Search Results - "Schneider, Christian K"

Biosimilars: what clinicians should know by Weise, Martina, Bielsky, Marie-Christine, De Smet, Karen, Ehmann, Falk, Ekman, Niklas, Giezen, Thijs J., Gravanis, Iordanis, Heim, Hans-Karl, Heinonen, Esa, Ho, Kowid, Moreau, Alexandre, Narayanan, Gopalan, Kruse, Nanna A., Reichmann, Gabriele, Thorpe, Robin, van Aerts, Leon, Vleminckx, Camille, Wadhwa, Meenu, Schneider, Christian K.

“…Biosimilar medicinal products (biosimilars) have become a reality in the European Union and will soon be available in the United States. Despite an established…”
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Risk of tumorigenicity in mesenchymal stromal cell–based therapies—Bridging scientific observations and regulatory viewpoints by Barkholt, Lisbeth, Flory, Egbert, Jekerle, Veronika, Lucas-Samuel, Sophie, Ahnert, Peter, Bisset, Louise, Büscher, Dirk, Fibbe, Willem, Foussat, Arnaud, Kwa, Marcel, Lantz, Olivier, Mačiulaitis, Romaldas, Palomäki, Tiina, Schneider, Christian K, Sensebé, Luc, Tachdjian, Gérard, Tarte, Karin, Tosca, Lucie, Salmikangas, Paula

“…Abstract In the past decade, the therapeutic value of mesenchymal stromal cells (MSCs) has been studied in various indications, thereby taking advantage of…”
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Human Genome Editing in the Clinic: New Challenges in Regulatory Benefit-Risk Assessment by Abou-El-Enein, Mohamed, Cathomen, Toni, Ivics, Zoltán, June, Carl H., Renner, Matthias, Schneider, Christian K., Bauer, Gerhard

“…As genome editing rapidly progresses toward the realization of its clinical promise, assessing the suitability of current tools and processes used for its…”
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What’s in a word? Defining “gene therapy medicines” by von Fritschen, Maren, Janosz, Ewa, Blume, Constanze, Jägle, Ulrike, Keating, Karen, Schneider, Christian K.

“…Gene therapy medicinal products (GTMPs) have emerged as a transformative class of medicines. Defining what a certain class of medicines encompasses, and what…”
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Biosimilars in rheumatology: the wind of change by Schneider, Christian K

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Regulatory evaluation of Glybera in Europe — two committees, one mission by Melchiorri, Daniela, Pani, Luca, Gasparini, Paolo, Cossu, Giulio, Ancans, Janis, Borg, John Joseph, Drai, Catherine, Fiedor, Piotr, Flory, Egbert, Hudson, Ian, Leufkens, Hubert G., Müller-Berghaus, Jan, Narayanan, Gopalan, Neugebauer, Brigitte, Pokrotnieks, Juris, Robert, Jean-Louis, Salmonson, Tomas, Schneider, Christian K.

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Biosimilars: the science of extrapolation by Weise, Martina, Kurki, Pekka, Wolff-Holz, Elena, Bielsky, Marie-Christine, Schneider, Christian K.

“…Despite the establishment of a specific approval pathway, the issuance of detailed scientific guidelines for the development of similar biological medicinal…”
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Manufacturing, characterization and control of cell-based medicinal products: challenging paradigms toward commercial use by Salmikangas, Paula, Menezes-Ferreira, Margarida, Reischl, Ilona, Tsiftsoglou, Asterios, Kyselovic, Jan, Borg, John Joseph, Ruiz, Sol, Flory, Egbert, Trouvin, Jean-Hugues, Celis, Patrick, Ancans, Janis, Timon, Marcos, Pante, Guido, Sladowski, Dariusz, Lipnik-Stangelj, Metoda, Schneider, Christian K

