Leveraging RWD to improve regulatory decisions

How real world evidence was used to support approval of Ibrance for male breast cancer “Leveraging RWD to improve regulatory decisions is a key strategic priority for the FDA. This data may be derived from a variety of sources, such as electronic health records, medical claims, product and disease registries, laboratory test results and even […]

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In the era of cell and gene therapy, how robust is RWE collection?

  “Data collection infrastructure for patient outcomes in the UK – opportunities and challenges for cell and gene therapies launching” “Existing data collection infrastructure in indications with potential cell or gene therapies launches in the next five years in the UK is overall not sufficient to facilitate outcomes-based reimbursement.” Click here to see the source article  Reference Jørgensen, J., […]

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