Industry Insights

1. Unpacking The EU's Mutual Recognition Agreements For Pharma 12/12/2025

   MRAs can save resources for regulators and drug makers by, among other things, reducing the number of inspections and waiving retesting requirements.

2. CSL's HEMGENIX Shows Durable Benefit, A New Future For Gene Therapy in Hemophilia B 12/12/2025

   CSL's Dr. Deborah Long and Diego Sacristan highlight HEMGENIX's five-year Phase 3 data as a watershed for hemophilia B gene therapy.

3. Cell 2025, Advanced Therapies USA Taught Me Why Platformization Is No Longer Optional 12/10/2025

   True scalability and global-ready CGT manufacturing depends on platformization that tightly integrates MES, ERP, LIMS, and related systems into a harmonized, leadership-driven digital backbone that treats data as a strategic asset.

4. Overcoming Cell Therapy Design Challenges To Treat AML And Other Life-Threatening Diseases 12/9/2025

   CERo CEO Chris Ehrlich discusses how a focus on safety, robust manufacturing, and key early indicators is rewriting the playbook for future personalized medicine trials.

5. Why Your MVP And Its Evolution Matters To Manufacturing 12/8/2025

   Minimum viable product is one of the most important inputs to developing a manufacturing process. It defines essentials that matter to the people who make the product.

6. Navigating The Challenges Of Cell Therapy Clinical Trials 12/5/2025

   IN8bio CEO William Ho shares how they overcame operational challenges unique to cell therapy research, including how to carefully conduct site expansion and onboard new sites without disrupting study timelines.

7. Biotech Wasn't Ready For AI's Speed; Here's How We Catch Up 12/5/2025

   Computational success is no stand-in for therapeutic readiness. Innovators must learn to discern between models rooted in science and those that speculate.

8. Strained Manufacturing, Complexity Stymie In Vivo Progress 12/4/2025

    Explicitly mapping delivery challenges to the associated GMP process steps converts biological risk into operational risk.

9. To Fight Cancer, Gene Editing Needs To Solve Its Delivery Problem 12/4/2025

   The choice of delivery dictates the complexity of manufacturing, which in turn determines the eventual cost and accessibility of the therapy.

10. Could Chicken Wisdom Help Cell Therapies Spread Wings? 12/2/2025

    Evolutionary theory could explain why cell therapies have hit a slump, and help developers get out of it, too.