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B1 | MORNING HALFDAY WORKSHOP | | | | Delivering Strategies to Help Generate Meaningfulinformation on Molecular Interactions to Support Biotherapeutics Development
| 8:00 | Morning Workshop Registration & Morning Coffee | | 9:00 | Workshop Begins | | 10:30 | 30-minute Networking Break | | 12:00 | Luncheon for morning workshop attendees and presenters |
Molecular interactions data is often used to support biotherapeutic development. Large molecules, such as monoclonal antibodies are very complex, often it is challenging to collect accurate information and interpret the data on interactions such as binding affinities and kinetics. This half-day workshop addresses challenges and presents strategies to help generate meaningful information on molecular interactions to support biotherapeutic development. John Corbin, Sr. Scientist, Molecular Interactions & Biophysics Group, XOMA |
| B2 | AFTERNOON HALFDAY WORKSHOP
| | | | Novel Approaches to Measuringfree and/or Total Antibody Drug | 12:30 | Afternoon Workshop Registration | | 1:00 | Workshop Begins | | 2:30 | 30-minute Networking Break | | 4:30 | Workshop Concludes |
Assays for “free” antibody in the presence of significant amounts of target ligand are unreliable and difficult to interpret. Case studies will be presented, illustrating the differences in free and total assay results in various studies. Bring your own experiences to share and be ready to discuss issues including - Applications for free assays and for total assays
- Pros and cons in developing free or total assays
- Is the “free” assay really free?
- How to manage the dissociation problems in method development, validation, and sample analysis
- The limitation of the current dissociation approaches in total assay
John Kamerud, PhD, Research Advisor, ELI LILLY AND COMPANY Mark Ma, PhD, Principal Scientist, Pharmacokinetics and Drug Metabolism Department, AMGEN |
| Back to topFULL DAY SYMPOSIUM B3 | DEVELOPMENT, VALIDATION AND ASSESSMENT OF RELATIVE POTENCY IN CELL-BASED BIOASSAYS | | | | 8:00 | Workshop Registration & Morning Coffee | | 9:00 | Chairpersons Opening Remarks Xu-Rong Jiang, PhD, MD, Associate Director, Analytical Biochemistry, MEDIMMUNE | | 9:15 | Development And Selection Of Potency Methods Max L. Tejada, Scientist, GENENTECH | | 9:45 | Cell-Based Functional Potency Assays For Antibodies Blocking TNF-Super Family Ligand Stimulation Judy Young, Scientist, Technology, GENENTECH | | 10:30 | 30-Minute Networking Break | | 11:00 | Flow Cytometry For Potency Assays And Cell Based Assays Harald Kropshofer, Pharmaceutical Research, F. HOFFMANN-LA ROCHE | | 12:00 | Luncheon for Presenters and Workshop Attendees | | 1:30 | Development Of A New Robust Cell-Based Assay For The Characterization Of A Humanized Monoclonal Antibody
Fengrong Zuo, PhD, Scientist Biological Technologies, Quality Bioanalytical Development Process Research and Development, GENENTECH | | 2:30 | 30-Minute Afternoon Break | | 3:00 | ROUNDTABLE SESSION Best Practices For Overcoming Potency Assays Challenges Table leaders Xu-Rong Jiang, PhD, MD, Associate Director, Analytical Biochemistry, MEDIMMUNE Fengrong Zuo, PhD, Scientist Biological Technologies, QUALITYBIOANALYTICALDEVELOPMENT Process Research and Development, GENENTECH Harald Kropshofer, Pharmaceutical Research, HOFFMAN LAROCHE | | 4:30 | Workshop Concludes | Back to top
| Tuesday, October 6, 2009 | General Session Day 1 |
