Ronald R. Bowsher, Ph.D. – Biography

Dr. Bowsher’s career in the pharmaceutical/biotechnology and CRO industries has spanned more than 40 years. He is recognized as an opinion and thought-leader in the areas of bioanalytical methods development to support regulatory-compliant bioanalysis, ADME and immunogenicity assessments of biotherapeutics. He received his M.S. and Ph.D. degrees in Biochemistry & Molecular Biology at the Indiana University School of Medicine (Indianapolis, IN). Currently, he is Partner and CSO at B2S Life SciencesTM (www.B2SLifeSciences.com), a laboratory in Franklin, IN specializing in the generation and life-cycle management of custom biological reagents, early assay development and ADME to support biotherapeutic drug development and serves as a Senior Research Advisor at AIT Bioscience (Indianapolis, IN).

In 2003, Dr. Bowsher retired after more than 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. In 2003, he co-founded LINCO Diagnostic Services (now a division of Eurofins), the first CRO dedicated solely to regulatory-compliant bioanalysis of biotherapeutics by LBA methodology and served as CSO until 2012. Since 1980, he has published > 200 research papers, monographs, and abstracts, has four patents, given about 75 invited lectures, been a consultant to more than 100 global companies and has served on several scientific advisory boards. Areas of research interest have included development and validation of ligand binding assay for conventional small molecule drugs, biotherapeutics, novel biomarkers, application of commercial kits for quantitative determination of biomarkers and the detection and characterization of anti-drug antibodies.

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.

B2S Life Sciences