Cell and Gene Regulatory

  1. Future Proof Process Design Through Risk-Focused Decisions, Automation Readiness, And Regulatory Pragmatism 10/29/2025

    In this segment of Cell & Gene Live, Designing Early Manufacturing For Long-Term Success In CGT, Raymond Luke, Senior Director of MSAT at Verismo Therapeutics and Todd Luman, Executive Director of Process and Product Development at Allogene share that future proofing begins with deep process understanding.

  2. Regulatory Pathways — With Real-Life Examples — For Successful CGT Clinical Trials 10/24/2025

    Discover the most effective regulatory pathways used to support CGT development, including two real-life examples.

  3. Ensure IRB And IBC Success For Your Gene Therapy With Strategic Planning 10/23/2025

    To successfully bring innovative gene therapies to patients with neurological disorders, drug sponsors must design safe and compliant clinical trials with rigorous approaches to ethics and consent.

  4. Pfizer's Accord For A Healthier World Program Challenges Stability Study Norms 10/22/2025

    The company developed a novel approach to address the historic lack of stability testing for underserved parts of the world, near the equator.

  5. Takeda Reimagines Biopharma Quality For The Digital Age 10/21/2025

    Artificial intelligence, even in its current form, is especially good at synthesizing large data sets. Here's how one company makes the most of it.

  6. Developing Antibodies To Block Neuroinflammation With MindImmune's Stevin Zorn, Ph.D. 10/20/2025

    In this episode of "Better Biopharma," host Tyler Menichiello is joined by MindImmune's president and CEO, Stevin Zorn, Ph.D. They discuss the development of the company's lead candidate, MITI-101, a monoclonal antibody designed to prevent peripheral immune cells from entering the brain and driving neuroinflammation linked to Alzheimer's disease.

  7. From Dollars To Debate: Why Clinical Trials Are At A Crossroad 10/20/2025

    Federal funding shifts in 2025 are impacting clinical research, with budget cuts and political scrutiny slowing innovation and threatening diversity in trial participation.

  8. Streamline Process Development, Digitize Data, And Maximize Your Investments 10/20/2025

    Discover how AI, digital twins, and automation are transforming biomanufacturing by cutting costs, improving quality, and accelerating timelines for smarter, more efficient production.

  9. Inside The Operational Hurdles Of Advanced Therapy Medicinal Products 10/20/2025

    Despite rapid approvals, ATMP patient access is limited by operational bottlenecks. Successfully delivering these therapies demands tightly synchronized logistics and resilient contingency planning.

  10. Hidden Risks In Your Supply Chain: Regulatory Support Can Save Your CGT 10/20/2025

    Unvalidated shipping lanes and incomplete documentation can cause regulatory delays. Proactive qualification and risk assessments are vital for compliance and safeguarding product integrity.