Insights on Clinical Trials

  1. The Promise Of MRD-Guided CAR-T Treatment 9/3/2026

    Minimal residual disease markers can reveal relapse before clinical signs appear, when off-the-shelf cell therapy may have its greatest advantage.

  2. Autoimmune CAR T Has Hit A Critical Moment. Are We Asking The Right Questions? 9/2/2026

    The promise of autoimmune CAR T is enormous, but recent safety pauses from Novartis and BMS underscore why the field needs a more patient-centered approach to risk, clinical outcomes, access, and real-world delivery.

  3. Strategic ADC Development In A Shifting Regulatory Landscape 8/28/2026

    As ADC development grows more complex, sponsors must align safety, dose optimization, global trial design, regulatory strategy and CMC readiness early to reduce risk and accelerate approval.

  4. The Rise Of Chinese Biotechs And The Global CRO Question 8/25/2026

    As innovative therapies move beyond home markets, early planning across regulators and geographies helps avoid costly delays and protect trial budgets.

  5. Receptor Occupancy In The Era Of Multispecific Therapeutics 8/21/2026

    Receptor occupancy studies face new challenges as multispecific therapeutics introduce complex target engagement, receptor trafficking, cellular interactions, and assay interpretation considerations.

  6. Advancing IHC Assays From RUO To Clinical Trials And CDx 8/21/2026

    Examine how an exploratory IHC assay evolved into a multi-indication clinical program through integrated assay development, validation, regulatory strategy, and scientific collaboration.

  7. A Practical Guide To Harnessing The Value Of APAC For Global Trial Success 8/21/2026

    As Phase III costs and complexity rise, APAC offers faster enrollment, lower costs, and market access advantages, but capturing that value requires early planning and in-region expertise.

  8. Scaling Investigational Drug Services: A Case Study in Overcoming Operational Bottlenecks 8/20/2026

    Are operational bottlenecks holding back your research site? Explore a blueprint for automating investigational product workflows and giving staff time back for patient care.

  9. 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.

  10. 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.