Foreword
Stefan Vieths, Johannes Löwer ................................ 1
Parallel Session III: Workshop on Bioinformatics Applied to
Allergen Molecules
Chair: Adriano Mari .......................................... 3
Allergen nomenclature: A need for the scientific community
Jørgen N. Larsen ............................................. 5
Computational resources: A regulatory need, a tool
for research
Renato Truffer, Michael B. Stadler, Monique Vogel,
Adriano Mari, Beda M. Stadler ............................... 11
Food allergy information resources for consumers, industry
and regulators
E.N. Clare Mills, John A. Jenkins, Ana I. Sancho, Susan
Miles, Charlotte Madsen, Errka Valovirta, Lynn Frewer ....... 17
Allergome: A unifying platform
Adriano Mari, Enrico Scala .................................. 29
Presentation and Round Table Discussion Harmonization
of Allergen Regulation in Europe
Chairs: Stefan Vieths, Jacqueline Dayan-Kenigsberg .......... 41
Summary of the response to the questionnaire marketing
authorization of allergen products in Europe sent to
national regulatory agencies
Gerald Reese ................................................ 43
Summary of the regulators' session
Carlo Pini .................................................. 45
Regulatory aspects of allergen products for immunotherapy -
considerations from the viewpoint of manufacturers
Albert M. Kroon ............................................. 49
EU procedures for marketing authorization of pharmaceutical
products
Rainer Seitz ................................................ 60
Marketing authorization for recombinant products in Europe
Michael Pfleiderer .......................................... 65
Plenary Session I: Progress in Allergen Standardization I -
The CREATE Project
Chairs: Martin Chapman, Enrique Fernández-Caldas ............ 69
The CREATE Project: An introduction
Ronald van Ree and the CREATE Consortium .................... 71
Physico-chemical characterization of candidate reference
materials
Fatima Ferreira, Michael Wallner, Gabriele Gadermaier,
Anja Erler, Gerhard Fritz, Otto Glatter, Martin Himly,
Peter Briza, Ronald van Ree and the CREATE Consortium ....... 75
Immune reactivity of candidate reference materials
Montserrat Fernandez-Rivas, Marja Aalbers, Kay Fötisch,
Pleuni de Heer, Silla Notten, Stefan Vieths, Ronald
van Ree ..................................................... 84
Validation of quantitative, allergen-specific ELISAs
Wolf-Meinhard Becker, Ronald van Ree, Helmut Fiebig,
Oliver Cromwell, Bernhard Weber, Rafael Monsalve,
Domingo Barber, Monika Raulf-Heimsoth, Philippe
Moingeon, Alain Didierlaurent, Gabriella di Felice,
Carlo Pini, Kay Fötisch, Stefan Vieths ...................... 91
The CREATE Project: Future perspectives
Ronald van Ree and the CREATE Consortium .................... 98
General Discussion ............................................ 100
Plenary Session II: Progress in Allergen Standardization II
Chairs: Fatima Ferreira, Henning Løwenstein ................ 105
Standardization of animal epithelia
Enrique Fernández-Caldas, Jerónimo Carnés, Mayte Gallego,
Adriano Mari, Juan Antonio Pagán Alemön25................... 107
Analyzing of ID50EAL data for the standardization of German
cockroach allergen extracts in the US
Robert James, Herman Mitchell, Peter J. Gergen,
Peyton A. Eggleston, Jay E. Slater ......................... 117
The importance of minor allergens in allergen
standardization
Domingo Barber, Florentino Polo, Manuel Lombardero,
Mayte Villalba, Rosalía Rodríguez .......................... 128
Test procedures for allergoids and hypoallergenic
recombinant allergens: Immunological characterization
Helmut Fiebig, Helga Kahlert, Andreas Nandy, Martin Wald,
Roland Suck, Dernhard Weber ................................ 135
Multiplex technology for allergen detection and
immunodiagnostics
Martin D. Chapman, Amy Tsay, Branka Saric, Rebecca
Godbout, Kerry G. Oliver ................................... 149
General Discussion ............................................ 155
Plenary Session III: SIT: Clinical Trials with Allergen
Products - Requirements and Criteria for Evaluation
Chairs: Jörg Kleine-Tebbe, Hans-Jórgen Mailing ............. 157
Clinical index-score and the ALMA study
Albrecht Bufe,Tim Holland-Letz ............................. 159
Usefulness of pollen chamber in the evaluation of clinical
trials with allergen products
Norbert Krug ............................................... 167
Clinical trials with allergen products - statistical
considerations
Peter Volkers .............................................. 172
Clinical trials with allergen products: In search of
biological markers of efficacy
Philippe Moingeon .......................................... 182
Plenary Session IV: Recombinant and Natural Allergens for
SIT and Diagnosis - Recent Developments
Chairs: Wolf-Meinhard Becker, Jay E. Slater ................ 189
Recombinant and modified allergens: The US perspective
Ronald L. Rabin ........................................... 191
Clinical evaluation of recombinant allergens
Oliver Cromwell, Annemie Narkus ............................ 195
Plenary Session V: Immunomodulation and Immunotherapy -
State of the Art and New Approaches
Chairs: Ulrich Kalinke, Rudolf Valenta ..................... 205
Future perspectives of novel immunomodulating substances
in immunotherapy
Esther С. de Jong, Martien L. Kapsenberg ................... 207
Understanding the immunological basis of asthma;
Immunotherapy and regulatory T cells
Dale T. Umetsu ............................................. 211
Prospects for CpG based immunotherapy in asthma and allergy
David H. Broide ............................................ 217
Recent advances in the use of genetically engineered
negative signaling molecules to treat allergic diseases
Andrew Saxon, Daocheng Zhu, Ke Zhang, Lisa A. Chan,
Christopher L. Kepley ...................................... 223
Plenary Session VI: Hot Topics
Chairs: Albrecht Bufe, Lars Jacobsen ....................... 235
A bright future for sublingual immunotherapy?
Jean Bousquet - Pro ........................................ 237
Jörg Kleine-Tebbe - Contra ................................. 242
Quality and clinical efficacy of allergen mixtures
Hans-Jørgen Mailing ........................................ 253
List of Contributors .......................................... 258
List of Participants .......................................... 259
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