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Virtual

Jun 23, 2021 1:00 PM - Jun 23, 2021 4:00 PM

#033P: eCOA 102: Beyond the Basics - Operational, Scientific, and Best Practices for eCOA and Wearable Devices in Clinical Trials

Instructors

Paul  O'Donohoe, MS, MSc

Paul O'Donohoe, MS, MSc

Senior Director, eCOA Product and Science, Medidata Solutions, United States

Paul O’Donohoe is Senior Director, eCOA Product and Science at Medidata Solutions, a clinical software platform provider. He is responsible for providing strategic oversight of the development of Medidata's electronic clinical outcome assessment technologies, and supporting internal teams and partners around the implementation of industry, regulatory and scientific best practices in clinical trials using mobile health technologies. He is passionate about developing the field of eCOA and mobile health through research and active involvement in industry consortia, and is currently the Industry Vice-Director of the C-Path ePRO Consortium.

Katherine  Zarzar

Katherine Zarzar

Head of Agile Execution, Patient-Centered Outcomes Research, Genentech, A Member of the Roche Group, United States

Kate Zarzar is a Principal PCOR Scientist and Head of Agile Execution focused on designing and delivering COA strategies at Roche. As head of Agile Execution, she focuses on leveraging agile methodology to improve how the business executes paper COA and eCOA strategies to generate patient-relevant evidence. Prior to joining Roche eight years ago, Kate spent six years at TransPerfect leading the design and oversight of linguistic validation programs for a variety of sponsors. Kate specializes in global cross-functional and cross-industry partnerships to drive improvement in the development and implementation of COA strategies. Kate is passionate about enabling further understanding and insight into the patient experience.

Estelle  Haenel, DrSc, PharmD

Estelle Haenel, DrSc, PharmD

Medical Director, Kayentis, France

As Medical Director at Kayentis, I aim at consolidating the medical and scientific expertise of our organization, and at securing we consider patients as partners. This is in this spirit that I proudly contribute to developing patient centric eCOA solutions, supporting digitalization of clinical trials and expanding our scientific legitimacy. I have worked in both preclinical and clinical research for more than 20 years in several big pharmas, and acted as Clinical Pharmacology Point of contact and Early Development Strategy Lead for Complex Generics for Pfizer essential Health before joining Kayentis.

Jeremy  Wyatt, MBA

Jeremy Wyatt, MBA

CEO, ActiGraph, United States

Jeremy Wyatt is the CEO of ActiGraph, a leading provider of motion-sensing wearable technology solutions for pharmaceutical and academic research. With two decades of embedded hardware systems development and related cloud technology expertise, Jeremy has a uniquely well-rounded perspective on the challenges and opportunities of deploying wearable technologies to capture accurate and meaningful data. He is a thought leader in the clinical biosensor space and frequent contributor at clinical drug development events, scientific consortiums, and regulatory meetings. Jeremy is a member and contributor to the Digital Medicine (DiMe) Society and participates in digital biomarker efforts with the Clinical Trial Transformation Initiative (CTTI).

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