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Bio International Convention 2008 World Stem Cell Summit
Volume 9, Number 1 (2006)
ABSTRACTS
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FEATURE ARTICLES

Looking for Ms. Right: Finding and Supporting Entrepreneurs in Nascent Entrepreneurial Environments
Joe Panetta, John Wetherell and Michelle Mehok

Patenting Personalized Medicine
Leena H. Karttunen, J. Amelia Feulner, David S. Resnick

Modernization of our Healthcare Information System: Information Cooperativity
George Gaines, III and Kevin Pang
The Legal Status of Embryos and Implications for Reproductive Technologies and Biotechnology Research
Krietta Kai Bowens


Financial Conflicts of Interest in Biomedical Human Subject Research
Nathan Goldstein


The Øresund: In the Middle of Scandinavia, In the Middle of the Revolution
Lawrence B. Landman


RECENT DEVELOPMENTS

The Bounds of Science and Ethics
Bryan A. Liang


Obesity Remains a Global Problem
Laura A. Lin


FDA Approves New Blood Test to Improve Treatment for Colorectal Cancer
Danielle Gleason


National Institutes of Health Enacts Final Ethics Regulations
April C. Ness


Research Examines the Minimal Risk Standard for Pediatric Research
Arlene D. Luu


Face Transplants and the Difficulties of Obtaining Research Approval
Aline Gaba


Stem Cell Research Debate Shifting to the Courts
Katherine R. Vick


BIOCOLUMNS

BioGovernance / A Contribution To the Transaction Cost Politics Theories: the Emerging 3Ps' Theory
Christine Huttin

Taxation
Industrial Biotech / Industrial Biotech: Ready for a Surge
Brent Erickson

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Feature
4 pages

Looking for Ms. Right: Finding and Supporting Entrepreneurs in Nascent Entrepreneurial Environments
Thomas P. Dickerson and David L. Day

Abstract: Of all the difficulties confronting locales attempting to develop their entrepreneurial environments, the most intractable is that of finding qualified entrepreneurs. A recognized, capable entrepreneur attracts both owners of the most promising technologies as well as investors. Such entrepreneurs are in short supply because the entrepreneurial task is so complex and so few people are capable of dealing with the variety of issues which entrepreneurs must face. The discussion which follows focuses on strategies that locales with developing entrepreneurial environments can undertake to ease these challenges.

©2006 by The Journal of BioLaw & Business. All Rights Reserved.

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Feature
(3 pages)

Patenting Personalized Medicine
Leena H. Karttunen, J. Amelia Feulner, David S. Resnick

Abstract: This article discusses the patentable subject matter and timing of filing patent applications on the discoveries in the emerging field of personalized medicine.

©2006 by The Journal of BioLaw & Business. All Rights Reserved.

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Feature
(7 pages)

Modernization of our Healthcare Information System: Information Cooperativity
George Gaines, III and Kevin Pang

Abstract: A number of legislative bills designed to speed the adoption of IT by providers through aid in capital investments necessary for the implementation of electronic health records or formation of regional health information are currently making their way through Congress. These bills do little to address several adoption hurdles; including the forward integration of patient health information resident on paper forms into electronic format, interoperability between different systems for effective information sharing, the creation of data capture, storage and transmission standards that allow relevant information to be accessed and presented, and the ability to scale while maintaining patient confidentiality and HIPAA regulation compliance. We examine some of the driving dynamics behind this recent legislative push, some important issues inhibiting adoption to consider, and the near and long term benefits of linking EHR systems to create the framework for a national health information network (NHIN).

©2006 by The Journal of BioLaw & Business. All Rights Reserved.

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Feature
(9 pages)

The Legal Status of Embryos and Implications for Reproductive Technologies and Biotechnology Research
Krietta Kai Bowens

 

Abstract: The legal status of embryos in American law is changing. At present, most states do not afford embryos the same protections as a born person, but some states are attempting to change this standard. Granting embryos the same legal status as born human beings poses a significant problem for industries that work with embryos, especially fertility treatment facilities and scientists researching stem cell and gene therapy technologies. This paper describes the methods of defining embryos in American law, and discusses the implications of granting embryos the same rights as born persons for the reproductive technology and scientific research industries.

©2006 by The Journal of BioLaw & Business. All Rights Reserved.

