Track 6: Translational Sciences and Precision Medicine
Preclinical and early-phase clinical research provides initial dosing and safety data for new drugs. This track focuses on the latest strategies used in early-stage compound selection, updates on safety considerations for both drugs and biologics, how PK/PD affects dosing strategies, and methods to improve data quality and integrity for proper downstream decision-making.
DIA recommends this track and associated sessions to professionals involved in pharmacology and toxicology, nonclinical safety testing, clinical research, clinical operations, 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, integration of the ‘patient’s voice’ early in preclinical development to define/refine the patient 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.
- Innovations in Early Development of Vaccines: Translation from Pre-Clinical to Clinical
- Diversity, Equity, and Inclusion in Early Drug Development
- What’s New in Gene Therapy
- What’s New in Gene Editing
- Innovative New Models and Methods for Medical Product Development
- Early Development Decisions and Mitigating Challenges in Rare Disease Drug Development
- Precision Medicines in Early-Phase Clinical Development
- The Microbiome Factor in Drug Discovery and Development