April 22, 2015
11 am to 12 pm EDT

Sponsored by

Webinar Description:

This seminar will demonstrate how to generate robust immunogenicity data for clinical studies that may run for many years involving multiple sites as well as post-marketing studies.

Monitoring Anti-Drug Antibodies (ADAs) is critical for ensuring safe and efficient administration of biotherapeutics. The key analytical challenge is to measure very low concentrations of ADAs in the presence of soluble drug, as well as ADAs of different isotypes. The ImmunoCAP® assay enables customized developed RUO assays on an automated IVD platform together with standardized reagents to yield performance, stability and reproducibility for reliable analysis.

Learning Objectives:

• How to avoid time delay in clinical development due to assay revalidation.
• How to mitigate risk of assay inconsistency over time and between laboratories.
• How to detect antibodies of specific isotype (e.g. IgG4 and IgE)
• Advantages of assay development on an IVD platform

Who should attend:

Managers, directors and principal scientists in pharma and biotechnology within areas of Biotherapeutics/Biosimilars development, Bioanalytics, Immunogenicity, Personalized Healthcare, Translational Medicine, Early Clinical Development

Speakers:

Åsa Marknell DeWitt, Ph.D.

Senior Scientist, Diagnostics Partnering

Thermo Fisher Scientific

“Åsa Marknell DeWitt, Ph.D., Senior Scientist and Manager for Scientific and Technical Support has been employed at ImmunoDiagnostics (former Phadia, now Thermo Fisher Scientific) for more than 20 years. Dr Marknell DeWitt oversees the scientific and technical aspects of collaborations with partners within the pharmaceutical industry. During her time at R&D, Dr. Marknell DeWitt was part of establishing the Component Resolved Diagnostics program which brought over 80 component ImmunoCAP tests to market. Her PhD work focused on the use of recombinant antigens for in vitro diagnostic development of specific IgE immunoassays and her team developed over 75 RUO assays within the EU-funded multidisciplinary integrated EuroPrevall project.”

Dohan K Weeraratne, BSc

Scientist, Pharmacokinetics & Drug Metabolism

Amgen Inc.

Dohan joined Amgen with the Clinical Immunology Department in April 1999 and has been working on anti-drug Antibody immunoassays for nearly 16 years. Currently, he is a member of the Pharmacokinetic Assay Development Team with the PKDM Department, providing expertise in a variety of assay platforms such as Biacore, MSD, ELISA and ImmunoCAP. He has written several publications on the development and validation of immunoassay methods, including an anti-ESA IgG4 antibody assay using ImmunoCAP®. Dohan is knowledgeable in ADA data interpretation in context of safety and efficacy in clinical settings. He has experience working with CROs in the areas of assay transfer and clinical program management.

Moderator:

Barbara Bislawska Axnäs, PhD

Marketing Manager, Diagnostics Partnering

Thermo Fisher Scientifi