2011 Agenda
| WORKSHOP DAY Monday, October 3, 2011 | ||
| MORNING WORKSHOPS | ||
| 8:30am | Workshop Registration and Morning Coffee | |
| 9:00am | Workshops A&B Begin | |
| 10:30am | 30-Minute Networking Break | |
| 12:00pm | Luncheon for Morning Workshop Attendees and Presenters | |
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Method Development for Liquid Chromatrography – Mass Spectrometry Applications in the Clinical Laboratory Setting Deb French, PhD, Assistant Professor, Lab Medicine, UCSF Roy Gerona, PhD, Research Scientist, UCSF Matt Petrie, PhD, Postdoctoral Fellow, UCSF
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Fundamentals of CBA — Tactics & Troubleshooting Renee Reijo Pera, PhD, Director, Center for Human Embryonic Stem Cell Research and Education, STANFORD UNIVERSITY |
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| AFTERNOON WORKSHOPS | ||
| 1:00pm | Afternoon Workshop Registration | |
| 1:30pm | Workshops C&D Begin | |
| 3:00pm | 30-Minute Networking Break | |
| 5:00pm | Afternoon Workshops Conclude | |
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Using Design Of Experiment to your Greatest Advantage in Reducing Variance
and Guaranteeing Translational Success Chandra Dixit, Researcher, NATIONAL BIOPHOTONICS AND IMAGING PLATFORM – IRELAND Click Here to download Chandra's pre-event podcast |
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Minimize Error Potential through Firm Establishment of Acceptance Criteria,
Baselines, Cutpoints, and Outliers Martin Kane, PhD, Senior Manager CRE, HUMAN GENOME SCIENCES |
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| MAIN CONFERENCE DAY 1 Tuesday, October 4, 2011 | ||
| 8:15am | Registration and Morning Coffee | |
| 9:00am | Co-Chairs' Welcome Shan Chung, PhD, Scientist, BioAnalytical Technologies and Strategies, BioAnalytical Sciences, Research and Early Development, GENENTECH Eric Wakshull, PhD, Group Leader, Bioanalytical R&D, GENENTECH |
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| 9:15am | KEYNOTE: Successful Strategies for Regulatory Reporting
in Assay R&D Jack Ragheb, MD, PhD, Senior Regulatory Research Officer, CDER, FDA |
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| 10:00am | KEYNOTE: Inputs and Expectations for International
Bioassay Standards Michael Tovey, PhD, Director of Research, Laboratory of Viral Oncology, NATIONAL CENTER FOR SCIENTIFIC RESEARCH, FRANCE |
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| 10:30am | Networking Break | |
| CELLBASED ASSAY DEVELOPMENT | BIOANALYTICAL METHOD DEVELOPMENT | |
| Cell Engineering | Assays for Biomarkers | |
| Chair: Michael Tovey, PhD, Director of Research, Laboratory of Viral Oncology, NATIONAL CENTER FOR SCIENTIFIC RESEARCH, FRANCE | Chair: Priti Hegde, PhD, Scientist, Biomarker Development, GENENTECH | |
| 11:00am | Match the Attributes of Diverse Cell Lines to your
Ongoing Drug Testing Needs Michael Tovey, PhD, Director of Research, Laboratory of Viral Oncology, NATIONAL CENTER FOR SCIENTIFIC RESEARCH,FRANCE |
Techniques for Correlating Molecular Biomarkers with
Noninvasive Signatures Derived from Image Analysis
of Dynamic Morphology in CBAs Thomas Baer, PhD, Executive Director, STANFORD PHOTONICS RESEARCH CENTER Novel Technologies Enabling Biomarker Analysis of Clinical Samples Rajiv Raja, Senior Scientist, GENENTECH |
| 11:45am | A Rapid Approach to Developing Reporter Cell Lines
for Bioassays Aaron Miller, PhD, Associate Scientist, Biological Technologies, GENENTECH |
Use of Hair Follicles as a Non-Invasive Surrogate Biomarker Investigation Assay in Clinical Trials Zhu Pirot, Associate Director, GERON CORPORATION |
| 12:15pm | Digital Deconstruction of Heterogeneous Cell Populations with High-Content Imaging and Cell-Specific Biomarkers Peter Antinozzi, PhD, Assistant Professor, Dept. of Biochemistry, WAKE FOREST UNIVERSITY SCHOOL OF MEDICINE | Deploy an Ultrasensitive Multiplex Magneto-
Nanosensor Platform for Improvements in Protein
Quantitation, Antibody Screening, and Kinetics Shan Wang, PhD, Director, Center for Magnetic Nanotechnology, STANFORD UNIVERSITY |
| 1:00pm | Lunch and Roundtable Discussions | |
| ASSAYS FOR VIROLOGY AND BACTERIOLOGY | FREE vs TOTAL PK IMMUNOASSAYS | |
| Chair: Fengrong Zuo, PhD, Senior Scientist,MEDIMMUNE | Chair: Jihong Yang, PhD, Senior Scientist, Bioanalytical Sciences, GENENTECH | |
| 2:00pm | Identification & Characterization of a Recombinant Fusion Protein-Product Variant, and the Impact on Functional Properties & Process Development Jun Kim, PhD, Team Leader, Analytical Biochemistry, MEDIMMUNE |
Theoretical and Experimental Approaches to Free/
Total Measurements of Monoclonal Antibody and
