Cell & Gene Unscripted: Real-World Evidence

Cell and gene therapies are producing remarkable results in clinical trials, but developers now face a harder question: can these treatments show lasting value once they reach real patients? In this episode of Cell & Gene Unscripted, Parexel's Chris Learn, Ph.D., M.B.A., P.M.P., Head of Cell & Gene Therapy and Early Phase, and Mike D'Ambrosio, SVP and Global Head of Real World Research, talk about how real-world data can shape trial design, support regulatory decisions, and track how patients do years after treatment. Mike also looks at new tools that could change the field, including artificial intelligence, digital twins, synthetic control arms (which use existing patient data in place of a placebo group), and value-based payment models. Listen to learn how to build a real-world evidence strategy that turns strong trial results into lasting proof of value for patients, regulators, and payers.