Dr Just (Joachim Klaus) Genius
Senior Clinical Development Consultant
Experience
Senior Clinical Development Consultant
Syndeio Biosciences
- Leading all clinical, regulatory and translational aspects of a novel NMDAR-PAM for Alzheimer’s disease and in undisclosed rare diseases.
Senior Clinical Consultant
BioNTech
- Established comprehensive indication strategy for a TNFR2 agonist, including translational strategy and clinical design options focusing on neurodegeneration and regeneration.
- Managed KOL and CRO relationships and competitive intelligence.
- Developed a score-based methodology to optimize indication selection across neurology, inflammation and fibrotic disorders, enabling critical decision-making on entering the neurology space.
Founder and CEO
Genius Biotech Solutions Ltd
- Consulting biotechnology and pharma companies with a focus on early clinical development.
- Providing strategic leadership across end-to-end clinical planning and execution under FDA regulations, including safety oversight, CRO selection and governance, biomarker strategy, KOL and site management, and regulatory strategy through FDA IND preparation and submission.
- Applying clinical and scientific background in neurology and psychiatry, including neurodegenerative disorders, neuroinflammatory disorders, brain and spinal cord trauma, major depression, schizophrenia and neuropediatric disorders, plus gastrointestinal inflammatory disorders, autoimmune disease and fibrotic disorders.
- Managing external stakeholders such as key opinion leaders, patient advocacy groups and regulatory authorities.
- Providing a scientific and business basis for strategic decisions and ensuring efficient team management and communication skills.
Senior Clinical Development Consultant
AC Immune
- Generated clinical protocols and translational strategies for an active Parkinson’s vaccination program and an early-stage FTD/ALS program (therapeutic antibody and novel PET-tracer).
- Developed strategy and translational planning for an early-stage program on morphomers for tauopathies (AD and PSP).
- Contributed to clinical development and translational plan for a novel antiinflammatory compound targeting non-alcoholic liver fibrosis.
- Developed a dedicated tool to benchmark potential target indications for strategic portfolio decisions, exploring orphan and fibrotic disorder indications with scientific rationale, feasibility, regulatory strategy and safety, and conducted competitive intelligence.
- Led the clinical work-package for digital transformation using novel wearable technologies, computational biology and artificial intelligence to optimize signal detection in clinical trials.
Senior Medical Director, Neurology Development
UCB
- Served as medical lead for an early phase clinical development program in Parkinson’s disease (ORCHESTRA study), achieving successful transition into Phase II.
- Led an international multidisciplinary team, including clinicians, translational scientists, regulatory experts, biostatisticians, operational experts and commercial leads, to transition an asset into Phase II ahead of schedule.
- Managed site selection and oversight, CRO benchmarking, study startup and safety monitoring for Phase I.
- Coordinated design of translational and analytical plans and led filing activities and FDA meetings.
- Co-developed a device/AI based trial strategy with Neuropore and Verily and implemented it in a Phase II trial.
- Selected and managed KOLs and advisory boards and conducted investigator and site selection.
- Contributed to development of a novel PRO instrument for Parkinson’s disease outcome measures.
- Led publication strategy as main senior author for core publications, posters and presentations.
- Designed hybrid trial plans to overcome COVID-19 challenges.
- Led translational strategy implementation of digital biomarkers and artificial intelligence in neurology development activities.
- Supported pipeline reshaping for neurodegeneration and neuroinflammation and identified alternative target indications.
- Contributed to biomarker consortia as Steering Committee member for the FNIH Neuroscience Steering Committee of the Biomarkers Consortium.
- Served as medical lead for a discovery stage gene therapy program in FTD preparing candidate selection and transition into FIH.
Medical Director and Head of Translational Biology
AbbVie
- Acted as main interface between Neuroscience Discovery and Clinical Development to bridge gaps, streamline processes and optimize budget decisions.
- Served as clinical lead for AbbVie-Calico collaboration on vanishing white matter disease and other rare diseases, initiating development programs.
- Led first-in-human and early-stage drug development for progressive MS (anti-RGMa) and spinal cord injury, including IND submission, trial design, translational plan generation and safety monitoring.
- Led development of a PET imaging technology to assess residual inflammation in Crohn’s disease and validated mitochondrial activity tracers.
- Initiated and led a glycobiology team to establish a microarray platform and evaluate small molecules modulating cell surface glycan composition for neurodegeneration, neuroinflammation, vascular diseases and fibrosis, with adoption by AbbVie in neurology and oncology.
