Click to buy Editorial (3 pages)

Biotechnology Industry Fundamentals Sound Carl B. Feldbaum

Abstract: At a time when a national security crisis is understandably monopolizing Congress's legislative calendar, as well as the energies of the multiple federal agencies that regulate biotechnology, the good news is that our industry's fundamentals are sound. Investors poured $33 billion into biotechnology companies in the halcyon year of 2000, leaving 50 percent of publicly traded companies with at least three years' worth of operating cash in the bank, according to the latest Ernst & Young report on biotechnology, Focus on Fundamentals. Even in the current economic downturn, biotechnology has outperformed both the broader markets and the high-technology sector. At the end of the first month after Sept. 11, the Nasdaq Biotechnology Index was actually up a hair from its close the day before the tragic terrorist attacks and continued to climb through the second half of October.

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

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Click to buy Feature Article (8 pages)

Bad Medicine: Why the Generic Drug Regulatory Paradigm Is Inapplicable to Biotechnology Products Lisa J. Raines

Abstract: Biotechnology products are different from traditional drug products in several important respects. These differences relate not only to their vastly greater size and complexity, but also to the inextricable relationship between such products and the biological processes that are used to make them. Biotechnology manufacturing involves hundreds of variables that can affect product identity, quality, purity, and potency. For this reason, a manufacturing process that has produced a biotechnology product that has been demonstrated clinically safe and effective may be modified only by changes that have been validated to ensure that product safety and effectiveness will not be compromised. A generic manufacturer can neither reproduce the innovator's customized and proprietary processes nor prove that its differently-produced product is as safe and effective as the innovator's product, without conducting clinical trials.

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

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Click to buy Feature Article (10 pages)

New Trends in the Regulation of Biologics Gregory J. Glover

Abstract: A confluence of activities by the Food and Drug Administration (FDA), the biotechnology industry, as well as recent court decisions involving traditional pharmaceutical products have raised concerns about a trend towards decreasing the regulatory hurdles that govern the approval of biologics that are similar, but not identical to already approved biologics. The following presents an analysis of the current regula-tory schemes governing the approval of both biologics and drugs, the recent changes adopted by FDA in its efforts to simplify the regulation of drugs and biologics, and controversial court decisions. Although the aforementioned have led some in the biotechnology industry to believe that biologics will eventually be subject to the same generic competition that drugs are, this paper will show that the approval of generic biologics lacks statutory authority and could create serious public health risks.

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

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Click to buy Feature Article (10 pages)

Digital Discovery: Emerging Issues for Biotechnology and Life Sciences Companies Phillip B.C. Jones

Abstract: Although the paperless office has not yet arrived, businesses are creating and storing electronic information at a rapidly increasing rate. Companies involved with drug discovery and development are amassing extensive stores of electronic data. Much of a company's electronic information may remain safely undisturbed for years. Unless, of course, that information becomes relevant to pretrial discovery in civil litigation. In that event, a company may be compelled to spend long hours and a substantial amount of money to retrieve relevant electronic records, spread over personal computers, mainframes, and various storage media, including files created with obsolete software. Organizations and companies that manage their electronic information may realize a tactical advantage in litigation due to their ability to produce documentation in an efficient and cost-effective manner. This article addresses some of the issues related to digital discovery as they pertain to the biotechnology and life science sectors.

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

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Click to buy Feature Article (11 pages)

The Regulation of Home Diagnostic Tests for Genetic Disorders: Can the FDA Deny a Premarket Application on the Basis of the Device's Social Impacts? James D. Kerouac

Abstract: This article discusses the Food and Drug Admin-istration (FDA) authority to regulate home use diagnostics for genetic disorders based on the social effects of the devices in the premarket approval process (PMA). It begins with a discussion of the potential social impacts of home use genetic diagnostics, focusing particularly on the psychological effects of the devices. The article then discusses the FDA's past experience in regulating home use diagnostics for HIV and for drugs of abuse testing under its PMA authority. In approving PMA applications for home tests for HIV and drugs of abuse, the FDA has considered various social effects of the devices and tailored its approval to these considerations. However, the agency did not deny approval because of social considerations. The author argues that the FDA's past experience in approving PMA applications indicates both a willingness to consider social considerations in the PMA process and that the agency may deny a PMA application based on social considerations in appropriate circumstances. The author also argues that the FDA may deny a PMA application if the social impacts and other health risks of the device greatly outweigh the therapeutic benefits of the device. For example, in applications involving late onset genetic disorders for which no therapeutic options currently exist, the social risks of the device may be found to outweigh the benefits to health and therefore the FDA may deny a PMA application in these situations.

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

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Click to buy Special Segment (11 pages)

The Øresund: The Biotechnology Investor's Guide to Scandinavia's Newest and Largest City Lawrence B. Landman

Abstract: Southern Sweden and Copenhagen, Denmark have together developed one of the world's major research centers, and Europe's fourth largest biotechnology industry. The new Øresund Bridge is now allowing the Danish capital and Lund and Malmö in Sweden to further integrate their economies. As they do so the region will become an even more important research center, and its biotechnology industry will grow considerably.

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

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Click to buy Special Segment (5 pages)

Biotechnology and Bio Medical Research in Australia Andrew Chalet, Mark Stevens and Sean Tully

Abstract: Australia has a substantial and respected reputation in biomedical research. It's scientists have contributed significantly and with innovation to drug discovery. Medical Research Institutes in particular have offered and delivered significant contributions to international drug discovery, fundamental research and biotechnology. In contrast, Australia has not excelled in building an industry based on this research. Commercialization, as opposed to academic recognition, of research has been regarded as spasmodic and indifferent. At best, early stage licenses have been granted to overseas companies with management expertise and access to money to capitalize on Australian inventions. Now, two States in particular in Australia are striving to change the status quo, and create a thriving local and international biotechnology industry. This article presents a view of the developments in this regard in Victoria and Queensland.

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

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Click to buy BioConversations (4 pages)

Automation and Robotic Systems Development in Biotechnology:An Interview with William Orinski and Richard Carone Paul Davis

Abstract: Biotechnology and pharmaceutical companies spent over $1 billion on automation in 1999. The sectors are expected to increase spending to over $2 billion in 2002 with a growth at or above 20% annually. The progress of genomic research is expected to drive the growth rates higher as a result of the demand for genomic drug discovery and high throughput processes. As the new biotech and pharma demands for efficient automated processes have increased, the industries have been required to modify and utilize a well-established set of systems and technology that were developed in other industries for different applications. In particular, biochips demands have help drive a need for the automated assembly systems that enables the current generation of process equipment.

Since the boom and bust of the early robotics industry in the 1980s, a set of surviving automation pioneers have created a leaner and more flexible industry that has solved the high volume automation issues that have challenged a series of businesses in areas like pharmaceutical packaging, disk drive assembly, semiconductor fabrication, test and packaging, flat panel assembly and fiber optic bundling.

William Orinski and Richard Carone are two of the leading developers of modern automation systems.

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

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Click to buy BioColumn (6 pages)

BioCaseNotes James Lindon

Abstract: Biotechnology and pharmaceutical companies spent over $1 billion on automation in 1999. Numerous cases pertaining to biotechnology and the life sciences are resolved within the Court of Appeals for the Federal Circuit each year. This column highlights four cases that have been decided during the year 2000. The sampling of cases highlight the need to be diligent in all phases of intellectual property development, from pre-patent filing scientific investigations to interaction with the U.S. Patent and Trademark Office (PTO) during patent prosecution and patent litigation.

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

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