Cell and Gene Regulatory

  1. Boost Compliance And Efficiency With Real-Time Asset Management 9/2/2025

    Explore a platform that empowers GMP-regulated industries with a unified EAM, CMMS, and APM platform to boost compliance, efficiency, and asset performance through real-time integration.

  2. Ensuring The Safety Of Cell Therapy Manufacturing Through Quality Control Solutions 9/2/2025

    Comprehensive quality control is vital for cell therapy CMC. Learn about key identity, potency, purity, and safety assessments to ensure compliance and streamline development from discovery to clinic.

  3. The Resurgence Of Antibody-Drug Conjugates 9/1/2025

    As advancements in ADC technology and clinical trial methodologies progress, Antibody-Drug Conjugates (ADCs) are poised to become pivotal in precision oncology.

  4. Your Environmental Monitoring Can't Be Your Only Line Of Defense 9/1/2025

    Environmental monitoring (EM) is essential, but it’s only part of the picture. Discover why a proactive contamination control strategy is key to keeping your cleanroom truly audit-ready.

  5. Navigating Project Optimus And The Rapidly Changing Oncology Development Landscape 9/1/2025

    Project Optimus and adaptive trial designs are reshaping oncology development, improving patient outcomes, and streamlining approval pathways.

  6. Accelerating Approval Pathway For Phase III Ovarian Cancer Trial 8/29/2025

    A late-stage biotech developing a first-in-class therapy for a rare, chemo-resistant form of ovarian cancer sought help for accelerated FDA approval.

  7. FDA Report Details FY24 Inspections, Shows Big Uptick In Key Countries 8/29/2025

    The 2024 Report on the State of Pharmaceutical Quality shows the agency's efforts to normalize post-pandemic oversight under the previous administration.

  8. Improving Cardiovascular Outcomes With Immediate Therapeutics' Atul Deshpande, Ph.D. 8/27/2025

    On this week's Business Of Biotech episode, Atul Deshpande, Ph.D., CEO at Immediate Therapeutics, talks about partnering with American cities to conduct clinical trials during ambulance rides to the hospital, with the goal of preserving heart function and reducing mortality related to acute cardiovascular events, including heart attacks.

  9. What Changes to FDA and CBER Mean for the Future of CGT with Daniela Drago 8/27/2025

    This is Episode 4 of "FDA Fridays," a special series from Cell & Gene: The Podcast, Chief Editor Erin Harris speaks with regulatory affairs expert Daniela Drago, Partner, NDA Partners, about how shifting FDA and CBER priorities under the current administration could influence the trajectory of cell and gene therapy development.

  10. Why New Zealand Is Emerging As A Clinical Trial Hub 8/27/2025

    New Zealand is rapidly emerging as a premier destination for clinical research, offering a unique combination of regulatory agility, scientific expertise, and cost efficiency.