Bridging Science and
Human Impact

Strengthening translational decision-making

The Translational Science Unit was established to strengthen the bridge between patient biology and clinical decisions. This unit brings together biobanking, biomarker sciences and translational model support to accelerate development timelines and enable faster, evidence-based Go/No-Go decision-making. Strategic partnerships with biobanks and hospitals broadened access to biorepository samples and enabled additional capabilities such as NGS and IHC.

Expanding bioanalytical and biomarker depth

The Central Laboratory successfully completed computer system validation of newly acquired instruments in compliance with 21 CFR Part 11 and transitioned to ISO 15189:2022, with NABL and CAP audits conducted during the year. The laboratory is also expanding its biomarker capabilities to support advanced translational research needs. Scientific capability was enhanced across small and large molecule bioanalytical domains, expanding support for advanced modalities including ADC and oligonucleotide programs, with integrated PK and ADA assessments.

Early-phase and advanced therapy progress

Early-phase programs included a first-in-India, first-in-class Phase 1b study, alongside advanced therapy trial execution capabilities through participation in a CAR T cell therapy trial program. An interdisciplinary opportunity in rare disease was progressed through end-to-end collaboration from discovery to clinical research, reflecting a more integrated model of working. Delivery discipline stood out through the year, including completing recruitment for a complex clinical study ahead of schedule.

Digitization

Digitization remained a key enabler of data quality, patient safety, compliance and operational efficiency. End-to-end digitization of BA/BE trials was initiated using an off-the-shelf platform, alongside continued digitization in late-phase clinical trials through advanced CTMS and AI-enabled electronic data capture platforms. Routine digital upgrades strengthened system reliability and audit-readiness.

Operating model and readiness

To sharpen execution and scalability, we strengthened the operating model through a talent refresh and a more agile structure to support seamless project delivery. A Business Strategy and Process Excellence function was established to enable business expansion through strategic partnerships and scaling up the business, harmonize processes, strengthen customer collaboration and drive productivity through an Operational Excellence program. Looking ahead, we are preparing for a more global footprint by strengthening translational and bioanalytical depth and building the partnerships needed to support end-to-end global clinical development delivery.

Clinical programs delivered at scale

Translational & Clinical Research advanced its ability to deliver complex, technology-enabled studies across geographies and phases. Our first Phase 3 clinical trial was initiated as an end-to-end program, recruiting patients across clinical sites in India and the U.S. To support multinational development needs, we built a global clinical trial partnership ecosystem spanning the U.S., U.K., Europe, Sri Lanka, Australia, New Zealand and Jordan, positioning Syngene’s Translational & Clinical Research Unit as the central CRO for global multicentric trials.