-
1
-
-
0034050063
-
Asilomar revisited: Lessons for today?
-
Barinaga, M. (2000). Asilomar revisited: Lessons for today? Science 287, 1584-1585.
-
(2000)
Science
, vol.287
, pp. 1584-1585
-
-
Barinaga, M.1
-
2
-
-
0034724857
-
Gene therapy of human severe combined immunodeficiency (SCID)-X1 disease
-
Cavazzana-Calvo, M., Hacein-Bey, S., De Saint-Basile, G., Gross, F., Yvon, E., Nusbaum, P., Selz, F., Hue, C., Certain, S., Casanova, J.L., Bousso, P., Le Deist, F., and Fischer, A. (2000). Gene therapy of human severe combined immunodeficiency (SCID)-X1 disease. Science 288, 669-672.
-
(2000)
Science
, vol.288
, pp. 669-672
-
-
Cavazzana-Calvo, M.1
Hacein-Bey, S.2
Saint-Basile, D.3
Gross, F.4
Yvon, E.5
Nusbaum, P.6
Selz, F.7
Hue, C.8
Certain, S.9
Casanova, J.L.10
Bousso, P.11
Le Deist, F.12
Fischer, A.13
-
3
-
-
0037057620
-
Regulators split on gene therapy as patient shows signs of cancer
-
Check, E., and Schiermeier, Q. (2002). Regulators split on gene therapy as patient shows signs of cancer. Nature 419, 545-546.
-
(2002)
Nature
, vol.419
, pp. 545-546
-
-
Check, E.1
Schiermeier, Q.2
-
4
-
-
4243463238
-
Clinical trials in Europe involving the use of adenoviral vectors: Results of an informal Euregenethy survey following the G-case in the USA
-
CIchutek, K., and Cohen-Haguenauer, O.. for the Euregenethy Network. (2000). Clinical trials in Europe involving the use of adenoviral vectors: Results of an informal Euregenethy survey following the G-case in the USA. J. Gene Med. 2, S2.
-
(2000)
J. Gene Med.
, vol.2
-
-
Cichutek, K.1
Cohen-Haguenauer, O.2
-
5
-
-
0011835106
-
Gene therapy in Germany and in Europe: Regulatory issues
-
Cichutek, K., and Krämer, I. (1997). Gene therapy in Germany and in Europe: Regulatory issues. Qual. Assur. J. 2, 141-152.
-
(1997)
Qual. Assur. J.
, vol.2
, pp. 141-152
-
-
Cichutek, K.1
Krämer, I.2
-
6
-
-
0034006951
-
Trials and tribulations
-
Cohen, B. (2000). Trials and tribulations. Nat. Genet. 24, 201.
-
(2000)
Nat. Genet.
, vol.24
, pp. 201
-
-
Cohen, B.1
-
7
-
-
0029113258
-
Overview of regulation of gene therapy in Europe: A current statement including reference to U.S. regulation
-
Cohen-Haguenauer, O. (1995). Overview of regulation of gene therapy in Europe: A current statement including reference to U.S. regulation. Hum. Gene Ther. 6, 773-785.
-
(1995)
Hum. Gene Ther.
, vol.6
, pp. 773-785
-
-
Cohen-Haguenauer, O.1
-
8
-
-
0030004380
-
Safety and regulation at the leading edge of biomedical biotechnology
-
Cohen-Haguenauer, O. (1996). Safety and regulation at the leading edge of biomedical biotechnology. Curt. Opin. Biotechnol. 7, 265-272.
-
(1996)
Curt. Opin. Biotechnol.
, vol.7
, pp. 265-272
-
-
Cohen-Haguenauer, O.1
-
9
-
-
0030947303
-
Gene therapy: Regulatory issues and international approaches to regulation
-
Cohen-Haguenauer, O. (1997). Gene therapy: Regulatory issues and international approaches to regulation. Curt. Opin. Biotechnol. 8, 361-369.
-
(1997)
Curt. Opin. Biotechnol.
, vol.8
, pp. 361-369
-
-
Cohen-Haguenauer, O.1
-
11
-
-
0001252857
-
Réglementation de la thérapie génique
-
Cohen-Haguenauer, O. (1999). Réglementation de la thérapie génique. M6d. Sci. 5, 682-690.
-
(1999)
Méd. Sci.
