{"type":"rich","version":"1.0","provider_name":"Transistor","provider_url":"https://transistor.fm","author_name":"Regulatory: The Emerging C-Suite Leader","title":"Regulatory Strategy for Accelerated Programs","html":"","width":"100%","height":180,"duration":2834,"description":"In this episode of Regulatory: The Emerging C-Suite Leader podcast, our hosts Debra Webster and Trevor Mill sit down with Murray Abramson, Chief Development Officer at Ascidian, to explore what it takes to accelerate drug development in complex settings, particularly in diseases with limited patient populations.\nAcceleration is often misunderstood. It is not about speed alone. Without a foundation in data, patient insight, and regulatory alignment, timelines are built on hope rather than reality.\nThe discussion highlights the importance of early, integrated planning across clinical, regulatory, and CMC functions. Misalignment across these areas is one of the most common reasons accelerated programs fall short, particularly when protocols are built in isolation or timelines are set without grounding in prior experience. Adaptive trial designs can create efficiencies, but they are not a universal solution and must be applied in the context of the disease, modality, endpoints, and available biomarkers.\nIdentifying and continuously reassessing the “source of truth” is critical, meaning grounding decisions in data rather than assumptions. This includes patient needs, enrollment feasibility, regulatory expectations, and operational realities. Successful programs are those that address risks early, create an environment where challenges are surfaced before they become crises, maintain open communication across teams and with regulators, and adapt as new information emerges.\nA clear tension exists between urgency and rigor. There is a moral imperative to move quickly for patients, but only when speed is supported by scientific rigor, transparency, and a well-grounded development strategy.\nHear it in Murray's own words.","thumbnail_url":"https://img.transistorcdn.com/d0PqD2yihsYzKiV3PJl0A9yOU0hvkh0UUwQNfLP7fkI/rs:fill:0:0:1/w:400/h:400/q:60/mb:500000/aHR0cHM6Ly9pbWct/dXBsb2FkLXByb2R1/Y3Rpb24udHJhbnNp/c3Rvci5mbS9kNTg5/MzhjM2RlYTU5ODI0/YzdlZjY1NTY0YjFi/YjI3Zi5qcGc.webp","thumbnail_width":300,"thumbnail_height":300}