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Samuel D. Waksal
Samuel D. "Sam" Waksal, Ph.D., (born September 8, 1947) is the founder and former CEO of the biopharmaceutical company ImClone Systems. He is also the founder and CEO of Kadmon Pharmaceuticals which was financed with private capital and commenced operations in New York City in 2010. At ImClone, Waksal led the company to develop the landmark cancer drug Erbitux (cetuximab). During the course of its review process with Food and Drug Administration (FDA) Waksal became involved in an insider trading scandal revolving around improper communications with personal friends and family members. He was convicted of several securities violations, served time in federal prison, and was released.
==Education and early career==
Samuel Waksal was born September 8, 1947 in Paris, France as the son of Holocaust survivors. Waksal earned a bachelor's degree in 1969 and a doctorate in immunobiology in 1974, both from The Ohio State University.
Over the next 15 years, he worked as a medical researcher at Stanford University, the National Cancer Institute, Tufts University and Mount Sinai Hospital, New York. However, his academic career was plagued by numerous ethical problems, including misrepresenting the source of material and fabricating lab results.
Undaunted, Waksal founded ImClone in 1984. The company was engaged in several research and development projects before filing its first Biologic License Application with the FDA in 2001. When it won the rights to develop Erbitux, a cancer antibody, the drug's clinical success caused ImClone's stock to reach a high of $70 a share. Bristol-Myers Squibb was intrigued enough by Erbitux to buy a large stake in the company in return for the rights to the drug. In December 2001 however the FDA issued a ''Refuse to File''〔(【引用サイトリンク】url=http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ProceduresSOPPs/ucm073474.htm )〕 decision effectively turning down ImClone's application due to concerns about the structure of the clinical trials.〔
抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』
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