Kenneth I Kaitin, PhD

Ken Kaitin

Professor and Director




.(JavaScript must be enabled to view this email address)


Dr. Kaitin is a Professor at Tufts University School of Medicine and is Director of the Tufts Center for the Study of Drug Development. Dr. Kaitin also holds appointments as Advisory Professor at Shanghai Medical College of Fudan University in Shanghai, China; Visiting Executive at the Tuck School of Business at Dartmouth College; and faculty of the European Center for Pharmaceutical Medicine at the University of Basel.  An internationally recognized expert on drug development science and policy, Dr. Kaitin writes and speaks regularly on factors that contribute to the slow pace and high cost of pharmaceutical R&D and efforts to improve the development process.  He has provided public testimony before the U.S. Congress on pharmaceutical development, regulation, and policy issues, and he currently serves as an expert consultant to the U.S. Department of Defense on bioterror countermeasures initiatives.  Dr. Kaitin is frequently quoted in the business and trade press on global R&D trends and new models of innovation.  A former President of the Drug Information Association, Dr. Kaitin is currently Editor-in-Chief of Expert Review of Clinical Pharmacology.  He is on the editorial boards of a number of peer-review journals, and he serves on the boards of directors and scientific advisory boards of several public, private, and not-for-profit life sciences companies and organizations.  In 2011, Dr. Kaitin received the Dr. Louis M. Sherwood Award, granted by the Academy of Pharmaceutical Physicians and Investigators.  Dr. Kaitin received a B.S. from Cornell University and an M.S. and Ph.D. in pharmacology from the University of Rochester.

Select Publications

1. Kaitin KI, Trimble AG.  Implementation of the Drug Price Competition and Patent Term Restoration Act of 1984: A progress report. Journal of Clinical Research and Drug Development 1987;1:263-275.

2. Kaitin KI, Richard BW, Lasagna L.  Trends in drug development: The 1985-86 new drug approvals. Journal of Clinical Pharmacology 1987;27:542-548.

3. Kaitin KI, Mattison N, Northington FK, Lasagna L.  The drug lag: An update of new drug introductions in the United States and in the United Kingdom, from 1977 through 1987. Clinical Pharmacology and Therapeutics 1989;46:121-138.

4. Kaitin KI.  Thalidomide revisited: New clinical uses for an old drug. Pharmaceutical Medicine 1988;3:203-210. 

5. Kaitin KI, Melville A, Morris B.  FDA advisory committees and the new drug approval process. Journal of Clinical Pharmacology 1989;29:886-890.

6. Kaitin KI.  Case studies of expedited review: AZT and L-Dopa. Law, Medicine & Health Care 1991;19:242-246. 

7. Kaitin KI, DiCerbo PA, Lasagna L.  The new drug approvals of 1987, 1988, and 1989: Trends in drug development. Journal of Clinical Pharmacology 1991;31:116-122. 

8. Kaitin KI, Phelan NR, Raiford D, Morris B.  Therapeutic ratings and end-of-phase II conferences: Initiatives to accelerate the availability of important new drugs. Journal of Clinical Pharmacology 1991;31:17-24. 

9. Kaitin KI, Walsh HL.  Are initiatives to speed the new drug approval process working? Drug Information Journal 1992;26:341-349.

10. Kaitin KI, Bryant NR, Lasagna L.  The role of the research-based pharmaceutical industry in medical progress in the United States. Journal of Clinical Pharmacology 1993;33:412-417. 

11. Kaitin KI, Manocchia M, Seibring M, Lasagna L.  The new drug approvals of 1990, 1991, and 1992: Trends in drug development. Journal of Clinical Pharmacology 1994;34:120-127. 

12. Kaitin, KI.  Pharmaceutical innovation in an era of reform. American Journal of Therapeutics 1995;2:730-734.

13. Kaitin KI, Brown J.  A drug lag update. Drug Information Journal 1995;29:361-373.

14. Bakke OM, Manocchia M, de Abajo F, Kaitin KI, Lasagna L.  Drug safety discontinuations in the UK, the US, and Spain, 1974-1993: A regulatory perspective. Clinical Pharmacology and Therapeutics 1995;58:108-117. 

15. Shulman SR, Kaitin KI.  The Prescription Drug User Fee Act of 1992: A five-year experiment for industry and the FDA. PharmacoEconomics 1996;9:121-133. 

16. Kaitin KI.  FDA reform: Setting the stage for efforts to reform the agency. Drug Information Journal 1997;31:27-33.

17. Kaitin KI.  The Prescription Drug User Fee Act of 1992 and the new drug development process. American Journal of Therapeutics 1997;4:167-172.

18. Kaitin KI, Manocchia M.  The new drug approvals of 1993, 1994, and 1995: Trends in drug development. American Journal of Therapeutics 1997;4:46-54. 

19. Kaitin KI.  Global drug development and international harmonization: The emergence of China as a world pharmaceutical player. Drug Information Journal 1998;32:1187S-1191S.

20. Kaitin KI, Healy EM.  The new drug approvals of 1996, 1997, & 1998: Drug development trends in the user fee era. Drug Information Journal 2000;34:1-14.

21. Kaitin KI, DiMasi JA.  Measuring the pace of new drug development in the user fee era. Drug Information Journal 2000;34:673-680.

22. Kaitin KI, Cairnes C.  The new drug approvals of 1999, 2000, & 2001: Drug development trends a decade after passage of the User Fee Act. Drug Information Journal 2003;37:357-371.  

23. Deng R, Kaitin KI.  The regulation and approval of new drugs in China. Drug Information Journal 2004;37:29-39.

24. Kaitin KI.  Obstacles and opportunities in new drug development. Clinical Pharmacology and Therapeutics 2008;83:210-212. 

25. Kaitin KI.  Deconstructing the drug development process: The new face of innovation. Clinical Pharmacology and Therapeutics 2010;87:356-361. 

26. Kaitin KI, DiMasi JA.  Pharmaceutical innovation in the 21st century: New drug approvals in the first decade, 2000-2009. Clinical Pharmacology and Therapeutics 2011;89:183-188. 

27. Kaitin KI, Milne CP. A dearth of new meds: Drugs to treat neuropsychiatric disorders have become too risky for big pharma. Scientific American 2011 Aug;305(2):16. 

28. Kaitin KI.  Translational research and the evolving landscape for biomedical innovation. Journal of Investigative Medicine 2012;60(7):995-998.

29. Evens RP, Kaitin KI.  The biotechnology innovation machine—A source of intelligent biopharmaceuticals for the pharma industry: Mapping biotechnology’s success. Clinical Pharmacology and Therapeutics 2014;95(5):528-532.

30. Evens RP, Kaitin KI.  The evolution of biotechnology and its impact on health care. Health Affairs 2015;34(2):210-219. 

31. Kaitin KI. Guest Editor. (Includes: Kaitin KI, editorial. Integrated partnerships and the transformation of pharmaceutical R&D, pp 1346-1348) Clinical Therapeutics 2014;30(10).

32. Christini A, Kaitin KI.  Regional trends in bioinnovation investment: Can the Cambridge growth model be duplicated? Pharmaceutical Executive 2014;34(4):43-46.

33. Milne CP, Kaitin KI.  Meeting unmet medical needs: The disparity dilemma. Pharmaceutical Executive 2015;35(2):26-28.