|7:30 AM||Check-in & Continental Breakfast|
Pamela Goldberg, MBA | President & CEO, MDIC
|8:40 AM||Fireside Chat|
Acting FDA Commissioner Ned Sharpless
Nadim Yared | MDIC Board Chair and President and CEO of CVRx
Rachael Fleurence, PhD (moderator)
Harlan Krumholz, MD, SM
Jeff Shuren, MD, JD
Diane Wurzburger, JD
The National Evaluation System for health Technology Coordinating Center (NESTcc) has made strides in achieving its 2019 Strategic Priorities, including preparing for the launch of NEST 1.0 by the end of the year. This multi-stakeholder panel will highlight the strategic importance of programmatic advancements this year—NESTcc’s expanding role in active surveillance, the launch of the increased test-case portfolio, and the development of frameworks to support high-quality data and methods across the NESTcc Data Network. In addition, the panel will discuss the importance of the upcoming launch of NEST 1.0 to accept and operationalize externally sponsored projects. NESTcc Executive Director Dr. Rachael Fleurence will introduce the panel composed of NESTcc Governing Committee members and provide an overview of NESTcc advances since last year’s Annual Public Forum and the vision for NESTcc 1.0. Following Dr. Fleurence, Dr. Jeff Shuren will provide the U.S. Food and Drug Administration (FDA) perspective on NESTcc’s recent milestones, and expectations for the future through NEST 1.0. Providing the perspective of a NESTcc Network Collaborator, Dr. Harlan Krumholz of Yale-New Haven Hospital will discuss the NESTcc Data Network, as well as his perspective as a member of the NESTcc Active Surveillance Task Force. Finally, Diane Wurzburger of GE Healthcare will also discuss the expectations for the launch of NEST 1.0, along with the impact of the advancements of the Data Network for industry stakeholders.
Jijo James, MD, MPH (moderator)
Bob Pearson, Jr.
In this session the audience will learn directly from our panel of patients about what the medical device industry has gotten right about patient engagement and where they have missed the mark. The patients will share their perspectives on how the medical device industry can continue to advance the art and science of patient input.
Seth Carmody, PhD (moderator)
Mitigating cybersecurity risks to ensure device security and patient safety requires implementation of regulatory standards and industry frameworks as well as increased collaboration of multiple stakeholders on various fronts. This interactive panel comprising of leaders from medical device industry, FDA, non-profit organizations as well as independent cybersecurity professionals, will engage in discussions aimed towards sharing insights into threat analysis and mitigation best practices. The session will showcase importance of threat modeling in medical device aligned with the total product life cycle approach. The session will also provide an opportunity to learn about the recent developments on the cybersecurity premarket guidelines and global regulatory landscape.
Michael S. Waters, PhD (moderator)
Pamela Banning, MLS(ASCP)cm, PMP
Hans Buitendijk, MSc
Jonathan Nebeker, MD
Rajeev Sehgal, MBA
Timothy Stenzel MD, PhD
This panel will highlight the practical approaches taken by the SHIELD Public Private Partnership (PPP) to reduce the burdens of laboratory data stewardship and enable access to understandable, high-quality, actionable Real-World Evidence (RWE) leveraged in clinical decisions and regulatory submissions. SHIELD has focused on harmonizing the adoption/development and implementation of lab data standards to ensure that the same type of test is described the same way in electronic healthcare systems. This panel will show how each stakeholder is doing their part to enable clinical decision support and remove ambiguity from RWE. This collaborative approach data interoperability enhancement can be adopted throughout healthcare to help drive affordable innovation and dramatically reduce preventable medical error.
Companies don’t have to choose between treating people well and setting high expectations. Robert Glazer, founder and CEO of Acceleration Partners, provides a proven framework that can be applied to any organization – including those in the MedTech industry – to build a culture where employees are happy, engaged and performing at a high level.
