MassBio Panel: Advancing Development with Innovative Trial Design and Regulatory Strategies

Join us for this expert panel discussion showcasing the impact of unified trial design and regulatory strategies on derisking and accelerating clinical development.

Biotechs face a series of high-stakes decisions as they design their clinical development programs. These decisions include trade-offs between factors such as speed and cost, as well as delivery and regulatory risk. In this balancing act, too often, companies default to traditional study designs and endpoints, often missing opportunities for innovative approaches that could reduce patient numbers or secure a faster regulatory pathway.

This panel-led session by MMS features Aiden Flynn, SVP Statistical Consulting, Amanda Beaster, Director Regulatory Strategy, and Ben Dudley, CCO, will examine real-life design optimization case studies, including using powerful statistical simulation software like KerusCloud. We'll explore innovative strategies including Real-world-data (RWD) augmentation, innovative trial designs, model-informed drug development, the role of statistical simulation, and best-practices for regulatory risk management when pursuing non-standard designs.