Digitized protocols can support more efficient workflows and help clinical operations teams accelerate trials. This interactive session will discuss the benefits of protocol digitization along with strategies and opportunities for adoption.
Learning Objectives
Learn how digital protocols can reduce the time and effort needed to manage trials from end-to-end, ultimately accelerating trials and bringing drugs to market faster. Discover how digital protocols are already driving connections and efficiencies at research sites. Understand how industry peers are addressing protocol digitization, including challenges, opportunities, and learnings.
Chair
Denise Meade, MBA
Tuesday June 17, 2025 11:40am - 12:10pm EDT TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
The session will provide an overview of FDA Diversity Action Plans and relevant implications for industry, equipping pharma and biotech professionals with essential knowledge and pragmatic guidance for navigating the evolving regulatory landscape.
Learning Objectives
Discuss key changes in recent guidance, impact on clinical trials, and trends for FDA Diversity Action Plans; Collect essential knowledge and pragmatic guidance to navigate the evolving regulatory landscape for Diversity Action Plans
Chair
Teresa Oblak, PhD
Tuesday June 17, 2025 12:20pm - 12:50pm EDT TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
This session explores evolving AI policies, governance frameworks, and the path toward harmonized AI regulation to ensure safe, ethical, and effective AI adoption in pharma.
Learning Objectives
1. Analyze key global AI regulations and their impact on pharmaceutical R&D and compliance requirements. 2. Distinguish between different regional AI regulatory frameworks and identify strategies for harmonizing AI governance across jurisdictions. 3. Apply best practices for AI risk management, ethics, and lifecycle monitoring in pharmaceutical AI implementation.
Chair
Christina Mack, PhD, MPH
Tuesday June 17, 2025 1:00pm - 1:30pm EDT TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
Currently some activities focus on accelerating rare diseases drug development by using tools and methods such as real-world data, Patient Centred Outcome measures integration, streamlined gene editing and technology transfer platforms, and innovative clinical trials designs.
Learning Objectives
To identify innovative methodologies, technologies and tools for innovative therapy development; To collaborate with an innovative Rare Disease research Ecosystem and recall its funding opportunities.
Chair
Solange Corriol-Rohou, DrMed, MD, PhD
Tuesday June 17, 2025 3:00pm - 3:30pm EDT TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
