Welcome and Opening Remarks

8:00AM – 8:30AM

Michael Mack and Marty Leon

Cracking the Case of EFS Site Selection

8:30AM – 9:35 AM

Moderators: Katherine Peterson and Lauren Baker

• Sponsor Perspective: Key Considerations in EFS Site Selection | Richard Dujmovic, Boston Scientific
• Site Perspective: Tips to Improve Efficiency | Katherine Peterson, Mayo
• A Tale of 3 Continents: FIH/EFS Clinical Trial Site Start-up Metrics | Chris Cain, Hyalex
• Round Table Discussion | Dalise Shatz, Banner Health University of Arizona, Margaret Kayo, HighLife Medical, Lisa Boyle, Veranex, Deborah Mange, NAMSA

Contracting Mysteries: Uncovering the Legal Clues for EFS Success

9:35 AM – 10:40 AM

Moderators: Jaime Walkowiak and Mitch Dean 

• Navigating the CTA Negotiation: Resources and Process | Barry Burgdorf (Hogan Lovells) 
• Site Perspective: Understanding Key Legal Terms and Associated Challenges | Brittany Compton (Baylor) 
• Round Table Discussion | Margaret Kayo (High Life Medical), Mitch Dean (Baylor), Amy Koski (OHSU), Kristy Oldham (Medtronic) 
• Final Words/Summary & Proposed Call to Action 

Break: 10:40 AM – 11:00 AM

Budgeting Complexities: Understanding Variability Across EFS Sites

11:00 AM – 12:15 PM

Moderators: Katherine Kumar and Amy Koski

• Site Budgeting and Financial Challenges | Lynne Goodreau (Northwestern) 
• Sponsor Perspective: Navigating Sponsor Risks  | Katherine Kumar (4C Medical) 
• Coverage Analysis | Kris Chionh (Baylor) 
• Round Table Discussion | Rahel James (Columbia), Amy Koski (OHSU) 
• Final Words/Summary & Proposed Call to Action 

Lunch: 12:15 AM – 1:00 PM

Operationalizing EFS: Designing Flexible Protocols, Overcoming Enrollment Barriers, and Optimizing EFS Execution

1:00 PM – 2:00 PM

Moderators: Kate Dalton and Sam McNeilly 

• Site Perspective: Building flexibility into Protocols to Empower Site Enrollment | Kate Dalton (Columbia) 
• Site/Sponsor Early and Ongoing Interaction – May this be the Solution? | Nicole Haratani (Supira Medical) 
• Round Table Discussion | Rahel James (Columbia), Lynett Stahl (Medtronic), Priya Jagasia (Abbott), Julie Byrne (Mayo)
• Final Words/Summary & Proposed Call to Action 

Break: 2:00 PM – 2:10 PM

Key Takeaways and Next Steps: Actionable Insights, Critical Learnings, Final Reflections

2:10 PM – 3:15 PM

• Key Takeaways Session 1: Optimizing Site Selection and IRB Efficiency for EFS | Moderators: Katherine Peterson and Lauren Baker 
• Key Takeaways Session 2: Streamlining EFS Contracting and Legal Agreements | Moderators: Jaime Walkowiak and Mitch Dean   
• Key Takeaways Session 3: Collaborative Budgeting and Financial Planning in EFS | Moderators: Katherine Kumar and Kate Dalton 
• Key Takeaways Session 4: Crafting Effective EFS Protocols Without Overburdening Sites  | Moderators: Nicole Haratani and Kate Dalton 
• Open Mic/Q&A
• Closing Remarks