Cell Based Assays and Bioanalytical Method Development Event

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Agenda at a Glance

Agenda at a Glance


Workshops Monday, October 5, 2009

Morning Half Day | Workshop B1

Afternoon Half Day | Workshop B2

Challenges in Generating Information on Molecular Interactions to Support Biotherapeutic Development

8:00 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 discusses challenges and strategies to help generate meaningful information on molecular interactions to support biotherapeutic development.

John Corbin, Senior Scientist, Molecular Interactions & Biophysics Group, XOMA

Novel Approaches to Measuring Free 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
  • How to manage the dissociation problems in method development, validation, and sample analysis

John Kamerud, PhD, Research Advisor, ELI LILLY AND COMPANY
Mark Ma, PhD, Principal Scientist, Pharmacokinetics and Drug Metabolism Department, AMGEN

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Full Day | Workshop B3 Monday, October 5, 2009
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 Using MesoScale Discovery and xCELLigence Platforms

Judy Young, Scientist, Technology, Genentech
10:30 30-Minute Networking Break
11:00

Development and Validation of Bioluminescent Cell Based Assays Frank Fan, PhD, Senior Research Manager, Promega
12:00 Luncheon for Presenters and Workshop Attendees
1:30

Development of a New MSD-Based, 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

3:30

Best Practices for Overcoming Potency Assays Challenges

Xu-Rong Jiang, PhD, MD, Associate Director, Analytical Biochemistry, MEDIMMUNE
Fengrong Zuo, PhD, Scientist Biological Technologies, Quality Bioanalytical Development Process Research and Development, Genentech
Frank Fan, PhD, Senior Research Manager, Promega
4:30 Workshop Concludes
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General Session | Day 1 Tuesday, October 6, 2009
8:00 Conference Registration and Morning Coffee
8:45  

Chairperson’s Welcome and Opening Remarks

An Song, Senior Scientist, Associate Director, Genentech
9:00

Technical Transfer to the Quality Environment with a Focus on International Assay Transfers and Training

Allen Callaway, Scientist, JOHNSON AND JOHNSON
9:30

Establishment of a Reporter Gene Bioassays as Platform Technology using Lenti-viral System

Kendall Carey, PhD, Bioassay Scientist, MEDIMMUNE
10:00 30-minute Morning Networking Break
10:30

Evaluation of Fluorometric and Electrochemiluminescence Assay Platforms for the Detection of Blocking Antibodies in Human Serum

Darshana Jani, Senior Supervisor, BIOGEN IDEC
11:00

A Neuronal Cell-based Assay for Highly Sensitive Detection of Pharmaceutical Preparations of BoNT/A and Patient Neutralizing Serum Antibodies

Eric A. Johnson, Professor, Department of Bacteriology, Food Research Institute, UNIVERSITY OF WISCONSIN, MADISON
11:30

Cut Point for Screening and Confirmatory Assays

Martin Kane, MS CRE, Senior Manager, Process Statistics, HUMAN GENOME SCIENCES
12:15 Networking Lunch
2:00

Round Table Discussions

A.Compare Instruments, Techniques and Technology Experiences
Fengrong Zuo, PhD, Scientist Biological Technologies, Quality Bioanalytical Development, Process Research and Development, GENENTECH

B. Clarify Data & Statistical Analysis Tools for Cell Based Assays
Martin Kane, MS CRE, Senior Manager, Process Statistics, HUMAN GENOME SCIENCES

C. Specific Strategies to Overcome Cell Based Assay Challenges
Xu-Rong Jiang, PhD, MD, Associate Director, Analytical Biochemistry, MEDIMMUNE

3:00 30-Minute Afternoon Networking Break
3:30

Round Table Round-Up

Allen Callaway, Scientist, JOHNSON AND JOHNSON
Darshana Jani, Senior Supervisor, BIOGEN IDEC
Martin Kane, MS, CRE, Senior Manager, Process Statistics, HUMAN GENOME SCIENCES
Xu-Rong Jiang, PhD, MD, Associate Director, Analytical Biochemistry, MEDIMMUNE
4:30 Conference Day One Concludes
6:00

Dine-Arounds – More Networking and the Berkeley Experience

This year, IIR has organized dinners to provide a venue for conference participants to meet others with similar interests. Berkeley, California is a genuine epicenter of food culture, offering a diverse, storied and delicious range of restaurants; we have chosen one fine dining and one down to earth casual restaurant. Sign-up will be available at the registration table onsite.*

* Cost of Dine-Arounds not included in conference registration price
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General Session | Day 2 Wednesday, October 7, 2009
8:00 Morning Coffee
8:15

Chairpersons Remarks

Eric Wakshull, PhD, Senior Scientist/Group Leader, BioAnalytical Research & Development, GENENTECH
Valerie Quarmby, Principal Scientist/Associate Director, Bioanalytical Research & Development, GENENTECH
8:30

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, GENENTECH
10:00 15-Minute Morning 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

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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