INSIGHTS ON CELL & GENE REGULATORY ISSUES

• Pioneering Gene Therapy In Rare Diseases

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

• From Open Cleanrooms To Closed Systems – What Is Driving The Change?

  Aseptic processing is evolving. Regulatory changes and technological advancements are driving a shift from open cleanrooms to closed systems for sterile drug manufacturing.

• Phase-Appropriate Approaches To Manufacturing And Testing

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

• Managing Risks In Injectable Drug Delivery

  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.

• Arcellx On Designing A Dynamic CAR-T

  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.

• BoB@JPM: Kasper Roet, Ph.D., QurAlis

  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.

• Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends

  Explore the evolution of the life sciences contract manufacturing sector, driven by technological advancements and regulatory changes, as well as learn how CMOs and CDMOs are navigating opportunities and challenges.

• Multi-Regional Clinical Trials: The Latest Guidance From FDA

  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.

• Human Factors Testing: Engaging End-Users In Med Device Development

  Explore the significance of human factors in the development of medical devices through an illustration of how important it is to incorporate the end users in the device development process.

• MHRA Issues New Regulation On Modular And Point Of Care Manufacture Of ATMPs

  The U.K.'s MHRA has issued a new regulation to allow for decentralized manufacturing of cell and gene therapies (advanced therapeutic medicinal products), describing modular and point of care manufacturing. It becomes effective July 23, 2025.