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Publications
Pharmacogenomics: 21st-Century Challenges and Opportunities for New Jersey’s Pharmaceutical and Medical Device Industries
Sedgwick, Becton, Dickinson and Company and Fairleigh Dickinson University welcomed attorneys, corporate executives, and graduate students to a half-dayconference exploring business, regulatory and legal hurdles confronting New Jersey’s pharmaceutical and medical device industries as organizations in those sectors seek cutting-edge ways of enhancing healthcare delivery.
Industry strategists, attorneys and academicians discussed the latest thinking in how new scientific knowledge about the human genome can best be integrated into the way medicines are made available to the public — while ensuring the safety, efficacy and ethical use of genomic-based medicine.
This conference was designed for industry innovators seeking new ways to think about personalized medicine; executives charting the course of the pharmaceutical and medical device industries; and in-house counsel charged with helping assess and avoid regulatory and litigation risks that may be associated with pharmacogenomics.
Richard H. Bagger, Senior Vice President, Worldwide Public Affairs and Policy, Pfizer Inc., served as keynote speaker, while the main portion of the event featured the following panels:
Pharmacogenomics and the Evolving Business Model
for the Pharmaceutical and Medical Device Industries
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How will pharmacogenomics affect the process for bringing new products to market?
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Do pharma companies and medical device companies have different views about the
future of pharmacogenomics? Should they?
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How will the economics of "personalized medicine" influence companies as they consider how to incorporate this technology into their business model?
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Is there a way for New Jersey to take advantage of its role as home to so many large pharma and medical device companies in spearheading development of this new technology and science?
Panelists
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M. J. Finley Austin, Ph.D.
Head, U.S. External Research and Innovation Environment Roche
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Charles (Sandy) E. Hance, Esq.
Special Counsel, Sedgwick, Detert, Moran & Arnold, LLP
Former Secretary of Commerce for the State of New Jersey
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Scott R. Diehl, Ph.D.
Professor, Department of Oral Biology; Director, Center for Pharmacogenomics and Complex Disease Research, New Jersey Dental School, University of Medicine &
Dentistry of New Jersey
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Dennis J. Scotti, Ph.D., FACHE, FHFMA
The Alfred E. Driscoll Professor of Healthcare & Life Sciences Management, Fairleigh Dickinson University
Legal Issues Presented by Personalized Medicine
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In what ways can we expect liability issues facing manufacturers to change with pharmacogenomics?
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Will labeling or rules about direct-to-consumer advertising be affected by "personalized medicine"?
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How will this affect traditional products liability defenses such as the "learned intermediary" defense?
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How should companies deal with ethical issues that may arise in the way "personalized medicine" is likely to develop and the ways in which it might impact the healthcare system?
Panelists
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Mark A. Rothstein
Herbert F. Boehl Chair of Law & Medicine; Director, Institute for Bioethics, Health Policy and Law, University of Louisville School of Medicine
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Joanne Williams, Esq.
Counsel, Bristol-Myers Squibb Company
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Edward B. Berg
Senior Counsel, R&D Organization, Bristol-Myers Squibb Company
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Eric M. Kraus
Partner, Sedgwick, Detert, Moran & Arnold, LLP
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Patti E. Russell
Associate General Counsel; Chief Employment Counsel; Director, Corporate Human Resources, Becton, Dickinson and Company
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