Tracy TreDenick-Fricke
VP, Regulatory/Quality
Tracy TreDenick-Fricke joined Adjuvance Technologies’ management team in 2019. Ms. TreDenick-Fricke is one of the founding partners of BioTechLogic, which was formed in 2004. She is the Head of Regulatory and Quality and has 28 years experience in pharmaceutical quality, manufacturing and regulatory. Most recently she has supported the development of 7 breakthrough therapy products including 4 gene and 3 cell therapies, one of which is approved. Tracy and her team has supported 39 different biologically derived molecules, including 16 recombinant proteins, 11 vaccines, 8 antibodies, 4 blood based-products. In addition, Tracy and the BioTechLogic team have supported 22 biosimilars, 15 synthesized macromolecules, and 12 combination products. This responsibility included serving as authorized US representative for foreign companies, development of global CMC strategies, authoring of CMC sections and briefing books/scientific advice packages for IND/IMPD and NDA/BLA submissions, as well as development of strategies related to combination products, vendor qualification, risk management and cross-contamination controls. This experience enabled a clear understanding of the expectations for the development and commercialization of breakthrough therapy products. Prior to joining BioTechLogic, Ms. TreDenick-Fricke directed the validation and pre- approval readiness programs for biopharmaceutical products within Pfizer (formerly Pharmacia Corporation), including the process validation, registration and commercialization of Somavert®, a protein product. Ms. TreDenick-Fricke received her B.A. in Biology/Pre-Med from Indiana Wesleyan University. She has also completed graduate study courses in Business Management at Keller Graduate School of Management.