Literature DB >> 22378030

Clinical development of advanced therapy medicinal products in Europe: evidence that regulators must be proactive.

Romaldas Maciulaitis1, Lucia D'Apote, Andrew Buchanan, Laura Pioppo, Christian K Schneider.   

Abstract

Mesh：

Year:  2012        PMID： 22378030      PMCID： PMC3293601          DOI： 10.1038/mt.2012.13

Source DB:  PubMed          Journal:  Mol Ther        ISSN： 1525-0016            Impact factor:   11.454


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  8 in total

1.  Comparison of different isolation techniques prior gene expression profiling of blood derived cells: impact on physiological responses, on overall expression and the role of different cell types.

Authors:  S Debey; U Schoenbeck; M Hellmich; B S Gathof; R Pillai; T Zander; J L Schultze
Journal:  Pharmacogenomics J       Date:  2004       Impact factor: 3.550

2.  Stem-cell pioneer bows out.

Authors:  Monya Baker
Journal:  Nature       Date:  2011-11-22       Impact factor: 49.962

3.  Use of unregulated stem-cell based medicinal products.

Authors: 
Journal:  Lancet       Date:  2010-08-14       Impact factor: 79.321

4.  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.

Authors: 
Journal:  Med Etika Bioet       Date:  2002 Spring-Summer

Review 5.  Typical pitfalls in applications for marketing authorization of biotechnological products in Europe.

Authors:  Christian K Schneider; Gabriele Schäffner-Dallmann
Journal:  Nat Rev Drug Discov       Date:  2008-11       Impact factor: 84.694

6.  Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency.

Authors:  Jan Regnstrom; Franz Koenig; Bo Aronsson; Tatiana Reimer; Kristian Svendsen; Stelios Tsigkos; Bruno Flamion; Hans-Georg Eichler; Spiros Vamvakas
Journal:  Eur J Clin Pharmacol       Date:  2009-11-20       Impact factor: 2.953

7.  European regulation tackles tissue engineering.

Authors:  Ralf Sanzenbacher; Anne Dwenger; Martina Schuessler-Lenz; Klaus Cichutek; Egbert Flory
Journal:  Nat Biotechnol       Date:  2007-10       Impact factor: 54.908

Review 8.  Challenges with advanced therapy medicinal products and how to meet them.

Authors:  Christian K Schneider; Paula Salmikangas; Bernd Jilma; Bruno Flamion; Lyubina Racheva Todorova; Anna Paphitou; Ivana Haunerova; Toivo Maimets; Jean-Hugues Trouvin; Egbert Flory; Asterios Tsiftsoglou; Balázs Sarkadi; Kolbeinn Gudmundsson; Maura O'Donovan; Giovanni Migliaccio; Jānis Ancāns; Romaldas Maciulaitis; Jean-Louis Robert; Anthony Samuel; Johannes H Ovelgönne; Marit Hystad; Andrzej Mariusz Fal; Beatriz Silva Lima; Anca Stela Moraru; Peter Turcáni; Robert Zorec; Sol Ruiz; Lennart Akerblom; Gopalan Narayanan; Alastair Kent; Fabrizia Bignami; J George Dickson; Dietger Niederwieser; María-Angeles Figuerola-Santos; Ilona G Reischl; Claire Beuneu; Rosen Georgiev; Maria Vassiliou; Alena Pychova; Mette Clausen; Taina Methuen; Sophie Lucas; Martina Schüssler-Lenz; Vasilios Kokkas; Zsuzsanna Buzás; Niall MacAleenan; Maria Cristina Galli; Aija Linē; Jolanta Gulbinovic; Guy Berchem; Mariusz Fraczek; Margarida Menezes-Ferreira; Nela Vilceanu; Mikulás Hrubisko; Petra Marinko; Marcos Timón; Wing Cheng; George Andrew Crosbie; Nick Meade; Michelino Lipucci di Paola; Thierry VandenDriessche; Per Ljungman; Lucia D'Apote; Olga Oliver-Diaz; Isabel Büttel; Patrick Celis
Journal:  Nat Rev Drug Discov       Date:  2010-03       Impact factor: 84.694
  8 in total
  17 in total

1.  CASMI TSCC launch event, Paris, France, July 2013: an assessment of the key barriers to the commercialization and clinical adoption of pluripotent stem cell therapies.

