Franklin-based B2S Life Sciences LLC, a biotherapeutic drug development company, has appointed William "Bill" Nowatzke vice president of laboratory operations and clinical laboratory improvement amendments testing. He is a board-certified clinical chemist with more than 20 years of academic, industry and contract research organization experience. Nowatzke implements and manages laboratory operations to support regulated bioanalysis of biotherapeutics (GxP) and CLIA programs for clinical diagnostics.

For the past 15 years, he has led regulated bioanalysis for research and development support of novel therapeutics within the pharma and biotech industries. Nowatzke 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 and the European Medicines Agency regulatory guidelines.

Nowatzke also has an expertise in the advancement and validation of laboratory developed tests and clinical diagnostic devices. After receiving his doctorate in chemistry at Indiana University, 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.