Track 6: Personalized Medicine, Combination Products, and Diagnostics
Precision medicine will combine medicine, diagnostics, and medical device technologies in unique ways to maximize healthcare services and outcomes. This track focuses on the latest precision medicine strategies used in compound selection from libraries, innovative combination products, 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 decision making. 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, 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 product development, preclinical and clinical studies, and challenges in rare and common diseases.
Priority Topics
- What’s New in the Evolving Space of Global Diagnostic Regulation)
- Medical Devices and Next Generation of Drug Delivery
- Regulatory Precision Medicine and Advanced Therapy Initiatives
- Clinical Development and Adaptive Translational Strategies
- Bioethics Landscape within Precision Medicine
- Pre-Clinical Modeling Development for Emerging Technologies
- Digital Pathology and Precision Diagnostics within Precision Medicine