ODAC Industry Presentation Introduction ApoPharma Inc. / CATO Research Ltd. / Apotex Inc / Non-Metastatic Castration-Resistant Prostate Cancer / ApoPharma Inc. / Patient / M.D / Mens Health Network Matthew R. Smith / /
Country
United States / /
Event
Product Issues / /
Facility
Oak Campus / Oncology Children’s Hospital / Pediatric Clinic / University of Pittsburgh School / Oak Conference Center / FDA White Oak Campus / White Oak Conference Center / /
Food and Drug Administration / office of Compliance / Division of Good Clinical Practice Compliance / Division of Hematology Products / Ellis Neufeld Associate Chief Division of Hematology/Oncology Children / Cooley’s Anemia Foundation / Medical Team Leader Division of Hematology Products / University of Pittsburgh / office of Scientific Investigations / office of Hematology Oncology Products / FDA / Oncologic Drugs Advisory Committee / European Union / Center for Drug Evaluation and Research / Anemia Foundation / /
Person
Maria Hadjidemetriou Amy Celento / Anthony J. Viola / Michael Spino / D. Ralph Colasanti / James Anderson / Scott T. Williams / Matthew R. Smith / Silver Spring / Gregory Kato / Thomas D. Coates / Caleb Briggs / Teresa Turchi Anthony / Mario Eisenberger / Mikkael Sekeres / Gregory Curt / D. Julie Vose / Howard Scher / Ann Zimrin / Joel B. Nelson / Paul Kluetz / Susan Shurin / Howard I. Scher / Frank Balis / Genitourinary Oncology / Deborah Armstrong / Dawn Aldrich / Patrick Loehrer / Joel Nelson / Jane Zones / Ann Farrell / M.D. Julie Vose / Wyndham Wilson / Richard Pazdur / M.D. Patrick Loehrer / Bhupinder Mann / Antoinette Wozniak / Nunzio D. Cazzetta Alicia Somma Thomas / George Shashaty / Brent Logan / John Johnson / Tejashri Purohit-Sheth / Richard Ward / Derek Raghavan / William Kelly / Ralph Freedman / Paul Kleutz / Timothy Donahue / Marc Garnick / David Penson / Kathy Robie-Suh / Cooley / D. Wayne Calloway Chair / /
Position
Professor & Chairman / Vice President Medical Affairs ApoPharma Inc. Clinical Perspective Dr. Renzo Galanello / President / Vice President / Speaker / Fernando Tricta Vice President / Chair Committee / Head / Officer / Federal Officer / Acting Director / Professor / Acting Director DHP / Chairperson / Major / Representative / National President / Director DHP / Director / National President of the Cooley / Chief / /
Summary Minutes of the Oncologic Drugs Advisory Committee Meeting September 14, 2011 Location: FDA White Oak Campus, Building 31, the Great Room, White Oak Conference Center (Rm. 1503), 10903 New Hampshire Avenue, Silver