Fourth Cell Therapy Insights event
The fourth Cell Therapy Insights Series event took place on November 19th at the Novo Nordisk Foundation in Copenhagen, hosted in collaboration with Thermo Fisher Scientific. With 217 participants from around the world, both in-person and online, it marked Cellerator’s largest event yet. This turnout reflects the strength and growing activity within the cell therapy field in the region.
The event focused on a pivotal milestone for cell therapy developers: ‘Preparing for your IND/CTA submission’. Eight international experts were invited to share regulatory, technical, and digital perspectives, all with the aim of elevating insights across the community and strengthening the bridge from research to patient access.
Ana Hidalgo-Simon, Former Head of Advanced Therapies, EMA, opened the programme with a clear message: successful development starts with the patient and healthcare system in mind. She warned of the “two valleys of death” in cell therapy: the first is reaching first-in-human trials, and the second is achieving commercial viability and broad patient access. Up to a third of approved therapies never reach patients due to commercial rather than scientific reasons - underscoring the need to plan for reimbursement and health system integration from the outset.
This call for early-stage planning was supported by Richard Dennett, Senior CMC Regulatory Strategy Director, Thermo Fisher Scientific, who outlined that the pre-IND/CTA phase is where successful clinical translation truly begins. Developers must simultaneously focus on ‘The Four Pillars’: Non-Clinical, CMC, Clinical, and Regulatory – to build a complete and resilient package for first-in-human trials. Richard McFarland, Chief Regulatory Officer at ARMI, further introduced the “Four C’s of Regulatory”: case-by-case assessment, characterization, clinical need, and communication. Central to this is the Target Product Profile, described as a living document that unifies teams and guides decision-making throughout development.
A recurring theme throughout the event was the need for robust, data-driven manufacturing. Renee Hart, President & Chief Business Officer, LumaCyte, addressed the persistent challenge of biological variability in starting materials and manufacturing processes. She demonstrated how real-time, label-free analytical technologies are becoming essential as demand for life-saving therapies grows, and argued that rapid, robust analytics will be critical to meeting future commercial manufacturing scales.
This message was supported by Uma Lakshmipathy, Head of Cell & Gene Translational Sciences, Thermo Fisher Scientific, who highlighted the rising importance of CMC quality in FDA approvals. She emphasized early platform selection, strong potency assay development, and scalable workflows as cornerstones of a successful regulatory strategy. Both Hart and Lakshmipathy agreed that a scalable manufacturing process, supported by a robust analytical plan, is a key driver of success.
The digital dimension of cell therapy development was explored by Vincenzo Di Cerbo, Program Head of Digital Innovation, Cell and Gene Therapy Catapult. He discussed the urgent need for data standards and interoperability across the cell therapy supply chain, warning that without them, digital transformation risks creating new data silos. He showcased Catapult’s work on digital twins, automated analytics, and AI-driven process optimization, and encouraged the sector to embrace AI to accelerate learning and reduce costs - pushing the boundaries of what is possible in cell and gene therapy.
Chris Demers, Head of Digital & Data, Skellig Automation, built on this emphasizing that data is risk mitigation, but only when it is captured, managed, and transformed effectively. He advocated for designing MES with a data-first mindset, ensuring that data can be translated into regulatory-ready evidence and used to strengthen process control across the development lifecycle.
Closing the speaker lineup, Timothy Miller, Global Head, Scientific & Therapeutic Development, Thermo Fisher Scientific, finished with the central takeaway: advancing cell therapy requires a connected ecosystem. Progress depends on strong partnerships between industry, academia, regulators, and technology providers. By sharing knowledge openly and building aligned standards, the community can accelerate innovation and ensure that promising therapies reach the patients who need them.
The event concluded with an interactive ‘Meet the Experts’ roundtable session covering four main topics: Regulatory Strategy, Data Management, Safety & Risk Assessment, and CMC & Analytical Development – letting the participants dive deeper into the challenges and opportunities discussed throughout the day.
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