Advancing Clinical Development with Innovative Trial Design and Regulatory Strategies

Biotech organizations face a series of high-stakes decisions when designing their clinical development programs. These decisions involve balancing speed, cost, regulatory risk, and trial delivery. Too often, companies default to traditional study designs and endpoints—missing opportunities to reduce patient numbers, streamline approval pathways, and enhance overall efficiency. This hesitation may be driven by a lack of awareness of available options, concerns about regulatory acceptance, or implementation challenges. However, by leveraging close collaboration between biopharma scientific leaders, statistical design experts, and regulatory strategists, companies can identify optimal trial designs that enhance success rates, reduce risk and cost, increase label coverage, and accelerate timelines. In some cases, these efficiencies can translate into savings of years of development time and tens of millions of dollars.

In this panel-led session, brought to you by MMS, industry experts will explore how strategic trial design innovations can improve R&D outcomes. Aiden Flynn, SVP of Statistical Consulting; Amanda Beaster, Director of Regulatory Strategy; and Irving Dark, Board Member and Industry Biometrics Thought Leader, will discuss real-world case examples showcasing design optimization strategies alongside regulatory best practices. They’ll examine the power of statistical simulation tools like KerusCloud and explore approaches such as:

• Innovative trial designs that reduce risk and accelerate development
• Model-informed drug development for data-driven decision-making
• Statistical simulation techniques to maximize the probability of success
• Regulatory risk management when pursuing non-standard designs

At the conclusion of the discussion, attendees will have the opportunity to engage directly with the experts in an interactive Q&A session. Join us for this insightful session and discover how advanced trial design strategies can unlock new pathways to success!