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The expansion forms part of Catalent’s ongoing global strategy to increase its ability to handle, store and manage advanced therapies for clinicalsupply, 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.,
Approaches to outsourcing clinicaltrials have changed significantly in recent years. It’s important to understand the differences between FSO and FSP solution models for outsourcing clinicaltrials and how best to combine approaches for optimization. Overseen by an insourced project manager.
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The launch of the expanded offering will coincide with Catalent exhibiting at the BIO International Convention (booth 785), which takes place at the Boston Convention & Exhibition Center, from June 5-8, 2023. At the BIO International Convention, Carey Connolly, Ph.D., at the BioProcess International Theater.
technical operations, product development or process development) to an internal or external receiving unit (e.g., clinical manufacturing, commercial manufacturing, or contract manufacturing organization). Development of the manufacturing process description The development of the MPD is an iterative process.
VTX-801 is a novel investigational gene therapy to be evaluated in a Phase 1/2 clinicaltrial 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 clinicaltrial.
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Melika Davis, Senior Vice President and Global Head of Clinical Operations at BeOne , has built a career at the intersection of science and operational leadership. Today, my team is advancing more than 100 trials supporting an expansive pipeline of innovative molecules, striving to improve outcomes for people with cancer around the world.
Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA ClinicalTrials Deals Drug Pricing Gene Therapy An article from FDA’s AI tool ‘Elsa’ is here, and the industry has questions The agency has provided only limited details about its AI pilot as it advances an “aggressive timeline” for the tool’s rollout.
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