Strategies for Biomarker-Driven Sub-population Optimization in Clinical Trials

It is no secret that the cost to bring a drug to market has increased and failed trials can cost sponsors upwards of a billion dollars. Statistics have shown that up to 65 percent of Phase II and over 35 percent of Phase III clinical trials do not progress to the next stage. This results in approximately 12 percent of clinical trials resulting in therapies approved by the US Food and Drug Administration (FDA).

Failed trials often have sub-populations of patients who respond well to the treatment being evaluated; however, the trial is abandoned because of the overall data. This results in a financial loss for sponsors and missed opportunity for patients to benefit from a therapeutic innovation. Moreover, the process of executing this analysis requires a resource-intensive, manual process.

Artificial intelligence (AI), enabled via technology platforms, is a key driver of change in the clinical trial industry. This webinar will delve into how AI, through a SaaS platform like IQVIA’s Sub-Population Optimization and Modeling Solution (SOMS), can rapidly analyze clinical data sets to identify promising patient sub-groups that could benefit from a therapy, thereby increasing safety and treatment outcomes.

SOMS uses an industry method called subgroup identification based on differential effect search (SIDES), which is validated, published and defendable to health authorities. By leveraging SIDES, sub-populations can be identified as fast as 30 seconds (up to 99 percent-time savings over current, manual biostatistics-based processes).

Harnessing the power of SIDES in a technology platform enables sponsors to:

• Identify predictive biomarkers and sub-populations
• Track sub-populations
• Design and adjust strategies to maximize trial success
• Develop rescue strategies for poorly performing trials
• Execute trial simulation and benchmarking

Join this webinar to learn how IQVIA’s SOMS is leveraging AI for biomarker-driven sub-population optimization to help conduct clinical trials.

Speakers

Adrian Kizewski, Associate Director, Clinical Technology, IQVIA Technologies

Adrian Kizewski brings expertise spanning R&D and clinical life sciences, business analysis, process design and improvement and product implementation. He is currently a lead for IQVIA’s Clinical Data Analytics Solution (CDAS) as well as Sub-population Optimization and Modeling Solution (SOMS). Adrian holds an MBA from the McDonough School of Business at Georgetown University, in addition to an MSc in Pharmacology from The Johns Hopkins University School of Medicine and a BSc in Biochemistry from Temple University.

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Naouel Baili, Director, AI Scientist, IQVIA Technologies

Naouel Baili is an expert in emerging technology solutions, leveraging over ten years of experience in the life sciences industry to transform clinical trial management. Her proficiency in embedding sophisticated AI tools into SaaS platforms has significantly improved both user experience and operational efficiency. A holder of a PhD in Computer Science, she excels in the development and design of innovative AI capabilities that streamline and optimize clinical research.

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