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Feature
(12 pages)

Financial Conflicts of Interest in Biomedical Human Subject Research
Nathan Goldstein

Abstract: The purpose of this paper is to examine the past, present and future of financial conflict of interest regulation in biomedical human subject testing. Part I will briefly review the forces giving rise to the current controversy. Part II will examine the more influential ethical codes on human subject testing and argue that they are inconclusive on the subject of financial conflicts of interest. Part III will examine the various regulations now in place and identify their serious flaws. Part IV will critique the leading proposals for reform. The Conclusion will synthesize the best features of the various proposals for reform and suggest improvements left unaddressed by these proposals.

©2006 by The Journal of BioLaw & Business. All Rights Reserved.

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Feature
(6 pages)

The Øresund: In the Middle of Scandinavia, In the Middle of the Revolution
Lawrence B. Landman

Abstract: Scandinavia's leading position in stem cell research is just the latest example of its long tradition of developing new medical technologies, and then turning these technologies into successful products. A recent report analyzed how entrepreneurial firms in the Copenhagen/Southern Sweden area are turning these technologies into tomorrow's products. The report concluded that firms in the area are to a surprising degree trying to develop, not technologies to license, but products to sell. And these firms are doing so effectively.

©2006 by The Journal of BioLaw & Business. All Rights Reserved.

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Recent Developments:
(2 pages)

The Bounds of Science and Ethics
Bryan A. Liang

Abstract: No Abstract

©2006 by The Journal of BioLaw & Business. All Rights Reserved.

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Recent Developments:
(2 pages)

Obesity Remains a Global Problem
Laura A. Lin

Abstract: Currently over one billion people are overweight globally, and if current trends continue, the World Health Organization (WHO) estimates 1.5 billion people will be overweight by 2015.

©2006 by The Journal of BioLaw & Business. All Rights Reserved.

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FDA Approves New Blood Test to Improve Treatment for Colorectal Cancer
Danielle Gleason

Abstract: The new blood test, Invader UGT1A1 Assay enables physicians to tailor dose of chemotherapeutic agents, which may be the beginning of "personalized medicine".

©2006 by The Journal of BioLaw & Business. All Rights Reserved.

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National Institutes of Health Enacts Final Ethics Regulations
April C. Ness

Abstract: NIH new ethics regulations limit its employees activities, investments, and receipt of awards of NIH employees.

©2006 by The Journal of BioLaw & Business. All Rights Reserved.

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Research Examines the Minimal Risk Standard for Pediatric Research
Arlene D. Luu

Abstract: The "minimal" risk standard for protection of pediatric research subjects often fails due to unclear definitions and uneven IRB application, requiring an alternative standard to better assist pediatric research assessment.

©2006 by The Journal of BioLaw & Business. All Rights Reserved.

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Face Transplants and the Difficulties of Obtaining Research Approval
Aline Gaba

Abstract: After over one year of consideration, the world's first face transplant has obtained research approval despite ethical and safety concerns.

©2006 by The Journal of BioLaw & Business. All Rights Reserved.

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Stem Cell Research Debate Shifting to the Courts
Katherine R. Vick

Abstract: California stem cell initiative faces legal challenges from groups opposing embryonic research and abortion opponents.

©2006 by The Journal of BioLaw & Business. All Rights Reserved.

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BioGovernance / A Contribution To the Transaction Cost Politics Theories: the Emerging 3Ps' Theory
Christine Huttin

Abstract: This article discusses an alternative form of governance of health care systems. It is particularly timely in the context of digital economies and e-governments. The term "3Ps" was proposed as a new terminology to replace the traditional 4Ps of the marketing mix: Product, Patient and Politics during a workshop in Brussels on the challenges for pharmaceutical policies in the 21st century. This article proposes a contribution to the transaction cost politics literature, with the integration of three Ps also on the demand side, representing individual or group strategies from Physicians, Pharmacists and Patients. With the growth of individualized medicines, it can provide new platforms and different levels of negotiation to discuss policy issues directly targeted to subgroups of patients or providers of care. 4 pages

©2006 by The Journal of BioLaw & Business. All Rights Reserved.

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Industrial Biotech / Industrial Biotech: Ready for a Surge
Brent Erickson

Abstract: The biotechnology sector has long believed in the immense value that industrial biotech processes can bring to manufacturing and other industries. Until recently, though, the statistics to prove this assertion have been lacking. This article provides a brief overview of industrial biotechnology and emerging policy issues. 2 pages

©2006 by The Journal of BioLaw & Business. All Rights Reserved.

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