R&D Planning and Governance

  • Ronald P. Evens
  • Joel Covinsky

A company needs the best people, advanced science, great products, the physical plant, the right operations, the financial wherewithall, the right leadership, appropriate patients, experienced investigators, a good dose of common sense, a vision of the future, and some luck to develop significant new products. Many companies may possess these attributes; however, how well companies can pull all these manifold, often disparate, and sometimes conflicting resources together in turn will differentiate themselves as leading companies. A metaphor for this situation is the pack elephant (“the product”) and the five different blind passengers (“the departments”) needing to reach a common destination (“approvals”). Each may touch the elephant at different areas, large flappy ears, stumpy legs, long flexible trunk, hard pointy tusks, the tail, or the broad back. Besides their different personal experiences and expectations, they each believe to be holding a different animal with different possible benefits and risks in reaching their destination. Someone or some group must be able to step back and see the whole animal, as well as its parts, to coordinate the individual players, help make the best judgments, and set the best direction. Governance and planning can be best practices in pulling it all together in product development and in differentiating the top companies from the pack. These best practices are needed for the products (the elephants), by the departments (the elephants’ passengers), and by the whole company (the elephants’ whole environment), as well as for all stages at which a product exists or at any stage of a company in its evolution. It is very easy to be myopic and become lost in the details and not focus on the big picture. In this chapter and book, we are focusing on the many common challenges associated with product development, always keeping in mind the big picture (the big outcome)—product approvals.


