Opening Remarks to the 10th International
Paul-Ehrlich-Seminar
Wolf-Meinhard Becker, Borstel, Germany ....................... 1
Welcome Address
Klaus Cichutek, Vice President of the
Paul-Ehrlich-Institut
Ernst Th. Rietschel, Acting Director of the
Forschungszentrum Borstel .................................... 1
Current State of Regulation
Chairmen: Samuel B. Lehrer, Oliver Cromwell .................. 5
The EAMG position on the regulation of existing products
for treatment with special reference to named patient
products (NPPs)
Albert M. Kroon .............................................. 7
Discussion ..................................................... 14
Specific immunotherapy in the USA: General concept and recent
initiatives
Robert E. Esch .............................................. 17
Discussion ..................................................... 23
Sample size considerations for establishing clinical
bioequivalence of allergen formulations
Ronald L. Rabin, J.E. Slater, P. Lachenbruch,
R.W. Pastor ................................................. 24
Discussion ..................................................... 33
Future aspects of regulation
Jay E. Slater ............................................... 34
Discussion ..................................................... 39
General Discussion ............................................. 42
Round Table Discussion
Chairman: Albert M. Kroon
The manufacturers' perspective: Regulation of allergen
products in European countries
B. Kristensen ............................................... 45
C. Garcia Carbonell ......................................... 47
O. Cromwell ................................................. 50
L. Champion ................................................. 53
Discussion ..................................................... 54
Standardization and Quality Control of Allergen Products
Chairmen: Martin Chapman, Stefan Vieths ..................... 65
Overview: Biological standardization in Europe and the USA
Henning Løwenstein .......................................... 67
Discussion ..................................................... 69
The CREATE project: A new beginning of allergen
standardization based on mass units of major allergens
Ronald van Ree .............................................. 70
Discussion ..................................................... 74
Mediator release assays based on human and murine IgE:
Potential and limitations in allergen standardization
Andreas Hoffmann, S. Kaul, K. Fötisch, N. Danz, D.
Lüttkopf, L. Hatahet, B. Kastner, L. Vogel, G. Höltz,
S. Vieths ................................................... 76
Discussion ..................................................... 85
In vitro and in vivo characterization of hazelnut skin prick
test extracts
Jaap H. Akkerdaas, M. Wensing, A.C. Knulst, R.С. Aalberse,
S.L. Hefle, R. van Ree ...................................... 87
Discussion ..................................................... 96
Immunochemical and biological quantification of peanut
extract
Lars K. Poulsen, M.H. Pedersen, M. Platzer, N. Madsen,
E. Sten, С. Bindslev-Jensen, С.G. Dircks, P. Stahl Skov ..... 97
Discussion .................................................... 106
Latex: A new target for standardization
Monika Raulf-Heimsoth, H.-P. Rihs, T. Brüning .............. 107
Discussion .................................................... 115
Experimental and Established Allergen Products for
Immunotherapy
Chairmen: Kurt Blaser, Hans-Jórgen Mailing ................. 117
Criteria for clinical efficacy - readout and monitoring of
clinical studies
Hans-Jórgen Mailing ........................................ 119
Discussion .................................................... 123
Oral, nasal and sublingual immunotherapy: Do they work,
are they safe?
