The AVANZA Advisory Board - Scientific and Regulatory

 

Marian Kelley, M.A.

 

Marian Kelley received her B.A. in biology in 1970 from Gwynedd Mercy College and her M.A. in biology in 1974 from West Chester State University. Kelley worked at J&J PRD and Centocor, J&J’s Biotech facility for over 12 years before forming MKelley Consulting LLC. Marian Kelley led the protein bioanalytical group at PRD conducting GLP bioanalysis in house and outsourcing to CROs to develop protein drugs. A major accomplishment was Marian’s work on the erythropoietin (EPO) project. To address the EPO immunogenicity issues she developed and validated LBAs methods to screen, and confirm positives, and characterized their anti-EPO neutralizing activity using cell-based assays. Kelley helped set up compliant CLIA labs in France, Germany and Australia and monitored the labs to ensure compliance and consistency. Marian transferred to Centocor as the Director of Compliance and helped the Clinical Pharmacology Department incorporate the latest thinking in GLPs into their preclinical and clinical bioanalysis programs to support PK and immunogenicity testing as well as “fit for purpose” assay validations to support biomarker studies. Marian Kelley was founding secretary of the Ligand Binding Assay Bioanalytical Focus Group (LBABFG) in the Biotech section of AAPS. She remains an active member of the Focus Group and co-chaired the Workshop on Assay Reproducibility for Incurred Samples held in Crystal City in February, 2008. Marian was the corresponding author of the DeSilva Paper: Recommendations for the Bioanalytical Method Validation of Ligand-binding Assays to Support Pharmacokinetic Assessments of Macromolecules; Pharm Res, 2003, Vol 20, No 11, pp. 1885-1900. Her most recent publications are on the topic of Bioanalytical Approaches to Quantify ‘Free and Total” Biotherapeutic Monoclonal Antibodies and Quality Assessment of Biotherapeutic Monoclonal Antibodies.

 

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