Why Attend

Agenda

CLE

Agenda Subject to Change.
All Times are Eastern Time.

We are going virtual! To promote optimal interaction between attendees, the conference will include ample audience participation and opportunities to connect with your peers between sessions.

Digital health is revolutionizing clinical trials, creating vast innovation in areas ranging from remote monitoring, to advanced data analytics for patient selection, disease diagnosis and treatment, to use of telemedicine, and in silico trials. These advances have intertwined with various agency initiatives at the federal and state level. This panel will discuss these federal and state approaches to regulating digital health tools used in clinical trials.

 

Louisa M. Daniels, Vice President and Assistant General Counsel, Pfizer, Inc.
Leonard Sacks, Acting Deputy Director, Office of Medical Policy, CDER
Moderated by Jeffrey K. Shapiro, Director, Hyman, Phelps & McNamara, PC

10:45– 10:55 AM
Post-Session Individual Speaker Q&As
Speakers from the prior session will be available to answer specific audience questions.

11:00– 11:05 AM
FDLI Welcome 
Laura Brown, Director, Educational Programs, FDLI

This session will discuss and compare the traditional approval pathways available for software-as-medical device products, as well as significant enforcement discretion policies and exemptions, both pre-and post-COVID-19. The panel will examine how FDA’s enforcement trends during COVID-19 have expanded beyond previously delineated requirements for products such as digital health therapeutic devices for psychiatric conditions, and whether those trends are likely to continue beyond the COVID-19 pandemic. The impact of increased funding for telehealth and remote patient monitoring tools under the CARES Act will also be discussed.     

 

Michele L. Buenafe, Partner, Morgan, Lewis & Bockius LLP
Kellie B. Combs, Partner, Ropes & Gray LLP
Kyle Y. Faget, Of Counsel, Foley & Lardner LLP
Moderated by Megan Coder, Executive Director, Digital Therapeutics Alliance

11:50 AM – 12:00 PM
Post-Session Individual Speaker Q&As
Speakers from the prior session will be available to answer specific audience questions.

11:50 – 12:05 PM
Virtual Networking

12:05 – 1:00 PM
Keynote Address
Bakul Patel, Director, Division of Digital Health, Center for Device and Radiological Health (CDRH), FDA

1:00 – 1:20 PM
Lunch and Virtual Networking

This panel will examine the future of digital health regulation post-COVID. Using the example of the CLEWICU System, an AI-based software platform providing early identification of  COVID-19 complications, speakers will discuss industry strategies for gaining permanent clearance/approval for products that have emergency use authorizations (EUAs)  during COVID-19, including use of data collected under EUAs or other emergency pathways in gaining post-COVID approval.

Nathan A. Carrington, Senior Regulatory Policy Advisor, Roche Diagnostics
Sugato De, Vice President–Technical, Parexel International Corporation
Ian M. Pearson, Senior Associate, Jones Day

2:05 – 2:15 PM
Post-Session Individual Speaker Q&As
Speakers from the prior session will be available to answer specific audience questions.

2:05 – 2:30 PM
Virtual Networking

This session will discuss the “Clinical Decision Support (CDS) Software” draft guidance and its implications for use during and after the COVID-19 crisis. The panel will examine why the CDS guidance was reissued in September 2019 in draft form, and a summary of comments received. The session will also discuss the interplay between the CDS guidance and the “Policy for Device Software Functions and Mobile Medical Applications” final guidance, also issued in September 2019, and the use of CDS for monitoring of COVID-19 and related conditions, as referenced in the June 2020 “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.”

 

Sonja Fulmer, Assistant Director for Digital Health Policy, CDRH
Jessica Paulsen, Director, Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices, CDRH, FDA
Moderated by Suzan Onel, Partner, Kleinfeld, Kaplan & Becker, LLP

3:15 – 3:25 PM
Post-Session Individual Speaker Q&As
Speakers from the prior session will be available to answer specific audience questions.

3:15 – 3:30 PM
Virtual Networking

FDA’s April 2019 discussion paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD),” proposed a total product lifecycle-based regulatory approach for AI/ML-based software that would allow for modifications based on real-world learning and adaptation. What feedback has FDA received on the Discussion Paper? How is FDA’s proposed framework currently being utilized, and is it effective? This panel will also provide some practical examples and key takeaways about how AI/ML is continuing to transform healthcare at breakneck speed for both COVID-related and other therapeutic uses.

 

Bakul Patel, Director, Division of Digital Health, CDRH, FDA
Marissa Urban, Associate Product Counsel, Google Health
Moderated by Wade Ackerman, Partner, Covington & Burling LLP

4:15 – 4:25 PM
Post-Session Individual Speaker Q&As
Speakers from the prior session will be available to answer specific audience questions.

4:15 – 4:30 PM
Virtual Networking

Increasing use of digital health tools for uses such as remote monitoring, electronic health records, telehealth, and data collection requires planning for privacy and cybersecurity considerations. What are the liability considerations a company needs to consider when utilizing or launching these tools? What lessons can be learned from recent breaches? The panel will also discuss some examples of FDA-regulated COVID-19 population tracking mechanisms.

 

Stephen Evans, Assistant General Counsel, Genentech, Inc.
Carmine Jabri, President, E.M.M.A. International Consulting Group, Inc.
Moderated by Allison Fulton, Partner, Sheppard Mullin Richter & Hampton LLP

5:15 – 5:25 PM
Post-Session Individual Speaker Q&As
Speakers from the prior session will be available to answer specific audience questions.

5:15 PM
Closing Remarks and Adjournment

5:15–5:40 PM
Virtual Networking Happy Hour