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DIA 2027 · San Diego, CA

Track 5: Personalized Medicine, Combination Products and Diagnostics

This track explores the convergence of medicines, diagnostics, and medical device technologies to advance precise medicine and improve patient outcomes. Sessions highlight advances in combination products, biomarkers, companion diagnostics, translational medicine, radioligand therapies, novel therapy platforms, and next-generation drug delivery systems that are reshaping therapeutic development. The track examines strategies for compound selection, preclinical and clinical development, optimized dosing, and innovative trial approaches that strengthen evidence generation and support informed decision-making. Additional sessions address commercialization, manufacturing, pharmacovigilance, and post-market considerations, while exploring global regulatory developments, emerging technologies, public policy, cross-sector collaboration, and early integration of the patient voice across diverse therapeutic areas, including rare diseases.

Themes
  • Complex Generics and Combination Products: Challenges in generic drugs, biosimilars, device integration, labeling, and regulatory considerations for combination product development
  • Radioligand Therapies (RLTs): Advances in radiopharmaceutical development, regulatory considerations, manufacturing, clinical development, and precision treatment strategies
  • Novel Therapy Platforms and Technologies: Emerging modalities including targeted cell and gene therapies, RLTs, rare disease therapies, and advanced drug delivery technologies
  • Global Developments in Diagnostics and Companion Products: Regional and international regulatory developments impacting diagnostics, companion diagnostics, AI-enabled regulations, and global initiatives
  • Translational Medicine and New Approach Methodologies (NAMS): Strategies for validation and integration of NAMS, case studies demonstrating preclinical-to-clinical translation, and their emerging role in the drug development pipeline
  • Digital Technology and AI in Precision Medicine: Applications of AI, digital twins, advanced analytics, and digital technologies to support diagnosis, targeted therapies, and precision medicine
  • Public Policy and Emerging Trends: Global policy developments affecting precision medicine, translational science, diagnostics, combination products, and emerging technologies
  • Pharmacovigilance for Combination Products, Medical Devices, and Advanced Therapies: Safety monitoring and lifecycle management for combination products, medical devices, radiopharmaceuticals, generics, biosimilars, and advanced therapies.
Key Questions to be Addressed
  1. How are advances in precision medicine, combination products, diagnostics, radioligand therapies, and emerging therapeutic platforms transforming drug development and patient care?
  2. How can organizations integrate biomarkers, companion diagnostics, AI, digital technologies, and translational science to accelerate personalized therapies and improve clinical decision-making?
  3. How are evolving global regulations, public policy, and cross-sector collaboration shaping the development, commercialization, and lifecycle management of combination products, diagnostics, and advanced therapies?
  4. What strategies strengthen evidence generation, manufacturing, pharmacovigilance, and patient engagement across the development and lifecycle of precision medicines and combination products?

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