FSD Pharma (CSE:HUGE, NASDAQ:HUGE) Inc said it has formed a regulatory advisory board and appointed Dr Joga Gobburu and Dr Mary Melnyk as members.
The Toronto-based company said that the regulatory board was formed by Lakshmi P. Kotra, CEO of FSD Pharma (CSE:HUGE, NASDAQ:HUGE)’s subsidiary Lucid Psycheceuticals.
“We are thrilled to welcome Drs. Gobburu and Melnyk as members of our recently established board and are looking forward to applying their combined expertise in global quality and regulatory systems as we advance our drug candidates toward the clinic to serve global markets,” said Kotra in a statement.
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Dr Gobburu is a professor at the School of Pharmacy and the School of Medicine, University of Maryland, Baltimore. Between 1998 and 2011, he held various positions at the US Food and Drug Administration (FDA), most recently as director of the division of pharmacometrics and office of clinical pharmacology.
He has led the review of thousands of investigational new drug (IND) applications, more than three hundred new drug and biological licensing applications, numerous FDA drug approvals, labeling guidelines, and policies.
Dr Gobburu has received several FDA awards, including the 2001 Outstanding Achievement Award, and was recognized with the Senior Biomedical Research Scientist appointment in 2007.
“FSD Pharma (CSE:HUGE, NASDAQ:HUGE) has a world-class team of scientists in the area of neurology and inflammation. I look forward to supporting their development program and applying my regulatory expertise to bring their innovative assets to market,” Dr Gobburu said.
The other board member, Dr Melnyk, is an expert in manufacturing and regulatory requirements for pharmaceutical and medical device development. She is currently the senior regulatory consultant at Innovalinks, a consulting firm serving the pharmaceutical industry in the quality and regulatory systems, process transfer, and validation and scale-up.
Dr Melnyk also led the scale-up and licensure of numerous biological products in global markets, including the Salk Polio and component pertussis vaccines. In addition to designing quality systems and medical devices, she oversaw global regulatory approvals of medical devices, natural health products, and medicinal products in the US, Canada, Australia, and the EU, with numerous successful applications.
FSD Pharma is a life sciences holding company with two wholly-owned subsidiaries dedicated to building a portfolio of diversified therapeutic assets and innovative healthcare and biotech services.
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