Relevance of an Academic GMP Pan-European Vector Infra-Structure (PEVI)

In the past 5 years, European investigators have played a major role in the development of clinical gene therapy. The provision of substantial funds by some individual member states to construct GMP facilities makes it an opportune time to network available gene therapy GMP facilities at an EU level. The integrated coordination of GMP production facilities and human skills for advanced gene and genetically-modified (GM) cell therapy, can dramatically enhance academic-led "First-in-man" gene therapy trials. Once proof of efficacy is gathered, technology can be transferred to the private sector which will take over further development taking advantage of knowledge and know-how. Complex technical challenges require existing production facilities to adapt to emerging technologies in a coordinated manner. These include a mandatory requirement for the highest quality of production translating gene-transfer technologies with pharmaceutical-grade GMP processes to the clinic. A consensus has emerged on the directions and priorities to adopt, applying to advanced technologies with improved efficacy and safety profiles, in particular AAV, lentivirus-based and oncolytic vectors. Translating cutting-edge research into "First-in-man" trials require that pre-normative research is conducted which aims to develop standard assays, processes and candidate reference materials. This research will help harmonise practices and quality in the production of GMP vector lots and GM-cells. In gathering critical expertise in Europe and establish conditions for interoperability, the PEVI infrastructure will contribute to the demands of the advanced therapy medicinal products* regulation and to both health and quality of life of EU-citizens. © 2010 Bentham Science Publishers Ltd.SCOPUS: ar.jinfo:eu-repo/semantics/publishe

Relevance of an Academic GMP Pan-European Vector Infra-Structure (PEVI)

In the past 5 years, European investigators have played a major role in the development of clinical gene therapy. The provision of substantial funds by some individual member states to construct GMP facilities makes it an opportune time to network available gene therapy GMP facilities at an EU level. The integrated coordination of GMP production facilities and human skills for advanced gene and genetically-modified (GM) cell therapy, can dramatically enhance academic-led "First-in-man" gene therapy trials. Once proof of efficacy is gathered, technology can be transferred to the private sector which will take over further development taking advantage of knowledge and know-how. Complex technical challenges require existing production facilities to adapt to emerging technologies in a coordinated manner. These include a mandatory requirement for the highest quality of production translating gene-transfer technologies with pharmaceutical-grade GMP processes to the clinic. A consensus has emerged on the directions and priorities to adopt, applying to advanced technologies with improved efficacy and safety profiles, in particular AAV, lentivirus-based and oncolytic vectors. Translating cutting-edge research into "First-in-man" trials require that pre-normative research is conducted which aims to develop standard assays, processes and candidate reference materials. This research will help harmonise practices and quality in the production of GMP vector lots and GM-cells. In gathering critical expertise in Europe and establish conditions for interoperability, the PEVI infrastructure will contribute to the demands of the advanced therapy medicinal products* regulation and to both health and quality of life of EU-citizens. © 2010 Bentham Science Publishers Ltd.SCOPUS: ar.jinfo:eu-repo/semantics/publishe

The new concrete

The New Concrete is a long-overdue survey of the rise of concrete poetry in the digital age. The accessibility of digital text and image manipulation, modern print techniques and the rise of self-publishing have invigorated a movement that first emerged in an explosion of literary creativity during the 1950s and 1960s. This new volume is a highly illustrated overview of contemporary artists and poets working at the intersection of visual art and literature, producing some of the most engaging and challenging work in either medium. Featuring an introductory essay by renowned American poet Kenneth Goldsmith and edited by celebrated poets Victoria Bean and Chris McCabe, The New Concrete is an indispensable introduction to the breadth of concrete poetry being produced today. Edited by Victoria Bean and Chris McCabe, with an essay by Kenneth Goldsmit