Archives: Agenda
Chairperson’s opening remarks
KEYNOTE Just how complex and inefficient are our clinical trials; and what can be done about it?
- Empirical Data quantifying the magnitude of the problem
- Identification of Opportunities to optimise protocol design and improve clinical trial performance
- Case examples of strategies and their impact
PANEL DISCUSSION New strategies to drive clinical trial efficiency and complicity
- Opportunities most resonating within panel member companies
- Strategies and tactics to address these opportunities
- Implementation challenges and how to overcome them
- Areas of future focus and opportunity
Moderator: Ken Getz, Executive Director, Research Professor (PHCM), Tufts Center for the Study of Drug Development
Simulate to Succeed: The Next Generation of Clinical Trials
Harnessing the convergence of high-fidelity data with advanced AI is now essential for de-risking clinical trials and accelerating therapies to patients. What if the distance between a draft protocol and a validated study execution plan was reduced to a single, unified simulation?
Join Medidata’s Rob Buka for a deep dive into the future of holistic trial design and planning. Learn how advanced modeling and simulation capabilities within a central workspace can revolutionize trial operations. This session will illustrate Medidata’s strategy for optimizing protocol design, predicting trial outcomes, and achieving greater clinical and operational success in the next generation of drug development.
Registration and refreshments
Drinks Reception
Morning refreshments and networking
Morning refreshments and networking
Interactive Breakfast Speaker-Hosted Roundtable Discussions
With drinks and refreshments, interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Each discussion will run twice and be led by a table moderator and will focus on a different challenge within clinical trials. Roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.
| Roundtable 1 | Navigating the latest release of ICH E6 (R3): How are you carrying out gap assessments of processes and what changes are you making?
Hosted by Christina Sanchez, Director, Clinical Quality Assurance, Neurocrine Biosciences |
| Roundtable 2 | Postproduction handling and administration of biologics drugs
Hosted by Kevin Zen, Director, Opthea |
| Roundtable 3 | Collaborative solutions between Sponsors and CROs for accurate site budgeting and forecasting
Hosted by Richard Firth, Associate Director, Development Business Operations, Arcturus Therapeutics |
| Roundtable 4 | Emerging startup company trends and challenges |
| Roundtable 5 | Implications of the latest administration on clinical trial progress |