| 7:00 | Conference Registration and Morning Coffee | | 8:15 | Chairpersons’ Welcome And Opening Remarks Eric Wakshull, PhD, Senior Scientist/Group Leader, BioAnalytical Research & Development, GENENTECH Valerie Quarmby, Principal Scientist/Director, Bioanalytical Research & Development, GENENTECH | | 8:30 | Equilibrium Modeling And Assays Development Strategies For Measurement Of Free Total And Bound Drug Or Target Lindsay King, PhD, Principal Scientist, PDM Regulated Biotherapeutics, PFIZER | | 9:15 | Challenges In Bioanalytical Development For Assays Having Subject Specific Matrix Interference Robert Dodge, PhD, Laboratory Director, Immunochemistry and Cell Biology, PHARMANET | | 10:00 | 30-minute Morning Networking Break | | 10:30 | Comparative Analysis Of Results Obtained In Various Assays Used In Support Of Antibody-Drug Conjugate Projects Boris Gorovits, PhD, Director, BioAnalytical, WYETH | | 11:15 | Challenges And Solutions For Developing Elisa Assays For Antibody-Drug Conjugates Katherine Kozak, PhD, Scientist (Technology), Assay & Automation Technology, GENENTECH | | 12:00 | Panel Discussion Antibody-Drug Conjugates - Bioanalytical Strategies To Implement In Your Lab | | 12:30 | Networking Lunch | | 1:30 | Resolving Heterophilic Antibody Interference In Biomarker Assays Laura DeForge, PhD, Senior Scientist, Assay & Automation Technology, GENENTECH | | 2:15 | Bioanalytical Challenges Of Enzyme Therapeutics: From Assay Development To Clinical Correlations Erik Foehr, Director, BioAnalytical Research and Development, BIOMARIN PHARMACEUTICALS | | 3:00 | 30-Minute Afternoon Networking Break | | 3:30 | Qualification Of Sensitive Assays For The Detection And Quantitation Of Protective Antigen (Pa) In Animals Challenged With B. Anthracis Thi Migone, PhD, Senior Director, Clinical Immunology, HUMAN GENOME SCIENCES | | 4:15 | Utilizing A Novel Bioanalytical Reagent To Overcome Interference Challenges In Sle Patient Sera Alyssa Morimoto, PhD, Scientist, BioAnalytical Research and Development, GENENTECH | | 5:00 | Day 1 Concludes | | 6:00 | Dine-Arounds And The Berkeley Experience * Cost of Dine-Arounds not included in conference registration price | Back to top | Wednesday, October 7, 2009 | General Session Day 2 |
| 8:00 | Conference Registration and Morning Coffee | | 8:15 | Chairpersons’Recap of Day One Eric Wakshull, PhD, Senior Scientist/Group Leader, BioAnalytical Research & Development, GENENTECH Valerie Quarmby, Principal Scientist/Director, Bioanalytical Research & Development, GENENTECH | | 8:30 | FC FUNCTIONALITY Application Of An Fc Gamma Receptor Iiia Binding Assay In Assessment Of Fc Structure And Functionalities Yucai Peng, PhD, Scientist II, BIOGEN IDEC | | 9:15 | Measuring Binding Of Antibody To Fcg Receptor Iii: Comparison Of Soluble Fc Receptor Elisas And Cell-Based Binding Assays Yanmei Lu, Associate Scientist, Assay & Automation Technology, GENENTECH | | 10:00 | 15 Minute Networking Break | | 10:15 | Mouse Models For Ab Therapy Of B-Cell Lymphoma M. Jules Mattes, formerly Associate Member, CENTER FOR MOLECULAR MEDICINE AND IMMUNOLOGY | | 11:00 | A Generic Method For Screening Antibody To Fc Receptor Binding By Spr Relating To Adcc Function Rosie Wong PhD, Principal Scientist, Analytical Development, MEDAREX | | 11:45 | Panel Discussion Assessment of Fc Functionality Panelists: Yucai Peng, PhD, Scientist II, BIOGEN IDEC Yanmei Lu, Associate Scientist, GENENTECH Rosie Wong PhD, Principal Scientist, Analytical Development, MEDAREX M. Jules Mattes, formerly Associate Member, CENTER FOR MOLECULAR MEDICINE AND IMMUNOLOGY | | 12:30 | Conference Concludes |
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