Bruce Yacyshyn

About Bruce Yacyshyn

Staff Gastroenterologist, Lexington VAMCConsultant, Tower Hill Consulting LLC.(https://towerhillconsulting.com/)Professor,University of Cincinnati Dept of Pharmacology and systems physiologyMedical and Scientific advisor for Biotechnology: VBI vaccines, Clostrabio, Musidora Bio Locums GastroenterologistVice President, Medical - MedpaceClinical Professor, University of LouisvilleStaff Physician, Robley Rex VAMC, Louisville, KentuckyMember, IRB Robley Rex VAMCProfessor of Medicine, University of CincinnatiPresident -College of Medicine Faculty, University of CincinnatiCo-director, Inflammatory Bowel disease program, University of CincinnatiData Safety Monitoring Board member Inc research/Seres therapeuticsMedical Director, Procter and Gamble pharmaceuticalsNorth America Clinical development, Procter and Gamble pharmaceuticalsRegulatory representative, P & GP to FDA, Health Canada and EMAMember, Biomarker Team P & GPMember, Licensing and Acquisitions for P & GPNAUI/PADI certificationNIH special programs grant reviewer- multiple years and ongoing (most recent 2024)Specialties: translational research, gastrointestinal diagnostics, pharmaceuticalsPreclinical drug and diagnostics development

Experience

1. Clinical Research Consultant

   Tower Hill Consulting

   Nov 2023 — Present · US

   Gastroenterology physician (Academic Professor and Clinical practice)with training in Gastroenterology, Hepatology and Nutrition including inflammatory bowel disease subspecialty training. As a Clinical and Research Physician with 30+ years\' experience in Translational research and the Clinical Research Industry at different levels (Pharma, Clinical Site, Biotech and CRO). Proficient in recognizing early signals of efficacy using validated assessments in human and model-based systems, Toxicology assessment, clinical development plan, clinical trial execution and management of all phases of drug development including preclinical. Over 30 years\' experience in Medical Monitoring and mentoring of academic and industry colleagues for a large range of therapeutic areas (GI, Liver, Nutrition, Inflammation and others).Experience includes:•Plan, manage, analyze and control multiple aspects of clinical research project development•Interaction with the FDA •Creation of clinical study protocols•Being a key “Medical Mind” interfacing with cross-functional teams within the Development Groups•Managing CRO and other vendors•Supervise participating clinical investigators to ensure studies are properly conducted•Manage approved budgets•Ensure adherence to standards of quality and compliance with GCP regulations•Preparation of abstracts, manuscripts and presentations on Company’s products for scientific conferences•Review and assess reports of adverse events (e.g, serious and unexpected); assess the causal relationship of the adverse events to the drug product(s); and review reports of safety data for submission to regulatory agencies. Clinical research experience in multiple therapeutic areas-Gastroenterology-Hepatology-Nutrition-disorders of Inflammation-Enteric infectious disease (C. difficile, COVID, Viral Enteritis)-Repurposing of drugs for new indications-BIomarkers (-omics) for predictive and precision medicine-Licensing and acquisition

Education

• Washington University School of Medicine in St. Louis

  Fellow, Gastroenterology

  1986 — 1989

Skills

• Biomarker Discovery
• Hardware Diagnostics
• Canada
• Biotechnology
• Research and Development (R&D)
• Biomarkers
• Biostatistics
• Clinical Research
• Clinical Pharmacology
• Drug Discovery
• Translational Research
• Eastern Europe
• Research
• Asia
• Clinical Trials
• Pharmaceutical Industry
• Fda
• Hospitals
• Drug Development
• Cancer
• Translational Medicine
• Life Sciences
• Clinical Development
• Lifesciences
• Gastroenterology
• Internal Medicine
• Biochemistry
• Infectious Diseases
• Medicine
• R&D
• Oncology
• Immunology
• Diagnostics
• Medical Research
• Molecular Biology
• Pharmaceuticals
• Treatment
• Emea
• Clinical
• Epidemiology