De-risking Drug Development through Translational Science: A Leadership Perspective

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Dr. Mrinal Kammili, Head of Translational and Clinical Research at Syngene International, discusses how translational science reshapes early-stage drug development in this exclusive feature. With a global perspective and Syngene's integrated capabilities, Dr. Mrinal highlights how forward-looking strategies reduce risk, enhance precision, and improve outcomes from bench to bedside.

Dr. Mrinal: The cost of bringing a new drug to market has soared, with estimates crossing $2.6 billion and timelines stretching over 10 years. At the same time, success rates remain low, particularly in the early clinical stages. In this environment, de-risking is no longer optional. It's a strategic imperative. Translational science bridges the gap between preclinical discovery and clinical development by generating data predictive of clinical outcomes (including immunogenicity), reducing late-stage attrition, optimizing candidate selection, and accelerating decision-making. Globally, sponsors are looking for partners who can provide integrated, real-world-ready translational insights much earlier in their drug development programs, and that's where I see Syngene providing a true value-add to our clientele.

Dr. Mrinal: There's growing pressure to improve clinical success rates while compressing timelines and controlling costs. Translational science provides a way to bridge the "lab-to-clinic," or you may say "bench-to-bedside" capabilities by generating data that improves predictability and reduces uncertainty. As drug development becomes more complex, with new modalities, rare diseases, and targeted therapies, integrating translational insights has become an existential need vis-à-vis a good-to-have strategy.

Dr. Mrinal: The most common risks include poor target selection, inadequate understanding of disease biology immunogenicity (i.e. the likelihood of a therapeutic protein triggering an unwanted immune response), and suboptimal dose prediction. Translational science helps mitigate these by integrating mechanistic insights, in silico models, biomarker validation, and human-relevant models early in the development cycle. This leads to more informed go/no-go decisions, optimized patient selection, and more efficient use of any R&D capital.

Dr. Mrinal: Syngene's newly integrated Translational and Clinical Research (T&CR) division offers end-to-end solutions that connect and bridge discovery to early clinical development. Our research services capabilities span nonclinical safety assessment, animal clinical models, DMPK, computational data sciences, large and small molecule bioanalysis, biomarker development, early phase trials, clinical trial design, global clinical trial execution and regulatory strategy. We support sponsors with IND-enabling studies and help design translationally informed First-in-Human (FiH) and proof-of-concept trials.

Our strength is providing a single scientific thread from target validation through Phase I, followed by larger phase-2 & 3 global clinical trials. Integrating preclinical and clinical functions, we help clients mitigate risks, reduce redundancies, and generate decision-enabling data earlier in the journey.

Dr. Mrinal: Regulatory agencies such as the FDA, EMA, and PMDA have increasingly emphasized the value of translational data in supporting IND/CTA submissions. Initiatives like the FDA's Model-Informed Drug Development (MIDD) program and Europe's Adaptive Pathways reflect a growing openness to innovative, data-rich strategies that rely on early human-relevant evidence. Translational science strengthens regulatory submissions and aligns with the global shift toward evidence-based, patient-centric development models.

Dr. Mrinal: One challenge is the fragmented nature of traditional R&D silos - biology, toxicology, bioanalytics, and clinical operations often operate in isolation. Another is the lack of high-quality translational models that accurately mimic human physiology. Finally, access to multidisciplinary talent connecting science to strategy remains limited. Addressing these barriers requires a shift in both infrastructure and mindset. Syngene’s research services division has addressed these silos where biology, toxicology, bioanalytics and clinical operations operate under the same umbrella for the desired continuum.

Dr. Mrinal: These complex therapies demand more nuanced translational strategies. For example, gene therapies require long-term expression models, immunogenicity assessments, and novel bioanalytical platforms. Antibody-drug conjugates (ADCs) involve dual mechanisms - antibody targeting and cytotoxic payload delivery - that must be understood in tandem. Translational science must now accommodate these new paradigms, often blending in-silico modelling, real-world data, and multi-omics approaches to provide a more holistic view of risk.

At Syngene, we are proactively expanding our translational infrastructure to support complex modalities. For example, our biologics platform includes capabilities for immunogenicity assessment, viral vector bioanalysis, and PK/PD modelling of long-acting biologics. We're also investing in disease-relevant in vitro and in vivo models for advanced therapies. The goal is to help clients address these therapies' unique safety and efficacy questions - questions that can't be answered using traditional tools alone.

Dr. Mrinal: Many global sponsors seek integrated partnerships rather than piecemeal outsourcing. They value CRO/CDMOs that combine discovery biology, DMPK, toxicology, biomarker development, and early clinical planning under one roof. The goal is to streamline development, reduce inter-functional lag, and generate cohesive and decision-enabling data. Trust, transparency, and a shared commitment to scientific excellence are key in selecting such partners.

Traditional CROs often operate in silos - discovery in one corner, clinical development in another. Syngene is intentionally breaking down these silos. We bring together scientists, clinicians, and regulatory experts under one integrated translational umbrella. Our approach is highly collaborative and science-first, with substantial crosstalk between discovery biologists, toxicologists, DMPK experts, and clinical strategists. This ensures that the clinical program is not an afterthought - it's an outcome of rational design and translational insight.

Dr. Mrinal: The future of translational science will be defined by precision, personalization, and platform thinking. We're moving toward a world where early development is not just about proving safety but also about de-risking efficacy, predicting long-term outcomes, and designing with patients in mind. Cross-functional teams, AI-driven data synthesis, and humanized model systems will play a defining role. The organizations that master this integration will set new benchmarks in drug development efficiency and innovation.

We envision Syngene as a partner of choice for global sponsors seeking science-led, end-to-end translational support. With our T&CR division, we're building a fully integrated ecosystem that doesn't just check regulatory boxes but empowers clients to make better, faster decisions.

We believe the next frontier lies in precision translational strategies - using multi-omics data, AI/ML, and patient-centric design to optimize every step from discovery to clinic. Our mission is to be at the forefront of this transformation, helping to redefine how the world approaches risk in drug development.

Dr. Mrinal Kammili serves as the Head of Translational and Clinical Research at Syngene International. He brings nearly two decades of experience in translational medicine, clinical pharmacology, and early-phase clinical development. At Syngene, Dr. Kammili leads cross-functional programs that advance novel therapeutics from preclinical validation through to first-in-human studies. His expertise spans multiple therapeutic areas, including oncology, cardiology, immunology, and metabolic diseases. A medical doctor with a specialization in Residency in Cardiology, he is recognized for his strategic leadership in integrating scientific, regulatory, and operational elements of early drug development.