OUTSOURCING ARTICLES
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Bridging The Atlantic: A European Executive's Guide To Entering The U.S. RNA Market (Pt. 1)
A practical roadmap for European biotech leaders navigating FDA expectations, market entry, and the strategic decisions that shape U.S. expansion.
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The Hidden Bottleneck In Advanced Therapies Isn't Science⦠It's Translational Friction
Scientific breakthroughs may spark innovation, but operational excellence ultimately determines which advanced therapies reach patients.
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RNA Therapeutics: Why CMC Strategy Will Define The Next Decade
As RNA matures into an industrial platform, long-term success will depend less on discovery and more on scalable CMC systems, integration, and execution.
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How Informal FDA Feedback Is Quietly Driving RNA Capital Allocation
Subtle 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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2026 RNA Investment Landscape: Recent Deals, IPOs, And Venture Trends
As 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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A Year Of Separation: Which Advanced Modalities Are Built For Commercial Scale In 2026?
In 2026, advanced therapies diverge: winners pair proven biology with scalable manufacturing, delivery, and workflow fit, while others advance more slowly under operational and economic limits.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Learn how you can stay ahead of the evolving cell and gene therapy landscape by leveraging innovative solutions to support the continued growth and success of therapies in 2025 and beyond.
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Drug development accelerates with AI, decentralized trials, and adaptive protocols, but legacy CRO infrastructure lags. Platform-based systems enable speed, quality, automation, and continuous improvement.
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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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Scaling cell and gene therapy operations in EMEA demands strategic planning, regulatory alignment, and robust logistics to meet growing demand and ensure consistent delivery across diverse markets.
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Choosing the right mRNA manufacturing model can define your success. Learn how to weigh control, cost, and flexibility to build a strategy that supports innovation and long-term growth.
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To overcome challenges in oligonucleotide LC/MS bioanalysis, consider optimizing probe design by evaluating alternative chemistries like PNA for improved recovery and chromatographic performance.
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Get a full overview of the role CROs play in clinical trials and their impact on site selection, site monitoring, patient recruitment, managing data, and more.