Tracy L. TreDenick BioTechLogic, Inc.

Tracy TreDenick is one of the founding partners of BioTechLogic, which was formed in 2004.  She is the Head of Regulatory and Quality, and has over 20 years’ experience in Technical Operations, Quality Assurance and Regulatory Affairs.  Most recently she has supported the development and remediation of 7 combination products, including 6 products using pre-filled syringes and 1 subcutaneous delivery system.  She also supported the strategies for filing two 2 co-packaged combination product convenience kits and 1 Type III medical device. Responsibilities included development of combination product CMC and medical device PMA readiness strategies, as well as preparation of documents that spanned across all aspects of design control.  For those products being brought into compliance with 21 CFR Part 4, strategies were developed for remediation using design control documentation based on risk evaluations.

Tracy and BioTechLogic team members have supported 32 different biologically derived molecules, including 14 recombinant proteins, 8 vaccines, 3 blood based products, and 7 biosimilars.  In addition, they have supported 10 synthesized macromolecules, 9 combination products, 2 gene therapy products, and 1 cell therapy product.

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.