GUEST EDITORIAL
	The Wake-Up Call of Corporate Governance Stuart N. Brotman
	FEATURE ARTICLES
	Sponsored Research Agreements, University and Government Licensing, and Clinical Trial Agreements: Special Contractual and Intellectual Property Rights Considerations Jeffrey P. Somers
	The Development of Entrepreneurial Infrastructures Across the United States Thomas P. Dickerson
	Corporate Codes of Conduct: Why Are We Here Again? Robert M. Gault, Lara M. Burnazian and Jesse A. Lynn
	FDA Regulation of Medical Device Software: A Delicate Balancing Act Suzan Onel
	SPECIAL SEGMENT KNOWLEDGE MANAGEMENT
	Learning from Experience: Privacy and the Secondary Use of Data in Health Research William W. Lowrance
	BIOCOLUMNS
	Pharmacogenomics Column Strategic Decisions and Pharmacogenomics Christine Huttin
	Intellectual Property Strategy Column Why Do Companies Fail? Yair Gibor

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The Wake-Up Call of Corporate Governance Stuart N. Brotman

©2003 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: This article addresses contractual and intellectual property considerations that frequently arise in the drafting and negotiation of sponsored research agreements ("SRAs"), license agreements with universities (and other non-profit organizations) and the federal government, and clinical trial agreements. Each of these subjects is addressed separately, but most of the article is devoted to sponsored research, which is the driver for much of the innovation in the medical and life sciences industries. (9 pages)

©2003 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: One of the more remarkable developments of the 1990's in the life science industry is the change in the geographic locale of entrepreneurial start-up activity. During the decades before the '90's, this sector of the economy grew rapidly principally in two areas: Boston/Route 128 and Palo Alto/Silicon Valley. This article discusses the more recent development of entrepreneurial infrastructures in the other 48 states, and sets forth a model of the common elements and trends that characterize the growth of such environments. (6 pages)

©2003 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: One of the most significant lessons to come out of the recent debacles involving ImClone, WorldCom, Enron, Tyco, Elan, Arthur Andersen and others is the importance of establishing a corporate code of conduct. A company that has in place a compliance program may be able to decrease or avoid liability for the misconduct of its employees, directors or officers. This article discusses issues facing public and private companies in connection with corporate codes of conduct in the post-Imclone and Elan era. (4 pages)

©2003 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The increased integration of medical devices and software has dramatically expanded the range and uses of medical devices in both critical and non-critical areas. This advancement in patient care presents regulatory challenges for industry as the Food and Drug Administration ("FDA") balances concerns about software related device failures against the need for innovation and timely approval of medical devices containing or operated by software. This article summarizes FDA's current regulation of medical device software, looking both at stand-alone software and software used as a component, part, or accessory of another product and discusses the regulatory challenges involved with pre-market submissions for software controlled medical devices, software validation, and FDA's Part 11 requirements for electronic records. (6 pages)

©2003 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: In this fast-moving age of data banking, data are a currency, and often a commodity. Electronic health records are being developed everywhere. Increasingly, data collected for various primary purposes are being re-used for research. With personal mobility, contracting of services, and telemedicine, health care data are crossing national borders, and therefore so are genetic information, biological materials, and reimbursement data. There is much public and legal concern about the implications. This article addresses the question: Under what conditions may data not collected specifically for research, such as primary medical data, be re-used for health research without compromising the privacy of the data-subjects? (31 pages)

©2003 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: Pharmacogenomics is a science which seeks to design new drugs and optimize the use of existing ones by focusing on both the specific genetic polymorphisms associated with the individual patient's disease and on polymorphisms affecting the disposition of the drug and the drug target. Individualisation of drug therapy in this way should result in increased drug efficacy and decreased toxicity. This article discusses the main strategic decisions involved with the use of pharmacogenomics for the development of new drugs. (4 pages)

©2003 by The Journal of BioLaw & Business. All Rights Reserved.

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Abstract: The ancient Greeks used to discuss the following paradox: Achilles, the fastest runner of the times during the Troy War, once raced a turtle. The question is - could Achilles ever pass the turtle in this race? The answer is - yes, provided Achilles carefully set his targets and timing. In this parable, companies can be likened to Achilles and the regulatory process can be likened to the turtle. Using a series of parables and analogies from the literature, this article addresses how smart companies can fine tune their corporate strategies for success. (3 pages)

©2003 by The Journal of BioLaw & Business. All Rights Reserved.

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