CLINICAL TRIALS ARTICLES
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![World health organization-GettyImages-1209486927]( "AI And Pharmaceutical Development: WHO Calls For Ethical Framework, Good Governance")
AI And Pharmaceutical Development: WHO Calls For Ethical Framework, Good GovernanceThe 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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![DNA-molecule-GettyImages-1316503044]( "FDA's Updated Guidance On Human Genome Editing: New Implications & Remaining Questions")
FDA's Updated Guidance On Human Genome Editing: New Implications & Remaining QuestionsOn 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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![HIV possitive blood sample-GettyImages-903375720]( "1 In 300 People In The U.S. Is Living With HIV. That's Not Okay With Jeff Galvin.")
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 growth forcasting-GettyImages-1768245455]( "2024's Market Outlook For Cell & Gene Therapies")
2024's Market Outlook For Cell & Gene TherapiesRSM 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![FDA-GettyImages-1139719728]( "FDA Draft Guidance On “Rare Diseases: Considerations For The Development Of Drugs And Biological Products”")
FDA Draft Guidance On “Rare Diseases: Considerations For The Development Of Drugs And Biological Products”Accenture Applied Life Science Solutions' Raj Bandaru, Ph.D. breaks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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![Developing mRNA Vaccines GettyImages-1307593959]( "RNA Vaccines: Just Scratching The Surface")
RNA Vaccines: Just Scratching The SurfaceRNA 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.
CLINICAL TRIALS VIDEOS
Hosted by Cell & Gene Collaborative's Director Anna Rose Welch, ARW on RNA puts a creative spin on the emerging mRNA + RNA therapeutics industry. Here, in Episode 1, Welch draws a few connections between the magical world of Harry Potter and the challenging scientific work mRNA companies are doing today to explore and/or broaden mRNA's therapeutic potential in a variety of indications.
The Advancing RNA Live panelists share several inconsistencies they’ve encountered working with global regulators, as well as on which aspects they’re seeing regulatory agencies applying greater scrutiny in mRNA development today.
In this video, Russell Johnson, VP Formulation Research for RVAC Medicines, and Aalok Shah, Director of Formulation & Drug Delivery, Strand Therapeutics, discuss what industry challenges should be top of mind for experts as it relates to the regulatory paradigm, toxicity/safety, and in vivo modeling.
Learn how to accelerate your clinical timeline for cell and gene therapies and improve next-generation GMP production facilities.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Outsourcing Business Human Resources--GettyImages-1305829382]( "Strategies For A More Secure Outsourcing Bottom Line")
A panel of experts from across the pharmaceutical/biopharmaceutical industry recently shared their experiences in mitigating financial risk before partnering with a contract research organization (CRO).
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![GettyImages-505657981 clinical]( "How To Establish Effective, Scalable Drug Safety Ops Across Multiple Vendors")
Numerous factors impact a drug safety program, but proper management of three key elements drives success while creating a scalable drug safety model.
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![GettyImages-597935610 cell and gene]( "The Sponsor's Clinical Development Handbook For Gene Therapy Trials")
Gene therapy has existed for decades, but the field is not as mature as it may seem. Here, the author provides essential insights and strategies for overcoming gene therapy development challenges.
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![Documentation Traps]( "Shifting The Approach: 4 Tactics For ICH E6(R3) Implementation")
In addition to codifying some best practices, R3 recommends that sponsors adopt an approach to identifying and managing areas of risk to mitigate potential issues and enhance overall success.
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![CRISPR Gene Editing]( "Advantages Of Cas9 mRNA For Gene Editing")
Discover why Cas9 mRNA is the preferred choice for precise gene editing, offering efficient delivery, transient expression, and flexible targeting.
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![Patient Interview]( "A New Era For Patient Recruitment And Retention In Rare Disease")
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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![GettyImages-1366661187 cell tech]( "CRISPR Clinical Trials To Follow In 2024 And Beyond")
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.
