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In this third installment of our Fireside series, presented in collaboration with FLUIDDA, Dr. Eleanor Canipa and Dr. Khaled Alzahabi from Nanopharm join Dr. Jan De Backer from Fluidda to discuss the FDA’s evolving viewpoint on in-silico methodologies for generic drug development. Throughout this detailed conversation, the panel explores what the agency’s current emphasis on the “optional” nature of modeling and simulation truly means, and how that status is likely to change as more validation data emerges. In discussing the integration of gamma scintigraphy techniques and the advantages of model master files, the panel reveals a clear path toward more streamlined and reliable in-silico bioequivalence evaluations. Their dialogue outlines how, over time, the industry may move beyond optional use of computational models, eventually embracing them as a standardized component of the regulatory framework. By examining the interplay between validated modeling platforms, cost-effective simulations, and the ultimate goal of ensuring patient safety, this session illuminates how these technologies not only have the potential to reduce complexity and expenses in generic drug approval, but also foster an era where clinical trials can be replaced or substantially supplemented by accurate, patient-relevant simulations. The experts present a vision of a future where acceptance of in-silico methodologies by regulatory authorities will allow companies to better manage risk, accelerate development, and deliver high-quality generics more efficiently to the patients who need them.