“…During the past decade, a large number of cell-based medicinal products have been tested in clinical trials for the treatment of various diseases and tissue…”
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Reconstitution of Paired T Cell Receptor α- and β-Chains from Microdissected Single Cells of Human Inflammatory Tissues by Seitz, Sabine, Schneider, Christian K., Malotka, Joachim, Nong, Xiao, Engel, Andrew G., Wekerle, Hartmut, Hohlfeld, Reinhard, Dornmair, Klaus

“…We describe a strategy to "revive" putatively pathogenic T cells from frozen specimens of human inflammatory target organs. To distinguish pathogenic from…”
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Development of the First World Health Organization Lentiviral Vector Standard: Toward the Production Control and Standardization of Lentivirus-Based Gene Therapy Products by Zhao, Yuan, Stepto, Hannah, Schneider, Christian K

“…Gene therapy is a rapidly evolving field. So far, there have been >2,400 gene therapy products in clinical trials and four products on the market. A…”
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Deciphering the EU clinical trials regulation by Abou-El-Enein, Mohamed, Schneider, Christian K

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Toward experimental assessment of receptor occupancy: TGN1412 revisited by Waibler, Zoe, PhD, Sender, Linda Y, Kamp, Christel, PhD, Müller-Berghaus, Jan, MD, Liedert, Bernd, PhD, Schneider, Christian K., MD, Löwer, Johannes, MD, PhD, Kalinke, Ulrich, PhD

“…In March 2006, 6 healthy volunteers experienced serious adverse reactions during a first-in-human clinical trial of the superagonistic anti-CD28 mAb TGN1412. A…”
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Diagnostics and the coronavirus: don’t let the standards slip by Page, Mark, Almond, Neil, Rose, Nicola J., Schneider, Christian K.

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Clinical Development of Advanced Therapy Medicinal Products in Europe: Evidence That Regulators Must Be Proactive by Maciulaitis, Romaldas, D'Apote, Lucia, Buchanan, Andrew, Pioppo, Laura, Schneider, Christian K

“…Advanced therapy medicinal products (ATMPs), defined as gene therapy medicinal products (GTMPs), somatic cell therapy medicinal products, and tissue-engineered…”
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Toward biosimilar monoclonal antibodies by Schneider, Christian K, Kalinke, Ulrich

“…To what extent is the existing framework for biosimilars in Europe likely to be applicable to monoclonal antibodies?…”
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Maintaining ‘standards’ for biosimilar monoclonal antibodies by Prior, Sandra, Metcalfe, Clive, Hufton, Simon E., Wadhwa, Meenu, Schneider, Christian K., Burns, Chris

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Cell therapy products: focus on issues with manufacturing and quality control of chimeric antigen receptor T‐cell therapies by Eyles, Jim E, Vessillier, Sandrine, Jones, Anika, Stacey, Glyn, Schneider, Christian K, Price, Jack

“…Recent accelerated approvals of Chimeric Antigen Receptor T‐cell (CAR‐T) therapies targeting refractory haematological malignancies underscore the potential…”
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Development and Regulation of Biosimilars: Current Status and Future Challenges by Tsiftsoglou, Asterios S., Ruiz, Sol, Schneider, Christian K.

“…Biologic medicinal products developed via rDNA technology as recombinant protein-based medicines that have been in clinical use since the early 1980s as…”
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The risks of risk aversion in drug regulation by Eichler, Hans-Georg, Bloechl-Daum, Brigitte, Brasseur, Daniel, Breckenridge, Alasdair, Leufkens, Hubert, Raine, June, Salmonson, Tomas, Schneider, Christian K., Rasi, Guido

“…Regulatory agencies have been criticized both for being overly tolerant of risks or being excessively risk-averse, but the potential for adverse effects on…”
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Biosimilars—why terminology matters by Weise, Martina, Bielsky, Marie-Christine, De Smet, Karen, Ehmann, Falk, Ekman, Niklas, Narayanan, Gopalan, Heim, Hans-Karl, Heinonen, Esa, Ho, Kowid, Thorpe, Robin, Vleminckx, Camille, Wadhwa, Meenu, Schneider, Christian K

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