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Category: Commercial Scale

New FDA guidance: cell therapies and patient identifiers

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When the US Food and Drug Administration (FDA) recently made two draft guidance documents for the cell and gene therapies available for comment, the Vineti…

Cell and gene therapies: the necessity of a purpose-built platform

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Given the wide array of CRMs and other digital systems already serving healthcare and biopharma, that reality might sound like overkill. But after more than…

Gene therapies – simpler doesn’t mean simple

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Cell and gene therapies are produced and delivered via the most complex workflows in the history of medicine. Among those workflows, though, there’s a range…

Vineti secures new patent from USPTO for individualized medicine platform

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SAN FRANCISCO, March ##, 2022 (GLOBE NEWSWIRE) – Vineti, Inc., the provider of the leading digital platform of record for cell and gene therapies, today…

Cell and gene therapies – new treatments, new value

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At the recent Gene Therapy for Rare Disorders conference in Boston, I had the opportunity to discuss thoughts on value with an audience dedicated to…

Vineti’s Personalized Therapy Management® (PTM) solution meets rigorous standards: Service Organization Control (SOC®) 2 Type II compliance audit

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Vineti, developer of the leading digital platform of record for personalized therapeutics, today announced a new Integration Suite as a cornerstone of its Personalized Therapy…

Vineti achieves SOC2 Type II compliance

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Vineti, Inc., the provider of the leading digital platform of record for personalized therapeutics, today announced the successful completion of its Service Organization Control (SOC®)…

Why an integrated, digital cell and gene therapy (CGT) ecosystem protects patients and their privacy

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Cell and gene therapies (CGTs) are modern, technologically advanced therapies that rely on a complex value chain for manufacturing and patient treatment. Patients are at…

Why CGT 3.0 success depends on interoperability

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The cutting edge therapies of CGT 3.0 require modern operations. That means far more than just stand-alone digital systems and select integrations — it means…

How integrated digital systems solve key challenges with cell and gene therapies (CGTs)

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One patient. One cell therapy. Ten or more distinct digital systems.
That’s often the number of heterogeneous digital systems across care sites, manufacturers, and…

Preparing for Cell and Gene Therapy 3.0

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Patient data is mission-critical data — especially in cell and gene therapy.

In cell and gene therapy (CGT), the patient is the process is the…

Patient data – the unique role in cell and gene therapies (CGTs)

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Patient data is mission-critical data — especially in cell and gene therapy.

In cell and gene therapy (CGT), the patient is the process is the…