In this episode, Andrea Braun-Scherhag, SVP and Global Head of Regulatory Affairs & Safety at Autolus, breaks down what it really takes to bring breakthrough therapies to market, especially when there’s no established playbook. From securing rapid global approvals to navigating entirely new pathways in cell and gene therapy, she shares why regulatory sits at the centre of Biotech success.
Andrea challenges the common perception of regulatory as operational, revealing it instead as one of the most impactful, forward-looking functions in any biotech. She also highlights the importance of engaging regulators early, aligning teams behind a clear strategy, and putting patients at the heart of development, particularly in rare diseases.
Podden och tillhörande omslagsbild på den här sidan tillhör
Tom Froggatt. Innehållet i podden är skapat av Tom Froggatt och inte av,
eller tillsammans med, Poddtoppen.
