메뉴 건너뛰기




Volumn 4, Issue 1, 2016, Pages

Advanced therapy medicinal products: current and future perspectives

Author keywords

advanced therapy medicinal products; ATMPs; clinical trials; market access

Indexed keywords


EID: 85164370727     PISSN: None     EISSN: 20016689     Source Type: Journal    
DOI: 10.3402/jmahp.v4.31036     Document Type: Article
Times cited : (77)

References (34)
  • 1
    • 85046471887 scopus 로고    scopus 로고
    • Commission Directive 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products
    • European Commission. Commission Directive 2009/120/EC of 14 September 2009 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products. Official Journal of the European Union 15.9. 2009. L242/3-12. 2009
    • (2009) Official Journal of the European Union 15.9. 2009. L242/3-12
  • 2
    • 85164349352 scopus 로고    scopus 로고
    • Available from: [cited 1 July 2015]
    • Regulation (EC) No 1394/2007 of the European Parliament and of the council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 official journal of the European Union, 10/12/2007. Available from: http://ec.europa.eu/health/files/eudralex/vol-1/reg_2007_1394/reg_2007_1394_en.pdf [cited 1 July 2015].
  • 4
    • 85164341720 scopus 로고    scopus 로고
    • JO L 311 du 28.11.2001, p. 67. Available from: [cited 1 July 2015]
    • Directive 2001/83/EC of the European Parliament and of the council of 6 November 2001 on the Community code relating to medicinal products for human use. JO L 311 du 28.11.2001, p. 67. Available from: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_fr.pdf [cited 1 July 2015].
  • 5
    • 84947293379 scopus 로고    scopus 로고
    • Treating patients with metastatic castration resistant prostate cancer: A comprehensive review of available therapies
    • Crawford ED, Higano CS, Shore ND, Hussain M, Petrylak DP. Treating patients with metastatic castration resistant prostate cancer: A comprehensive review of available therapies. J Urol. 2015; 194(6): 1537–47. [PubMed Abstract].
    • (2015) J Urol , vol.194 , Issue.6 , pp. 1537-1547
    • Crawford, E.D.1    Higano, C.S.2    Shore, N.D.3    Hussain, M.4    Petrylak, D.P.5
  • 6
    • 85015249064 scopus 로고    scopus 로고
    • Re-examination of regulatory opinions in Europe: Possible contribution for the approval of the first gene therapy product Glybera
    • 14066: []
    • Watanabe N, Yano K, Tsuyuki K, Okano T, Yamato M. Re-examination of regulatory opinions in Europe: Possible contribution for the approval of the first gene therapy product Glybera. Mol Ther Methods Clin Dev. 2015; 2: 14066, doi: http://dx.doi.org/10.1038/mtm.2014.66 [PubMed CentralFull Text].
    • (2015) Mol Ther Methods Clin Dev , vol.2
    • Watanabe, N.1    Yano, K.2    Tsuyuki, K.3    Okano, T.4    Yamato, M.5
  • 9
    • 85164315453 scopus 로고    scopus 로고
    • Available from: [cited 1 July 2015]
    • European Medicines Agency. EPAR summary for the public, Holoclar EMA/6865/2015, 2/2015. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002450/WC500183406.pdf [cited 1 July 2015].
    • EPAR summary for the public, Holoclar EMA/6865/2015, 2/2015
  • 10
    • 85092451306 scopus 로고    scopus 로고
    • EMA/733307/2014, 19/11/2014. Available from: [cited 1 July 2015]
    • European Medicines Agency. Closure of EU manufacturing site for MACI. 2014. EMA/733307/2014, 19/11/2014. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/Maci_20/WC500173680.pdf [cited 1 July 2015].
    • (2014) Closure of EU manufacturing site for MACI
  • 11
    • 85164369579 scopus 로고    scopus 로고
    • EMA/303072/2015, 11/5/2015. Available from: [cited 1 July 2015]
    • European Medicines Agency. Provenge, Withdrawal of the marketing authorisation in the European Union. EMA/303072/2015, 11/5/2015. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Public_statement/2015/05/WC500186950.pdf [cited 1 July 2015].
