John Simon

… holds a B.Sc. from the University of Alberta, is a Senior Member of the American Society for Quality, Certified Quality Auditor (CQA) through the American Society for Quality; Regulatory Affairs Certification (RAC) through the Regulatory Affairs Professional Society; and RQAP-GLP certification through the Society of Quality Assurance. With 30+ years experience in drug development, medical devices and regulatory affairs, he has held a series of management positions and has consulted to a number of public companies in biotech, natural health and cannabis industries.  His drug development experience ranges from concept to marketed product, including submissions to Health Canada and the FDA for product licensing in the areas of Clinical Trials, Drug Manufacturing and Testing, and Medical Device Manufacturing.  Moreover, John has experience with setting up the process control and documentation requirements for controlled substance manufacturing.  John’s experience includes: Grenex Pharms (CEO-cannabis), EyeTech (Macugen for macular degeneration), Biomera (3 therapeutic cancer vaccines), 10 COVID-19 Interim Order Projects, 5 FDA Emergency Use Authorization projects, Expert Advisor to 20+ projects through Innovate Calgary, Executive in Residence w/TEC Edmonton on 100+ projects, 30+ FDA Submissions (all licenses successfully issued), 100+ Health Canada Submissions (all licenses successfully issued), 10+ Clinical Trials and support for many more.

At BlueThera, John is responsible for all regulatory submissions, oversight of clinical trial protocol, drug development, facility design, extraction and cultivation processes, quality assurance and general corporate strategy, and human resources.