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In this episode, Dr. Greg Goldmacher, Associate VP of Clinical Research at Merck, known as MSD outside of the United States and Canada, explains how AI is transforming imaging, clinical trials, and early-stage drug development. Greg describes endpoints as the core of every clinical trial, since they determine whether a therapy is safe or effective. He notes that AI is not new to imaging and aligns well with pattern recognition, yet its real value lies in identifying details that humans often miss.

Greg stresses that drug development still depends on huge volumes of data spread across legacy systems. Without strong data standardization, AI cannot deliver reliable results. He also points to the FDA’s evolving guidance on AI and emphasizes the need for rigorous validation before using AI-derived measurements for regulatory decisions.

Greg highlights the opportunity to improve efficiency, reduce human burden, and generate more consistent insights. With thoughtful adoption, AI can support better decisions in clinical development and improve outcomes for patients. Take a listen. 

Dr. Gregory Goldmacher is currently Associate Vice President in Clinical Research, and Head of Clinical Imaging & Pathology at Merck Research Laboratories. With his team of physicians and scientists he oversees the use of imaging and clinical pathology assessments in approximately 300 clinical trials across all therapeutic areas. In addition, he leads multi-disciplinary research efforts in artificial intelligence, tumor modeling, novel oncology response criteria, and other innovative approaches in drug development. He also supports business development, strategic venture investments, data standardization, and educational initiatives.

Prior to Merck, he was a senior medical director and Head of Oncology Imaging at ICON. He has held leadership positions in numerous collaborative groups across industry and academia focused on clinical trial methods, artificial intelligence, quantitative imaging, and data standards.

Greg received his bachelor’s degree from the University of Chicago, his MD and PhD in Neuroscience from the UT Southwestern Medical Center, and his MBA from Temple University’s Fox School of Business. He did his clinical training in diagnostic radiology, with fellowships in neuroscience and neuroimaging at the Massachusetts General Hospital and Thomas Jefferson University. He lives in the Boston area.