Industry Insights

1. Reimagining Solid Tumor Immunotherapy With SRC-3-Edited Tregs 8/20/2026

   CoRegen’s investigational autologous cell therapy, CRG-150, is designed to disrupt tumor-driven immune suppression by knocking out SRC-3 in Tregs, potentially exposing solid tumors to the patient’s own immune response without lymphodepletion.

2. Unlocking The Future Of Cell And Gene Therapies 8/19/2026

   We took the opportunity to speak with some BioPhorum members about issues such as emerging technologies, regulatory challenges, and engagement with regulators in the advanced therapy medicinal products (ATMP) space.

3. Why Delivery Is Defining The Next Era Of Neuromuscular Therapeutics 8/19/2026

   Emerging therapies are being designed to safely deliver oligonucleotides to disease-relevant tissues. Delivery is no longer a technical hurdle to overcome but a strategic lever.

4. What Goes Into Restarting A Shelved Orphan Drug Candidate? 8/19/2026

   The Orphan Therapeutics Accelerator wants to help viable clinical-phase products reach patients. Its cofounder describes the complexity of rebooting a shelved candidate.

5. A Much-Improved Approach For Understanding And Managing Safety Risks 8/18/2026

   Learn how causal mechanism and effect analysis (CMEA) and its principles can be used to develop and maintain safer working environments in the pharma/biotech and medical device industries.

6. Immune Reset In Rheumatology: Moving Beyond Disease Suppression Toward Durable Remission 8/18/2026

   EULAR 2026 highlighted growing momentum behind “immune reset,” an approach adapted from oncology that is quickly gaining traction in autoimmune rheumatic diseases.

7. CSV Assumes The AI System Sits Still — It Doesn't. 8/17/2026

   The computer system validation playbook was written for software that holds its shape. AI doesn't. Validating it has to become an act of governance.

8. Building Antigen-Specific Immune Tolerance For Autoimmune Disease 8/10/2026

   Antigen-specific immune tolerance could redefine autoimmune disease treatment by precisely retraining the immune system rather than broadly suppressing it.

9. July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing 8/7/2026

   Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.

10. Combination Cell Therapy's Clinical Success Hinges On Manufacturability 8/5/2026

    Cell therapy could help unlock checkpoint inhibitors’ potential in solid tumors, but combination regimens raise the bar for manufacturing consistency and scalability.