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.

CMC Expertise Accelerating Biologics Development for 20 Years and Counting

Working with my co-founders, colleagues, and clients on many fascinating projects over the last twenty years has been an honor. From the founding of the firm with former Pfizer colleagues until today, we have specialized in supporting the CMC and regulatory programs for an array of biologic modalities, including gene and cell therapies, recombinant proteins, oligonucleotides, peptides, antibody-based therapeutics, recombinant proteins, vaccines, and more.

These 20 years have been exciting for the industry, as 20 years ago, large-molecule biologics had just started coming into their own. Today, they account for 46% of pharmaceutical industry revenue in the U.S., and BioTechLogic has played a meaningful role in helping to manifest the commercial prosperity of numerous biotherapeutics. We have provided CMC resources that augmented our clients’ teams through hands-on and expert consultancy to speed their journeys to the market.

Often, we helped our clients overcome significant obstacles that had or would have significantly delayed filings and commercial approval. For the last ten years, BioTechLogic has focused primarily on the gene and cell therapy sector, and we see this segment of the market maturing just as large-molecule biologics did.

We have also completed many successful projects in biosimilars, synthesized macromolecules (i.e., oligonucleotides and peptides), vaccines, and combination drug product areas, and we see tremendous opportunity in these areas as well. As BioTechLogic continues celebrating its 20th anniversary, we decided to reflect on our accomplishments.

20 Years of CMC Excellence

1,400+ projects, 257 clients

Modalities Served

• 73 gene therapy products
  • 3 approved
• 26 cell therapy products
• 76 biologically derived innovator products
  • 26 recombinant proteins
  • 18 vaccines
  • 23 antibodies
  • 9 blood-based products
• 34 biosimilar products
• 23 synthesized macromolecules
  • 15 oligonucleotides
  • 8 peptides
• 35 combination products
  • 18 pre-filled syringes
  • 6 drug device delivery systems
  • 1 needle-free injector
  • 1 drug with excipient in a PFS
  • 1 novel therapeutic API for use in a fibrin sealant
• 2 Type III medical devices
• A variety of complex drug products with unique formulations
• Led and provided the overall strategy for 57 Process Validation Programs, including:
  • 20 approved by the FDA and/or EMA
  • 2 submitted and in review by FDA and/or EMA
  • 9 ongoing global process validation programs
  • 6 – gene therapies, 2 – cell therapies, 7 – biosimilars, 8 – vaccines, 5 – antibodies, 11 – recombinant proteins, 1 – peptide, 1 – oligonucleotide, 2 – blood-based, 8 – drug-device combination products, 4 – other
• Primary CMC author for 102 Submissions:
  • 48 INDs (2-antibodies, 3 – oligonucleotides, 3 – peptides, 1 – recombinant proteins, 7 – cell therapies, 1 modified particle, 23 – gene therapies, 4-biosimilars, 3 – drug-device combination products, 2-other)
  • 6 IMPDs (2 – gene therapies, 2 – vaccines, 1 – cell therapy, 1 – biosimilar)
  • 26 BLAs (4 – vaccines, 3-antibodies, 3- recombinant proteins, 3 – gene therapies, 1 – peptide, 4 – biosimilars, 6 – drug-device combination products, 1 – oligonucleotide, 1 – blood-based,
  • 3 BLAs / 315(K) (3 – biosimilars)
  • 2 NDAs (1 – peptide, 1 – oligonucleotide)
  • 7 MAAs (1 – vaccine, 1 – recombinant protein, 1- gene therapy, 1-biosimilar, 2 – oligonucleotides, 1 – fusion/protein combo)
  • 1 PMA (1 – drug-device combination product)
  • 9 CTAs, Health Canada (9 –gene therapies)
• Major contributors to 31 approved submissions that have resulted in commercial products, including:
  • 17 FDA-approved biological products (BLAs and NDAs)
  • 6 EMA-approved biologic medicinal products (MAAs)
  • 2 EMA-approved biologic biosimilar (MAAs)
  • 1 FDA-approved drug/device combination product (NDA)
  • 4 FDA-approved small molecule products (NDAs)
  • 1 FDA-approved device (PMA)

It brings me a lot of joy to appreciate what we’ve accomplished throughout the last twenty years, and we’re looking forward to continuing to play our role in the industry’s success in the years to come. Thanks so much to all of you who have been a part of our journey, and we’re always looking forward to our next exciting challenge.