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INDUSTRIES: Business History of Biotechnology
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April 7, 1976 - Venture capitalist Robert A. Swanson,  biochemist Dr. Herbert W. Boyer (pioneered recombinant DNA technology) founded biotechnology company, Genentech in South San Francisco in one rented building and two staff members; 1977 - produced first human protein (somatostatin) in microorganism (E. coli bacteria); 1978 - cloned human insulin; 1979 - cloned human growth hormone; 1980 - went public; 1982 - marketed First recombinant DNA drug, human insulin (licensed to Eli Lilly and Company); 1985 - received approval from U.S. Food and Drug Administration (FDA) to market first product, Protropin® (somatrem for injection) growth hormone for children with growth hormone deficiency (first recombinant pharmaceutical product manufactured, marketed by biotechnology company); 1990 - majority interest (56%) acquired by Roche Holdings Ltd. (Basel, Switzerland) in $2.1 billion deal; total assets of $1.1 billion; 1995 - extended for four years Roche's option to purchase outstanding redeemable common stock of company at predetermined price; 1997 - launched a service for patients, their physicians called SPOC (Single Point of Contact) to provide customer-focused reimbursement assistance (renamed Genentech Access Solutions in 2008); 1998 - dedicated $250 million manufacturing facility in Vacaville, CA (received FDA licensure as multi-product facility in 2000); 1999 - Roche Holdings, Inc. exercised its option, Genentech redeemed all of outstanding special common shares not owned by Roche; announced its intent to publicly sell up to 19% of Genentech shares, continue Genentech as publicly traded company with independent directors; July 20, 1999 - went public, considered largest public offering in history of U.S. health care industry (NYSE trading symbol, DNA); October 20, 1999 - Roche conducted secondary offering of 20 million Genentech shares, largest secondary offering in U.S. history; 2008 - FORTUNE magazine named Genentech (#5) one of "100 Best Companies to Work For" (tenth consecutive year); March 26, 2009 - 44% interest (balance of outstanding shares) acquired by Roche for $47 billion; 7th-largest pharmaceutical company (market share), annual sales of $17 billion, 17,500 employees (in U.S. segment).

Robert A. Swanson Dr. Herbert W. Boyer, Robert A. Swanson - Genentech (

June 16, 1980 - Supreme Court ruled in Diamond v. Chakrabarty that living, manmade microorganisms  which are products of "human ingenuity and research" and not "nature's handiwork" are patentable; microbiologist, Ananda Chakrabarty, distinguished professor of microbiology and immunology at the University of Illinois College of Medicine, appealed had  rejection of his 1972 patent application for human-made, genetically engineered bacterium capable of breaking down crude oil, which no naturally occurring bacteria could do.

March 31, 1981 - Ananda M. Chakrabarty, of Latham, NY, received a patent for "Microorganisms Having Multiple Compatible Degradative Energy-Generating Plasmids and Preparation Thereof"; single cell genetically engineered life form; assigned to General Electric Company. 

June 18, 1981 - First genetically engineered vaccine  announced: first effective subunit vaccine for any animal or human disease using gene splicing; designed to prevent hoof and mouth disease (FMD); 1980 - U.S. Dept of Agriculture scientists turned to recombinant DNA technology, collaborated with scientists from Genentech, a private company; inserted a bioengineered plasmid containing the gene for VP3 into Escherichia coli bacteria which grew obeying orders from the guest DNA, mass-producing the VP3 proteins for the vaccine.

April 16, 1987 - U.S. government authorized patents on genetically engineered processes, first nation in world to allow such patent applications.

April 12, 1988 - Geneticists Philip Leder, of Chestnut Hill, MA, and Timothy A. Stewart, of San Francisco, CA, received a patent for "Transgenic Non-Human Mammals"; assigned to the President and Fellows of Harvard University; designed to be highly susceptible to breast cancer; designated as "oncomice," intended for use in testing anticancer therapies with more efficiency and accurate results.

August 1991 - Calgene Inc. (Davis, CA) submitted first commercially grown genetically engineered food to U.S. Food and Drug Administration for approval; first time FDA had evaluated whole food produced by biotechnology (vs. cross-breeding); May 18, 1994 - Food and Drug Administration approved Flavr Savr, new tomato developed through biotechnology, as safe as tomatoes bred by conventional means .

