Anti-Biopharmaceutical Immunization: prediction
and analysis of clinical relevance to minimize the RISK
Publications repository & other external communications
2018 |
Published papers |
Lilija Miller, Eva Ringler, Klaus Maximilian Kistner, Zoe Waibler, on behalf of ABIRISK consortium.
Human Dendritic Cells Synergistically Activated by FVIII Plus LPS Induce Activation of Autologous CD4+ T Cells.
Thromb Haemost. 2018 Mar 19. doi: 10.1055/s-0038-1637734. [Epub ahead of print]
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Christine Keipert, Carla J. Jonker, H. Marijke van den Berg and Anneliese Hilger.
Clinical Trials and Registries in rare diseases: Opponents or collaborators? Comparison of Hemophilia A PUP data derived from different data sources.
Haemophilia. Feb 13. doi: 10.1111/hae.13421. [Epub ahead of print].
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Florian Deisenhammer, Marlies Jank, Anna Lauren, Anders Sjödin, Malin Ryner, Anna Fogdell-Hahn, Claudia Sievers, Raija Lindberg, Poul Erik Jensen, Finn Sellebjerg, Louis Christodoulou, Mary Birchler, Marc Pallardy, Michael Auer, Roland Liblau, ABIRISK consortium.
Prediction of Natalizumab anti-drug antibodies persis.
Mult Scler. 2018 Jan 1:1352458517753721. doi: 10.1177/1352458517753721. [Epub ahead of print]
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2017 |
Published papers |
Sylvain Meunier, Catherine Menier, Elodie Marcon, Sébastien Lacroix-Desmazes and Bernard Maillère.
CD4 T cells specific for Factor VIII are present at high frequency in healthy donors and comprise both naïve and memory cells.
Blood Adv. 2017 Sep 25;1(21):1842-1847. doi: 10.1182/bloodadvances.2017008706. eCollection 2017 Sep 26.
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Sudhakar Reddy Kalluri, Verena Grummela, Zsussanna Hrascoa, Viola Biberachera, Verena Pernpeintnera, Christiane Gasperia, Dorothea Bucka, Bernhard Hemmer; ABIRISK Consortium.
Interferon-beta specific T cells are associated with the development of neutralizing antibodies in interferon-beta treated multiple.
J Autoimmun. 2017 Oct 20. pii: S0896-8411(17)30587-5.
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Sarah Flora Jonas, Cyprien Mbogning, Philippe Broët.
A test for comparing current status survival data with crossing hazard functions and its application to immunogenicity of biotherapeutics.
Stat Med. 2017 Aug 30. doi: 10.1002/sim.7439. [Epub ahead of print]
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Nicky Dunn, Alexander Juto, Malin Ryner, Ali Manouchehrinia, Katharina Fink, Fredrik Piehl, Anna Fogdell-Hahn.
Rituximab in multiple sclerosis; Frequency and clinical relevance of anti-drug antibodies.
Mult Scler. 2017 Jul 1:1352458517720044. doi: 10.1177/1352458517720044. [Epub ahead of print]
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Heidi S. Schultz, Stine Louise Reedtz-Runge, Björn Thomas Bäckström, Kasper Lamberth, Christian R. Pedersen, Anne M. Kvarnhammar, on behalf of the ABIRISK consortium.
Quantitative analysis of the CD4+ T cell response to therapeutic antibodies and coagulation factor VIII (FVIII) in healthy donors using a novel T cell:PBMC assay.
PLoS One. 2017 May 31;12(5):e0178544.
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Jenny Link, Ryan Ramanujam, Michael Auer, Malin Ryner, Signe Hässler, Delphine Bachelet, Cyprien Mbogning, Clemens Warnke, Dorothea Buck, Poul Erik Hyldgaard Jensen, Claudia Sievers, Kathleen Ingenhoven, Nicolas Fissolo, Raija Lindberg, Verena Grummel, Naoimh Donnellan, Véronique Berthou, Manuel Comabella, Xavier Montalban, Bernd Kieseier, Per Soelberg Sorensen, Hans-Peter Hartung, Tobias Derfuss, Andy Lawton, Dan Sikkema, Marc Pallardy, Bernhard Hemmer, Florian Deisenhammer, Philippe Broët, Pierre Dönnes, Julie Davidson, Anna Fogdell-Hahn, on behalf of the ABIRISK Consortium.
