Immunogenicity of Therapeutic Biologics
Sheraton Boston Hotel

Boston, Massachusetts


   The need to predict and counter immunogenicity in therapeutic
   antibodies and proteins is a serious concern and it remains a
   significant challenge to address immunogenic properties in drug
   candidates. Bioanalytical assays need to be developed and validated to
   support the development of immunogenicity protocols. This conference
   will discuss how immunogenicity is evaluated in compounds in the
   pre-clinical phase or entering the clinic and will examine steps that
   were taken to minimize or otherwise eliminate adverse effects of
   biologic drugs. Case studies from the clinic will be highlighted to
   illustrate the process and demonstrate a successful approach.

Schedule of Presentations:

Monday, May 17, 2010
07:00:00 Registration and Morning Coffee
08:25:00 How Do You Begin?
08:30:00 Chairperson’s Opening Remarks
08:40:00 Keynote Presentation - Thinking about Product Immunogenicity: From Tolls to Packaging Daniela Verthelyi
09:10:00 Immunogenicity Issues With Biosimilars: The Need for Comparability Assessment Meenu Wadhwa
09:40:00 Importance of T cells to Antibody Response Sara J. Brett
10:10:00 Grand Opening Coffee Break, Poster and Exhibit Viewing
11:10:00 Development of Point-of-Care Assay for Detection of Anti-Drug Antibodies  Tatiana Plavina
11:40:00 Protein Structures Responsible for Immunogenicity of Biologics    Barend Bouma
12:10:00 Potential Clinical Adverse Consequences Related to the Immunogenicity of Therapeutic Biologics Jacques Descotes
12:40:00 Luncheon Presentation I - Immunogenicity: Detection and Characterization on the Meso Scale Discovery® (MSD®) Platform Neeta Shenoy
13:10:00 Luncheon Presentation II (Sponsorship Opportunity Available) or Lunch on Your Own
14:00:00 Chairperson’s Remarks
14:05:00 Amgen Experience with Immunogenicity Studies – Five FPX Proteins Vibha Jawa
14:35:00 HLA 1501 and Animal Models for Immunogenicity Screening Birgit Reipert
15:05:00 Networking Refreshment Break, Poster and Exhibit Viewing
15:45:00 Non-Clinical Case Studies of the Interplay of Pharmacokinetics, Pharmacodynamics and Immunogenicity Holly W. Smith
16:15:00 Review of the Immunogenicity of Therapeutic Insulins S. Edwin Fineberg
16:45:00 Break-out Discussion Groups: ASK THE EXPERTS Catherine Wang, Anne S. De Groot, Daniela Verthelyi, Joy A. Cavagnaro
17:45:00 Networking Cocktail Reception in the Exhibit Hall
18:45:00 End of Day
Tuesday, May 18, 2010
08:00:00 Registration and Morning Coffee
08:20:00 Factors Driving Immunogenicity:The Science
08:25:00 Chairpersons’ Opening Remarks Laurent Audoly
08:30:00 How Cells Resist Human Treg Suppression: A Role in Autoimmunity? Clare Baecher-Allan
09:00:00 The Potential for Clinical Tolerance: New Targets for Co-stimulatory Molecule Blockade John Iacomini
09:30:00 Relevance of Glycosylation to Recombinant Therapeutic Proteins and Monoclonal Antibodies Jeremy P. Kunkel
10:00:00 Coffee Break, Poster and Exhibit Viewing
10:45:00 A Novel Homogeneous Biotin-Digoxigenin Based Assay for the Detection of Human Anti-Therapeutic Antibodies in Autoimmune Serum Julia Qiu
11:15:00 Molecular Determinants of T Cell Epitope Recognition in Timothy Grass Allergy Alessandro D. Sette
11:45:00 Immunization to Ameliorate Atherosclerotic Cardiovascular Diseases Mark Carvlin
12:15:00 Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own
13:55:00 Innovative Approaches For Prediction
14:00:00 Chairperson’s Remarks
14:05:00 Computational Simulations of the Immune System: Applications for Vaccine Development Vladimir Brusic
14:35:00 A Human Lymphoid Organ Model (HuALN) for Predictive Testing of Immunogenicity, Immunotoxicity and Immune Functions in vitro Christoph Giese
15:05:00 Sponsored Presentation I
15:20:00 Sponsored Presentation II (Opportunity Available)
15:35:00 Networking Refreshment Break, Poster and Exhibit Viewing
16:15:00 Immunogenicity of Human Therapeutic Proteins: Lessons for Immune Tolerant Transgenic Mouse Models Huub Schellekens
16:45:00 Vaccine Development in Enhanced Hu-NSG Chimeric Mice      Robert T. Woodland
17:15:00 End of Conference
3D Tissue Models
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