Michael Gold, Chief R&D Officer at Compass Pathways

🧠 Mastering Clinical Operations in Psychedelic Trials

Clinical R&D Leadership in Psychedelics | Power to the Patients

🎙️ Guest: Dr. Michael Gold, Chief R&D Officer at Compass Pathways

“The best designed clinical trial, if it’s not executed correctly, is useless. Execution is part of our moral contract with patients.”

👋 Episode Overview

In this episode, Dr. Michael Gold, Chief R&D Officer at Compass Pathways, shares his nearly 30 years of experience in neuroscience R&D, spanning roles at global pharma leaders and small biotech startups. He discusses what it takes to run rigorous, patient-centered clinical trials in the emerging psychedelic medicine space, where execution and integrity are as critical as design.

🧭 Top Takeaways

• ✅ Quality > speed > cost — a trial’s integrity can’t be compromised
• ✅ Pressure test designs early and remain vigilant with real-time data monitoring
• ✅ Simplify protocols to reduce participant burden and improve data reliability

🔑 Key Topics Covered

1. Guest Background

• 30 years in neuroscience drug development
• Roles across pharma giants (J&J, GSK) and small biotech startups
• Now leading R&D at Compass Pathways in psychedelic medicine

2. The Problem They’re Solving

• Poorly executed clinical trials waste data, resources, and participant trust
• Small biotechs cannot afford mistakes—quality must be right the first time

3. Their Innovation or Contribution

• Advocating for obsessive vigilance over trial data in real time
• Designing “dream dashboards” to monitor recruitment, retention, missing data, and safety signals continuously
• Pragmatic trial design—removing unnecessary data collection and focusing only on what informs critical outcomes

4. Challenges & Barriers

• Operational silos between CROs, sponsors, and sites
• Interoperability and data-sharing hurdles across platforms
• Industry reluctance to publish operational learnings, limiting shared wisdom

5. Vision for the Future

• Greater adoption of wearables and digital tools for ecologically valid, unobtrusive data collection
• Regulatory bodies as collaborators, not adversaries—encouraging early engagement with the FDA
• More representative patient populations through realistic inclusion criteria (e.g., allowing comorbidities in PTSD studies)

💬 Speaker Spotlights

On the integrity of trials:

“It’s part of the social contract. Patients give us their time and trust. The least we can do is ensure the data are high quality and meaningful.”

On small biotech constraints:

“Biotech doesn’t have the luxury of doing a trial twice. Quality is even more critical when resources are scarce.”

On simplifying protocols:

“If it’s a nice-to-have, get rid of it. Keep what’s critical and stand behind it.”

On regulators:

“What’s overrated is people’s fear of the FDA. They’re not the boogeyman—engage them, they often have the broadest perspective.”

On patients:

“At the end of the day, it’s about doing it for patients. Even if a trial fails, we must walk away knowing we ran it with integrity.”

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💡 Keep Exploring

• Subscribe to Power to the Patients
• Follow: Michael Gold on LinkedIn
• Related episodes:
  
  • Matthew Leoni on Navigating the Challenges in Neuro Drug Development
  • Anthony Yanni on the Framework of Patient Centricity

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