Chemistry in the Pharmaceutical Industry

  • John F. Kadow
  • Nicholas A. Meanwell
  • Kyle J. Eastman
  • Kap-Sun Yeung
  • Joseph Payack
Chapter

Abstract

This chapter discusses the role of chemistry within the pharmaceutical industry [1–3]. Although the focus is upon the industry within the United States, much of the discussion is equally relevant to pharmaceutical companies based in other first-world nations such as Japan and those in Europe. The primary objective of the pharmaceutical industry is the discovery, development, and marketing of safe and efficacious drugs for the treatment of human disease. However, drug companies do not exist as altruistic, charitable organizations. As with other shareholder-owned corporations within a capitalistic society, drug companies must earn profits in order to remain viable. Profits from the enterprise finance the essential research and development that leads to new drugs designed to address unmet medical needs. Thus, there exists a tension between the dual goals of enhancing the quality and duration of human life and that of increasing stockholder equity. Much has been written and spoken in the lay media about the high prices of prescription drugs and the hardships these place upon the elderly and others of limited income. Consequently, some consumer advocate groups support governmental imposition of price controls on ethical pharmaceuticals in the United States, such as those that exist in a number of other countries. However the out-of-pocket dollars spent by patients on prescription drugs must be weighed against the more costly and inherently risky alternatives of surgery and hospitalization, which can often be obviated by drug therapy. Consideration must also be given to the enormous expense associated with the development of new drugs. It typically takes 10 or more years from the inception of a drug in the laboratory to registrational approval and marketing at an overall cost which is now estimated to be in excess of $800 million and increasing, a figure that includes the opportunity costs of failed development campaigns. Only 1 out of 10,000–20,000 compounds prepared as potential drug candidates ever reach clinical testing in humans and the attrition rate of those that do is >80%, a success rate that has been stubbornly difficult to change despite advances in improving candidate quality and significant increases in investment in research and development. The expense of developing a promising drug grows steadily further through the pipeline it progresses; clinical trials can be several orders of magnitude more costly than the preclinical development of a compound. While the sales of drugs that complete clinical trials and reach the shelves of pharmacies can eventually recoup their developmental expenses many times over if successful, many fail to do so and the cost of the drugs that fail is never recovered.

Keywords

Migraine Risperidone Atorvastatin Enalapril Gabapentin 

References

  1. 1.
    Krogsgaard-Larsen P, Liljefors T, Madsen U (eds) (1996) A textbook of drug design and development, 2nd edn. Harwood Academic, AmsterdamGoogle Scholar
  2. 2.
    Spilker B (1989) Multinational drug companies; issues in drug discovery and development. Raven, New YorkGoogle Scholar
  3. 3.
    Wermuth CG (ed) (1996) The practice of medicinal chemistry. Academic, San DiegoGoogle Scholar
  4. 4.
    Wess G, Urmann M, Sickenberger B (2001) Medicinal chemistry: challenges and opportunities. Angew Chem Int Ed 40:3341–3350CrossRefGoogle Scholar
  5. 5.
    Lipinski CA, Lombardo F, Dominy DW, Feeny PJ (1997) Experimental and computational approaches to estimate solubility and permeability in drug discovery and development settings. Adv Drug Deliv Rev 23:3–25CrossRefGoogle Scholar
  6. 6.
    Stella VJ, Borchardt RT, Hageman MJ, Oliyai R, Maag H, Tilley JW (eds) (2007) Prodrugs: challenges and rewards, vols. 1–2. Springer, New YorkGoogle Scholar
  7. 7.
    Gauwerky K, Borelli C, Korting HC (2009) Drug Discov Today 14:214–222CrossRefGoogle Scholar
  8. 8.
    Miertus S, Fassina G (eds) (1999) Combinatorial chemistry and technology; principles, methods and applications. Marcel Dekker, New YorkGoogle Scholar
  9. 9.
    Dolle R (2001) Comprehensive survey of combinatorial library synthesis: 2000. J Comb Chem 3:477–518CrossRefGoogle Scholar
  10. 10.
    Anderson NG (2000) Practical process research and development. Academic, New YorkGoogle Scholar
  11. 11.
    Laird T (2010) Organic process research and development 14(4): 942–1045Google Scholar
  12. 12.
    Rubin AE, Tummala S, Both DA, Wang C, Delaney E (2006) Emerging technologies supporting chemical process R&D and their increasing impact on productivity in the pharmaceutical industry. Chem Rev 106:2794–2810CrossRefGoogle Scholar
  13. 13.
    Farina V, Reeves JT, Senanayake CH, Song JJ (2006) Asymmetric synthesis of active pharmaceutical ingredients. Chem Rev 106:2734–2793CrossRefGoogle Scholar
  14. 14.
    Brands KM, Payack JF, Rosen JD, Nelson TD, Candelario A, Huffman MA, Zhao MM, Li J, Craig B, Song ZJ, Tschaen DM, Hansen K, Devine PN, Pye PJ, Rossen K, Dormer PG, Reamer RA, Welch CJ, Mathre DJ, Tsou NN, McNamara JM, Reider PJ (2003) Efficient synthesis of NK(1) receptor antagonist aprepitant using a crystallization-induced diastereoselective transformation. J Am Chem Soc 125:2129–2135CrossRefGoogle Scholar
  15. 15.
    Hewitt Bradley D, Burk Mark J, Johnson Nicholas B (2000) Improved process for asymmetric hydrogenation. Pharmacia & Upjohn. WO 00/055150, Sep, 21 2000.Google Scholar
  16. 16.
    Hansen KB, Hsiao Y, Xu F, Rivera N, Clausen A, Kubryk M, Krska S, Rosner T, Simmons B, Balsells J, Ikemoto N, Sun Y, Spindler F, Malan C, Grabowski EJ, Armstrong JD III (2009) Highly efficient asymmetric synthesis of sitagliptin. J Am Chem Soc 131:8798CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media New York 2012

Authors and Affiliations

  • John F. Kadow
    • 1
  • Nicholas A. Meanwell
    • 1
  • Kyle J. Eastman
    • 1
  • Kap-Sun Yeung
    • 1
  • Joseph Payack
    • 2
  1. 1.Bristol-Myers Squibb Co., Research and Development, Virology ChemistryWallingfordUSA
  2. 2.Bristol-Myers Squibb Co., Research and Development, Process R&D Chemistry TechnologiesNew BrunswickUSA

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