Soluble or Shed Target Ligands Lindsay King, PhD, Senior Principal Scientist, PDM Regulated Biotherapeutics, PFIZER The Use of Free and Total Pk Data and Proof-of- Mechanism Biomarker Data in the Development of Protein Drugs: A Modeling Perspective Meina Liang, PhD, Associate Director, PKPD & Bioanalysis, MEDIMMUNE |
| 2:45pm | Virus Neutralization Assays Using
Multiple Image-based Technology
Platforms in Support of MedImmune's
Vaccine Pipeline R&D Fengrong Zuo, PhD, Senior Scientist, MEDIMMUNE |
Appropriate Reagent Selection for PK Assays Xiangdan Wang, PhD, Associate Scientist, GENENTECH Characterization of Soluble Non-cross Linking Immune Complexes in Vivo Hamsell Alvarez, PhD, DMPK and Bioanalytics, MERCK RESEARCH LABORATORIES |
| 3:30pm | Validation of Cell Based Virus
Neutralization Assay for Pharmaco- Dynamics Measurement of Human Monoclonal Influenza Specific Antibody Bregje Mommaas, PhD, Scientist, Clinical Assays, CRUCELL |
Case study on Developing Assays for Free and Total
Antibody and Ligand: Impact of Assay Design and
Reagent Selection Jianyong Wang, PhD, Scientist, Assay and Automation Technologies, GENENTECH |
| 4:00pm | Networking Break | |
| NEUTRALIZING ANTIBODIES | LIQUID CHROMATOGRAPHY/ MASS SPECTROMETRY IN PROTEIN ANALYSIS | |
| Chair: Chanchal Sadhu, PhD, Senior Scientist, Bioanalytical Assay Development,TEVA PHARMACEUTICALS | Chair: Ola Saad, PhD, Scientist, BioAnalytical Research & Development, GENENTECH | |
| 4:30pm | Development and Validation of Cell-Based NAb Assays to Support Clinical Programs for Protein Therapeutics Xiao-Yan Cai, PhD, Associate Director, Biologics Bioanalytical Research, MERCK RESEARCH LABORATORIES |
Basics of Protein Quantitation in Biological Matrices
using LC-MS Sara Gaucher, PhD, Senior Scientist, Proteomics / Metabolomics Group Leader, AMYRIS Overcoming Hurdles in Mass Spectrometry-based mAb Quantification Xiaotao Duan, PhD, Center of Excellence in Bioinformatics & Life Sciences, STATE UNIVERSITY OF NEW YORK - BUFFALO |
| 5:15pm | Validation of a Cell-Based Neutralizing Antibody
Assay: Challenges and Adaptation to Recent
Developments Chanchal Sadhu, PhD, Senior Scientist, Bioanalytical Assay Development, TEVA PHARMACEUTICALS |
Pharmacokinetic Assessment of Biotherapeutics by Immuno-Enrichment LC-MS/MS: Applications to a Therapeutic-Fc Fusion Protein and a Monoclonal Antibody Mireia Fernandez Ocana, PhD, Pharmacokinetics, Dynamics, and Metbolism, PFIZER Influence of Mass Spectrometry in Bioanalysis of Antibody Therapeutics to Support Non-Clinical PK Studies Luna Liu, Senior Research Associate, Bioanalytical Research and Development, GENENTECH |
| 6:00pm | End of Day One | |
| MAIN CONFERENCE DAY 2 Wednesday, October 5, 2011 | ||
| 8:30am | Registration and Morning Coffee | |
| 9:15am | Co-Chairs' Day 1 Recap Shan Chung, PhD, Scientist, BioAnalytical Technologies and Strategies, BioAnalytical Sciences, Research and Early Development, GENENTECH Eric Wakshull, PhD, Group Leader, Bioanalytical R&D, GENENTECH |
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| 9:30am | Keynote: Strategies for Control and Assessment of Fc Effector Functions on Therapeutic Antibodies Shan Chung, PhD, Scientist, GENENTECH |
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| ADVANCES IN POTENCY ASSAYS | ||
| 10:00am | Impedance-based Bioassays for Assessing the
Potency of Therapeutic Antibodies Judy Young, PhD, Scientist, Assay and Automation Technologies, GENENTECH |
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| 10:30am | Justification of Potency Assays for Batch
Release and Stability Studies of Nanobodies ® Hans Ulrichts, PhD, Pharmacodynamics Team Head,ABLYNX |
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| 11:00am | Bioassay Development for an anti-Alpha Toxin mAb Xianzhi Zhou, Senior Scientist, MEDIMMUNE | |
| 11:30am | Networking Break |
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| FOCUS ON ASSAYS WITH UNUSUAL NEEDS | ||
| 12:00pm | Introduction Mauricio Maia, PhD, Scientist, Bioanalytical Sciences, GENENTECH |
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| 12:15am | Novel Approach for Eliminating Target Interference in Pharmacokinetic Immunoassays by Very Low pH Exposure Michael Partridge, PhD, Scientist, Assay Development, REGENERON |
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| 12:45pm | "Must-Have" Design Elements for Bioanalytical Tests that Facilitate Comparability Studies for
Biosimilar Drug Development Xiao-Yan Cai, PhD, Associate Director, Biologics Bioanalytical Development, MERCK RESEARCH LABORATORIES |
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| 1:15pm | Pinpoint the Implications of Pre-Existing Anti-Drug Target Abs to your Assay Development Linda Lin, M.A. Research Associate, GENENTECH |
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| 2:00pm | END OF CONFERENCE |
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