B2S Life Sciences announced in November 2018 that Dr. William (Bill) Nowatzke, Ph.D., DABCC joined the team as vice president of laboratory operations and Clinical Laboratory Improvement Amendments (CLIA) testing.
Nowatzke is a board-certified clinical chemist with more than 20 years of academic, industry and contract research organization (CRO) experience. He implements and manages laboratory operations to support regulated bioanalysis of biotherapeutics (GxP) and CLIA programs for clinical diagnostics.
“We are thrilled to welcome Bill to our growing B2S family, as we know his impressive background will take our work in diagnostics to the next level,” said B2S Life Sciences Chief Executive Officer Aleks Davis. “His expertise in both the biotherapeutic industry and CLIA is unmatched, and all of us at B2S look forward to working with Bill to enhance our customer relationships and outcomes.”
For the past 15 years, Nowatzke has led regulated bioanalysis for research and development support of novel therapeutics within the pharma and biotech industries. He most recently was with Radix BioSolutions located in Georgetown, Texas.
His experience includes developing and validating bioanalytical methods to support pharmacokinetics and toxicokinetics (PK/TK), detecting anti-drug antibodies for immunogenicity testing and assessing a variety of platforms for biomarker assessments. These programs were executed under the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regulatory guidelines.
Nowatzke also has an expertise in the advancement and validation of laboratory developed tests (LDTs) and clinical diagnostic devices. After receiving his doctorate in chemistry at Indiana University Bloomington, Nowatzke completed a postdoctoral fellowship in clinical chemistry at Washington University School of Medicine in St. Louis. Upon receiving certification from the American Board of Clinical Chemistry, he transitioned to the university’s department of medicine providing leadership in a CLIA laboratory developing and validating LDTs for esoteric biomarkers to support registration phase clinical trials.
He remains active in professional organizations and continues to publish and speak on bioanalytical issues pertaining to GxP and CLIA applications.