Much of the costs associated with developing new drug compounds stems from the costs of designing and managing multiple large clinical trials involving hundreds or even thousands of patients and dozens of qualified clinicians.
The process begins with preclinical studies,
followed by initial safety studies (Phase 1),
initial proof of concept studies (Phase 2),
and finally, large, well-designed
efficacy studies (Phase 3).
PsiloTec’s approach is expected to reduce the timelines, costs and issues that typically
arise from the clinical trial process.
PsiloTec’s in-house team has combined experience with over 300 clinical studies.
This expertise will enable us to reduce the risks, costs, and time
required to complete our clinical trials.
PsiloTec will also utilize the latest clinical trial design and technology, complemented by our management skill-sets in such areas as computational psychiatry and artificial intelligence,
to support our goals. This valuable expertise will provide a robust body of clinical trial
evidence to support and advance the development of PsiloTec’s
compounds to the commercial marketplace.
We are confident that PsiloTec’s highly experienced clinical team and our innovative
approach to drug development will allow us to more rapidly and cost-effectively
develop novel IP-protected products.
We intend to manage our trials with a focus on IP-achievable compounds and processes,
thereby distinguishing PsiloTec from other players in the emerging psychedelics sector,
and we believe our on-site lab expertise and partnerships with
post-secondary institutions will also prove to be invaluable as we
begin our march toward commercial profitability.