Clinical trial methodology and human relationships are the cornerstones of successful drug development, particularly in psychiatry and neuroscience research.

In this episode of Power to the Patients, host Brandon Li speaks with Dr. Steve Brannan, Chief Medical Officer of Karuna Therapeutics (recently acquired by Bristol Myers Squibb), about the art and science of running successful clinical trials, particularly in psychiatry, and the future of precision medicine in mental health.

- How to build trust-based relationships with research sites to ensure high-quality trial execution

- Why the "right pace" principle in clinical trials matters more than speed

- The framework for detecting and preventing fraudulent trial participants through data monitoring

- How digital biomarkers and AI are reshaping psychiatric clinical trials

- Why successful trial execution depends on balancing hard metrics with "soft touch" site management

- How neuroplasticity-based treatments are changing the paradigm for psychiatric drug development

- The importance of looking beyond traditional biomarkers to digital precision measures in psychiatry

- Why clinical operations excellence is often the overlooked key to trial success

- The emerging role of ecological momentary assessment in capturing real-world patient data

- How to maintain trial quality while scaling across multiple research sites

Dr. Steve Brannan is the Chief Medical Officer of Karuna Therapeutics, recently acquired by Bristol Myers Squibb, where he played a pivotal role in developing the first new-mechanism schizophrenia drug in decades. With extensive experience as a psychiatrist and clinical researcher, Dr. Brannan has held leadership positions at major pharmaceutical companies including Eli Lilly, Cyberonics, Novartis, and Takeda. His expertise spans clinical trial methodology, neuroimaging, and psychiatric drug development, having been instrumental in bringing several successful medications to market. In this episode, Dr. Brannan shares invaluable insights on clinical trial optimization, the evolution of precision psychiatry, and the critical importance of clinical operations excellence in drug development. His work at Karuna Therapeutics, where he was employee number two, culminated in the successful development and FDA approval of a groundbreaking schizophrenia treatment, demonstrating his deep understanding of both the scientific and operational aspects of psychiatric drug development.

00:00 Intro: Leading Innovation in Psychiatric Drug Development

04:01 The Story Behind Karuna's Breakthrough Schizophrenia Drug

11:23 Navigating Big Pharma vs Biotech: Lessons from Both Worlds 

17:12 The Art of Managing Trial Variance in Psychiatry

26:29 Building Trust Through "Soft Touch" Site Management

37:56 The Promise of Digital Biomarkers in Psychiatric Trials 

46:52 AI's Role in Clinical Development: Opportunities and Limitations

49:47 Neuroplasticity and the Future of Psychiatric Medicine

56:37 Clinical Operations: The Unsung Heroes of Trial Success

Episode Resources: