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Eli Lilly and Company :Drug Development Strategy (A)
Introduction to  the Pharmaceutical Industry In the mid 1990s
	By the mid 1990s, annual worldwide pharmaceutical  sales were around $250 billion, with roughly 80 percent  originating in the industrialized G7 nations.  Top Blockbuster drugs targeted diseases of particular  concern to industrialized nations.
U.S. Pharmaceutical Market  by Therapeutic Category (1994)
Summary of Drug Development  in the USA
	Under current law, a patent’s term expired  20 years from the time the patent application  was field (prior to 1995, patent protection  extended 17 years after the patent was issued.) 	Sales of only a few products could provide  exceptional returns. In the mid 1990s,  14 products had annual sale over $1 billion,  enabling profit margins of 15-20 percent.
Top 20 Prescription Drugs by  Worldwide Sales (1994) (dollar in millions)
Top 20 Firms Active in the  Pharmaceutical Industry (1994) (dollars in millions)
Eli Lilly and Company
	Eli Lilly and Company was  found In Indianapolis, Indiana  in 1876 by Colonel Eli Lilly. 	In the mid 1990s, Lilly,  operating in 150 countries,  was one of the world’s largest pharmaceutical  company, with over  25,000 employees and  1994 sales of $5.7 billion.
Eli Lilly and Company - Organization Chart
Chairman and CEO R. L. Tobias A. M. Watanabe, MD Executive VP Science & Technology VP, Human Resources Executive VP, Finance & CFO VP & General Counsel President & COO VP,  Cardiovascular Eisenstein, MD VP Technology Core & Infectious Disease VP,  Regulatory Affairs CNS Business Unit VP,  Endocrinology VP,  Development M. Haslanger, PhD Executive Director, Research Technology And Proteins, President, Sphinx Pharmadeuticals VP,  Cancer VP, Medical (Phases II & III) VP, Central Nervous System Bianca Sharma, Project Manager S. Kaldor, PhD, Head of Combinatorial Chemistry J. Schaus, PhD, Senior Research Scientist
Eli Lilly and Company ,[object Object],(dollars in million)
Eli Lilly and Company ,[object Object],(dollars in million)
Innovation in the new Drug Development Process
Combinatorial Chemistry At Lilly
     Combinatorial chemistry is an emerging  technology for generating a large collection  or “library” of related chemical compounds  rapidly, instead of having to make one  compound at a time. This allows for creating  variations around the backbone of a basic  molecular structure.
Combinatorial Chemistry  (the “Split-and-Mix” Method)
Central Nervous System (CNS) Diseases
	CNS Diseases accounted for roughly  10 percent of all lifetime years lost to disease. E.g. clinical depression, severe insomnia (sleeplessness), and migraine 	Each of which affected over 10 percent  of the population – could take a severe toll on  society. For instance, depression might  predispose people to suicide
Lilly’s Migraine Project
“Migraine” ,[object Object],  headaches often severe enough to restrict    physical and mental activity ,[object Object],  with a 3:1 preponderance in women
Imitrex, ,[object Object]
was a mildly effective drug  that act by  constricting blood vessels ,[object Object],      Many scientists felt that the makers of  Imitrex had followed the wrong path by  trying to find a compound that constricted  blood vessels(known as “vasoconstriction”).
	By March 1994, out of over 1,000  previously synthesized serotonin-like  compounds one particularly good “lead”  had been found. In addition, Lilly’s experiments  in which lab animals were administered these  lead compounds further promise of the “1f”  serotonin receptors as treatment targets for  migraine without the need for inducing  vasoconstriction.
Timeline
Difficult choices: The Project Team Advisory  Committee(PTAC) Meeting
The three key business  issues for PTAC Presentation

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BA401 EliLilly and Company Drug Development Strategy

  • 1. Eli Lilly and Company :Drug Development Strategy (A)
  • 2. Introduction to the Pharmaceutical Industry In the mid 1990s
  • 3. By the mid 1990s, annual worldwide pharmaceutical sales were around $250 billion, with roughly 80 percent originating in the industrialized G7 nations. Top Blockbuster drugs targeted diseases of particular concern to industrialized nations.
  • 4. U.S. Pharmaceutical Market by Therapeutic Category (1994)
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  • 6. Summary of Drug Development in the USA
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  • 8. Under current law, a patent’s term expired 20 years from the time the patent application was field (prior to 1995, patent protection extended 17 years after the patent was issued.) Sales of only a few products could provide exceptional returns. In the mid 1990s, 14 products had annual sale over $1 billion, enabling profit margins of 15-20 percent.
  • 9. Top 20 Prescription Drugs by Worldwide Sales (1994) (dollar in millions)
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  • 11. Top 20 Firms Active in the Pharmaceutical Industry (1994) (dollars in millions)
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  • 13. Eli Lilly and Company
  • 14. Eli Lilly and Company was found In Indianapolis, Indiana in 1876 by Colonel Eli Lilly. In the mid 1990s, Lilly, operating in 150 countries, was one of the world’s largest pharmaceutical company, with over 25,000 employees and 1994 sales of $5.7 billion.
  • 15. Eli Lilly and Company - Organization Chart
  • 16. Chairman and CEO R. L. Tobias A. M. Watanabe, MD Executive VP Science & Technology VP, Human Resources Executive VP, Finance & CFO VP & General Counsel President & COO VP, Cardiovascular Eisenstein, MD VP Technology Core & Infectious Disease VP, Regulatory Affairs CNS Business Unit VP, Endocrinology VP, Development M. Haslanger, PhD Executive Director, Research Technology And Proteins, President, Sphinx Pharmadeuticals VP, Cancer VP, Medical (Phases II & III) VP, Central Nervous System Bianca Sharma, Project Manager S. Kaldor, PhD, Head of Combinatorial Chemistry J. Schaus, PhD, Senior Research Scientist
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  • 21. Innovation in the new Drug Development Process
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  • 24. Combinatorial chemistry is an emerging technology for generating a large collection or “library” of related chemical compounds rapidly, instead of having to make one compound at a time. This allows for creating variations around the backbone of a basic molecular structure.
  • 25. Combinatorial Chemistry (the “Split-and-Mix” Method)
  • 26. Central Nervous System (CNS) Diseases
  • 27. CNS Diseases accounted for roughly 10 percent of all lifetime years lost to disease. E.g. clinical depression, severe insomnia (sleeplessness), and migraine Each of which affected over 10 percent of the population – could take a severe toll on society. For instance, depression might predispose people to suicide
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  • 32. By March 1994, out of over 1,000 previously synthesized serotonin-like compounds one particularly good “lead” had been found. In addition, Lilly’s experiments in which lab animals were administered these lead compounds further promise of the “1f” serotonin receptors as treatment targets for migraine without the need for inducing vasoconstriction.
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  • 37. Difficult choices: The Project Team Advisory Committee(PTAC) Meeting
  • 38. The three key business issues for PTAC Presentation
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  • 40. Member of the group วริษฐา ภิรมย์รัตน์ 4902680521 ณัฐกานต์ มีสัตย์ 4902682055 อัจฉรา บัญชากร 5002686094 หฤษฎ์ พรรณพานิช 5002686185