BioAnalytical Method Development 
Agenda Day One
| MAIN CONFERENCE DAY 1 Tuesday, October 7, 2008 |
| 8:00 |
| Conference Registration and Morning Coffee |
| 8:45 |
| Chairpersons Welcome and Opening Remarks - EricWakshull, PhD, Senior Scientist/Group Leader, BioAnalytical Research & Development, GENENTECH |
| Molecular Interaction Strategies |
| 9:00 |
| Challenges in Generating Information on Molecular Interactions to Support Biotherapeutic Development Information on molecular interactions has been widely used to support biotherapeutic development. However, accurate information on these interactions such as binding affinities and kinetics are sometimes hard to obtain due to the complexity of large molecules such as monoclonal antibodies. In addition, interpretation of the information could be challenging due to complex biological systems. The talk will use case studies to discuss challenges and strategies to help generate meaningful information on molecular interactions to support biotherapeutic development. - Jihong Yang, PhD, Scientist, BioAnalytical Research and Development, GENENTECH |
| 9:30 |
| Binding Parameters Of Antibodies Binding To The Cell Surface As antibodies (Abs) are increasingly used for therapy, it is essential to have reliable methods to compare the binding properties of standard Abs and Ab derivatives. It has become accepted practice to measure the functional affinity (equilibrium association constant). However, because of multivalent binding, such measurements do not adequately describe the interactions that occur. Ab binding is predominantly irreversible, but it is important to determine the level of dissociation that occurs (usually < 30%), and the rate of internalization. - Jules Mattes, PhD, CENTER FOR MOLECULAR MEDICINE & IMMUNOLOGY |
| 10:15 |
| 30-Minute Morning Networking Break |
| 10:45 |
| Accelerating Identification of High Potential Therapeutic Antibody Candidates Using Molecular Interaction Analyses The ability to quickly identify promising therapeutic candidates allows for increased throughput and deep interrogation of multiple antibody phage display libraries in parallel, as well as rapid evaluation of hybridoma-generated antibodies. Biosensor technologies are powerful tools for analyzing antibodies or fragments in complex media such as bacterial extracts and hybridoma culture supernatants, as well as purified proteins. XOMA accelerates the identification of high potential therapeutic candidates through customized development of target-specific biosensor-based assays in order to evaluate clones as early as possible. Case studies will be presented to demonstrate various screening strategies for therapeutic antibody discovery and development including appropriate consideration of the affinity, epitope, function, and potency. - Marina K. Roell, PhD, Associate Director, Molecular Interactions and Biophysics Group, Preclinical Research and Development, XOMA |
| 11:15 |
| Label-Free Screening Of Bio-Molecular Interactions The potential of label-free approaches to complement or even displace other detection technologies has never been higher. This presentation will cover the latest and emerging developments in label-free detection systems, their underlying technology principles and end-user case studies that reveal the power and limitations of label-free in areas of drug discovery and diagnosis. Unlike label- and reporter-based technologies that simply confirm the presence of the detector molecule, label-free techniques can provide direct information on analyte binding to target molecules typically in the form of mass or stress addition or depletion from the surface of a sensor substrate. However, these technologies have failed to gain widespread acceptance due to technical constraints, low throughput, high user expertise requirements, and cost. Whilst they can be powerful tools in the hands of a skilled user evaluating purified samples, they are not readily adapted to every day lab use where simple to understand results on high numbers of samples are the norm. This talk seeks to address some of the issues surrounding the unmet needs in the market place, and the difficulties faced by technology developers in meeting these needs with innovative products. It will also outline recent trends from newer technology developers who are in the race to release products for the general lab user. - Matthew A. Cooper, PhD, Managing Director, CAMBRIDGE MEDICAL INNOVATIONS |
| PANEL DISCUSSION |
| 11:45 |
