Dr. Just Joachim Klaus Genius

providing the full arc of leadership in early clinical development — from operational and business development aspects over translational strategy and IND/CTA preparation through First in-Human execution, dose escalation, safety monitoring, and Proof-of-Concept/ Proof of-Mechanism. CRO selection oversight, safety monitoring, KOL/site preparation of all relevant documents representing companies

Genius Biotech Solutions Ltd. provides strategic consulting and operational program execution to biotechnology and pharmaceutical companies with a focus on early clinical development and biomarker strategies in neurology for companies like BioNTech, AC Immune and others. I lead all aspects of clinical development planning and execution, including biomarker strategy, data reviews, dose escalation meetings, adaptive interims, study report writing, CRO/vendor selection and management, KOL and site engagement, regulatory strategy, and IND/CTA preparation and submissions. Strong experience in business development and Medical Affairs functions . I bring a strong clinical and scientific foundation in neurology and support companies in implementing innovative technologies into their development strategy. This includes blood /CSF biomarkers, wearable multisensor technologies, gene expression platforms, proteomics, novel molecular and structural imaging technologies, OCT in MS and retinal disorders, wearable EEG, sleep monitoring and multiplex assay technologies. I have been involved in validating these

Project Lead for all clinical, regulatory, and translational aspects of a novel NMDAR-PAM in development (in FIH stage) for Alzheimer's disease and in undisclosed rare diseases, coordinating a diverse international team of industry and academic experts, which allowed proceeding to Phase 2 ahead of timelines.