 Ronald R. Bowsher, Ph.D. |
Dr. Bowsher received his B.S. in chemistry in 1977 from Indiana University and his M.S. and Ph.D. degrees in biochemistry from the Indiana University School of Medicine in 1981 and 1986, respectively. He has worked in pharmaceutical/biotech and CRO industries in the area of bioanalytical methods development for more than 35 years and is an adjunct assistant professor of biochemistry and molecular biology at the IU School of Medicine. His primary research interest is the development and validation of ligand binding assays (immunoassays) for the bioanalysis of macromolecules, endogenous compounds and conventional xenobiotic drugs to support regulatory-compliant assessments of pharmacokinetics/toxicokinetics, pharmacodynamics and safety. |
 Marian Kelley, M.A. |
Marian worked at J&J PRD and Centocor, J&J’s Biotech facility for over 12 years before forming MKelley Consulting LLC and joining B2S as a senior consultant. Marian 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 methods to screen, confirm and characterize the neutralizing activity of anti-EPO antibodies using cell-based assays. She 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. |
 Jeff Sailstad, B.S. |
Jeff has nearly 30 years of experience in the pharmaceutical and biotechnology industries. His “large pharma” experience (24 years) included Burroughs Wellcome, Glaxo Wellcome and Glaxo SmithKline. He rose through the ranks, initially developing and applying bioanalytical methods, assuming additional responsibilities for the regulatory compliance of the validation and application of group’s procedures. In his final position at GSK he managed a laboratory that developed, validated and applied cellular, molecular and biochemical surrogate markers for clinical studies. |
 Dan Wierda, Ph.D. |
Dan is an immunotoxicologist with more than 30 years of experience in academia and the industry with expertise in the areas of immunotoxicity, immunogenicity and biopharmaceutical preclinical drug development. He was a research fellow at Eli Lilly and Company until he retired in 2010. As an independent toxicology consultant, he can provide expertise in conducting preclinical pharmacology and GLP toxicology studies for biologics and small-molecule drugs. He also has in-depth experience in the technical conduct of GLP immunogenicity and immunotoxicity studies and in developing immunogenicity risk-mitigation strategies for biopharmaceuticals. |