CLINICAL TRIALS ARTICLES
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![Vector Retro Astronaut Team Exploring a Planet on a Jetpack-GettyImages-2186580479]( "A New Space Race: Reclaiming Efficiency In The mRNA Industry")
A New Space Race: Reclaiming Efficiency In The mRNA IndustryIt goes without saying that efficiency in drug development is tantamount — especially when it comes to getting much-needed clinical data. So, when I asked Allan Shaw about the ongoing trends he anticipates seeing more of in 2026, he immediately pointed to the increasing prominence of overseas development, particularly in nations like Australia and China.
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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.
CLINICAL TRIALS VIDEOS
Panelists Tiffany Lucas and Ulrike Jägle address an audience question about when and how to approach the regulatory agencies for mRNA process development. In addition to listing the different FDA and EMA meeting opportunities available to sponsors, Jägle reminds us of one critical best practices sponsors shouldn’t forget when approaching the agencies.
Gain an understanding of how an advanced nuclease portfolio is designed to support CRISPR-based cell and gene therapy development, providing scientists with the best solutions for therapeutic success.
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.
Capstan Therapeutics' CEO, Laura Shawver, Ph.D., talks us through the company's in vivo CAR therapies and what led to the in vivo cell engineering breakthrough that has been decades in the making. Shawver explains the promise of harnessing mRNA and targeted LNP delivery to train a patient’s body to make CAR-T cells in vivo. She also details best practices to garner funding and investment partnership.
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.