- Founded and co-led a project optimizing antibody targeting via specific protein glycoforms.
- Provided managerial direction and clinical/scientific guidance to early-stage drug development/discovery across neurology, gastrointestinal inflammatory disorders and fibrosis.
- Managed one direct report and a global matrix team.
- Oversaw clinical safety for multiple Phase 0 and Phase 1 studies in immunology, gastroenterology and neurosciences.
- Implemented biomarkers for enrichment and novel clinical endpoints in progressive MS, AD and PD, including nonconventional MR imaging, PET, OCT and biochemical tools.
- Served as translational lead for calpain inhibitor and S1P5 antagonist exploration.
- Developed a communication strategy for early patient access in rare diseases.
- Explored business options and clinical-translational plans for genetic neuropediatric orphan diseases.
- Supported clinical development strategies in MS and alternative indications (spinal cord injury, AD, ALS, FTD, LHON, Huntington, neuropaediatric storage disorders and leukencephalopathies) by identifying KOLs, designing development scenarios and forming advisory boards.
- Assessed in-licensing opportunities for MS, AD, PD, ALS and retinal diseases under aggressive timelines for AbbVie and AbbVie-Calico collaboration.
- Participated in regulatory consortia to promote acceptance of novel biochemical biomarkers in AD and MS (e.g., ADNI-PPSB, CAMD).
- Scouted novel technologies, including imaging and blood/CSF biomarkers, for ongoing development programs.
- Established partnerships with US MS study sites, handling selection, training, surveillance and document authoring (IND/IRB).
- Led teams responsible for safety reports and data presentations to monitoring boards, FDA and regulatory authorities.
Clinical Research Assistant (Psychiatry) and Research Group Lead
University of Duisburg-Essen
- Founded and led the experimental research section “Environmental Stress and Neurodegeneration.”
- Supervised multiple PhD and MD students.
- Established and managed a biobank for neurodegenerative disorders.
- Set up and led a laboratory for advanced confocal live cell imaging in in vitro Alzheimer’s models.
- Focused on excitotoxic mechanisms in AD, FTD, ALS, TBI and other neurodegenerative disorders.
- Initiated projects to assess and validate potential Alzheimer’s CSF biomarker candidates in collaboration with industry partners.
- Contributed to clinical work packages in international biomarker consortia (JPND-BIOMARKAPD, PURE).
- Served as clinical lead for nanotechnology diagnostics in the EU NADINE nanobiotechnology project.
Resident Physician and Researcher
Ludwig-Maximilians-University Munich
- Conducted research on the molecular background of schizophrenia and neurogenetics, securing substantial third-party funding.
- Received a German-Israeli Foundation grant to study the MOA of riluzole in ALS.
- Obtained grants to investigate NMDA and mGlu receptor dysfunction in neurodegenerative diseases and schizophrenia.
- Implemented new translational in vivo and in vitro models for schizophrenia.
- Trained in Dialectical Behavior Therapy (DBT) and suicide intervention.
- Served as sub-investigator in clinical studies on anti-dementia therapies, including vaccination and neurochemical/imaging biomarker studies.
- Tutored neurology and psychiatry students within the Munich-Harvard Teaching Alliance and MECUM Program.
- Supervised multiple MD and PhD students independently.
- Acted as psychiatric expert witness in high-profile criminal and civil cases.
- Gained extensive teaching experience through seminars and bedside teaching.
Summary
Physician-scientist (MD) and senior clinical development leader with 11+ years in biotech/pharma and 45+ peer-reviewed publications. Founder/CEO of Genius Biotech Solutions providing end-to-end early clinical development leadership (FIH/Phase 1–2 strategy, IND/CTA readiness, CRO selection/oversight, safety monitoring, biomarker and translational strategy, KOL/site engagement). Deep expertise in neurology and psychiatry with primary focus on neurodegeneration (Alzheimer’s, Parkinson’s, MS, FTD/ALS) and rare CNS disorders, plus experience in inflammation/fibrosis. Proven track record leading global cross-functional teams, regulatory interactions, and innovative endpoint strategies integrating imaging, biofluid, digital and AI-enabled biomarkers.
Languages
Education
Medical University of Lübeck
M.D. Medicine · Medicine · Lübeck, Germany · 1.0 (Overall grade of the German Medical State Examination)
Profile
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