Ron Bowsher, Ph.D.
Senior Research Advisor
Dr. Bowsher’s career in the pharmaceutical/biotechnology and CRO industries has spanned 40 years. He is recognized as a global thought-leader in the area of bioanalytical methods development to support regulatory-compliant Bioanalysis and ADME of biotherapeutics, especially in the area of insulin, insulin analogues and other endocrine related peptides. He received his M.S. and Ph.D. degrees in Biochemistry and Molecular Biology at the Indiana University School of Medicine (Indianapolis, IN). Currently, he serves as a Senior Research Advisor at AIT Bioscience (Indianapolis, IN), is Partner and President at Bowsher Brunelle Smith LLC (B2S Consulting®, www.B2S-Stats.com), and Partner and CSO at B2S Labs™ (www.B2SLabs.com), a laboratory specializing in the production and life-cycle management of custom immunoanalytical and biological-based reagents to support biotherapeutic drug development. In 2003, Dr. Bowsher retired after > 30 years at the Lilly Research Laboratories where he led research groups responsible for bioanalysis and ADME of biotherapeutics and the determination of novel biomarkers and anti-drug antibodies. His group supported commercialization of a number of products, including Humatrope (human growth hormone), Humulin (human insulin), Humalog (insulin lispro), Humulin Fixed Mixtures (70:30 & 50:50), Humalog and Fixed Mixtures (70:30 & 50:50), Evista, Forteo’ (hPTH 1-34), rDNA-glucagon, Xigris (rhAPC) and Permax (pergolide). Since 1980, he has published > 200 research papers, monographs, and abstracts, has four patents, given > 50 invited lectures, been a consultant to > 60 companies and has served on scientific advisory boards. Specifically relating to insulin and insulin analogues, Dr. Bowsher has published 28 manuscripts and 31 abstracts. Other areas of emphasis for publications have included development and validation of ligand binding assay for biomarkers, application of commercial kits for quantitative determination of biomarkers and the detection and characterization of anti-drug antibodies following exposure to the biotherapeutics. In addition, he has served on committees for the American Diabetes Association for Standardization of Insulin Assays (1993-95 and 2004-06), the JDF for the Insulin Sensor Initiative (2013), and been a grant reviewer for NCI (1999) and NIDDK (2011). In 2001, he led the effort within AAPS (American Association of Pharmaceutical Scientist) to create the Ligand Binding Assay Bioanalytical Focus Group, a forum to address issues, seek harmonization and promote education for the development, validation and application of ligand binding assay methods to support drug development. This group has published a number of key white papers that are now recognized as industry standards for guiding biotherapeutic drug development. In 2004, Dr. Bowsher was elected as an AAPS Fellow. He is a Past-Chair of the AAPS BIOTEC Section and AAPS Fellows Committee. In 2007, Ron served as Chairman of the AAPS National Biotechnology Conference. In 2008, he was awarded an AAPS Presidential citation for his efforts to establish educational training programs. In 2011, Dr. Bowsher received the AAPS BIOTEC Section distinguished service award. In 2012 he received the Distinguished Alumnus Award, School of Science, Indiana University-Purdue University (IUPUI), Indianapolis IN. In 2014, he was given the prestigious Distinguished Service Award by AAPS.