, vol.5
, pp. 682-690
-
-
Cohen-Haguenauer, O.1
-
12
-
-
4243673720
-
Regulation of gene therapy in Europe: A scientific network of users
-
Cohen-Haguenauer, O., and the Euregenethy Network. (2000a) Regulation of gene therapy in Europe: A scientific network of users. Mol. Ther. 1, S302.
-
(2000)
Mol. Ther.
, vol.1
-
-
Cohen-Haguenauer, O.1
-
13
-
-
0011874643
-
Meeting highlights: Second euregenethy multidisciplinary forum on regulatory and safety issues in gene therapy
-
Cohen-Haguenauer, O. (2000b) Meeting highlights: second euregenethy multidisciplinary forum on regulatory and safety issues in gene therapy. J. Gene Med. 2, 3-7.
-
(2000)
J. Gene Med.
, vol.2
, pp. 3-7
-
-
Cohen-Haguenauer, O.1
-
14
-
-
0011901796
-
Regulatory aspects in gene therapy: Special highlights on European regulation
-
G. Subramanian ed. (Kluwer Academic/Plenum Publishers, London)
-
Cohen-Haguenauer, O. (2002) Regulatory aspects in gene therapy: Special highlights on European regulation. In Manufacturing of Gene Therapeutics: Methods, Processing, Clinical Trials, Regulation and Validation. G. Subramanian ed. (Kluwer Academic/Plenum Publishers, London) pp. 289-310.
-
(2002)
Manufacturing of Gene Therapeutics: Methods, Processing, Clinical Trials, Regulation and Validation
, pp. 289-310
-
-
Cohen-Haguenauer, O.1
-
15
-
-
0033950206
-
Biotechnology industry responds to gene therapy death
-
Commander, H. (2000) Biotechnology industry responds to gene therapy death. Nat. Med. 6, 118.
-
(2000)
Nat. Med.
, vol.6
, pp. 118
-
-
Commander, H.1
-
16
-
-
0011835455
-
-
Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes Official Journal. No L 358 of 18. 12. 86
-
Commission of the European Communities. (1986a). Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes Official Journal. No L 358 of 18. 12. 86.
-
(1986)
-
-
-
17
-
-
0011914680
-
-
Council Directive 87/18/EEC of 18 December 1986 on the harmonization of laws, regulations or administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances Official Journal No L 15 of 17. 1. 87
-
Commission of the European Communities. (1986b). Council Directive 87/18/EEC of 18 December 1986 on the harmonization of laws, regulations or administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances Official Journal No L 15 of 17. 1. 87.
-
(1986)
-
-
-
18
-
-
0011829246
-
-
Council Directive 88/320/EEC of 9 June 1988 on the inspection and verification of Good Laboratory Practice (GLP). Official Journal. No L 145 of 11. 6. 88
-
Commission of the European Communities. (1988a). Council Directive 88/320/EEC of 9 June 1988 on the inspection and verification of Good Laboratory Practice (GLP). Official Journal. No L 145 of 11. 6. 88.
-
(1988)
-
-
-
19
-
-
0011867994
-
-
Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms. Official Journal. No L 117 of 8. 5. 90
-
Commission of the European Communities. (1990a). Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms. Official Journal. No L 117 of 8. 5.90.
-
(1990)
-
-
-
20
-
-
0011914162
-
-
Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms. Official Journal. No L 117 of 8. 5. 90
-
Commission of the European Communities. (1990b). Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms. Official Journal. No L 117 of 8.5. 90.
-
(1990)
-
-
-
21
-
-
0011905889
-
-
Council Directive 90/679/EEC of 26 November 1990 on the protection of workers from risks related to exposure to biological agents at work (seventh individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC). Official Journal. No L 374 of 31. 12 90
-
Commission of the European Communities (1990c). Council Directive 90/679/EEC of 26 November 1990 on the protection of workers from risks related to exposure to biological agents at work (seventh individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC). Official Journal. No L 374 of 31. 12. 90.
-
(1990)
-
-
-
22
-
-
0011867995
-
-
Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use. Official Journal. No. L 193 of 17.7.91
-
Commission of the European Communities (1991a). Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use. Official Journal. No. L 193 of 17.7.91.
-
(1991)
-
-
-
23
-
-
0011874645
-
-
Commission Decision 91/448/EEC of 29 July 1991 concerning the guidelines for classification referred to in Article 4 of Directive 90/219/EEC. Official Journal. No L 239 of 28.8.91
-
Commission of the European Communities. (1991b). Commission Decision 91/448/EEC of 29 July 1991 concerning the guidelines for classification referred to in Article 4 of Directive 90/219/EEC. Official Journal. No L 239 of 28.8.91.
