Industry Insights
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First AMT Program OK'd Under New FDA Designation — Here's What To Know
5/21/2025
The FDA's new Advanced Manufacturing Technology program has its first recipient, a development expected to reveal the specific ways the program benefits drug innovators.
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Designing Our Way Toward Circular RNA Medicines With AI
5/21/2025
The closed-loop structure of circular RNA can offer sustained, durable expression. We caught up with Sail Biomedicines' Kerry Benenato and Rajesh Ramaswamy to chat about ways to leverage AI for design/engineering.
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How Modeling Predicts Bottlenecks In Takeda's Multimodal Facilities
5/20/2025
A functional simulation requires many manual inputs, including data smoothing, vendor collaboration, and even direct communication with tenured employees who know the job best.
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Will Genome Modifications Define Next-Gen AAV Vectors?
5/20/2025
AAV vectors composed of naturally occurring capsids are suboptimal. Gentle genetic alterations hold promise for safer, more efficient therapy.
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Ferring Builds A Global Gene Therapy Manufacturing Network Around ADSTILADRIN
5/16/2025
Ferring Pharmaceuticals has built a global manufacturing and support network around its flagship gene therapy, ADSTILADRIN, enabling scalable production, provider education, patient access, and real-world data collection to ensure sustainable and widespread adoption.
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Good Distribution Practice Is Evolving — Here's How
5/15/2025
Managing a global supply chain for increasingly complex biologic drugs takes special attention and expertise. Explore the key drivers of a modern logistics management plan.
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Atsena Therapeutics Advances Gene Therapy For XLRS
5/13/2025
Atsena Therapeutics exemplifies the field’s growing shift toward non-oncology indications with its targeted gene therapy for X-linked retinoschisis, a rare inherited retinal disorder with no approved treatments.
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3 Strategies For A Successful Journey Toward Cell And Gene Therapy Commercialization
5/13/2025
CTMC's Amy Hay provides 3 recommendations for teams developing cell and gene therapies, from clinical research through commercialization.
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A Case For Paying Allogeneic Cell Therapy Product Donors
5/9/2025
The debate over whether to pay donors for cell therapy starting materials comes down to four areas of disagreement: altruism, availability, ethics, and safety.
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Protecting Intellectual Property In The Genomics Revolution
5/9/2025
Providing superior IP protection for genomics-related inventions already requires — and will require in the future — a more nuanced strategy combining patents, trade secrets, and copyrights.