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Dr. Bowsher’s career in the pharmaceutical/biotechnology and CRO industries has spanned 41⁄2 decade, including 3 decades at the Lilly Research Labs and nearly 2 decades as a consultant and an advisor in the CRO industry. He is a recognized thought-leader in the areas of bioanalytical methods development for 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 biotechnology drug development support laboratory in Franklin, IN specializing in the generation and life-cycle management of custom biological reagents, ligand binding assay development and ADME, and data analytics to support biotherapeutic drug development. In 2003, Dr. Bowsher retired from the Lilly Research Laboratories where he led research groups responsible for supporting regulated bioanalysis of biotherapeutics and conventional small molecule drugs by ligand binding assay methodology. His Lilly tenure included more than a decade of experience as the Lilly Clinical Radiation Safety Officer and as a member of the Lilly Corporate and IUMC Radiation Safety and Radionuclide Human Use committees. Since 1980, he has published > 250 research papers, monographs, and abstracts, has four patents, 75 invited lectures, been a consultant to > 100 global companies and has served on several scientific advisory boards. In 2000, he led creation of the Ligand Binding Focus Group within AAPS which culminated in a number of key white papers with emphasis on ligand binding assays for supporting PK of biotherapeutics, ADA testing and quantitative biomarker assessments. In 2004, Dr. Bowsher was elected as an AAPS Fellow. In 2008, he was given an AAPS Presidential citation for his efforts to establish educational training programs for supporting Biotech R&D. In 2011, Dr. Bowsher received the AAPS BIOTEC Section distinguished service award.
Aleks Davis has over twenty years of experience in biotechnology industry with a proven track record in multiple facets of drug development. As a project director in Tailored Therapeutics at Eli Lilly and Company, Aleks was responsible for the planning, implementation and financial tracking of projects supporting early stage biomarker hypothesis. Several of these projects were in the neuroscience field. As the global director at ICON PLC, Aleks developed policies and procedures, business development strategies, marketing and profit and loss accountability. There he directed operations spanning four continents. Now at B2S Life Sciences, Aleks is the CEO and works with over one hundred different clients by helping them navigate the important, yet, challenging aspects of bioanalysis in biotherapeutic development. His Chemistry degree is from Georgia Southern University and Executive MBA is from Kelley School of Business, Indiana University. In 2019, he was a member of the B2S Life Sciences team that was honored by the Small Business Administration as Indiana’s Exporter of the Year.
Dr. Nowatzke has more than twenty years of academic/industry/Contract Research Organization experience providing bioanalytical support for diagnostics and pharmaceutical programs. After receiving a Ph.D. in chemistry at Indiana University (Bloomington, IN), Dr. Nowatzke completed a postdoctoral fellowship in clinical chemistry at Washington University School of Medicine (St. Louis, MO). After successfully completing the Clinical Chemistry certification exam from the American Board of Clinical Chemistry he transitioned to the Department of Medicine providing leadership in a CLIA laboratory developing and validating laboratory-developed tests for esoteric biomarker testing in support of late phase safety / efficacy clinical trials. More recent focus has been providing bioanalytical support for biological therapeutics and assessing the efficacy of drug candidates. These activities include developing and validating bioanalytical methods and managing the analysis of samples in support of pharmacokinetic, anti-drug antibody, and biomarker programs utilizing immunoassay platforms. Dr. Nowatzke has remained active in professional organizations, and continues to publish and speak on challenging issues related to the advancement of bioanalytical techniques.