Tracy TreDenick

Tracy TreDenick is a founding partner of BioTechLogic, which was formed in 2004. Tracy is the Head of Regulatory and Quality and has over 30 years of experience in the pharmaceutical industry including roles in manufacturing, quality, and regulatory. She has supported the development of 55 breakthrough therapy products including the following:

40 viral and non-viral gene therapy programs (e.g. AAV vectors, CRISPR/CAS9-based gene editing lipid nanoparticle (LNP), and CRISPR mediated AAV- gene editing)
15 cell therapy programs (e.g. gene-modified stem cells, autologous CAR-T, allogeneic and autologous stem and progenitor cells, induced pluri-potent stem (IPSCs) cells, allogeneic UC-MSCs, and autologous combination product tissue therapy) This includes three gene therapy products that have been approved by FDA and other regions of the world.

Since 2004, Tracy and the BioTechLogic Regulatory and Quality team have also supported 76 different biologically derived molecules, including 26 recombinant proteins, 18 vaccines, 23 antibodies, and 9 blood-based products.  Her responsibilities have included serving in Executive and Head of Quality and Regulatory leadership roles for sponsor companies, serving as technical gene therapy advisory board member, performing the duties of US Agent (authorized regulatory representative) for foreign companies, development of global CMC strategies for NDA, BLA and MAA submissions, authoring of CMC Modules 3 and 2.3 sections, preparing briefing books and scientific advice packages for IND and IMPDs as well as development of strategies related to drug or biologic/medical device combination products, vendor qualification, risk management and cross-contamination controls.  This experience enabled a clear understanding of CMC requirements for the development and commercialization of breakthrough therapy products.

PRESENTATIONS/PANELS/E-BOOKS

1. Women in Science Webinar Series, Wish I had Known.  Invited Speaker by Lara Silverman, PhD, University of Pennsylvania, Cell &Gene Therapy Translational Expert. (April 26th, 2023)
2. CMC Development and Regulatory Challenges for Rare Diseases:  Case Studies for an Individual Patient Expanded Access IND for Glioblastoma and Rare Genetic Disease BLA, North Carolina Biotechnology Center, Research Triangle Park, NC (2019)
3. Regulatory Panel Member: Key Consideration in Gene Therapy Manufacturing for Commercialization, Cell & Gene Therapy Bioprocessing & Commercialization, KNect365, Boston, MA (2018)
4. Process Validation and Regulatory Approval Strategies Required for Drugs that Have Been Designated Fast-track and Breakthrough Therapies, BioProcess International (BPI) West, San Francisco, CA (2018)
5. Key Considerations in Gene Therapy Manufacturing for Commercialization:  The State of Gene Therapy Regulation, Cell Culture Dish Inc.(2018)
6. Risk Management and Design Control Challenges for Combination Products: A Deeper Dive into Complex Drug /Device Combination Products and Co-Packaged Kits, Parenteral Drug Association (PDA) Annual Meeting, Anaheim, CA (2017)
7. Bringing Legacy Combination Products into Compliance with 21 CFR Part 4, CASSS CMC Strategy Forum North America: CMC Strategies for Cell & Gene Therapy, Gaithersburg, MD (2016)
8. Turner, W., TreDenick, T., Late Stage CMC Challenges for Oligonucleotide/Adjuvants Used in Vaccines (Case Study), TIDES Annual Meeting, Las Vegas, NV (2012)
9. Turner, W., TreDenick, T., Late Stage CMC Challenges for Oligonucleotide/Adjuvants Used in Vaccines (Case Study), BioProcess international Conference, Vaccine and Complex Biologics Development and Production, Boston, MA (2012)
10. Attributes of Success: Development through Commercialization (Case Study), 46^th Annual Drug Information Association (DIA) Meeting, Washington, D.C. (2010)
11. Biotechnology: The Pursuit of Quality in the Globalized World, 20th Annual Drug Information Association (DIA) EuroMeeting, Barcelona, Spain (2008)
12. Technical & Regulatory Challenges of Validation: Quality Risk Management and Technical & Regulatory Challenges of Validation: FDA/EMEA Quality and Regulatory Trends, Jordan Food and Drug Administration (JFDA), Amman, Jordan (2007)
13. TreDenick, T., Giljum P., Technical & Regulatory Challenges of Validation: Facility, Utility and Equipment Validation, Jordan Food and Drug Administration (JFDA), Amman, Jordan (2007)
14. Preparing for a Pre-Approval Inspection & Managing Risk (Case Study), Parenteral Drug Association (PDA) Audio Conference (2005)

Prior to joining BioTechLogic, Tracy had increasing roles of responsibility within Pfizer (also formerly Pharmacia and Searle) and Baxter. She directed the validation and pre-approval readiness programs for biopharmaceutical products while at Pfizer. Prior to Pfizer, Tracy worked for Baxter in Round Lake, IL where she was responsible for Aseptic Filling manufacturing operations.

Ms. TreDenick received her B.A. in Biology/Pre-Med from Indiana Wesleyan University.