PsyBio Appoints Dr. Michael Spigarelli as Chief Medical Officer
Dr. Spigarelli’s extensive clinical and research development expertise will be integral in leading PsyBio’s development and clinical goals
PsyBio Therapeutics Corp.(CVE: PSYB), a biotechnology company pioneering the next generation of targeted psychoactive medications, today announced the appointment of Michael Spigarelli, M.D., Ph.D., MBA, as Chief Medical Officer to lead the ongoing development of PsyBio’s drug discovery platform technology. Dr. Spigarelli brings his extensive expertise in research and development of biopharmaceuticals including the clinical and regulatory strategy for numerous mental health therapeutics and other conditions. Dr. Spigarelli will provide PsyBio with decades of clinical product development experience, including clinical trial design and execution, data analytics and presentation, regulatory approval, quality control and GXP project management.
In this new role, Dr. Spigarelli will provide leadership and insight into clinical operations, research & development, regulatory and quality affairs and program management to lead product development of new psychoactive therapies. Mike’s unique combination of skills, from treatment to therapeutic device and diagnostic product development, including numerous U.S. Food and Drug Administration (the “FDA”) and global regulatory approvals, will be critical for compiling pre-clinical data and clinical trial designs for IND submissions. We are excited to leverage his experience and demonstrate the full potential of our portfolio of psychoactive candidates as we move our products into clinical trials.Evan Levine, Chief Executive Officer of PsyBio
“What excites me is the unique position PsyBio is in to potentially develop numerous, novel, and clinically-needed solutions for individuals and their families suffering from a variety of mental health conditions,” stated Michael Spigarelli. “I am eager to lead the Company’s development and advance its strong pipeline of products through clinical development into human studies and, subject to receipt of all necessary approvals, onto the global markets. Such products will be studied to determine the potential efficacy to positively impact patients lives by better managing their mental health conditions.”
In connection with the appointment of Dr. Spigarelli as Chief Medical Officer of the Company, the board of directors of the Company has approved the granting of options to Dr. Spigarelli to purchase up to two million subordinate voting shares in the capital of the Company, pursuant to the Company’s stock option plan. The options are exercisable at a price of $0.35 per share for a period of three years from the date of issuance.
About Dr. Michael Spigarelli
Before joining PsyBio Therapeutics, Dr. Spigarelli served as Chief Medical Officer for Lumen Bioscience, a clinical-stage biopharmaceutical company developing biologic drugs for highly prevalent diseases. Prior to that, he served as Vice President of Medical Affairs for Immucor, Inc., a leading provider of transfusion and transplantation diagnostic products worldwide. During that time, he helped develop strategy and obtain FDA as well as global regulatory approval for numerous assays and reagents including monoclonal and polyclonal antibodies and has led assay development, clinical affairs, program management and regulatory & quality affairs with extensive experience in the U.S., EU and global product development and regulatory approval. Dr. Spigarelli previously served as Chair of the American Board of Clinical Pharmacology and worked directly with numerous late stage drug development companies on clinical trial design, site selection, KOL relationships, pharmacogenomics, pharmacometrics, pharmacology, due diligence evaluations and regulatory strategies. He began his career in academia, reaching the rank of Professor of Pediatrics, Internal Medicine and Pharmaceutics & Therapeutics having worked at several major universities developing infrastructure to improve clinical research and industrial partnership. Dr. Spigarelli received his MBA from the University of Utah, both his Ph.D. in Medicinal Chemistry, and his M.D. with distinction in research from the University of Michigan in Ann Arbor.
About PsyBio Therapeutics Corp.
PsyBio is a biotechnology company developing novel formulations of psychoactive medications produced by genetically modified bacteria for the treatment of mental health and other disorders. The team has experience in drug discovery based on synthetic biology as well as clinical and regulatory experience moving drugs through human studies and regulatory protocols. Research and development is currently ongoing for naturally occurring psychoactive tryptamines originally discovered in different varieties of halucinogenic mushrooms, other tryptamines and phenethylamines and combinations thereof. The Company is also researching and developing new non-naturally occurring molecular structures which may have unique therapeutics properties.
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