X4 Talks
Welcome to X4 Talks, where you'll get an exclusive look into the minds of the world's top business leaders! Our goal is to bring you inspiring stories from game-changing entrepreneurs, innovative CEOs, and experienced professionals who are paving the way for the future.
Through our conversations, we'll explore the breakthrough technologies and cutting-edge methodologies that are driving their success, and share valuable insights that you can apply to your own life and business.
Join our global community of like-minded individuals. Together, we'll dive deep into the most exciting trends and ideas shaping the future of the business world, one conversation at a time.
X4 Talks
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 thinking
- What leaders should know when preparing therapies for human challenge trials
- Why science alone isn’t always enough in early development
- The role of regulatory affairs in volunteer and patient recruitment
- Advice for those looking to move into regulatory affairs
This episode is hosted by Alicia Cliff, Head of Medical Communications at the X4 Group.