-
(1991)
-
-
-
24
-
-
0011829248
-
-
Directorate-General Industry III/E/3. Production and Quality Control of Medicinal Products Derived by Recombinant DNA Technology. III/3477/92
-
Commission of the European Community. (1992), Directorate-General Industry III/E/3. Production and Quality Control of Medicinal Products Derived by Recombinant DNA Technology. III/3477/92. Available at: www.emea, eu.int.
-
(1992)
-
-
-
25
-
-
0011885260
-
-
Council Directive 93/41/EEC of 14 June 1993 repealing Directive 87/22/EEC on the approximation of national measures relating to the placing on the market of high technology medicinal products, particularly those derived from biotechnology. Official Journal. No L 214 of 24.8.93
-
Commission of the European Communities. (1993a). Council Directive 93/41/EEC of 14 June 1993 repealing Directive 87/22/EEC on the approximation of national measures relating to the placing on the market of high technology medicinal products, particularly those derived from biotechnology. Official Journal. No L 214 of 24.8.93.
-
(1993)
-
-
-
26
-
-
0011870113
-
-
Council Regulation No. (EEC) 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. Official Journal No. 214 of 24.8.93
-
Commission of the European Communities. (1993b). Council Regulation No. (EEC) 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products. Official Journal No. 214 of 24.8.93.
-
(1993)
-
-
-
27
-
-
0011835244
-
-
Committee for proprietary medicinal products (CPMP): Ad hoc Working Party on Biotechnology / Pharmacy: Gene Therapy Products-Quality Aspects in the Production of Vectors and Genetically Modified Somatic Cells. Approved by CPMP December 1994:II1/5863/93 Final
-
Commission of the European Communities (1994). Committee for proprietary medicinal products (CPMP): Ad hoc Working Party on Biotechnology / Pharmacy: Gene Therapy Products-Quality Aspects in the Production of Vectors and Genetically Modified Somatic Cells. Approved by CPMP December 1994:II1/5863/93 Final. http ://www.emea. eu.int/
-
(1994)
-
-
-
28
-
-
0011886160
-
-
CPMP. Note for guidance on Good Clinical Practice. CPMP/ ICH/135/95-consolidated FDA: Guidance for Industry. E6 Good clinical Practice. April 1996
-
Commission of the European Communities (1996). CPMP. Note for guidance on Good Clinical Practice. CPMP/ ICH/135/95-consolidated FDA: Guidance for Industry. E6 Good clinical Practice. April 1996. http://www.emea.eu.int/
-
(1996)
-
-
-
29
-
-
0011905103
-
-
Council Directive 98/81/EC of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms. Official Journal No. L 330,05.12.1998
-
Commission of the European Communities. (1998). Council Directive 98/81/EC of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms. Official Journal No. L 330,05.12.1998.
-
(1998)
-
-
-
30
-
-
0011873612
-
-
European Parliament & Council Regulation on Orphan drugs 98/0240 (COD) LEX 184. PE-CONS 3637/99ECO410SAN 194CODEC 788
-
Commission of the European Communities. (2000). European Parliament & Council Regulation on Orphan drugs 98/0240 (COD) LEX 184. PE-CONS 3637/99ECO410SAN 194CODEC 788. Available at www.emea.eu.int/.
-
(2000)
-
-
-
31
-
-
0011867999
-
-
Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. Official Journal of the European Commission. Official Journal No. L 106/1 of 17 April 2001
-
COMMISSION OF THE EUROPEAN COMMUNITIES. (2001a). Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. Official Journal of the European Commission. Official Journal No. L 106/1 of 17 April 2001.
-
(2001)
-
-
-
32
-
-
0011829963
-
-
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official Journal of the european Communities. Official Journal No. L121/34 of 1 May 2001
-
Commission of the European Communities. (2001b). Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official Journal of the european Communities. Official Journal No. L121/34 of 1 May 2001.
-
(2001)
-
-
-
33
-
-
0011889909
-
-
CPMP. Note for guidance on the quality, preclinical and clinical aspects of gene transfer medicinal products. CPMP/BWP/3088/99-final May 2001
-
Commission of the European Communities. (2001c). CPMP. Note for guidance on the quality, preclinical and clinical aspects of gene transfer medicinal products. CPMP/BWP/3088/99-final May 2001. Available at: www.emea.eu.int/.
