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Volume 20, Issue 3, Pages (March 2012)

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Presentation on theme: "Volume 20, Issue 3, Pages (March 2012)"— Presentation transcript:

1 Volume 20, Issue 3, Pages 479-482 (March 2012)
Clinical Development of Advanced Therapy Medicinal Products in Europe: Evidence That Regulators Must Be Proactive  Romaldas Maciulaitis, Lucia D'Apote, Andrew Buchanan, Laura Pioppo, Christian K Schneider  Molecular Therapy  Volume 20, Issue 3, Pages (March 2012) DOI: /mt Copyright © 2012 The American Society of Gene & Cell Therapy Terms and Conditions

2 Figure 1 Regulatory pathways for ATMPs in Europe. The usual sequence in which procedures are requested by applicants. Note that all procedures can be requested at any time during development. ATMP, advanced therapy medicinal product; CAT, Committee for Advanced Therapies; EMA, European Medicines Agency; SME, small and medium-sized enterprise. Molecular Therapy  , DOI: ( /mt ) Copyright © 2012 The American Society of Gene & Cell Therapy Terms and Conditions

3 Figure 2 The ATMP landscape in Europe 2004–2010. ATMP, advanced therapy medicinal product; CA, cancer; CBMP, cell-based medicinal product; DC, dendritic cell; GTMP, gene therapy medicinal product; HBSC, hematopoietic blood stem cell; MCRC, metastatic colorectal cancer; MSC, mesenchymal stem cell; SCTMP, somatic cell therapy medicinal product; SME, small and medium-sized enterprise; TEP, tissue-engineered product; Tx, transplantation. Molecular Therapy  , DOI: ( /mt ) Copyright © 2012 The American Society of Gene & Cell Therapy Terms and Conditions

4 Figure 3 Numbers of ATMPs and sponsors by country and type. ATMP, advanced therapy medicinal product; DC, dendritic cell; GTMP, gene therapy medicinal product; HBSC, hematopoietic blood stem cell; MSC, mesenchymal stem cell; TEP, tissue-engineered product. Molecular Therapy  , DOI: ( /mt ) Copyright © 2012 The American Society of Gene & Cell Therapy Terms and Conditions


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