Authors:  Anna French; Kim Bure; David A Brindley
Journal:  Rejuvenation Res       Date:  2014-02       Impact factor: 4.663

2.  From lipoproteins to chondrocytes: a brief summary of the European Medicines Agency's regulatory guidelines for advanced therapy medicinal products.

Authors:  Sadik H Kassim; Robert P T Somerville
Journal:  Hum Gene Ther       Date:  2013-06       Impact factor: 5.695

3.  Regulatory evaluation of Glybera in Europe - two committees, one mission.

Authors:  Daniela Melchiorri; Luca Pani; Paolo Gasparini; Giulio Cossu; Janis Ancans; John Joseph Borg; Catherine Drai; Piotr Fiedor; Egbert Flory; Ian Hudson; Hubert G Leufkens; Jan Müller-Berghaus; Gopalan Narayanan; Brigitte Neugebauer; Juris Pokrotnieks; Jean-Louis Robert; Tomas Salmonson; Christian K Schneider
Journal:  Nat Rev Drug Discov       Date:  2013-08-19       Impact factor: 84.694

4.  Regulation of cell-based therapies in Europe: current challenges and emerging issues.

Authors:  Alessandro Blasimme; Emmanuelle Rial-Sebbag
Journal:  Stem Cells Dev       Date:  2013-12       Impact factor: 3.272

5.  Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Products Successfully to the Market - Report from the CAT-DGTI-GSCN Workshop at the DGTI Annual Meeting 2014.

Authors:  Patrick Celis; Nicolas Ferry; Marit Hystad; Martina Schüßler-Lenz; Pieter A Doevendans; Egbert Flory; Claire Beuneu; Ilona Reischl; Paula Salmikangas
Journal:  Transfus Med Hemother       Date:  2015-04-28       Impact factor: 3.747

6.  Perspective: communications with the Food and Drug Administration on the development pathway for a cell-based therapy: why, what, when, and how?

Authors:  Ellen G Feigal; Katherine Tsokas; Jiwen Zhang; Marc V Cromer; Kevin J Whittlesey; Michael J Werner
Journal:  Stem Cells Transl Med       Date:  2012-10-17       Impact factor: 6.940

7.  Whither advanced therapy medicinal products?

Authors:  Mark D Smith; Jan C Brune; Britt Wildemann; Axel Pruss
Journal:  Transfus Med Hemother       Date:  2013-11-12       Impact factor: 3.747

8.  White paper on how to go forward with cell-based advanced therapies in Europe.

Authors:  Reinhold G Erben; Beatriz Silva-Lima; Ilona Reischl; Gustav Steinhoff; Gudrun Tiedemann; Wilfried Dalemans; Alexander Vos; Rob T A Janssen; Katarina Le Blanc; Gerjo J V M van Osch; Frank P Luyten
Journal:  Tissue Eng Part A       Date:  2014-06-03       Impact factor: 3.845

Review 9.  Advanced Therapy Medicinal Products and the Changing Role of Academia.

Authors:  Christoph Priesner; Martin Hildebrandt
Journal:  Transfus Med Hemother       Date:  2022-05-16       Impact factor: 4.040

Review 10.  Regulatory authorities and orthopaedic clinical trials on expanded mesenchymal stem cells.

Authors:  Enrique Gómez-Barrena; Cristina Avendaño Solá; Carmen Painatescu Bunu
Journal:  Int Orthop       Date:  2014-04-15       Impact factor: 3.075
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