Industry Insights

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.