How do early-stage biotechs navigate regulation? With Bruno Speder, Vice President Regulatory Affairs – Aletheia Life Science

In this episode of X4 Talks, we sit down with Bruno Speder, Vice President Regulatory Affairs at Aletheia Life Science, who brings nearly two decades of experience guiding global drug development programmes and leading interactions with major health authorities, including the FDA and EMA. Having worked across CROs, biotech companies, and early-stage spin-offs in the UK, France, and Belgium, Bruno offers rare insight into why regulatory leadership is essential from day one.Discussions in the episode:Why early scientific innovation must be matched with strategic regulatory thinkingWhat leaders should know when preparing therapies for human challenge trialsWhy science alone isn’t always enough in early developmentThe role of regulatory affairs in volunteer and patient recruitmentAdvice for those looking to move into regulatory affairsThis episode is hosted by Alicia Cliff, Head of Medical Communications at the X4 Group.