Cambridge Healthtech Institute’s Inaugural

Medical Device Clinical Trial Operations and Regulations

Navigating Regulations and Operational Challenges for Quality Medical Device Clinical Trials

February 19-20, 2020


The medical device industry comes with its own set of unique challenges when it comes to clinical trials, especially in light of the new medical device regulation coming out of the EU. CHI's Inaugual Medical Device Clinical Trial Operations and Regulations conference will offer insight into navigating this new regulation ahead of the May 2020 deadline, as well as insights into pre- and post-market studies. The conference will also take a deep dive into risk-based monitoring for device trials and the impact of ICH E6 R2.

Stay on and attend Part 2 (Thurs-Fri): Implementing Risk-Based Monitoring (Part 2)

Final Agenda

Tuesday, February 18

9:00 am - 7:15 pm Registration Open

2:00 - 5:00 pm User Group Meetings

2:00 - 5:00 pm The NEW SCOPE China Clinical Development Partnering Forum and The NEW SCOPE Scientific Symposium*

*Separate registration required. Must be a Best Value registered attendee.

5:00 - 6:20 pm Evening Kick-Off Plenary Keynote and Participant Engagement Awards

6:20 - 7:30 pm SCOPE’s Kick-Off Networking Happy Hour

(Co-Sponsorship Opportunities Available)

7:30 pm Close of Day

Wednesday, February 19

7:15 am Registration Open and Morning Coffee

8:15 Morning Opening Plenary Keynotes

9:40 Grand Opening Coffee Break in the Exhibit Hall

OPERATIONALIZING CLINICAL TRIALS UNDER REGULATIONS: EUROPEAN MEDICAL DEVICE REGULATION, FDA GUIDANCE, AND MORE

10:40 Chairperson’s Remarks

Jane M. Jacob, PhD, CCRP, Vice President, Research and Clinical Affairs, Orthofix, Inc.

10:45 Clinical Trials in Diabetes Medical Devices

Rohan Sonawane, Clinical Marketing Manager, Diabetes, Medtronic

This presentation will give attendees an overview of key aspects related to planning and execution of clinical trials for diabetes medical devices for insulin delivery systems. It will talk about latest guidelines update and how Medtronic has executed trials to align new product developments and approvals with the guidelines.  

11:15 INTERACTIVE PANEL: Navigating the EU MDR and Other Regulations

Bolton_JenniferJennifer Bolton, Senior Fellow, Regulatory Affairs, Boston Scientific Corporation

This panel will discuss strategies in finalizing device companies’ preparedness for the impending European Medical Device Regulation, and how this new regulation will – or will not – affect larger changes around the FDA’s regulations.

12:15 pm Sponsored Presentation (Opportunity Available)

12:45 Transition to Lunch

12:50 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:20 Coffee and Dessert Break in the Exhibit Hall

PRE- VS. POST-MARKET STUDIES

2:15 Chairperson’s Remarks

2:20 Pre- and Post-Market Studies: Addressing Challenges Unique to Medical Devices

Jacob_JaneJane M. Jacob, PhD, CCRP, Vice President, Research and Clinical Affairs, Orthofix, Inc.

Medical device studies, either pre- or post-market, are unique compared with drug studies. Knowing what those similarities and differences are, and how to tackle them, is the key to running successful studies. In this presentation, I will discuss some of the strategies I have found that work for both IDE and post-market studies in terms of site identification, qualification, start-up and follow-up, and suggest different approaches one can take to (hopefully) achieve success.

2:50 Pre- and Post-Market Studies: Use of Real Word Data (RWD)

Bolton_JenniferJennifer Bolton, Senior Fellow, Regulatory Affairs, Boston Scientific Corporation

This presentation will outline the purpose of pre- and post-market studies and why multiple types are necessary. I will provide a comparison of requirements by study type and share how real-world data and experience (RWD/RWE) could be used in both pre- and post-market studies. This presentation will highlight a case study in embedding post-market studies in national registries.

3:20 CO-PRESENTATION: Abbott EDC Portal, A Collaborative Platform for Sites and Sponsors to Manage Trials From Start-Up to Completion

Rocks_KrupaKrupa Rocks, Associate Director, Clinical Data Systems, Abbott Medical Devices Division

Corinne Vasquez, Staff Clinical Systems Analyst, Abbott Medical Devices Division

In order to successfully manage trials, both sites and sponsors require a unified, integrated platform to provide a real-time view of the status and health of studies across the different phases of trial conduct. There are several different tools available in the market today to address different needs ranging from start-up, to e-TMF, to study health dashboards but they are all disconnected and require major integration efforts. This presentation will highlight how Abbott’s new EDC Portal is aiding in addressing different operational challenges in conducting medical device pre and post market clinical trials today (site activation, securing better compliance to collect device generated data, integration with CTMS for site user account maintenance, targeted communications from the sponsor, etc.). We will also cover our plans for the introduction of Machine Learning and Cognitive Services components to achieve further automation and efficiencies in reaching remote sites in different geographies especially for post market studies.

