🧠 Inside Clinical Operations: Lessons from Annovis

Building Trials in Alzheimer’s & Neurology | Power to the Patients Podcast

🎙️ Guests: Sarah MacCallum & Melissa Gaines, Clinical Operations Leaders at Annovis

“Great clinical operations isn’t about a perfect trial with no problems. It’s about expecting road bumps—and building systems and teams strong enough to overcome them.” – Melissa Gaines

👋 Episode Overview

In this episode, we sit down with Melissa Gaines, Senior VP of Clinical Operations, and Sarah MacCallum, Director of Clinical Operations  at Annovis Bio. Together, they share their journeys into clinical research, their approach to running best-in-class neurology trials, and the unique challenges of working in Alzheimer’s disease.

🧭 Top Takeaways

• ✅ Expect speed bumps—success comes from preparation, not perfection.
• ✅ The right site partners make or break a study.
• ✅ Site engagement must be proactive and continuous.
• ✅ Alzheimer’s research brings both scientific and deeply human challenges.
• ✅ ClinOps leaders thrive by embracing chaos and making decisions with confidence.

🔑 Key Topics Covered

1. Guest Background

• Melissa: 25+ years in CNS clinical research, spanning pharma, CRO, and now biotech leadership.
• Sarah: From nursing to clinical research, with site, CRO, and sponsor-side experience.

2. The Problem They’re Solving

• Running complex neurology and Alzheimer’s trials where patients are highly vulnerable.
• Navigating logistical hurdles like study partner requirements, supply chain issues, and site startup delays.

3. Their Innovation or Contribution

• Risk-management mindset: expecting problems but ensuring they don’t derail trials.
• Site-centric approach: rigorous vetting, empowering CRAs, and investing in long-term site relationships.
• Engagement strategy: adding a dedicated site engagement lead to keep momentum high.

4. Challenges & Barriers

• Broken “telephone” of communication between sponsors, CROs, and sites.
• Contracting timelines that delay startup.
• Emotional difficulty in Alzheimer’s studies when patients are deemed ineligible due to disease stage.

5. Vision for the Future

• Building empowered teams that can make decisions in real time.
• Leveraging long-term relationships across CNS to accelerate trial success.
• Creating systems that respect both patients and their study partners as equal contributors.

💬 Speaker Spotlights

On what great clinical operations really looks like:
“Not a perfect trial, but one where problems are identified and solved quickly so patients can get the treatments they need.” – Melissa Gaines

On teamwork and empowerment:
“Great clinical operations looks like leadership that empowers people to make decisions.” – Sarah MacCallum

On site selection:
“Choosing the right partners at startup is the biggest win—or loss—you can make.” – Sarah MacCallum

🎧 Listen to the Full Episode

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💡 Keep Exploring

• Subscribe to Power to the Patients for more conversations at the intersection of clinical trials and patient impact.
• Learn more about Annovis Bio’s work in Alzheimer’s and neurodegenerative disease.

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