Archives: Agenda

• Battling site competitiveness to reduce delays on study start-up: what can you do differently to tackle these operational challenges?
• When there are immense pressures on the trial ecosystem, how can we build quality and ensure quantity in an innovative way
• Developing an optimized strategy as a small to medium-sized biotech with limited resources to stay afloat
• Discussing the importance of protocol optimization and specialized statistical support to reduce the pressure on sites and relieve bottlenecks

Chair: Susan Edelstein, PhD, SVP, Clinical Research, Ardelyx

• Redefining hope: navigating tough conversations about disease-modifying treatments.
• Genetic testing’s unexpected role in driving patient enthusiasm for trials.
• When science outpaces understanding: bridging the gap with patients and clinicians.
• Lessons from case studies

• Designing and executing a successful RBQM framework to meet your specialized trial goals
• Sharing best practice on implementing new modern EDC systems to provide built-in validation checks and automated information checks when some CROs are lacking
• Focusing on critical data and processes by documenting risks, roles, and mitigation strategies
• Meaningful key performance indicators for RSQM

• Overcoming regulatory hurdles: How are agencies responding to new technologies?
• Ethical considerations: Ensuring patient data privacy and compliance.
• Operational barriers: Integration with existing trial frameworks (or do we need to adapt?)
• Future Outlook: What technologies will dominate in the next 5–10 years?

Chair: Joshua Cox, Vice President of Clinical Data & Analytics Capabilities, Eli Lilly and Company

• How is the industry approaching diversity and what should the primary focus be?
• Increasing accessibility to trials whilst simultaneously maintaining an appropriate level of patient safety
• Assessing the link between restrictive eligibility criteria and rates of serious adverse events to make informed decisions on expanding exclusion conditions
• Alternative solutions to improve patient numbers amidst pressures to hit recruitment milestones
• How have increased pressures of patient recruitment lead to the questioning of traditional enrollment methods?

Chair: Cathy Scharf, Patient Advocate, Patient Advocates of the East Bay