CHEMICALS KNOWLEDGE HUB issue 2 / October 2025

63 CHEMICALS KNOWLEDGE HUB Issue 2 / October 2025 DCAT SUMMIT SPECIAL Achieving better process efficiency for improved batch size and increasing production yields, while handling highly potent compounds and optimizing purity, are keys to addressing the complexity associated with this modality. Overcoming these challenges enables these targeted therapies to be delivered to patients safely and quickly. Overcoming barriers in cell therapy David Smith, Vice President and Head of Development at Made Scientific, a CDMO of cell and gene therapies, addressed the disconnect between promise and access in cell therapies. Despite major clinical advancements, only 1% of eligible patients have received these treatments. The complexity of personalized manufacturing—where every batch is tied to one individual—demands a new kind of ecosystem, he said. Smith called for tighter alignment between biotech companies, hospitals, academic centers, and supply partners to improve scalability and reduce time to treatment. “This is a call to arms to support this venture and to get these medicines to those who need them,” said Smith. “The need is growing, the opportunity is real, and the impact is measurable.” Designing patient-centered drug delivery Anthony Cheung, Chief Scientific Officer at enGene, a clinical-stage bio/pharma company, reminded attendees that innovation isn’t just about molecules—it’s about how the product can get to the patient in developing a bladder cancer gene therapy for use in community clinics, his team intentionally avoided cold-chain and specialized handling to reduce logistical hurdles. “It was very important to understand where these patients are being treated, and the limitations the patients and caregivers will face, before we developed a product for them,” said Cheung. This design choice allows for safer, more scalable treatment in frontline care settings—not just university hospitals. Staying ahead of the curve These discussions at the DCAT Summit at Lugano reinforced that delivering on the promise of new therapies depends on the ability to adapt—scientifically, operationally, and collaboratively. From early development through manufacturing and delivery, every step presents an opportunity to reduce delays and remove barriers to access. Moving faster, and smarter, will be essential to meeting that challenge.

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