GUEST EDITORIAL
	Preserving Our Digital Heritage: The Stakes Are High Mike Ruettgers
	FEATURE ARTICLES
	A Recipe for Restoring Investor Confidence: Zeroing In On Non-Financial Risk Exposures Leslie A. Platt and Odell Guyton
	Know Your Options: What Accounting Changes Mean for Equity Compensation Plans in Life Science Companies Jill Hemphill and Tom Montminy
	Individual Researcher Liability for Clinical Research on Humans Ruth K. Miller
	Strategic Considerations in Internet-Enabled Patient Recruitment Joseph Avellone
	CASE STUDY: The High Road to Success: How Investing in Ethics Enhances Corporate Objectives Richard Dashefsky
	SPECIAL SEGMENT BEHAVIORAL GENETICS
	Behavioral Genetics: Scientific and Social Acceptance David R. Lorenz
	Science Benefiting Gay Rights? The impact of a scientific discovery of the "gay gene" on equal protection for gays and lesbians Andrew E. Saxon
	BIOCOLUMNS
	Corporate Biotech In 2003: A Time To Hunker Down William T. Whelan
	State of the Industry Biotechnology - A Consistent Record of Growth Dan Eramian
	Intellectual Property Intellectual Property Due Diligence Thomas A. Turano

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Preserving Our Digital Heritage: The Stakes Are High Mike Ruettgers

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©2002 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Historically, investors have relied on financial statements as an accurate proxy for the overall health of an organization. Times, however, are changing. There is now a crisis in investor confidence in the wake of Enron, World Com and other corporate failures. To restore and sustain investor confidence, both financial and non-financial areas of business risk exposures must be addressed and standards for measuring and reporting risks to the public must be raised. This article highlights the non-financial business risks that must be properly measured - particularly those in intangible-asset based industries like the biomedical and information technology industries. (3 pages)

©2002 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The biotechnology and pharmaceutical industries rely on creative and strategic input from personnel at all levels within the organization. Many companies use stock options and other equity compensation awards to fuel this creativity and reward top performers. However, recent market volatility, corporate governance concerns, worldwide tax issues and potential accounting changes have caused companies to re-think their equity compensation strategy. While many issues contribute to this renewed debate over equity compensation, this article focuses on accounting changes and considers what these potential changes mean for the future of equity compensation. (5 pages)

©2002 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Despite international guidelines and federal regulations, a recent rash of problems in clinical trials have highlighted weaknesses in the oversight process. The federal regulatory system depends on self-policing by researchers and institutions. Because the existing system is overworked, applying common law forms of liability to clinical researchers may encourage improvements in this self-regulation. While research necessarily involves uncertainties, researchers have the greatest direct control over the implementation of the research protocol and the most extensive direct contact with subjects, and must bear corresponding responsibility for acts which fall below the standard of care. This paper argues that the existing FDA patient protections should be adopted as the standard of care for researchers. It examines the possible application of negligence, negligence per se, and fraud and misrepresentation claims against researchers. (9 pages)

©2002 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The major bottleneck in drug development is delays in clinical trials due to patient recruitment. More than eighty percent of trials are delayed an average of three months. Each day of delay results in approximately $1 million in lost revenue to the pharmaceutical company sponsor. The Internet, a rapidly growing source of healthcare information for 70 million Americans, provides a cost-efficient solution to the growing problem of patient recruitment. Important considerations in maximizing the use of the Internet for this purpose, include: defining the optimal mix of recruitment solutions, leveraging the Internet's targeting capabilities, employing optimal timeframes to maximize online effectiveness, and potentially implementing an Internet platform to inform and screen patients across multiple trials and over time. (3 pages)

©2002 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: There is a growing gap between the tidal wave of information emerging from the Human Genome Project and other molecular biology initiatives, and the clinical research needed to transform these discoveries into new diagnostics and therapeutics. While genomics-based technologies are being rapidly integrated into pharmaceutical R&D, many steps in the experimental process are still reliant on traditional surrogate model systems whose predictive power about human disease is incomplete or inaccurate. There is a growing trend underway in the research community to introduce actual human disease understanding as early as possible into discovery, thereby improving accuracy of results throughout the R&D continuum. Such an approach (known as clinical genomics: the large scale study of genes in the context of actual human disease) requires the availability of large quantities of ethically and legally sourced, high-quality human tissues with associated clinical information. Heretofore, no source could meet all of these requirements. Ardais Corporation was the first to address this need by pioneering a systematized, standardized network for the collection, processing, dissemination and research application of human tissue and associated clinical information, all of which rest on the highest ethical standards. Based on a novel model of collaboration between industry and the academic/medical community, Ardais has created procedures, structures, technologies, and informatics tools that collectively comprise a new paradigm in the application of human disease to biomedical research. Ardais now serves as a clinical genomics resource to dozens of academic researchers and biopharmaceutical companies, providing products and services to accelerate and improve drug discovery and development. (5 pages)

©2002 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Human behavioral genetics can be broadly defined as the attempt to characterize and define the genetic or hereditary basis for human behavior. Examination of the history of these scientific enterprises reveals episodes of controversy, and an apparent distinction between scientific and social acceptance of the genetic nature of such complex behaviors. This essay will review the history and methodology of behavioral genetics research, including a more detailed look at case histories involving behavioral genetic research for aggressive behavior and alcoholism. It includes a discussion of the scientific versus social qualities of the acceptance of behavioral genetics research, as well as the development of a general model for scientific acceptance involving the researchers, the scientific literature, the scientific peer group, the mainstream media, and the public at large. From this model follows a discussion of the means and complications by which behavioral genetics research may be accepted by society, and an analysis of how future studies might be conducted. (10 pages)

©2002 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The social enigma of the existence of homosexuality has for years inspired many to propound theories of causation. In recent times, with advancements in the science of physiology, scientists are increasingly looking towards the human body and genetic information for a biological basis for variances in sexuality. While the scientific community makes incremental, but far from convincing, progress in this search, society at large begins to question what would happen should such a discovery occur.
Of particular concern to this article is how such a discovery may affect the legal status of gays and lesbians. Specifically, this article will address the potential changes in the way in which the U.S. Constitutional protects gays and lesbians from discrimination through its equal protection clause of the Fourteenth Amendment. The article concludes that any changes resulting from a discovery of a gay gene will be determined not by the discovery, but by the social and moral climate in which the discovery occurs. Thus, advocators of gay and lesbian rights need to ensure that social mores are engaged and progressed to a more liberal stature in order to allow such a discovery to really work towards the improvement of gays and lesbians. (9 pages)

©2002 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: In the simplest terms, 2003 is shaping up as a forgettable year for the biotech industry. In the coming months, industry analysts expect many companies will close their doors as financing options dry up. At the same time, some survivors will have to abandon promising research projects in favor of activities that produce near-term revenue and satisfy investors. What's a biotechnology company to do amid these troubled times? This article provides an overview of how companies can respond to the difficult financing environment. (2 pages)

©2002 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: : NO Abstract: (2 pages)

©2002 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: A company involved in a merger, public offering, license or any of number of other transactions may be required to undergo an intellectual property due diligence. For a company which has not undergone such a review, the requirements of a due diligence can be disconcerting. Although the requirements of the actual due diligence may vary according the nature of the transaction and the personalities of the parties involved, there is a certain commonality to every due diligence which, if understood, can ease the process. (3 pages)

©2002 by The Journal of BioLaw & Business. All Rights Reserved.

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