Archives: Agenda

• Site assessment: evaluating available clinical and research resources and performing a gap analysis
• Centralized training for providers and research staff
• Stepwise trial implementation with frequent monitoring
• Shared resources from the academic center to support partner sites
• Improving access to oncology clinical trials in community settings

• Identifying how to use technology to enhance clinical processes
• Curbing competition by integrating technology effectively into your biotech
• Understanding when your biotech is at the right stage for technology integration

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• Navigating CRO relations as a small biotech to ensure your trial is ran successfully
• Communicating goals effectively to ensure your CRO understands and meets expectations
• Encouraging collaboration to ensure your trial is a success for all parties involved

Seats available

• Understanding regulatory expectations for adaptive clinical trial designs across all phases of development in cell and gene therapy, including current FDA and global guidance.
• Learning how to design adaptive trials that maintain compliance and data integrity, with appropriate pre-specification, statistical rigor, and documentation strategies.
• Identifying operational and regulatory challenges unique to adaptive trials, and explore best practices for real-time decision-making, monitoring, and regulator engagement.
• Applying lessons learned from real-world cell and gene therapy case studies to balance innovation, speed, and patient safety while accelerating development.

• Creating a shared understanding of clinical development and operational fundamentals for teams rooted in discovery science
• Leveraging external partners efficiently – CROs, consultants, vendors -especially when in-house experience is limited
• Building lightweight processes that educate and empower, rather than overwhelm
• Managing a “learning by doing” culture – iterative planning, open communication, and mentorship across disciplines

• Optimizing clinical research through effective technological integration
• A case study from the University of Berkeley scientists on how they’ve successfully implemented technology in drug development

• Working with both cooperative groups and biotechs in a harmonious way
• How to streamline processes and improve trial design
• Avoiding pitfalls which can have lasting global impacts
• Setting up trials for offsite patients and ensuring remote data can be obtained

• How decentralized and hybrid solutions can be used to increase patient access to clinical trials
• In-home visits have benefits for participants, sites and sponsors
• How to ensure uptake and adoption to drive global results
• What’s next for the hybrid trial model

• Overviewing the current political landscape and understanding what the impact is on small biotech’s
• Adapting to change by effectively navigating a small biotech though uncertainty
• Understanding and leveraging new start-up opportunities by reviewing investment and marketing trends