Michal Konstacky

🚩 Chiesi Farmaceutici, Italy – Senior Consultant, Clinical Research Physician (Neonatology; 03/2025–present)

🚩 Aptarion, Germany – Clinical Development Director /medical monitor, business development (Severe community acquired pneumonia; 03/2025–present)

🚩Biorce, Spain (AI in clinical development; 3/2025 till present)

🚩 SpyraSoft, Poland – Business Development Consultant (Medical technologies; 2025)

🚩 NanoZymeX. Switzerland - Clinical Consultant (11/2025-present)

🚩 Merck, Germany – Clinical & Business Development Consultant (2024)

🚩 Idorsia Pharmaceuticals Ltd., Switzerland – Clinical Trial & Safety Physician (Consultant, 2023)

Neurosciences: Insomnia, paediatric Phase II (daridorexant/Quviviq)

Autoimmune diseases: Systemic lupus erythematosus, Phase III (cenerimod)

🚩 BridgeBio, US – Consultant (Gene therapy; 2025)

🚩 Creative Partners in Health (CPiH), Switzerland – Medical consultant on project CARE for Jazz Pharmaceuticals (Rare epilepsies; 2025)

🚩 Czech Academy of Sciences, CZ – Evaluation Commission Member (Primary research; 2024–2025)

🚩 Charles University in Prague, CZ – Mentor for Postgraduate Students (10/2024–present)

🚩 Czech Ministry of Education, CZ – Evaluator, EU Excels grant programmes (2023, 2026)

🚩 Pfizer – Cardiovascular, Switzerland: ATTR cardiomyopathy registry; chronic heart failure (tafamidis)

🚩 HTG Medical, CZ – Chief Medical Officer (Medical devices: Gait monitoring device)

🚩 AstraZeneca, CZ – Cardio-metabolic diseases: Diabetes, renal and heart failure (Forxiga)

🚩 Profimed, CZ – Senior Advisor (Longevity: Spermidine research)

🚩 Sherpa Health, UK / Zenith Swiss Longevity, CZ – Chief Medical Officer (Longevity: Metabolomics panels and biomarkers in preventive medicine)

🚩 Primevigilance (UK) – Senior Advisor (Acute lymphoblastic leukaemia)

🚩Zenith Swiss Longevity (2025-present) project co-founder and CMO

🚩Alpha Roster (2026) project founder and CEO

Global Clinical Development: Extensive experience managing clinical trials across EU/EMEA, US, and APAC regions, including Phases I, II, and III studies. Proficient in Proof of Concept (PoC) and Proof of Mechanism (PoM) trials. Led cross-functional teams of up to 60 professionals across multiple geographies. Therapeutic Expertise: Neurosciences: Alzheimer's disease (anti-amyloid beta treatments). Cardio-metabolic Diseases: Diabetes (long-acting insulin, GLP1 receptor agonists), heart failure, and renal disease. Dermatology: Atopic dermatitis (anti-IL4) and psoriasis (anti-IL17). Gastroenterology: Eosinophilic esophagitis. Pain Management: Expertise in chronic pain therapies. Anticoagulation Studies: fXI for myocardial infarctions. Regulatory Expertise: Prepared BLA and NDA submissions for FDA, EMA, and Chinese health authorities. Strategic Leadership: Development of Target Product Profiles (TPPs). Crafting medical strategies for product lifecycle management. Designing and implementing diversity plans. Conducted human factor studies in diabetes (e.g., Ypsomed auto-injectors). Stakeholder Engagement: Organized and facilitated advisory boards with experts and key stakeholders. Due diligence for business development.

Translational Medicine & Early Clinical Development: Expertise spanning Phase 0 to Phase II studies, focusing on innovative approaches to drive Proof of Concept (PoC) and Proof of Mechanism (PoM) trials. Therapeutic Focus: Rare Diseases: Specialized in Dup15q and Angelman syndrome (allosteric modulators such as basmisanil and mRNA antisense therapies). Neurosciences: Broad experience in pediatric and rare neurological conditions. Regulatory Expertise: Developed and contributed to key regulatory documents, including Briefing Packages, Investigator Brochures (IB), and submissions to FDA and EMA. Leadership in Governance: Led the pRED Governance Reform Squad, driving strategic improvements and operational efficiencies. Stakeholder Engagement: Organized and facilitated advisory boards with experts and patient representatives. Integrated patient and expert input into clinical trial design and therapeutic strategies.