| Strategies for Applying Molecular Interaction Information to Aid Drug Discovery & Development Molecular interactions, affinity, in vitro vs. in vivo, alternative technologies…these topics are not often discussed at open forums and this is a great time to initiate such discussions within a broad scientific community that ultimately generates and interprets such information to support Research & Development. This unique panel provides a rare opportunity to openly discuss molecular interaction challenges and allow you to ask experts your most pressing questions! Panelists: - Jihong Yang, PhD, Scientist, BioAnalytical Research and Development, GENENTECH - Jules Mattes, PhD, CENTER FOR MOLECULAR MEDICINE & IMMUNOLOGY - Marina K. Roell, PhD, Associate Director, Molecular Interactions and Biophysics Group, Preclinical Research and Development, XOMA - Matthew A. Cooper, PhD,Managing Director, CAMBRIDGE MEDICAL INNOVATIONS |
| 12:15 |
| Networking Lunch |
| PK Assay Strategies |
| 1:30 |
| PK Assay Strategies for Biotherapeutics Although there are white paper recommendations describing best practices for ligand binding assay development and validation, there is no clear guidance as to whether methods are needed to quantitate and/or differentiate between unbound therapeutic and therapeutic complexed with soluble forms of a target. However, the format and reagents chosen for a given PK assay may impact which drug species are detected and therefore affect the resulting observed PK parameters. A case study will be presented where different assay formats were compared and circulating target appears to have differentially impacted observed PK profiles. In addition, various factors which should be considered when developing a PK assay strategy for a biotherapeutic will be discussed. - Alyssa Morimoto, PhD, Scientist, BioAnalytical Research and Development, GENENTECH |
| 2:00 |
| Characterizing The In Vivo Disposition And Clearance of Biotherapeutics: Influence of Bioanalytical Assay Format Interaction with soluble target ligands can alter the disposition of a therapeutic monoclonal antibody. These interactions can also produce interference and artifact in bioanalytical methods. As a result, the choice of assay format is critical to the appropriate characterization of the pharmacokinetics and disposition of this class of biotherapeutic agents. Examples in which differences or limitations in analytical approach influenced the interpretation of preclinical PK/PD studies will be discussed. - Victor J.Wroblewski, PhD, Research Fellow, Drug Disposition, Global PK/PD/TS, ELI LILLY |
| 2:30 |
| PK/PD Perspectives on the Measurement of Ligand Levels Across Therapeutic Areas - Jian-Feng Lu, PhD, Principal Scientist, Pharmacokinetics, AMGEN |
| 3:00 |
| 30-Minute Afternoon Networking Break |
| 3:30 |
| PK Assay Formats for Antibody Therapeutics PK assay formats for antibody therapeutics may differentially impact the accuracy of drug measurement, depending on the nature of the target and the dosing schedule. Two case studies in which distinct PK assay formats were compared will be discussed. Specifically, comparisons between an antigen capture vs. an anti-idiotype capture formats, the effect of circulating target levels and the nature of the target (multimeric targets: trimeric vs heptameric molecules) will be covered. Finally, the impact of the PK assay formats on drug measurement in the presence of anti-drug antibodies, will also be discussed. - Thi Migone, PhD, Senior Director, Clinical Immunology, HUMAN GENOME SCIENCES |
| 4:00 |
| Assay Format Selection During Method Development – First Step Assay format selection is the crucial step for developing a high quality method for the quantification of macro molecule therapeutics. This presentation will focus on a case study to reveal the principles and technical approaches during assay development. A monoclonal antibody (drug) was developed to its receptor (A) to reach the therapeutic effects. Three types of reagent were available: the recombinant receptor A, anti-human IgG Fc antibody, and antiidiotypic drug antibodies. To support preclinical and clinical studies, two ELISAs were developed; a total assay to measure the bound and free drug and a “free” assay to only measure the “free” drug. Experimental results led the project team to make the decision to use the total assay as the validated assay to support regulated work. The “free” assay was used for research and exploratory purposes only. - Mark Ma, PhD, Principal Scientist, Pharmacokinetics and Drug Metabolism Department, AMGEN |
| PANEL DISCUSSION |
| 4:45 |
Analytical Strategies for Measuring Protein Therapeutics— Pharmacokinetic Assays |
| 5:15 |
| Day One Concludes |
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