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Appendix B: Workshop Agenda
Pages 59-66

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From page 59...
... The miniaturization and proliferation of devices and mobile technology has led to an explosion of interest in developing tools that provide reliable, high-quality, continuous data collection from large patient populations in their natural settings and activities. The use of devices to advance research and treatment for CNS disorders holds tremendous promise, including enabling major advances in identifying prodromal and subclinical states, but also raises important technological, methodological, ethical, privacy, security, and regulatory issues.
From page 60...
... Workshop Objectives: The workshop will bring together experts and key stakeholders from academia, government research and regulatory agencies, the technology and pharmaceutical sectors, and nonprofit organizations to explore current opportunities afforded by developments in device and mobile health technology to advance research and treatment of CNS disorders. Invited presentations and discussions will: • Explore innovative approaches to using device and mobile health tech nology to predict, diagnose, monitor, assess adherence, and develop treatments for CNS disorders, including discussion of methodology, analytical techniques, and the evidence needed to validate the data for use in research and the clinic.
From page 61...
... 1:40pm Introductory Remarks STEVEN HYMAN, Stanley Center for Psychiatric Research, Broad Institute of Harvard and Massachusetts Institute of Technology, Moderator 1:50pm Speakers WILLIAM MARKS, Verily HUSSEINI MANJI, Janssen Research & Development, LLC JP ONNELA, Harvard T.H. Chan School of Public Health 2:25pm Discussion 2:50pm Break
From page 62...
... Chan School of Public Health, Moderator 3:30pm Speakers DANIELA BRUNNER, Early Signal Foundation TANZEEM CHOUDHURY, Cornell University MUNMUN DE CHOUDHURY, Georgia Institute of Technology LUÍS MATOS, Roche 4:30pm Discussion 5:30pm Adjourn Session
From page 63...
... • Examine how to "future-proof" research through the evolving Common Rule, and consider key Health Insurance Portability and Accountability Act compliance issues in research and develop ment of wearables. 8:40am Session Overview VAIBHAV NARAYAN, Janssen Research & Development, LLC, Moderator 8:50am Speakers CARLOS PEÑA, Center for Devices and Radiological Health, FDA JACQUELINE CORRIGAN-CURAY, Center for Drug Evaluation and Research, FDA STEPHEN ARNERIĆ, Critical Path Institute KRISTEN ROSATI, Coppersmith Brockelman; Past President, American Health Lawyers Association 9:50am Discussion 10:45am Break
From page 64...
... 11:00am Session Overview LINDA BRADY, National Institute of Mental Health, Moderator 11:10am Speakers DROR BEN-ZEEV, University of Washington LARA MANGRAVITE, Sage Bionetworks 11:40am Discussion 12:00pm Lunch Session 4: Designing with the Users Part 2: Patient Attitudes and Preferences Session Objectives: • Describe user/consumer attitudes and ideas related to mobile technologies -- both universal themes across different populations of people with health conditions as well as preferences and considerations specific to patients with CNS disorders. • Explore potential benefits to patients; innovative digital technologies that enable implementation of patient preferences on data ownership, access, and privacy; and use of digital technologies in patient self-management.
From page 65...
... 2:30pm Session Overview HUSSEINI MANJI, Janssen Research & Development, LLC, Co-Chair JP ONNELA, Harvard T.H. Chan School of Public Health, Co-Chair 2:45pm Panel Discussion KATIE KOPIL, The Michael J
From page 66...
... 66 HARNESSING MOBILE DEVICES FOR NERVOUS SYSTEM DISORDERS 3:45pm General Discussion 4:50pm Closing Remarks from the Co-Chairs 5:00pm Adjourn Workshop


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