In the fast-moving world of regenerative medicine, the open secret among industry experts is that manufacturing is exceedingly difficult and will take a Herculean effort to scale. Left behind in that shuffle have been new advances in how drugmakers actually keep track of where a patients’ cells are going — and that could leave the field ripe for a disaster.

As part of a broad consortium of biopharma and tech companies working to drive new standards for advanced therapies, San Francisco’s Vineti plans to create what it calls a “modern patient ID” that can track human cells from apheresis centers through a complicated manufacturing supply chain and back into those patients.

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XyloCor Therapeutics is one step closer to accomplishing the tough task of delivering gene therapies straight into the heart for coronary artery disease.

Three years after its first fundraise, XyloCor has raised an additional $22.6 million in a Series A extension, with the goal of expanding its lead program into further trials. Called XC001, the program is currently being studied in patients who have refractory angina, and XyloCor wants to study its use as a potential adjunctive for those undergoing bypass surgery.

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On the same day that their former COO found a new job steering the ship at a biotech focused on engineering B cells, bluebird bio said goodbye to another C-suite executive.

David Davidson, bluebird’s longtime chief medical officer, is jumping ship as questions continue to swirl about the safety of their gene therapy programs, the company revealed in an SEC filing Tuesday. Davidson will leave effective April 16, and will work as a consultant for six months as bluebird transitions to a new CMO. He’ll also receive 12 months of severance starting at the end of April.

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When Aravind Asokan and Mavis Agbandje-McKenna first pulled together their respective research at the University of North Carolina-Chapel Hill and the University of Florida on engineering adeno-associated virus vectors and started StrideBio in 2015, the FDA was still two years away from an eventual groundbreaking first approval for an AAV gene therapy.

But even then — and moreso since — preclinical and clinical studies had exposed the glaring room for improvement in the way genes are delivered.

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Those who have been following the gene therapy space would be familiar with Solid Bio’s IGNITE-DMD trial. Beset with safety issues, the Phase I/II study was held down by clinical holds for the better part of the last three years, while the Duchenne-focused biotech watched bigger rivals dash by toward pivotal work.

There was just one thing that we’ve never seen: data from the study on how patients are doing.

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