Carsten Spannhuth, MD, eMBA

Pioneering biopharmaceutical company focused on developing a platform of first-in-class positive allosteric modulators of TrkB/BDNF for obesity as well as the treatment and prevention of neurodegenerative diseases (e.g., WAGRO, Angelman's disease, Huntington's disease) and other CNS disorders.

Partnering with biopharma & investors to accelerate CNS and neuroscience programs from translational concept through commercialization. Whether you need strategic guidance to de-risk a pipeline, hands-on leadership to transform clinical development, expert evaluation of investment opportunities, or strategic intelligence to guide program development and portfolio decisions: we bring both clinical depth and operational execution. Our services span clinical development strategy (translational through commercialization), regulatory intelligence and pathway optimization, innovative trial design, digital biomarkers and endpoints, and comprehensive investment due diligence. We’ve guided pivotal programs to regulatory approval across multiple indications and maintained deep relationships with US-FDA, EMA, MHRA, and PMDA. We combine extensive clinical expertise, proven track record in complex international programs, and investment evaluation rigor to help you navigate risks, accelerate timelines, and make informed decisions. Major projects include: External Expert @European Investment Bank, Luxembourg • Investment Due Diligence Assessor @CerebrumDAO, Zug, Switzerland • Senior Consultant @Adelaide University (Adelaide, Australia) • CMO Consultant @reconnect labs (Winterthur, Switzerland) Past projects: Senior Consultant @Synendos Therapeutics, Basel, Switzerland • Chief Development Officer @Neurolentech (Vienna, Austria) • Associate Chief Medical Officer @GeNeuro (Geneva, Switzerland) • Senior Consultant @Biorasi (Aventura, FL, USA)

Global Clinical Lead in psychiatric (including PASC/Post-COVID-19 Syndrome) development programs & Therapeutic Area Expert for new product concepts, strategic plans and licensing due diligence

Global Clinical Lead in a global phase 3 clinical development program in Insomnia Disorder (daridorexant/Quviviq) as well as Therapeutic Area expert in early-phase translational neuroscience projects and due diligence assessments for out-licensing opportunities

Global Clinical Lead for the portfolio of neuroscience drugs, due diligence for in-licensing opportunities & interactions of Digital Development and Clinical teams across Therapeutic Areas to assure best practice implementation of digital technologies in clinical development programs

Global Medical Lead for the CNS products portfolio of 80 established products, including valproate, amisulpride, zolpidem, metamizole, riluzole and vigabatrin

Developed the global strategy, designed & supervised worldwide psychiatry clinical development programs

[Now: 'Syneos Health Clinical Solutions']

Digital technology company focused on clinical development

[Now: 'Nuvisan Pharma Services']

Medical faculties of „Freie Universität Berlin“ and „Humboldt-Universität Berlin“ were merged into „Charité – Universitätsmedizin Berlin“ in 2003