INSIGHTS ON CELL & GENE CLINICAL TRIALS
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Successful Special Procedure Study Conduct: Cerebrospinal Fluid (CSF) And Concurrent Muscle Biopsy
Worldwide assisted a trial sponsor with a study exploring a novel therapeutic protein (TP) in 48 healthy volunteers.
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Partnering For Precision In An IPF Study: Securing Timely Deliverables And Key Endpoints
A pharmaceutical company enlisted Worldwide Clinical Trials to help achieve on-time results for their Phase IIa IPF clinical trial, enabling them to manage vendors and meet challenging deadlines.
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Leveraging Real-World Data And AI To Broaden Patient Diversity In Oncology Clinical Trials
The convergence of recent technological advancements and Diversity Action Plans holds great promise for creating more inclusive clinical trials. Dr. Anosheh Afghahi explains why embracing diversity is important to clinical research.
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Diffuse Large B-Cell Lymphoma- Global Clinical Trial Landscape
Learn about advancements in diffuse large B-cell lymphoma (DLBCL) research and personalized care strategies.
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Muscular Dystrophy: Multi-National And Multi-Site Trials
Learn about the success ReveraGen found when expanding their partnership with Novotech to a larger phase 2b trial (VBP15-004) in Duchenne Muscular Dystrophy (DMD).
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How Elixirgen Manufactures Hematopoietic Stem Cells At The Bedside
The company uses a mobile manufacturing system to produce autologous stem cell therapy for patients with dyskeratosis congenita and other telomere biology disorders.
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A Phase-Appropriate Approach For Assay Validation In Cell & Gene Therapies
This article promotes alignment on a common phase-appropriate approach to analytical assay validation with respect to the critical quality attributes of the most common cell/gene therapy modalities.
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Building Successful Studies: A Proven Framework
To gain a deeper understanding of successful study design, this article explores study personas, core design, a seven-step process for post go-live (PGL) changes, and more.
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New Economics Of Cell And Gene Therapy – Part II
It’s not just about the science. This article explores some steps that can be taken now to make the next generation of CGTs affordable and accessible not just approvable.
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Keys To Successful CMC Source Document Preparation For Cell & Gene Therapies
Chemistry, manufacturing, and controls (CMC) source documents are the foundation for module 3 of a cell/gene therapy FDA regulatory submission.