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Nearly every biopharma with a portfolio of drugs in development spanning traditional small molecules and biologics and the newer CGT operates with separate clinicalsupply organizations per these therapy areas. This is due to major differences throughout the clinicalsupply chain in both requirements and management practices.
The growth of ecommerce has spurred expectations of consumer-like experiences in the lifesciences industry. Modern software development concepts from ecommerce applications are helping eClinical applications meet the precise needs of each clinical trial. The real paradigm should be, ‘what’s your version of this function?’
Collaboration provides clinical trial sponsors with access to the world’s most efficient clinicalsupply processes using a single contract. As a result, global clinicalsupply and operations teams can now single source their commercial drug requirements by utilizing two best-in-class solution providers.
Supply chain uncertainty is a challenge every clinicalsupply 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 clinicalsupply chain flexibility now and in the future.
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. Pfizer is collaborating with Vivet on the clinicalsupply of VTX-801 for the Phase 1/2 clinical trial.
The companies have also expanded a contract manufacturing agreement with Novartis that will help produce Carvykti for both commercial and clinicalsupply at the New Jersey plant through the end of 2029. In addition, the companies are also gunning for a first-line setting approval.
The companies are exploring these advances through their newly created Pfizer Amazon Collaboration Team (PACT) initiative, which applies AWS capabilities in analytics, machine learning, compute, storage, security, and cloud data warehousing to Pfizer laboratory, clinical manufacturing and clinicalsupply chain efforts.
XTALKS WEBINAR: Fostering Patient-Centricity: ClinicalSupply Chain Strategies and Sourcing Solutions Live and On-Demand: Thursday, July 20, 2023, at 10am EDT (4pm CEST/EU-Central) Register for this free webinar to learn how to review clinical trial trends and supply strategies that impact the patient experience.
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