Management

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.

Mr. Brunelle obtained a BS in mathematics in 1970 and a MS in Public Health Biostatistics in 1974 with emphasis in mathematical and applied statistics from the University of Massachusetts.  After graduation, Mr. Brunelle was hired as a statistician at Eli Lilly and Company working primarily in the clinical area supporting registration and post-marketing clinical trials.   Mr. Brunelle has worked in many clinical areas including cardiovascular, central nervous system, dermatology, anti-emetic, arthritis, and endocrine.  He has helped design clinical plans, designed and analyzed data from many phase I, II and III studies and has interacted extensively with various global regulatory agencies.

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.