Archives: Agenda

• Introducing design principles to support sustainability and circularity
• Discussing roadmap considerations
• Utilizing best practices from other industries
• Exploring the advantages of an end-to-end solution

• Strategic sourcing and supplier management
• Inventory management, technology and automation
• Regulatory readiness
• Risk management framework
• Solutions / considerations / cost efficiency

• Strengthening regulatory and ethical frameworks and ensuring trials follow global standards and Good Clinical Practice
• Building capacity and infrastructure, training researchers and enhancing facilities for high-quality trial execution
• Promoting data transparency and global collaboration, registering trials and sharing data to improve research outcomes
• Streamlining approval processes, speeding up trial initiation for urgent health needs while maintaining safety and compliance

• Strengthening regulatory and ethical frameworks and ensuring trials follow global standards and Good Clinical Practice
• Building capacity and infrastructure, training researchers and enhancing facilities for high-quality trial execution
• Promoting data transparency and global collaboration, registering trials and sharing data to improve research outcomes
• Streamlining approval processes, speeding up trial initiation for urgent health needs while maintaining safety and compliance

• Changing foreign relations priorities in US
• History of the US BioSecure Act, its future, and potential impact on the Pharmaceutical Industry
• US pharma industry reliance on foreign CROs and CDMOs to advance research
• Risk assessment for companies with ongoing drug development activities with a foreign CRO/CDMO

The evolving regulatory landscape following the Trump administration has introduced significant changes that continue to affect clinical trials. This session will explore the lasting impact of policy shifts on trial design, patient recruitment, and data transparency. Industry experts will discuss key regulatory updates, including FDA guidance changes, supply chain implications, and funding adjustments. Attendees are welcome to interact and discuss how these developments are shaping clinical research strategies and what steps organizations can take to ensure compliance and operational efficiency in this new environment.

• Milli Expanding Vaginal Dilator’s Regulatory Arc: Wellness to Rx to OTC
• Market told us robust clinical would support adoption—need to do fast and cheap
• Developing the study protocol and clinical operations POMPOM – Milli
• Recruitment strategies and metrics
• Remote data collection and compensation
• Baseline Data Abstract accepted by ISSWSH
• What we learned
• Future studies: lather-rinse-repeat

• Recognizing and preserving patient trust: how and why should their data be shared?
• How data sharing platforms can work for you and what are the pragmatic ways to achieving the benefits?
• Ensuring an ROI on your data: Key financial considerations of data curation
• Logistical and regulatory challenges hindering the progress of data sharing