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Appendix D: Biographical Sketches of Invited Speakers
Pages 65-76

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From page 65...
... He immediately joined Eli Lilly and Company in the area of clinical development of psychiatric medications. He was responsible for Prozac from the time of its U.S.
From page 66...
... He has extensive experience interacting with multiple divisions of the FDA, European regulatory authorities, and Japanese regulatory authorities. He is a member of the American Osteopathic Association, the American Psychiatric Association, the American Society for Clinical Psychopharmacology, the American College of Psychiatrists, the American College of Neuropsychopharmacology, and the American Federation for Clinical Research.
From page 67...
... OTS comprises the Office of Biostatistics, Office of Clinical Pharmacology, and provides oversight to CDER research involving human subjects as well as CDER regulatory science research. OTS is responsible for providing coordination for Critical Path Initiatives across CDER in partnership with individual CDER offices.
From page 68...
... Dunlop Smith Award for distinguished teaching and educational service. He has been the director of an NIMH-funded training program in psychiatric statistics for pre and postdoctoral fellows; has served on data monitoring and safety boards and scientific advisory committees for a number of NIH and Veterans Administration studies; and has served on several National Academy of Sciences committees, including the Committee on National Statistics and the Institute of Medicine's Committee on the Assessment of Family Violence Interventions.
From page 69...
... As division director for the Division of Psychiatry Products, he oversees the review of all psychiatric drug development activities conducted under INDs and the review of all NDAs and supplements for new psychiatric drug claims. He has authored or coauthored many papers on regulatory and methodological issues pertaining to the development of psychiatric drugs and is a frequent speaker at professional meetings on these same
From page 70...
... , the Mogens Schou Distinguished Research Award, the American College of Neuropsychopharmacology's (ACNP's) Joel Elkes Award for Distinguished Research, the Canadian Association of Professors in Psychiatry Award, the Henry and Page Laughlin Distinguished Teacher Award, the Brown University School of Medicine Distinguished Researcher Award, the Depression and Bipolar Support Alliance Klerman Senior Distinguished Researcher Award, the NIMH Award for Excellence in Clinical Care and Research, and the NIMH Director's Career Research Award for significant scientific achievement.
From page 71...
... Dr. Mann is the director of the NIMH Conte Center for the Neuroscience of Mental Disorders, director of the Stanley Center for Applied Neuroscience of Bipolar Disorders, and president of the International Academy of Suicide Research.
From page 72...
... A related line of his research focuses on the evaluation of treatments for impulsive, aggressive, and self-injurious behaviors and on factors that mediate and moderate clinical change. Kelly Posner, Ph.D., is the founder and principal investigator of the Center for Suicide Risk Assessment at Columbia University/New York State Psychiatric Institute and an associate clinical professor at Columbia University College of Physicians and Surgeons.
From page 73...
... Prior to joining Merck he served as the executive director and Lilly clinical research fellow of the Neuroscience Therapeutic Area at Lilly Research Laboratories. He developed a Lilly/Indiana University fellowship early in 1996 and was named professor of psychiatry at Indiana University Medical Center.
From page 74...
... He has served as the chair of the Depression Work Group of the International Psychopharmacology Algorithm Project and as the scientific content expert for the San Antonio Cochrane Center's evidence-based, AHCPR-funded efforts to update the Depression Guidelines. He spearheaded the rollout of best practices for the treatment of major depressive disorder in various mental health and mental retardation centers across the state of Texas.
From page 75...
... He has received numerous awards including the Gerald L Klerman Award from the National Depressive and Manic-Depressive Association Scientific Advisory Board -- NDMDA and the Psychiatric Excellence Award from the Texas Society of Psychiatric Physicians -- TSPP.


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