Training Course Information: 2-Day Event
Saturday, June 21 and Sunday, June 22
Saturday, June 21
Registration
Saturday, June 21, 2008
7:00 am - 12:00 pm
2008 Ligand Binding Assay Training Course Agenda
Saturday, June 21, 2008
8:00 am - 6:00 pm
An additional fee is required to attend this course. Please note that this is a two day event.
Goals and Objectives
- Even though this training course will include LBA theory, it will emphasize practical aspects of LBAs to enable attendees to apply learning immediately following course completion. We will provide an intensive learning experience for the basic principles and regulatory (GLP) considerations of LBAs to support the bioanalysis of biopharmaceuticals.
- Participants are welcome to bring examples of assay development or validation issues they are currently experiencing, as time permits these will be used to demonstrate both the power of collective insight as well potential design of experiments resolve the issues.
- The course spans all LBA stages from method conception, through design/optimization, validation, and implementation with test samples (preclinical through clinical) and statistical considerations.
- We will cover important aspects of LBAs for quantitative determination of therapeutic proteins and monoclonal antibodies in biological matrices.
- The course will also offer an introduction to basic pharmacokinetic principles and concepts with an emphasis on biotherapeutic drug products.
- This course is intended for current pharma/biotec BS/MS lab scientists who perform or have an interest in developing/performing LBAs, recent graduates/new hires who wish to perform LBAs, non-lab scientists and professionals who want in-depth LBA training, pharmacokineticists who utilize LBA data, and regulatory professionals in the biotech field.
7:30 am
Coffee Break
8:00 am
Introduction
Ronald R. Bowsher, Ph.D. (Moderator)
Millipore Corporation
B2S Consulting
8:30 am-11:30 am
Module 1: Introduction to Biopharmaceuticals
Marie T. Rock, Ph.D.
Midwest BioResearch LLC
10:00 am - 10:15 am
Coffee Break
11:30 am - 12:30 pm
Lunch
Complimentary to all course attendees
12:30 pm - 3:00 pm
Module 2: Basics of Macromolecule Protein Chemistry and Immunochemistry for Application to Ligand Binding Assay Development
Bonita J. Rup, Ph.D.
Wyeth Research
3:00 pm - 3:15 pm
Coffee Break
3:15 pm -5:45 pm
Module 3: Development and Optimization of Ligand Binding Assays to Support Pharmacokinetic Assessment of Biopharmaceuticals
Jeffrey M. Sailstad
Sailstad & Associates
5:45 pm
Wrap Up and Discussion
6:00 pm
Adjournment
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