We help small to medium life science companies launch novel psychoactive therapies.
Pharmaka Clinical Consulting
Our mission is to provide expert consulting services that adhere to regulatory standards, foster innovation, and drive growth for emerging biotech companies in the neuropsychiatry industry.
The landscape of treatments for mental health disorders is rapidly evolving, and new approaches present complex scientific, regulatory, and ethical challenges.
With world-class expertise in psychedelic drug development, we combine the best of traditional and innovative approaches to psychiatric clinical research.
Our Services
Clinical Trial and Regulatory Roadmaps
Guidance on navigating the complex regulatory landscape for neuropsychiatric medicines, including:
Pre-IND consultations
IND preparation
Clinical development plan design
Phase I, II, and III clinical trial design
Commercialization & post-marketing strategy
Business Strategy and Market Research
Support for businesses entering the neuropsychiatric and psychedelic medicine space, including:
Market analysis
Competitive intelligence
Business model development
Partnership strategies
Fundraising guidance
Regulatory compliance for scheduled drug storage
Clinical Guidance and Healthcare Integration
Development of frameworks and clinical protocols for the integration of psychedelic therapies into clinical practice, addressing:
Patient safety
Informed consent
Therapist training
Equitable access
Culturally-relevant messaging for Healthcare Professionals
Founder & CEO
Kevin Lanzo, PharmD
Kevin Lanzo is a pharmacist, clinical scientist, and consultant specializing in researching the clinical effects of psychoactive medicines.
As President of Pharmaka Clinical Consulting LLC, Kevin supports the development of novel psychiatric treatments for mental health disorders. He brings five years of pharmaceutical industry experience at the renowned global pharmaceutical company Roche/Genentech, where he worked in late-stage clinical development. Kevin also completed a postdoctoral pharmaceutical industry fellowship with Rutgers University.
During his tenure at Genentech, Kevin investigated the potential of psychedelics and psychoplastogens as novel psychiatric medications. His roles included clinical development planning, business development and partnership strategies, and education and advocacy.
Kevin is also a co-founder and past president of the Psychedelic Pharmacists Association, a non-profit professional association. As a pharmacist, he advocates for the value of the pharmacy profession as drug experts and for the cost-effective and sustainable rollout of effective psychiatric medicines.
Our goal is to communicate clearly and effectively, using terminology that is both accurate and appropriate for the specific context.
We embrace terms like psychoplastogens to highlight the neuroplasticity-enhancing properties of novel compounds and our commitment to understanding their mechanisms of action.
News & Resources
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FDA's Multifaceted Role On Display In MDMA Therapy Scrutiny
July 23, 2024
Expert Analysis: Psychedelic Regulation
Co-written by Kevin Lanzo, PharmD, and Kimberly Chew, JD -
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Psychedelic Pharmacists Association Is Working to Promote, Establish the Role of the Pharmacist in Psychedelic-Assisted Therapy
January 17, 2024
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LSD D-Tartrate Receives Breakthrough Therapy Designation From FDA for Generalized Anxiety Disorder
March 15, 2024
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Pharmacy Focus: World Psychedelics Day
June 14, 2024
Let’s Connect
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