A new player in the real-world evidence (RWE) space is aiming to transform how biopharma companies generate and utilize critical data. Landmark Science has launched specialized services designed to bridge the traditional gap between vendors and pharmaceutical companies through what they describe as a "white-glove, high-touch approach" to evidence generation.
Founded by industry veteran Shivani Aggarwal, PhD, MS, Landmark Science focuses on delivering agile, tailored solutions that help clients navigate the complex regulatory landscape while avoiding bureaucratic delays that often hamper evidence generation efforts.
"Our approach goes beyond traditional evidence generation—we partner closely with our clients to provide tailored, high-touch support that meets their unique needs," explains Aggarwal. "By combining deep industry expertise with cutting-edge methodologies, we empower biopharma organizations with impactful insights that drive innovation and regulatory success at exceptional speed."
Expertise Across Complex Therapeutic Areas
Landmark Science has assembled a team of seasoned epidemiologists and advanced statistical programmers to deliver comprehensive RWE services. The company offers expertise across multiple complex therapeutic areas, including hematology, oncology, immunology, and rare diseases—fields where robust evidence generation is particularly challenging but essential for regulatory approval and market access.
Their service portfolio includes data landscaping, full-scale RWE studies, and advanced analytics, all designed to help pharmaceutical companies transform evidence into actionable insights regarding patient care, access, and outcomes.
Industry Experience Driving Innovation
Aggarwal brings 15 years of experience in RWE and clinical trials from her previous roles at leading life science organizations including Amgen, Regeneron, and IQVIA. This background has informed the company's approach to bridging what they identify as a critical gap in the industry—the disconnect between traditional vendors and the specific needs of biopharma companies.
The company's focus on personalized service aims to eliminate the "red tape" that often delays critical evidence generation. This approach appears particularly timely as regulatory bodies increasingly incorporate real-world evidence into their decision-making processes for drug approvals and label expansions.
Meeting Growing Demand for Quality RWE
As pharmaceutical companies face growing pressure to demonstrate real-world effectiveness and safety of their products beyond controlled clinical trials, the demand for sophisticated RWE capabilities continues to rise. Landmark Science positions itself at the intersection of this trend, offering what they describe as "rigorous scientific insights" combined with highly personalized service.
The company's launch comes at a time when the FDA and other global regulatory agencies are developing frameworks for the use of real-world data in regulatory submissions, making specialized expertise in this area increasingly valuable to drug developers navigating complex approval pathways.
For biopharma companies developing treatments in complex therapeutic areas, particularly those addressing rare diseases with limited patient populations for traditional clinical trials, these specialized RWE capabilities may provide critical support in demonstrating treatment value to regulators, payers, and healthcare providers.
