3D Tissue Models
Pre-Clinical / Clinical Development of Therapeutic Antibodies
Sheraton Boston Hotel

Boston, Massachusetts


   Monoclonal antibodies represent about half of all biologics in
   development, with more than 150 compounds currently in clinical
   trials. However, the attrition rate of monoclonal antibodies has been
   higher than for other biologics. While early studies in pre-clinical
   settings have been encouraging, the predictability and confirmation of
   these same findings in humans has been difficult. The reasons for this
   may include: 1) target antigen properties; 2) antibody design; 3) PK
   and PD properties; 4) limited species cross reactivity (limited
   availability of suitable animal models); 5) appropriate translation of
   pre-clinical data to pick FIH dose; and 6) accurate identification of
   patients who could benefit from target therapy. This conference will
   provide a forum to review strategies and technologies that are being
   used to increase the probability for success in the development of
   therapeutic antibodies.

Schedule of Presentations:

Wednesday, May 19, 2010
07:00:00 Registration and Morning Coffee
08:25:00 Toxicology
08:30:00 Chairperson’s Opening Remarks
08:40:00 OPENING KEYNOTE PRESENTATION - Revealing the “Magic” of Monoclonal Antibodies Joy A. Cavagnaro
09:10:00 Recommendations for Nonclinical PK Comparability Study Designs for Monoclonal Antibodies Wendy Putnam
09:40:00 The Role of Pharmacokinetics in the Design, Conduct and Interpretation of Toxicology Studies with Antibody-Based Biotherapeutics Stanley A. Roberts
10:10:00 Coffee Break, Poster and Exhibit Viewing
11:05:00 Tox - Safety
11:10:00 Nonclinical Reproductive and Developmental Toxicity Testing Strategies with Antibody Therapeutics William J. Breslin
11:40:00 Translational Safety for Therapeutic Antibodies: Protecting Subjects and Enabling Risk:Benefit Decisions During Early Clinical Development Andrew Erdman
12:10:00 Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own
13:25:00 Tox - Testing Models
13:30:00 Chairperson’s Remarks
13:35:00 Species Selection: The Foundation of the Nonclinical Toxicology Program Marque Todd
14:05:00 Surrogates: Their Use, Qualification and Challenges Janet Clarke
14:35:00 Real Time Cell Surface Interaction Analysis: A Focus on Lectin-Cell Glycan Interactions Julien Saint-Guirons
15:05:00 Networking Refreshment Break, Poster and Exhibit Viewing
15:50:00 Problem Solving Break-Out Sessions
16:10:00 Table 1: Toxicologists & Clinicians – We’re Talking, But Are We Communicating? Meredith Rocca
16:25:00 Table 2: Cross Species Specificity – The Challenge Faced When Characterizing Targets Shane Olwill
16:40:00 Table 3: Data Integration – Do You Need to Work Across Silos? Jeffrey A. Engelhardt
16:50:00 Networking Cocktail Reception in the Exhibit Hall
18:00:00 End of Day
Thursday, May 20, 2010
08:00:00 Registration and Morning Coffee
08:25:00 Novel Therapies In Development
08:30:00 Chairperson’s Opening Remarks
08:35:00 Targeting GPCRs with Therapeutic Antibodies Hai Yan
09:05:00 Fsn0503: A Novel Cathepsin S Specific Antibody that Blocks Angiogenesis and Tumor Invasion Shane Olwill
09:35:00 Development of Antibody Drug Conjugates: An Emerging Class of Drugs Carmel Lynch
10:05:00 Coffee Break, Poster and Exhibit Viewing
11:00:00 Pre-Clinical Strategies
11:05:00 Nonclinical Regulatory Strategy and Interacting with Regulators Jeffrey A. Engelhardt
11:35:00 Nonclinical Dosing Strategies to Support First-in-Human (FIH) Clinical Studies Meredith Rocca
12:05:00 End of Conference
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