Archives: Agenda

• 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?

• With uncertainty and constant change in the US, is the solution to look overseas for clinical trial sites?
• Working with CROs and partners overseas: assessing benefits as well as potential challenges
• Positive and negative impacts of trials abroad on clinical trial finances and budgeting
• What advantages are there of keeping trials inside the US?

MODERATOR Revati Tatake, Global Head of Pharma Research, Analysis and Competitive Intelligence, GlobalData Healthcare

• The importance of transferrable skills and assessing potential hires based on more than direct industry experience
• Challenging your mindset to expand your talent pipeline
• Integrating fresh perspectives and how this can drive innovation and broaden your knowledge
• Onboarding and supporting cross-sector hires for long term impact and retention

• Fostering transparent and constant communication with CROs and other suppliers to minimize delays and ensure timelines stay on track
• Ensuring your suppliers’ goals align with your study goals
• Monitoring CRO and supplier performance with clearly defined KPIs
• Aligning on project timelines, milestones and quality expectations from the beginning

MODERATOR
Rich Polgar, Managing Director, Danforth Advisors

• Focus of the innovation and phase of AI implementation (pilot, partial implementation, full implementation) as well as the organizational resources required to deploy the innovation
• Impact on cycle times and costs
• Key challenges to implementation and how they have been addressed by organizations
• Metrics tracked and outcomes that have resulted

• Why today’s constraints make nimbleness essential
  Innovative approaches to accelerate time to market
• Creating an ecosystem of collaborations that inspire and enable flexibility

• Understanding the provider-patient conversations: point-of-patient and provider discussions to shape trial design that is patient centric
• Survey design: creating questions focused on patient and caregiver needs during the trial and post-trial to keep patients engaged and enrolled leading to better outcomes
• Share your Rare Action: mention your post-session action to improve your process that includes rare patients, caregivers, and non-profits