While at the FDA, I was the medical reviewer for the first genetically engineered drugs and thus instrumental in the rapid licensing of human insulin and human growth hormone.
Lilly saw immediately the promise of this technology for the production of unlimited quantities of human insulin in bacteria.
Lilly began clinical trials of its human insulin in July 1980.
Based on a thorough review of data submitted by Lilly that was obtained from pre-clinical testing in animals and clinical trials in thousands of diabetics, FDA granted marketing approval for human insulin in October 1982.
Over many years the FDA had had prodigious experience with insulins and with drugs derived from various microorganisms, so it was decided that no fundamentally new regulatory paradigms were necessary to evaluate the recombinant human insulin.
After obtaining from Genentech, Inc. the recombinant E. coli bacteria that contained the genetic blueprint for and that synthesized human insulin, they developed processes for the large-scale cultivation of the organism (in huge fermenters similar to those that make wine or beer) and for the purification and formulation of the insulin.
According to evidence submitted to the court, banned substances such as EPO, HGH, testosterone, insulin and fertility drug Human Menopausal Gonadotropin were sometimes combined with the transfusions.
That generic versions of high-tech protein drugs such as human growth hormone, insulin, or Amgen 's Epogen are likely to reach the market with any great speed.
That generic versions of high-tech protein drugs such as human growth hormone, insulin, or Amgen 's (nasdaq: AMGN - news - people ) Epogen are likely to reach the market with any great speed.
The JDRF was among the first prominent health advocates to call for greatly increased research on stem cells harvested from discarded human embryos, which could grow into insulin-producing cells.
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