Bioanalytical & Ligand Binding Assays

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 worked in pharmaceutical industry in the area of bioanalytical methods development for 30 years and is an adjunct Assistant Professor of Biochemistry and Molecular Biology, Indiana University 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, pharmacodynamics and safety.

Dr. Smith received his B.S. in Mathematics from Purdue University in 1966, and his M.S. and Ph.D. degrees in Mathematical Statistics from Iowa State University in 1969 and 1974, respectively. His professional career has included positions as Mathematician, General Motors Corporation (1966-1968) and Assistant Professor of Biostatistics, University of North Carolina (1974-1979), followed by more than 23 years as a research scientist at Eli Lilly and Company. Dr. Smith is recognized within the pharmaceutical industry as a leader in promoting the application of appropriate statistical methods to the development and validation of analytical procedures for the discovery, product development, quality control, and preclinical/clinical evaluation of pharmaceutical products.

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 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.

• Extensive experience in R&D of biologics and therapeutics, including development of viral and bacterial vaccines, gene therapies for oncology, and protein and peptide-based therapeutic products.
• Leadership of Assay Development and Quality Control functions in small, mid-sized and large biopharmaceutical companies (including study design, method and equipment qualification and validation, product release, and stability tracking and trending).
• International Project Team experience.