Kenneth I Kaitin, PhD

Ken Kaitin

Director and Professor




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Dr. Kaitin is Director of the Tufts Center for the Study of Drug Development and holds Professorships in Medicine, Pharmacology, and Public Health & Community Medicine at Tufts University School of Medicine.  He is also a visiting lecturer at the Tuck School of Business at Dartmouth College, and he serves on the faculty of the European Center for Pharmaceutical Medicine at the University of Basel.  Dr. Kaitin writes and speaks regularly on factors that contribute to the slow pace and high cost of pharmaceutical R&D and the impact of efforts to speed the drug 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.  An internationally recognized expert on the science of drug development, Dr. Kaitin is frequently quoted in the business and trade press on trends in the R&D-based industry and new models of innovation.  He is a former President of the Drug Information Association, and he 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, Honig PK.  Guest editors. (Includes: Kaitin KI and Honig PK, editorial, Reinventing innovation, pp 279-283) Clinical Pharmacology and Therapeutics 2013;94(3).
  2. Getz KA, Kaitin KI.  Editorial. Open innovation: The new face of pharmaceutical R&D. Expert Review of Clinical Pharmacology 2012;5(5):481-483.
  3. Martell RE, Sermer D, Getz K, Kaitin KI.  Oncology drug development and approval of systemic anticancer therapy by the U.S. Food and Drug Administration. The Oncologist 2013;18:104-111.
  4. Kaitin KI.  Translational research and the evolving landscape for biomedical innovation. Journal of Investigative Medicine 2012;60(7):995-998.
  5. Kaitin KI, Cohen JP.  Commentary. Weighing access and affordability. Pharmaceutical Technology 2012;36(11):30.
  6. Milne CP, Kaitin KI.  FDA review divisions: Performance levels and the impact on drug sponsors. Clinical Pharmacology and Therapeutics 2012;91:393-404.
  7. Kaitin KI. Commentary. 21st century bioinnovation: Academic-industry partnerships are increasingly important in biopharmaceutical innovation. Pharmaceutical Technology 2011;35(6):32.
  8. Kaitin KI. Commentary. Creating innovation nodes to meet unmet medical needs. Pharmaceutical Technology 2011;35(12):27.
  9. 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.
  10. Kaitin KI, Milne CP.  Commentary. A dearth of new meds: Drugs to treat neuropsychiatric disorders have become too risky for big pharma. Scientific American 2011 Aug;305(2):16.
  11. Kaitin KI.  Deconstructing the drug development process: The new face of innovation. Clinical Pharmacology and Therapeutics 2010;87:356-361.
  12. Milne CP, Kaitin KI.  Impact of the new US health care reform legislation on the pharmaceutical industry: Who are the real winners? Clinical Pharmacology and Therapeutics 2010;88:589-592.
  13. Kaitin KI.  Obstacles and opportunities in new drug development. Clinical Pharmacology and Therapeutics 2008;83:210-212.
  14. Deng R, Kaitin KI.  The regulation and approval of new drugs in China. Drug Information Journal 2004;37:29-39.
  15. 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. 
  16. Kaitin KI, DiMasi JA.  Measuring the pace of new drug development in the user fee era. Drug Information Journal 2000;34:673-680.
  17. 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.
  18. Rawson NSB, Kaitin KI.  New drug approval times and “therapeutic potential” in Canada, Australia, Sweden and the United States during the period 1992 to 1998. Canadian Journal of Clinical Pharmacology, 2000;7:97-101.