Dose #21: Supply Chain Planning for ATMPs & Overcoming Complexity with Tom Walls—Spark Therapeutics скачать в хорошем качестве

Dose #21: Supply Chain Planning for ATMPs & Overcoming Complexity with Tom Walls—Spark Therapeutics

In this episode of SCW for Pharma, host Evren Ozkaya welcomes Tom Walls, former Head of Supply Chain Planning at Spark Therapeutics, a Roche company. The conversation kicks off with Tom sharing his career evolution from small molecules to his current focus on advanced therapy medicinal products, expressing his optimism for the potential of cell and gene therapies to treat many previously untreatable rare diseases. Evren and Tom then explore the different types of advanced therapies, clarifying that some are highly personalized (batch for a single patient) while others follow a bulk production model, all targeting rare diseases but never reaching the scale of high-volume small molecule drugs. The discussion then delves into the unique complexities of the cell and gene therapy supply chain. Tom outlines several challenges, including highly variable yields, the need for skilled teams for stability studies, small batch sizes leading to production difficulties, and the hurdles of country-specific regulations. He underscores that the short 36- to 72-hour shelf life necessitates precise scheduling, and the high cost of manufacturing capacity makes idle time a financial challenge. Tom confirms that this inherent complexity is a primary factor contributing to the therapies' high price points, often reaching the million-dollar plus range. Evren and Tom shift their focus to what defines a strong planning organization in this specialized field. Tom explains that top performers are clear communicators who make confident, data-aware decisions and can quickly align teams during unexpected issues. He highlights that planning covers several areas, including analytical, regulatory, and clinical planning, with risk management being central. Tom notes that while AI-driven production scheduling can help manage complexity and yield variability that traditional ERPs miss, the technology landscape remains fragmented, lacking a single holistic platform that covers regulatory, supply chain, demand planning, production scheduling and production monitoring domains. The conversation continues by examining the need to link planning and execution systems on top of others to understand the impact of decisions, especially with yield variability. Bringing planning and execution closer together supports optimization and strengthens communication, since plan adjustments need to translate into clear actions for teams on the ground. Evren then asks about tariffs, trade tensions, and reshoring in the United States. Tom explains that many inputs, from plasma materials to tubing components, come from China. While the US is large, not everything can be reshored due to the specialized nature of these materials. Decisions must be made carefully. They close by examining the role of AI in cell and gene therapy. Tom highlights the importance of linking regulatory, supply chain, demand planning, and execution. He sees opportunities in digital twins and anomaly detection to help teams manage risk more effectively. In the final segment, Tom shares the advice he would give his younger self. He wishes he had worked at more production sites to better understand how different operations run and how planning decisions affect people in manufacturing. He also would have spent more time with finance and regulatory teams, since planning sits at the intersection of all these functions. He encourages future professionals to build skills across these domains to succeed in this field.