Denis Katz, MD
From a regulatory standpoint, this isn't just interesting it's a problem. Agencies evaluate drug products. They don't regulate psychotherapy.
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Salience Clinical Consulting
Psilocybin is almost never given in isolation. Most clinical protocols include extensive preparation sessions before dosing, six to eight hours of supported monitoring during the session itself, and multiple integration sessions afterward.
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Denis Katz Medical Affairs
Most organizations start with something genuinely promising a strong hypothesis, a compelling mechanism, an innovative platform. The misalignment creeps in later, as that science moves toward regulatory review.
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Salience Clinical, LLC
The FDA's 2024 non-approval of MDMA-assisted therapy was a hard lesson. Methodological weaknesses don't get overlooked just because the science feels compelling or the patient need is real.
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Salience Clinical, LLC
Over the course of my career, I've participated in and advised development programs across pharmaceuticals, biologics, regenerative medicine, diagnostics, neuroscience and many other therapeutic areas. One pattern keeps showing up regardless of the therapeutic area.
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