CHEMICALS KNOWLEDGE HUB issue 2 / October 2025

62 CHEMICALS KNOWLEDGE HUB Issue 2 / October 2025 DCAT SUMMIT SPECIAL Designing for patient accessibility Justin Schroeder, Vice President of Global Technical Services, PCI Pharma Services, underscored that combination drug–device products, particularly for self-administration, require careful integration of drug, device, and packaging—right from the beginning. Companies often want to rush to Phase I, but early decisions, such as container choice, can determine whether a product can later transition into a patient-friendly device. Making drug administration easy can also improve the path through the clinic. “A good patient experience drives adherence, and adherence drives improved health outcomes,” Schroeder said. Using digital twins for achieving sustainability goals Looking ahead to the ever-accelerating gains of digitalization, speakers zeroed in on the power of digital twins—complete digital replications of an entire facility. “Digital twins provide an opportunity to pressure test systems, to break things and see how they react, to implement different solutions,” said Fujifilm Biotechnologies’ Ulrich. From a sustainability perspective, a digital twin enables teams to test solutions, such as water-recovery systems, without interrupting production. Building for the future For an industry facing rising complexity and global demand, these talks reinforced the gains available from addressing tough challenges. The future supply chain will be built on modular designs, sustainable chemistry, circular resource use, and patient-ready delivery, and the companies embedding these principles now will be the ones setting the pace tomorrow. Serving patients through agility and innovation in development and manufacturing With treatment modalities becoming more complex and competitive pressures mounting on development timelines, companies must continually adapt to stay ahead and serve patients better. At the DCAT Summit at Lugano, “EXPEDITION PHARMA: Innovation from a Patient-First Perspective,” held June 4–5, 2025, in Lugano, Switzerland, industry leaders emphasized that agility and innovation are not optional—they are essential to delivering needed therapies faster and more effectively. Speakers From Eli Lilly & Company, Axplora, Made Scientific and enGene shared strategies for nimble development, streamlining manufacturing, and ensuring that new therapies are designed with real-world care settings in mind. Accelerating clinical milestones Jesús Castañón, Senior Director of Discovery Chemistry at Eli Lilly & Company, underscored the need to move drug candidates into the clinic faster— even as molecular structures become more complex. Achieving this goal requires technical capabilities, bold execution, operational excellence, and what Castañón calls “extreme collaboration.” He pointed to precompetitive partnerships with academic institutions as critical for early access to enabling technologies such as flow chemistry ozonolysis, and electrochemistry. Internally, tight coordination across medicinal chemistry, synthetic chemistry, and CMC teams allows development hurdles to be addressed earlier—before they become bottlenecks. “The early partnership between discovery and development is essential for acceleration,” Castañón said. Advancing manufacturing for antibody–drug conjugates To meet patient needs, Arul Ramadurai, Chief Commercial Officer at Axplora, underscored the importance of continual innovation in manufacturing for antibody–drug conjugates (ADCs), a strong and growing modality in cancer treatments. “ADCs are powerful new therapies that are evolving all the time, with over 600 companies out there working on them,” said Ramadurai. “Manufacturing organizations have to be prepared for the wave that is coming.” ADCs face unique development and manufacturing challenges to get from pre-clinical to commercial production in just a handful of years, he noted. Advanced therapies and biologics – Accelerating development with next-generation manufacturing

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