Archives: Agenda

• Exploring how building authentic relationships with patients and local healthcare providers create meaningful opportunities for research participation
• Sharing how consistent engagement, education, and community-first strategies foster trust and drive better outcomes in clinical trials through real-world stories and examples from local outreach events.
• Insights into how inclusive outreach expands trial access, strengthens provider partnerships, and delivers measurable impact for both patients and sponsors

• Navigating the evolving VC landscape and investor expectations
• Leveraging funding options such as grants, strategic partnerships and government programs
• Building strong enough data to convince investors while managing with limited capital

Consistent patient engagement is vital to clinical trial success, yet dropout and non-compliance remain persistent challenges. This session introduces gamification as a scientifically grounded strategy to boost retention, enhance adherence, and streamline trial execution.

• Understand the Science: Explore the behavioral and psychological foundations that make gamification a powerful tool for sustaining patient motivation
• See Real Results: Review real-world case studies where gamification significantly improved retention, compliance, and trial timelines
• Apply Proven Methods: Learn practical strategies and best practices for integrating gamified elements into clinical trial protocols

• We’ll discuss findings from a recent study on site and patient perspectives on Direct-to-Patient shipments of investigational product.
• Explore feasibility across different treatment types, and what investigative sites see as the key benefits and drawbacks.
• Learn how shipping models like site-to-patient (STP) and warehouse-to-patient (WTP) are perceived by sites and how these influence enrollment speed, study start-up, and close-out.
• Understand how patients perceive direct-to-patient shipments, what has worked well and where common challenges arise from the patient’s perspective.

• Weighing up pros and cons of FSP vs other outsourcing models: is FSP right for your clinical trial?
• Defining the FSP model and understanding when it is the right fit for your organization
• Selecting the right FSP partners to complement internal capabilities
• Optimizing cost efficiency and scalability through flexible FSP partnerships

MODERATOR John Seman, Chief Executive Officer, Revitale Pharma

• Reviewing last year’s FDA feedback on audits: what were the main reasons for failure?
• Tips and tricks to ensure you are ready for inspection
• Simplifying processes in order to prepare for an FDA inspection

MODERATOR Leticia Tarilonte, Vice President, Head of Global Clinical Operations, Pyxis Oncology

• ow integrating cross-functional risk assessment of the feasibility process can enhance site strategy, clinical oversight, system selection(s) product solutions, and long-term trial delivery
• How to identify feasibility approaches that align with execution, not just enrollment, and how a more connected model helped de-risk a complex study
• Practical strategies to elevate feasibility from a planning task to a foundational element of trial success
• Understand the difference between traditional feasibility and true operational feasibility, and why that distinction matters
• Learn how early cross-functional risk assessments can expose delivery risks before they surface mid-study
• Discover how to align feasibility insights with cross-functional oversight, site strategy, and fit-for-purpose systems with customized solutions from the outset
• Explore how an integrated feasibility-to-delivery model can improve performance in high-complexity, high-variability trials

• Top tips for working with and supporting naïve physicians in order to ensure their success
• The importance of maintaining and growing the pool of investigator sites
• Lessons learned for the future: what should you consider when working with naïve doctors?