Product Development Senior Management Product Profile Product Team Product Approval 
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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  1. 1.
    Guy P. Rising to the productivity challenge. A strategic framework for biopharma. Boston Consulting Group. July 2004.Google Scholar
  2. 2.
    Engel S, King J. Biotech innovation. Pipeline gaps. Can biotech fill them? R&D Directions 2004;10(7):42–56.Google Scholar
  3. 3.
    Booth B, Zemmell R. Prospects for productivity. Nature Reviews Drug Discovery 2004;3(5):451–6.CrossRefPubMedGoogle Scholar
  4. 4.
    Rawlins MD. Cutting the cost of drug development. Nature Reviews Drug Discovery 2004;3(4):360–4.CrossRefPubMedGoogle Scholar
  5. 5.
    Cohen CM. A path for improved pharmaceutical productivity. Nature Reviews Drug Discovery 2003;2(9):751–3.CrossRefPubMedGoogle Scholar
  6. 6.
    R&D business. Mostly growth for big pharma in 2003. R&D Directions 2004;10(3):14–15.Google Scholar
  7. 7.
    Booth B, Zemmel R. Quest for the best. Nature Reviews Drug Discovery 2003;2(10):838–41.CrossRefPubMedGoogle Scholar
  8. 8.
    Lawyer P, Kirstein A, Yabuki H, Gjaja M, Kush D. High science: a best-practice formula for driving innovation. In Vivo The Business & Medicine Report 2004;22(4):1–12.Google Scholar
  9. 9.
    Malek J. The path to smart R&D. Pharmaceutical Executive 2003;23(11):70–80.Google Scholar
  10. 10.
    Engel S. How to manage a winning pipeline. R&D Directions 2002;8(2):36–41.Google Scholar
  11. 11.
    The pipeline problem. The pipeline solution. R&D Directions 2004;10(5):42–54.Google Scholar
  12. 12.
    Tollman P, Goodall S, Ringel M. Good governance gives good advice. BCG Focus. Boston Consulting Group. 2004.Google Scholar
  13. 13.
    Tollman P, Guy P, Altshuler J, Flanagan A, Steiner M. A revolution in R&D. How genomics and genetics are transforming the biopharmaceutical industry. Boston Consulting Group, November 2001.Google Scholar
  14. 14.
    Preziosi P. Science, pharmacoeconomics and ethics in drug R&D: a sustainable future scenario? Nature Reviews Drug Discovery 2004;3(6):521–6.CrossRefPubMedGoogle Scholar
  15. 15.
    Balekdjian D, Russo M. Managed care update: show us the value. Pharmaceutical Executive special report. September 2003.Google Scholar
  16. 16.
    Kaitin KI (ed.). Decline in drug approvals is driving industry, FDA to enhance efficiency. Impact Report, Tufts Center for the Study of Drug Development 2005:7(1):1–6.Google Scholar
  17. 17.
    Tufts CSDD. Outlook 2005;1–8.Google Scholar
  18. 18.
    Tufts CSDD. Outlook 2004;1–8.Google Scholar
  19. 19.
    Tufts CSDD. Outlook 2003;1–5.Google Scholar
  20. 20.
    Tufts CSDD. Outlook 2002;1–5.Google Scholar
  21. 21.
    Tufts CSDD. Outlook 2001;1–5.Google Scholar
  22. 22.
    R&D Directions 2004 Drug Development Summit, How to Build and Maintain a Winning Pipeline. Feb. 8–11, 2004.Google Scholar
  23. 23.
    Anonymous. Report to the nation 2003. Improving public health through human drugs. Center for Drug Evaluation and Research. Food and Drug Administration. U.S. Department of Health and Human Services.Google Scholar
  24. 24.
    Kotter J. What Leaders Do. Harvard Business Review Book. Cambridge, MA. 1999.Google Scholar
  25. 25.
    Walton M. The Deming Management Method. Putnam Books, New York. 1986.Google Scholar
  26. 26.
    Covey SR. Seven Habits of Highly Successful People. Simon & Schuster, New York. 1989.Google Scholar
  27. 27.
    Heider J. Leadership of Tao. Humanics New Age, Atlanta, GA. 1985.Google Scholar
  28. 28.
    Pitino R. Success is a Choice. Ten Steps to Overachieving in Business and Life. Broadway Books, Bantam Doubleday Dell Publishing Group, New York. 1997.Google Scholar
  29. 29.
    Maxwell JC. The 21 Irrefutable Laws of Leadership. Maxwell Motivation Inc, Thomas Nelson, Nashville, TN. 1998.Google Scholar
  30. 30.
    Bynum WC, Cox J. Zapp! The Lightening of Empowerment. Harmony Books, New York. 1988.Google Scholar
  31. 31.
    Peters T, Waterman Jr RH. In Search of Excellence. Lessons from America's Best-run Companies. Warner Books. Harper & Row Publishers, New York. 1982.Google Scholar
  32. 32.
    Dupree M. Leadership Jazz. Dell Publishing, New York. 1992.Google Scholar
  33. 33.
    Kouzes JM, Posner BZ. The Leadership Challenge. How to Keep Getting Extraordinary Things Done in Organizations. Josey-Bass Publishers. San Francisco, CA. 1997.Google Scholar
  34. 34.
    Frankel LP. Overcoming Your Strengths. Harmony Books, New York. 1997.Google Scholar
  35. 35.
    Welch J. Leadership and Mangement. The 2002 Linkage Excellence in Management & Leadership Series. Linkage, Inc. Lexington, MA. 2002.Google Scholar
  36. 36.
    Bennis W. The Essence of Leadership. The Linkage Leadership and Strategy Series and PBS The Business Channel. Lexington, MA. 1999.Google Scholar
  37. 37.
    Shelton K (ed.). A New Paradigm of Leadership. Visions of Excellence for 21st Century Organizations. Executive Leadership Publishing, Provo, UT. 1997.Google Scholar
  38. 38.
    Albright M. Global Leadership. 2001 Linkage Excellence in Management & Leadership Series. Linkage Inc. 2001.Google Scholar
  39. 39.
    Vander Walde L, Choi K, Higgins J. Health Care Industry Market Update. Pharmaceuticals. Centers for Medicare and Medicaid Services. U.S. Department of Health and Human Services. January 2003, 1–52.Google Scholar
  40. 40.
    Anonymous. Profile pharmaceutical Industry 2004, Focus on innovation. PhRMA. 2004.Google Scholar
  41. 41.
    Kennedy T (ed). Pharmaceutical Project Management. Drugs and the Pharmaceutical Sciences, Vol. 86. Marcel Dekker, New York. 1998.Google Scholar
  42. 42.
    Cooper RG, Edgett SJ, Kleinschmidt EJ. Portfolio Management for New Products. Perseus Publishing, Cambridge, MA. 2001.Google Scholar
  43. 43.
    Boesig C. Why NDAs fail. 15 pitfalls and how to avoid them. R&D Directions 2003;9(2):26–42.Google Scholar
  44. 44.
    Razavi H. Managing and valuing the development pipeline in a major pharmaceutical company. DIA Annual Meeting, June 17, 2003, Chicago, IL.Google Scholar
  45. 45.
    Lamberti MJ (ed). An Industry in Evolution, 4th ed. Thomson, CenterWatch. 2003.Google Scholar
  46. 46.
    King J. Today's drug discovery unlocking greater potential. R&D Directions 2004;10(2):28–39.Google Scholar
  47. 47.
    Engel S. Drug-discovery companies aim for commercialization. Good leads good medicine. R&D Directions 2002;8(7):34–42.Google Scholar
  48. 48.
    Lam MD. Knowing when to pull the plug on your experimental drug. Pharmaceutical Executive 2004;24(2):55–60.Google Scholar
  49. 49.
    Bernard S. The 5 myths of pharmacogenomics. Pharmaceutical Executive 2003;23(10):70–8.Google Scholar
  50. 50.
    Shah J. Economic and regulatory considerations in pharmacogenomics for drug licensing and healthcare. Nature Biotechnology 2003;21(7):747–753.CrossRefPubMedGoogle Scholar
  51. 51.
    King J. Can a drug live forever? R&D Directions 2003; 9(4):40–52.Google Scholar
  52. 52.
    Ho JH. Extending the product lifeline. Pharmaceutical Executive 2003;23(7):70–76.Google Scholar
  53. 53.
    Li G, Dalton D. Balanced scorecard for R&D. Pharmaceutical Executive 2003;23(10):84–90.Google Scholar

Copyright information

© Springer Science+Business Media, LLC 2007

Authors and Affiliations

  • Ronald P. Evens
    • 1
  • Joel Covinsky
    • 2
  1. 1.University of FloridaFL
  2. 2.Chandler Medical CenterUniversity of Kentucky, clinical residency at A.BKY

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