Genius Biotech Solutions Ltd is consulting biotechnology and pharma companies with a focus on translational strategy support and all aspects of the design and execution of complex clinical trials, including clinical aspects, operational execution, biomarker strategy, regulatory aspects, safety and filing activities. I cover the entire spectrum of neurological diseases, including PD (as a focus area), AD, MS, FTD and ALS with additional focus on inflammatory diseases, fibrosis, NASH, vascular diseases and neuropediatric diseases, specifically orphan diseases. I am very experienced and have developed a dedicated tool in matching novel indications to emerging or existing pipeline assets, and supporting successful entry into new therapeutic areas. I am highly experienced in managing external stakeholders (key opinion leaders, patient advocacy groups and regulatory authorities). My company is operating from Gozo Island (Malta). Currently, I am mainly working for a biotech company from Switzerland (AC Immune, mainly PD, ALS and FTD as well as neuroinflammatory disorders and neurogenetic disorders). I collaborate with an artificial intelligence company providing services to optimize antibody design (EVQLV, New York) . I have generated the clinical protocols for an active PD vaccination program, which has just successfully proceeded into Phase 2 as well as for an early-stage program on FTD/ALS (therapeutic antibody and novel PET-tracer) and an early-stage program for tauopathies. Currently, I am clinical lead for a novel, anti-inflammatory compound exploring multiple potential, target indications and providing the necessary translation framework. This activity also includes intense, competitive intelligence work. For BioNtech, I have established a neurology strategy for compounds entering FIH, including all aspects of translational strategy, clinical design, KOL management and competitive intelligence. I have developed a new score-based methodology to optimize indication selection. A special focus is the digital transformation utilizing novel wearable technologies, computational biology and artificial intelligence to optimize signal detection in clinical trials.
Strategic Vision