Raymond L. Woosley

Raymond L. Woosley, M.D., Ph.D. is the founding President & CEO of Critical Path Institute (C-Path). C-Path is an independent, non-profit organization created by the U.S. Food and Drug Administration (FDA) and The University of Arizona that leads global collaborations to improve health and save lives by accelerating the development of safe and effective medicines.[1]

Contents

Background and Training

Dr. Woosley, a native of Bowling Green, Kentucky, received his medical degree from the University of Miami, FL,[2] his doctorate in pharmacology from the University of Louisville, KY, and his bachelor's degree from Western Kentucky University. He served his internship and residency in internal medicine and completed a fellowship in clinical pharmacology at Vanderbilt University. He is a Fellow of the American College of Physicians, the American College of Clinical Pharmacology, the American College of Cardiology, and the American Heart Association.

Professional Experience

After completing his Ph.D. training, Dr. Woosley was the first scientist at Meyer Laboratories (now GlaxoSmithKline) from 1968-71. He completed medical school, internal medicine, and clinical pharmacology training in 1976 and joined the Clinical Pharmacology faculty at Vanderbilt University Medical School, rising to the rank of professor of Medicine and Pharmacology. At Vanderbilt he served as the Associate Director of the NIH-funded General Clinical Research Center (GCRC) and was a founding member of the Vanderbilt Cardiac Arrhythmia Clinical Program.

In 1988, he was appointed Chairman of the Department of Pharmacology at Georgetown University Medical Center in Washington, D.C. During his tenure as Chairman, the Department of Pharmacology became one of the highest ranked pharmacology departments in research funding and received the largest endowment of any pharmacology department in the nation. At Georgetown, he founded the Division of Clinical Pharmacology, was Principal Investigator for the NIH-sponsored GCRC, and in 2000, Dr. Woosley was appointed Associate Dean for Clinical Research at Georgetown University.

In 2001, Dr. Woosley joined the faculty at The University of Arizona as Vice President of the Arizona Health Sciences Center and the Dean of the College of Medicine. He founded C-Path in 2004.

Medical Research

Dr. Woosley’s research has been continuously supported by competitively-awarded, federal grants since 1976; his research has been reported in over 260 peer-reviewed publications and in eleven patents.[3] He has investigated the basic and clinical pharmacology of drugs, factors contributing to variable response to medicines, the medical management of arrhythmias, and the cardiac toxicity of drugs. While at Vanderbilt, Dr. Woosley was the co-director of the landmark NIH-sponsored Cardiac Arrhythmia Suppression Trial (CAST) that found arrhythmia suppression by drugs to be an invalid biomarker for the prediction of drug therapy that prevents sudden death.

Dr. Woosley’s research at Georgetown contributed substantially to the recognition that non-cardiovascular drugs, such as antihistamines (e.g., terfenadine (Seldane®), may have arrhythmogenic effects.[4] Dr. Woosley’s invention, fexofenadine (Allegra®), resulted from this research and is today marketed as a safer non-sedating antihistamine replacing Seldane®. His research on drug safety led Dr. Woosley to champion the development of the Centers for Education and Research on Therapeutics (CERTs),[5] now a network of federally-funded centers designed to improve outcomes in medical therapeutics.[6]

In 2002, Dr. Woosley’s research discovered the primary mechanism of methadone-induced sudden death.[7] His subsequent research on methadone resulted in the addition of warnings to the official label.[8] He is an authority on drugs, like methadone, that prolong the QT interval on the electrocardiogram and cause a particular potentially lethal cardiac arrhythmia, torsade de pointes.[9] He leads a team of scientists at C-Path that maintains a web-based list of the drugs that have this potential toxicity; this website, with over 3,000 visits daily, is an internationally recognized resource cited in textbooks and used by researchers to evaluate the impact of drug safety programs.[10]

Leadership and Service

Dr. Woosley was elected President of the American Society for Clinical Pharmacology and Therapeutics and the Association for Medical School Pharmacology Chairs. He has served on numerous advisory committees for the Food and Drug Administration, the National Institutes of Health, and the Department of Veterans Affairs.[11] He is a member of the Drug Forum, a committee of the National Academy of Science's Institute of Medicine. He has served on the editorial boards for numerous cardiology and pharmacology journals. He has provided testimony on a wide range of healthcare and drug safety issues to Congressional Committees and hearings on 18 occasions.

Honors and Recognition

For his contributions to medicine, Dr. Woosley received the Rawls-Palmer Award from the American Society of Clinical Pharmacology. He received the Harry Gold Award in Therapeutics from the American Society for Pharmacology and Experimental Therapeutics. He was the Sir Henry Hallet Dale Visiting Professorship in Clinical Pharmacology at the Johns Hopkins University School of Medicine. Dr. Woosley received the FDA Commissioner’s Special Citation for his work on the toxicity of dietary supplements containing ephedra. In 2010 the PhRMA Foundation granted Dr. Woosley the Award in Excellence in Clinical Pharmacology. Dr. Woosley was chosen by his physician-colleagues for inclusion in the Best Doctors in America for several years. The University of Miami School of Medicine and Western Kentucky University have selected Dr. Woosley as a Distinguished Alumnus.

References

  1. ^ Woosley, R. L., R. T. Myers, and F. Goodsaid. "The Critical Path Institute’s Approach to Precompetitive Sharing and Advancing Regulatory Science." Clinical Pharmacology and Therapeutics (2010) 87.5: 530–533.
  2. ^ University of Miami Miller School of Medicine Medical Alumni Association
  3. ^ Arizona Center for Education and Research on Therapeutics
  4. ^ Woosley, R. L. Cardiac Actions of Antihistamines. Annual Review of Pharmacology and Toxicology. 36 (April 1996): 233-252; Woosley, R. L. et al. "Mechanism of the Cardiotoxic Actions of Terfenadine." Journal of the American Medical Association. March 24/31 (1993): 1532-1536.
  5. ^ Woosley, R. L. Response to AHCPR on CERTs. Georgetown University Medical Center. 17 December 1998.
  6. ^ Arizona Center for Education and Research on Therapeutics
  7. ^ Katchman, A.N., K.A. McGroary, M.J. Kilborn, C.A. Kornick, P.L. Manfredi, R.L. Woosley, and S.N. Ebert. "Influence of Opioid Agonists on Cardiac Human Ether-a-go-gorelated Gene K+ Currents." The Journal of Pharmacology and Experimental Therapeutics 303 (2002): 688–694
  8. ^ Pearson, E.C. and R.L. Woosley. "QT prolongation and torsades de pointes among methadone users: reports to the FDA spontaneous reporting system." Pharmacoepidemiol Drug Safety 14.11 (2005): 747-53
  9. ^ Kornick, C.A., M.J. Kilborn, J. Santiago-Palma, D.L. Keefe, A.N. Katchman, G. Schulman, S.N. Ebert, R.L. Woosley, R. Payne, and P.L. Manfredi. "QTc Interval Prolongation Associated with Intravenous Methadone." Pain 105.3 (2003): 499-506; Woosley, R.L. and K. Romero. "Time to Replace Bazett's QT-Correction." Pacing Clinical Electrophysiology. 32.11 (2009): 1379-380.
  10. ^ QT Drug List by Risk Groups
  11. ^ Woosley, R.L. Dangerous Prescription. Frontline. PBS. 25 October 2002; Flaherty, Julie. "Five Questions for Dr. Raymond L. Woosley." New York Times. 29 September 2002.

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