Are You Still Relying on MTD?

The FDA’s Project Optimus has changed the game. Sponsors who adapt early are gaining faster approvals, better safety profiles, and stronger commercial positioning. This ebook shows you how.

Inside this free resource, you’ll learn:

• Why MTD is no longer enough, and what regulators expect instead
• How adaptive trial designs and PK/PD modeling are driving smarter dose decisions
• Real-world examples of sponsors who reduced timelines and improved outcomes
• The economic upside of early dose optimization (hint: it’s not just clinical)
• How Precision for Medicine helps biotech teams stay ahead of the curve

For years, oncology trials chased the highest tolerable dose. But today’s therapies, like checkpoint inhibitors, ADCs, and bispecifics, don’t follow that rule. Regulators know it. Patients feel it. And sponsors who ignore it are falling behind. Project Optimus is reshaping how biotech leaders plan, justify, and execute dose strategies.

What You'll Gain from Reading

This ebook outlines the new dose optimization landscape, and is applicable for those preparing for IND, designing Phase I/II trials, or refining a combination regimen. You will  walk away with:

• A clear understanding of FDA expectations
• Proven frameworks for smarter dose selection
• Insights into biomarker-informed and patient-centric dosing
• A roadmap for integrating real-world data and adaptive design

Download your copy and start smarter optimization.