- This presentation explores how AR1001 is poised to redefine the Alzheimer’s disease (AD) treatment landscape as a first-in-class, oral, disease-modifying therapy — bringing fresh momentum to a field that has seen limited progress over the past two decades
- We will delve into the scientific breakthroughs and strategic learnings gained through years of innovation and perseverance within the highly challenging global AD space
- Finally, we spotlight AriBio’s commitment to delivering the right therapy to the right patients at the right time, while upholding rigorous global regulatory and quality standards to support successful approvals in both the U.S. (FDA) and Europe (EMA)
Archives: Agenda
Registration and refreshments
Chairperson’s closing remarks
PANEL DISCUSSION: Stronger Together: Mastering Vendor Relationships for Game Changing Clinical Supply Results
| · Cultivating trust and shared value through End-to-End clinical supply chain collaboration
· Creating effective communication channels to enhance transparency and strengthen trust · Aligning incentives between sponsors and vendors to prevent supply shipment delays |
KEY NOTE: Ensuring Safe and Efficient Clinical Supply Management in Global Trials: Practical Strategies and Optimization Approaches
• Real-world challenges in IP (Investigational Product) supply management – balancing safety, compliance, and cost in global trials
• Adaptive strategies to prevent stockouts and manage variable recruitment
• Enhancing operational efficiency through optimized IRT configurations
• Leveraging modeling and simulation tools to forecast demand and reduce waste
Afternoon refreshments and networking
Streamlining Success: An Integrated Approach to Clinical Quality Assurance in Supply Chains
| · Regularly auditing suppliers and manufacturing partners to ensure compliance with regulatory standards
· Conducting regular training and workshops to align all parties on quality assurance standards and practices · Developing and maintaining detailed risk management plans |
Enhancing Drug Forecasting to Reduce Waste and Optimize Supply Chains
• Challenges in Clinical Drug Supply Management
• New Technologies in Clinical Drug Supply Management
• Global Case Studies & Best Practices
Lunch and networking
Optimizing Central Lab Supply Chains: Overcoming Logistical Barriers in Clinical Sample Management
| · Addressing challenges in collection, labeling, packaging, and international shipping
· Ensuring cold chain integrity to maintain sample viability and data accuracy · Navigating cross-border requirements, permits, and documentation delays |