Bioanalytical Challenges for Optimizing Protein Therapeutics
Sheraton Boston Hotel

Boston, Massachusetts


   One of the key reasons Protein Therapeutics have achieved significant
   success stems from their ability to bind to specific targets, such as
   receptors or cell surface proteins, with high affinity. As Protein and
   other Macromolecule Therapeutics become more complex, bioanalytical
   challenges have increased, especially for multi-domain and
   multi-valent biopharmaceuticals. Ligand Binding Assays (LBAs), which
   indirectly measure reactions with the binding reagents, continue to be
   the preferred method of analyzing macromolecule therapeutics. However,
   to date no clear guidance or consensus exists that outlines how to
   consistently monitor and validate specificity and selectivity for
   ligand binding assays, and what methods are necessary to differentiate
   between “free” and “total” therapeutic. Additionally, there is a need
   to establish criteria for reagent quality, lot-to-lot consistency, and
   maintaining a sustainable reagent supply. Emerging tools and
   technologies are responding to the current needs for evaluating
   binding capacities and efficiencies, including modeling and other
   forms of software that assess kinetic processes to support the
   development of biopharmaceuticals. This meeting will explore the
   bioanalytical challenges of optimizing protein therapeutics to achieve
   enhanced safety, half-life and PK, and reduced toxicity. Please join
   this in-depth discussion and information exchange to advance
   biopharmaceuticals into the next generation.

Schedule of Presentations:

Thursday, May 20, 2010
12:00:00 Registration
13:25:00 Emerging Tools & Technologies
13:30:00 Chairperson’s Opening Remarks
13:40:00 Emerging Mass Spectrometry-Based Tools to Characterize Higher Order Structure and Dynamics of Biopharmaceuticals Igor A. Kaltashov
14:10:00 Quantitative Method for Measurement of Antibody Internalization using Fluorescent Imaging Inna Vainshtein
14:40:00 Antibody Screening using Multiplexed SPR
14:55:00 High Throughput, Small Scale, and Optimization of Protein Separations Using Automated PhyNexus Platform Technology Lee Hoang
15:10:00 Refreshment Break, Poster and Exhibit Viewing
16:00:00 Combining Label Free Assay Platforms to Support Therapeutic Antibody Development from Identification of Candidate Antibodies through Pre-Clinical Development Robin Barbour
16:30:00 Proteomic Profiling of Novel Protein Targets by Selective Epitope Inhibition and SILAC/MS Analysis Christian Freund
17:00:00 End of Day
Friday, May 21, 2010
07:45:00 Continental Breakfast in the Exhibit Hall
08:25:00 Ligand Binding Assays
08:30:00 Chairperson’s Opening Remarks
08:35:00 Talk Title to be Announced Albert F. Torri
09:05:00 Design of Experiments: Case Studies from a Bioanalytical Lab Franklin Spriggs
09:35:00 Reagent Selection & Management Adrienne Clements-Egan
10:05:00 Coffee Break, Poster and Exhibit Viewing
11:00:00 Free Vs. Total
11:05:00 Free vs. Total Ligand Binding Assays: Points to Consider in Drug Development Jihong Yang
11:35:00 Free and Total Immunoassays for Monoclonal Antibodies to Soluble Targets and Target as Biomarker Lindsay King
12:05:00 Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own
13:20:00 Optimizing For Oncology
13:25:00 Chairperson’s Remarks
13:30:00 The Mesothelin-CA125/MUC16 Interaction Mitchell Ho
14:00:00 Hyaluronan: The Glue that Holds a Tumor Together Curtis Thompson
14:30:00 Networking Refreshment Break
15:00:00 Immunogenicity: Regulatory and Technical Overview with Case Studies of Assay Challenges Eric Wakshull
15:30:00 Determination of the Mechanism of Action of an Antibody using Orthogonal Approaches Victor H. Obungu
16:00:00 The Impact of Shed Target Antigen on the Quantitation of Therapeutic mAb and its Pharmacokinetics Implication Bing Kuang
16:30:00 End of Conference
3D Tissue Models
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