Tracy TreDenick is one of the founding partners of BioTechLogic, formed in 2004. She is the Head of Regulatory and Quality and has over 20 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, including one that is approved. This responsibility included development of combination product CMC strategies, preparation of CMC sections for IND and BLA submissions, as well as development of strategies related to vendor qualification, risk management and cross-contamination controls. This experience enabled a clear understand of the expectations for the development and commercialization of Breakthrough therapy products. Prior to joining BioTechLogic, Ms. TreDenick 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 received her B.A. in Biology/Pre-Med from Indiana Wesleyan University. She also completed graduate study courses in Business Management at Keller Graduate School of Management.