Click here for Ms. Kelley's CV.
Marian has 10 years experience in academia and another 26 years experience in pharmaceutics research & development encompassing E. I. DuPont, Sterling Drug and J&J. Marian spent her early years in Pharma heading up monoclonal antibody development and production facilities at both DuPont and Sterling. She focused on unique hybridoma screening and selection methods, and monoclonal antibody production and modifications to support analysis. Her work naturally progressed to the utilization of monoclonals in ligand binding assay methods development in support of cytokine assessment, antibodies etc. A review of Marian’s literature references will give you a flavor of the scope of methods and analytes she has developed over her career.
With her move to J&J in the early 90’s Marian became involved in the regulated aspect of drug development and she was introduced to the assay validation papers from the FDA. Building on those recommendations from the authorities, Marian and colleagues from across Pharma, Biotech and Contract Organizations brought together their best practices in developing and validating ligand binding assays in support of pharmacokinetics for large molecules resulting in a white paper published in Pharma Res. Marian was centrally involved in the development and validation of assay methods that assessed the antibodies to EPO across the world. She helped set up compliant CLIA labs in France, Germany and Australia and managed the proficiency testing program to ensure accuracy of all Labs performing the EPO antibody testing. Marian’s final years in Pharma were spent at Centocor, J&J’s Biotech facility, where she led the bioanalytical group to incorporate the latest thinking in GLPs into their work as well as “fit for purpose” assay validations to support biomarker studies. Marian 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 is co-chairing the upcoming Workshop on Assay Reproducibility for Incurred Samples to be held in Crystal City in February, 2008.
Most recently Marian has moved to consulting full-time. She set up MKelley Consulting LLC and has joined the staff at B2S Consulting for supporting bioanalytical projects particularly in the areas of assay method development and validation for large molecules, and GLP compliance.
