In drug development, a go/no-go decision can be a high-stakes trade-off between speed and certainty. Move too slow, and competitors can seize the market before you arrive. Move too fast on poor-quality data, and you risk progressing a non-viable therapeutic – or worse, kill a promising one.
In this candid panel discussion, former Genentech/Roche Global SVP Nancy Valente joins seasoned drug developer and TruTechnologies Co-Founder Richard Graham to discuss the real-world operational and strategic hurdles to making data-driven go/no-go decisions.
You’ll gain a clearer understanding of:
The Data Gauntlet: How to navigate the tension between speed and quality, from the bottlenecks that delay real-time data access to the common pitfalls – like site quality and noisy data – that compromise data integrity.
The Boardroom Pressure-Cooker: How to balance intense investor and board-level pressure to expedite with the operational need for robust data, and what it takes to differentiate your program to secure funding in the current biotech climate.
The Modern Framework: What strategies and frameworks, including risk-based quality management (RBQM), can be implemented from day one to mitigate these hurdles and enable more timely data-driven decisions.
If you're looking for real strategies to de-risk your development program and make more confident go/no-go decisions, this conversation is for you.