-
(2001)
-
-
-
34
-
-
0011833089
-
-
CPMP. Points to consider on the manufacture and quality control of human somatic cell therapy medicinal products. CPMP/BWP/ 41450/98-final May 2001
-
Commission of the European Communities. (2001d). CPMP. Points to consider on the manufacture and quality control of human somatic cell therapy medicinal products. CPMP/BWP/ 41450/98-final May 2001. Available at: www.emea.eu.int/.
-
(2001)
-
-
-
35
-
-
0011835111
-
Euregenethy
-
O. CohenHaguenauer, ed. (EDK, Paris)
-
Euregenethy. (1999). Euregenethy Newsletter, No. 1. O. CohenHaguenauer, ed. (EDK, Paris).
-
(1999)
Euregenethy Newsletter
, vol.1
-
-
-
36
-
-
0034708778
-
Principles for human gene therapy studies
-
Friedmann, T. (2000). Principles for human gene therapy studies. Science 287, 2163-2165
-
(2000)
Science
, vol.287
, pp. 2163-2165
-
-
Friedmann, T.1
-
37
-
-
0033782862
-
An adenovirus E1A mutant that demonstrates potent and selective systemic anti-tumoral efficacy
-
Heise, C., Hermiston, T., Johnson, L., Brooks, G., Sampson-Johannes, A., Williams, A., Hawkins, L., and Kirn, D. (2000c). An adenovirus E1A mutant that demonstrates potent and selective systemic anti-tumoral efficacy. Nat. Med. 6, 1134-1139.
-
(2000)
Nat. Med.
, vol.6
, pp. 1134-1139
-
-
Heise, C.1
Hermiston, T.2
Johnson, L.3
Brooks, G.4
Sampson-Johannes, A.5
Williams, A.6
Hawkins, L.7
Kirn, D.8
-
38
-
-
0033954691
-
Researchers and regulators reflect on first gene therapy death
-
Hollon, T. (2000a). Researchers and regulators reflect on first gene therapy death. Nat. Med. 6, 6.
-
(2000)
Nat. Med.
, vol.6
, pp. 6
-
-
Hollon, T.1
-
39
-
-
0034020883
-
Gene therapy investigations proliferate
-
Hollon, T. (2000b). Gene therapy investigations proliferate. Nat. Med 6, 235.
-
(2000)
Nat. Med.
, vol.6
, pp. 235
-
-
Hollon, T.1
-
40
-
-
0034567122
-
Working toward an adenoviral vector testing standard
-
Hutchins, B., Sajjadi, N., Seaver, S., Shepherd, A., Bauer, S.R., Simek, S., Carson, K., and Aguilar-Cordova, E. (2000). Working toward an adenoviral vector testing standard. Mol. Ther. 2, 532-534.
-
(2000)
Mol. Ther.
, vol.2
, pp. 532-534
-
-
Hutchins, B.1
Sajjadi, N.2
Seaver, S.3
Shepherd, A.4
Bauer, S.R.5
Simek, S.6
Carson, K.7
Aguilar-Cordova, E.8
-
41
-
-
0034050904
-
Evidence for gene transfer and expression of factor IX in haemophilia B patients treated with an AAV vector
-
Kay, M.A., Manno, C.S., Ragni, M.V., Larson, P.J., Couto, L.B., Mcclelland, A., Glader, B., Chew, A.J., Tai, J.S., Herzog, R.W., Arruda, V., Johnson, F., Scallan, C., Skarsgard, E., Flake, A.W., and High, K.A. (2000). Evidence for gene transfer and expression of factor IX in haemophilia B patients treated with an AAV vector. Nat. Genet. 24, 257-261.
-
(2000)
Nat. Genet.
, vol.24
, pp. 257-261
-
-
Kay, M.A.1
Manno, C.S.2
Ragni, M.V.3
Larson, P.J.4
Couto, L.B.5
Mcclelland, A.6
Glader, B.7
Chew, A.J.8
Tai, J.S.9
Herzog, R.W.10
Arruda, V.11
Johnson, F.12
Scallan, C.13
Skarsgard, E.14
Flake, A.W.15
High, K.A.16
-
42
-
-
0033533669
-
Virus treatment questioned after gene therapy death
-
Lehrman, S. (1999). Virus treatment questioned after gene therapy death. Nature 401, 517-518.
