This eChalk talk will
explore the possibilities and challenges in the analysis and interpretation of
multiplex cytokine data in the context of non-clinical safety studies. The
focus of the discussion will be on strategies to improve the application of multiplex
analysis to obtain a better understanding of adverse immune events or
immunotoxicity in non-clinical models. 
Dr. Farmer obtained his doctorate in Cellular and Molecular
Physiology at the University of Alabama at Birmingham studying the role of
lymphocyte derived growth hormone (LDGH) in primary human T and B lymphocytes
and Ramos and Jurkat B & T lymphocyte cell lines. This academic work
described the anti-apoptotic intracrine mechanism of LDGH through increased
expression of insulin like growth factors I & II (IFG-I & II), insulin
like growth factor receptors (IFG- I & II R), and TGF-Beta-1 expression and
activation. This work was performed using molecular and cellular
techniques including northern, southern, western blots, cell culture, RT-PCR,
dominant negative constructs for RNA interference, and standard immunological
techniques including ELISA, flow cytometry, and cell based functional assays.
Industry training and experience in the conduct of regulated studies in excess
of ten years obtained at three different CROs includes ligand binding, cell
based, and flow cytometric assay development, and validation of PK/TK/ADA
methods quantifying immunological responses to multiple classes of
biotherapeutics including peptides, proteins, cytokines, vaccines, anti-body
drug conjugates, and gene vectors. Additional experience includes
direction of immunotoxicology studies assessing innate, cellular, and humoral
immune responses in multiple immune competent models including murine, hamster,
canine, and multiple species of NHP including Rhesus, cynomolgus, and African
green monkeys. Technical experience includes ELISA, ECL, cytokine multiplex
analysis, flow cytometry, complement activity assays, and standard immune cell
functional assessments including T cell proliferation, NK cell assays, mixed
lymphocyte reaction (MLR), ELISPOT, macrophage and neutrophil oxygen dependent
and independent killing.