36th Expert Session: Regulatory Essentials – From Proof of Concept to First-in-Human Clinical Studies and What It All Means for Xenotransplantation

For developers of innovative therapies, the path from a promising proof of concept to a first-in-human clinical trial is shaped as much by regulatory strategy as by science. Regulatory questions are often addressed late in development, even though early planning can save considerable time, costs and avoidable detours on the way to the clinic.

In this Expert Session, Dr. Stefan Blesse, Chief Strategy Officer and Executive Consultant at Granzer Regulatory Consulting in Munich, will provide an overview of the regulatory fundamentals every developer should be familiar with. He brings many years of experience from regulatory leadership roles in the pharmaceutical and animal health industries, including at Bayer Pharmaceuticals and Intervet/Schering-Plough Animal Health. He will explain which nonclinical studies are required to support a first-in-human trial and how to plan effective interactions with regulatory authorities, including scientific advice meetings. Drawing on his background in veterinary medicine, with a doctorate from Justus-Liebig-Universität Gießen, he will also discuss what these requirements mean for the emerging field of xenotransplantation.

Whether you are preparing your first nonclinical program or are just beginning to think about your regulatory strategy, this session offers practical guidance on bringing your innovation from the lab into the clinic.

This session is opened up to all six Bavarian university medicine sites as part of UMB Ventures, the joint start-up incubation program of Universitätsmedizin Bayern e.V.