ARTICLES BY ERIN HARRIS
-
FDA Approval Of TREGZI Signals A New Era For Precision Engineered Cell Therapy7/9/2026
Following the FDA approval of TREGZI, Orca Bio's precision engineered allogeneic cell therapy is redefining stem cell transplantation through improved immune control, advanced manufacturing, and a platform designed to expand the future of cell therapy.
-
How CGT Developers Should Think About Manufacturing Models, Hybrid Strategies, And Scale6/29/2026
Our latest Cell & Gene Live examined how CGT developers can choose manufacturing models that support long-term commercial success by aligning biology, operations, supply chain, and scalability from the earliest stages of development.
-
In Vivo Gene Editing Is Moving From Promise To Proof6/15/2026
CGT is shifting from technical promise to clinical execution as in vivo approaches reach an inflection point where delivery, durability, specificity, and manufacturability will determine whether the field can turn breakthrough science into safe, scalable, repeatable therapies.
-
Driving Gene Therapy Beyond Rare Disease Will Define The Next Era Of CGT6/2/2026
Gene therapy’s next test is not proving it works, but proving it can scale.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.