Clinical practice of analysis of anti-drug antibodies against interferon beta and natalizumab in multiple sclerosis patients in Europe: a descriptive study of test results.
PLoS One. 2017 Feb 7;12(2):e0170395.
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Oral presentations |
American Association of Pharmaceutical Scientists AAPS – Annual Meeting, San Diego
Sebastian Spindeldreher (Novartis)
12-15 November 2017
3rd European Workshop on Protein Aggregation and Immunogenicity, Innsbruck, Austria
Catherine Prades (SARD)
30-31 January 2017
2016 |
Published papers |
Michael Auer, Harald Hegen, Thomas Luft, Gabriel Bsteh, Anna Fogdell-Hahn, Amy Loercher and Florian Deisenhammer; on behalf of the ABIRISK consortium.
Serum cotinine does not predict neutralizing antibodies against Interferon-beta in an Austrian MS-cohort.
J Interferon Cytokine Res. 2016 Dec;36(12):667-670. Epub 2016 Oct 19.
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Anja Schmidt and Christoph Königs on behalf of the ABIRISK consortium.
Regulatory T cells and their potential for tolerance induction in haemophilia A patients.
Hamostaseologie. 2016 Nov 8;36(Suppl. 2):S5-S12.
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Bachelet, D, Hässler, C. Mbogning, J. Link, M. Ryner, R. Ramanujam, M. Auer, P.E. Hyldgaard Jensen, N. Koch-Henriksen, C. Warnke, K. Ingenhoven, D. Buck, V. Grummel, A. Lawton, V. Berthou, N. Donnellan, A. Hincelin-Mery, D. Sikkema, M. Pallardy, B. Kieseier, B. Hemmer, H. Hartung, P. Soelberg Sorensen, F. Deisenhammer, P. Dönnes, J. Davidson, A. Fogdell-Hahn, P. Broët.
Occurrence of anti-drug antibodies against interferon-beta and natalizumab in multiple sclerosis: A collaborative cohort analysis.
PLoS One. 2016 Nov 2;11(11):e0162752.
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Y Gallais, N Szely, F-X Legrand, A Leroy, M Pallardy, I Turbica, on behalf of the ABIRISK Consortium.
Effect of growth hormone and IgG aggregates on dendritic cells activation and T-cells polarization.
Immunol Cell Biol. 2016 Oct 7. doi: 10.1038/icb.2016.100. [Epub ahead of print]
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Vultaggio A, Petroni G, Pratesi S, Nencini F, Cammelli D, Milla M, Prignano F, Annese V, Romagnani S, Maggi E, Matucci A; ABIRISK Consortium.
Circulating T cells to infliximab are mainly detectable in treated patients developing anti-drug antibodies and hypersensitivity reactions.
Clin Exp Immunol. 2016 Dec;186(3):364-372. doi: 10.1111/cei.12858.
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Roni Weisshof, Bella Ungar, Alexandra Blatt, Aviva Dahan, Matti Waterman, Uri Kopylov, Shomron Ben-Horin and Yehuda Chowers, on behalf of the ABIRISK consortium.
Anti-infliximab antibodies with neutralizing capacity in inflammatory bowel disease patients: Distinct clinical implications revealed by a novel assay.
Inflamm Bowel Dis. 2016 Jul;22(7):1655-61.
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Cyprien Mbogning and Philippe Broët.
Bagging survival tree procedure for variable selection and prediction in the presence of nonsusceptible patients.
BMC Bioinformatics. 2016 Jun 7;17(1):230.
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Karine Chemin, Sabrina Pollastro, Eddie James, Changrong Ge, Inka Albrecht, Jessica Herrath, Christina Gerstner, Karolina Tandre, T.S. Rizzi, Lars Rönnblom, Anca Catrina, Rikard Holmdahl, Lars Klareskog, Niek de Vries, Vivianne Malmström.
A novel HLA-DRB1*10:01 restricted T cell epitope from citrullinated type II collagen relevant for Rheumatoid Arthritis.
Arthritis Rheumatol. 2016 May;68(5):1124-35.
