We are happy to announce a new partnership with Granzer Regulatory Consulting & Services GmbH and welcome Stefan Blesse (CSO, Granzer) as a new member of our Selection Committee.

Granzer Regulatory brings decades of expertise in guiding drug and device development — from strategy and clinical planning to marketing authorization. With Stefan’s regulatory leadership, INCATE strengthens its ability to evaluate and support the most promising AMR ventures.

We are eager to collaborate and provide even stronger guidance to early-stage innovators tackling antimicrobial resistance.

About Granzer Regulatory Consulting & Services GmbH

Granzer Regulatory Consulting & Services GmbH is a leading consultancy specializing in global regulatory strategy and drug development. With deep expertise across pharmaceuticals, biologics, and advanced therapies, the company supports clients in navigating complex regulatory environments in Europe (EMA), the US (FDA), and worldwide. Its services span all stages of development — covering chemistry, manufacturing, control (CMC), pre-clinical and clinical strategy up to marketing authorization — ensuring efficient, compliant, and quickest science-driven pathways to market. Trusted by biotech, pharma, and healthcare innovators, Granzer Regulatory Consulting & Services combines decades of regulatory leadership with a commitment to advancing patient access to innovative medicines.

About Stefan Besse

Stefan Blesse has over 30 years of experience in Regulatory Affairs, holding senior leadership roles with both large and small pharmaceutical companies across Europe. He has extensive expertise in global drug development across the US, Europe, and Asia-Pacific, covering a wide range of therapeutic areas — from oncology, dermatology, and CNS disorders to vaccines, advanced therapies, and biologics – including anti-infectives where he is involved in current new developments.

He is a member of the German Society for Regulatory Affairs (DGRA) and lectured in the Master of Drug Regulatory Affairs program at the University of Bonn.

Stefan has deep knowledge of European (CP, DCP, MRP) and US (IND, NDA with CDER and CBER) regulatory pathways, with extensive experience in authority interactions, global regulatory strategy, pediatric development (PIP), orphan drug designations, and risk management planning.