Agenda

10:00 - 10:20 a.m.	Introductory Remarks Nora D. Volkow. MD, Director, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH) Suzanne Schwartz, MD, MBA, Director, Office of Strategic Partnerships and Technology Innovation, Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA)
10:20 - 10:35 a.m.	Research and Device Development Considerations for Monitoring Devices Stacie Gutowski, PhD, NIDA
10:35 - 10:50 a.m.	Regulation of Medical Devices for Opioid Use Marianela Perez-Torres, PhD, FDA
10:50 - 11:00 a.m.	Patient Science and Engagement Program and Medical Device Development Eva Rorer, MD, FDA
11:00 a.m. - 12:30 p.m.	Patient Panel: Health Effects and Daily Impacts of Opioid Use on Patients Co-moderators: Kathryn Capanna, CDRH, FDA Gioia Guerrieri, DO, CDER, FDA Patient Panel Discussion
12:30 - 1:15 p.m.	Lunch
1:15 - 2:05 p.m.	Medical Devices for Opioid Use: Challenges and Opportunities Session Planning Leads/Presentation Chair Moderators: Charles Viviano, MD, PhD, FDA Leonardo Angelone, PhD, NIDA Opportunities for Monitoring and Prevention Across the Spectrum of Opioid Use Kelly Dunn, PhD, MBA, Johns Hopkins University Clinical Outcome Assessments (COA), Biomarkers, and other Tools to Evaluate Device Performance Fraser Bocell, PhD, FDA Daniel Krainak, PhD, FDA Innovative Digital Health Technologies across the Spectrum of Opioid Use Kelly Clark, MD, MBA, Addiction Crisis Solutions Considerations for Care in Adolescent Patients Using Opioids Sharon Levy, MD, MPH, Harvard Medical School Questions and Answers
2:05 - 2:15 p.m.	*Break*
2:15 - 3:10 p.m.	Multistakeholder Panel Discussion: Scenario #1 - Preventing and Detection of Overdose in the Outpatient Setting Moderators: Vivek Pinto, PhD, FDA Leonardo Angelone, PhD, NIDA Expert Speaker on Prevention and Detection of Opioid Overdose Desislava Hite, MD, Ayuda Medical LLC Patrick Purdon, PhD, Massachusetts General Hospital, Harvard Medical School Panel Discussion Sharon Levy, MD, MPH, Harvard Medical School Desislava Hite, MD, Ayuda Medical LLC Kelly Clark, MD, MBA, Addiction Crisis Solutions Patrick Purdon, PhD, Massachusetts General Hospital, Harvard Medical School Kumar Dharmarajan, MD, MBA, Yale School of Medicine Rhonda Robinson Beale, MD, UnitedHealth Group (remote) Jeff Horwitz, Stop the Addiction Fatality Epidemic (S.A.F.E.)
3:10 - 3:20 p.m.	*Break*
3:20 - 4:15 p.m.	Multistakeholder Panel Discussion: Scenario #2 - Facilitating Remote Monitoring for Stress and Cravings Moderators: Anindita (Annie) Saha, FDA Stacie Gutowski, PhD, NIDA Expert Speaker on Stress and Cravings in Opioid Use Disorder Stephanie Carreiro, MD, UMass Medical School Scott Burwell, PhD, Neurotype Inc. Panel Discussion Kelly Dunn, PhD, MBA, Johns Hopkins University Scott Burwell, PhD, Neurotype Inc. Stephanie Carreiro, MD, UMass Medical School Kumar Dharmarajan, MD, MBA, Yale School of Medicine Rhonda Robinson Beale, MD, UnitedHealth Group (remote) Sharon Levy, MD, MPH, Harvard Medical School Jessica Hulsey, Addiction Policy Forum
4:15 - 4:30 p.m.	Closing Remarks and Day Summary Michelle Tarver, MD, Deputy Director, Office of Strategic Partnerships and Technology Innovation, Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA) Leonardo Angelone, PhD, Deputy Director, Office of Translational Initiatives and Program Innovations (OTIPI), National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)