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Ing M, Gupta N, Teyssandier M, Maillère B, Pallardy M, Delignat S, Lacroix-Desmazes S; ABIRISK consortium.
Immunogenicity of long-lasting recombinant factor VIII products.
Cell Immunol. 2016 Mar;301:40-8.
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Hermanrud Christina, Ryner Malin, Luft Thomas, Jensen Poul Erik, Ingenhoven Kathleen, Rat Dorothea, Deisenhammer Florian, Soelberg Sørensen Per, Bertotti Elisa, Kramer Daniel, Creeke Paul, Fogdell-Hahn Anna, on behalf of the ABIRISK consortium.
Development and validation of cell-based luciferase reporter gene assays for measuring neutralizing antibodies to interferon beta.
J Immunol Methods. 2016 Mar; 430:1-9. doi: 10.1016/j.jim.2016.01.004. Epub 2016 Jan11.
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Oral presentations |
32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), London, UK
Marsilio Adriani (UCL)
14-17 September 2016
Immunogenicity Workshop, London, UK
Dan Sikkema (GSK)
13–14 June 2016
The Essential Protein Engineering Summit (PEG) 2016, Boston, MA
Florian Deisenhammer (IMU)
25-29 April 2016
Drug Hypersensitivity Meeting 2016 of European Academy of Allergology and Clinical Immunology (EAACI), Malaga, Spain
Enrico Maggi (UNIFI)
21–23 April 2016
The 68th American Academy of Neurology Annual Meeting, Vancouver, Canada
Signe Hässler (INSERM)
15-21 April 2016
8th European Immunogenicity Platform Symposium, Lisboa, Portugal
Anna Fogdell-Hahn (KI)
Timothy Hickling (Pfizer)
Bernard Maillère (CEA)
22-24 February 2016
2015 |
Published papers |
Cécile Desvignes, Soujanya Ratna Edupuganti, Francois Darrouzain, Anne-Claire Duveau, Gilles Painteaud, Denis Mulleman.
Development and validation of Enzym-Linked Immunosorbent assay to study adalimumab pharmcokinetics.
Bioanalysis 2015;7(10):1253-60.
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Cyprien Mbogning, Hervé Perdry and Philippe Broët.
A Bagged partially linear tree-based regression procedure for prediction and variable selection.
Human Heredity 2015 Jul;79(3-4):182-93.
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Christine Keipert, Janina Hesse, Birgit Haschberger, Margarethe Heiden, Rainer Seitz, Marijke van den Berg, and Anneliese Hilger.
The growing number of haemophilia registries: Quantity versus Quality.
Clinical Pharmacology & Therapeutics 2015 May;97(5):492-501.
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Lilija Miller, Sabrina Weissmüller, Eva Ringler, Peter Crauwels, Ger van Zandbergen, Rainer Seitz, Zoe Waibler, on behalf of ABIRISK consortium.
Danger signal-dependent activation of human dendritic cells by plasma-derived factor VIII products.
Thrombosis and Heamostasis 2015 Jul 28;114(2):268-76.
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Rup B, Pallardy M, Sikkema D, Albert T, Allez M5, Broet P, Carini C, Creeke P, Davidson J, De Vries N, Finco D, Fogdell-Hahn A, Havrdova E, Hincelin-Mery A, Holland MC, Erik P, Jensen H, Jury EC, Kirby H, Kramer D, Lacroix-Desmazes S, Legrand J, Maggi E, Maillère B, Mariette X, Mauri C, Mikol V, Mulleman D, Oldenburg J, Paintaud G, Ross Pedersen C, Ruperto N, Seitz R, Spindeldreher S, Deisenhammer F, ABIRISK Consortium.
Standardizing terms, definitions and concepts for describing and interpreting unwanted immunogenicity of biopharmaceuticals: Recommendations of the innovative medicines initiative ABIRISK consortium.
Clinical and Experimental Immunology 2015 Sep;181(3): 385-400.
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Warnke C, Stettner M, Lehmensiek V, Dehmel T, Mausberg AK, von Geldern G, Gold R, Kümpfel T, Hohlfeld R, Mäurer M, Stangel M, Straeten V, Limmroth V, Weber T, Kleinschnitz C, Wattjes MP, Svenningsson A, Olsson T, Hartung HP, Hermsen D, Tumani H, Adams O, Kieseier BC.
