CLINICAL TRIALS ARTICLES
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![Global health safety regulation-GettyImages-2245658628]( "How Informal FDA Feedback Is Quietly Driving RNA Capital Allocation")
How Informal FDA Feedback Is Quietly Driving RNA Capital AllocationSubtle FDA signals — especially in pre-IND talks — are quietly shaping RNA investment. Early regulatory feedback on CMC and comparability now drives how investors assess risk and allocate capital.
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![Investment in medical and pharma business GettyImages-1299804755]( "2026 RNA Investment Landscape: Recent Deals, IPOs, And Venture Trends")
2026 RNA Investment Landscape: Recent Deals, IPOs, And Venture TrendsAs RNA investing matures, capital is flowing toward delivery, durability, and regulatory credibility. This column breaks down the deals, IPO signals, and venture theses shaping RNA’s 2026 winners—and why.
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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.
CLINICAL TRIALS VIDEOS
In this episode of the Cell & Gene podcast, Host Erin Harris speaks with Alicia Zhou, Ph.D., CEO of the Cancer Research Institute (CRI), about CRI’s mission to advance cancer immunotherapy and the critical role of federal funding, particularly from the NIH, in supporting basic and translational cancer research.
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.
Watch as experts in a multidisciplinary panel discuss the biological and clinical burden of obesity, emerging innovations in biotech and clinical practice, and patient experiences and societal factors.
In this Advancing RNA Live clip, BioNTech’s Ben Muir and Hopewell Therapeutics’ Kate Zhang share their perspectives on the most exciting novel screening methods, innovative preclinical models, and next-gen technologies they hope can/will eventually help us bridge the translation gap between preclinical models and the clinic.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Single-Vendor CDMOs Bring Speed And Cost Savings To The Table]( "The Bioanalysis CRO Selection Checklist Every Sponsor Should Use Before Signing An MSA")
Choosing a CRO requires more than proposals. Assess reliability, automation, GLP rigor, scientific engagement, pricing clarity, and capacity to find partners who deliver defensible data on real timelines.
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![GettyImages-1333253892-laboratory-scientist-regulatory-compliance]( "GLP Compliance In A Modern Lab: What Compliant Actually Requires In 2025")
GLP compliance isn’t binary. Real defensibility depends on rigorous QA, validated electronic systems, and operational maturity — not just a label.
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![CGT-cro-GettyImages-2256752073]( "What Sponsors Get Wrong When Selecting A CRO")
Gene therapy immunogenicity requires platforms, judgment, and regulatory fluency beyond ADA norms. Relying on biologics criteria creates gaps; CGT expertise ensures reliable, interpretable results.
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![cell-therapy-GettyImages-1494029118]( "Why CGT Programs Need A Different CRO Mindset")
Advanced therapies need bioanalysis partners built for complexity, not scale. CGT expertise, specialized platforms, and flexible timelines ensure dosing and safety data traditional CROs can’t support.
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![bioanalysis-CRO-GettyImages-2257695920]( "Transparent Pricing In Bioanalysis: A Feature, Not A Bonus")
Unclear CRO pricing leaves small biotechs vulnerable to budget swings. Transparent, itemized costs cut financial risk, sharpen planning, and build trust by setting expectations from the start.
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![cro-vendor-selection-GettyImages-1220794892]( "How Smaller Biotechs Are Rethinking CRO Relationships Post-Pandemic")
Smaller biotechs are rethinking CRO partnerships, valuing speed, scientific access, flexibility, and transparent pricing over scale — driven by pandemic lessons and a sharper focus on operational fit.
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![bioanalysis-GettyImages-2204603461]( "The Bioanalysis Report You Actually Get Back Fast")
Manual bioanalysis variability creates data noise. Automation replaces inconsistencies with repeatable processes that boost precision, support compliance, and deliver more reliable results.
