The committee for advanced therapies' of the European Medicines Agency reflection paper on management of clinical risks deriving from insertional mutagenesis.

Alessandro Aiuti; Giulio Cossu; Pablo de Felipe; Maria Cristina Galli; Gopalan Narayanan; Matthias Renner; Axel Stahlbom; Christian K. Schneider; Caroline Voltz-Girolt

doi:10.1089/humc.2013.119

The committee for advanced therapies' of the European Medicines Agency reflection paper on management of clinical risks deriving from insertional mutagenesis.

Alessandro Aiuti, Giulio Cossu, Pablo de Felipe, Maria Cristina Galli, Gopalan Narayanan, Matthias Renner, Axel Stahlbom, Christian K. Schneider, Caroline Voltz-Girolt

Research output: Contribution to journal › Article › peer-review

Abstract

In the European Union, the Committee for Advanced Therapies of the European Medicines Agency takes the lead in the scientific assessment for marketing authorization applications for advanced therapy medicinal products, which include gene therapy medicinal products, somatic cell therapy medicinal products, and tissue-engineered products. The Committee for Advanced Therapies also takes the lead in defining the scientific framework for the quality, nonclinical and clinical development of such products. This reflection paper represents the Committee's current thinking on management of clinical risks deriving from insertional mutagenesis. A multidisciplinary approach to insertional mutagenesis is provided. This reflection paper has been adopted by the committee in its April 2013 meeting.

Original language	English
Pages (from-to)	47-54
Number of pages	7
Journal	Human gene therapy. Clinical development
Volume	24
Issue number	2
DOIs	https://doi.org/10.1089/humc.2013.119
Publication status	Published - Jun 2013

Access to Document

10.1089/humc.2013.119

Cite this

Aiuti, A., Cossu, G., de Felipe, P., Galli, M. C., Narayanan, G., Renner, M., Stahlbom, A., Schneider, C. K., & Voltz-Girolt, C. (2013). The committee for advanced therapies' of the European Medicines Agency reflection paper on management of clinical risks deriving from insertional mutagenesis. Human gene therapy. Clinical development, 24(2), 47-54. https://doi.org/10.1089/humc.2013.119

@article{24609bdc7ea443df86cab45789740a50,

title = "The committee for advanced therapies' of the European Medicines Agency reflection paper on management of clinical risks deriving from insertional mutagenesis.",

abstract = "In the European Union, the Committee for Advanced Therapies of the European Medicines Agency takes the lead in the scientific assessment for marketing authorization applications for advanced therapy medicinal products, which include gene therapy medicinal products, somatic cell therapy medicinal products, and tissue-engineered products. The Committee for Advanced Therapies also takes the lead in defining the scientific framework for the quality, nonclinical and clinical development of such products. This reflection paper represents the Committee's current thinking on management of clinical risks deriving from insertional mutagenesis. A multidisciplinary approach to insertional mutagenesis is provided. This reflection paper has been adopted by the committee in its April 2013 meeting.",

author = "Alessandro Aiuti and Giulio Cossu and {de Felipe}, Pablo and Galli, {Maria Cristina} and Gopalan Narayanan and Matthias Renner and Axel Stahlbom and Schneider, {Christian K.} and Caroline Voltz-Girolt",

year = "2013",

month = jun,

doi = "10.1089/humc.2013.119",

language = "English",

volume = "24",

pages = "47--54",

journal = "Human gene therapy. Clinical development",

issn = "2324-8645",

publisher = "Mary Ann Liebert Incorporated",

number = "2",

}

Aiuti, A, Cossu, G, de Felipe, P, Galli, MC, Narayanan, G, Renner, M, Stahlbom, A, Schneider, CK & Voltz-Girolt, C 2013, 'The committee for advanced therapies' of the European Medicines Agency reflection paper on management of clinical risks deriving from insertional mutagenesis.', Human gene therapy. Clinical development, vol. 24, no. 2, pp. 47-54. https://doi.org/10.1089/humc.2013.119

TY - JOUR

T1 - The committee for advanced therapies' of the European Medicines Agency reflection paper on management of clinical risks deriving from insertional mutagenesis.

AU - Aiuti, Alessandro

AU - Cossu, Giulio

AU - de Felipe, Pablo

AU - Galli, Maria Cristina

AU - Narayanan, Gopalan

AU - Renner, Matthias

AU - Stahlbom, Axel

AU - Schneider, Christian K.

AU - Voltz-Girolt, Caroline

PY - 2013/6

Y1 - 2013/6

N2 - In the European Union, the Committee for Advanced Therapies of the European Medicines Agency takes the lead in the scientific assessment for marketing authorization applications for advanced therapy medicinal products, which include gene therapy medicinal products, somatic cell therapy medicinal products, and tissue-engineered products. The Committee for Advanced Therapies also takes the lead in defining the scientific framework for the quality, nonclinical and clinical development of such products. This reflection paper represents the Committee's current thinking on management of clinical risks deriving from insertional mutagenesis. A multidisciplinary approach to insertional mutagenesis is provided. This reflection paper has been adopted by the committee in its April 2013 meeting.

AB - In the European Union, the Committee for Advanced Therapies of the European Medicines Agency takes the lead in the scientific assessment for marketing authorization applications for advanced therapy medicinal products, which include gene therapy medicinal products, somatic cell therapy medicinal products, and tissue-engineered products. The Committee for Advanced Therapies also takes the lead in defining the scientific framework for the quality, nonclinical and clinical development of such products. This reflection paper represents the Committee's current thinking on management of clinical risks deriving from insertional mutagenesis. A multidisciplinary approach to insertional mutagenesis is provided. This reflection paper has been adopted by the committee in its April 2013 meeting.

U2 - 10.1089/humc.2013.119

DO - 10.1089/humc.2013.119

M3 - Article

C2 - 23862696

SN - 2324-8645

VL - 24

SP - 47

EP - 54

JO - Human gene therapy. Clinical development

JF - Human gene therapy. Clinical development

IS - 2

ER -

The committee for advanced therapies' of the European Medicines Agency reflection paper on management of clinical risks deriving from insertional mutagenesis.

Abstract

Access to Document

Fingerprint

Cite this