Optimi Health Strengthens Clinical and Regulatory Expertise
Optimi Health Corp. has engaged industry veteran John Simon to enhance its regulatory submissions and psychedelic research efforts. Simon brings extensive experience in regulatory affairs and has worked with FDA and Health Canada. His role is pivotal for Optimi's goal of conducting clinical trials on psilocybin-based formulations, meeting international standards, and securing intellectual property rights. The company aims to improve mental health through its innovative mushroom products and has received regulatory exemptions for research into psilocybin and psilocin.
- Engagement of John Simon enhances regulatory submission processes.
- Focus on conducting clinical trials that meet international standards.
- Strategic aim to improve mental health with psilocybin-based formulations.
- None.
VANCOUVER, British Columbia, July 27, 2021 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTC: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), as part of its strategic aim to fully investigate the science of mushrooms, is pleased to announce the engagement of industry veteran Mr. John Simon to facilitate regulatory submissions and planning relevant to key elements of psychedelic research.
Mr. Simon specializes in gaining site and product licences and related commercialization pathway development efforts. He has served in a variety of managerial and consulting roles overseeing quality assurance and regulatory affairs with direct involvement with the FDA and Health Canada audits relevant to medical device manufacturing, drug manufacturing and testing, drug and device establishments and clinical trial site implementation.
Mr. Simon stated, “Working on the Optimi project is an exciting opportunity to help people with unmet medical needs. The IMPACT team is aiming for a clinical trial that meets international standards and this is the sort of goal I find compelling. I believe our studies will offer an extraordinary opportunity to identify the beneficial differences between systemic and natural formulations, and the FDA’s botanical guide/framework could offer strategic insights as to how Optimi can achieve intellectual property (IP) rights even while executing the clinical trial. I have worked in drug development before, and one project in particular went on to become the largest biotech licensing deal in Canadian history at that time. I am keenly aware that mental health & overall wellness is an immense field of opportunity and look forward to helping unlock the potential of psychedelics.
A long-time resident of Edmonton, Canada, he was the very first cannabis sector license holder in that city which he later sold to Avant Brands. He was instrumental in assisting Aurora Cannabis Inc. as well as Radient Technologies in the implementation of Quality Management Systems (QMS) regarding key commercial activities. He has built an extensive client base in the region including a major chocolatier’s cannabis infusion goals. He has undertaken research & development efforts for globally recognized non-cannabis health & wellness clients in the treatment of common colds, skin beautification, sunscreens, and conditioners. His clinical trial experience includes advanced studies for therapeutic cancer vaccines, as well as numerous projects supporting clinical trials for drugs, natural health products and medical devices.
Organizationally, Mr. Simon serves under the auspices of Optimi’s service agreement with the IMPACT Clinical Trial Accelerator Program of Alberta’s Life Sciences Innovation Hub at the University of Calgary. The IMPACT program provides Optimi expert clinical support towards commercializing proposed psilocybin-based formulations through the conduct of clinical trials and expert assistance towards securing regulatory approval. John Simon B.Sc., RAC, CQA, RQAP-GLP earned his B.Sc. from the University of Alberta, is a Senior Member of the American Society for Quality, is a Certified Quality Auditor (CQA) through the American Society for Quality and holds Regulatory Affairs Certification (RAC) through the Regulatory Affairs Professional Society and RQAP-GLP certification through the Society of Quality Assurance.
JJ Wilson, Optimi Board Chair, notes, “We were very pleased when the IMPACT team presented John as the expert to assist in managing our path through these particularly critical aspects of our strategic plan. To credibly work towards a successful commercial future for psychedelics, we have to align our efforts to meet the standards of both the FDA and Health Canada. With John’s participation, we have significantly upped our game and ability to participate in a much larger arena. Our ultimate goals are for the betterment of mental health and human optimization around the world, and today is an important step forward in meeting that expectation.”
On Behalf of the Board of Directors,
Optimi Health Corp.
Mike Stier
President, Chief Executive Officer and Director
ABOUT OPTIMI (CSE: OPTI) (OTC: OPTHF) (FRA: 8BN)
Optimi is developing a sophisticated mushroom brand that focuses on the health and wellness markets. With a vertically integrated approach, Optimi intends to cultivate, extract, process and distribute high quality functional mushroom products at its two facilities comprising a total of 20,000 square feet nearing completion in Princeton, British Columbia. To fully investigate the science of mushrooms, the Company has received a research exemption under Health Canada Food and Drug Regulations (FDR) for the use of Psilocybin and Psilocin for scientific purposes via its wholly owned subsidiary Optimi Labs Inc. Optimi has also applied for a dealer’s license under Canada’s Narcotic Control Regulations governing possession, distribution, sale, laboratory analysis of and research and development of Psilocybin and Psilocin formulations. Optimi is committed to expert cultivation and quality production subject to and in accordance with the terms of all applicable laws and governing regulations to ensure safe, superior Canadian fungi production. Find out more at: https://optimihealth.ca/.
FOR FURTHER INFORMATION CONTACT:
Investor Relations
Email: investors@optimihealth.ca
Phone: +1 (778) 930-1321
Web: https://optimihealth.ca/
FORWARD‐LOOKING STATEMENTS
This news release contains forward‐looking statements and forward‐looking information within the meaning of Canadian securities legislation (collectively, "forward‐looking statements") that relate to Optimi’s current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as "will likely result," "are expected to," "expects," "will continue," "is anticipated," "anticipates," "believes," "estimated," "intends," "plans," "forecast," "projection," "strategy," "objective," and "outlook") are not historical facts and may be forward‐looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward‐looking statements. No assurance can be given that these expectations will prove to be correct and such forward‐looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release. In particular and without limitation, this news release contains forward‐ looking statements pertaining to the Company’s potential Nasdaq listing, the dealer’s license application, activities proposed to be conducted under the Company’s research exemption and associated business related to Psilocybin and Psilocin and Optimi’s plans, focus and objectives.
Forward‐looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi’s control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward‐looking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID‐19 pandemic and other factors set forth under “Forward‐Looking Statements" and “Risk Factors” in the Company’s Final Prospectus dated February 12, 2021. Optimi undertakes no obligation to update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward‐looking statement. Any forward‐looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.
The CSE does not accept responsibility for the adequacy or accuracy of this release.
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