3:50 Sponsored Presentation (Opportunity Available)

INTERACTIVE BREAKOUT DISCUSSION GROUPS

4:20 Find Your Table and Meet Your Moderator

4:25 Interactive Breakout Discussion Groups

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions. To get the most out of this interactive session and format, please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and most importantly, participate in active idea sharing.

5:10 Welcome Reception in the Exhibit Hall

6:45 Close of Day

Thursday, February 20

7:15 am Registration Open

7:45 Breakfast Presentation to be Announced

8:15 Session Break

RISK-BASED MONITORING FOR MEDICAL DEVICE TRIALS

8:20 Chairperson’s Remarks

Francois Torche, CEO, Management, CluePoints

8:25 Novel Approaches to Risk-Based Monitoring for Medical Device Trials

Wetherby_MichelleMichelle Wetherby, MS, CCRP, Associate Director, Clinical Operations, Abbott Laboratories

As organizations become increasingly savvy about the implementation of risk-based monitoring, it is critical to evaluate current practice and make adjustments accordingly. This presentation will describe one organization’s evolution in the practice of risk-based monitoring.

8:55 CO-PRESENTATION: Risk-Based Monitoring at Johnson & Johnson: From Pharma to Medical Device Clinical Trials

Clark_StephanieStephanie Clark, Director, Risk Management-Central Monitoring, Janssen R&D (J&J)


Creedon_ErinErin Creedon, Associate Director, Clinical Operations, Ethicon (J&J)

RBM has been an industry buzz word for over 6 years now, but is the methodology relevant only for pharmaceutical clinical trials? Could there be benefits for medical device studies? Join to hear how J&J is leveraging its success with RBM in pharma studies on a variety of medical device trials to learn more about global regulatory support for RBM, lessons learned from pharma and early experience with mMedical device studies, and the future of RBM in the medical device space – the realization of value.

9:25 Risk-Based Quality and Compliance Management in Clinical Trials with Combination Products

Malikova_MarinaMarina Malikova, PhD, Executive Director, Surgical Translational Research: Operations and Compliance, Boston University School of Medicine

A risk-based approach requires not only a strategy, but also tools to define key indicators to measure specific risks. As reference from the recent FDA’s and EMA’s recently updated guidelines, Key Risk Indicators (KRIs) and Key Quality Indicators (KQIs) metrics should focus on “what really matters”, and safety of research subjects and data integrity should be emphasized. Combination products, due to their specific nature, can increase risks while being tested in clinical trials. These critical metrics should be linked to particular processes within a development program for combination products.

9:55 Sponsored Presentation (Opportunity Available)

10:25 Coffee Break in the Exhibit Hall

THE ROLE OF CLINICAL DATA IN BRINGING MEDICAL DEVICES TO MARKET

11:20 Chairperson’s Remarks

Glenda Guest, President, Assured of Quality Consulting & Training

11:25 INTERACTIVE PANEL: Medical Device Pathways to Market in the US and the Role of Clinical Data

Guest_GlendaModerator: Glenda Guest, President, Assured of Quality Consulting & Training


Panelists: Chris Cain, Vice President, Clinical & Regulatory Affairs, Conformal Medical, Inc.

Additional Panelists To Be Announced

As EU Device Regulations become more harmonized with the FDA there is a greater focus on the role clinical trial data in the US. Following an overview of the major pathways to market and the role of clinical data for devices in the US (Premarket Notification, Premarket Approval, Humanitarian Device Exemptions) the panel will discuss trends, FDA’s new breakthrough device designation and global harmonization challenges. Audience participation will be encouraged.

12:25 pm Transition to Lunch

12:30 Bridging Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:00 Coffee and Dessert Break in the Exhibit Hall

2:00 Close of Conference


Stay on and attend Part 2: Implementing Risk-Based Monitoring (Part 2)

PLENARY KEYNOTES

Tuesday Evening, Wednesday Morning, Wednesday Afternoon Plenary Keynotes Featuring:

SCOPE’s 2020 Participant Engagement Award, in Memory of Jerry Matczak
Patient Perspectives as an Input to Feasibility and Clinical Trial Design
Digital Trends that Are Changing Clinical Research
Health Literacy Throughout Drug Development – Why It Matters to Pharma and to Patients
Implementing an Innovation Methodology to Accelerate Clinical Trial Innovation within Your Organization

For more details on the Plenary Keynotes: www.scopesummit.com/keynotes
For more details on the Participant Engagement Award: www.scopesummit.com/participant-engagement-award

INTERACTIVE BREAKOUT DISCUSSION GROUPS

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing: www.scopesummit.com/breakouts