Click to buy Guest Editorial (3 pages)

Bioterrorism: A Challenge We Cannot Decline to Meet Carl B. Feldbaum COMING SOON PLEASE DO NOT ORDER THIS ARTICLE IT HAS NOT BEEN PUT INTO THE SHOPPING CART YET!

Abstract: : COMING SOON PLEASE DO NOT ORDER THIS ARTICLE IT HAS NOT BEEN PUT INTO THE SHOPPING CART YET!

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

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Click to buy Feature Article (29 pages)

Structuring a Start-up Company for Venture Capital Financing Peter B. Finn

Abstract: Venture capitalists are result oriented. They are not looking to finance the development of an idea but rather are seeking an appropriate return for their investors. Founders need to understand and appreciate that companies have to be structured to make money, not to research or perpetuate an idea. This natural tension must be recognized and the relationship balanced if a company expects to receive a venture capital investment. This article identifies the key issues and outlines the legal structure that the venture capitalist will expect to see when reviewing an investment opportunity.

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

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Abstract: Technological advances in genetic and biomedical research have led to a startling number of adverse events in clinical trials. Reporting systems for adverse and serious adverse events should be aimed at reducing the future risks through analysis of the conditions leading to the adverse events. Unfortunately, current reporting systems are not adequate for performing this function. Many medical organizations, most notably the Institute of Medicine (part of the National Academy of Sciences), have written suggestions on how to renovate the current reporting systems. It is the author's view that these suggestions and the responses from other organizations fall short of developing a fully useful system of adverse event reporting. Instead, a system that the public, the regulatory bodies, and the researchers can easily understand and utilize for developing safer, more responsible, clinical trials is proposed.

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

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Abstract: Scientific discovery and knowledge expansion in the post genome era holds great promise for new medical technologies and cellular-based therapies with multiple applications that will save and enhance lives. While human beings long have hoped to unlock the mysteries of the molecular basis of life; our society is now on the verge of doing so. But new scientific and technological breakthroughs often come with some risks attached. Research - especially clinical trials and research involving human participants - must be conducted in accordance with the highest ethical and scientific principles. Yet, as the number and complexity of clinical trials increase, so do pressures for new revenue sources and shorter product development cycles, which could have an adverse impact on patient safety. This article explores the use of risk management tools in clinical research.

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

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Abstract: In recent years there has been a shift in focus from national and international "Ethics Influentials" related to the approval of life-saving therapies to a national and international reassessment of the conduct of clinical trials and human subject protection. Due to intense and ongoing pressure from several groups (including the media, patients and families, tort lawyers, patient advocacy groups, ethicists, and government advisory bodies), there are several initiatives underway to revise ethical standards for the conduct of clinical trials. This article discusses the need for an integrated approach to improving the ethical conduct of clinical trials as well as the need to promote the equally important ethical consideration of efficient approval of safe and effective life-saving medical therapies.

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

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Abstract: Efforts to obtain Food and Drug Administration (FDA) approval of new drugs on a "fast track" are not without hazards for physicians and other providers involved in conducting clinical research. Increasingly, research sponsors have implemented competitive subject recruitment techniques that encourage investigators and their staffs to move studies along rapidly, but may also raise concerns about subject safety. The purpose of this article is to examine competitive recruitment practices and to examine the ethical and legal issues related to obtaining information consent for clinical research within this current framework.

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

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Abstract: As flaws in the informed consent process have come to light, rising research costs and heightened competition have exposed informed consent to increasing scrutiny as a possible source for industry savings. However, we believe that the informed consent process needs to be refined and strengthened, not weakened or abandoned. This article describes why protecting human research participants through informed consent is necessary for institutions that conduct human research.

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

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Abstract: The enactment of the Health Insurance Portability and Accountability Act (HIPPA) has garnered significant attention in the health care sector. This legislation represents a major effort to address patient confidentiality and privacy. In general, HIPAA has three goals: first, to create a framework in which protected health information may flow; second, to make it difficult for this information to escape outside the system, and finally, to give patients more control over their medical records and to inform them about how their medical information is used. The effects of HIPAA will impact virtually every aspect of health care. Pharmaceutical manufacturers and biotechnology companies conducting clinical trials or research involving treatment in a covered entity need to be aware of the additional duties that HIPAA imposes on collaborators. This article offers a brief overview of HIPAA privacy rules and the ways in which HIPAA regulations may create obstacles for clinical research efforts, along with initial observations on how research organizations may limit these obstacles.

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

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Abstract: Incorporating data safety monitoring during the trial design is critical to assuring patient safety and the success and usefulness of the trial. The safety reporting process should be determined in advance of the trial, spelling out deadlines and reporting requirements in the event of an adverse event. A Data Safety Monitoring Board (DSMB) can ensure a more independent review because it is comprised of individuals who are not otherwise affiliated with the trial. This article discusses the role of a DSMB and the need for new systems to assure data quality.

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

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Abstract: Although recent advances in biotechnology have brought with them a raft of ethical issues, other ethical challenges are arising not from new technologies, but rather from the expansion of biotechnology into "commodified" mass consumer applications, non-medical applications with no "purpose" other than entertainment or the satisfaction of consumer demand. In other words, commodity products targeted at a market that biotechnology does not currently exploit - the mass consumer market. This article will discuss two such examples of commodified biotechnology, the use of DNA sequence comparisons to construct genealogies; and the use of such comparisons to derive "ethnic" identities, and will conclude with a discussion of the possible consequences of such applications.

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

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Abstract: Federal medical record privacy regulations (45 CFR Part 164) finalized by the Department of Health and Human Services (DHHS) in April of 2001 will become effective on April 13, 2003. However, these rules will have a significant impact on the handling of clinical trial data, which companies must now plan for in ongoing or planned trials. This articles provides an overview of these changes and their impact on clinical trial research.

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

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Abstract: In this era of electronic distribution, numerous businesses have begun to take advantage of the faster, more efficient modes of distributing information and other content offered by internal networks and the Internet. Many of these businesses, consciously or not, have thus become "electronic publishers." This article describes the impact of copyright law on business publishing practices.

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

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Abstract: Companies promoting or knowing of off-label use need to be aware of the $16.2 million jury award in a recent case involving liability for third party off-label use of an in vitro diagnostic (IVD) device, where the device manufacturer and University-based medical team were held jointly liable in a case involving the misdiagnosis of cancer. A summary analysis of liability issues raised in the case based on our review of the court documents is presented in this article.

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

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Abstract: Having first been proposed over a decade ago to harmonize European patent law for the benefit of Europe's fledgling biotechnology industry, the Biotechnology Patent Directive underwent a somewhat tortured introduction to adolescence when its adoption was challenged by a legal annulment action from the Governments of The Netherlands, Italy and Norway. This article explores the nature of the legal challenge to the Directive, which to an extent typify European concerns about biotechnological inventions, particularly the "patenting of life."

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

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