Drug Development – 3 Phase Approach


Research & Development

Dr. Lekos oversees Research and Development (R&D) alongside Dr. Kang to lead exploration of Intellectual Property (IP) formulations for APEX’s synthetic drug product APEX-002 used in upcoming clinical trials and medical access. Dr. Lekos and Alex Winstead will head further R&D projects on genetics, extraction and formulation of botanical psilocybin products for clinical trials.


Clinical Trial Planning

Dr. Tomlinson, Dr. Wood and Dana Nohynek will oversee regulatory efforts and manage the Clinical Trial Application (CTA) and Investigational New Drug Application (IND) for all clinical trials with help from the Clinical Research Organization (CRO) JSS Medical Research will support the clinical trials as a private CRO by auditing target clinical sites and assisting with monitoring and data management.


Clinical Trial Execution

Dr. Rampakakis and Dr. Tomlinson combined clinical and GMP expertise will allow APEX to develop, protect and commercialize drug products manufactured under GMP standards. A minimum of two different drug products are planned for clinical trials - one with psilocybin as an API and another with a botanical extract of psilocybin. Other tryptamines and beta carbolines are also being evaluated.

Patient Recruitment & Access Channels

APEX is working with JSS Research to further identify how Veterans can benefit from medical access and psychedelic-supported psychotherapy based on clinical evidence.


APEX’s Veteran-focused research team will be studying PTSD, treatment resistant depression, traumatic brain injury and chronic pain in the Canadian and American Veteran communities. We believe in a whole-person approach to recovery for Veterans who suffer from chronic service-related conditions with patient support from over 5,000 Veteran patients.

Exemptions & SAP

Currently Health Canada allows psilocybin access to patients through two avenues outside of clinical trials, subsection 56(1) exemptions and the recently revised Special Access Program (SAP). With Therapsil’s assistance, APEX has filed subsection 56(1) exemptions for Veterans to access psilocybin for therapeutic benefit where other treatments have failed. APEX believes that the SAP will provide an additional path to medical access in specific cases.

Special Access Program

On March 21st, 2022, Dr. Valorie Masuda MD received authorization under the Special Access Program (SAP) to treat six patients experiencing end-of-life distress with psilocybin and psychotherapy. GMP synthetic psilocybin was donated by Psygen Labs Inc., and Apex Labs Ltd. provided access to its psilocybin investigators’ brochure, in support of the SAP application. This is the first known case of psilocybin being accessed through Canada’s SAP since the Food and Drug Regulations were amended on January 5th, 2022, to allow access to psilocybin and other restricted drugs through the SAP. The six patients were treated in early April of 2022 by Roots to Thrive, co-led by Dr. Masuda.

This is the first legal medical access to psilocybin outside of a clinical trial in Canadian history.