and Oversight of Human Subjects Research in Nanomedicine: Project Analysis & Recommendations 

Susan M. Wolf, JD, University of Minnesota
Leili Fatehi, JD, University of Minnesota
Frances P. Lawrenz, PhD, University of Minnesota
Jeffrey McCullough, MD, University of Minnesota Medical School
Jeffrey P. Kahn, PhD, MPH, University of Minnesota
Ralph Hall, JD, University of Minnesota Law School
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10:45am
Panel—Reaction to Recommendations 
Moderator: Frances Lawrenz, PhD, University of Minnesota

Panelists:
Mihail C. Roco, PhD, National Science Foundation (NSF)
John Howard, MD, MPH, JD, LLM, National Institute for Occupational Safety and Health (NIOSH)
Jerry Menikoff, MD, JD, MPP, U.S. Department of Health & Human Services
Jeffrey A. Schloss, PhD, National Human Genome Research Institute (NHGRI), National Institutes of Health (NIH)
R. Alta Charo, JD, University of Wisconsin-Madison
Warren Lux, MD, U.S. Environmental Protection Agency (EPA)
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12:15pm
Networking Lunch

1:00pm
Concurrent Workshops

Session A: Defining the Problem & Core Risks
Moderator: Jeffrey McCullough, MD, University of Minnesota

Panelists:
Jeffrey McCullough, MD, and Michael Etheridge, MSME and MS candidate, University of Minnesota, on “Mapping the Nanomedicine Landscape”
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Ron Siegel, ScD, University of Minnesota, on “What Is Unique About Nanomedicine? The Significance of the Meso-Scale”
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Andrew Maynard, PhD, University of Michigan, on “Proposals for Governance of Nanomedicine Research”
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Christy Haynes, PhD, Professor of Chemistry, University of Minnesota, (paper with Melissa Mauer-Jones, PhD candidate, Chemistry, University of Minnesota) on “Discrepancies in In Vivo and In Vitro Nanotoxicology Studies”
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Robert Hoerr, MD, PhD, Nanocopoeia, Inc., on “Collaborative Governance of Nanomedicine in the Face of Uncertainty”
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Q&A 
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Session B: First-in Human Research
Moderator: Jeffrey P. Kahn, PhD, MPH, and Ralph Hall, JD, University of Minnesota

Panelists:
Jerry Menikoff, MD, JD, MPP, OHRP, U.S. Department of Health & Human Services, on “Nanomedicine First-in-Human Research: OHRP Oversight”
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Rebecca Dresser, JD, Washington University in St. Louis, on “Building an Ethical Foundation for First-in-Human Nanotrials”
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Efrosini Kokkoli, PhD, University of Minnesota, on “What Does Pre-Clinical Research Tell Us About Moving Into Humans” 
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Nancy M.P. King, PhD, Wake Forest University School of Medicine, on “Nanomedicine First-in-Human Research: Challenges to Informed Consent”
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Q&A 
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2:30pm
Break

2:45pm
Concurrent Workshops

Session C: Human Subjects Protection
Moderator: Susan M. Wolf, JD, University of Minnesota

Panelists:
Ralph Hall, JD, University of Minnesota, on “FDA Approaches to Protecting Human Subjects in Nanomedicine Trials”
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Frances Lawrenz, PhD, University of Minnesota, on “Current Approaches to Oversight of Human Subjects Research in Nanomedicine”
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Gary Marchant, JD, PhD, MPP, Arizona State University, on “Applying Prudent Precaution to Nanomedicine Clinical Trials” 
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Jeffrey P. Kahn, PhD, MPH, University of Minnesota, on “Models of Exceptional Oversight for Nanomedicine”
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Susan M. Wolf, JD, and Cortney Jones, JD, University of Minnesota, on “Designing Oversight for Nanomedicine Research in Human Subjects: Systematic Analysis of Exceptional Oversight for Emerging Technologies” 
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Q&A 
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Session D: Beyond the Common Rule
Moderator: Moira Keane, MA, University of Minnesota

Panelists:
Jonathan Kimmelman, PhD, McGill University, on “Predicting Ethical and Safety Risks to Bystanders from Nanomedicine Research” 
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David Resnik, JD, PhD, National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), on “Responsible Conduct in Nanomedicine Research: Concerns Beyond the Common Rule”
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Moira Keane, MA, CIP, University of Minnesota, on “Institutional Oversight of Nanomedicine Human Subjects Research: From the IRB to the IBC and Beyond”
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Gurumurthy Ramachandran, PhD, University of Minnesota, on “Handling Worker and Third-Party Exposures in Nanomedicine Research”
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Arthur Erdman, PhD, University of Minnesota, on “Nanomedicine Commercialization Issues, including Barriers to Start-Up Companies” 
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Q&A 
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4:15pm
Reports from Concurrent Sessions and Next Steps
Workshop Moderators 
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4:45pm
Reception