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. 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.
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.
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. 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. 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.
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.
