36th Expert Session
UMB Ventures...
... is the joint start-up incubation program of Universitätsmedizin Bayern e. V. funded by Bayerisches Staatsministerium für Wissenschaft und Kunst. The programs aims to support early-stage ventures across the six Bavarian university clinics and medical faculties.
As the program aims to make formats accessible that already exist at each of the six locations this event opens up TUM Venture Lab Healthcare Expert Session.
About this Expert Session
Regulatory Essentials – From Proof of Concept to First-in-Human Clinical Studies and What It All Means for Xenotransplantation
The path from a promising proof of concept to the first clinical trial in humans is shaped as much by regulatory strategy as by science. This talk provides an overview of the regulatory fundamentals that developers of innovative therapies should be familiar with. It covers the nonclinical studies required to support a first-in-human trial and how to plan effective interactions with regulatory authorities, including scientific advice meetings. Finally, it discusses what these requirements mean for the emerging field of xenotransplantation.
About the speaker
Dr. Stefan Blesse is Chief Strategy Officer and Executive Consultant at Granzer Regulatory Consulting in Munich. Since joining Granzer as Principal Consultant, he has advised clients on regulatory affairs and strategic product development for innovative drugs. He previously held regulatory leadership roles in the pharmaceutical and animal health industries, including positions at Bayer Pharmaceuticals, Intervet/Schering-Plough Animal Health, Hoechst Roussel Vet in Paris, and Chassot AG in Bern. He holds a doctorate in veterinary medicine from Justus-Liebig-Universität Gießen.