The company is ramping up for the Phase 3 trial of CYB003, its proprietary deuterated psilocin program in development for the adjunctive treatment of MDD.
Cybin announced that it has expanded its clinical operations team with the appointment of two senior executives as well as two program leads.
The company said it has hired Dr. Mirza Rahman as senior vice president, patient safety & pharmacovigilance, and Dr. Marcelo Gutierrez as vice president, clinical pharmacology.
Cybin made the additions to its senior clinical team as the company ramps up for the Phase 3 trial of CYB003, its proprietary deuterated psilocin program in development for the adjunctive treatment of MDD.
Previously, Cybin announced the hiring of experienced drug-development leaders Dr. Atul Mahableshwarkar, and Tom Macek, as program leads for CYB003 and CYB004, respectively.
Cybin CEO Doug Drysdale asserted that Rahman’s “expertise in patient safety and pharmacovigilance” and 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,” Drysdale added. “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.”
Dr. Mirza Rahman, M.D., M.P.H., FACPM
Rahman has more than 25 years of experience in the pharmaceutical industry, primarily in pharmacovigilance, but also in clinical development, medical affairs, pharmacoeconomics, manufacturing and regulatory affairs, according to Cybin.
Previously, Rahman served in leadership positions at global healthcare companies including Organon and Otsuka Pharmaceuticals, where he played an integral role in leading pharmacovigilance strategy and prioritizing patient safety.
Rahman is board-certified in public health & 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.
Dr. Marcelo Gutierrez, Ph.D.
Gutierrez has extensive experience leading clinical pharmacology programs across central nervous system and other therapeutic areas.
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 centers of excellence and successfully contributed to bringing four drugs through NDA submission and approval.
Dr. Atul Mahableshwarkar M.D., DLFAPA
Mahableshwarkar, who is leading the CYB003 program, is a board-certified psychiatrist and accomplished drug-development executive with experience in both large global and small startup pharmaceutical companies. He brings varied experiences from academia and industry as a site principal investigator for industry-sponsored studies and has submitted several INDs and NDAs leading to drug approvals, according to Cybin.
Dr. Tom Macek, Pharm.D., Ph.D.
Macek is leading the CYB004 program, Cybin’s proprietary deuterated DMT program in development for the treatment of Generalized Anxiety Disorder.
Macek brings decades of pharmaceutical industry experience in new-drug development across all phases of research (pre-IND to post-approval) across diverse treatment modalities and has submitted or supported several INDs and NDAs/BLAs leading to drug approvals, according to Cybin.