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Asian Journal of Biomedical and Pharmaceutical Sciences | Volume 8
March 26-27, 2018 | Orlando, USA
World Summit on
Healthcare & Hospital Management
&
International Conference & Exhibition on
Biologics and Biosimilars
T
heAmericanAssociationof Pharmaceutical Scientists (AAPS)
biosimilar focus group on nonclinical and clinical assays has
developed a manuscript to guide the industry on best practices
and testing strategies when developing neutralizing antibody
(NAb) assays for biosimilar programs. Establishing that there
are no clinically meaningful differences in immune response
between a proposed product and the originator product is a key
element in the demonstration of bio-similarity. It is critical to
collect, evaluate and compare the safety and immunogenicity
data from the clinical pharmacology, safety, and/or efficacy
studies especially when the originator drug product is known
to have potential for immune-mediated toxicity. In this
presentation, a comprehensive review and recommendations
on assay formats, critical reagents, approaches to method
development, and validation of the neutralizing antibody assays
will be discussed.
Speaker Biography
Todd Lester is the Bioanalytical Project Manager in BioAgilytix, oversees and leads all
technical aspects of BioAgilytix’s bioanalytical studies including design, interpretation,
analysis, documentation, and reporting. He is a seasoned Biotech/Pharmaceutical
Project Management Professional with broad GxP expertise. He is well-versed in
the regulations and filing requirements for FDA and EMA, particularly regarding
biosimilar development and the related immunogenicity assessment strategy and
data interpretation. He has completed his BS in Biological Sciences from Cornell
University and is a licensed Project Management Professional (PMP) with the Project
Management Institute (PMI).
e:
todd.lester@bioagilytix.comTodd Lester
BioAgilytix, USA
Recommendations for the development and validation of neutralizing antibody
assays in support of bio-similar assessment