Natalizumab exerts a suppressive effect on surrogates of B cell function in blood and CSF.
Mult Scler. 2015 Jul;21(8):1036-44.
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Oral presentations |
Immunogenicity of TNF-alpha inhibitors course, Goteborg, Sweden
Anna Fogdell-Hahn (KI)
26-27 November 2015
2015 BioSafe European Annual General Membership Meeting, Ludwigshafen, Germany
Sebastian Spindeldreher(Novartis Pharma)
4-5 November 2015
2015 tranSMART Foundation Annual Meeting
Pierre Doennes (SciCross)
19-21 October 2015
Pfizer Immunogenicity Research Forum, Nice, France
Anna Fogdell-Hahn (KI)
15-16 September 2015
U.S. Food and Drug Administration (FDA) workshop “New Methods to Predict the Immunogenicity
of Therapeutic Coagulation Proteins”, Bethesda, Maryland
Dan Sikkema (GSK)
Timothy Hickling (Pfizer)
17-18 September 2015
Satellite Symposium on Immunogenicity of Biopharmaceuticals, Vienna, Austria
Florian Deisenhammer (IMU)
Claudia Mauri (UCL)
Bernard Maillère (CEA)
6 September 2015
4th European Congress of Immunology, Vienna, Austria
Alessandra Vultaggio (UNIFI)
Sara Pratesi (UNIFI)
6-9 September 2015
Workshop on Haemophilia Registries, European Medicines Agency (EMA), London, UK
Christine Keipert (PEI)
1-2 July 2015
7th Open 7th Open Scientific European Immunogenicity Platform (EIP) Symposium on Immunogenicity
of Biopharmaceuticals, Lisbon, Portugal
Sebastian Spindeldreher (Novartis Pharma)
Florian Deisenhammer and Thomas Luft (IMU)
Paul Creeke (QMUL)
Tim Hickling (Pfizer)
23–25 February 2015
2015 FDA/BioSafe/DruSafe Meeting, Silver Springs, Maryland
Sebastian Spindeldreher (Novartis Pharma)
26 June 2015
Poster presentations |
4th European Congress of Immunology, Vienna, Austria
Andrea Matucci (UNIFI)
J. Link (KI)
Moustafa Hamze (CEA)
Peter Milanov (DRK-BSD)
Yann Gallais (INSERM)
Delphine Bachelet and Signe Hässler (INSERM)
6-9 September 2015
2014 |
Published papers |
Warnke C, Dehmel T, Ramanujam R, Holmen C, Nordin N, Wolfram K, Leussink VI, Hartung HP, Olsson T, Kieseier BC.
Initial lymphocyte count and low BMI may affect fingolimod-induced lymphopenia.
Neurology. 2014 Dec 2;83(23):2153-7.
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Nencini F, Pratesi S, Petroni G, Matucci A, Maggi E, Vultaggio A.
Assays and strategies for immunogenicity assessment of biological agents.
Drug Dev Res. 2014 Nov;75 Suppl 1:S4-6.
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Warnke C, von Geldern G, Markwerth P, Dehmel T, Hoepner R, Gold R, Pawlita M, Kümpfel T, Mäurer M, Stangel M, Wegner F, Hohlfeld R, Straeten V, Limmroth V, Weber T, Hermsen D, Kleinschnitz C, Hartung HP, Wattjes MP, Svenningson A, Major E, Olsson T, Kieseier BC, Adams O.
Cerebrospinal fluid JC virus antibody index for diagnosis of natalizumab-associated progressive multifocal leukoencephalopathy.
Ann Neurol. 2014 Dec;76(6):792-801.
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Lundkvist Ryner M, Farrell RA, Fogdell-Hahn A.
The case for measuring anti-drug antibodies in people with multiple sclerosis.
Expert Rev Clin Immunol. 2014 Jun; 10(6):697-9.
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Mbogning C, Perdry H, Toussile W, Broët P.
A novel tree-based procedure for deciphering the genomic spectrum of clinical disease entities.
J Clin Bioinforma. 2014 Apr 16; 4:6.
