Archives: Agenda

• Aligning in-house capacity to outsourcing needs to ensure your biotech sticks to budget
• Understanding when it is time to outsource to ensure sufficient oversight and management of all vendors
• Looking ahead to identify your biotech needs to integrate services seamlessly into current processes

• 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

• 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

• 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

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• 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.

• 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

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• 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