-
(1999)
Nature
, vol.401
, pp. 517-518
-
-
Lehrman, S.1
-
43
-
-
0037134031
-
Murine leukemia induced by retroviral gene marking
-
Li, Z., Düllman, J., Schiedlmeier, B., Schmidt, M., Von Kalle, C., Meyer, J., Foster, M., Stocking, C., Wahlers, A., Frank, O., Ostertag, W., Kühlcke, K. Eckert, H.-G., Fehse, B., Baum, C. (2002). Murine leukemia induced by retroviral gene marking. Science 296, 497.
-
(2002)
Science
, vol.296
, pp. 497
-
-
Li, Z.1
Düllman, J.2
Schiedlmeier, B.3
Schmidt, M.4
Von Kalle, C.5
Meyer, J.6
Foster, M.7
Stocking, C.8
Wahlers, A.9
Frank, O.10
Ostertag, W.11
Kühlcke, K.12
Eckert, H.-G.13
Fehse, B.14
Baum, C.15
-
44
-
-
0028968026
-
Guidelines for the design and implementation of clinical studies in somatic cell therapy and gene therapy in Germany
-
Lindemann, A., Rosenthal, F.M., Hase, S., Markmeyer, P., Mertelsmann, R., for the German Working Group for Gene Therapy. (1995). Guidelines for the design and implementation of clinical studies in somatic cell therapy and gene therapy in Germany. J. Mol. Med. 73, 207-211.
-
(1995)
J. Mol. Med.
, vol.73
, pp. 207-211
-
-
Lindemann, A.1
Rosenthal, F.M.2
Hase, S.3
Markmeyer, P.4
Mertelsmann, R.5
-
45
-
-
0034640230
-
Gene therapy on trial
-
Renault, B. (2000). Gene therapy: A loss of innocence. Nat. Med. 6, 1
-
Marshall, E. (2000). Gene therapy on trial. Science 288, 951-957
-
(2000)
Science
, vol.288
, pp. 951-957
-
-
Marshall, E.1
-
46
-
-
0033977721
-
Gene therapy: A loss of innocence
-
Renault, B. (2000). Gene therapy: A loss of innocence. Nat. Med. 6, 1.
-
(2000)
Nat. Med.
, vol.6
, pp. 1
-
-
Renault, B.1
-
48
-
-
0034594986
-
NIH tightens up monitoring of gene-therapy mishaps
-
Smaglik, P. (2000). NIH tightens up monitoring of gene-therapy mishaps. Nature 404, 5.
-
(2000)
Nature
, vol.404
, pp. 5
-
-
Smaglik, P.1
-
49
-
-
0025447655
-
Safety considerations in somatic gene therapy of human disease with retrovirus vectors
-
Temim, H.M. (1990). Safety considerations in somatic gene therapy of human disease with retrovirus vectors. Hum. Gene. Ther. 1, 11-123.
-
(1990)
Hum. Gene. Ther.
, vol.1
, pp. 11-123
-
-
Temim, H.M.1
-
52
-
-
0011829974
-
-
Federal Register, May 11, 1999, (64 FR 25361), Appendix M: Points to consider in the design and submission of Protocols for the transfer of recombinant DNA molecules into one or more human subjects (Points to consider)
-
U.S. Department of Health and Human Services. NIHOBA (1999b). Guidelines for Research involving recombinant DNA Molecules (NIH Guidelines). Federal Register, May 11, 1999, (64 FR 25361), Appendix M: Points to consider in the design and submission of Protocols for the transfer of recombinant DNA molecules into one or more human subjects (Points to consider), pp 92-103. Available at: www4.od.nih.gov/oba/Rdna.htm.
-
(1999)
Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines)
, pp. 92-103
-
-
-
56
-
-
0033523899
-
NIH panel to limit secrecy on gene therapy
-
Wadman, M. (1999). NIH panel to limit secrecy on gene therapy. Nature 402, 6.
-
(1999)
Nature
, vol.402
, pp. 6
-
-
Wadman, M.1
-
57
-
-
0033649396
-
Policy statement of the American Society of Gene Therapy on reporting of patients adverse events in gene therapy trials
-
Woo, S.L.C. (2000). Policy statement of the American Society of Gene Therapy on reporting of patients adverse events in gene therapy trials. Mol. Ther. 1, 7.
-
(2000)
Mol. Ther.
, vol.1
, pp. 7
-
-
Woo, S.L.C.1
|