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Catalent Adds New Cryogenic Capabilities at Shiga, Japan, Facility to Support Clinical Supply Demand for Cell and Gene Therapy Development

The Pharma Data

The expansion forms part of Catalent’s ongoing global strategy to increase its ability to handle, store and manage advanced therapies for clinical supply, and follows investments at its facilities in Philadelphia, Singapore, and Shanghai, China, in specialized, ultra-low temperature storage capabilities. With sites in the U.S.,

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Logistics in Focus: Orchestrating the Challenges of Cell Therapy

Conversations in Drug Development Trends

While clinical supply is essential to any successful trial, autologous cell therapy trials occupy the far end of the spectrum regarding risk tolerance. We offer dedicated Clinical Supply Coordinators for complex IP programs, scaling resources to dovetail into pre-existing frameworks when needed.

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How to plan for uncertainty while maximizing the efficiency of your clinical sup…

The Pharma Data

Supply chain uncertainty is a challenge every clinical supply chain manager wrestles with – stemming from increasing product demand and quality, the growing complexity of clinical trial designs and a lack of visibility in the supply chain. Achieving clinical supply chain flexibility now and in the future.

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How direct-to-patient clinical trial models can accelerate speed-to-market

The Pharma Data

Analyzing the benefits and challenges of implementing direct-to-patient services in the clinical supply chain to help meet patient requirements, improve supply chain efficiency and accelerate speed to market. The benefits of developing a patient-centric clinical supply chain. Add bookmark.

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VTX-801 RECEIVES U.S. FDA FAST TRACK DESIGNATION FOR THE TREATMENT OF WILSON DISEASE

The Pharma Data

Vivet Therapeutics (“Vivet”), a clinical-stage biotechnology company, and Pfizer Inc. VTX-801 is a novel investigational gene therapy to be evaluated in a Phase 1/2 clinical trial to determine the safety, tolerability, and pharmacological activity of a single intravenous infusion in adult patients with Wilson Disease.

Disease 52
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AlgoTherapeutix Receives Regulatory Approval to Initiate Clinical Development of ATX01

The Pharma Data

Over half of cancer patients treated with chemotherapy – over two million patients in the US and Europe – develop CIPN and experience sensory symptoms and pain in the hands and feet: loss of sensitivity, tingling, burning, cold and intense pain can persist for months to years after treatment. 15, 2020 07:15 UTC.

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A Biotech Midsummer’s Madness

LifeSciVC

And importantly, breaks from treatment or treatment protocols can literally make or break trials. There is no room for a missed dose, a scheduled follow-up visit or opportunities to bring new clinical sites on board. can have a significant impact on manufacturing timelines and drug supply chains.