Industry Insights

  1. Bringing CGT Home: Equipping Community Hospitals For The Next Frontier 10/6/2025

    Decentralizing CGTs to community hospitals presents a crucial opportunity to improve patient access by reducing travel burdens, but requires overcoming significant challenges such as building specialized clinical infrastructure, coordinating complex care pathways, ensuring data interoperability, and more.

  2. Import Product Specifications And Drug Registration Testing For China 10/6/2025

    This overview and its recommendations are valid for drug registration testing (for marketing authorization application in China) as well as import testing (for commercial batches to be imported to China after approval).

  3. Navigating Regulatory Frameworks For Allogeneic CAR-NK Control Strategies 10/3/2025

    The regulatory landscape for this emerging modality is vast and tortuous. One regulatory CMC expert, a former FDA reviewer, helps us with a path through it all.

  4. Advancing Telomere Targeting Therapy For Non-Small Cell Lung Cancer 10/3/2025

    MAIA Biotechnology's Dr. Vlad Vitoc shares insights into how the company is advancing a novel therapeutic strategy that could redefine the treatment landscape for hard-to-treat cancers.

  5. Trust But Verify: Validating AI In Pharma's GxP World 10/3/2025

    Here are practical tips to build validated, transparent, and auditable AI systems that align with GxP principles, paving the way for smarter and more resilient manufacturing processes.

  6. What You Should Know About USP's Bioassay Updates 10/2/2025

    The United States Pharmacopeia is overhauling general chapters to align them with current industry standards. One scientist on the project helps us unpack the changes.

  7. BlueRock Advances Cell Therapy For Parkinson's Disease 9/30/2025

    BlueRock Therapeutics has advanced its allogeneic stem cell-derived therapy bemdaneprocel into the pivotal Phase III trial for Parkinson’s disease, aiming to restore regulated dopamine signaling, improve quality of life, and potentially transform the treatment paradigm.

  8. On The Ground At BPI: Takeda's Amy Shaw On Scaling Cell Therapy Manufacturing 9/26/2025

    Takeda head of process development, Amy Shaw, explains what factors to consider when scaling up or scaling out cell therapy manufacturing.

  9. Driving Prostate Cancer Innovation Through Immunotherapy With OS Therapies' Dr. Robert Petit 9/26/2025

    OS Therapies' Dr. Robert Petit discusses the evolving role of immunotherapy in prostate cancer.

  10. The Future of Cancer Immunotherapy Through Allogeneic NK Cell Innovation 9/26/2025

    Our recent Cell & Gene Live, Building The Future Of Cancer Immunotherapy Through Allogeneic NK Cell Innovation, featuring expert panelists NKILT Therapeutics' Raphaël Ognar and NKore BioTherapeutics' Tracy Ryan covered the state of NK cell science, persistence challenges, safety, scalability, and the unique engineering breakthroughs shaping the future of oncology care.