Fast-Tracking FIH To PoC: Strategies For Accelerated Drug Development

Success in early-phase drug development depends on balancing cost, speed, and regulatory compliance to reach proof of concept (PoC). Experts Dr. Andreas Reichl and Dr. Kevin Schaab advocate for hybrid protocols and early regulatory collaboration to streamline this process. They identify three pivotal factors for successful first-in-human studies: integrating biomarkers and pharmacodynamic endpoints, involving actual patients in early trials, and utilizing purpose-built manufacturing infrastructure. By applying these data-driven strategies, developers can more efficiently transition novel molecules from initial testing to clinical validation while navigating the complexities of the pharmaceutical landscape.