Bioanalytical Method Development

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Agenda at a Glance

Agenda at a Glance

Workshops | Symposium | Day One | Day Two

Monday, October 5, 2009
Workshops & Symposium

B1
MORNING HALFDAY WORKSHOP
  Delivering Strategies to Help Generate Meaningfulinformation on Molecular Interactions to Support Biotherapeutics Development
8:00Morning Workshop Registration & Morning Coffee
9:00Workshop Begins
10:3030-minute Networking Break
12:00Luncheon 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
12:30Afternoon Workshop Registration
1:00Workshop Begins
2:3030-minute Networking Break
4:30Workshop 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


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FULL DAY SYMPOSIUM
B3
DEVELOPMENT, VALIDATION AND ASSESSMENT OF RELATIVE POTENCY IN CELL-BASED BIOASSAYS
  8:00Workshop 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

10:3030-Minute Networking Break
11:00

Flow Cytometry For Potency Assays And Cell Based Assays

Harald Kropshofer, Pharmaceutical Research, F. HOFFMANN-LA ROCHE

12:00Luncheon 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

2:3030-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

4:30Workshop Concludes

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Tuesday, October 6, 2009
General Session Day 1

7:00Conference 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

10:0030-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

12:00Panel Discussion Antibody-Drug Conjugates - Bioanalytical Strategies To Implement In Your Lab
12:30Networking 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

3:0030-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

5:00Day 1 Concludes
6:00

Dine-Arounds And The Berkeley Experience

* Cost of Dine-Arounds not included in conference registration price


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Wednesday, October 7, 2009
General Session Day 2

8:00Conference 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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