PsyBio Therapeutics appoints Dr Michael Spigarelli as chief medical officer to lead ongoing development of its drug discovery platform technology

He will provide PsyBio with decades of clinical product development experience, including clinical trial design and execution, data analytics and presentation, regulatory approval, and quality control

Psybio Therapeutics - PsyBio Therapeutics Corp appoints Dr Michael Spigarelli as chief medical officer to lead the ongoing development its drug discovery platform technology
Before joining PsyBio, Dr Spigarelli served as chief medical officer for Lumen Bioscience

PsyBio Therapeutics Corp (CVE:PSYB) announced Monday the appointment of Dr Michael Spigarelli as chief medical officer to lead the ongoing development of the company’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, the company said in a statement.

He 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.

READ: PsyBio Therapeutics starts process development of its biosynthetic formulation of norbaeocystin, an analogue of psilocybin

“In this new role, Dr. Spigarelli will provide leadership and insight into clinical operations, research and development, regulatory and quality affairs and program management to lead product development of new psychoactive therapies,” said CEO Evan Levine.

“Mike’s unique combination of skills, from treatment to therapeutic device and diagnostic product development, including numerous US Food and Drug Administration 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.”

Dr Spigarelli added: “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. 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.”

Before joining PsyBio Therapeutics, Dr Spigarelli served as chief medical officer for Lumen Bioscience. Prior to that, he served as vice president of medical affairs for Immucor Inc. During that time, he helped develop strategy and obtain FDA as well as global regulatory approval for numerous assays and reagents.

In connection with the appointment of Dr Spigarelli, the board of directors has agreed to grant him stock options to purchase up to 2 million subordinate voting shares. The options are exercisable at $0.35 each for a period of three years from the date of issuance.

Contact the author: patrick@proactiveinvestors.com

Follow him on Twitter @PatrickMGraham