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By Amy Raymond, PhD, PMP, Executive Director, Therapeutic Strategy Lead, Rare Disease Cell and gene therapies (CGTs) include cutting-edge approaches that offer the hope of a healthier, happier, and better tomorrow for a wide range of patient populations.
Analyzing the benefits and challenges of implementing direct-to-patient services in the clinicalsupply chain to help meet patient requirements, improve supply chain efficiency and accelerate speed to market.
The benefits of developing a patient-centric clinicalsupply chain.
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This is especially true for rare disease trials with so few patients or trials involving patients with numerous concomitant or life-threatening conditions. can have a significant impact on manufacturing timelines and drug supply chains. vacations, which are typically more ‘off the grid’ than in the U.S.,
About MorphoSys
MorphoSys is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for patients suffering from cancer and autoimmune diseases.
. “In collaboration with our partner, Novartis, our team continues to move at extraordinary speed from idea to bench to clinical trials, driven by a common desire to help patients against this devastating disease and help bring the world back closer to normalcy.” million doses of MP0420, if it is approved in Switzerland.
Results of preclinical studies demonstrating Betalutin® reverses tumour resistance to rituximab in NHL disease models published in Journal of Nuclear Medicine.
In addition, travel restrictions could create logistical challenges for the shipment of clinicalsupplies.
Financial Highlights.
Food and Drug Administration (FDA) has granted Fast Track designation to VTX-801, Vivet’s clinical-stage gene therapy for the treatment of Wilson Disease – a rare, genetic disorder that reduces the ability of the liver and other tissues to regulate copper levels, causing severe hepatic damage, neurological symptoms, and potentially death.
BioNTech plans to manufacture additional therapeutic and vaccine drug candidates at the plant, such as other mRNA vaccines, antibody and cell and gene therapy candidates to support the development of its diversified cancer and infectious disease product pipeline.
Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Food and Drug Administration (“FDA”) 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.
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