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

Join us at the MassBioHub in Cambridge, Massachusetts (USA) on March 12, 2025 for this exclusive complimentary event and expert panel discussion showcasing the impact of unified trial design and regulatory strategies on derisking and accelerating clinical development.

Registration: From 11:30 am

Panel discussion:12:00

Post discussion lunch: 12:45-13:30

Secure faster development and regulatory pathways

Biotech organizations 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.

Learn from our regulatory and statistical experts

This panel-led session, brought to you by MMS and featuring Aiden Flynn, SVP Statistical Consulting, Amanda Beaster, Director Regulatory Strategy, and Ben Dudley, Chief Commercial Officer, will examine real-life design optimization case studies, including using powerful statistical simulation software like KerusCloud. The presenters will explore innovative strategies including Real-world-data (RWD) augmentation, innovative trial designs, model-informed drug development, the role of statistical simulation in optimizing the probability of success, and best-practices for Regulatory risk management when pursuing non-standard designs. At the conclusion of the panel discussion, there will be the opportunity for the audience to ask the experts their most pressing questions in an interactive Q&A.