Scaling smarter: a case study in overcoming cell therapy manufacturing and regulatory hurdles

Wednesday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

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Scaling smarter: a case study in overcoming cell therapy manufacturing and regulatory hurdles

Gain a real-world view of the challenges T cell-based therapy developer Tr1X Bio overcame during a highly specialized manufacturing process, revealing key lessons for scalability and workflow design.

Avoid costly delays

Hear how Tr1X navigated IND-enabling studies under FDA scrutiny and avoided a projected 6-month setback - gaining IND clearance in only 30 days. Plus, learn how PQ run failure was resolved, with the root cause identified and GMP production restarted in 2-3 weeks

Optimize vector development with limited resources

Learn how Tr1X optimized critical parameters (e.g., MOI selection and reduction) without a dedicated vector biology team, offering a roadmap for resource-constrained teams.

Achieve exceptional product purity

A CD271-based purification approach enabled 95–98% purity—exceeding typical industry benchmarks.

Scale the platform across indications

The same process supported multiple indications, including Crohn’s disease and CD19 CAR programs, with accelerated timelines.

Real-world insights will support attendees to:

• Learn when to “lock” a process early, even at proof-of-concept stage, to preserve nonclinical validity while accelerating IND timelines

• Gain practical takeaways on handling MSAT transitions, reducing engineering runs, and designing PQ runs with resilience in mind

• Successfully navigate pre-IND and IND regulatory interactions, even with unconventional product characteristics

• Apply Tr1X’s decision-making framework to evaluate CDMO partners based on speed, flexibility, and analytical depth

This session is designed for biotech leaders, clinical operations professionals, regulatory experts, and academic researchers who are looking to improve efficiency, reduce risk, and accelerate timelines in their CGT program.

James Adams

Chief Technical Officer at Tr1x Bio

James Adams, MBA, brings over 30 years of operational leadership spanning research and development, manufacturing, quality operations, and commercial strategy. He currently serves as Chief Technical Officer at Tr1X, Inc., where he drives the development of allogeneic Treg cell therapies by aligning process development, bioanalytical sciences, and quality with manufacturing and supply chain functions. James is deeply experienced in overseeing cGMP-compliant production from inception through distribution, ensuring reliable, high-quality therapies reach patients.

Previously, James was Vice President of Manufacturing at Sonoma Biotherapeutics, where he built and led a technical operations team advancing cell therapies and biologics targeting autoimmune disorders. Prior to Sonoma, he headed the clinical manufacturing division at the Fred Hutchinson Cancer Center, managing the technical execution of more than 20 INDs and 9 DMFs across biologics and cell and gene therapy programs. James holds an MBA from Rivier University and a BS in Microbiology from Michigan State University.

Ron Maddux

Clinical Sales Manager at Miltenyi Biotec

Ron Maddux is the Clinical Sales Director for Miltenyi Biotec in North America, where he leads a team of over 30 cell therapy professionals. His team includes a number of top-tier leaders in sales and application sciences, all of whom are dedicated to supporting clinicians, hospitals, and cell therapy companies in advancing treatments for cancer and other diseases. Ron is a seasoned and results-driven cell and gene therapy consultant, recognized for enhancing awareness and driving revenue growth in graft engineering and cell therapy sectors. He specializes in building strong relationships with industry leaders (KOLs) and leveraging technical expertise to deliver impactful solutions.

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