ISPOR 2025

Bridging the Gap in Early Stage Clinical Research: Lessons for EU Stakeholders From the US FDA Early Feasibility Studies Program

Date: 15/05
Time: 13:45 – 14:45 (PDT)
Location: Montreal, QC, Canada
Session Type: Concurrent Breakout Session

Join us for an engaging session on Bridging the Gap in Early Stage Clinical Research: Lessons for EU Stakeholders From the US FDA Early Feasibility Studies Program. This event will explore the challenges and opportunities in early-stage clinical investigations for medical devices (MDs) and what the EU can learn from the US FDA’s Early Feasibility Studies (EFS) Program.

Moderator:

• Giuditta Callea, PhD, SDA Bocconi School of Management, Milano, Italy

Speaker:

• Kevin Drisko, Edwards Lifesciences, Irvine, CA, United States

Session Overview:

• Issue: Developing innovative, significant risk MDs often requires early-stage clinical investigations when non-clinical testing is unavailable or not informative. The US FDA’s EFS Program, established in 2013, provides guidance and oversight to MD developers while safeguarding patients. The fragmented EU regulatory system poses challenges to conducting EFS, potentially hindering innovation. This session will discuss what the EU and other global jurisdictions can learn from the FDA’s experience to facilitate safe and harmonized EFS.
• Kevin Drisko (EDW) will offer insights into the advantages of EFS as an integrated step in MD clinical evidence generation.
• Prof. Giuditta Callea will discuss the challenges of pre-market clinical research for MDs in the EU, representing multi-stakeholder perspectives and presenting findings from the HEU-EFS project.
• Audience Q&A: Prof. Callea will direct audience questions.

This session is highly beneficial for regulators, healthcare providers, patient associations, academic and research organizations, CROs, ethical and legal experts, and technology developers. Don’t miss this opportunity to gain valuable insights and engage with experts in the field. Register here!

MedTech Forum 2025

Empowering European Innovators With Early Feasibility Studies

Date: 14/05
Time: 14:10 – 15:00 (GMT+1)
Location: Lisbon, Portugal
Session Type: Parallel session

Join us for an insightful session on Empowering European Innovators With Early Feasibility Studies (EFS). This event is part of the HEU-EFS project, an initiative by the Innovative Health Initiative (IHI) aimed at developing a harmonized EU framework to enhance the uptake of EFS for medical devices across Europe. EFS are vital in the evidence-generation cycle for medical devices, and conducting these studies in a coordinated manner will bring significant benefits to patients, innovators, and the entire healthcare system.

Moderator:

• Niklas BLOMBERG, Executive Director, Innovative Health Initiative (IHI)

Speakers:

• Alexandra POULSSON, Senior Advisor, Division for Health Services, Norwegian Institute of Public Health
• Laura SAMPIETRO-COLOM, Innovation Deputy Director, Head Assessment Innovation and New Technologies Unit, Clinic Barcelona University Hospital
• Rosanna TARRICONE, Associate Dean at SDA Bocconi, SDA BOCCONI SCHOOL OF MANAGEMENT
• Fanny VAN DER LOO, Senior Director Government Affairs EMEA, Canada, Latin America, Edwards Lifesciences
• Yasemin ZEISL, Project Coordinator, European Patients’ Forum (EPF)

Don’t miss this opportunity to learn from leading experts and engage in discussions that will shape the future of medical device innovation in Europe. Register here!

ISPOR Europe 2024

[17-20 November 2024 | Barcelona, Spain] Representing the HEU-EFS project, partners from SDA Bocconi and Trinity College Dublin will present a series of poster sessions.

Subject of Debate

Innovative, high-risk medical devices can revolutionize treatment but often require numerous modifications before arriving at a final design. Addressing both the important risks and significant benefits for patients, research centres, regulatory bodies, and sponsors is crucial. The main objective of the 4-year HEU-EFS Project, funded by the Innovation Health Initiative and involving 22 public and private partners, is to develop a harmonized methodology for the uptake of Early Feasibility Studies (EFS) in the EU that mitigates risks and reinforces benefits for various stakeholders.

Poster Sessions and Presenters:

• Global Assessment of Pre-Market Approval Pathways for Medical Devices: Highlighting the Need for Harmonization across 55 Jurisdictions
  Session Time: 18 November 4:00 PM – 7:00 PM – HPR67
  Speaker: Francesco Malandrini from SDA Bocconi
• Use of Early Feasibility Studies to Inform Development of Medical Devices
  Session Time: 20 November 9:00 AM – 11:30 AM – MT58
  Speakers: Franco Luigi Zurlo from SDA Bocconi
• The EU Regulatory Framework for Medical Device Early Feasibility Studies: What Do We Know to Date?
  Session Time: 18 November 4:00 PM – 7:00 PM – HPR98
  Speaker: Majella Geraghty from Trinity College Dublin

Who Should Attend:

These poster sessions can provide valuable insights for a diverse group of stakeholders, including EU-wide and national regulators, competent authorities, notified bodies, HTA bodies, healthcare providers, patient organizations, research organizations, legal and ethical experts, CROs, and health technology developers.