Giovanni Passalacqua, G. W. Canonica ....................... 126
Discussion .................................................... 130
Peptide-based immunotherapy: New developments
Mark Larché ................................................ 133
Discussion .................................................... 139
Preventive aspects of specific immunotherapy
Lars Jacobsen .............................................. 141
Discussion .................................................... 145
Recombinant and Natural Allergens
Chairmen: Dietrich Kraft, Stefan Vieths .................... 147
Developing a manufacturing process and analyses for a
recombinant protein drug
Ebba Florin-Robertsson ..................................... 149
Discussion .................................................... 150
Engineering and validation of recombinant proteins for
allergen vaccines
Michael D. Spangfort ....................................... 151
Discussion .................................................... 155
Mechanisms of immunotherapy with allergoids: Lessons for
the development of recombinant allergens with reduced
IgE-binding activity
Oliver Cromwell, H. Kahlert, G. Schramm, R. Suck,
A. Nandy, B. Weber, H. Fiebig .............................. 156
Discussion .................................................... 161
Utility of pure allergen components in the continuing
development of in vitro diagnostics for inhalant and
food allergies
Jonas Lidholm .............................................. 163
Discussion .................................................... 172
Comparison of natural grass pollen allergens and their
recombinant counterparts expressed in bacterial and
mammalian systems
Arnd Petersen, B. Klostermann, J. Saloga, W.-M. Becker ..... 173
Discussion .................................................... 177
Expression of allergens in E.coli and plants - benefits and
drawbacks
Heimo Breiteneder, B. Wagner ............................... 178
Discussion .................................................... 187
Approaches based on mutated or modified recombinant grass
pollen allergens - in vivo evaluation of the constructs
Ute Lepp, F. Eberhardt, G. Schramm, P. Zabel, R. Suck,
H. Meyer, H. Fiebig, O. Cromwell, W.-M. Becker ............. 188
Discussion .................................................... 191
Recombinant food allergens in the diagnosis of pollen-
related food allergy
Barbara K. Ballmer-Weber, A. Wangorsch, S. Scheurer ........ 192
Discussion .................................................... 197
Hypoallergenic variants of the Parietaria judaica major
allergen Par j 1: In vitro and in vivo evaluation
Paolo Colombo .............................................. 198
Discussion .................................................... 204
Recombinant mite allergens: Validation strategies and
clinical trials
Martin D. Chapman .......................................... 205
Discussion .................................................... 210
General Discussion ............................................ 213
Immunomodulation and Immunotherapy - New Approaches
Chairmen: Rudolf Valenta, Fatima Ferreira .................. 217
Mechanisms of specific immunotherapy: Current knowledge
Cezmi A. Akdis, K. Blaser .................................. 219
Discussion .................................................... 227
Allergic rhinitis and its impact on asthma (ARIA) - what
does it mean for the future of SIT?
Claus Bachert .............................................. 229
Discussion .................................................... 235
New perspectives for the treatment of food allergy (peanut)
Hugh A. Sampson, K. Srivastava, X.-M. Li, A. W. Burks ...... 236
Discussion .................................................... 244
Alternative approaches to immunotherapy of allergy
Irwin Ziment ............................................... 247
Discussion .................................................... 257
Parallels between parasite infections and specific
immunotherapy
Ronald van Ree, M. Yazdanbakhsh ............................ 260
Discussion .................................................... 263
Immunomodulation and Immunotherapy - New Approaches
Chairmen: Alain de Weck, Wolf-Meinhard Becker .............. 267
Anti-IgE therapy combined with specific immunotherapy: Pro
Ulrich Wahn, E. Hamelmann .................................. 269
Anti-IgE therapy combined with specific immunotherapy:
Contra
Mark Larché ................................................ 272
Discussion .................................................... 276
Strategies for the development of safe and effective DNA
vaccines for allergy treatment
A. Hartl, R. Weiss, R. Hochreiter, S. Scheiblhofer,
R. Bauer, R. Valenta, F. Ferreira, W. Leitner, Josef
Thalhamer* ................................................. 279
Discussion .................................................... 299
Protection against infectious diseases by DNA-based
vaccination strategies -lessons for allergy treatment?
Jörg Schneider ............................................. 300
Discussion .................................................... 303
Progress in the development of new methods of immunotherapy:
Potential application of immunostimulatory DNA conjugated to
allergens for treatment of allergic respiratory conditions
Peter S. Creticos, L. M. Lichtenstein ...................... 304
Discussion .................................................... 312
General Discussion ............................................ 314
Closing Ceremony
History and future of allergen standardization and of
the Paul-Ehrlich-Seminar
Alain L. de Weck ........................................... 317
Closing remarks
Stefan Vieths .............................................. 328
List of contributors .......................................... 330
List of participants .......................................... 331
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