Cell and Gene Regulatory

  1. Pioneering Gene Therapy In Rare Diseases 3/17/2025

    Overcoming barriers to gene therapy development requires continued innovation in manufacturing processes, harmonized regulatory approaches, and outcome-based pricing models.

  2. Evolution Of Clinical Trials In Europe 3/17/2025

    The CTR and CTIS represent a paradigm shift in European clinical research, fostering a more efficient and transparent trial environment.

  3. The Future Of Good Clinical Practice: The ICH E6(R3) Update 3/17/2025

    The release of the ICH E6(R3) Good Clinical Practice guideline in January 2025 marks a shift in clinical research, with significant implications for CROs, trial design, and quality management. 

  4. Phase-Appropriate Approaches To Manufacturing And Testing 3/14/2025

    Accelerate the development of high-quality biopharmaceuticals by implementing phase-appropriate, risk-based manufacturing and testing strategies that ensure timely progression.

  5. Managing Risks In Injectable Drug Delivery 3/13/2025

    Gain insights pertinent to efficient and effective drug development. Understand and execute a risked-based critical thinking approach related to injectable drug packaging and delivery.

  6. Arcellx On Designing A Dynamic CAR-T 3/13/2025

    Arcellx's CMO and CTO talk about the company's platform technology, its partnership with Kite, and preparing its lead asset, anito-cel, for commercial launch.

  7. Emerging Manufacturing Technologies For Cell Therapies 3/13/2025

    Cell & Gene Live explored the cutting-edge manufacturing technologies impacting cell therapy production. Our expert panel delved into innovative approaches such as automation solutions for increased efficiency, strategies for optimizing cell therapy delivery, and more.

  8. BoB@JPM: Kasper Roet, Ph.D., QurAlis 3/12/2025

    On this episode of the Business of Biotech, Life Science Leader's Ben Comer joins to co-host a conversation with Dr. Roet that goes deep on his company's genetic medicine approach to ALS, and even deeper into his opinions on, and growing influence over, the regulatory environment.

  9. Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends 3/12/2025

    Review contract manufacturing's evolution, driven by technological advancements and regulatory changes, and how CMOs and CDMOs are navigating opportunities and challenges.

  10. Multi-Regional Clinical Trials: The Latest Guidance From FDA 3/12/2025

    Conducting multi-regional clinical trials (MRCTs) is essential for accelerating oncology drug development and ensuring broader patient access. However, differences across regions can impact findings.