    • Provenge, Withdrawal of the marketing authorisation in the European Union
  • 12
    • 84945906575 scopus 로고    scopus 로고
    • ®)–Autopsy of an innovative paradigm change in cancer treatment: Why a single-product Biotech company failed to capitalize on its breakthrough Invention
    • ®)–Autopsy of an innovative paradigm change in cancer treatment: Why a single-product Biotech company failed to capitalize on its breakthrough Invention. Bio Drugs. 2015; 29(5):301–7.
    • (2015) Bio Drugs , vol.29 , Issue.5 , pp. 301-307
    • Jaroslawski, S.1    Toumi, M.2
  • 14
    • 84860407683 scopus 로고    scopus 로고
    • A comprehensive assessment of ATMP. Difficulties and approaches
    • Thanner M, Nagel E. A comprehensive assessment of ATMP. Difficulties and approaches. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2011; 54(7): 843–8. doi: http://dx.doi.org/10.1007/s00103-011-1300-7 [PubMed Abstract].
    • (2011) Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz , vol.54 , pp. 843-848
    • Thanner, M.1    Nagel, E.2
  • 15
    • 84857756807 scopus 로고    scopus 로고
    • Clinical development of advanced therapy medicinal products in Europe: Evidence that regulators must be proactive
    • Maciulaitis R, D'Apote L, Buchanan A, Pioppo L, Schneider CK. Clinical development of advanced therapy medicinal products in Europe: Evidence that regulators must be proactive. Mol Ther. 2012; 20(3): 479–82. [PubMed Abstract] [PubMed CentralFull Text].
    • (2012) Mol Ther , vol.20 , Issue.3 , pp. 479-482
    • Maciulaitis, R.1    D'Apote, L.2    Buchanan, A.3    Pioppo, L.4    Schneider, C.K.5
  • 16
    • 84874346554 scopus 로고    scopus 로고
    • Gene therapy clinical trials worldwide to 2012–An update
    • Ginn SL, Alexander IE, Edelstein ML, Abedi MR, Wixon J. Gene therapy clinical trials worldwide to 2012–An update. J Gene Med. 2013; 15: 65–77. doi: http://dx.doi.org/10.1002/jgm.2698 [PubMed Abstract].
    • (2013) J Gene Med , vol.15 , pp. 65-77
    • Ginn, S.L.1    Alexander, I.E.2    Edelstein, M.L.3    Abedi, M.R.4    Wixon, J.5
  • 17
    • 84936998148 scopus 로고    scopus 로고
    • Stem cell therapies in clinical trials: Progress and challenges
    • Trouson A, Mc Donald C. Stem cell therapies in clinical trials: Progress and challenges. Cell Stem Cell. 2015; 17(1): 11–22. doi: http://dx.doi.org/10.1016/j.stem.2015.06.007.
    • (2015) Cell Stem Cell , vol.17 , pp. 11-22
    • Trouson, A.1    Mc Donald, C.2
  • 18
    • 84926470092 scopus 로고    scopus 로고
    • Landscape of current and emerging cell therapy clinical trials in the UK: Current status, comparison to global trends and future perspectives
    • Bisson I, Green E, Sharpe M, Herbert C, Hyllner J, Mount N. Landscape of current and emerging cell therapy clinical trials in the UK: Current status, comparison to global trends and future perspectives. Regen Med. 2015; 10(2): 169–179. doi: http://dx.doi.org/10.2217/rme.14.71 [PubMed Abstract].
    • (2015) Regen Med , vol.10 , pp. 169-179
    • Bisson, I.1    Green, E.2    Sharpe, M.3    Herbert, C.4    Hyllner, J.5    Mount, N.6
  • 20
    • 85037563743 scopus 로고    scopus 로고
    • Market access of ATMPs: Overview and expected challenges
    • Hanna E, Tavella F, Rémuzat C, Auquier P, Toumi M. Market access of ATMPs: Overview and expected challenges. Value Health. 2015; 18(7): A518–19. [PubMed Abstract].
    • (2015) Value Health , vol.18 , Issue.7 , pp. A518-A519
    • Hanna, E.1    Tavella, F.2    Rémuzat, C.3    Auquier, P.4    Toumi, M.5
  • 21
    • 85059802999 scopus 로고    scopus 로고
    • French health technology assessment of antineoplastic drugs indicated in the treatment of solid tumours: Perspective for future trends
    • A489
    • Chouaid C, Borget I, Braun E, Bazil M, Schaetz D, Rémuzat C, etal. French health technology assessment of antineoplastic drugs indicated in the treatment of solid tumours: Perspective for future trends. Value Health. 2016; 18(7):A489.
