CLINICAL TRIALS ARTICLES
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AI And Pharmaceutical Development: WHO Calls For Ethical Framework, Good Governance
The World Health Organization (WHO) recently released a document titled Benefits and risks of using artificial intelligence for pharmaceutical development and delivery describing the ethical issues and governance considerations for using AI in drug discovery, preclinical development, and clinical trials.
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FDA’s Updated Guidance On Human Genome Editing: New Implications & Remaining Questions
On Jan. 29, 2024, the FDA released the final version of the guidance document on human gene therapy products incorporating genome editing. This article shares what changed between the draft and now final version of the guidance, and what open questions remain for the industry and scientific community to help resolve.
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1 In 300 People In The U.S. Is Living With HIV. That’s Not Okay With Jeff Galvin.
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
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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FDA Draft Guidance On “Rare Diseases: Considerations For The Development Of Drugs And Biological Products”
Accenture Applied Life Science Solutions' Raj Bandaru, Ph.D. breaks down, summarizes, and shares detailed insight on the recent FDA Draft Guidance that addresses “Rare Diseases: Considerations for the Development of Drugs and Biological Products.”
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RNA Vaccines: Just Scratching The Surface
RNA vaccines have shown promise in preventing infectious diseases and treating cancer, but clinical development varies markedly between the two. HDT Bio’s Dr. Berglund discusses this and how they can be improved.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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In addition to codifying some best practices, R3 suggests sponsors take a proportionate approach to identifying and managing areas of risk.
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Discover why Cas9 mRNA is the preferred choice for precise gene editing, offering efficient delivery, transient expression, and flexible targeting.
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Pharma and biotech companies prioritize innovation in areas of high and rare unmet need. Though the R&D landscape for these rare diseases can be difficult to navigate, changes are on the horizon.
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CRISPR therapies are being developed for genetic disorders, cancer, and infectious diseases. Explore which CRISPR clinical trials are worth keeping an eye on this year.
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Delve into the latest advancements in clinical trials, targeted therapies, and the promising horizon of cancer care.
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Stay informed with the latest advancements in the fight against Duchenne Muscular Dystrophy, a disease that impacts thousands of lives worldwide.
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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.