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Volume 23 Issue 9, September 2005

This issue focuses on antibody engineering and manufacturing. The stylized image of antibodies is by Jacque Deshaies and is entitled "Deshaies 99—Antibody #1 to #4" (original 4: 28 x 36 cm, acrylic on paper) http://www.JacquesDeshaies.com

Editorial

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News

  • While the FDA waits for someone to come up with a plan to improve the accelerated approval program, some argue that as it is, drugs are not getting to the people who need them.

    • Jeffrey L Fox
    News
  • As new drug approval rates drop in Europe compared to the US, the EU Commission plans to spur innovation by doubling financial support for the biotech industry.

    • Peter Mitchell
    News
  • Mexico's genomic researchers believe a mestizo “hapmap” might reveal a genetic basis for some of the nation's health problems, although they are mindful of the potential for the misuse of personal genetic information.

    • Veronica Guerrero Mothelet
    • Stephan Herrera
    News
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News in Brief

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News

  • Seizing upon a favorable business climate in Europe, US businesswoman Lisa Drakeman has blended goal-oriented American culture with a European focus on team effort to move her firm's antibodies closer to the market.

    • Laura DeFrancesco
    News
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Data Page

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News Feature

  • Industry hopes to build on recent successes of monoclonal antibodies in oncology and inflammatory disease. But evidence is mounting that the exquisite selectivity and binding capacity of these therapeutics can have unwanted side effects, particularly in autoimmune disease. Christopher Thomas Scott investigates.

    • Christopher Thomas Scott
    News Feature
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Correspondence

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Commentary

  • Academic ownership of intellectual property facilitated wide dissemination and commercialization of antibody technology. Moves at the University of Cambridge to reclaim institutional IP rights should thus be treated with caution.

    • Mike Clark
    Commentary
  • At the end of next month, the European Medicines Agency (EMEA) will implement a new legislative framework and several provisions that seek to provide incentives and streamline regulatory oversight of certain monoclonal antibodies and other biologic products.

    • Lincoln Tsang
    Commentary
  • Ensuring adequate manufacturing capacity for recombinant and monoclonal antibodies is one of the greatest challenges facing the biotech industry. The following factors should be taken into account when designing product development and production strategies.

    • Keith L Carson
    Commentary
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Investors Lab

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Feature

  • The current generation of antibodies has done more than make a few companies rich. It has laid the groundwork for ambitious companies to move to maturity.

    • Monya Baker
    Feature
  • Most monoclonal antibodies in clinical trials are owned by small biotech companies. But with blockbuster-sized revenues and approval rates higher than those for small-molecule drugs, that all may be set to change.

    • Janice M Reichert
    • Clark J Rosensweig
    • Matthew C Dewitz
    Feature
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Patents

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News & Views

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News and Views Feature

  • Comparing the metabolic pathways of parasites and their hosts facilitates the identification of new drug targets.

    • Kshitiz Chaudhary
    • David S Roos
    News and Views Feature
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News & Views

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Commentary

  • The failure of many bio-ontologies to follow international standards for ontology design and description is hampering their application and threatens to restrict their future use.

    • Larisa N Soldatova
    • Ross D King
    Commentary
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Perspective

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Review Article

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Article

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Letter

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New on the Market

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Careers and Recruitment

  • India's thriving biotechnology industry is threatened by a change in the law. Will the current high levels of investment be enough to secure its future?

    • K S Jayaraman
    Careers and Recruitment
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People

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Focus

  • A focus examining recent progress in antibody research and the commercial and regulatory developments that are shaping it.

    Focus
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