Current therapies for most human genetic diseases are inadequate. In response to the need for effective treatments, modern molecular genetics is providing tools for an unprecedented new approach to the treatment of diseases; e.g. the direct manipulation of mutant genes or the input on new therapeutic genes. The treatment of human disease by gene transfer has now moved from the theoretical to the practical realm. With the initiation of clinical trials involving somatic gene therapy in different countries, a critical assessment of the different aspects involved with this new technique is…mehr
Current therapies for most human genetic diseases are inadequate. In response to the need for effective treatments, modern molecular genetics is providing tools for an unprecedented new approach to the treatment of diseases; e.g. the direct manipulation of mutant genes or the input on new therapeutic genes. The treatment of human disease by gene transfer has now moved from the theoretical to the practical realm. With the initiation of clinical trials involving somatic gene therapy in different countries, a critical assessment of the different aspects involved with this new technique is necessary. This volume provides an overview on all these interdisciplinary aspects by some well known experts all over the world.
Prof. Dr. Stefan Müller ist Inhaber der Professur für Allgemeine Betriebswirtschaftslehre an der Helmut-Schmidt-Universität, Universität der Bundeswehr Hamburg, und Mitglied im Arbeitskreis IFRS des Internationalen Controller Vereins.
Inhaltsangabe
I: Scientific Aspects of Gene Therapy.- to Principles and Examples of Somatic Gene Therapy.- Gene Therapy with Non-Viral Vector Systems.- Gene Therapy of Human Melanoma - from Animal Experiments to the Clinical Trial.- Development of a Gene Therapy for Arthritis.- The Industrial Perspective of Somatic Gene Therapy.- Industrial Aspects of Gene Transfer Systems.- Safety Considerations in Construction of Viral Vectors for Gene Therapy.- Safety Aspects During Manufacturing of Gene Therapeutic Material.- Gene Therapy and Medical Genetic Service: Biological Safety and Ethical Aspects.- II: Legal Aspects of Gene Therapy.- Legal Aspects of Genetic Therapies in Germany.- The Regulation of Genetic Technology in the United Kingdom: Hard or Soft Options?.- Legal Aspects of Gene Therapy - The Austrian Regulation Model.- Survey About Regulation on Gene Therapy in Some European Countries.- Development of Agents for Somatic Gene Therapy - Role of European Drug Agencies.- Regulation of Gene Therapy from the EU's Point of View.- Regulation of Genetic Therapy - The American Experience.- "Is there a Demand for the Worldwide Regulation of Gene Therapy".- Patents and Gene Therapy.- III: Ethical Aspects of Gene Therapy.- Free Access to Gene Therapy and Dictates of Application.- A Survey of Ethical Questions Concerning Gene Therapy.- Ethical Assessment of Gene Therapy in Asia.- Gene Therapy from the Viewpoint of Parent and Patient Organisations.- The Genome, Artificial Evolution, and Human Rights-A New Way to Post-Modem Global Communty.- Germ Line Risks of Somatic Gene Therapy-an Ethical Issue.- Ethics and Gene Therapy from UNESCO'S Viewpoint.- A Project on Medical Ethics Accompanying the Gene Therapy Symposium in Lüneburg (in March 1996).
I: Scientific Aspects of Gene Therapy.- to Principles and Examples of Somatic Gene Therapy.- Gene Therapy with Non-Viral Vector Systems.- Gene Therapy of Human Melanoma - from Animal Experiments to the Clinical Trial.- Development of a Gene Therapy for Arthritis.- The Industrial Perspective of Somatic Gene Therapy.- Industrial Aspects of Gene Transfer Systems.- Safety Considerations in Construction of Viral Vectors for Gene Therapy.- Safety Aspects During Manufacturing of Gene Therapeutic Material.- Gene Therapy and Medical Genetic Service: Biological Safety and Ethical Aspects.- II: Legal Aspects of Gene Therapy.- Legal Aspects of Genetic Therapies in Germany.- The Regulation of Genetic Technology in the United Kingdom: Hard or Soft Options?.- Legal Aspects of Gene Therapy - The Austrian Regulation Model.- Survey About Regulation on Gene Therapy in Some European Countries.- Development of Agents for Somatic Gene Therapy - Role of European Drug Agencies.- Regulation of Gene Therapy from the EU's Point of View.- Regulation of Genetic Therapy - The American Experience.- "Is there a Demand for the Worldwide Regulation of Gene Therapy".- Patents and Gene Therapy.- III: Ethical Aspects of Gene Therapy.- Free Access to Gene Therapy and Dictates of Application.- A Survey of Ethical Questions Concerning Gene Therapy.- Ethical Assessment of Gene Therapy in Asia.- Gene Therapy from the Viewpoint of Parent and Patient Organisations.- The Genome, Artificial Evolution, and Human Rights-A New Way to Post-Modem Global Communty.- Germ Line Risks of Somatic Gene Therapy-an Ethical Issue.- Ethics and Gene Therapy from UNESCO'S Viewpoint.- A Project on Medical Ethics Accompanying the Gene Therapy Symposium in Lüneburg (in March 1996).
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