April 23, 2007 - AstraZeneca agreed to pay $15.6 billion for MedImmune, maker of FluMist nasal spray flu vaccine = largest acquisition of biotechnology company in history; reflected growth by acquisition strategy as patent protection lapsed for pharmaceutical companies' existing drug products.

May 2008 - Ernst & Young's annual financial report on biotech industry cited 2007 financing from all sources topped $21.3 billion for U.S. biotech companies; $5.5 billion contributed by venture capital firms beat record set in 2000 (Human Genome Project); of 386 publicly traded U.S. biotechnology companies, 49% have more than two years of cash on hand (27% of those) have more than five years of cash; total potential value of mergers, acquisitions drug development alliances was nearly $60 billion in United States, surpassed levels in all prior years; number of approvals for new drugs dropped to lowest level in two decades (FDA faced resource constraints, lawmakers pressed for more-stringent safety reviews); market capitalization of San Francisco Bay Area's 77 public companies was $148.6 billion (40% of total market value of U.S. biotech companies) on revenue of $22.1 billion (34% of U.S. total for the sector); Boston area's 62 public companies had market capitalization of $65.1 billion (17.6% of U.S. biotech market capitalization). 

(Amgen), Gordon Binder (2008). Science Lessons: What the Business of Biotech Taught Me About Management. (Boston, MA: Harvard Business School Press, 292 p.). Former Chief Financial Officer, Chief Executive Officer, Chairman of Amgen (1982 -2000). Biotechnology industries -- United States -- Management; Chief executive officers -- United States -- Biography; Biotechnology -- economics -- Personal Narratives; Biotechnology -- history -- Personal Narratives; History, 20th Century -- Personal Narratives; Industry -- Personal Narratives. Amgen's climb to success, highs and lows in race to develop blockbuster drugs; 1989 - launch of Epogen, Neupogen followed; managing creative employees, navigating IPO process, protecting intellectual property.

(CellPro), Rick Murdock with David Fisher (2000). Patient Number One: A True Story of How One CEO Took on Cancer and Big Business in the Fight of His Life. (New York, NY: Crown, 308 p.). Murdock, Rick--Health; Lymphomas--Patients--Washington--Seattle--Biography; Cell separation; Biotechnology industries--Washington--Seattle.

(Cetus Corporation), Paul Rabinow (1996). Making PCR: A Story of Biotechnology. (Chicago, IL: University of Chicago Press, 190 p.). Polymerase chain reaction -- History.

(Genentech), Maureen D. McKelvey (1996). Evolutionary Innovations: The Business of Biotechnology. (New York, NY: Oxford University Press, 319 p.). Genentech, Inc.; KabiVitrum Sverige AB; -  Genetic engineering; Biotechnology industries--United States; Biotechnology industries--Sweden; Recombinant human insulin; Recombinant human somatotropin.

(ImClone Systems), Alex Prud'homme (2004). The Cell Game: Sam Waksal's Fast Money and False Promises--and the Fate of ImClone's Cancer Drug. (New York, NY: HarperCollins, 288 p.). Waksal, Samuel David; ImClone Systems Incorporated--History; Businessmen--United States--Biography; Antineoplastic agents industry--Corrupt practices--United States; Monoclonal antibodies--Research--United States--History; Cancer--Chemotherapy; Drugs--United States--Testing; Insider trading in securities--United States.

(Monsanto), Peter Pringle (2003). Food, Inc.: Mendel to Monsanto--The Promises and Perils of the Biotech Harvest. (New York, NY: Simon & Schuster, 239 p.). Agricultural biotechnology; Genetically modified foods; Food--Biotechnology. 

Robert Bud (1993). The Uses of Life: A History of Biotechnology. (New York, NY: Cambridge University Press, 299 p.). Biotechnology--History. How modern biotechnology grew out of this century's hopes for new relationship between biology, engineering.

Claire Hope Cummings (2008). Uncertain Peril: Genetic Engineering and the Future of Seeds. (Boston, MA: Beacon Press, 240 p.). Agricultural biotechnology--Political aspects.; Transgenic plants--Economic aspects; Transgenic plants--Risk assessment; Consumer protection--Citizen participation; Seeds--Biotechnology. Interdependence between plants,  people amidst privatization of Earth's seed stock.

