Cell and Gene Regulatory

  1. ThinkLive Cell and Gene Therapy Summit 2025 Summary 6/11/2025

    From patient support to intricate logistics, ThinkLive CGT Summit 2025 leaders tackled the essential commercial strategies needed to deliver these innovative therapies to patients globally.

  2. Advancing Nitrosamine Testing For Evolving Regulations 6/10/2025

    Explore how specialized analytical expertise and advanced instrumentation enable precise nitrosamine testing to help drug developers meet strict and evolving regulatory requirements.

  3. EMA Support For Rare Disease Therapies 6/10/2025

    Review how the EMA supports rare disease drug development through regulatory and financial incentives for therapies that meet strict eligibility and ongoing compliance criteria.

  4. The Role Of A Consulting Firm In The IND Process 6/10/2025

    Navigate the complex IND process with expert guidance and discover how early FDA engagement can accelerate your path to clinical trials.

  5. Microbial Identification Via DNA-Seq 6/9/2025

    Learn how DNA sequencing-based microbial identification supports regulatory compliance and enhances contamination control in critical environments.

  6. Validation Of A qPCR Assay For Host Cell DNA Quantitation 6/9/2025

    Here, we share the development and validation of a new, highly sensitive and accurate integrated solution for detection and quantitation of host cell DNA to help meet regulatory requirements.

  7. Bracing For The Impact Of The Federal Workforce Reduction 6/9/2025

    The federal workforce reductions pose significant challenges for the life sciences industry, particularly for R&D, supply chain oversight, and industry workforce development.

  8. Demystifying The Common Technical Document For Global Submissions 6/5/2025

    The CTD's Module 3 is notoriously complex and challenging. Here are strategies for an easier path toward CMC submission readiness.

  9. 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. 

  10. Bridging Development and Regulation in CGT with Halloran Consulting Group's Monika Swietlicka 6/3/2025

    On this episode of Cell & Gene: The Podcast, Host Erin Harris welcomes Monika Swietlicka, Principal, Regulatory Strategy at Halloran Consulting Group to discuss the key regulatory challenges facing cell and gene therapy companies.