
Archives: Agenda
Afternoon refreshments and networking
PANEL DISCUSSION: Is clinical trial exclusion criteria too stringent?
- 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
Session reserved for Jenni Herber
The benefits of building trials, focused on patients, delivered in their own community
- 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
The 2025 Biotech Landscape: Perspectives and Projections
- Trends observed during the JP Morgan Healthcare conference
- The impact of the new administration on clinical trials
Unlocking trial success: How clinical adjudication drives sponsor and regulatory confidence in study results
- How independent adjudication improves endpoint accuracy and consistency in trials.
- Ways adjudication improves data accuracy and regulatory compliance.
- Strategies to reduce risk and streamline trial timelines.
- How to reduce variability and disputes in clinical endpoint assessments.
Chair’s closing remarks and close of stream
FIRESIDE CHAT: Successful strategies on CRO FSP management, scaling teams, and bridging low-cost offshore footprint while maintaining quality and efficiency
- Evolution of CRO FSP models
- Balancing growth and quality in a hybrid model
- The future of scaling and offshore integration
Beyond traditional labels: Customized outsourcing strategies for biotech and pharma
- Prioritizing your organizational structure and goals
- Key considerations for developing a bespoke outsourcing framework
- Building resilient outsourcing strategies that align with future clinical development needs