GUEST EDITORIAL
	The Biopharmaceutical Industry in Massachusetts-The Triple Helix in Action Ashley J. Stevens
	FEATURES
	A Common Sense Approach to Authorized Generics David J. Dykeman and David A. Fazzolare
	Philanthropy Is Key To Rapid Life Science Innovation Ann A. Kiessling
	Labeling and Failure-to-Warn Concerns for FDA-Regulated Goods Incorporating Nanotechnology Achal Oza
	Creating Savior Children Jessica Smith
	RECENT DEVELOPMENTS
	Research and Momentum Bryan A. Liang
	$217 Million for Research on Stem Cells in California Nicole Wells
	FDA Orders Switch to Inhalers that Do Not Omit CFCs Erin Minelli
	Climate Ready Genetically Modified Crops T.K. Mackey
	Issues in At-Home Genetic Tests Cameron Rhudy
	Tysabri Approved to Treat Crohn's Disease Laura Biddle
	BIOCOLUMNS
	BioBusiness/Exporting Biotechnology: When a Telephone Call or Email Is More Than Meets the Eye William M. Weisberg and Joyce L. Tong
	Stem Cells/ Stem Cell Research Progresses by Turning Back the Clock Brock C. Reeve
	BioTalent/The Graceful Exit: Lessons from CEOs Jack Schlosser

Abstract: In 1980, Massachusetts was home to defense contractors and computer manufacturers and what Governor Michael Dukakis later called "The Massachusetts Miracle" did not bring to mind the life sciences. What economic activity there was in life sciences consisted of a largely invisible medical device industry, while the future biotechnology industry was just starting to spin-out of the laboratories of Harvard, MIT and Boston University. Yet in the space of just 25 years Massachusetts has become a leading center, worldwide, of first biotechnology research, then pharmaceutical research and most recently for the production of biopharmaceuticals. A number of its home grown biotechnology companies have developed into fully integrated biopharmaceutical and pharmaceutical companies, with substantial marketing, sales and other corporate functions The term "Triple Helix" was coined by Henry Etzkowitz in 1993 to describe the intertwining of academia, industry and government to create research driven high technology clusters. Nowhere is this paradigm more vividly seen in action than in the emergence of the Massachusetts biopharmaceutical mega-cluster. The Triple Helix has undergone at least four full turns in Massachusetts. This article explores some of the actions that catalyzed this phenomenon. 8 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Brand-name drug companies market authorized generics as a shield to retain revenue once a branded drug patent is successfully challenged under Abbreviated New Drug Application ("ANDA"), Paragraph IV, of the Hatch-Waxman Act. Congress views authorized generics as an anticompetitive sword used by brand-name drug companies to extend drug patent monopolies. Without evidence to substantiate alleged anticompetitive effects of authorized generics, Congress is attempting to enact legislation making authorized generic sales during the marketing exclusivity period unlawful. However, authorized generics are no more harmful than other risks already assumed by generic drug companies undertaking Paragraph IV challenges, including shared exclusivity, marketing exclusivity forfeiture, and unsuccessful Paragraph IV challenges. Common sense dictates that, because authorized generics pose no greater threat than risks that generic drug companies already know and assume, authorized generics are unlikely to have the alleged anticompetitive effect of deterring Paragraph IV challenges. Congress should tread cautiously before interfering with authorized generics. 7 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The over-dependence on federal government funding for biomedical research that has become the norm in the past few decades is actually stifling new discoveries and thwarting the research advantage held by U.S. science, which was designed and launched by philanthropists. Recent federal research blockades and funding limitations highlight the need to return to philanthropy if U.S. science is to move forward rapidly and maintain it's global eminence. Tax codes, historically supportive of charitable giving, need to be broadened to encourage both individuals and corporations to donate ample resources to life science discovery efforts. 5 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Nanotechnology is rapidly emerging as one of the foremost innovations of the 21st Century, poised to become a two trillion dollar industry within the next ten years. This technology enables manufacturers to create and manipulate materials at the nanoscale - 100 nanometers or less. A wide variety of consumer products today already use nanotechnology, including tennis rackets, sweat-repellent socks, face creams, nutritional supplements, beer bottles, and cooking oils to name a few. Many of these consumer products are subject to FDA regulation. FDA guidelines do not currently require disclosure of the presence of nanoscale components because the FDA has determined that "current science does not support a finding that classes of products with nanoscale materials necessarily present greater safety concerns than classes of products without nanoscale materials." Despite the FDA guidelines, however, a firm may still be liable under products liability law for failure-to-warn by not disclosing the presence of nanoscale components. This article explores the tort liability for failure-to-warn claims that firms selling FDA-regulated goods incorporating nanotechnology may face. It finds that a firm may be liable for a failure-to-warn claim under an unknown ingredient theory if a product's nanoscale component injured a consumer and a court were to determine that the disclosure of a bulk scale ingredient was insufficient disclosure of its nanoscale counterpart. Such a finding is possible because materials at the nanoscale are subject to quantum physics rather than the classical laws of physics and exhibit very different properties than their bulk scale counterparts due to their increased surface area to volume ratio. 9 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Since the creation of the first "savior child" in the United States, announced in 2001, this procedure has received both support and criticism. Through the use of in vitro fertilization procedures, as well as pre-implantation genetic selection and HLA-typing of an embryo, doctors and parents together can create a child who is free of a heritable genetic disease or even a perfect match tissue donor for an existing child. Proponents advocate this procedure as a remarkable new opportunity to create and prolong life, while opponents cite the variety of legal and ethical issues which could arise as reason to limit its use. To combat these concerns, the professional regulation of doctors and clinics offering these services should be strengthened. Further, hospitals should develop standards giving greater scrutiny to the decisions of parents to allow their savior child to donate tissue or organs to their ill child. Finally, family law courts must develop standards to protect savior children and their families when decisions of tissue and organ donation are made. These changes would protect society from the risks inherent in this technology while still allowing the world to fully benefit from these beneficial scientific advantages. 9 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: No Abstract 1 page

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Despite the lack of federal funding, California has awarded $271 million in grants to build 12 stem cell research centers in the state, representing the largest contribution awarded at one time by California's taxpayer-backed stem cell program. 2 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The phase out of traditional inhalers containing CFCs is creating new issues for patients such use variation, cost, lack of a generic alternative, and other health side effects. 2 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: While, the potential merits of "climate ready" genetically modified crops are well documented, concerns regarding the exclusivity of patent protection, private funding for research and commercialization of potentially life-saving health advances has created controversy. 2 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The advances in genetic research have generated an emerging market for at-home genetic tests and an increase in direct-to-consumer advertising of these services, but these tests may lead to many consumers obtaining information they do not understand with regard their genetic makeup. 2 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The FDA has approved a new drug, Tysabri, to treat Crohn's Disease, which provides hope to the millions of people who suffer from the disease, but also poses serious risks. 2 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The U.S. government is placing a renewed emphasis on controlling the export of technology. Through civil and criminal enforcement actions, the Departments of Commerce, State, Defense and Justice are paying particular attention to the transfer of technology completed outside of a traditional sale or licensing arrangement. These alternative forms of technology transfer are legally classified as "exports," and are subject to the full panoply of license, classifications and other controls. Such controls can have a potentially serious impact on biotechnology and life sciences companies. 4 pages

©2008 by The Journal of BioLaw & Business. All Rights Reserved.

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Stem Cells/ Stem Cell Research Progresses by Turning Back the Clock

Brock C. Reeve