Transformation of a Research Platform into Commercial Products

The Impact of United States Federal Policy on Biotechnology
  • Michael J. Malinowsk
  • Nick Littlefield


The 20th Century, a century of accomplishment in the life sciences, has ended with a deluge of discovery and established a footing for innovation that will bridge well into the next millennium. The impact of biotechnology has been particularly profound. An entire industry of companies and a generation of innovative drugs have reached the market more quickly than the average bench-to-market time frame—roughly 14.9 years, and at a cost of $500 million (PhRMA 1998, 20, 24–25). Today, there are approximately 1,300 US biotechnology companies, and 93 biotech drugs have reached the market, 58 of those since 1995 (PhRMA, New Drugs Jan. 1999; Med Ad News, “Bursting with Innovation” Dec. 1998, 44–45 ; see also BIO 1998). While only 10 percent of pharmaceutical product launches were attributable to the biotechnology industry in 1996 and 1997, that number reached 25 percent of launches in 1998 (Dorey 1999, 128; Med Ad News, “New Drugs”. Feb. 1999, 11 (descriptive identification) of all new drug products approved in 1998). The biotech family of drugs includes breakthrough products such as Avonex for multiple sclerosis (Biogen, Inc.), Ceredase/Cerezyme for Gaucher’s disease (Genzyme Corp.), Herceptin for metastasized breast cancer (Genentech, Inc.), and Pulmozyme for cystic fibrosis (Genentech, Inc.). Moreover,Herceptin, approved by the Food and Drug Administration on Sept. 25, 1998, marks a new era of applied pharmacogenomic therapeutics—drugs that intercede in disease pathways at the molecular level to impact cellular funcation and disease eapression with extreme precision, and that can be matched to patients genetically predisposed to respond (Carey 1999, 98–100; Hoyle 1998, 887; Med Ad News, “Biological Warfare” Dec. 1998, 3 & 44–47; Editorial, “Pharmacogenomics” 885)


Technology Transfer Human Genome Project North American Free Trade Agreement Research Platform Coordinate Framework 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


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Copyright information

© Springer Science+Business Media New York 1999

Authors and Affiliations

  • Michael J. Malinowsk
    • 1
  • Nick Littlefield
    • 1
  1. 1.Foley, Hoag & ElliotUSA

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