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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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13th International Paul-Ehrlich-Seminar - Allergen Products for Diagnosis and Therapy: Regulation and Science

Date(s) And Time(s):
Sep 14 2011 8:00AM - Sep 17 2011 5:00PM

Location:
Hyatt Regency Washington on Capitol Hill
400 New Jersey Ave NW
Washington, DC 20001-2097

REGISTRATION IS REQUIRED FOR ALL ATTENDEES

Overview:

SAVE THE DATES!
September 14-17, 2011

FEATURED TOPICS

  1. Legal Aspects of the Regulation of Allergen Products
    • Legal Status and Regulation of Allergen Products in the US
    • Regulation of Allergen Products in Europe (including NPPs)
    • Current Status and Regulation of Allergen Products in Different Countries
  2. Standardization and Characterization of Allergen Products
    • Update on the FDA/CBER Allergen Standardization Program
    • Validation of Major Allergen References and ELISAs – Current State of the BSP 090 Project
    • Molecular and Functional Characterization of Natural Allergen Extracts
    • Standardization of Major Allergen Measurements and Implications for Assessments of Biologic Potency
    • The Potential of Mass Spectrometry as Novel Tool in Standardization of Natural Allergen Extracts
  3. Methods in Product and Study Design of Effective Allergen Products for Therapy
    • Quality by Design
    • Primary Endpoints, Validation, Clinical Efficacy of Specific Immunotherapy (SIT) Trials
    • Specific Aspects of SIT Trials in Children
    • Efficacy Testing of Allergen Mixtures
    • Surrogates and Biomarkers for Determining Efficacy
    • Multiplex IgE Testing as Tool to Define Study Populations
    • Pollen Count Variation Within and Among Regions of North America
    • Environmental Exposure Chamber in SIT Clinical Trials
    • Statistical Analysis for Demonstrating Efficacy in SIT Trials
  4. Standardization and Characterization of Modified and Recombinant Allergen Products
    • Physicochemical Characterization of Allergoids and Adsorbed Allergoids
    • Physicochemical Characterization of Recombinant Allergens and Hypoallergenic variants
    • Antibody-based Techniques for Characterization of Allergoids and for Stability Studies of Alum Adsorbed Drug Product
  5. Immunological Mechanisms of Allergy Immunotherapy
    • An Overview of Proposed Mechanisms of SIT
    • Mechanisms of Immunotherapy Specific to the Sublingual or Oral Route
    • Oral Immunotherapy for Food Allergy
    • Th2 heterogeneity: Do specific Th2 Subpopulations Alternatively Drive Allergy vs. Tolerance
    • Use of Trichuris suis ova (TSO) Therapy for the Treatment
  6. Immunotherapy with Purified Allergen Components
    • Current Status of Subcutaneous and Sublingual Immunotherapy with Recombinant Allergens
    • Recombinant Allergens for SIT of Mite Allergy
    • Recombinant Allergens for SIT of Cat Allergy
    • Novel Approaches of Immunotherapy for Food Allergy
    • Targeting Antibody Receptors as an Approach Towards Immunotherapy
  7. Extrinsic Adjuvants in the Use of Allergen Immunotherapy
    • Aluminum Hydroxide: Mechanism of Action and Safety Assessment
    • Toll Like Receptor Ligands as Adjuvants
    • Adjuvants and Vector Systems for the Sublingual Route
  8. Immunomodulatory Properties of Allergens
    • Inherent Adjuvant Biological Properties of Natural Allergens
    • Inherent Adjuvant Structural Properties of Natural Allergens
  9. State-of-the-Art Immunotherapy in Different Allergic Diseases
    • Sublingual Route (SLIT)—Overview of American Experience
    • SLIT for Allergic Rhinitis in the United States
    • The Role of Subcutaneous Immunotherapy (SCIT) and SLIT in Rhinoconjunctivities across Europe
    • SIT for the Treatment of Atopic Dermatitis
    • SIT for the Treatment of Asthma

Target Audience:
Professionals, researchers, academia, regulatory affairs, contract research organizations, and clinicians focused in standardization,vdiagnosis and clinical immunology for allergen products.

Event Code:
11018

Contact Information:
Constance Burnett, Program Developer
Telephone 215.293.5800
Fax 215.442.6199
Email ConstanceBurnett@diahome.org
or
JoAnn Boileau, Program Manager
Telephone 215.442.6175
Fax 215.442.6199
Email JoAnn.Boileau@diahome.org