Mr. Gabriel Fahel reports
CYBIN EXPANDS CLINICAL TEAM TO SUPPORT CYB003 PHASE 3 PROGRAM
Cybin Inc. has appointed senior clinical team leaders Dr. Mirza Rahman as senior vice-president, patient safety and pharmacovigilance, and Dr. Marcelo Gutierrez as vice-president, clinical pharmacology, and the company has expanded its clinical operations team.
These additions have been made in preparation for the commencement of Cybin's phase 3 pivotal trial of CYB003, its proprietary deuterated psilocin program in development for the adjunctive treatment of MDD. Previously, the company announced the hiring of experienced drug development leaders Dr. Atul R. Mahableshwarkar and Dr. Tom Macek as program leads for CYB003 and CYB004, respectively. Together, the team provides significant expertise and decades of experience across critical domains that are integral to the company's upcoming pivotal program.
"As we stand ready to commence our phase 3 pivotal trial of CYB003, we are pleased to welcome these talented and experienced industry leaders to our clinical development team," said Doug Drysdale, chief executive officer of Cybin. "Dr. Mirza Rahman's expertise in patient safety and pharmacovigilance and Dr. Marcelo Gutierrez's proven track record of delivering clinical pharmacology packages for advancing drugs through the regulatory process will be instrumental to our efforts. These seasoned industry leaders, as well as the other additions to our clinical operations team, bring a wealth of knowledge and experience around mental health disorders and will further bolster our internal capabilities, pharmacovigilance and chemistry, manufacturing and controls management. As we advance to our phase 3 program, which consists of three studies across 12 different countries, we look forward to benefiting from the guidance and operational experience of Cybin's newest team members," concluded Mr. Drysdale.
Cybin has strengthened its clinical and R&D (research and development) team with the recent addition of senior team members:
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Dr. Rahman, MD, MPH, FACPM, senior vice-president, patient safety and pharmacovigilance: Dr. Rahman has over 25 years of experience in the pharmaceutical industry, primarily in Pharmacovigilance, but also in clinical development, medical affairs, pharmacoeconomics, manufacturing and regulatory affairs. Previously, Dr. Rahman served in leadership positions at global health care companies including Organon and Otsuka Pharmaceuticals, where he played an integral role in leading pharmacovigilance strategy and prioritizing patient safety. Dr. Rahman is board-certified in public health and general preventive medicine and serves as the president of the American College of Preventive Medicine. In addition, he is an adjunct associate professor at both Columbia University and the University of Guyana.
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Dr. Gutierrez, PhD, vice-president, clinical pharmacology: Dr. Gutierrez has extensive experience leading clinical pharmacology programs across central nervous system (CNS) and other therapeutic areas. Dr. Gutierrez previously held leadership positions in the field of clinical pharmacology and global health at various pharmaceutical companies, including Forest Research Institute, Actelion Pharmaceuticals, Novartis and Amylyx, where he led the creation of several clinical pharmacology centres of excellence and successfully contributed to bringing four drugs through NDA submission and approval.
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Atul R. Mahableshwarkar, MD, DLFAPA, senior vice-president, clinical development: Dr. Mahableshwarkar is leading the CYB003 program, Cybin's proprietary deuterated psilocybin analog program in development for the adjunctive treatment of MDD. Dr. Mahableshwarkar is a board-certified psychiatrist and accomplished drug development executive with experience in both large global and small start-up pharmaceutical companies. He brings varied experiences from academia and industry as a site principal investigator for industry-sponsored studies and has submitted several INDs (investigational new drugs) and NDAs (non-disclosure agreements) leading to drug approvals.
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Dr. Tom Macek, PharmD, PhD, senior vice-president, clinical development: Dr. Macek is leading the CYB004 program, Cybin's proprietary deuterated DMT program in development for the treatment of generalized anxiety disorder. Dr. Macek brings decades of pharmaceutical industry experience in new drug development across all phases of research (pre-IND to postapproval) across diverse treatment modalities and has submitted or supported several INDs and NDAs/BLAs leading to drug approvals.
About Cybin
Inc.
Cybin is a late-stage breakthrough neuropsychiatry company committed to revolutionizing mental health care by developing new and innovative next-generation treatment options to address the large unmet need for people who suffer from mental health conditions.
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