Archives: Agenda

• 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

• 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

Data plays an increasingly critical role in the age of AI in life sciences. Using data and AI effectively can help:

• accelerate research & development by making new and larger data points easily accessible
• optimize trial design and enrolment by analyzing population and patient characteristics
• improve manufacturing efficiency and commercialization

• In-home trial delivery makes participation easier, more convenient and more accessible
• Increasing trial access to more patients by empowering and supporting a variety of community research sites
• How trial design can deliver increased recruitment and retention in a cost-effective way

• 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