Michael Schrago

Biography

Michael is a pharmacologist trained and dedicated to drug discovery and development. His main areas of interest and experience are internal medicine, oncology and tropical diseases. He also has experience in biotechnology, ICH-GCP, general topics in clinical research and evidence-based medicine. Experience Co-founder & Director of Clinical Operations – IPSUM  (August 2014 – Present) – Provide leadership and experience in the planning, implementation, and execution of clinical studies.  Ensure all clinical studies are conducted in accordance with company SOPs, GCPs and ICH guidelines. – Work collaboratively with cross-functional teams and direct clinical study teams to ensure clinical strategic plans are implemented. Clinical Trial Manager – General Hospital Medellin  (July 2014 – Present) Merck Sharp & Dohme SPIRO:  A 26-week randomized, double-blinded, active controlled study comparing the safety of mometasone furoate/formoterol fumarate MDI fixed dose combination versus mometasone furoate MDI monotherapy in adolescents and adults with persistent asthma. BPL (Bio Products Laboratory Ltd) OPTIVE: Multicentre, non-controlled, prospective, post-marketing safety study following long-term prophylactic Optivate® treatment in subjects with severe haemophilia A. Janson & Janson MARINER: Global trial to evaluate prophylactic safety and efficacy of extended treatment with an orally administered anticoagulant, rivaroxaban, in high risk medically ill patients for the prevention of venous thromboembolic events (VTE), including pulmonary embolism (PE).  Trombosis Janson & Janson CREDENCE: (Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation) Randomized, double-blind, event-driven, placebo-controlled, multicenter study of the effects of Canagliflozin on renal and cardiovascular outcomes in subjects with type 2 diabetes mellitus and diabetic nephropathy. Vice President – ABC Genetics (August 2011 – Present) – Global Sales & Business Manager, decision-making, market analysis and determination of course of action – Vision creation, generation of new ideas to improve products and services, testing of new methods and opening of new markets in S. America – Making deals, negotiating contracts, managing conflicts Researcher – Pharmaceutical Biochemistry, University of Geneva (February 2010 – August 2011)Development of novel tyrosine kinase inhibitors (TKIs) as molecular probes for positron emission tomography (PET) imaging and treatment of cancers

Research Interest

Business and Management