Building High-Performance Global Trials: Strategies for Scalable Clinical Development
Explore how India’s clinical research ecosystem provides scalable solutions to accelerate drug development while maintaining global quality standards.
The pharmaceutical industry faces increasing pressure to design faster, more efficient, and cost-effective clinical development programs. As sponsors in the US and the EU seek to optimize R&D pipelines, many evaluate geographical extensions that offer a combination of scientific excellence and regulatory alignment.
In this panel discussion, Mrinal Kammili, Partha Chatterji, Siddangouda Patil, Kalavathy Elango, and Rajkumar Agarwal will discuss the technical and operational infrastructure in India that supports Phase 1 through Phase 3 trials, biometrics, and integrated clinical-to-submission capabilities.
What You’ll Learn:
- Leveraging large populations to accelerate enrollment in oncology, immunology, and metabolic disease
- Maintaining global quality standards and data integrity to support international submissions
- Utilizing centralized laboratories and biostatistics to streamline the transition from clinic to submission
- Managing complex study designs and early-phase pharmacology to improve budget and resource efficiency
Topical Drug Delivery in Preclinical Research: Navigating Promise and Complexity
Topical drug delivery presents a promising strategy in drug development, offering direct access to the site of action while bypassing the gastrointestinal tract and hepatic first-pass metabolism. This targeted approach reduces systemic exposure and minimizes adverse effects. Despite its advantages, the discovery of drug candidates suitable for topical administration involves complex ADME challenges, including transdermal absorption and the need for simple formulations for screening NCEs.
In one of our integrated drug discovery programs, we employed a topical delivery system as a mitigation strategy to address toxicity concerns. This approach not only enhanced safety profiles but also demonstrated the practical utility of topical administration in early-stage drug development.
Why Watch the Webinar?
- Learn from real-world case studies in topical drug delivery
- Understand the ADME complexities in preclinical models
- Gain insights into formulation strategies that drive clinical success
- Interact with industry leaders and ask your questions live
Speakers Panel
Dr. Mrinal Kammili
Dr. Mrinal Kammili brings over 27 years of experience across healthcare, pharmaceuticals, and clinical research. At Syngene, he leads translational and clinical programs that bridge discovery and clinical development, driving strategy and execution across early- to late-phase studies. A medical doctor and AHA-certified intensivist, his expertise spans clinical operations, program leadership, and outcomes-focused delivery.
Partha Chatterji
Partha Chatterji brings over 22 years of global experience across clinical trials, central laboratory operations, and translational research. At Syngene, he leads clinical trial strategy and execution, with expertise in biomarker development, clinical pathology, and end-to-end trial delivery. His experience spans pharmaceuticals, biosimilars, medical devices, and nutrition studies, driving operational excellence across diverse global programs.
Dr. Siddangouda Patil
Dr. Siddangouda Patil leads Syngene’s Human Pharmacology Unit and Medical & Scientific Writing, with strong expertise in early-phase clinical pharmacology. He oversees first-in-human and early-stage studies, ensuring scientific rigor, patient safety, and operational excellence. He also drives high-quality medical and regulatory writing, enabling clear communication and efficient decision-making across global clinical programs.
Dr. Kalavathy Elango, PhD, MBBS
Dr. Kalavathy Elango brings over 23 years of experience across early-phase drug development, clinical research operations, and business strategy. At Syngene, she drives end-to-end development strategies by integrating translational science, clinical execution, and scalable delivery models. A Lean Six Sigma Black Belt, she focuses on enhancing quality, speed, and operational performance, particularly in complex early-phase programs.
Rajkumar Agarwal
Rajkumar Agarwal leads business development for Syngene’s Clinical Development division, driving growth, strategic partnerships, and global client engagement. With prior leadership roles at Veeda Clinical Research and GVK Biosciences, he brings extensive experience in commercial strategy and clinical services. His combination of scientific background and business acumen enables client-centric solutions across integrated clinical development programs.
