December 3, 2014
1:00 pm to 2:00 pm EST

Sponsored by

Webinar Description:

The gold standard for ligand binding assays has traditionally been ELISAs, however more sensitive, greater detection range, and more automated assays are desired to support pharmacokinetic programs. Herein we will discuss quantification of a PEGylated domain antibody in human serum using BioScale’s AMMP technology. This presentation will also include a proof of concept to expand the dynamic range of the assay on the AMMP technology to support multiple ascending dose studies of biotherapeutics.

Learning Objectives:

• How to construct your own ligand binding assay to quantify biotherapeutics and biomarkers
• How to attain a bioanalytical assay to support pharmacokinetic programs that meet regulatory standards
• How immunoassays on the ViBE Platform are automated, thus enabling more productivity and increasing accuracy and precision
• How to achieve a greater dynamic range to support sample analysis

Speakers:

Binodh Desilva, PhD

Executive Director of Immunogenecity and Biomarker Development
Bristol-Myers Squibb

Shannon Chilewski, MS

Research Scientist II
Analytical and Bioanalytical Development
Bristol-Myers Squibb

Matthew Dickerson, PhD

Principle Scientist
Assay Development
BioScale

Speaker Bios:

Binodh DeSilva, PhD

Dr. DeSilva is the Executive Director of Immunochemistry and Biomarker Development at Bristol-Myer Squibb Company in Lawrenceville, NJ. She received her Bachelor’s in Analytical Chemistry from the University of Colombo, Sri Lanka in 1987, and a Ph.D. in Chemistry (Bioanalytical) in 1994 from the University of Kansas. She was a Post Doctoral Research Associate in the Pharmaceutical Chemistry Department at the University of Kansas from 1994-1995. She was at Procter & Gamble Pharmaceuticals, Norwich, New York, from 1995-2001 and at Amgen, Thousand Oaks, CA leading the bioanalytical team from 2001-2010. She joined BMS in November of 2010. Dr. DeSilva leads the Immunochemistry and Biomaker Development group in ABD supporting bioanalytical support for all biologics from discovery to life cycle management. She is the co-chair of the immunogenicity council. Dr. DeSilva has been an active member of AAPS since 1997. Currently, she is a Member-at-Large on the AAPS Executive committee, the past-chair of the Biotech section of the AAPS, member of the Steering Committee of the Global Bioanalytical Consortium representing North America. She is one of the organizers of the Bioanalytical Workshop.

Shannon Chilewski, MS

Shannon Chilewski is currently a Research Scientist II in the Bioanalytical Sciences-Biologics Department at Bristol-Myers Squibb where she is responsible for the bioanalysis of biotherapeutics to support pre-clinical and clinical studies. She has played a critical role in the evaluation of new technologies and is an active member of the SOP committee. She received her Master’s in Biotechnology from the University of Connecticut, and upon completion, joined The Broad Institute of MIT and Harvard where she performed immunology and genetics research. She has over 6 years experience in the bioanalysis of biotherapeutics, starting when she joined Merck, where she developed bioanalytical assays to support pharmacokinetics and immunogenicity. She is active in the AAPS Ligand Binding Assay Bioanalytical Focus Group where she serves as the communications editor for the quarterly newsletter.

Matthew Dickerson, PhD

Dr. William M Dickerson is a Senior Scientist in Assay Development. Matt Dickerson has more than 10 years of experience in the development and optimization of biological assays. He is currently one of the chief architects at BioScale for the design and development of assays utilizing the AMMP technology for bioanalytical, preclinical and clinical development. His work includes assays for cytokines, inflammatory biomarkers, phosphoproteins, kidney injury markers, and cell-based assays. Prior to BioScale, Matt was a senior scientist at ILEX Oncology where he focused on the production and development of antibodies for potential therapeutic development. He has also developed cell-based screening assay for potential cancer therapeutics which included Tumistatin and Mucin-1. Dr. Dickerson had similar positions at both Wyeth and Biotransplant. Matt received his BS in biology at Mary Washington College and PhD in pharmacology at Northeastern University. He has been an invited speaker at major industry conferences and has multiple publications in peer-reviewed journals.

Cost: No cost