Gene therapies need new development models
October 4, 2012
The design, development and manufacture of products such as Glybera — a virus engineered to carry a correct copy of the defective gene — is complex and done mostly in academic centres. Yet legislation introduced in the past decade in Europe and the United States demands that these products be produced under the same rules that cover conventional drugs, in establishments operated with industry-like standards and certified by government agencies. (Nature)
