Michal Konstacky
Managing Director
Experience
Managing Director
K Medical Consulting GmbH
Consulting/Contracting (AstraZeneca – Forxiga/chronic renal & heart failure, T2DM, Pfizer – ATTR cardiomyopathy registry (tafamidil), Profimed – spermidine/ longevity, Hemex – acute lymphoblastic leukemia/regulatory, Sherpa Health – metabolomics/CMO, HTG – gait monitor/CMO), Vaud Medical – Wilson disease /CMO, Czech Ministry of Education & Czech Academy of Sciences – EU scientific grants in medicine reviewer. Micro consultations with management consulting companies.
Director, Clinical Trials & Safety Physician
Idorsia
daridorexant /insomnia paediatric, cenerimod /systemic lupus erythematosus (SLE), medical monitoring. DSURs, RMPs.
Senior Medical Director
Luzsana
Medical leadership in EU/US/China for global Phase I-III clinical programs, regulatory submissions, protocol development, and human factor studies, clinical trial diversity. Managing cross functional team of 60 people in China.
Diabetes - T1DM & T2DM (long-acting insulin, GLP1 RA /Ph I & II, human factor studies, FDA & EMA interactions, briefing book, protocols), atopic dermatitis, eosinophilic oesophagitis (anti IL4), Alzheimer (anti amyloid beta, Ph II).
Co-lead: FXI, chronic pain, oncology (chemo induced thrombocytopenia)
Medical Director
Roche
Led neurosciences/ultrarare diseases translational medicine, Ph I-II protocol development, Proof of Concept, Proof of Mechanism, regulatory negotiations, pRED (Pharma Research & Early Development) governance reform squad lead.
Medical lead for Dup15q & Angelman syndrome (basmisanil, allosteric modulators, mRNA). Briefing book, protocol design, FDA negotiations, 2 Ad Boards.
Global Medical Director IBDs & PSC
Takeda
Led SHP647 (ontamalimab) medical strategy for Crohn's disease, ulcerative colitis, and primary sclerosing cholangitis in a divested program under the supervision of the European Commission. Pregnancy registry, ad boards, patients' engagement.
Senior Director / Head of EMEA Med Affairs & Clinical
Aegerion
Team lead (17 people, incl. 2 Senior Directors) for metreleptin/Mylepta (partial and generalized lipodystrophy, congenital leptin deficiency) clinical development, EU launch & reimbursement, developed strategic plans, created pharmacovigilance, medical info structures, Head of EMEA patient advocacy, orchestrated business expansion to the Middle East, HCP & vendors trainings with sever insulin resistance diabetes centres (UK, Oman), responsible for set up of clinical trials in partial LD, paediatrics, immunogenicity and a drug registry. Interim UK, France, Benelux, Scandinavia, MENA Medical Head.
Global Medical Director Rare Neurological Diseases
Takeda
Neurosciences/ metabolic field. Lysosomal storage disorders: MPS II (neuronopathic form of Hunter syndrome) SHP609 (idursulfase-IT) Ph II/III paediatric program, managed regulatory submissions for ERT, HOS safety registry. Publications, cognitive & developmental assessment task force, ad boards, new intrathecal catheter search, new digital endpoints. Interim US Medical Head & team lead, interim lead for MLD, MPS IIIa, Fabry disease (cardiomyopathy), hereditary angioedema. Main organizer of two LSD Forum Conferences (€0.7M investment).
Medical Head EMEA
Aerocrine
Launched FeNO medical devices (Niox Vero) in asthma Th2 mediated inflammation detection, led European medical and clinical operations teams, provided medical monitoring, negotiated payor and regulatory aspects. Collaboration activities with Apoteket AB. Interim US Medical Head. Lead Chinese medical team and started to build Japanese medical team. One of the FeNO devices is utilized by the crew aboard the International Space Station (ISS).
