CLINICAL TRIALS ARTICLES
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![Skyscraper under construction-GettyImages-1949243231]( "Money In The Bank: Why 2025's Setbacks Were The Foundation RNA Needed")
Money In The Bank: Why 2025's Setbacks Were The Foundation RNA NeededI saw 2025 as a year that was foundational for our efforts to learn more about the biology and function of our products. However, there were two developments in particular that, to me, encapsulated the trials, tribulations, and ultimately the success of an industry that is doing its damnedest to answer one of the biggest questions facing us: “Why RNA?”
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![Potter at work-GettyImages-1142834523]( "Beyond The Hype: How 2025's Successes & Realities Will Shape mRNA In 2026")
Beyond The Hype: How 2025's Successes & Realities Will Shape mRNA In 2026Here, in part two of this multi-part series, we hear from Melissa Bonner, CSO of nChroma Bio and Andy Geall, CDO of Replicate Biosciences, who call attention to several developments of the past year they’ve been watching and how they see these developments informing our conversations about and work with mRNA in 2026 and beyond.
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![T-Cells Work to Fight Cancer, Immunotherapy, CAR T-cell therapy-GettyImages-1317697233]( "Overcoming CMC Challenges In The Development Of Conjugated LNP Platforms For In Vivo CAR-T Therapy")
Overcoming CMC Challenges In The Development Of Conjugated LNP Platforms For In Vivo CAR-T TherapyOvercoming CMC hurdles is key to advancing conjugated LNP platforms for in vivo CAR-T therapy, enabling scalable, precise mRNA delivery to T cells while maintaining stability, potency, and regulatory compliance.
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![Bubble burst-GettyImages-1215335273]( "Beyond the Hype: Industry Experts on the Reality of mRNA in Cancer Care")
Beyond the Hype: Industry Experts on the Reality of mRNA in Cancer CareWhen I asked a panel of experts at RNA Leaders why mRNA was best positioned to shine in oncology, I was met with a few expected talking points and — better yet — a few I wasn’t expecting.
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![Magnifying Glass, explain mechanism of mRNA vaccine-GettyImages-1903242094]( "Tackling Challenges In RNA Stability And Organ Targeting")
Tackling Challenges In RNA Stability And Organ TargetingRNA therapeutics are reshaping medicine, but instability and limited organ targeting still pose challenges. Discover how next-gen lipid nanoparticles and smart delivery systems are advancing RNA precision.
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![Telemedicine, human Brain recovery-GettyImages-1397374666]( "Developing Exosome-Based RNA Therapeutics For CNS Regeneration")
Developing Exosome-Based RNA Therapeutics For CNS RegenerationInside the effort to use exosomes as natural nanocarriers that deliver RNA therapeutics safely across the blood–brain barrier to heal damaged neural tissue.
CLINICAL TRIALS VIDEOS
Gain valuable insights into the role of sponsor-side Clinical Operations leadership, the risks of over-relying on CROs, and key strategies for fostering collaboration between sponsors and partners.
Among the more prevalent genetic conditions, Duchenne muscular dystrophy affects an estimated one in 3,500 male births worldwide. It's caused by mutations of the DMD gene, which regulates the production of a protein called dystrophin. Approved DMD treatments haven't demonstrated strong clinical outcomes, but James McArthur, Ph.D. and his team at PepGen are seeking to change that with a pipeline of disease-modifying peptide-conjugated oligonucleotide candidates derived from the company's Enhanced Delivery Oligonucleotide platform. The Business of Biotech caught up with Dr. McArthur at PepGen's Cambridge headquarters to learn more.
Dr. Francois Vigneault, Co-Founder, President, and CEO at Shape Therapeutics joins Cell & Gene: The Podcast's Erin Harris to discuss how RNA technologies are shaping the future of gene therapy. They also discuss AI's role in gene therapy as well as how the CGT sector is benefiting from RNA, AI, and synthetic biology.
Watch this presentation to equip stakeholders with actionable strategies and a comprehensive understanding of the evolving clinical trial management landscape in the context of ICH guidelines.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Bioanalysis-CRO-GettyImages-1315366428]( "How A Strategic Bioanalysis CRO Partnership Empowers Sponsors")
Choosing the right bioanalysis CRO is vital to avoid costly delays. Sponsors need evaluation strategies that prioritize proven quality, predictable timelines, and submission-ready data.
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![crossroad intersection railroad tracks-GettyImages-1582678578]( "Europe At A Crossroads: Biotech Investment, Regulation, And Partnership In Real Life")
Position your biotech for Europe’s next phase by aligning strong science, smart clinical strategy, and the right global partners to navigate funding, regulation, and growth.
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Bioanalysis is crucial for biopharma success. Here, Dash Bio’s Ander Tallett discusses selecting a bioanalysis CRO and collaborating effectively for assay results that accelerate drug development.
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Bioanalysis service quality significantly impacts project success. Don't settle for typical CRO claims; demand better technology, pricing transparency, and dedicated partnership.
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![GettyImages-2006338804 conference]( "ESMO Congress 2025: Highlights From Berlin")
Turn the insights from last year’s ESMO into action by partnering to accelerate innovation through smarter trial design, stronger biomarker planning, and truly global collaboration.
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![GettyImages-2152658176 oncology, doctor, patient]( "How Are Therapeutic Radiopharmaceuticals Advancing Precision Oncology?")
By directing radioactive isotopes straight to diseased tissue, these agents deliver potent, localized treatment while sparing healthy cells — a major leap forward for patients with metastatic or treatment-resistant cancers.
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![Doctors board room meeting-GettyImages-1365555907]( "Highlights From The 2025 International Hepatitis B Meeting")
For biotech and pharmaceutical teams, the core message was clear: progress is accelerating, but success still depends on smart study design, fit-for-purpose endpoints, and operational execution.