|1:00 PM||Coverage and Analysis Group Update|
Tamara Syrek Jensen | CAG Director, CMS
Kathryn O’Callaghan (moderator)
Perry Bridger, MPH
Lindsay Bockstedt, PhD
Scott Goats, PhD
The National Evaluation System for health Technology Coordinating Center (NESTcc) announced a new slate of twelve Real-World Evidence (RWE) Test-Cases in June 2019, bringing the full portfolio to twenty Test-Case projects. NESTcc Test-Cases have a dual purpose of answering important stakeholder questions and testing the capabilities of NESTcc’s Data Network. Now, the first test-cases are launching, preliminary results will start to be submitted this fall, and lessons are being learned. NESTcc Data Network Director Dr. Robbert Zusterzeel will lead the discussion and provide an overview of NESTcc Test-Case projects, describe what they hope to accomplish, and the progress NESTcc has made since announcing the first set of projects in January 2018. Dr. Fred Resnic of Lahey Health, a NESTcc Data Network Collaborator, will showcase the experience of the data partners participating in the Test-Cases. Dr. Frances Thorndike of Pear Therapeutics and Dr. Ron Yustein of the U.S. Food and Drug Administration (FDA) will discuss the anticipated value of the Test-Cases to their organizations, both as submitting organizations with Test-Cases in the portfolio.
Chip Hance (moderator)
Liliana Rincon-Gonzalez, PhD
Andrew Farb, MD, FACC
Mark Carlson, MD
David R. Holmes, Jr., MD, MACC
Tamara Syrek Jensen
Attendees will hear outputs from data collected on EFS administration from the sponsors and sites who participate in the EFS Site Network Pilot. The session will share how the administration of EFS has evolved in the past two years since we first collected, consolidated, and updated the metrics from sponsors two years ago. The data presented will cover IRB approval timing, contracting and budgeting timing, and time to first patient enrollment. Attendees will also have an opportunity to hear about data collected from clinical sites and how other sites can employ EFS as we take a look at the number of studies performed and tools used across the site network. Panelists from industry, sites, and FDA will discuss the implications of the data presented for each of the stakeholders. This session will provide all attendees with highlights from best practices as we aim to increase first-in-world access to innovative medical devices to patients in the US.
Jon Hunt (moderator)
Jeff Shuren MD, JD
During this session, the panel will explain how CDRH and industry have worked together to develop the Framework for the Case for Quality Voluntary Improvement Program. The audience will learn how a quality maturity assessment is different than a regulatory audit and how CDRH will simplify regulatory requirements for medical device manufacturers who practice and demonstrate mature quality practices.
|3:00 PM|| BREAK |
Theodore Lystig, PhD (moderator)
Vandana Bhatia, PhD
Daniel Caños, PhD, MPH
Tina Morrison, PhD
Ram Tiwari, PhD
Jin Wang, PhD
With the issuance of FDA guidance on use of real-world evidence to support regulatory decision making for medical devices, data derived from different sources can be considered to support regulatory decisions. MDIC External Evidence Methods (EEM) program aims to develop an External Evidence framework that will catalog existing methods for leveraging data from different data sources, such as, historical clinical study data, registry data, administrative data (e.g., claims data) and computational modeling, identify existing methodological gaps, and develop new innovative methods to support the use of external data for regulatory decision making throughout the total product life cycle for medical devices. In this session, speakers will provide an overview of MDIC/FDA jointly organized EEMs Workshop held on April 2,2019 and present case studies.
Mark Carlson (moderator)
Michelle Tarver, MD, PhD
Attendees of this session will learn about methodologies for involving patients in study design to reduce barriers of participation. They will learn how to identify practices that can maximize retention and compliance of patients in clinical trials. Panelists will also provide an overview about how MDIC is partnering with CDRH and patients to advance the science of patient input.
Robbert Zusterzeel, MD, PhD, MPH (moderator)
Fred Resnic MD, MSc
Frances Thorndike, PhD
Aron Yustein, MD
Innovative Approaches Access and use of real-world data sources, such as administrative claims data and electronic health records, is increasing for the evaluation of medical devices, which is resulting in a variety of applications for payer decision-making. This panel will highlight innovative approaches of augmenting traditional clinical trial data with real-world data to generate evidence to enable payer decision-making related to coverage and payment.
|4:00 PM||CDRH Town Hall|
Nadim Yared (moderator)
Owen Faris, PhD
Jeff Shuren, MD, JD
Timothy Stenzel, MD, PhD
Michelle Tarver, MD, PhD
Bram Zuckerman, MD
Suzanne Schwartz, MD, MBA
|4:50 PM||Closing Remarks|
Pamela Goldberg, MBA | President & CEO, MDIC
|5:00 PM||Networking Reception|