Insights on Clinical Trials
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FDA’s CBER Issues Final Guidance For CAR T Cell Products
2/15/2024
The FDA issued the final guidance document, Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products, on January 29. This article shares a useful and thorough summary of the guidance and where it differs (or not) from the earlier draft version of the guidance.
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Pursuing Breakthrough Therapies For Rare Metabolic Diseases
2/14/2024
Discover how Veristat’s full-service clinical trial team helped tightly coordinate a gene therapy's dosing administration and data review.
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Big Risks Yield Great Rewards In Cell Therapy
2/14/2024
George White, Cytiva’s GM of Product Management for Cell and Gene Therapy, provides insight into the latest developments and strategies in cell therapy and where this dynamic field is headed.
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Strategic Clinical Consulting Success Stories
2/13/2024
Explore real-world examples of how the combination of strategic consulting, regulatory insights, and technical expertise can impact the development and approval process.
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1 In 300 People In The U.S. Is Living With HIV. That’s Not Okay With Jeff Galvin.
2/12/2024
By modifying CD4 T cells using miRNA, Jeff Galvin’s company thinks it can deliver a functional cure for HIV. Here’s the ongoing story of Addimmune and its unique clinical strategy.
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2024’s Market Outlook For Cell & Gene Therapies
2/9/2024
RSM is back for the third consecutive year to provide an outlook analysis of the cell and gene therapy market. This article discusses the 2024 state of the macroeconomy, its effects on cell and gene therapy companies, growing approval pipelines and approvals, funding factors, and the unique prospects for the market.
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Discussing mRNA: Challenges And Opportunities For Scale-Out And Optimization
2/6/2024
In a recent Cell & Gene Live event, experts explored challenges surrounding raw materials – both quality and supply – as well as the importance of achieving more efficient scale-out and turnaround times for mRNA production.
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Exploring Global Clinical Research Perspectives On RA Insights
2/5/2024
Explore how the research into Rheumatoid Arthritis, which affects 17.6 million people worldwide, aims to improve treatment effectiveness and future interventions.
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Insights Into Candidiasis: Global Clinical Research Overview
2/5/2024
Explore how drug-resistant strains are posing challenges when it comes to the treatment of candidiasis, but therapeutic advancements and ongoing research are offering hope for improved outcomes.
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Candidiasis – Global Clinical Trial Landscape
1/31/2024
Get an overview of the diverse therapeutic modalities in drug development as it relates to the clinical trial landscape and prospects in Candidiasis treatment.