Agenda for Day 3 - Wednesday 11 November, 2026Wednesday, 11 November 2026

• Explore critical lessons learned from failed and successful clinical trials

• Gain insights into improving trial design and operational processes

• Examine real world case studies to enhance future trial outcomes

• Explore how cellular therapy platforms are expanding from oncology into autoimmune diseases, leveraging translational and clinical insights across therapeutic areas

• Review the evolving clinical and study landscape, including emerging efficacy and safety data across oncology and autoimmune indications, and discuss lessons learned for future development strategies

• Examine how benefit–risk expectations, endpoints, regulatory considerations, and development paradigms fundamentally change when moving from oncology into chronic autoimmune diseases

• Address organizational challenges of working across multiple departments with different priorities and stakeholder expectations, including governance, resource allocation, manufacturing considerations, and portfolio prioritization

Australia has become a strategic launchpad for clinical innovation, with high-quality clinical data helping companies accelerate development, support regulatory submissions, attract investment, and expand into global markets. This panel will explore how Australian-generated clinical data is being used to advance products into multinational trials and international commercialisation. The discussion will showcase examples of how clinical success in Australia can serve as the starting point for global growth, reinforcing Australia's role as a gateway to international markets.

• Explore bold and innovative strategies for Phase 3 trials in rare diseases, focusing on risk-taking and challenging existing literature to achieve groundbreaking results.

• Learn how to design clinical trials that differentiate first-in-class therapeutics and position novel therapies for success.

• Discover adaptive, platform, and basket trial designs to enhance efficiency and accelerate the development of breakthrough therapies

• Explore financial barriers in clinical trials and their impact on operations

• Discuss cost-saving strategies and innovative approaches to streamline trial processes

• Highlight mission driven investments that balance capital and clinical impact

• Learn what sponsors should evaluate when choosing a CRO and what CROs need sponsors to know about managing timeline pressures and operational constraints

• Discover practical strategies for establishing transparent communication, setting realistic expectations, ensuring timely payments, and creating collaborative relationships across sponsors, CROs, and sites that ultimately serve patient needs while supporting the infrastructure required to deliver quality care