Site Feasibility & Sponsor Business Development
Assess readiness, position the site, and support sponsor feasibility conversations.
The site activation partner for psychedelic and psychoactive clinical trials.
Build the regulatory, DEA, and operational readiness sponsors need - before gaps become activation delays.
01
Feasibility
Month 002
Schedule I Licensure
Months 1–1203
SOPs & Dosing Room
Months 2–604
Staff Training
Months 3–905
Site Evaluation Visit
Months 9–18Federal policy is shifting in favor of psychedelic medicine. The FDA is actively prioritizing it. Dozens of drug development sponsors are running trials right now, and they are looking for sites that are ready.
The challenge is that readiness takes time. Most sites need nine to eighteen months to achieve DEA Schedule I licensure, train staff, and develop the standard operating procedures a psychedelic protocol demands. Sites that start early - with a knowledgeable guide supporting them - get selected. Sites that wait don’t.
That’s where Pharmaka comes in.
End-to-end site activation, in the order it actually happens.
Five coordinated workstreams move from feasibility through sponsor readiness, sequenced around the actual critical path of site activation.
DEA Schedule I Licensure
Prepare the application, security plan, controlled-substance storage, and inspection readiness.
Psychedelic-Specific SOPs
Build the operating procedures required for drug handling, dosing rooms, and patient monitoring.
Staff Training & Facilitator Network
Prepare clinical staff for protocol demands and support facilitator recruitment and credentialing.
Site Evaluation Visit Preparation
Run readiness checks, review documentation, and support sponsor site evaluation visits.
Engagement structure
One coordinated engagement around the workstreams.
Retainer plus milestone-based pricing, with a defined scope and a study contingency clause if a qualifying study cannot be sourced.
Kevin Lanzo, PharmD
A career built at the intersection of late-stage pharmaceutical development and psychedelic clinical research.
Kevin spent five years at Roche/Genentech in late-stage clinical development, working on the clinical strategy for novel psychiatric medications - including investigational psychedelics and psychoplastogens. He founded Pharmaka to help established research sites participate in the emerging psychedelic Phase III landscape.
Prior
Clinical Scientist, Roche / Genentech - Late-Stage Neuroscience & Psychiatry
Currently
Executive in Residence, Lionheart Ventures
Founding Role
Co-founder & past president, Psychedelic Pharmacists Association
Industry
Active contributor to industry working groups on psychedelic clinical trial standards
Professional memberships
Connected to the clinical psychopharmacology, CNS trials, and psychedelic pharmacy communities.
Kevin’s professional affiliations span clinical psychopharmacology, CNS clinical trials methodology, and psychedelic pharmacy.
American Society of Clinical Psychopharmacology
International Society for CNS Clinical Trials and Methodology
Psychedelic Pharmacists Association
What collaborators say
Experienced support when clinical and regulatory readiness gets real.
Kevin was a huge help as we prepared our clinic for a psychedelic-assisted therapy trial. He supported our feasibility response and Controlled Substances SOPs, reviewed our security setup, and led a mock DEA inspection that left our team much more confident in scheduled drug handling and regulatory requirements. He was thoughtful, knowledgeable, and easy to collaborate with throughout.
Zakariya Al-Sarraf, MB ChB
Medical Doctor · Clinical Trials Manager - Alzheimer’s Disease and CNS Research
Kevin is a passionate, well-spoken, and thoughtful leader in the growing psychedelic landscape. His ability to drive complex projects to completion while staying tapped into the evolving ecosystem, regulatory requirements, and shifting science speaks to the immense value he brings to any operation. He’s accountable, intentional, and genuinely cares about the work - exactly the kind of partner you want in the room when readiness has to be real.
Sa’ed Al-Olimat, PharmD
Doctor of Pharmacy · Healthcare Growth & Commercial Strategy - Life Sciences & Emerging Therapeutics
We work best with sites that already have the clinical foundation.
Pharmaka accelerates activation for research sites with an established psychiatric trial history. The strongest engagements begin with these ingredients already in place.
- 01Phase III psychiatric trial historyMDD, GAD, bipolar, schizophrenia, PTSD, or a comparable mental-health indication.
- 02Board-certified psychiatrist or clinical neuroscience PI on staff
- 03Raters experienced with standard mental-health assessmentsMADRS, CAPS-V, HAM-A, and comparable instruments.
- 04Existing DEA-registered controlled substance handlingAny schedule - nice to have but not required.
- 05Infrastructure that supports a low-stimulation dosing roomNearby or, ideally, a directly connected private bathroom.
Kevin in the field.
FDA’s Multifaceted Role On Display In MDMA Therapy Scrutiny
Expert analysis on psychedelic regulation, co-written with Kimberly Chew, JD.
Read the PDFThe Psychedelic Pharmacists Association’s Push to Define the Pharmacist’s Role
Interview coverage of the PPA’s mission in psychedelic-assisted therapy.
Read on Pharmacy TimesLSD D-Tartrate Receives Breakthrough Therapy Designation for GAD
Commentary on the FDA’s Breakthrough Therapy designation for MM120.
Read on Pharmacy TimesPharmacy Focus: World Psychedelics Day
Podcast conversation on the pharmacist’s role in psychedelic care.
ListenWhere does your site stand?
A focused conversation to review your current readiness, discuss your goals, and determine whether Pharmaka is the right fit for the road ahead.