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Clinical Pharmacology and Drug Development Course

Presented January 16-19, 2006 as partial fulfillment of course requirements for the HST Clinical Investigator Training Program.

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Monday, January 16, 2006

• Introduction -- CITP Clinical Pharmacology and Drug Development Course
  Robert H. Rubin, M.D., F.A.C.P., F.C.C.P., Director of the Center for Experimental Pharmacology and Therapeutics, Harvard-M.I.T. Division of Health Sciences and Technology, and Associate Director, Division of Infectious Disease, Brigham and Womens Hospital.  He is the Gordon & Marjorie Osborne Professor of Health Sciences and Technology, Harvard-MIT Division of Health Sciences and Technology and Professor of Medicine at Harvard Medical School
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• Introduction -- General Principles and Role of Clinical Pharmacology in Drug Development
  Presenter: Keith Gottesdiener, MD, Vice President, Clinical Pharmacology, Merck & Co., Merck Research Laboratories, Rahway, New Jersey, USA
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• Pharmacokinetics covering ADME
  Presenter: Rajesh Krishna, PhD, FCP, Associate Director, Clinical Pharmacology, Merck Research Laboratories, Merck & Co., Merck Research Laboratories, Rahway, New Jersey, USA
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• Drug Interactions and Pharmacogenetics
  Presenter: Karthik Venkatakrishnan, PhD, Associate Director, Clinical Pharmacology, Pfizer Inc., Groton, Connecticut, USA
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Tuesday, January 17, 2006

• Pharmacodynamics, Biomarkers and Experimental Medicine
  Presenter: John A. Wagner, MD, PhD, Executive Director, Clinical Pharmacology, Merck Research Laboratories, Merck & Co., Rahway, New Jersey, USA
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• Pharmacokinetic/Pharmacodynamic Modeling (theoretical concepts and examples of integration in drug development
  Presenters: Lisa J. Benincosa, PhD, Executive Director, Clinical Pharmacology, Pfizer Inc., Groton, Connecticut, USA; Armarnath Sharma, M.Pharm., PhD, Senior Director, Clinical Pharmacology, Pfizer Inc., New London, Connecticut, USA
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Wednesday, January 18, 2006

• Discovery -- from idea to drug candidate: Including drug target identification methods, screening concepts and tools, structure based design, etc.
  Presenter: Nick Terrett, PhD, Head of Chemical Sciences, Pfizer Research Technology Center, Cambridge, Massachusetts, USA
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• Preclinical Drug Development: Strategies and Tactics for Successful Drug Candidate Selection and Clinical Trial Initiation
  Presenter: James T. Mayne, PhD, DABT, Executive Director, Worldwide Safety Sciences/Worldwide Regulatory Strategy, Pfizer Global Research & Development, New London, Connecticut, USA
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• The Regulatory Environment – Part I:
  The regulatory process from IND to NDA
  Presenter: Lee Scaros, Pharm.D , Associate Director, Worldwide Regulatory Strategy, CNS Strategic Line Manager, Pfizer Inc., Groton, Connecticut, USA
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• The Regulatory Environment – Part II: 
  Regulatory process for approval (NDA)
  Presenter: Lee Scaros, Pharm.D , Associate Director, Worldwide Regulatory Strategy, CNS Strategic Line Manager, Pfizer Inc., Groton, Connecticut, USA
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• Phases of Clinical Development and Approaches to Clinical Trials
  Presenters: Paul Glue, MD, PhD, Executive Director, Clinical Sciences, Pfizer Inc, New York, New York, USA; Richard Anziano, MS, Director, Infectious Diseases Statistics and Clinical Pharmacology Statistics groups, Groton/New London, Connecticut, USA
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Thursday, January 19, 2006

• Introduction to Pharmaco-Epidemiology and practical aspects of post-marketing surveillance (pharmacovigilance)
  Presenter: Jerome Avorn, MD, Professor of Medicine, Harvard Medical School, Chief, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, Boston, Massachusetts, USA
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• Coxibs, NSAIDs, and CV Events: Continued Controversies
  Presenter: Daniel Solomon, MD, MPH, Assistant Professor of Medicine, Harvard Medical School; rheumatologist in the Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, Boston, Massachusetts, USA
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• Pharmacoepidemiology of Psychiatric Medications
  Presenter: Philip S. Wang, MD, Dr.PH, Assistant Professor of Psychiatry, Medicine, Health Care Policy (Harvard Medical School) and Epidemiology (Harvard School of Public Health)
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