Early Feasibility Studies Best Practices Workshop

This workshop is intended to bring together the FDA, CMS, Industry, and clinical site partners to discuss how to implement EFS trials. It will provide a half day of presentations delivered by recognized thought leaders in the medical device ecosystem. The agenda will consist of lectures and engage in high level panel discussions focused on EFS in Electrophysiology.

View the Agenda Brochure!

1:00 PM Welcome

Pete Weiss, MD and Justin Klein, MD, JD

1:10 PM History of the Early Feasibility Pathway for Novel Medical Devices

Andrew Farb, MD (FDA)

1:15 PM MDIC led Transformation of the Structural Heart Regulatory Pathway: The Return of Early Feasibility Studies to the U.S.

Chip Hance or Eileen Mihas

1:20 PM Session I: The Evolving Regulatory Pathways for Novel EP Devices

Session Leaders: Ken Stein, MD and Vivek Reddy, MD

Speakers:

• Vivek Reddy, MD – “Trends in Electrophysiology Clinical Studies and the Need for an Effective Clinical Trial Ecosystem”
• Kit Schneider – “Farapulse: Clinical and Regulatory Journey”
• Ken Coffey – “An EP Startup’s Perspective on the Clinical Pathway”
• George VanHare, MD – “FDA Perspectives on Electrophysiology Clinical Studies”
• Jerome Kalifa, MD, PhD

1:55 PMOpen Discussion / Q&A

2:30 PM Break

2:45 PM Session II: EFS and the Bridge to Pivotal – Clinical Site Experience

Session Leaders Tony Hong, MD and Devi Nair, MD

Speakers

• Site Learnings: Devi Nair, MD – “Conducting Early EP Clinical Research in the U.S.: A Clinical Site Success Story”
• Site Learnings: Mass Gen – “Ambitions and challenges in conducting early research in the U.S.”
• Site Learnings: St. David’s – “Ambitions and challenges in conducting early research in the U.S.”
• Aaron Kaplan, MD – “A Sponsor’s Perspective: Utilizing the EFS Pathway for a Novel Electrophysiology Device”
• Avi Fischer, MD – “Considerations as a Study Sponsor Bringing an EFS to the U.S.”
• Holger Friedrich, MD – “Quality Enrollment is Essential, But Time is Money”

3:20 PMOpen Discussion / Q&A

3:50 PM Break

4:05 PM Session 3: Shortening Time to First Patient In: Timely and Effective Contracting

Session Leaders: Jaime Walkowiak, JD

Speakers:

• Jaime Walkowiak, JD – “Yes We Can Negotiate Contracts in 60 Days!”
• Lynne Goodreau (NMH) – “8 Successful EFS Studies and Counting at a Leading Clinical Site – It can be Done”
• Kate Dalton (Columbia) – “Institutional Alignment in a Teaching Hospital for Early Feasibility Studies”
• Brad Horst – Boston Scientific
• Randy Werneth – Maxwell
• Aneesh Deoras, FDA – “CMS Commitment to Support Early Feasibility Studies”

4:35 PM Open Discussion /Q&A

5:05 PM Wrap Up and Closing Remarks: Challenge the Audience to Meet New People at the Reception

Pete Weiss, MD and Justin Klein, MD, JD

Summary of Next Steps - Eileen Mihas

5:30 PMCocktail Networking Reception

6:30-8:30 PM Dinner Keynote Speaker Bram Zuckerman, MD

Event Venue & Nearby Stays

Omni Boston Hotel at the Seaport, 450 Summer Street, Boston, United States