Cell and Gene Regulatory

  1. Groundbreaking Casgevy Approval Retrospective 3/21/2024

    How is the approval of the US' first CRISPR therapy reshaping the landscape of CRISPR regulations and ongoing clinical trials?

  2. Accelerated Adventitious Virus Testing In Viral Vector Vaccines 3/21/2024

    Implementing NGS technology for adventitious virus testing in viral vector vaccine development and manufacturing is crucial for ensuring safety. Gain insights for an optimized sequencing method.

  3. Navigating Regulatory Challenges For CGT Products In 2024 And Beyond 3/20/2024

    The cell and gene therapy (CGT) regulatory landscape is complex and continuously evolving. Review expert insights based on recent FDA guidance as well as important considerations for CGT development.

  4. FDA Recommendations For Gene Therapy For Primary Mitochondrial Diseases 3/18/2024

    Explore insight into the strategies and FDA recommendations for executing gene therapy development programs, specifically for primary mitochondrial diseases (PMDs).

  5. Overcoming Regulatory Challenges For A Complex Product 3/18/2024

    A novel, in-house technology and complex combination product presented a number of regulatory challenges to overcome before FDA approval could be obtained.

  6. Navigate The Complexities Of CGTs With Regulatory And CMC Expertise 3/18/2024

    Explore how strategic regulatory and CMC expertise helped guide a biopharmaceutical company’s regulatory and development strategy for a cell and gene therapy product.

  7. Expertly Navigating The Regulatory Landscape Together 3/18/2024

    Cardinal Health Regulatory Sciences is a team of driven solutionists who expertly navigate the complex and evolving regulatory landscape, accelerating paths to market — and the critical therapies your patients need.

  8. CRISPR Therapeutic Regulatory Expertise And Support 3/13/2024

    Explore regulatory support services that can help you successfully to navigate CRISPR-based therapeutic development and prepare you for a successful IND submission.

  9. A Structured Approach To Regulatory Information Management Vendor Selection 3/13/2024

    Deploying a formal system for regulatory information management is a given now for all life sciences companies, irrespective of their size and focus. Regulators expect this, particularly as data rather than static documents evolves to become the default.

  10. Serial Success With Triumvira's Rob Williamson 3/10/2024

    Rob Williamson's mind and hands have shaped more than 20 biotech startups, leading some to IPO and landing others firmly in Big Bio through acquisition by companies like Merck. Hanging around as many successful exits as Williamson has seen, one might become an expert via osmosis. But Williamson isn't passive about honing his vision for progressive therapeutic dealmaking.