Archives: Agenda

• Navigating new regulations around clinical trials smoothly and successfully
• The impact of artificial intelligence: how far can we expect to move forward in the next 12 months?
• Patient centricity in clinical trials: how can burden be reduced in order to make trials easier for patients to participate in?
• How may geopolitical and geoeconomic events including the financial crisis, the Inflation Reduction Act and the upcoming election impact clinical trials in the US?
• Technological developments into 2025 and beyond: what changes can we expect to see in the next 3-5 years?

MODERATOR: Revati Tatake, Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare

• Examining common pitfalls in site selection for complex therapies and how data informed approaches can help sponsors overcome them
• Exploring strategies to balance sponsor preferred sites, CRO recommendations, KOL influence, and community investigators for stronger performance
• Understanding how to connect internal knowledge with external databases to drive greater accuracy and efficiency in early development
• Reviewing real world case studies that highlight innovative solutions to early phase challenges in complex therapies, from timeline management to site readiness

A look at the pros and cons of various outsourcing models including Full-Service Outsourcing (FSO), Functional Service Provision (FSP), and single service. A discussion of the benefits of a hybrid approach are explored.

• Biospecimens are foundational for all clinical trial data: they are data at an early stage
• Errors in collection, logistics, or analysis can have major impacts.
• Pre-analysis processes (requirements, collection, logistics, lab contracting, analysis, data transfer) are critical and should not be left to chance.
• Clinical Trial logistical design is increasingly complex, and errors can occur at any stage
• Compliance with evolving regulations is essential.
• Informed consent, ownership rights, and privacy are key issues.
• Transparent policies, ethical oversight, and robust tracking of samples and data are necessary
• We need to Focus on the entire lifecycle to ensure compliance and trust.

• How to keep up with rapid changes in technology?
• How do all the systems interact with each other?
• What is the ultimate goal?

• Designing the study and getting IRB permission to run it
• Site selection
• The importance of electronic data capture
• Why a sponsor’s representative must be there
• The physician’s or surgeon’s muscle memory

• Budget considerations
• In house vs outsourced
• Site relationship management
• Effective risk-based approach
• Remote vs on-site

• Non-pathogenic, non-replicative, immune protected bacteria engineered to safely deliver biologic therapeutic payloads intracellular to targeted tissues
• Bacteria capable of delivering biologics as in mRNA, siRNA, proteins/nanobodies, and CRISPR/Cas, independent of size
• Reaches tissues that cannot be targeted by viral vectors or lipid nanoparticles
• Efficiently target even hard-to-reach tissues and tumors
• Revolutionizes future of treatment by ensuring better outcomes for patients