Assessment of Immunogenicity in Clinical Trials
Intercontinental Hotel Boston
500 Atlantic Ave
the essential protein engineering summit,
Phage Display
Diffi cult to Express Proteins
Recombinant Antibodies
Monoclonal Antibodies
Engineering Proteins for Delivery
Clinical Development of
Therapeutic Antibodies
Immunogenicity in Clinical Trials
Protein Scale-Up & Manufacturing
Phage Display of Antibodies and Peptides,

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Schedule of Presentations:

Wednesday, April 30, 2008
07:30:00 Registration Open IMMUNOGENICITY ASSAYS
08:30:00 Chairperson’s Opening Remarks
08:40:00 Evaluation of Cut Points and Related Characteristics for the Identification and Confirmation of Anti-Drug Antibody Positive Samples Viswanath Devanarayan
09:10:00 Application of Recommendations Concerning Validation of Anti-Drug Antibody Assays Boris Gorovits
09:40:00 Cell-Based Versus Non-Cell Based Assays to Characterize Neutralizing Antibodies Deborah Finco Kent
10:10:00 Coffee Break in the Exhibit Hall
11:10:00 Case Study Characterization of Neutralizing Antibodies to Interferons Using a Novel Cell-Based Assay Michael Tovey
11:40:00 Case Study Detection of Anti-Drug Antibodies in the Presence of Excess Drug Annette Zaar
12:10:00 Luncheon Technology Workshop (Sponsorship Available) or Lunch on Your Own
13:10:00 Break
13:30:00 Chairperson’s Remarks
13:35:00 Case Study - Clinical Immunogenicity of Protein Therapeutics Surinder Sharma
14:05:00 Immunogenicity Testing in Non-Clinical Studies What Questions are We Trying to Answer, When Should Evaluations be Performed, What Evaluations are Needed Bonita Rup
14:35:00 Solutions Showcase I
14:50:00 Solutions Showcase II
15:05:00 Refreshment Break in the Exhibit Hall
15:50:00 Preclinical Immunogenicity Screening Strategies Philippe Stas
16:20:00 Decreasing the Cost of Developing Protein Products: Eradicating Immunogenicity by Screening, Re-engineering and Treg Induction Anne S. De Groot
16:50:00 Networking Cocktail Reception in the Exhibit Hall
Thursday, May 1, 2008
08:30:00 Chairperson’s Remarks
08:35:00 Risk-Based Bioanalytical Approaches for Immunogenicity Gopi Shankar
09:05:00 Case Study –Risk-based Immunogenicity Assessment Plan for an Antibody Drug Conjugate Therapeutic Valerie Quarmby
09:35:00 Problem Solving Break-Out Session Drafting a Risk-Based Immunogenicity Plan for a New Biologic Drug Candidate
10:35:00 Coffee Break in the Exhibit Hall
11:05:00 Problem Solving Break-Out Session – Reporting back on Risk-Based Immunogenicity Plans
11:50:00 End of Conference
11:50:00 END
20:00:00 Registration Open RISKED-BASED ASSESSMENT PLANS
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