Head of Respiratory Medical
Takeda
Head of Medical Dpt. (7 people). Pre-launch & launch activities for roflumilast (Daxas) in COPD, Alvesco in asthma, Omnaris in chronic rhinitis. Risk mitigation activities. Co-designed COPD mortality study SIGNATURE (€120M). Interim UK Medical Head.
International Medical Affairs Director
Abbott
Created and implemented a global key opinion leaders' strategy across all therapy areas, co-chaired the publication board of the OSCAR cardiometabolic trial, and coordinated the Metabolic Syndrome Institute (a project with Joslin Diabetes Clinic, Harvard, Boston), involving a $1M investment.
International Med Affairs Respiratory Manager
Almirall
Pre-launch activities for aclidinium bromide in COPD, LCM – designing Ph II for combo projects. Coordinator for co-development with Forest Laboratories. Responsible for scientific publications, ad boards, human factor studies, lung deposition studies. Genuair inhaler development. HEOR & RWE.
Medical Affairs and Pharmacovigilance Manager
AstraZeneca
Medical support for cardio/metabolic (Attacand, Betaloc, Plendil, Crestor, ximelagatran, Cerovive/NXY 059), GI (Losec, Prilosec), neurosciences (Quetiapin, Zomig). JUPITER trial (rosuvastatin in subjects with elevated hsCRP, 89,890 patients screened for enrollment). C-MLR review / nominated signatory. Manager of CZ & SK Drug Safety Officers, responsible for PSURs, ICSRs, RMPs, PBRERs. Member of AZ Consulting Committee in Stanhope Gate HQ, London.
Assistant Professor
Charles University Hospital
Internal medicine & cardiometabolic department, cardiovascular and haematological ICU, accidents & emergency physician, heart echo (TTE, TEE, 7,000 examinations), vascular ultrasonography, transesophageal echocardiography expert on call for 0.5 mil inhabitant region, treated around 60,000 patients, chronic heart failure and PVD clinic. Preventive cardiology and echocardiography lecturer.
Trained in lower and upper GI endoscopy, including ERCP. Liver catheterizations.
Academia research (chemo induced cardiomyopathy, multiple myeloma, 18F FDG-PET scans in liver transplants, animal surgical experiments in portal hypertension, liver regeneration. Colorectal cancer national study coordinator, H. pylori UBT C13 research – including development of antibiotic eradication protocols, acute pancreatitis & antibiotics).
PhD theses: H. pylori: Chronic infection, inflammation, and their relation to cardiovascular diseases.
Principal investigator in Ph III clinical trials (e.g. ximelagatran in DVT, acute heart failure).
Consultant for Europæiske ERV (Denmark) - Travel Insurance and global repatriation services.
Summary
With over 20 years in the pharmaceutical industry and 12+ years in academia and medical practice, I bring extensive experience and a proven track record in managing large (60 people) diverse multinational teams, leading key strategic initiatives and developing medical content. I have significant hands-on regulatory expertise, including interactions with the FDA and EMA, and have managed NDA & BLA/MAA submissions followed by successful drug & device launches. My broad therapeutic knowledge spans neurosciences, rare diseases, immunology, respiratory medicine, cardiometabolic, and GI.
I have designed, planned and delivered early and late-stage clinical trials (€120- 255M), successfully negotiated with authorities & payors, developed registries, RWE, key publications, and organized advisory boards. My global perspective, gained from roles in EMEA, US, APAC, and MENA regions, includes serving as Interim Medical Director in the UK, US, BENELUX, and MENA. I have extensive experience in due diligence and investor consulting within the pharma and healthcare sectors. I am an enthusiastic supporter of negotiation strategies and new technologies in medicine and a mentor of MedTech startups. Additionally, I am a patient advocate in rare diseases.
Languages
Education
City University of Seattle
MBA · United States
Charles University
PhD & MD · Prague, Czech Republic · Suma cum laude
Certifications & licenses
Shane Snow on Storytelling
Creativity Bootcamp
Artificial Intelligence in Healthcare: Fundamentals and Applications
Similar Freelancers
Discover other experts with similar qualifications and experience