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Samuel D. Waksal

Also Known As Waksal

CEO of ImClone Systems

Education

  • Bachelor's degree - Ohio State University
  • doctorate in immunobiology - Ohio State University

Overview

Samuel D. Waksal is the founder and former CEO of the biopharmaceutical company ImClone Systems. He is also the founder 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 cancer drug Erbitux (cetuximab). During the course of its review process with the 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.

ImClone Systems :

Waksal founded ImClone Systems 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. In September 2001, Bristol-Myers Squibb was intrigued enough by Erbitux to sign a $2 billion deal with the company in return for the marketing rights to the drug. In December 2001, however, the FDA issued a Refuse to File decision effectively turning down ImClone's application due to concerns about the structure of the clinical trials. In 2004, Erbitux was approved by the FDA. In 2008, the drug generated over $1.5 billion in sales and was credited with aiding thousands of cancer patients. That same year, ImClone was sold to Eli Lilly and Company for $6.5 billion.

Early Life

Waksal was born September 8, 1947, in Paris, France, as the son of Holocaust survivors. He 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, he often faced scrutiny for misrepresenting the source of material and fabricating lab results.

Career

  • ImClone Systems - CEO

Reference

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