INSIGHTS ON CELL & GENE REGULATORY ISSUES
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Overcoming Regulatory Challenges For A Complex Product
A novel, in-house technology and complex combination product presented a number of regulatory challenges to overcome before FDA approval could be obtained.
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Navigate The Complexities Of CGTs With Regulatory And CMC Expertise
Explore how strategic regulatory and CMC expertise helped guide a biopharmaceutical company’s regulatory and development strategy for a cell and gene therapy product.
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Expertly Navigating The Regulatory Landscape Together
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.
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Strategic Deals With CinRx's Gavin Samuels, M.D.
Gavin Samuels, M.D., found his work as an intensive care physician boring. It wasn't until he left the hospital and entered biopharma that he found his footing. Now, he's Chief Business Officer and General Partner at CinRx Pharma, where a deep pipeline of early- to late-stage candidates keeps him on his dealmaking toes. Dr. Samuels' introspective reflections on biotech dealmaking and negotiations plants this episode firmly on the Business of Biotech podcast highlight reel.
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CRISPR Therapeutic Regulatory Expertise And Support
Explore regulatory support services that can help you successfully to navigate CRISPR-based therapeutic development and prepare you for a successful IND submission.
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A Structured Approach To Regulatory Information Management Vendor Selection
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.
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Serial Success With Triumvira's Rob Williamson
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. Learn secrets to his serial success on this week's Business of Biotech podcast.
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Serial Success With Triumvira's Rob Williamson
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.
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What Proposed Plasmid DNA Standards Say For GMP/Non-GMP Production
Today’s standards for plasmid DNA production lack specificity, and manufacturers have been clamoring for more. In late 2023, USP published draft General Chapter <1040> to help fill in the cracks.
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Building A Fit-For-Purpose, Strategic Cell & Gene Production Facility
By employing flexible and sustainable design strategies and best practices, combined with contingency planning, cell and gene therapy companies can make building their own facilities a reality.