    • (2016) Value Health , vol.18
    • Chouaid, C.1    Borget, I.2    Braun, E.3    Bazil, M.4    Schaetz, D.5    Rémuzat, C.6
  • 22
    • 85164322576 scopus 로고    scopus 로고
    • London: European Medicines Agency, Available from: [cited 14 December 2015]
    • European Medicines Agency recommends 39 medicines for human use for marketing authorisation in first half of 2014. 2014; London: European Medicines Agency.Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/07/news_detail_002135.jsp&mid=WC0b01ac058004d5c1 [cited 14 December 2015].
    • (2014)
  • 23
    • 84869093392 scopus 로고    scopus 로고
    • Is there a statistical relationship between economic crises and changes in government health expenditure growth? An analysis of twenty-four European countries
    • Cylus J, Mladovsky P, McKee M. Is there a statistical relationship between economic crises and changes in government health expenditure growth? An analysis of twenty-four European countries. Health Serv Res. 2012; 47(6): 2204–24. [PubMed Abstract] [PubMed CentralFull Text].
    • (2012) Health Serv Res , vol.47 , Issue.6 , pp. 2204-2224
    • Cylus, J.1    Mladovsky, P.2    McKee, M.3
  • 25
    • 84924404163 scopus 로고    scopus 로고
    • $1-million price tag set for Glybera gene therapy
    • Morrison C. $1-million price tag set for Glybera gene therapy. Nat Biotechnol. 2015; 33(3): 217–8. [PubMed Abstract].
    • (2015) Nat Biotechnol , vol.33 , Issue.3 , pp. 217-218
    • Morrison, C.1
  • 27
    • 84871874725 scopus 로고    scopus 로고
    • The high cost of cancer drugs and what we can do about it
    • Siddiqui M, Rajkumar SV. The high cost of cancer drugs and what we can do about it. Mayo Clin Proc. 2012; 87(10): 935–43. doi: http://dx.doi.org/10.1016/j.mayocp.2012.07.007 [PubMed Abstract] [PubMed CentralFull Text].
    • (2012) Mayo Clin Proc , vol.87 , pp. 935-943
    • Siddiqui, M.1    Rajkumar, S.V.2
  • 28
    • 84945960375 scopus 로고    scopus 로고
    • Available from: [cited 3 July 2015]
    • Institute for Quality and Efficiency in Health Care (IQWIG). Sipuleucel-T in prostate cancer: Indication of added benefit. 2015. Available from: https://www.iqwig.de/en/press/press-releases/press-releases/sipuleucel-t-in-prostate-cancer-indication-of-added-benefit.6618.html [cited 3 July 2015].
    • (2015) Sipuleucel-T in prostate cancer: Indication of added benefit
  • 29
    • 85164330436 scopus 로고    scopus 로고
    • Sipuleucel-T for treating asymptomatic or minimally symptomatic metastatic hormone-relapsed prostate cancer
    • Available from: [cited 3 July 2015]
    • National Institute for Health and Care Excellence (NICE). Sipuleucel-T for treating asymptomatic or minimally symptomatic metastatic hormone-relapsed prostate cancer. NICE technology appraisal guidance [TA332]. 2015. Available from: https://www.nice.org.uk/guidance/ta332 [cited 3 July 2015].
    • (2015) NICE technology appraisal guidance [TA332
  • 30
    • 84886722919 scopus 로고    scopus 로고
    • Economic burden of cancer across the European Union: A population-based cost analysis
    • Luengo-Fernandez R, Leal J, Gray A, Sullivan R. Economic burden of cancer across the European Union: A population-based cost analysis. Lancet Oncol. 2013; 14: 1165–74. [PubMed Abstract].
    • (2013) Lancet Oncol , vol.14 , pp. 1165-1174
    • Luengo-Fernandez, R.1    Leal, J.2    Gray, A.3    Sullivan, R.4
  • 31
    • 85164307675 scopus 로고    scopus 로고
    • Vienna: Austria; 2012. Available from: [cited 15 September 2015]
    • ESMO 2012 Press release: The true costs of cancer in Europe revealed. Vienna: Austria; 2012. Available from: http://www.esmo.org/Conferences/Past-Conferences/ESMO-2012-Congress/News-Press-Releases/ESMO-2012-Press-Releases/The-true-costs-of-cancer-in-Europe-revealed [cited 15 September 2015].


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.