Leveraging Regulatory Momentum to Accelerate the Path to Approval for Personalized Cancer Vaccines
Time: 5:00 pm
day: Conference Day Two
Details:
• Strategically pursuing designations like Breakthrough Therapy or ISTs to validate early clinical signals, gain FDA partnership, and build external confidence in your platform’s viability
• Using regulatory milestones to strengthen investor narratives by showcasing derisked development timelines, alignment with FDA expectations, and faster routes to market
• Designing early trials with regulatory engagement in mind, including endpoint justification, biomarker integration, and data packages that support designation eligibility and smooth progression to pivotal trial