Janet Hope (2007). Biobazaar: The Open Source Revolution and Biotechnology. (Cambridge, MA: Harvard University Press,, 448 p.). Member of the Australian National University's Center for Governance of Knowledge and Development. Biotechnology--Patents; Technological innovations--Patents; Patent licenses; Biotechnology--Economic aspects; Technological innovations--Economic aspects. Appeal of open source approach lies in its safeguarding of community access to proprietary tools without discouraging valuable commercial participation; detailed picture of "open source biotechnology" as desirable, broadly feasible.

Ed. Robert W. Kolb (2007). The Ethics of Genetic Commerce. (Malden, MA: Blackwell Pub., 240 p.). Frank W. Considine Chair in Applied Ethics (Loyola University Chicago). Genetic engineering industry; Genetic engineering--Moral and ethical aspects; Genetic screening; Genetically modified foods. Moral, ethical concerns derived from increasing knowledge of genetics, variety of its commercial applications (genetic screening, use of individual’s genetic information, rise of genetically modified foods, patenting, pharmaceutical mergers and monopolization, implications of genetic testing on non-human mammals).

Sharon McAuliffe and Kathleen McAuliffe (1981). Life for Sale. (New York, NY: Coward, McCann & Geoghegan, 243 p.). Genetic engineering--Economic aspects; Genetic engineering--Social aspects; Recombinant DNA--Economic aspects; Recombinant DNA--Social aspects.

Chris Meyer and Stan Davis (2003). It's Alive: The Coming Convergence of Information, Biology, and Business. (New York, NY: Crown, 275 p.). Director, Research Fellow, respectively (Cap Gemini Ernst & Young's Center for Business Innovation). Information technology--Economic aspects; Life cycles (Biology); Business cycles. 

Luigi Orsenigo (1989). The Emergence of Biotechnology: Institutions and Markets in Industrial Innovation. (New York, NY: St. Martin's Press, 230 p.). Biotechnology industries--History.

Gary P. Pisano (2006). The Science Business: The Promise, the Reality, and the Future of Biotech. (Boston, MA: Harvard Business School Press, 237 p.). Harry E. Figgie, Jr. Professor of Business Administration (Harvard Business School). Biotechnology industries--History. Science-based business poses 3 unique challenges: 1) how to finance highly risky investments under profound uncertainty and long time horizons for R&D, 2) how to learn rapidly enough to keep pace with advances in drug science knowledge, and 3) how to integrate capabilities across a broad spectrum of scientific and technological knowledge bases.

Cynthia Robbins-Roth (2001). From Alchemy to IPO: The Business of Biotechnology. (Cambridge, MA: Perseus Pub., 253 p.). Biotechnology -- History; Biotechnology industries.

Edward J. Sylvester and Lynn C. Klotz (1987). The Gene Age: Genetic Engineering and the Next Industrial Revolution (New York, NY: Scribner, 239 p. [rev. ed.]). Genetic engineering.

Robert Teitelman (1989). Gene Dreams: Wall Street, Academia, and the Rise of Biotechnology. (New York, NY: Basic Books, 237 p.). Genetic engineering industry; Biotechnology industries. 

Eric J. Vettel (2006). Biotech: The Countercultural Origins of an Industry. (Philadelphia, PA: University of Pennsylvania Press, 273 p.). Bancroft Postdoctoral Fellow in United States History (University of California, Berkeley), Founding Executive Director of the Woodrow Wilson Presidential Library in Staunton Virginia. Biotechnology industries --History. Story behind genetic engineering, recombinant DNA, cloning, stem-cell research - practical application of biological knowledge supported by private investors expecting profitable returns eclipsed basic research supported by government agencies.

Junfu Zhang and Nikesh Patel (2005). The Dynamics of California’s Biotechnology Industry. (San Francisco, CA: Public Policy Institute of California, 139 p.). Biotechnology industries--California; Venture capital--California. State accounts for 47% of national R&D spending on biotechnology, generates 53% of nation's biotech revenues.



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