59 TWENTYFOURSEVENBIOPHARMA Issue 3 / October 2025 driven by external factors. Geopolitical pressures have accelerated the diversification away from single-market manufacturing and trial strategies. At the same time, regulatory reforms — such as India’s New Drugs and Clinical Trials (NDCT) rules — are reshaping what is feasible within local jurisdictions, particularly for early-phase trials involving foreign molecules. While India’s regulatory environment still places limits on certain types of first-in-human trials, organizations are responding with hybrid models. Some have built partnerships with Australian clinical sites to plug these gaps, allowing preclinical development to occur locally, while early dosing takes place offshore. Others are exploring regulatory workarounds, such as local manufacturing under specific development umbrellas, although this is highly dependent on intellectual property strategy and client preference. In terms of therapeutic areas, the trend is most pronounced in oncology. Given the biological complexity, narrow therapeutic windows, and demand for rapid proof-of-concept, cancer trials increasingly rely on translational frameworks that bring discovery scientists, PK modellers, clinical investigators, and regulatory specialists into one decision-making loop. Similar dynamics are beginning to emerge in rare diseases and cell and gene therapy, where small patient populations and tight timelines increase the value of integrated planning. What’s striking is that this trend isn’t confined to large pharma. Small and mid-sized biotechs, often operating with lean internal resources, are seeking external partners who can support both strategy and execution across the translational-clinical divide. This has led to a wave of activity among CROs and CDMOs, many of whom are repositioning themselves not as service providers but as scientific collaborators with cross-domain expertise. For example, we recently restructured our clinical division into a Translational and Clinical Research platform. Previously, we supported early-phase studies using capabilities like in vitro assays and DMPK models. Today, we are working to connect those strengths directly to clinical execution, ensuring that each step in the development process is informed by robust, data-driven science. This evolving approach reflects a wider industry effort to formalise integration that, until recently, relied heavily on ad hoc cross-functional collaboration. At the same time, the competitive dynamics of outsourcing are shifting. Speed and cost remain important, but they are no longer the only differentiators. Sponsors are placing growing emphasis on scientific depth, data fluency, and the ability to adapt across development phases. . Traditional outsourcing metrics — like number of sites or turnaround time — are being re-evaluated in favour of capabilities that help answer critical early questions: Can the compound be formulated? Is the PK profile adequate? Are the biomarkers validated? What is the most efficient route to patient data? Looking forward, the convergence of translational and clinical functions is likely to become the default model, particularly in high-risk or novel therapeutic areas. But true integration goes beyond structural reorganization. It demands alignment across scientific teams, operational processes, digital platforms, and governance structures. It also requires trust that the data being generated upstream is fit for clinical decision-making, and that the same scientific lens is being applied throughout the process. And the rate of change is only accelerating. Across the industry, emerging technologies like organoidbased models, digital twins, and in silico trials are reshaping early decision-making, while decentralized trial designs and systems biology approaches are enhancing how we generate and apply data throughout development. These innovations are reinforcing the same momentum: a shift toward earlier, smarter, and more connected translational strategies. As development timelines shorten and product complexity grows, companies that can collapse the space between discovery and clinical insight – and do so without sacrificing rigour – will find themselves at a distinct advantage. The question is not whether translational and clinical integration is coming. It is how fast organizations can move to make it real, and gain the benefits from improved science, development timelines, and overall success rates. SYNGENE KENNETH BARR Head of Strategic Collaborations Syngene
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