Archives: Agenda

• The link between food and disease remains largely elusive
• Machine learning and food exposome knowledge provide novel research opportunities
• We integrated data on thousands of individual food compounds from different food composition databases
• Multivariate statistics (AI Random Forest model) were applied to identify food compounds that may play a role in IBD
• Compounds from dairy were found to correlate to disease remission

• Codex Alimentarius
• Food allergen risk assessment
• Global priority allergenic foods
• Mandatary and precautionary allergen declaration
• Exemptions from mandatory allergen declaration

• Streamlining processes form data inception to submission for faster and more efficient trials
• Enhancing data collection through real-time monitoring, adaptive forms, and predictive analytics for improved data quality
• Accelerating data tabulation with automated extraction, transformation, and loading (ETL) processes, reducing manual efforts
• Navigating compliance requirements for data submission through intelligent automation

• Overview how EHR to EDC technology can address common clinical data management challenges, with a demonstration of Flatiron’s EHR to EDC tool, Clinical Pipe
• Review of recent research that delves into the potential time and cost savings when using EHR to EDC technology
• Exploration of the benefits of EHR to EDC technology for clinical data managers and how to adopt in your organization

• Defining the concept of data stewardship within the context of clinical research
• Exploring patient perspectives, hopes, and concerns about research data sharing
• Fostering participant community understanding of risks and benefits of future use and sharing of clinical trial data

• Navigating the changing dynamics in data management and the imperative to align expectations with the capabilities of today’s data managers
• Recognizing the evolution towards strategic roles, including data governance, compliance, and leveraging advanced technologies
• Embracing individuals with proficiency in emerging technologies, including data analytics, machine learning, and cloud computing
• Emphasizing the importance of effective communication and collaboration between data mangers and stakeholders
• Advocating for ongoing training and professional development to keep data managers abreast of latest technologies and best practices

Join for an insightful session on the world of data governance and security for the modern biotech. In this session, we will provide invaluable insights and practical strategies to help you optimize your clinical trial operations while ensuring the security of your sensitive data. Gain insight into areas such as mastering your data, the role of data governance in life sciences, and solving challenges in implementing data governance within your organization.

• How can expanding into diverse geographies support meeting DEI regulations for trials?
• DEI in rare diseases: how to ensure your trial participants represent the overall population in trials with limited patient numbers
• Navigating FDA regulations and devising a strategy for diversity and inclusion
• Building trust and relationships with communities who may not traditionally participate in clinical trials
• Working with advocacy groups to increase trial diversity and patient numbers

MODERATOR:

Rosalie Filling, Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

PANELLISTS:

Ram Raju, Senior Vice President and Community Health Investment Officer, Northwell Health

Dija Atta, Senior Director, Clinical Operations, Incyte

Jenifer Waldrop, Executive Director, Rare Disease Diversity Coalition

Mohammed Ali, M&D Head of Reporting, Analytics and Insights, Astellas Pharma