Personalized medicine is a broad term that may refer to a medical model that use the characterization of individuals to tailor the right therapeutic strategy for the right person at the right time. There are three areas that must be considered when determining the impact of personalized medicine approaches on regulatory science.

• Subsetting of common conditions to rarer entities;
• Subsetting of rare conditions to ultrarare or n of 1;
• Shared molecular entity conditions;

If we are to maximize the benefits of twenty-first-century science, a common view of rare that incorporates the fast-evolving diagnostic landscape is needed. Reaching a consensus will strengthen the foundations of small-population research that can be applied to help develop novel approaches in drug development and the regulatory framework, helping to address the high unmet medical need.
 

In pharmaceutical and clinical research, effective collaboration among stakeholders is crucial for success but organizations often face challenges engaging effectively with their pathologists.  Pathologists play a pivotal role in analyzing tissue data, and their seamless interaction with pharmaceutical and research teams is vital. In this session we will discuss the use and impact of digital pathology for clinical trials.  We will highlight the importance of robust and comprehensive solutions for creating, customizing, and managing clinical trial studies using whole slide imaging, and consider data security and compliance requirements.  Finally, we will delve into the use of AI and image analysis to automate complex tasks and generate reproducible, and auditable data.
 

Whilst laboratory workflows and clinical use of digital images are significantly different between Pathology and Radiology, the potential synergies around reporting workflow management, system integration and life-cycle management are extensive. Incorporation into the Imaging Timeline and MDT workflow, all offer new opportunities to enhance clinician knowledge about patient pathologies, improve care pathways and clinical outcomes.

Using his systems knowledge and experience with PACS and Enterprise Imaging, Nick will offer insights into opportunities provided by Enterprise Imaging for Pathology - designed by pathologists for pathologists!