Accelerating Complex Drug Development: IND/CTA Strategy

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This presentation outlines a strategic approach to accelerating drug development timelines, focusing on mitigating critical failure points in clinical, safety, and manufacturing processes. Key areas include objective endpoints, robust safety modelling, and GMP scalability within a 24-month framework. Case studies highlight challenges such as endpoint bias and unforeseen safety issues, while mitigation strategies provide actionable solutions. The financial roadmap details cost estimates and...