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Gene Therapy Trials and Tribulations

This article was originally published in Start Up

Executive Summary

The increased scrutiny of gene therapy by the National Institutes of Health and the Food and Drug Administration hasn't, to date, affected companies' clinical trials or long-term strategies, say executives of companies working in the field. This is partly because the NIH and FDA have yet to announce what new requirements, if any, companies must meet. Another reason is that few companies are working with adenoviral vectors--the focus of much attention following the death in September of an 18-year-old patient while in a gene therapy experiment.

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