INSIGHTS ON CELL & GENE REGULATORY ISSUES

  • Development Pathways For ATMPs: Virus Safety Challenges And Regulatory Perspective
    Development Pathways For ATMPs: Virus Safety Challenges And Regulatory Perspective

    There is an increased risk of viral contamination in settings where ATMPs are prepared, making it critical to understand the contamination risks and the solutions available to control them.

  • Virtual Patient Registries: Real-World Evidence For Cell And Gene Therapies
    Virtual Patient Registries: Real-World Evidence For Cell And Gene Therapies

    In recent years, cell and gene therapies have been generating highly promising results in clinical studies, advancing them toward the market. However, the small number of products launched to date have not been proven commercial successes, with a number of advanced therapies being withdrawn from the EU market and limited sales of CAR-T therapies in the U.S.

  • 4 Key Ingredients Of A Robust Risk Management Framework
    4 Key Ingredients Of A Robust Risk Management Framework

    It is certainly no surprise that risk management continues to hold the spotlight as a hot topic within the biotechnology/pharmaceutical industry. With the increased focus by regulatory authorities on an organization’s ability to identify, mitigate, and control risks, the industry remains in a state of growth, developing and evolving practices to ensure proper alignment with industry best practices and regulators’ expectations. Many organizations are finding it difficult to establish and embed risk management practices, as doing so requires a paradigm shift from a traditional risk-averse industry culture.

  • Toward A More Robust Regenerative Medicine Regulatory Pathway
    Toward A More Robust Regenerative Medicine Regulatory Pathway

    In recent months, the U.S. Food and Drug Administration has increased its compliance focus on the regenerative medicine industry, vowing to crack down on illicit stem cell clinics and others advertising the untested use of human cell and tissue-based products (HCT/P), many of which are used in orthopedics.

  • ICH Q12 Updates: Increasing Efficiency Of Post-Approval Changes
    ICH Q12 Updates: Increasing Efficiency Of Post-Approval Changes

    Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharma quality system with less need for oversight prior to implementation.

  • 6 Regulatory Changes Affecting Bioprocessing In China
    6 Regulatory Changes Affecting Bioprocessing In China

    This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.

  • Critical Considerations About The Future Of Global Cell Culture Bioprocessing
    Critical Considerations About The Future Of Global Cell Culture Bioprocessing

    In today’s changing industry, it is critical we consider several factors about cell culture bioprocessing and the impact they will have on the future of patient treatment.

  • Combatting Unproven Cell And Gene Therapies Through Regulation And Education
    Combatting Unproven Cell And Gene Therapies Through Regulation And Education

    According to the inaugural annual report from the International Society for Cell and Gene Therapy (ISCT), the number of CGTs with marketing authorization increased by 45 percent between 2015 and September 2018.

  • Beyond The IND: Regulatory And Clinical Planning For Cell And Gene Therapies
    Beyond The IND: Regulatory And Clinical Planning For Cell And Gene Therapies

    A quick and nimble approach is often sought after in the cell and gene therapy product space due to the likely one-time or limited patient dosing and/or rare disease conditions limiting the number of available patients, which reduces the number of clinical studies.

  • Key Takeaways From FDA’s New Guidance On First-In-Human Multiple Expansion Cohort Trials
    Key Takeaways From FDA’s New Guidance On First-In-Human Multiple Expansion Cohort Trials

    The FDA published a new draft guidance on August 10, 2018 entitled, Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics. The comment period for the draft guidance closed on October 12, 2018 and approximately 20 comments were submitted to the docket. The guidance provides sponsors with recommendations for designing and conducting first-in-human (FIH) multiple expansion cohort trials within their oncology development programs.

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