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Track 6: Translational Delivery Technologies and Precision Medicine

Preclinical and early-phase clinical research provides initial dosing and safety data for the next generation of products. This track focuses on the latest precision medicine strategies used in compound selection from libraries, utilizing biomarkers, updates on risk management safety considerations, impact to dosing strategies, next generation drug delivery, companion diagnostics and methods to improve data quality and integrity for proper downstream decisionmaking. Precision medicine is an innovative approach that considers individual differences in patients’ genes, environments, and lifestyles. Millions of people have already been touched by the area of precision medicine that has grown directly from biomedical research.

DIA recommends this track and associated sessions to professionals involved in pharmacology and toxicology, nonclinical safety testing, clinical research, clinical operations, medical devices/ combination products, biomarkers and companion diagnostics, safety and pharmacovigilance, project management, patient centricity, and statistics; formulation science, pharmacokinetics/ pharmacodynamics, epidemiology, toxicology, and regulatory affairs

Included Topic Areas

Personalized medicine, clinical trial data disclosure, collaborations, bioethics, compliance, stem cells, regenerative therapies, cell and gene therapies, gene editing, organoids/micro-physiological systems, ICH (S), study endpoints, devices and diagnostics, integration of the ‘patient’s voice’ user needs early in preclinical development to define/refine the patient population and clinical endpoints, and challenges in rare and common diseases.population and clinical endpoints, preclinical studies, and challenges in rare and common diseases. Topics related to bioethical issues are also welcome and may be considered for a special track in the meeting.

Priority Topics

  • What’s New in the Evolving Space of EU In Vitro Diagnostic Regulation (IVDR)
  • Innovative Opportunities in Dose Optimization
  • Application of Artificial Intelligence (AI) and Machine Learning (ML) in Precision Medicine
  • Disruptive Technologies in the Next Generation of Drug Delivery
  • New Concepts and Applications in Gene Editing
  • Regulatory Precision Medicine Initiatives
  • Clinical Development and Adaptive Translational Strategies
  • Digital Biomarkers utilization in Clinical Trials
  • Bioethics Landscape within Precision Medicine

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