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Link J, Lundkvist Ryner M, Fink K, Lima I, Brynedal B, Kockum I, Hillert J, Fogdell-Hahn A.
Human leukocyte antigen genes and interferon Beta preparations influence risk of developing neutralizing anti-drug antibodies in multiple sclerosis.
PLoS One. 2014 Mar 7: 9(3):e90479 doi:10.1371.
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Pashov AD, Calvez T, Gilardin L, Maillère B, Repessé Y, Oldenburg J, Pavlova A, Kaveri SV, Lacroix-Desmazes S.
In silico calculated affinity of FVIII-derived peptides for HLA class II alleles predicts inhibitor development in haemophilia A patients with missense mutations in the F8 gene.
Haemophilia. 2014 Mar;20(2):176-84.
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Ungar B, Chowers Y, Yavzori M, Picard O, Fudim E, Har-Noy O, Kopylov U, Eliakim R, Ben-Horin S; on behalf of ABIRISK consortium.
The temporal evolution of antidrug antibodies in patients with inflammatory bowel disease treated with infliximab.
Gut. 2014 Aug;63(8):1258-64.
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Oral presentations |
Exploratory Clinical Development World Europe, London
Sylvia Julien (IPSEN)
3–5 June 2014
International Organization For the Study of Inflammatory Bowel Disease meeting, Amsterdam, The Netherlands
Yehuda Chowers (RAMBAM)
March 2014
Mastering Immunogenicity Conference, Boston, USA
Amy Loercher (GSK)
Sept 2014
PEGS, Boston, USA
Florian Deisenhammer (IMU)
May 2014
Presentation at conference
DHM6 Drug Hypersensitivity Meeting 6, Bern, Switzerland
Alessandra Vultaggio (UNIFI)
9-12 Apr 2014
AAPS, National Biotechnology Conference, San Diego, USA HOT TOPIC
Bonnie Rup (Pfizer)
Bernard Maillère (CEA)
Sebastian Spindeldreher (Novartis)
20 May 2014
Pfizer Immunogenicity Meeting, Oslo, Norway
Anna Fogdell-Hahn (KI)
12 Feb 2014
German Society for Transfusion Medicine and Immunohematology, Dresden, German
Peter Milanov (DRK-BSD)
12-14 Sep 2014
Danish Agency for Science, Technology, and Innovation
Arsalan Kharazmi (BM)
28 August 2014
6th European Immunogenicity Plateform Symposium, Lisboa, Portugal
Liz Jury (UCL)
Bernard Maillère(CEA)
Marc Pallardy (Inserm2)
23-25 Feb 2014
Immunogenicity for Biologics, Berlin, Germany
Bernard Maillère (CEA)
9-10 Sep 2014
Coral Gables Symposium, Miami, USA
Claudia Mauri (UCL)
Bernard Maillere (CEA)
Sebastian Spindeldreher (Novartis)
Florian Deisenhammer IMU
6 Apr 2014
Immunoconvention, Berlin, Germany
Anna Fogdell-Hahn ( KI)
Denis Mulleman (CNRS)
Bonnie Rup (Pfizer)
Michael Tovey (BM)
31 Oct - 1 Nov 2014
Poster presentations |
PhD's conference day, University Paris Sud, Orsay, France
Yann Gallais (Inserm 2)
25-27 Feb 2014
LabEx LERMIT annual symposium, Orsay, France
Yann Gallais (Inserm2)
21 Nov 2014
9th National SIICA Conference, Florence, Italy
Francesca Nencini (UNIFI)
Giulia Petroni (UNIFI)
28-31 May 2014
EAACI (European Academy of Allergy and Clinical Immunology) Congress 2014, Copenhagen, Denmark
Andrea Matucci (UNIFI)
Giulia Petroni (UNIFI)
7-11 June 2014
2013 |
Published papers |
Creeke PI, Farrell RA.
Clinical testing for neutralizing antibodies to interferon-β in multiple sclerosis.
Ther Adv Neurol Disord. 2013 Jan;6(1):3-17.
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Repesse Y, Peyron I, Dimitrov JD, Dasgupta S, Farrokhi Moshai E, Costa C, Borel-Derlon A, Guillet B, D' Oiron R,Aouba A,
Rothschild C, Oldenburg J, Pavlova A, Kaveri SV, Lacroix-Desmazes S.
