Biography
Biotechnology and medical device innovation professional with over two decades of research experience as an investigator on over 200 clinical research protocols. Regulatory affairs professional and expert in the life-cycle of a biotech innovations, research compliance, and the intersection between operations and clinical research. Experienced in a wide variety of investigational products including: drugs, devices, biologics, gene therapies, and combination products. Instructor of graduate courses in clinical research ethics, FDA law, and the business of medicine and biotechnology. Internationally recognized expert in integrated quality management, research compliance, and enterprise risk management in clinical research.
Professional Experience
Brent Ibata, PhD JD MPH FACHE, is a healthcare executive with a contagious enthusiasm for creative inquiry and strategic innovation. He has proven talent acquisition and management experience bringing together multidisciplinary teams within highly matrixed organizations to brainstorm, design and execute human-centered process and performance improvement initiatives. He has demonstrated strategic management expertise identifying and engaging symbiotic collaboration opportunities to align organization, physician, and patient needs. Ibata has mentored and coached dozens of performance and quality improvement initiatives bridging volume-based with value-based healthcare delivery to achieve zero events of preventable harm. He is a lifelong teacher and learner who still carries and believes in a fortune from his early career that reads, “One learns most from teaching others.”
EXPERTISE
Built environment – Creative confidence – Design thinking – Enterprise risk management – Environmental and occupational health and safety – High reliability organizations – Healthcare innovation – Health law – Improvisational ideation – Integrated quality management – ISO 9001 – Internal audits – Joint Commission/DNV – Life Safety Code – Patient and family experience – Population public health – Quality improvement – Rapid cycle innovation – Research contracting – Research compliance – TeamSTEPPS – Value-based purchasing
Professional Activities & Accomplishments
Fellow of the American College of Healthcare Executives (FACHE) and registered patent agent.