ACT: You were a part of panel discussion on start-up companies. Can you briefly discuss what the panel entailed?
Coppe: A few innovative startup companies were selected to share their insights on advancing innovation in clinical development and ensuring that pharma sponsors and CROs can effectively leverage these solutions. Additionally, there is a growing need to adopt a more patient-centric approach in clinical trials.
ACT: Startups often face challenges in gaining traction. What has been the biggest hurdle for One2Treat in advancing clinical trial innovation, and how are you overcoming it?
Coppe: Over the past two years, the FDA and EMA have provided valuable guidance, particularly in patient-focused drug development and optimal project management. While this guidance is helping pharma companies make progress, there remains some uncertainty about how regulators can further support the adoption of concrete methodologies.
At times, sponsors may be hesitant to embrace innovative opportunities, which underscores the need for clearer frameworks and greater confidence in emerging solutions.