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Appendix D: Workshop Speaker Biographical Sketches
Pages 113-120

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From page 113...
... As the acting chief information officer, she oversees FDA's data and technical vision and its execution. She has held multiple executive roles at Flatiron Health and was a professor of medicine at the Duke University School of Medicine, where she ran the Center for Learning Health Care and the Duke Cancer Care Research Program.
From page 114...
... Chan develops advanced methods, digital tools, and technology platforms to derive realworld clinical and health economics evidence in collaboration with internal and external collaborators. She provides medical input to all aspects of product development at Otsuka's digital medicine division.
From page 115...
... Ritu Kapur, Ph.D., is the head of digital biomarkers at Verily Life Sciences (formerly Google Life Sciences) , a translational research and engineering organization focused on improving health care by applying scientific and technological advances to significant problems in health and biology.
From page 116...
... Oncology Center of Excellence, where he built and led the center's bioinformatics capabilities and efforts. He was also the founder of Information Exchange and Data Transformation, FDA's first data science and technology incubator for de-risking solutions through internal R&D and strategic partnerships for improving global biomedical research and advancing national public health priorities.
From page 117...
... She is a member of numerous expert and advisory boards, including the National Academy of Medicine's Leadership Consortium for a Value and Science-Driven Health Care System; Public Responsibility in Medicine and Research Public Policy Committee; Duke-Margolis Center for Health Policy Real World Evidence Collaborative Advisory Group; and International Consortium for Health Outcomes Measurement PatientReported Outcome Measures National Steering Committee. Prior to joining PatientsLikeMe she practiced as a community-based palliative and end-of-life care specialist.
From page 118...
... He also oversees Moffitt's portfolio of digital innovation, including the development and commercialization of health products, tools, and technology. With this role, Moffitt aims to create and test new services, programs, partnerships, and technologies that apply digital innovations, while challenging the status quo to reduce the cost of care, improve quality, increase access to care, and enhance the patient experience.
From page 119...
... Currently, she is concentrating on challenges to regulating and adopting artificial intelligence–enabled software as a medical device, using mHealth to collect real-world data, and characterizing real-world data quality and relevancy. Her projects have included the use of patient-generated health data in medical device evaluations, the exploration of value-based payments for medical devices, and convening the National Evaluation System for Health Technology planning board.
From page 120...
... She has co-led several research studies on how patients share information in online forums and seek out clinical trial opportunities. An early adopter of social media, she co-founded #BCSM, which attracts more than 250 global participants each week to its scheduled online discussions.


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