ARTICLES BY ERIN HARRIS
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CGT Manufacturing Shifts From Capacity To Strategy5/21/2026
As manufacturing overcapacity reshapes the CGT landscape, success now depends less on access to capacity and more on strategic alignment across development, regulatory readiness, and long-term commercialization.
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Dr. Peter Marks On Why Gene Therapy May Need A New Regulatory Playbook5/13/2026
At the 2026 @Philly Cell and Gene Therapy Annual Conference, Dr. Peter Marks highlighted how gene therapy science is surging ahead and called for smarter regulatory evolution to unlock treatments for thousands of rare disease patients.
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Regeneron Advances In Vivo Gene Therapy For Hearing Loss5/1/2026
Regeneron’s Otarmeni marks a major CGT milestone, showing that in vivo gene therapy can restore hearing in OTOF-related deafness while expanding the field’s clinical and delivery possibilities.
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Sana, Mayo Clinic Advance A New Model For Cell Therapy Delivery In T1D4/27/2026
Sana Biotechnology and Mayo Clinic are partnering to standardize delivery of a one-time hypoimmune cell therapy, aiming to scale access and redefine care for type 1 diabetes.
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Reprogramming T-Cell Access To Solid Tumors Through Improved Trafficking And Entry4/17/2026
Here's why trafficking and entry remain key barriers to CAR T success in solid tumors.
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Target Selection Drives The Future Of CAR T Therapy In Solid Tumors4/13/2026
Target selection is the defining challenge in CAR T therapy for solid tumors, shaping safety, efficacy, and the field’s path forward.
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Mitigating Challenges In Solid Tumor Delivery4/3/2026
CAR T-cell therapy is advancing in solid tumors by improving target selection, trafficking, tumor-microenvironment resistance, and long-term function, but major biological barriers still require combined solutions.
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Ensuring Quality Of CGT Materials3/24/2026
Here's why strong material selection, risk-based controls, and early analytics are critical for successful CGT development.
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Building Harmonized Real‑World Data In Oncology3/13/2026
Experts at PMWC 2026 emphasized that regulatory‑grade real‑world data in oncology will require prospectively collected, harmonized datasets that integrate multimodal clinical information.
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The In Vivo Cell Therapy Shift On Display At PMWC 20263/10/2026
At PMWC 2026 in Santa Clara, we saw how in vivo CAR T and MRD‑guided strategies could reshape cell therapy by moving curative intent earlier while balancing bold innovation with practical scalability.