Fernando Kreutz
Seminars
• Deploying a unique mechanism that bypasses complex neoantigen prediction by letting the patient’s own tumor drive antigen presentation, eliminating the need for upfront epitope mapping
• Cutting manufacturing costs and compressing turnaround to just three weeks by growing tumor-derived cells directly to avoid extensive sequencing, synthesis, and custom design
• Targeting patients with minimal residual disease and healthy immune systems to maximize vaccine response, moving beyond late-stage metastatic settings where immune function is severely compromised
• Incorporating adjuvant strategies that strengthen immune activation earlier in the disease course, improving the odds of durable remission
• 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