Development of inhibitory antibodies to therapeutic factor VIII in severe hemophilia A is associated with
microsatellite polymorphism in the HMox1 promoter.
Haematologica. 2013 May 28; 28(10): 1650-1655.
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Teyssandier M., André S., Gupta N., Dasgupta S., Bayry J., Kaveri S.V., Lacroix-Desmazes S.; The ABIRISK Consortium.
Therapeutic factor VIII does not trigger TLR1.2 and TLR2.6 signalling in vitro.
Haemophilia. 2013 May;19(3):399-402).
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Matucci A, Pratesi S, Petroni G, Nencini F, Virgili G, Milla M, Maggi E, Vultaggio A.
Allergological in vitro and in vivo evaluation of patients with hypersensitivity reactions to infliximab.
Clin Exp Allergy. 2013 Jun;43(6) : 659-64.
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Oral presentations |
Institute of Therapeutic Innovation, Paris Sud University, Châtenay-Malabry, France
Bernard Maillere (CEA)
Marc Pallardy (Inserm)
14 Oct 2013
9th Annual Meeting of The Institute of Therapeutic Innovation School, Paris Sud University, Le Kremlin-Bicêtre, France
Bernard Maillere (CEA)
17-18 June 2013
3rd Mastering Immunogenicity Conference, Boston, USA
Florian Deisenhammer (IMU)
16-17 Sep 2013
PEGS Immunogenicity prediction and mitigation
Dan Sikkema (GSK)
Bernard Maillere (CEA)
29 Apr - 4 May 2013
AAPS, San Antonio, Texas, USA
Bonnie Rup (Pfizer)
10-14 October 2013
EUROTOX, Interlaken, Switzerland
Marc Pallardy (Inserm2)
1-4 Sept 2013
LabEx LERMIT annual symposium, Orsay, France
Marc Pallardy (Inserm2)
26 Nov 2013
European Immunogenicity Plateform Symposium, Munich, Germany
Marc Pallardy (Inserm 2)
25-27 Feb 2013
Immunogenicity for mAbs, RABs, ADCs, Peptides, Bispecifics and Biosimilars, London UK
Dan Sikkema (GSK)
13-14 Mar 2013
Coral Gables Symposium, Miami, USA
Florian Deisenhammer ( IMU)
Claudia Mauri (UCL)
Sebastian Spindeldreher (Novartis)
Bernard Maillere (CEA)
24-28 Apr 2013
Poster presentations |
B cell Autoimmunity, Milan, Italy
William Sanderson (UCL)
24 Aug 2013
International Congress of Immunology , Milan, Italy
William Sanderson (UCL)
20-21 Aug 2013
German Society for Immunology, Mainz, Germany
Zoe Waibler (PEI)
11-13 Sep 2013
2012 |
Oral presentation |
Mastering Immunogenicity, Boston
Sebastian Spindeldreher (Novartis)
18-09-2012
Drug Hypersensitivity Meeting 2012, Munich
Sebastian Spindeldreher (Novartis)
12-04-2012
Regulatory aspects in Innovative Medicines Initiatives Projects’, EMA, London, UK
Dan Sikkema (GSK)
07-11-2012
Munich, EEACI “Drug Hypersensitivity meeting 5”
Enrico Maggi (UNIFI)
11-14/04- 2012
Munich, EEACI “Drug Hypersensitivity meeting 5”
Alessandra Vultaggio (UNIFI)
11-14/04-2012
Miami, Coral Gables Symposium 2012
Enrico Maggi (UNIFI)
18-21/04-2012
Geneva, EEACI Congress 2012
Alessandra Vultaggio (UNIFI)
16-20/06 - 2012
Wissenschaftliche Zweijahrestagung der Ständigen Kommission Pädiatrie der GTH (Conference of the pediatric committee of the Society of Thrombosis and Haemostasis research) Hannover, Germany
Christoph Königs (KGU)
30-09-2012
Immunogenicity of Biopharmaceuticals; Miami , USA
Florian Deisenhammer (IMU)
21-04-2012
“Academia meets Industry” - Senate of the Parliament of the Czech Republic
Petra Nytrova (CUNI)
27-11-2012