An increasing number of advanced therapies and orphan drugs, targeting small patient populations, face challenges when aligning with the traditional drug development pathway. It means walking the tightrope between having early access to new medicines for patients who urgently need it while maintaining the rigorous control of safety and efficacy of the product throughout the approval process.

In this webinar our NDA Advisory Board Member, Jan Sjöberg (former IWA, SAWP and CHMP member),  discusses the regulatory perspective of unmet medical need as a key criterion for drug development, based on his experience as an former EU regulator.