Institute for International Research

Dear Colleague,

The Institute for International Research is proud to present the second annual conference on Cell Based Assays in Biopharmaceuticals Drug Development. This three day conference presents case studies that highlight key lessons learned in how biopharmaceutical labs can work through the obstacles associated with developing, validating, maintaining, and transferring these complex cell based assays in a quality control environment.

Whether you are new to developing and characterizing bioassays or you have several years of experience, this conference offers you fresh information on how your biopharmaceutical colleagues are approaching solutions to these difficult assays.

The content covered in this program focuses on regulatory considerations, drug characterization, potency assays, transfers to quality control, neutralization antibodies assays, technological advancements, and statistical analysis. The format for learning will be a combination of case studies in the morning and interactive working group sessions in the afternoon.

Cell Based Assay Applications Include:
• Potency
• Immunogenicity
• Characterization
• In Vitro Toxicology
• Immunotoxicolgy

New for 2006
In-Depth Half Day Pre Conference Workshops
• Potency Assays
• Neutralizing Antibody Assays

New for 2006 Hot Topics and Working Groups:
• Innovating novel assay formats
• Identify key assay validation parameters
• Discover how novel cell lines are constructed
• New approaches and methodologies for development, validation and transfer of cell based assays
• Regulatory considerations for using binding assays or cell based assays for detection of neutralizing antibodies and in potency assays

IIR's Cell Based Assays in Biopharmaceutical Drug Development conference presents an opportunity to gain exposure to companies and industry experts leading the pace toward providing technologies, services and solutions to complexities of cell based assays.

Register Today. Space is Limited. Have your entire team benefit by taking advantage of our group discount – send three individuals from the same company and receive a 15% discount off each registration. Please use the registration form on the back of this brochure. Or, if you prefer, phone us at (888) 670-8200 US; (941) 951-7885 Int'l; or fax us at (941) 365-2507. We look forward to greeting you on October 4th in San Francisco.

Sincerely,

Shalini Gupta, PhD, Associate Director, Clinical Immunology,
AMGEN

Susan Richards, Group Vice President, Clinical Laboratory Sciences
GENZYME

Anne Reel, Program Director, IIR Cell Based Assay and Immunogenicity Conferences

Valerie Bowling, General Manager, Pharmaceutical and Biotechnology Division,
IIR