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Track 5: Personalized Medicine, Combination Products and Diagnostics

This track explores the convergence of medicines, diagnostics, and medical device technologies to deliver more precise, personalized treatment options and improve patient outcomes. It highlights advances in combination products, biomarkers, companion diagnostics, translational medicine, and next-generation drug delivery systems that are reshaping the therapeutic landscape. Sessions will showcase innovative strategies in compound selection, preclinical and clinical development, optimized dosing, and approaches to strengthen trial data quality and integrity for informed decision-making. Regulatory considerations, global trends, and emerging technologies will be examined, with emphasis on cross-sector collaborations and the integration of the patient’s voice early in development to ensure meaningful outcomes across diverse populations and therapeutic areas, including rare diseases and women’s health.

  • Complex Generics and Combination Products: Challenges in the generic drug space, device integration, labeling, and regulatory considerations for biosimilar and combination product development
  • Novel Therapy Platforms and Technologies: Emerging modalities including targeted cell and gene therapies, radioligands, rare disease therapies, and advanced drug delivery technologies
  • Global Developments in Diagnostics and Companion Products: Evolving regional and international rules impacting diagnostics, AI-driven regulations (e.g., EU AI Act), and lessons from initiatives such as COMBINED trial pilots and China CDx frameworks
  • Translational Medicine and New Approach Methodologies (NAMS): Strategies for validation and integration of NAMS, case studies demonstrating preclinical-to-clinical translation, and their role in refining patient populations and endpoints
  • Precision Medicine in Women’s Health: Innovations in drug delivery and therapy design to address women-specific health needs and historically underrepresented populations
  • Digital Technology and AI in Precision Medicine: Applications of AI, digital twins, and advanced analytics to support diagnosis, targeted therapy selection, and trial execution for personalized treatments
  • Public Policy and Emerging Trends: How global policy changes affect translational medicine, precision therapies, and the evolving landscape of drug-device-diagnostic development
  1. How can precision medicine approaches, including combination products and companion diagnostics, be better integrated into clinical development to maximize patient benefit?
  2. What are the key scientific, operational, and regulatory challenges impacting novel therapy platforms and diagnostic innovations globally, and how can they be overcome?
  3. How can data quality and integrity be optimized in precision medicine trials, particularly with the use of advanced diagnostics, AI tools, and next-generation drug delivery platforms?
  4. What are the emerging policy trends and global developments that will shape the future of precision medicine and combination product development over the next 3–5 years?

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