Somatic gene therapy intends to provide specific cells of a patient with the genetic software required to produce therapeutic proteins for the prevention, modulation, or correction of a disease. One of the unique advantages of harnessing the patient's body to produce therapeutic proteins by administration of plasmid therapeutics as pharmaceutical products (i.e., gene medicines ) is to create a radically improved quality of pharmacological response for the prophylactic and therapeutic treatment of genetic or acquired diseases. The opportunity of administering formulated plasmids, as pre-drugs, that use the patient's body to produce proteins in a natural, controllable, cell-specific manner would introduce a new quality of medical treatment. The success of gene medicines will require the ability to control both the location and the functioning of an administered gene in accessible tissues (e.g., skeletal muscle, solid tumors) in order to provide local or systemic effects (e.g., in cardiovascular diseases with angiogenic and hematological factors, or in cancer treatment with immunotherapy and anti-angiogenesis). Cell-specific control of gene expression and drug-dependent regulation of gene expression (e.g., with a GeneSwitch™) in vivo would also enable unique product opportunities. In addition, the systemic administration of formulated plasmid to target sites would create additional product opportunities, for instance, in the treatment of disseminated tumors and metastases. This presentation describes some of the technologies and product concepts evaluated in animal models, and gene medicines that are being evaluated in clinical trials for local and systemic gene therapy.