Looking beyond the 95%: A New Data-Driven Framework to Assess Regulatory Approval Risk

April 17, 2024

Speakers: Lan Ding (GSK) and Co-presenting Eric Johnson (GSK)

Abstract:

Regulatory approval plays a pivotal role in drug development, yet reliance on aggregate industry approval rates can mask compound-specific risks. To guide more informed decision-making, GSK pioneered a robust framework that systematically captures regulatory risks and opportunities on a customized, per program basis.

Spearheaded by Lan, a cross-functional team spanning statistics, decision science and global regulatory leaders overcame organizational barriers to design the new evaluation framework. Implementation required persuading stakeholders to adopt more granular, data-driven risk evaluation despite fundamental changes to existing processes.

The session will detail learnings from the 12-month journey. How do you drive adoption of value-added but disruptive change? What objections were raised against augmenting models perceived as sufficient? How did emphasizing decision quality over motives shift mindsets? The team strived for enhancements offering better capital allocation and patient impact – come hear how.