Oncology is an example of where regulatory perspectives have shifted in the last few years. Previously, Progression Free Survival was a key metric, but the FDA is increasingly focusing on Overall Survival. This has been an impactful change for many in the oncology space, particularly smaller biotechs which do not have as many resources for longer-term confirmatory studies that measure OS.

En mi experiencia en el ámbito del diagnóstico clínico, he enfrentado resistencia regulatoria hacia innovaciones biotecnológicas. Esta situación a menudo surge debido a preocupaciones sobre la seguridad y la eficacia de nuevos procedimientos. Para abordar esta resistencia, considero fundamental establecer un diálogo transparente con los reguladores, presentando datos sólidos que respalden la innovación. Además, colaborar con otros actores de la industria para generar consenso y construir confianza es clave. Educar a los reguladores sobre las ventajas y el impacto positivo de las nuevas tecnologías puede ayudar a superar obstáculos y facilitar la adopción de innovaciones que beneficien a la salud pública.

Educating regulators on emerging modalities is essential for ensuring that regulatory frameworks can effectively accommodate these innovative treatments while maintaining patient safety and efficacy standards. For example, the rapid evolution of CAR T cell technology poses challenges for existing regulatory frameworks, which are not yet fully equipped to address the unique aspects of cell and gene therapies. Establishing feedback mechanisms where regulators can share their experiences and challenges related to CAR-T therapies with industry stakeholders and academic researchers can help identify areas where further education or resources are needed.

Let's think outside of the box: Rather than presenting your innovations as complete, invite regulators to co-create solutions with you. “Let’s work together to shape the guidelines that foster innovation while ensuring safety!” This approach turns resistance into collaboration, making them part of the solution rather than the opposition.