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Insuring International Clinical Trials: Navigating the Quirks and Avoiding the Quagmires
Frank Goudsmit, Cesar Rios and Jill Wadlund
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Abstract:
The recent enactment of the European Union (EU) directive on human clinical research illustrates the ever-increasing complexity of multi-site clinical research. The overarching goal of the directive is to raise standards for protecting study volunteers throughout the EU while streamlining regulations to make it easier to conduct multi-center trials in member states. This article discusses the importance of insurance protection against liability in international clinical trials.
5 pages
©2005
by The Journal of BioLaw & Business. All Rights Reserved.
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(3 pages)
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Beyond Sarbanes-Oxley: The Growing Scrutiny of Market Disclosures of FDA Developments for Life Sciences Companies
Greg Glover
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Abstract:
The Sarbanes-Oxley Act is post-Enron legislation, enacted in July 2002, which created new standards for corporate accountability and stiff new penalties for acts of wrong doing. The most dramatic change to federal securities laws since the 1930s, the Act radically redesigns federal regulation of public company corporate governance and reporting obligations. Among other requirements, each company must disclose "on a rapid and current basis" additional information about the company's financial condition or operations as the SEC determines is necessary or useful to investors or in the public interest. This requirement can often be a challenge to life sciences companies that are developing new products alone or with development partners who have inconsistent financial disclosure priorities. One response to these challenges has been an initiative to enhance cooperation between the SEC and FDA regarding disclosures of FDA regulatory developments.
(3 pages)
©2005
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(4 pages)
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Creating Value with the CREATE Act
Scott A.M. Chambers and Marc R. Labgold
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Abstract:
The CREATE Act amends Section 103 of Title 35 to remove certain secret prior art from patentability determinations at both the U.S. Patent and Trademark Office (USPTO) and before the United States District Courts. The Act negates much of the harmful effect of OddzOn Products, Inc. v. Just Toys, Inc., 122 F.3d 1396 (Fed. Cir. 1997) for collaborative researches and is intended to foster greater communication within collaborative research agreements. The Act retroactively affects prior art previously available under § 102(e), (f) and (g) in determining compliance with 35 U.S.C. § 103, provided the claimed invention was created under a joint research agreement. While the Act has a retroactive effect with respect to collaborative research agreements, it only applies to patents issued after the enactment of the legislation. Remedial in nature, the Act
raises several potential pitfalls for collaborative research parties, including the prospect of inadvertently rendering one party to a CREATE Act agreement the unintended licensing agent of the other.
(4 pages)
©2005
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(5 pages)
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Funding Seed Stage Companies: Virtuous Cycles, Vicious Cycles and the "Capital Gap"
Thomas P. Dickerson
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Abstract:
Entrepreneurial environments require the interplay of three elements: research and development, capital and entrepreneurs. In any given locale, successful development of the entrepreneurial environment requires that each of these elements supports and reinforces the others in a "virtuous cycle." While getting R&D out of the university setting isn't always easy, the real rate limiters today are the other two elements of the equation: finding entrepreneurs and finding capital. The discussion which follows focuses on challenges which nascent companies face in obtaining initial infusions of capital - an issue which has come to be known as the "capital gap."
(5 pages)
©2005
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(8 pages)
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Hatch Waxman: A Work in ProgressResponding to the Conundrum: How to Encourage Innovative New Drugs While Reducing the Cost of Access
Raymond S. Fersko, Eugene Trogan, and Pamela M. Harinstein
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Abstract:
This article explores The Drug Price Competition and Patent Term Restoration Act of 1984 and the amendment thereto as part of the Medicare, Prescription Drug, Improvement and Modernization Act of 2003. The development of the generic drug industry is analyzed in the context of the incremental development of legislation in response to the competing policy interests of the innovative manufacturers of pioneer brand-name drugs and the need to bring lower cost drug products to the market that are safe and efficacious. Hatch Waxman as enacted and/or as amended is an attempt to strike the right balance of meeting the public demand for lower price drugs while encouraging innovative new drugs.
©2005
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(9 pages)
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Ethics and Policy Perspectives on Personalized Medicine in the Post-Genomic Era
Melissa R. Landon
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Abstract:
The completion of the human genome project and the accompanying biotechnological revolution hold great promise for the creation of pharmaceutical agents to combat not only previously incurable diseases, but also those for which therapeutics exist, yet they either cause severe adverse effects or exhibit no benefit in subsets of the population. In many instances variation in therapy response can be attributed to genetic differences, more particularly single nucleotide polymorphisms (SNPs). Detection of the genetic differences which affect drug response, commonly referred to as pharmacogenomics, may result in further classification of diseases and, consequently, the development of 'personalized' therapies. While of potential great benefit, the widespread use of pharmacogenomic data poses social, ethical, and economic risks that need to be addressed by regulatory agencies such as the Food and Drug Administration (FDA). This paper explores some of the common problems associated with the use of pharmacogenomic data including validation of the data, patient confidentiality, social stratification, economic risks faced by pharmaceutical and insurance companies, and offers suggestions for regulatory procedures to ensure the appropriate use of the data in drug development and clinical trials.
©2005
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Special Segment:
(9 pages)
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Conflicts of Interest in Medical Research: How Much Conflict Should Exceed Legal Boundaries?
Kaley Klanica
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Abstract:
This article addresses the current plague of financially conflicted research from various perspectives including the research community, the medical community, patients/subjects, the Food and Drug Administration (F.D.A.), and other government agencies. Part one lays out the current conflicts of interest within medical research. Part two explains the actual and potential effects of these conflicts, highlighting the conflict of interest associated with the death of Jesse Gelsinger. Part three describes how conflicts of interest are currently regulated by government agencies and within individual institutions. Lastly, part four concludes by recommending a system of seven balanced reform measures that protect research subjects and the scientific integrity of medical research while encouraging scientific progress.
©2005
by The Journal of BioLaw & Business. All Rights Reserved.
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Recent Developments:
(2 pages)
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Moving Forward By Reliving the Past
Bryan A. Liang
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Abstract:
No Abstract
©2005
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Innovative R&D Remains Key To Development of New Prescription Drugs
Anna M. Dubiak
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Drug developers must implement new research and development strategies to increase the flow of novel prescription drugs.
©2005
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The Effects of Contamination on Stem Cell Research
Charles Salahuddin
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Recent stem cell contamination intensifies debate over stem cell research in the U.S.
(2 pages)
©2005
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Judge Declares Pre-Embryo is Human
Katherine Vick
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State court holds pre-embryo is human; decision may have research implications
(2 pages)
©2005
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Has the European Union Reopened the Door to Genetically Modified Agricultural Products?
Elisabeth M. W. Trefonas
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European Food Safety Authority approval of Genetically Modified Corn may or may not signal a reopening of the European Union market.
(2 pages)
©2005
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