Guest Columns & From The Editor

  1. Everything To Know About Long-Term Data Collection For Cell And Gene Therapy Trials In The EU 6/4/2025

    Discover how to secure uninterrupted access to long-term trial data for CAR-T therapies by participating in the European Society for Blood and Marrow Transplantation (EBMT) CAR-T Data Collection Initiative. 

  2. A Road Map For Transitioning From A Research-Focused To Commercialization Mindset 6/3/2025

    As the timeline for commercialization closes in, it’s necessary to best position the organization for a successful launch. Where to start?

  3. Expanding A Bow Tie Risk Analysis Model Using Relational Risk Analysis 6/2/2025

    Relational risk analysis can be used to enhance and expand a bow tie analysis in the pharma and medical device industries to more effectively analyze risks as relationships between mechanisms and events.

  4. The Latest On CRISPR Deployment In TIL Therapy Development 5/30/2025

    Here’s a quick look at how CRISPR’s emerging as an enhancer to improve TIL pharmacokinetics, efficacy, and tolerability without disrupting production.

  5. Clues To Mapping A Crisis-Ready Tech Transfer Playbook 5/28/2025

    One of the many people behind AstraZeneca's COVID-19 response describes lessons learned during the biggest global health emergency of the modern era.

  6. How To Automate Bioprocesses Without Locking Out Future Upgrades 5/28/2025

    Introducing automation now means you limit your ability to upgrade later. Early attention could give you options when the next generation of technology rolls around.

  7. Inside The Trials Aiming To Stop Vision Loss For Rare Eye Disease Patients 5/27/2025

    Ocugen Chief Medical Officer Huma Qamar, MD, MPH, CMI, discusses two rare disease trials and how the company's managed their protocol design, PI selection, and patient recruitment.

  8. Don't Miss These 2025–2026 EMA IDMP Compliance Deadlines For Product Management Services 5/22/2025

    The EMA's Product Management Services will serve as a comprehensive database for consistent identification of medicines internationally. One deadline is quickly approaching on May 31. Are you ready?

  9. Unlocking The Potential Of iPSC Therapies In Regenerative Medicine 5/21/2025

    In a recent Cell & Gene Live, leaders from Mayo Clinic and Astellas discussed the transformative potential of iPSC therapies in regenerative medicine, highlighting regulatory alignment and manufacturing innovation to realize their full impact.

  10. First AMT Program OK'd Under New FDA Designation — Here's What To Know 5/21/2025

    The FDA's new Advanced Manufacturing Technology program has its first recipient, a development expected to reveal the specific ways the program benefits drug innovators.