Welcome to Mind the Methods, the official podcast of the International Society for CNS Clinical Trials and Methodology (ISCTM). We are your gateway to the latest insights, innovations, and conversations at the forefront of central nervous system clinical research.
Our series dives deep into the science and strategy behind CNS research, bringing together a global community of researchers, clinicians, regulators, and industry leaders. We explore the critical challenges and breakthroughs shaping the future of therapeutics development, with a dedicated focus on advancing trial methodology and improving patient outcomes.
Accelerating CNS Drug Development Using Biomarkers
In this episode of Mind the Methods (the ICTM podcast), Dr. Kemi Olugemo, ISCTM Scientific Committee member and consulting Chief Medical Officer at Junevity, and Dr. Siân Ratcliffe Smethurst, ISCTM President-Elect and Chief Operating Officer of Premier Research, discuss how biomarkers can accelerate CNS drug development without creating false confidence and what practical methods sponsors can use to create regulatory flexibility while preserving scientific rigor. A biomarker is only use...
2 Sept 2026
Enhancing Precision and Safety in the Development of CNS Genetic Medicines
Tune in to ISCTM’s Mind the Methods podcast with Dr. Kemi Olugemo, ISCTM Scientific Committee member and consulting Chief Medical Officer at Junevity, and Dr. Mo Heidaran, NIH-trained scientist and former FDA Division of Cell and Gene Therapy leader. Together, they explore precision and safety in genetic medicines for CNS disorders—from gene-editing platforms and manufacturing quality to patient selection, off-target effects, and long-term safety monitoring. They also discuss how AI can suppo...
26 Mar 2026
Including People with Suicidal Ideation/Behavior in CNS Trials
In this episode of Mind the Methods (the ISCTM podcast), Dr. Mark Opler speaks with Dr. Elizabeth Ballard, Associate Scientist at the NIMH Intramural Research Program and the 2025 recipient of the ISCTM Lewis Alan Opler Prize, about the evolving science of suicidal ideation and behavior. Dr. Elizabeth Ballard explains why many commonly used tools were built for risk documentation and legal protection, not for detecting treatment-related changes in clinical trials, and how repurposing them can...
6 Feb 2026
Use of AI in Clinical Research, Part 2
In Part 2, Amir Kalali, MD, Independent Consultant, continues the discussion with Luca Pani, MD, focusing on how AI could fundamentally transform CNS drug development by enabling deeper biological insight, patient enrichment, and real-world outcome assessment, while emphasizing the cultural resistance, regulatory transparency, ethical trust, and leadership readiness required for responsible adoption.
6 Feb 2026
Use of AI in Clinical Research, Part 1
In Part 1, Gary Sachs, MD, Clinical Vice President at Signant Health, moderates a discussion with Luca Pani, MD, President of ISCTM and Chief Regulatory and Innovation Officer at NetraMark. The conversation examines how AI can be used to support drug development, clinical trial design, and data interpretation, alongside key regulatory, ethical, and scientific considerations.
5 Feb 2026
Intro to Mind the Methods
In this introductory episode of Mind the Methods, host Elizabeth Pappadopulos, PhD, introduces the mission, scope, and audience of the ISCTM podcast. She outlines how the series will explore innovations in CNS clinical trial design and methodology ranging from digital endpoints, adaptive protocols, and generative AI to patient-centric approaches and real-world challenges across psychiatric, neurologic, and neurodegenerative research. Episode 00 sets the stage for thoughtful, expert-led conver...
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